Extemporaneous

Compounding-I

Pharmaceutical Compounding -I

This is a learning module prepared for Ethiopian TVET students in

pharmacy level III & IV program. The module covers important
knowledge, skill and attitude in the area of small scale
pharmaceutical compounding activities.
 Pharmaceutical Compounding -I

Preface
In response to the critical shortage of Pharmacy professionals a group of experts from
universities and colleges have developed an Outcome based TVET Model curriculum for
Pharmacy Level III & IV programs.

The outcome based curriculum was developed in reference to the level based 2014 Ethiopian
Occupational standard. The guiding principle in the development of the outcome based
curriculum was to train Pharmacy professionals in focused, time efficient and outcome based
approach, and to fill the existing pharmacy work force shortage with competent professionals.

The key features of the outcome based curriculum include the use of variety of teaching/learning
methods, repeated exposure of trainees to skill laboratories, practical attachment/cooperative
training and the delivery of the training in standardized learning modules (information sheets)
and skill lab manual/checklists (Operation sheets).

This learning module was developed by a diverse group of experts from higher teaching
institutions, experts from TVET, COC agency and professional associations.
This Basic Pharmaceutical Science I learning Module covers 3 unit of competencies in the level
III pharmacy program. The learning module covers both theoretical and practical aspects of the
competencies.

Dear Trainee, you are expected to read all the information presented in the learning module,
attempt all the self-check questions and perform skill activities as per the skill lab learning
guide/checklist.

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Table of Contents

Preface..............................................................................................................................................i

Acknowledgments..........................................................................Error! Bookmark not defined.

Table of Contents............................................................................................................................ii

Module Syllabus.............................................................................................................................iv

Module Schedule...........................................................................Error! Bookmark not defined.

1. PREPARE FOR PRODUCTION PROCESS..........................................................................1

1.1. Introduction.......................................................................................................................1

1.2. Importance ofExtemporaneous compounding..................................................................2

1.3. The compounding process................................................................................................3

1.3.1. Standards for extemporaneous compounding............................................................3

1.3.2. Equipments used in pharmaceutical compounding.................................................19

1.4. Role of Pharmacy Technicians in Extemporaneous Compounding................................27

2. QUALITY CONTROL IN PHARMACEUTICAL COMPOUNDING................................30

2.1. Introduction.........................................................................................................................30

2.2. Relationships of QA, QC & GMP..................................................................................31

2.3. Quality assurance principles...............................................................................................32

2.4. Good compounding/manufacturing practices (GCP/GMP)................................................33

2.5. Continuous quality improvement.......................................................................................34

3. OBTAIN AND PROCESS RAW MATERIALS..................................................................37

3.1. Introduction.........................................................................................................................37

3.2. Commonly used pharmaceutical ingredients......................................................................38

3.3. Packaging and pre-pack of pharmaceutical products.........................................................41

3.3.1. Pharmaceutical Packaging...........................................................................................41

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3.3.2. Packaging Types..........................................................................................................44

3.4. Inventory control................................................................................................................48

3.5. Deriving working formula from master formula................................................................49

3.6. Weighing and measuring techniques of pharmaceutical ingredients.................................51

3.6.1. Weight..........................................................................................................................51

3.6.2. Volume........................................................................................................................56

4. COMPOUNDING EXTEMPORANEOUS PRODUCTS.....................................................62

4.1. Introduction.....................................................................................................................62

4.2. Compounding methods...................................................................................................63

4.2.1. Compounding of pharmaceutical solutions.............................................................63

4.2.2. Compounding of pharmaceutical suspension........................................................122

4.2.3. Compounding of Emulsions..................................................................................136

4.2.4. Compounding of Semisolid dosage forms.............................................................148

4.2.5. Compounding of Powders.....................................................................................180

4.2.6. Compounding of Suppositories.............................................................................187

References....................................................................................................................................198

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Module Syllabus
Module title: Pharmaceutical Compounding I
Module code:PHA M4 1017
Nominal duration: 280hrs Hours

Module Description: This module aims to provide the learners with the knowledge, skills and
right attitudes required to prepare extemporaneous non-sterile pharmaceutical products from
fixed formulas
Unit of Competencies: HLT PHA 3 04 0611 Compound Small Scale Pharmaceutical Products

Module Outcomes
At the end of the module the learner will be able to:
 Prepare for production process
 Participate in quality control
 Obtain and process raw materials
 Manufacture/compound products
 Complete production process

Teaching/learning methods
o Lecture o Case study
o Demonstration and coaching o Group discussion
o Guided reading

Teaching/learning materials
o Ppt slides o Checklist
o Lecture note o IFRR format
o Compounding lab o Case scenario
o Cleaning materials o Procedure manual
o Reference book o Balance and pan
o Learning module o Audiovisuals

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 Pharmaceutical Compounding -I

o Sample packages for liquids, solids o Compounding sheet

and semisolids o Compounding sheet SOP
o Lab manual o Sample preparations
o Packaging and labeling materials

Methods of assessment
o Oral exam o MCQ
o Essay o Group/individual assignment
o Short answer o Workout
o Structured observation o Observation of product

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1. PREPARE FOR PRODUCTION PROCESS

Dear trainee, in this chapter you will learn on the general processes followed during
pharmaceutical compounding. Please follow your instructor’s interactive presentation attentively
and read this material for further understanding and be competent in preparing the compounding
process.

Objectives:
At the end of this chapter you will be able to:
 Describe the importance of extemporaneous compounding
 Outline the compounding process in extemporaneous preparations
 Clean compounding areas and equipment as per the procedure
 Maintain personal hygiene as per the product requirements
 Apply right dressing code as per the product and institutional requirement
 Identify different equipments used in extemporaneous dispensing

1.1. Introduction
Compounding is the preparation, mixing, assembling, packaging or labeling of a drug in
response to a prescription written by a licensed practitioner.
Extemporaneous compounding is defined as the timely preparation of a drug product according
to a physician’s prescription, a drug formula, or a recipe in which calculated amounts of
ingredients are made into a homogenous (uniform) mixture.

Distinguishing Compounding from Manufacturing

Compounding
- Compounding is the act of preparing, mixing, assembling, packaging, and/or labeling
a drug or device as the result of a practitioner’s prescription drug order or initiative
based on the practitioner–patient–pharmacy professional relationship in the course of
professional practice, or for the purpose of, or incident to, research, teaching, or
chemical analysis and not for sale or dispensing.

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- Compounding also includes the preparation of drugs or devices in anticipation of

prescription drug orders, on the basis of routine, regularly observed prescribing
patterns.
Manufacturing
- Manufacturing is the production, preparation, propagation, conversion, and/or
processing of a drug or device, either directly or indirectly, through extraction from
substances of natural origin or independently through means of chemical or biological
synthesis; the term includes any packaging or repackaging of the substance(s) or
labeling or relabeling of its container and the promotion and marketing of such drugs
or devices.
- Manufacturing also includes the preparation and promotion of commercially available
products from bulk compounds for resale by pharmacies, practitioners, or other
persons.

1.2. Importance of Extemporaneous compounding

Most dosage forms of medications are already pre-packaged by the manufacturer and thus the
Pharmacy professional redistributes medications and involve in the clinical aspect of Pharmaceutical
Care. In addition to this, Extemporaneous compounding is done when certain medical needs of
individual patients cannot be met by the use of an approved commercial drug product.

Reasons for Extemporaneous Compounding include;

a. Unavailable dosages, strengths and routes of commercial products
b. Dilution of adult doses of medications to Pediatric/Geriatric strengths
c. Conversion of solid dosage forms to solutions or suspensions
d. Combination of topical dermatological products not available by the manufacturer
e. Inactive ingredients of commercial products which may cause allergic reactions in
individuals

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1.3. The compounding process

During the compounding process, the compounder adheres to strict procedures to ensure the
safety of the patient for whom the extemporaneous formulation is intended. The measures
indicated below are designed to ensure that the compounding process is undertaken in a logical
and safe manner for both the intended recipient of the medication and the compounder.

Because of the diversity of the types and number of preparations that can be formulated
extemporaneously, compounder experience and expertise are significant factors in the production
of safe and effective extemporaneous formulations.

1.3.1. Standards for extemporaneous compounding

The products produced in the pharmacy must be suitable for use, accurately prepared, and
prepared in such a way as to ensure theproducts meet the required standard for quality assurance.
So although this is small-scale production, the same careful attention to detail is required as
would be found in a manufacturing [Link] following measures must be taken into
consideration when preparing a product extemporaneously.

A. Personal hygiene and protective equipment

Personal hygiene is extremely important. This is because medications are being prepared for
patients who may already be ill.

A clean white coat should be worn to protect the compounder from the product and, conversely,
the product from contamination from the compounder. During the compounding process, safety
glasses should always be worn and, depending on the nature of the ingredients to be incorporated
into the preparation, additional safety equipment (e.g. facemasks, gloves) may also be required.

It is the responsibility of the individual compounder to assess the risk posed by any
pharmaceutical ingredient and to ensure that the correct safety equipment is in use. Similarly,
long hair should be tied back and hands washed, ensuring any open cuts are covered.
(For further reference see pharmacy grooming standard and dress code in Box 1 below).

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Box 1: Pharmacy Grooming Standards & Dress Code

Professional appearance and attire helps convey an image of confidence and competence to the public.
Pharmacy Grooming Standards
Hair: Must be clean, conservatively colored, styled and neatly combed so that it will not hinder vision, work performance
or cause a safety hazard. Contact of hair with hands must be avoided.
Male: The length of the hair must not extend past the top of the shirt collar.
Female: Long hair must be pulled back off of the face.
Hands and fingernails: Are to be kept neat, clean and well-groomed at all times. For females, the length of the
fingernails shall not inhibit job functions; clear, neutral or conservative color polish may be worn, if desired.
Male facial hair: Must be clean‐shaven at all times. Sideburns shall be neatly trimmed and shall not extend more than
1/2” below the earlobe. Mustaches are permitted, provided they are neatly groomed, shaped and do not extend past the
corners of the mouth. Beards, goatees and handlebar mustaches, etc., are not permitted.
Jewelry: If worn, it should be simple and businesslike.
Male: Neck chains should be worn inside the shirt so as not to cause a safetyHazard. No earrings or visible
piercings.
Female: Necklaces should be worn inside the shirt and earrings should be kept small. No visible piercings other
than earrings.
General appearance:
Adequate personal hygiene must be maintained. Precautions need to be taken to prevent unpleasant breath or body odor.
Objectionable habits (i.e., running hands through the hair, biting nails, hands in mouth, coughing or sneezing without a
tissue) are to be avoided.
Employees should have no fashion extremes in dress or grooming (i.e., tattoos, hair color/style, and body ornamentation
visible in public view).
Visible tattoos are not acceptable and must be covered by a company approved garment.
Badge: an employee name badge must be worn on the upper left side of the uniform at all times.
Pharmacy Dress Code
Smock: A short or long sleeved, crisp, white, laundered pharmacist smock with a front zipper or buttons will be provided
and will be worn unless otherwise authorized by Regional Pharmacy Manager. Dirty or wrinkled smocks are prohibited.
Sleeve length of smock will match the sleeve length of shirt, blouse, or dress.
All clothing:
 Clothing must be clean, pressed, properly fitted and in good condition. All dress code
deviations from Classic White or Blue shirt professional attire and tie will be accompanied by
a crisp, white, laundered pharmacist smock.
 Conservative holiday accent attire is permitted such as holiday theme ties and/or shirt/blouse
pins.
Male:

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A white or solid colored professional, button front, collared dress shirt must be worn. A solid white T‐shirt may be worn
underneath the professional collared dress shirt. No decals or writing are permitted on the T‐shirt. A white cardigan or
sweater may be worn under the smock. No sweatshirts or jackets are allowed.

Female:
A white or colored professional, button front, collared dress shirt or a dress with long or short sleeves are acceptable. If
the shirt has buttons, it must be buttoned to assure a professional appearance. Avoid overly bright, potentially distracting
colors. Must be accompanied by a crisp, white, laundered pharmacist smock.

Shoes: Must be polished at all times. Polished, dark leather shoes must be worn. Athletic shoes made of all polished
leather (no fabric) are acceptable. Rubber heels should be worn for safety. No canvas shoes, saddle shoes, boating shoes,
open toe/backless shoes, or sandals are allowed.

Procedure: Hand washing

Objective: To use proper technique during hand hygiene procedures to reduce the read of infection.
Equipment Needed: sink, running water, antimicrobial liquid soap, a nail brush (or orange stick), paper towels within a
dispenser, water-based antimicrobial lotion, and a properly labeled biohazard waste container.
Step 1: Remove all jewelry.
Step 2: Turn on the water faucets with a paper towel if they are not foot-operated.
Step 3: Make sure that the water is lukewarm.
Step 4: Wet your hands.
Step 5: Apply soap and lather with a circular motion and friction, holding the fingertips downward
Step 6: Make sure to rub well between the fingers
Step 7: If this is the first time of the day you are washing your hands, use a nail brush (or orange stick) to clean under
every fingernail.
Step 8: Rinse well while holding the hands with the fingertips still pointed downward
Step 9: Repeat the scrubbing procedure a second time, for 1 to 2 minutes.
Step 10: Rinse again.

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Step 11: Dry hands with paper towels, avoiding touching the paper towel dispenser
Step 12: Turn off the water faucets with a paper towel if they are not foot-operated
Step 13: Place used towels in the biohazard waste container.
Step 14: Apply the water-based antibacterial hand lotion to prevent chapping or drying of the skin.

Exercise: Hand hygiene

Objective: To reinforce the importance of hand hygiene.
 Practice the procedure of hand washing.

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B. Clean work area and equipment

The cleanliness of the work area and equipment used during the compounding procedure is of
vital importance. The risk of contaminating the final product with either dirt or microorganisms
from the surroundings, or from ingredients from a previous preparation, can be considerable if
attention is not paid to the cleanliness of the work area and equipment. Before starting to
compound a product, the work area and equipment should be cleaned with a suitable solution
which must be allowed to dry fully. Detailed procedures and cleaning methods are presented in
below.
Procedure of Cleaning and Disinfecting
Objective: To properly clean and disinfect work areas and equipment to prevent the spread of infection.
Equipment Needed: disinfectant, cloth.
Step 1: Thoroughly rinse and/or clean items before a disinfectant is used. The foundation of manual cleaning is
friction, which loosens the organic materials and allows their removal during the rinsing process.
Step 2: When cleaning stainless steel instruments, use a back-and-forth motion to follow the grain of the instrument,
rather than a circular motion, which can scratch the surface of the item
Step 3: To avoid spotting on the instruments, dry the items immediately after rinsing

C. Appropriate work area

In addition to the cleanliness of the work area, consideration needs to be given to the work area
itself to ensure that it is suitable for its intended purpose. Both lighting and ventilation need to be
adequate. Some pharmaceutical ingredients are highly volatile and if the ventilation within the
work area is inadequate this could cause problems for the compounding staff. For additional
information, see premises standards below.

D. Label preparation
The label for any pharmaceutical product must be prepared before starting the compounding
procedure. This will enable the product to be labeled as soon as it has been compounded and
packaged, eliminating the possibility that an unlabeled product will be left on the bench. It also
reduces the possibility of the product being mislabeled and given to the wrong patient.
Reasons for having labels include;
 To give the patient clear and complete instructions on how to use the preparations.

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 To indicate the storage condition necessary to ensure full potency through the period of
treatment.
 To uniquely identify the contents of the container
 To increase patients’ compliance by giving clear and concise information about the
preparation
 To provide information about some cautions /warnings about the preparations
Requirements for labels
There are both legal and professional requirements, which must be complained between labeling
a dispensed medicine. It is the pharmacist responsibility to ensure that these requirements are
satisfies and that all labeling is accurate. The regulation indicates the standard details which must
appear on label.
Requirements for labeling compounded medicines
All labels must be type written or computer generated. The details, which must appear on the
label of a dispensed medicine, are:
 The name and address of the pharmacy
 The patient’s name
 Name of the preparation
 Quantity of the preparation
 Formula of the preparation (for unofficial preparations only)
 The strength of the preparation
 Use of the preparation
 Instructions for the patient
 The date of compounding
 Beyond used date (shelf life)
 Storage conditions
 Additional label
o Precautions
o Advise
For further details on the preparation of a suitable label, please read the table below.
Table1: Special labeling instructions for particular type of dispensed dosage form
Sr. No. Name of preparation Labeling instructions

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1 Aerosol inhalation Pressurized containers keep away from heat source.

Shake before use.
Do not exceed the prescribed dose follow the instructions
2 Applications For external use only
3 Capsules Swallow with a draught of water
4 Creams For external use only, Store in a cool place
5 Dusting powders For external use only
Not to be applied on open wound or to raw or weeping surface.
6 Ear drops For external use only
7 Emulsions Shake the bottle before use
8 Enemas For rectal use only
Shake well before use
Warm to body temperature before use.
9 Eye drops To be used in 30 days after first opening
10 Eye lotions To be used with 24 hrs after first opening
11 Gargles and mouth washes Not to be swallowed in large amounts
12 Granules To be dissolved or dispersed in water before taking
13 Inhalation Not to be taken
Shake the bottle before use
14 Nasal drops For nasal use only
15 Ointments For external use only
16 Paints For external use only
17 Pessaries for vaginal use only
store in cool place
18 Pastes For external use only
19 Solutions For external use only
20 Suppositories For rectal use only
Store in a cool place
21 Tablets
1. For soluble or dispersible tablets Dissolve or dispensed in water before taking
2. For chewable tablets Chew before swallowing
3. For sustain release, Enteric Do not crush or chew
coated or unpleasant tasting tablets
Stability and Beyond-use Dating (BUD)
 Compounding professionals should avoid ingredients and conditions that could result in
excessive physicaldeterioration or chemical decomposition of drug preparations,
especially when compounding.
 The beyond-use date is the date after which a compounded preparation is not to be used
and isdetermined from the date the preparation is compounded. Because compounded
preparations are intended for administration immediately or following short-term storage,
their beyond-use dates is assigned based on criteria different from those applied to
assigning expiration dates to manufactured drug products.

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 Compounders should consult and apply drug-specific and general stability documentation
and literaturewhen available, and should consider the nature of the drug and its
degradation mechanism, the containerin which it is packaged, the expected storage
conditions, and the intended duration of therapy whenassigning a beyond-use date.
 At all steps in the compounding, dispensing, and storage process, the compounder should
observe thecompounded drug preparation for signs of instability. However, excessive
chemical degradation and otherdrug concentration loss due to reactions may be invisible
more often than they are visible.
 In the absence of stability information that is applicable to a specific drug and
preparation, the followingmaximum beyond-use dates are recommended for non-sterile
compounded drug preparations that arepackaged in tight, light-resistant containers and
stored at controlled room temperature unless otherwiseindicated.

BUD For Non-aqueous Liquids and Solid Formulations:

 Where the compounded drug Product is the source of Active ingredient— the beyond-
use date is not later than 25% of the time remaining until the product’s expiration date or
6 months, whichever is earlier.
 Where a United States Pharmacopoeia(USP) or British Pharmacopoeia (BP) Substance is
the Source of Active Ingredient— the beyond-use date is not later than 6 months.
For Water-Containing Formulations (prepared from ingredients in solid form):
 The beyond-use date is not later than 14days for liquid preparations when stored at cold
temperatures between 2°C and 8°C (36°F and 46°F).

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For All Other Formulations:

 The beyond-use date is not later than the intended duration of therapy or 30 days,
whichever is earlier. These beyond-use date limits may be exceeded when there is
supporting valid scientific stability information that isdirectly applicable to the specific
preparation (i.e., the same drug concentration range, pH, recipients, vehicle,water
content, etc.).

E. Weighing and measuring procedure

During weighing and measuring, unless strict guidelines are followed, it can be very easy to mix
up different pharmaceutical ingredients as many ingredients resemble each other. It is preferable
to incorporate a weighed or measured ingredient into a product as soon as possible to prevent any
accidental switching. If this is not possible, when weighing or measuring more than one
ingredient, place each on a piece of labeled paper as soon as it has been weighed or measured.
This will avoid any accidental cross-over of ingredients. (For further details of Weighing and
measuring procedures and techniques read chapter three of this module and learning module of
basic pharmaceutical sciences).

F. Premises standards
The premises where an extemporaneous product is being prepared needs to be of an appropriate
standard.
 Premises’ decoration should be of a good basic standard.
 The floor should be covered but in such a manner as to be easily cleaned, surfaces should
be smooth.
 Sinks should be clean and have a supply of hot and cold water.
 There should be a functioning, clean refrigerator.
 There should be a supply of mains (potable) water.

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Premises Standards for the establishment and practice of pharmaceutical compounding in

Ethiopia are given next Page.

G. Equipment requirements
A dispensary should have sufficient equipment available in order to be able to operate
effectively. Equipment commonly required for extemporaneous compounding are described
belowunder sub title “Equipments used in pharmaceutical compounding”.

Premises Standards for the establishment and practice of pharmaceutical compounding in

Ethiopia(September 2002)
• A pharmaceutical compounding laboratory shall have adequate number of rooms suitable for
the purpose of pharmaceutical compounding.
• A pharmaceutical compounding laboratory shall have rooms of minimum sizes as indicated
below:

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• The walls, floor ceilings, and floor of a compounding laboratory shall be smooth,
have no cracks or holes.
• The walls, floor and ceilings shall be painted and/or made of washable material.
• The compounding room shall have adequate light and ventilation (ventilator, etc.)
• The compounding room should be protected from direct sunlight.
• The window(s) of the compounding room shall be high enough and sealed.

H. Avoidance of contamination
To avoid contamination of any extemporaneously prepared product, compounders should adhere
to the following guidelines:
 Ensure all equipment is clean and dry prior to use.
 Keep the dispensing area clear of unnecessary items.
 Do not leave lids off stock bottles: always replace immediately after use.
 Do not return material to stock containers once removed.
 Do not leave weighed and measured items unlabeled on the work surface.
 Do not allow raw materials or the final product to come in contact with the hands (if
necessary wear gloves).

I. Suitable record keeping

Suitable record keeping is a vital part of good extemporaneous preparation. Poor record keeping
can lead to dispensing errors which could result in the patient receiving a product other than that
intended by the prescriber. Therefore, the completion of the record will be another safety check
for the patient and is an essential part of any standard operating procedure for extemporaneous
dispensing. A suggested layout for a dispensing record sheet is given in Figure 1-2 below.

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Compound record
• Name, strength, and dosage form of the compounded preparation (CP)
• Master Formulation Record reference for the CP, when used
• Date and time of preparation of the CP
• Assigned internal identification number (e.g., prescription or lot number)
• Signature or initials of individuals involved in each step (e.g., technician or pharmacist)
• Name, vendor or manufacturer, lot number, and expiration date of each ingredient and
container-closure system
• Weight or measurement of each ingredient
• Documentation of the calculations, made to determine and verify quantities and/or
concentrations of components, if appropriate
• Documentation of quality control procedures in accordance with the SOP (e.g., filter
integrity, pH, and visual inspection)
• Any deviations from the Master Formulation Record, if used, and any problems or errors
experienced during the compounding of the CP
• Total quantity compounded
• Assigned Beyond Use Date
• Duplicate container label if prepared in a batch

A master formulation record is recommended when performing batch or high risk compounding.
The following is a Best Practice recommendation on the elements of a master formulation
record.
Master formulation record
• Name, strength, and dosage form of the CP
• Physical description of the final preparation
• Identities and amounts of all ingredients and appropriate container-closure systems
• Complete instructions for preparing the CP, including equipment, supplies, and a
description of the compounding steps
• BUD and storage requirements
• Quality control procedures (e.g., pH, filter integrity, and visual inspection)

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• Sterilization method, if applicable (e.g., filter, steam, or dry heat)

• Any other information needed to describe the operation and ensure its repeatability (e.g.,
adjusting pH and tonicity and temperature)

In addition to recording the compounding process for extemporaneously dispensed items, other
records (e.g. fridge temperatures) should be routinely recorded. Refrigerators used in pharmacies
must be capable of storing medicines between 2°C and 8°C and must be equipped with a
maximum/minimum thermometer. This should be checked each day the premises are open and
the maximum/minimum temperatures recorded to ensure that the equipment is operating
correctly and that patient safety is not compromised.

Extemporaneous record sheets should be kept for a minimum of two years, although ideally five
years would be advisable. All records and reports should be readily available in the pharmacy for
authorized inspection during the retention period. The proper recording of information is so vital
to ensuring consistent preparation of a formulation that an entire chapter is devoted to the
subject, discussing each type of record in detail.

Figure 1-1: Compounding Process Recoding Form (Compounding sheet)

Name of the dispensary/health institution __________________________Date
_______________

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Batch number/control number_____________________________ Batch

quantity______________

J. Storing or transporting the compounded product

After drugs have been compounded and repackaged, they must be properly stored. Appropriate
storage requires environmental, security, and safety considerations. Certain medications require
storage that includes freezing, refrigeration, light-protection, or room-temperature conditions.
Certain toxic chemicals should be kept inside cabinets and kept low to the ground; they should
never be stored out in the open. The proper storage of every substance in the pharmacy is the
responsibility of all pharmacy employees.

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K. Patient Counseling
Compounded prescriptions offer an excellent opportunity for patient counseling. The
compounder can explain that the particular prescription has been prepared especially for the
patient and can describe steps that are required before its administration. This occasion can also
be used to discuss other routine subjects with the patient.

In general, the common procedures in compounding of extemporaneous preparations are listed

below.
Activity: Be in groups and discuss each procedure of the compounding process.

General Procedures for Compounding

1. Receive, validate and interpret the prescription as per the Standard Operating Procedures (SOP) for
dispensing
2. Ensure that the compounding area, equipments and containers are ready for the process and don’t
compromise the quality of the final product
3. Calculate the quantity of each ingredient accurately
4. Weigh and measure the ingredients necessary for compounding of the product as per the procedures
for weighing and measuring, respectively
5. Compound the preparation following the appropriate procedure
6. Transfer to the final container, if it is not prepared in the final container, and make up to volume, if
necessary
7. Close the container and shake well as appropriate
8. Assign beyond-use date for the preparation
9. Prepare and attach a proper label on the product container
10. Clean all the equipments used for the compounding process and return to their original place
11. Clean the working table
12. Record the compounding process on the Compounding Sheet
13. Dispense the product to the patient with proper counseling
14. Record the prescription on the Compounding Prescription Registration Book

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In summary, the steps to be followed before, during, and after compounding can be grouped into
five categories: preparatory, compounding, final check, sign-off, and cleanup steps. These are
summarized in the sidebar below.
Preparatory
 Judging the suitability of the prescription in terms of its safety and intended use and the
dose for the patient.
 Performing the calculations to determine the quantities of the ingredients needed.
 Selecting the proper equipment and making sure it is clean.
 Donning the proper attire and washing hands.
 Cleaning the compounding area and the equipment, if necessary.
 Assembling all the necessary materials and ingredients to compound and package the
prescription.
Compounding
 Compounding the prescription according to the formulary record or the prescription,
using techniques of the art and science of pharmacy.
Final Check
 Checking, as indicated, the weight variation, adequacy of mixing, clarity, odor, color,
consistency, and pH.
 Entering the information in the compounding log.
 Labeling the prescription.
Sign-Off
 Signing and dating the prescription, affirming that all of the indicated procedures were
carried out to ensure uniformity, identity, strength, quantity, and purity.
Cleanup
 Cleaning and storing all equipment.
 Cleaning the compounding area.

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1.3.2. Equipments used in pharmaceutical compounding

A wide variety of equipment is used in extemporaneous dispensing, depending on the product type
to be prepared.

Mortars and pestles

Mortars and pestles are used to:
 Mix powders
 Reduce the particle size of powders
 Grind crystals into powder form and liquids
 Make emulsions.
It should be noted that the mortar is the bowl and the pestle is the pounding/shearing/grinding
implement, so compounders mix in a mortar with a pestle. In pharmacy two main types of mortar
and pestle are used:
Glass –The surfaces of a glass mortar and its pestle are very smooth, making them less
suitable for size reduction of powders, although they are efficient when grinding crystals into
powder form. Glass mortars are particularly useful when dissolving small amounts of
medicament or when incorporating substances such as potassium permanganate or dyes that
are absorbed by and stain porcelain mortars.
Porcelain – Generally much larger than their glass counterparts, these lend themselves to
larger scale production. They are ideal for the size reduction of powders for mixing powders
with other powders, for mixing powders with liquids, and for the preparation of emulsions.

Figure 1-2: Porcelain and glass mortars and pestles

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Tiles and spatula

Ointment tile or slab is the term used to describe the piece of equipment used to prepare ointments
by means of trituration or levigation. Tiles are usually made of glazed porcelain or glass and should
be large enough for the quantity of ointment to be prepared. Spatula is equipments used to pick solid
or semi solid ingredients, and also used for levigation of ointment bases with other ingredients on
tiles.

Figure 1-3: Ointment tile and spatulas.

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Stirring rods
Stirring rods are used to agitate liquids to speed up the process of dissolution of solids. These are
normally between 20 and 30mm in length and made of glass. Care must be taken not to stir too
vigorously as this may cause the stirring rod to break.

Figure 1-4: Glass Rods

Suppository moulds
Traditionally, suppository moulds come in a range of sizes: 1 g, 2 g, 4 g and 8 g. These weights are
nominal and imply calibration with Theobroma Oil BP. For accurate calibration a mould would need
to be filled with base alone, the individual suppositories formed weighed, and the mean weight taken
as the true capacity. Suppositories and pessaries are made using the same moulds when no weight is
specified a 1g mould is used for suppositories and the larger 4 g and 8 g moulds are used for
pessaries (see Figure 1-7 below).

Figure 1-5:Metal and plastic suppository moulds

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Water baths
A water bath is laboratory equipment made from a container filled with heated water. It is used to
melt or heat reagents as required. The item to be melted or heated is placed in an evaporating basin
over a water bath containing hot water and allowed to melt or get heated.
All water baths have a digital or an analogue interface to allow users to set a desired temperature.

Figure 1-6: Water bath

Weighing balances
Balance is one of important equipment used to weigh the required amount of pharmaceutical
ingredients in pharmaceutical extemporaneous preparation. Balances are differentiated each other by
the following parameters.
1. Sensitivity: Is the smallest weight that makes a perceptible change in the pointer which
indicates equilibrium.
2. Sensitivity Requirement (SR): Is the weight necessary to move the pointer of the balance
one division on the index plate against which equilibrium is observed.
3. Capacity: The maximum weight, which a balance can weigh.

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Figure 1-7: Triple beam balance and digital balance

Watch glasses
Watch glass is used as a surface to evaporate a liquid, to hold solids while being weighed, for
heating a small amount of substance and as a cover for a beaker.

Figurer.1-8:Watch glasses

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Measuring apparatus
Measuring apparatus are glass or plastic equipments used to measure different volumes of liquid
ingredients.
There are several types of measures. Some of them are the following.
Cylindrical graduatesBeakers
Conical graduates Graduated pipettes
Bottles Burette
Dropper

Figure 1-9: Cylindrical and conical graduates

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Figure.1-10: Graduated pipette

Figure 1-11: Beakers and dropper

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Box 2: How to use a pipette

1. Select a pipette that is suitable for the required volume to be measured and graduated
suitably, i.e. the one that has a maximum volume nearest to the volume to be measured.
2. Check whether the pipette is a ‘drainage’ type or ‘blow out’ variety.
3. Check that the pipette is clean and dry.
4. Attach a bulb or teat over the mouth of the pipette (never use mouth suction).
5. Pour some of the solution to be measured into a small clean, dry beaker (never pipette
from a stock bottle).
6. Insert the tip of the pipette into the liquid and suck up a sufficient amount of the liquid so
that it is well over the required volume.
7. Adjust the meniscus as required to measure the appropriate volume.
8. Remove any excess droplets of fluid on the outside of the pipette by wiping with a non-
shed disposable towel.
9. Transfer the volume required to the final container of the product.

Figure 1-12: Burettes with its holder

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Figure 1-13:Medicine bottles

1.4. Role of Pharmacy Technicians in Extemporaneous Compounding

The pharmacy technician’s role in compounding is always changing and expanding. Most
commonly, pharmacy technicians are involved in assisting compounding of extemporaneous
preparations (sterile or non-sterile)

Pharmacy technicians may participate in all of the following:

 The securing of all prescribed medications or devices from inventory.
 Measuring finished dosage forms (known as “quality sufficient” or “q.s.”)
 Collecting ingredients for preparations.
 Determining amounts of ingredients to be compounded.

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 Compounding sterile preparations using appropriate aseptic technique, equipment

 Compounding cytotoxic or other hazardous preparations.
 Disposing of hazardous or non-hazardous waste materials.
 Packaging of finished preparations.
 Generating accurate and complete labels and affixing them appropriately.
 Storing all medications correctly prior to dispensing.

Summary
Compoundingis the preparation, mixing, assembling, packaging or labeling of a drug in response
to a prescription written by a licensed [Link] compounding is important
when certain medical needs of individual patients cannot be met by the use of an approved
commercial drug product. During the compounding process, the compounder adheres to strict
procedures to ensure the safety of the patient for whom the extemporaneous formulation is
intended. The general procedures for compounding starts with receiving, validating and
interpreting of the prescription as per the Standard Operating Procedures (SOP) for dispensing.

Following different standardized steps, it ends with recording of the prescription on the
Compounding Prescription Registration Book. The products produced in the pharmacy must be
suitable for use, accurately prepared, and prepared in such a way as to ensure the products meet
the required standard for quality assurance.

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2. QUALITY CONTROL IN PHARMACEUTICAL COMPOUNDING

Dear trainee, in this chapter you will be introduced about quality control aspects of
pharmaceutical extemporaneous compounding. Please read the content carefully. After
completing this chapter, you are expected to perform quality control checks for extemporaneous
preparations.

Objectives:
At the end of this chapter you will be able to:
 Define Quality Assurance, Good compounding practice and Quality control
 Discuss quality assurance principles
 Recognize the essential elements of current good compounding practice
 Perform QC checks for extemporaneous preparations

2.1. Introduction
Quality control and assurance is designed to achieve the utmost quality, purity, effectiveness, and
safety concerning drug products. The Food and Drug Administration (FDA) has issued many
guidelines overseeing specific dosage forms and operations that include aseptic manufacturing,
stability testing, and validation. Quality system inspections are a regular part of regulatory pre-
approval programs for new drugs.

Quality control and assurance is designed to achieve the utmost quality, purity, effectiveness, and
safety concerning drug products. Inadequate quality control practices may lead to contamination
of pharmaceuticals as well as medication errors. The pharmacy professional is responsible for the
storage of all pharmaceuticals, for monitoring expiration dates, and for monitoring the
temperature of refrigerators and freezers used to store pharmaceuticals.

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Definitions
Quality Assurance: is all system which ensures activities involving planning, quality
control, quality assessment, reporting and quality improvement to ensure that a product or
service meets defined standards of quality with a stated level of confidence.

Quality control (QC): is overall system of activities concerned with sampling,

specification and testing and organization, documentation and release of procedure to
ensure the quality of the product
GMP (Good Manufacturing Practice): is part of quality assurance that ensures products
are consistently produced and controlled to the quality standard appropriate to their
intended use

2.2. Relationships of QA, QC & GMP

The three terms, QA, QC, & GMP are frequently used interchangeably, but three are real
differences as discussed above, i.e. GMP is a component of quality assurance and QC is a
component of GMP. Or GMP and QC are components of quality assurance

Figure 2-1: Relationships of QA, QC & GMP

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[Link] assurance principles

Principle: “Quality assurance” is a wide-ranging concept covering all matters that individually
or collectively influence the quality of a product. It is the totality of the arrangements made with
the objective of ensuring that pharmaceutical products are of the quality required for their
intended use. Quality assurance therefore incorporates GMP/GCP, QC and other factors,
including those outside the scope of this guide such as product design and development.

The system of quality assurance appropriate to the compounding/manufacture of pharmaceutical

products should ensure that:
a. Pharmaceutical products are designed and developed in a way that takes account of the
requirements of GMP/GCP and other associated codes such as those of good laboratory
practice (GLP)
b. Production and control operations are clearly specified in a written form and GMP/GCP
requirements are adopted
c. Managerial responsibilities are clearly specified in job descriptions
d. Arrangements are made for the manufacture, supply and use of the correct starting and
packaging materials
e. All necessary controls on starting materials, intermediate products, and bulk products and
other in-process controls, calibrations, and validations are carried out
f. The finished product is correctly processed and checked, according to the defined
procedures
g. Pharmaceutical products are not sold or supplied before the authorized persons have
certified that each production batch has been produced and controlled in accordance with
the requirements of the marketing authorization and any other regulations relevant to the
production, control and release of pharmaceutical products;

h. Satisfactory arrangements exist to ensure, as far as possible, that the pharmaceutical

products are stored by the manufacturer, distributed, and subsequently handled so that
quality is maintained throughout their shelf-life
 There is a procedure for self-inspection and/or quality audit that regularly appraises
the effectiveness and applicability of the quality assurance system

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i. Deviations are reported, investigated and recorded

j. There is a system for approving changes that may have an impact on product quality
k. Regular evaluations of the quality of pharmaceutical products should be conducted with
the objective of verifying the consistency of the process and ensuring its continuous
improvement.

2.4. Good compounding/manufacturing practices (GCP/GMP)

Good Compounding or manufacturing Practices for pharmaceutical products is that part of
quality assurance which ensuresthat products are consistently produced and controlled to the
quality standardsappropriate to their intended use. GCP/GMP is aimed primarily at diminishing
the risks inherent in any pharmaceutical production. Such risks are essentially of two types: cross
contamination (in particular of unexpected contaminants) and mix-ups (confusion) caused by, for
example, false labels being put on containers.
Under GCP/GMP:
a. All compounding or manufacturing processes are clearly defined, systematically reviewed
in the light of experience, and shown to be capable of consistently compounding/
manufacturing pharmaceutical products of the required quality that comply with their
specifications
b. Qualification and validation are performed
c. All necessary resources are provided, including:
i. Appropriately qualified and trained personnel;
ii. Adequate premises and space;
iii. Suitable equipment and services;
iv. Appropriate materials, containers and labels;
v. Approved procedures and instructions;
vi. Suitable storage and transport;
vii. Adequate personnel, laboratories and equipment for in-process controls;
d. Instructions and procedures are written in clear and unambiguous language, specifically
applicable to the facilities provided;
e. Operators are trained to carry out procedures correctly;
f. Records are made (manually and/or by recording instruments) during manufacture to show
that all the steps required by the defined procedures and instructions have in fact been
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taken and that the quantity and quality of the product are as expected; any significant
deviations are fully recorded and investigated;
g. Records covering manufacture and distribution, which enable the complete history of a
batch to be traced, are retained in a comprehensible and accessible form;
h. The proper storage and distribution of the products minimizes any risk to their quality;
i. A system is available to recall any batch of product from sale or supply
j. Complaints about marketed products are examined; the causes of quality defects
investigated, and appropriate measures taken in respect of the defective products to
prevent recurrence.

Activity: Read the principles of quality assurance and Current Good Compounding Practices

2.5. Continuous quality improvement

Before dispensing the prescription to the patient, the pharmacist should ensure the accuracy and
completeness of the compounded preparation by reviewing each step in the preparatory,
compounding, final check, and sign-off phases. In the preparatory review, the pharmacy
professional checks that all preparations for the compounding process were handled
appropriately.

Aspects to be reviewed in quality control include the following:

• Appropriate ingredients, adjuvants, and equipment were selected for the specific
preparation.
• Calculations are correct
• Measurements were performed accurately with properly functioning equipment
• The formulation is appropriate for the intended use and stability limits of the preparation

The pharmacy professionalthen reviews the compounding steps to ensure that the procedures and
techniques used to prepare the formulation were faithfully followed and appropriately
documented. This review also ensures that the formulation is reasonably aesthetic and uniform in
content.

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Thereview of the final check phase should be comprehensive. It is intended to verify the
following:
• The calculated yield is consistent with the actual yield.
• The tolerance for individual dose weight variation has been met by a sampling technique
when appropriate (e.g., capsule weight).
• The physical characteristics (clarity, color, and odor) of the preparation are consistent
with those predicted for the preparation.
• Physical tests have been performed when appropriate, and the preparation meets the test
limits.
• The preparation is suitably labeled, and the contents have been verified with the
prescription order. All legal requirements have been imprinted on the label and in the
compounding record.
• The preparation is suitably packaged for patient use, and the container that is selected
will protect the preparation from undue environmental exposure until at least the discard-
after or beyond-use date.
• Documentation is appropriate
• The patient or caregiver has been adequately informed about ways to identify obvious
evidence of instability in the compounded preparation.
• The preparation is labeled with explicit storage and administration instructions.

The compounder may also decide to submit samples of compounded preparations to an

analytical testing laboratory or test it within the pharmacy. Such analytical testing could include
dissolution rates and concentrations of compounded medications. Additional tests, assays, or
visual observations of samples of the preparation may be performed to ensure the content,
stability, pH, sterility, and non pyrogenicity.

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Summary
Quality control and assurance is designed to achieve the utmost quality, purity, effectiveness, and
safety concerning drug [Link] Assurance is all systems which ensure of activities
involving planning, quality control, quality assessment, reporting and quality improvement to
ensure that a product or service meets defined standards of quality with a stated level of
confidence.

As a part of quality assurance GMP ensures products are consistently produced and controlled to
the quality standard appropriate to their intended [Link] controlis overall system of
activities concerned with sampling, specification and testing and organization, documentation
and release of procedure to ensure the quality of the product. Pharmacy technicians participate in
quality control of extemporaneous preparations through inspection and continuous quality
improvement.

1.

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3. OBTAIN AND PROCESS RAW MATERIALS

Dear trainee, this chapter will give you important knowledge and skill about pharmaceutical
ingredients, weighing and measuring techniques which are important steps in pharmaceutical
compounding. After completing this chapter, you are expected to identify different
pharmaceutical ingredients and packaging materials. You should also acquire basic skills of
weighing and measuring techniques

Objectives:
At the end of this chapter you will be able to:
• Identity the types and uses of pharmaceutical ingredients
• Classify packaging materials based on dosage forms
• Explain the procedures for ordering and receiving pharmaceutical products.
• Derive compounding formula from the master formula
• Perform weighing of solid and semi solid ingredients as per the procedure
• Operate measuring of liquid ingredients following the procedure manual

3.1. Introduction
Drug substances are seldom administered alone; rather they are given as part of a formulation in
combination with one or more non-medicinal agents that serve varied and specialized
pharmaceutical functions. Selective use of these nonmedical agents, referred to as
pharmaceutical ingredients or excipients, produces dosage forms of various types.
Drug = API (Active Pharmaceutical Ingredient) + Non-API (Excipient)
Non-API: Material that is deliberately incorporated into the formulation to aid some
physicochemical process of drug manufacturing. It has no pharmacological action but establish
the primary features of the product Physical form, texture, stability, taste, appearance.

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3.2. Commonly used pharmaceutical ingredients

a. Pharmaceutical solvents:
Dissolve another substance in preparation. The selection of the proper solvent for a particular
solute depends on, knowledge of the chemical characteristics of drugs, Factors of solubility (size,
Temperature, pH, extent of agitation, Clarity, low toxicity, viscosity, compatibility, chemical
inertness, palatability, odor, color, and economy). The most common solvent is water.

b. Preservatives:
Prevents the formulation from chemical, physical and microbial degradation
E.g. Benzoic acid, boric acid, Sorbic acid, Benzalkonium Chloride, Phenols, Alcohols,

c. Anti-oxidant:
Prevent the degradation of a drug by oxidation. Have higher oxidative potential or inhibit free
radical-induced drug decomposition. Employed in low concentrations (<0.2%w/w).
E.g. Ascorbic acid, sodium bisulfate, sodium formaldehyde, sodium meta bisulfite

d. Buffers and pH adjusting agents:

Buffers resist changes in PH upon addition of an acid or base and adjust [Link] is composed of a
weak acid and its conjugate base or a weak base and its conjugate acid.

Buffers are added as pharmaceutical ingredient to:

• Increase comfort to the site of administration
• Render the formulation more stable
• Enhance the aqueous solubility of the drug
• Enhance the drug’s bioavailability
• Maximize preservative efficacy
E.g. Potassium metaphosphate, Potassium phosphate, monobasic Sodium acetate, Sodium
citrate (anhydrous and dehydrate).

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e. Viscosity inducing agents:

Render preparations more resistant to flowSuspensions, ophthalmic solutions, topical
creamsandoral solutions.E.g. Alginic acid, Bentonite, Carbomer, sodium carboxy methyl
cellulose, Sodium alginate, Tragacanth, glycerol etc.

f. Emulsifying agents and Surfactant:

Promote and maintain dispersion of liquid in another liquid in which it is immiscible (Suspension
and emulsion). E.g. Tragacanth, Bentonite, Polysorbate 80, Accacia,

g. Colorants:
Colorants are added to impart color to liquid and solid preparations
• For esthetics and patient compliance
• For identification
• To minimize the medication errors
• To protect the contents of the formulation
E.g. Titanium dioxide, Calamine, Azo dye, Nitroso dyes, xanthenes, Nitro dyes,

h. Flavorants and Sweeteners:

Flavorants impart a pleasant flavor and often odor for unpleasant or disagreeable taste, primarily
to liquids intended for oral administration.
Sweeteners: Impart sweetness to the preparation.
 E.g. Aspartame, Dextrose, Glycerin, Mannitol, Saccharin sodium, Sorbitol, Sucrose

i. Disintegrants: Overcome the cohesiveness imparted during compression. It increases

break up → increase surface area → increase dissolution → increase absorption
• Eg. Starch, Alginic acid, Polacrilin potassium, Sodium alginate, Microcrystalline
cellulose

j. Lubricants:
 Reduce friction during tablet compression
 Enhance the flow of the material

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 Minimize wear of the part of the machines

 Prevent fill material from sticking
 Produce tablets with sheen
E.g. Fine silica, magnesium stearate, Talc

k. Adhesives or Binders: Promote adhesion in Granules and tablets.

E.g. Acacia, Alginic acid, Carboxymethylcellulose sodium, Compressible sugar,

Ethylcellulose, Gelatin, Liquid glucose, Methylcellulose, Povidone, Pregelatinized starch,
dibasic calcium phosphate, polyvinyl pyrollidine.

l. Other pharmaceutical ingredients

 Ointment bases: Parts of an ointment which is used as a Vehicle
 Suppository bases: Vehicles for suppositories
 Gelling agents: They are ingredients that give the preparation a gel like consistency.
Some of the gelling agents used are: Tragacanth- bassorin pastes, Sodium alginate,
Pectin, Starch.
 Diluents or Fillers: Create tablet of proper size and consistency. Quantity of AI is
small or difficult to compress so that diluents and fillers are added.

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3.3. Packaging and pre-pack of pharmaceutical products

3.3.1. Pharmaceutical Packaging
All dispensed medicinal products will need to be dispensed to the patient in a suitable product
container. The function of a container for a medicinal product is to maintain the quality, safety
and stability of its contents. The outward appearance of the prescription drug package is often the
only tangible basis for a patient’s judgments of a pharmacist’s care and skill.

 Pharmaceutical Packaging is an economical means of providing presentation,

protection, identification/information, containment, convenience and compliance for
a product during storage, carriage, display and use until such time as the product is used
or administered.
 Packaging is the science, art and technology of enclosing or protecting products for
distribution, storage, sale, and use. This total time scale must be within the shelf-life of
the product, which is controlled by the selection of the right combination of product and
pack.

Pharmaceutical products generally require a standard of packaging which is superior to that of

most other products in order to support and comply with their main requirements, such as
efficacy, integrity, purity, safety, and stability.

For these reasons packaging technology should be based on the understanding of pharmaceutical
products, characteristics of formulations, and dosage forms, including the physical and chemical
properties of the drug substance.

Packaging involves various types or categories of containers. A container is defined as “that

which holds the article and is or may be in direct contact with the article”. The closure is “a part
of the container”.

Desirable qualities of a container

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 Protect the contents from physical and mechanical hazards. i.e. Vibration, compression,
shock, abrasion, punctures etc.
 No reaction with the content
 Should not release any chemical
 No adsorption of the product
 Should not impart taste or odors and not shed the particles
 Should be nontoxic
 Should give convenient and easy with drawl of the required dose
 Be capable of withstanding extremes of temperature and humidity.
 Protect the contents from both water loss and gain.
 Protect the content from loss of volatile materials.
 Be sufficiently transparent to permit the inspection of the content. This may be
impracticalfor drugs sensitive to light.
 Be easy to label and thus to identify the product.
 Be cheap and economical.
 Adoptable to certain high speed filling equipment

The purposes of packaging and package labels

 Protection: is almost invariably the most critical factor as it controls the total shelf-life of the
product.
 Physical protection - The objects enclosed in the package may require protection
from shock, vibration, compression, temperature, etc.
 Reduce costs due to breakage
 Protect the product in transit: for example, breakable or perishable items such as
injections, bottles
 Protect the product on the shelf: from theft, damage or tampering
 Barrier protection - A barrier from oxygen, water vapor, dust, etc., is often
required.
Permeation is a critical factor in design. Some packages contain desiccants or
oxygen absorbers to help extend shelf life.

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Keeping the contents clean, fresh, sterile and safe for the intended shelf life is a primary
function.
 Containment or agglomeration - Small objects are typically grouped together in one
package for reasons of efficiency as well as for ease of handling and transport.
E.g. Liquids, powders, and granular materials need containment
 Informationtransmission - Packages and labels communicate how to use, transport, recycle,
or dispose of the package or products. Some packages and labels also are used for tracing
purposes.
 Marketing - The packaging and labels can be used by marketers to encourage potential
buyers to purchase the product.
 Security - Packaging can play an important role in reducing the security risks of shipment
Packages can be made with improved tamper resistance to deter tampering and also can have
tamper-evident features to help indicate tampering. Packages can be engineered to help
reduce the risks of package pilferage: Some package constructions are more resistant to
pilferage and some have pilfer indicating seals.

Packages may include authentication seals and use security printing to help indicate
that the package and contents are not counterfeit. Packages also can include anti-theft
devices, such as dye-packs or electronic article surveillance tags that can be activated or
detected by devices at exit points and require specialized tools to deactivate.
 Convenience - Packages can have features that add convenience in distribution, handling,
stacking, display, sale, opening, reclosing, use, dispensing and reuse.
 Offer consumer safety: warn of hazards due to improper use of dangerous substances (such
as the information on cigarette packaging) or design considerations (such as not standing on
the top step of a ladder).

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3.3.2. Packaging Types

Packaging may be described in relation to the type of product being packaged: medical device
packaging, bulk chemical packaging, over-the-counter drug packaging, pharmaceutical
packaging, etc. It is sometimes convenient to categorize packages by layer or function:
"primary", "secondary", or tertiary.

i. A primary pack (container)

It consists of those packaging components that form the part of the pack directly containing the
product (i.e. bottle, cap). Itis that which is in direct contact with the product. The purpose is to
provide the product protection from the environment during storage and handling. The main
functions of the primary pack are to contain and to restrict any chemical, climatic or biological or
occasionally mechanical hazards that may cause or lead to product deterioration.

Because the primary pack also represents the pack of 'use', it must also function in the hands of
the user as a means of drug administration. Primary packages are primarily made of glass,
plastic, single or laminated flexible material, and metal.
Examples of primary packaging materials include: Containers, Ampoules, Vials, Dosing dropper,
Closures (plastic, metal), Syringe, Strip package, Blister packaging

Figure 3-1: Primary packs

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ii. Secondary packaging

This is not in direct contact with the product but does provide product stability protection. This
include an over-pack, over-wrap or pouch to provide moisture, gas, light or microbial protection
that is not provided by the primary container

It may be used for the final market presentation of the product, often used to carry the required
labeling for the product. It can also provide protection against damage in the handling and
distribution system.

Figure 3-2: secondary pack

iii. Tertiary packaging

It is used for bulk handling, warehouse storage and transport shipping. The most common form
is a palletizedunit load that packs tightly into containers.

Figure 3-3: Tertiary pack

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The USP classifies containers according to their ability to protect their contents from external
conditions as follows.
 A well-closed container: protects the contents from extraneous solids and from loss of
the article under the ordinary or customary conditions of handling, shipment, storage and
distribution.

 A tight container: protects the contents from contamination by extraneous liquids, solids
or vapors, from loss of the article, and from efflorescence, deliquescence, or evaporation
under the ordinary or customary conditions of handling, shipment, storage and
distribution and is capable of tight re-closure.

 Hermetic sealed containers: are impervious to air or any other gas under pharmaceutical
preparations. Sterile hermetic containers generally hold preparations intended for
injection or parenteral administration. Hermetic sealed containers may be:
 Single dose containers in which the quantity of sterile drug contained is intended as
a single dose and which once opened cannot be resealed with assurance that sterility
has been maintained. These containers include fusion sealed ampoules and prefilled
syringes and cartridges
 Multi dose container permits withdrawal of successive portions of the contents
without changing the strength or endangering the quality or purity of the remaining
[Link] containers are commonly called vials.

 A light–resistant container: protects the contents from the effects of light by virtue of
the specific properties of the material of which it is composed. Another option is to make
a clear and colorless or translucent container light-resistant by an opaque covering.
Agents termed ultraviolet absorbers may be added to plastic to decrease the transmission
of short ultraviolet rays.

 Tamper evident containers: are closed containers fitted with a device that irreversibly
indicates if the container has been opened.

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 Pharmaceutical compounding I

 Child resistant containers: A child-resistant container is defined as one that is

significantly difficult for children under 5 years of age to open or to obtain a harmful
amount of its contents within a reasonable time and that is not difficult for “normal
adults” to use properly. They are designed to prevent the child accessing the potentially
hazardous product.

 A single-unit package: is termed a unit dose package. The single-unit packaging of

drugs may be performed on a large scale by a manufacturer or distributor or on a smaller
scale by the pharmacy dispensing the medication. In either instance, the single-unit
package must be appropriately labeled with the product identity, quality and/or strength,
name of manufacturer, and lot number to ensure positive identification of the medication

 Strip packs: have at least one sealed pocket of material with each pocket containing a
single dose of the product. They are common ways of unit packaging of a solid drug
formulation. The packaging materials may be combinations of paper, foil, plastic, or
cellophane.

 Pressurized packs (aerosol containers): are also available which expel the product
through a valve.

 Original packs are pharmaceutical packs that are commercially produced and intended
for finite treatment periods. It is always good practice to dispense medication to patients
in the same type and quality of container as that used by the manufacturer.

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3.4. Inventory control

Role of the Technician in Inventory
The responsibilities of pharmacy technicians in inventory control include:
• Following the policies and procedures of inventory control.
• Providing accurate inventory records.
• Determining sources of pharmaceutical products.
• Identifying and ordering needed pharmaceutical products.
• Receiving and storing pharmaceutical products.
• Removing obsolete or expired products.

Procedures for ordering and receiving raw materials

Receiving
Pharmacy personnel must follow the pharmacy’s procedures for receiving raw materials. The
supplier includes an invoice, which is a listing of the items. The invoice must be checked item by
item against the items to make sure that nothing is missing, and that there are no items included
that were not ordered. After this, you may document the receipt of goods by entering the
information into a computer, or by scanning bar codes.

Returning Items
After checking all items against the orders that you receive, you may find that some items are
defective; some products are expired, or more than needed. The pharmacy technician must use
appropriate return forms when returning goods. On a return form, the followinginformation must
be included:
• Original purchase order (P.O.) number
• Item number
• Quantity
• Reason for return
Similar procedures are followed for obtaining and returning raw materials for compounding.
IFRR form is used for this purpose.

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3.5. Deriving working formula from master formula

As a result of the requirement of consistency when compounding, formulas (standards of
compounding) should be strictly adhered to in assuring that the proper preparation methods and
ingredients are used for each compounded product. These standards ensure batch-to-batch
consistency and a documented process of work flow to reduce future errors. Documentation can
be made on formula worksheets or “logs.” Reviews of the techniques used in compounding may
be made regularly to improve quality.

A master formula sheet may be used to document information about each formulation that is
used in the pharmacy. These sheets commonly contain:
• Information about the ingredients of a formulation
• Its manufacturer
• Lot number(batch number)
• The manufacturer’s expiration date
• The formula quantity
• The quantity used
• Preparation date
• The compounder name and
• The person who checked it for accuracy.
These sheets also usually contain the required equipment for formulating, manufacturing
directions, description of the final appearance of the mixture, information that will appear on its
label, and a description of the length it will be stable.

Based on the information on the compounding sheet, the pharmacy technician should take
appropriate amounts for compounding, i.e. apply reducing or enlarging formulas to get the
required amount of compounding ingredients.

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 Pharmaceutical compounding I

Exercise: be in groups and practice how to derive working formula for compounding from the master formula

Preparation of boric acid ointment National Formulary (NF)

Example label (it is assumed that the name and address of the pharmacy and the words 'Keep out ofthe reach and sight of
children' are pre-printed on the label):
Compound Boric acid ointment NF
Product directions.
For external Use Only
Do not use after (3 months)
Patient name Date of dispensing
________________ _____________________

Product formula (National Formulary):

Boric acid Ointment, NF
Boric acid, in very fine powder----------------100g
Liquid petrolatum ------------------------------- 50g
Whit ointment ----------------------------------- 850g
Send: 30g

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 Pharmaceutical compounding I

3.6. Weighing and measuring techniques of pharmaceutical ingredients

In chapter one of this module, you have learnt that weighing and measuring of pharmaceutical
ingredients is one of the major steps in compounding process. In this chapter, you will discuss
the detail techniques of weighing and measuring procedures.

3.6.1. Weight
Weight is measured by means of a balance. In dispensing (hospital and community pharmacies)
the type of balance used is called prescription balance.
Forcompounding purpose, usually we use the following two types of prescription balances.
• Beam balance
• Digital balance
Cares that should be taken in weighing are the following.
• Keep the balance in a place where there is no environmental disturbance (Vibration, dust,
moisture, wind, etc.)
• Keep the balance cover down except when the balance is in use.
• Use powder papers or watch glasses to prevent direct contact of the pan(s) and the
material to be weighted.
• Support the pan(s) when weights and materials are added or removed.
• Handle weights only with forceps
• Adjust the scale to perfect balance (0 positions) before each weighting.

Procedures for Weighing techniques

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 Pharmaceutical compounding I

1. Select a balance with appropriate capacity and sensitivity.

2. If weighing a solid material which requires being size reduced (ground) or sieved, always ensure
that this iscarried out before weighing.
3. Ensure that the balance is clean, dry and working properly
4. Put the balance on a level, non-vibrating and clean table
5. Adjust the balance, put the container for the material to be weighed and weigh it (to deduct from
the final total weight) or use auto-zero to cancel its weight. Grease-proof papers should be used
for weighing ofsemisolids.
6. Read carefully the label of the material to be weighed (check name, strength, expiry date)
7. Check the appearance and any sign of stability problems.
8. Add the material to be weighed on to the container using spatula until the correct weight is
obtained, close the container and return to the original place
9. Carefully remove the weighed material and transfer to the suitable container
10. Clean the balance and its accessories.
11. Return the balance and its accessories to the original place
12. Clean the working table

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 Pharmaceutical compounding I

Skills practice session 3-1

Weighing of zinc oxide BP and white soft paraffin on beam balance

Purpose: The purpose of this activity is to enable you to practice weighing techniques of solid
and semi solid ingredients

Instruction
1. Weigh 2.5g and 10g of zinc oxide BP
2. Weigh 5gWhite soft paraffin using beam balance

Resources (equipment tools and materials)

Chemicals/Ingredients
 zinc oxide
 Liquid paraffin.
Equipment/Tools

 beam balance
 spoon spatula
 weighing paper/watch glass/greasy proof paper

(To be completed by students/Peers)

Rate the performance of each step or task observed using the following rating scale:
1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary), or is
omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if necessary) but
participant/student does not progress from step to step efficiently
3. Proficiently Performed: Step or task performed efficiently and precisely in the proper sequence
(if necessary)

** You will only be competent when you efficiently perform all the steps

Procedure-learning guide/checklist
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 Pharmaceutical compounding I

Rate
[Link] Step/Task
Proficiently Competently Needs Remark
Performed Performed Improvement

1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Select a balance with
appropriate capacity and
sensitivity
6 Check that the balance is clean
and dry
7 Put the balance on a level, non-
vibrating and clean table and
adjust the it
8 put the container for the
material to be weighed and
weigh it (to deduct from the
final total weight) or use auto-
zero to cancel its weight
9 Using a spatula, transfer, 10 g
of Zinc Oxide BP to the paper/
watch glass. Check the weight,
check the ingredient.
Repeat the same procedure for
10g of white soft paraffin by
using watch glass/greasy proof
paper
10 Transfer the weighed zinc
oxide and a to its respective
packages and label it(repeat the
same procedure for white soft

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 Pharmaceutical compounding I

paraffin )
Return the stock pot to the
shelf.
13 Clean the working equipments
and the surroundings
15 Complete recordings and
documentation
16 Store the weighed zinc oxide
to an appropriate place

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 Pharmaceutical compounding I

3.6.2. Volume
An important factor in the accuracy of an instrument used for measuring volume is the surface
area of the liquid in it. Accuracy increases as surface area decreases. However, a decrease in
surface area decreases the convenience of transferring a liquid to and from the instrument.
Therefore, accuracy and convenience should be compromised. Volume is measured by using
measures.
Volumetric flasks Meniscus- The volume under the horizontal tangent touching the lowest
point of the surface is the meniscus volume.

Figure 3-6: Meniscus reading in measuring volumes

Techniques of measuring liquids with regard to graduates:

Pharmaceutical graduates are available in both cylindrical and conical varieties. Cylindrical
graduates are generally considered to be more accurate than conical graduates. The following
steps will help to maximize accuracy when using cylindrical or conical graduates.
 Hold the selected graduate at the bottom with the thumb & the forefinger and support in on
the curved middle finger of the left hand (for a right handed person). And elevate the
graduate so that the desired mark is at eye level.
 Hold the stock bottle with the right hand (label face up), and remove the stopper of the bottle
with the little finger of the left hand.
 Pour the liquid to be measured into the center of the graduate, to avoid error resulting from
the adherence of material to the wall (especially with viscous liquids like glycerol).
 As the surface of the liquid approaches the desired mark, decrease the flow rate or use a
dropper or pipette to bring to final volume. The final volume should be determined by

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aligning the bottom of the meniscus with the desired graduation mark. If the liquid is densely
colored or opaque, such as a suspension, the top of the meniscus should be read.
 Transfer the liquid from the graduate to the appropriate vessel or container, allowing about
15 seconds for aqueous and hydro-alcoholic fluids to drain. Approximately 60 seconds (or
more) are required for more viscous liquids such as syrups, glycerin, propylene glycol, and
mineral oil to drain.

Always select the smallest device (graduate, pipette, and syringe) that will accommodate the
desired volume of liquid. This will minimize the potential for errors of measurement associated
with misreading the scale.

Use a graduated pipette, syringe, or calibrated dropper to measure/deliver volumes <1 ml.
Remember that oily and viscous liquids will be difficult to remove from graduates and pipettes,
and at best require long drainage time. Consider using a disposable syringe instead, or better yet,
measuring by weight rather than volume.

[Link] use prescription bottles, non-volumetric flasks, beakers, or household teaspoons as

measurement devices, unless you calibrate it yourself. When small (<5 ml) or very accurate
doses are required, provide the patient with a calibrated dropper, oral syringe, or similar device
to ensure proper dosing.

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 Pharmaceutical compounding I

Skills practice session 3-2

Measuring techniques of liquids

Purpose: The purpose of this activity is to enable you to practice measuring techniques of
liquids

Instruction
a. Measure 1ml, 5ml,25ml,50ml and 100ml of potable water
b. Measure 25ml and 50 ml of liquid paraffin

Resources (equipment tools and materials)

Chemicals/Ingredients
 water
 liquid paraffin
Equipment/Tools
 Measuring cylinder
 Final container(bottle/conical flasks)

(To be completed by students/Peers)

Rate the performance of each step or task observed using the following rating scale:

1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary), or is
omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if necessary) but
participant/student does not progress from step to step efficiently
3. Proficiently Performed: Step or task performed efficiently and precisely in the proper sequence
(if necessary)
** You will only be competent when you efficiently perform all the steps

Procedure-learning guide/checklist

58
 Pharmaceutical compounding I

Rate
Ser. Step/Task
Proficiently Competently Needs Remark
No
Performed Performed Improvement

1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Select an appropriately sized
conical measure.

6 Check that the measure is clean

and dry.

7 Measure the specified amount of

potable water for water
measuring practice and liquid
paraffin for its practice
8 Label the measured liquids
9 Clean the working equipments
and the surroundings

10 Complete recordings and

documentation
11 Store the measured liquids

Summary

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 Pharmaceutical compounding I

Drug dosage forms are generally composed of two types of ingredients, Active Pharmaceutical
Ingredients and none active Pharmaceutical Ingredients (excipients). Active Pharmaceutical
Ingredients are the main components that are intended to furnish the Pharmaco-therapeutic
effect; while none active ingredients are materials that are deliberately incorporated into the
formulation to aid some physicochemical process of drug manufacturing.

Themostcommonly used pharmaceutical ingredients include;Pharmaceutical solvents,

Preservatives, Anti-oxidant, Buffers and pH adjusting agents, Viscosity inducing agents,
emulsifying agents and Surfactant, Emulsifying agents and Surfactant, Colorants, Flavorants and
Sweeteners, Disintegrants, Lubricants, Adhesives or Binders, Others (Ointment bases,
Suppository bases, Gelling agents, Diluents or Fillers).

All dispensed medicinal products will need to be dispensed to the patient in a suitable product
container. The function of a container for a medicinal product is to maintain the quality, safety
and stability of its contents. The Primarypurposes of packaging and package labels is to protect
the contents of product from physical, mechanical; chemical hazards and microbial
contamination. It also helps to transmit information how to use, transport, recycle, or dispose of
the package or products. Packaging can be categorized by layer or function: "primary",
"secondary", or tertiary.

Knowledge and application of accurate pharmaceutical measurements are essential for pharmacy
professionals to practice their [Link] measurements mostly involved are
Weighing and Measuring Volumes.

Self-check Questions

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 Pharmaceutical compounding I

Instruction:Match the following questions.

Pharmaceutical ingredient Uses
1. Preservatives A. Promote and maintain dispersion
2. Viscosity inducing agents B. prevent spoilage of the preparation by microbes
3. Emulsifying agents and surfactant C. increase thickness of liquids
4. Flavorants and sweeteners D. vehicle for semisolids
5. Ointment Bases E. impart pleasant taste to the preparation

Instruction: choose the following questions from the given alternatives

1. Appropriate packaging of compounding products requires which of the following factors?
A. the products beyond use date
B. Safety
C. Formulation type
D. all of the above
2. Type of packaging used for final market presentation of the product often used to carry the
required labeling for the product is
A. Primary packaging
B. Secondary packaging
C. Tertiary packaging
D. All of the above
3. A liquid’s concave surface, which results from surface tension, is known as its:
A. Viscosity
B. Gauge
C. Meniscus
D. None of the above
4. Which of the following equipment is used to pick up prescription weights?
A. Pestles
B. Counter balances
C. Forceps
D. Compounding slabs

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4. COMPOUNDING EXTEMPORANEOUS PRODUCTS

Dear trainee, this chapter will give you important knowledge and skill about compounding
methods for preparing extemporaneous preparations. So, please go through the document and
follow your instructor’s lecture and skill lab sessions attentively and be competent in
compounding of extemporaneous preparations.

Objectives:
At the end of this chapter you will be able to:
 Discuss different Compounding methods
 Explain Storage conditions of compounded products
 Apply appropriate Beyond use dates on labels

4.1. Introduction
In previous chapters of this module, you have studied the basic principles and processes of
compounding in pharmacies. Now you will be introduced about different types of formulations
that could be prepared in prescription compounding and the methods for the preparation for these
products. For details of labels and packaging materials, you can refer to chapter one and three of
this module. Storage conditions for pharmaceuticals and shelf life is well explained in other
modules.

Definitions
Levigation: The process of grinding an insoluble substance to a fine powder, while wet.
Trituration: Theprocess of creating fine particles from powders by grinding using mortar and
pestle.
Dissolution:The process of mixing solutes with appropriate solvent to get homogeneous
solutions

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 Pharmaceutical compounding I

4.2. Compounding methods

4.2.1. Compounding of pharmaceutical solutions
A solution is a thermodynamically stable, one-phase system composed of two or more
components, one of which is completely dissolved in the other. The solution is homogeneous
because the solute, or dispersed phase, is dispersed throughout the solvent in molecular or ionic
sized particles. Broadly defined, a solution may be any combination of solids, liquids, and/or
gases. We will restrict our definition of pharmaceutical solutions to those composed of a solid,
liquid, or gas dissolved in a liquid solvent.

The assignment of the terms solute and solvent is sometimes arbitrary. Generally, the solute is
the component present in the smallest amount and the solvent is the larger, liquid component.
Water is nearly always considered the solvent. Pharmaceutical solutes may include active drug
components, flavoring or coloring agents, preservatives, and stabilizers or buffering salts. Water
is the most common solvent for pharmaceutical solutions, but ethanol, glycerin, propylene
glycol, isopropyl alcohol or other liquids may be used, depending on the product requirements.
To be an appropriate solvent, the liquid must completely dissolve the drug and other solid
ingredients at the desired concentration, be nontoxic and safe for ingestion or topical application,
and be aesthetically acceptable to the patient in terms of appearance, aroma, texture, and/or taste.

Solution are homogenous liquid preparation containing one or more dissolved ingredients and
are used for a variety of purposes as both internal and external dosage forms.

In addition to the active ingredient (medicaments), solutions also contain vehicles and adjuncts.
The vehicle is the medium in which the ingredient of a medicine is dissolved or dispersed for
solution this is the solvent.
E.g. water, aromatic waters, alcohol, glycerol, syrup, etc.
Water is the vehicle of choice for the majority of pharmaceutical solution. This is because water
is generally available, relatively inexpensive, palatable, non- toxic for oral use and non-irritant
for external use. It also acts as a solvent for a wide range of substances. The adjuncts are
additives that are added to improve the quality of the preparations.
E.g. chemical stabilizers, colorants, Flavorants, preservatives, etc.

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 Pharmaceutical compounding I

Types of solutions
1. Solution taken orally: mixtures, elixirs, syrups, linctuses draughts
2. Solution used in mouth and throat: - mouth washes and gargles, throat paints, throat
sprays.
3. Solution instilled into body cavities: douches, enemas, eardrops, eyes, drops, nasal
drops, nasal sprays.
4. Solution applied to body surface: collodions, liniments, lotion and paints.

General Method of preparation of Solution

The following general method should be used in the preparation of a solution:
1. Write out the working formula either from the prescription (unofficial) or from an official
text (official).
2. Calculate the quantities required for each ingredient in the formula to produce the
required final volume. Additionally, as far as is practically possible, the product will be
assembled in the final measure, thus reducing any transference losses.
3. Complete all sections of the product worksheet.
4. Prepare a suitable label.
5. Weigh all solids.
6. Identify the soluble solids and calculate the quantity of vehicle required to dissolve the
solids fully. If more than one solid is to be dissolved, they are dissolved one by one, in
order of solubility (i.e. the least soluble first). In almost all cases, dissolution will take
place in a glass (or occasionally plastic) beaker, not a conical measure. Remember that
the solubility of the soluble solids will be dependent on the vehicle used.
7. Transfer the appropriate amount of vehicle to a glass beaker.
8. If necessary, transfer the solid to a glass mortar and use the glass pestle to reduce particle
size to aid dissolution.
9. Transfer the solid to the beaker and stir to aid dissolution. If a mortar and pestle have
been used to reduce particle size, ensure that the mortar is rinsed with a little vehicle to
ensure complete transfer of the powders.

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 Pharmaceutical compounding I

10. When all the solid(s) has/have dissolved, transfer the solution to the conical measure that
will be used to hold the final solution.
11. Rinse out the beaker in which the solution was made with a portion of the vehicle, and
transfer the rinsing’s to the conical measure.
12. Add any remaining liquid ingredients to the conical measure and stir.
13. Make up to final volume with remaining vehicle.
14. Transfer to a suitable container, label and dispense to the patient

Aromatic water
 Aromatic waters are aqueous solutions usually saturated of volatile oils or other volatile
substances that are characterized by very low water solubilities. E.g. Chloroform.
 Aromatic waters are used externally as perfumes (e.g. Rose water) and internally as
flavoring agents (e.g. peppermint water, cinnamon water has been used as carminative
and chloroform water was used in expectorant preparations).

Method of Preparation of Aromatic waters

The U.S.P. prescribes 3 general methods of preparation of aromatic waters: Distillation, Solution
and Alternate Solution. A fourth method, Dilution, is also recommended by the B.P.C.

1. Distillation
 Place the odoriferous portion of the plant or drug in a suitable still with sufficient purified
water.
 Distill most of the water, carefully avoiding the development of an odor of burnt as a
result of decomposition at high [Link] the excess oil from the distillate.
 Then the aqueous phase is the product.
2. Solution
 Agitate the volatile substance with purified water for a period of 15 minutes
 The mixture is set aside for at least 12 hrs to ensure saturation
 Then filter through wetted filter paper. The filter paper must be wet to prevent the
passage of excess oil into the filtrate and to eliminate absorption of dissolved aromatics
by the filter.
3. Alternate Solution

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 Pharmaceutical compounding I

 Mix thoroughly the volatile material with 15g of purified talc.

Then agitate the mixture with a liter of purified water for 10 min., prior to filtration
 The timesaving factor is an important advantage of this method.
4. Dilution
 Mix an alcoholic solution of the volatile oil with purified water and add talc.
 Agitate the mixture and set aside for several hours
 Filter and the filtrate is call concentrated aromatic water. The concentrate contains 50 to
55 percent alcohol by volume.
 One volume of concentrated aromatic water is diluted with 39 volumes of water,
producing the aromatic water, which contains less than 1.5% of alcohol.

Spirits and tinctures

Spirits
 Sprits also known as essences are alcoholic or aqueous alcoholic solutions of volatile
substances. Like the aromatic water the active ingredients in the sprits may be a solid, liquid
or gas. The volatile substance in the majority of case is volatile oils.
 Some sprits are used internally for their medical value a few medically by inhalation. But a
large number are used as flavoring agents.
Preparation
 Most spirits are prepared by simple solution in alcohol, although some can be prepared
by distillation, maceration, and chemical reaction methods.
 In preparing spirits, it must be kept in mind that the oils dissolved in alcohol are
precipitated, causing turbidity when the solution are mixed with water. In order to avoid
this turbidity, water, except as specified in the formula, should be avoided.
 Graduates and other equipment used should be thoroughly dry. Filter paper should be
moistened with alcohol.
Storage
 Spirits should be kept in well-closed containers and stored at temperature not exceeding
25oc.
 Good storage conditions prevent evaporation and volatilization of either the alcohol or
the active ingredient(s).

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 Pharmaceutical compounding I

Tinctures
 Tinctures are alcoholic or hydro alcoholic solution of principles extracted from natural
sources or of pure chemical merely dissolved in these solvent systems an example of the
latter being iodine tincture.
 Tinctures vary widely in their method of preparation the strength of their volatile
ingredients their alcoholic content and their intended use
 Tinctures are prepared by a number of processes: maceration (process M), percolation
(process p), solution and dilution.

Syrups, elixirs and linctuses

Syrups
 Syrups are concentrated aqueous solutions of sucrose other sugars or sweetening agents
to which small quantities of suitable polyhydric alcohols may be added to retard
crystallization or to increase the solubility of the other ingredients
 Syrups usually contain aromatic or other flavoring materials.

Elixirs
 An elixir is a liquid oral preparation that usually containseither potent or unpleasant-
tasting drugs.
 Theformulation is clear and generally contains a high proportionof sugar or other
sweetening agent, included tomask offensive or nauseating tastes.
 Pediatric elixirsare usually formulated with fruit syrup as a baseflavoring agent.
Linctuses
 A linctus is a liquid oral preparation that is chiefly used for a demulcent, expectorant or
sedative purpose,principally in the treatment of cough.
 A linctus is intended to be sipped slowly and allowed to trickledown the throat in an
undiluted form.
 Consequently, linctuses are formulated as viscous solutions which contain sugars.

Skill practice session 4-1

Dilution of hydrogen peroxide (30%)

67
 Pharmaceutical compounding I

Purpose:The purpose of this activity is to enable you to practice the dilution methods of
hydrogen peroxide
Instruction
Prepare 50ml of 3% and 6% H2O2 from 30% stock solutions and label it

Resources (equipment tools and materials)

Chemicals/Ingredients
 hydrogen peroxide 30%
 Purified water

Equipment/Tools
 Measuring cylinder
 Bottle/Flask

(To be completed by students/Peers)

Rate the performance of each step or task observed using the following rating scale:
1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary), or is
omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if necessary) but
participant/student does not progress from step to step efficiently
3. Proficiently Performed: Step or task performed efficiently and precisely in the proper sequence (if
necessary)

Procedure-learning guide/checklist

68
 Pharmaceutical compounding I

Rate
[Link] Step/Task
Proficiently Competently Needs Remark
Performed Performed Improvement

1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Tare the bottle
8 Measure hydrogen peroxide
9 Add the calculated amount of
hydrogen peroxide to the tarred
dispensing bottle
10 Add the purified water to the
bottle and adjust to the final
volume
13 Clean the working equipments
and the surroundings

14 Label
15 Complete recordings and
documentation
16 Store the preparation to an
appropriate place

Skills practice session 4-2

Dilution of alcohol

Purpose: The purpose of this activity is to enable you to practice the dilution methods of alcohol
solution
Instruction
Prepare 50ml of 70% ethanol from 98% stock solutions and label it.

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 Pharmaceutical compounding I

Resources (equipment tools and materials)

 Chemicals/Ingredients
o 98% stock solutions
o Purified water
 Equipment/Tools
o Measuring cylinder
o Bottle/Flask

(To be completed by students/Peers)

Rate the performance of each step or task observed using the following rating scale:

1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary), or is
omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if necessary) but
participant/student does not progress from step to step efficiently
3. Proficiently Performed: Step or task performed efficiently and precisely in the proper sequence (if
necessary)

Procedurelearning guide/checklist
Rate
[Link] Step/Task
Proficiently Competently Needs Remark
Performed Performed Improvement
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments

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 Pharmaceutical compounding I

6 Develop your working formula

7 Tare the bottle
8 Measure ethanol 98% stock
solution
9 Add the calculated amount of
Alcohol to the tarred dispensing
bottle
10 Add the purified water to the
bottle and adjust to the final
volume
13 Clean the working equipments
and the surroundings

14 Label
15 Complete recordings and
documentation
16 Store the preparation to an
appropriate place

Skills practice session4-3

Preparation of chloroform water, BP 1988

Purpose: The purpose of this activity is to enable you to practice the preparation methods and
dissolution techniques of chloroform water.
Instructions
Prepare 100 ml of chloroform water, Bp. 88 using the following master formula.
Chloroform …………..2.5 ml
Purified water q.s. ……1000 ml.
Send 100 ml
Storage: Store in a well closed container in a cool place.
Use: Pharmaceutical Aid (flavoring, sweetening, and preservative)

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Instruction
Prepare 100 ml of Double strength chloroform water, Bp. 88 using the following
master formula.
Chloroform …………..5 ml
Purified water q.s. ……1000 ml.
Send 100 ml
Storage: Store in a well closed container in a cool place.
Use:Pharmaceutical Aid (flavoring, sweetening, and preservative)

Role of ingredients
 Chloroform: sweetening agent, carminative
 Water: Vehicle
Conditions or situation for the operations
 In this preparation Chloroform is required to be shaken vigorously to divide the
Chloroform in small globules so as to increase the surface area and hence solubility. It is
to be stored in well closed container as chloroform is volatile in nature and also in amber
color glass bottles as it is light sensitive. In the presence of light it forms a poisonous gas
Phosgene.

Resources (equipment tools and materials)

 Chemicals/ Ingredients
 Chloroform stock solution
 Purified water
 Equipment tools
 Amber colored dispensing bottle
 Label –white paper
 Measuring cylinder
 Tarring marker
 Pipette
 droppers

72
 Pharmaceutical compounding I

(To be completed by students/Peers)

Rate the performance of each step or task observed using the following rating scale:
1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary), or is
omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if necessary) but
participant/student does not progress from step to step efficiently
3. Proficiently Performed: Step or task performed efficiently and precisely in the proper sequence
(if necessary)

Procedure learning guide/checklist

Rate
[Link] Step/Task
Proficiently Competently Needs Remark
Performed Performed Improvement
1 Wear Gown
2 Wash your hands
3 Glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Tare the bottle to the desired
volume by using purified water
8 Measure Chloroform using
pipette/measuring cylinder
9 Add the Chloroform to the
dispensing bottle
10 Close the bottle

73
 Pharmaceutical compounding I

11 Measure purified water

12 Add the purified water to the
dispensing bottle to the final
volume
13 Shake the bottle vigorously to
facilitate the solubility of
chloroform
14 Label
15 Clean the working equipments
and the surroundings
16 Complete recordings and
documentation
17 Store the preparation to in
appropriate place

Skills practice session 4-4

Preparationof concentrated camphor water bp.1988

Purpose: The purpose of this activity is to enable you to practice the preparation methods and
dissolution techniques of camphor water
Instructions
Prepare 50 ml of concentrated camphor water BP.1988 using master formula.
Camphor …………………. 40 g
Alcohol (90%)……………. 600 ml
Purified water, qs………… 1000 ml
Send 50 ml
Storage: should be stored in airtight container, in a cool place.
use: Solvent carminative, flavor and mild expectorant)
Direction for use: as directed by the physician

Role of ingredients
 Camphor: Main ingredient

74
 Pharmaceutical compounding I

 Alcohol (90%):solvent of camphor

 Purified water: Vehicle

Conditions or situation for the operations

The solubility of camphor is only 1: 700 parts in water but it is freely soluble in alcohol
i.e. 1 part of alcohol. The addition of alcoholic solution to water yields a finely divided
precipitate of camphor which re-dissolves easily on shaking
Resources (equipment tools and materials)
 Chemicals/Ingredients
 Camphor powder
 Alcohol (90%)
 Purified water
 Equipment /Tools
 Amber colored dispensing bottle
 Beam /digital balance
 Weighing paper
 Spoon spatula
 Label –white paper
 Measuring cylinder
 Pipette

(To be completed by students/Peers)

Rate the performance of each step or task observed using the following rating scale:

1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary),
or is omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if
necessary) but participant/student does not progress from step to step efficiently
3. 3. Proficiently Performed: Step or task performed efficiently and precisely in the proper
sequence (if necessary)

Precautions

75
 Pharmaceutical compounding I

1. Water should not be added to the alcoholic solution of camphor because in this case whole of
the camphor will be precipitated out which will not re-dissolve easily on shaking.
2. Camphor is volatile in nature so it should be stored in well closed container to prevent the
volatilization of camphor

Procedure learning guide/checklist

Rate
[Link] Step/Task
Proficiently Competently Needs Remark
Performed Performed Improvement
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Adjust the balance to zero scale
8 Tare the bottle to the desired
volume by using purified water
9 Weigh the desired amount of
camphor
10 Measure Alcohol (90%) using
measuring cylinder
11 Add the Alcohol (90%) to the
tarred dispensing bottle
12 Dissolve camphor in the alcohol
(90%)
13 Measure purified water
14 Add sufficient water in successive
small portions to produce required
volume
15 Shake the bottle vigorously after
each addition of purified water
until you get homogeneous solution
16 Label

76
 Pharmaceutical compounding I

17 Clean the working equipments and

the surroundings
18 Complete recording and
documentation
19 Store the preparation to an
appropriate place

Skills practice session4-5

Preparationof peppermint water
Purpose: The purpose of this activity is to enable you to practice the preparation methods,
dissolution techniques in compounding Peppermint water.

Instruction
Prepare 50 ml of Peppermint water using the following master formula.
Peppermint oil ----------------0.2 ml
Water, FBC to ----------------100ml
Send 50 ml
Use: Carminative and Flavoring agent
Storage: Store in a well closed container at cool place
Direction for use: As directed by the physician

Role of ingredients:
 Peppermint oil: sweetening agent and carminative
 Purified water: vehicle/solvent

Resources (equipment tools and materials)

Chemicals/Ingredients
 Peppermint oil
 Alcohol (90%)
 Purified water
 Equipment/Tools
 Amber colored medicinal bottle

77
 Pharmaceutical compounding I

 Label –white paper

 Measuring cylinder
 Pipette

Procedurelearning guide/checklist

Rate
[Link] Step/Task
Proficiently Competently Needs Remark
Performed Performed Improvement
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Tare the bottle to the desired
volume by using purified water
8 Measure peppermint oil using
pipette
9 Add the peppermint oil to the
tarred dispensing bottle
10 Close the bottle
11 Measure purified water
12 Add the purified water to the
dispending bottle in small
quantities with vigorous
shaking after each addition to
produce the final volume
13 Clean the working equipments
and the surroundings
14 Label
15 Complete recordings and
documentation
16 Store the preparation to an
appropriate place

78
 Pharmaceutical compounding I

Skills practice session4-6

Preparation of pharmaceutical chloroform spirit

Purpose: The purpose of this activity is to enable you to practice the preparation methods and
dissolution techniques of chloroform Spirits
Instruction
Prepare 40 ml of chloroform spirit using the following master formula.
Chloroform………………………….50ml
Alcohol (90%) q.s…………………...1000ml
Send 40 ml
Use: It is used as a flavoring g agent, carminative and preservative

Storage: It should be stored in well closed container to prevent volatilization of ingredients.

Direction for use: As directed by the physician

Role of ingredients
 Chloroform: flavoring, carminative and preservatives ingredient,
 Alcohol (90%): Solvent

79
 Pharmaceutical compounding I

Conditions or situation for the operations

 Spirits are the alcoholic or hydro alcoholic solutions of volatile substances. They may be
used internally or externally.
 They are mainly used as flavoring agents, sweetening agents.
 In all cases the volatile oil content of the official spirit is much greater than that of the
corresponding aromatic water.
Resources (equipment tools and materials)
 Chemicals/Ingredients
o Chloroform stock solution
o Alcohol (90%)
o Purified water

 Equipment/tools
o Amber colored medicinal bottle
o Label –white paper
o Measuring cylinder
o pipette

(To be completed by students/Peers)

Rate the performance of each step or task observed using the following rating scale:

1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary),
or is omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if
necessary) but participant/student does not progress from step to step efficiently
3. 3. Proficiently Performed: Step or task performed efficiently and precisely in the proper
sequence (if necessary)

Procedure-learning guide/checklist
Rate
[Link] Step/Task Proficiently Competently Needs Remark

80
 Pharmaceutical compounding I

Performed Performed Improvement

1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working
formula
7 Tare the bottle to the desired
volume by using purified
water
8 Measure chloroform stock
solution Add the desired
amount of chloroform in to the
tarred bottle
9 Measure Alcohol (90%) and
add in to the chloroform bottle
to the final volume
10 Shake well
11 Clean the working equipments
and the surroundings
12 Label
13 Complete the recordings and
documentation
14 Store the preparation to an
appropriate place

81
 Pharmaceutical compounding I

Skills practice session 4-7

Preparation of pharmaceutical peppermint spirit, B.P. 1988 (peppermint essence) spirit

Purpose: The purpose of this activity is to enable you to practice the preparation methods and
dissolution techniques of peppermint spiritB.P.88 (peppermint Essence)
Instruction
Prepare 30 ml of peppermint spirit, B.P.88 (peppermint Essence) using the following formula.
Peppermint oil ……………….100ml
Ethanol (90%) to……………..1000ml
Send 20 ml
Use: It is used as a Flavoring agent and carminative

Storage: It should be stored in well closed container to prevent volatilization of ingredients.

Direction for use: As directed by the physician

Role of ingredients
 Peppermint oil: Flavoring agent
 Alcohol 90%: Solvent of Peppermint oil

Conditions or situation for the operations

 Official peppermint spirit is prepared by maceration process but peppermint spirit BPC is
prepared by solution method in which the peppermint oil is dissolved in alcohol. Peppermint
oil is obtained by distillation from the fresh flowering tops Mentha piperata

Resources (equipment tools and materials)

 Chemicals /Ingredients
o Peppermint oil
o Alcohol (90%)
o Purified water
 Equipment/Tools
o Amber colored medicinal bottle
o Label –white paper

82
 Pharmaceutical compounding I

o Measuring cylinder
o pipettes

(To be completed by students/Peers)

Rate the performance of each step or task observed using the following rating scale:

1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary), or is
omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if necessary) but
participant/student does not progress from step to step efficiently
3. Proficiently Performed: Step or task performed efficiently and precisely in the proper sequence (if
necessary)

Procedure-learning guide/checklist
Rate
[Link] Step/Task
Proficiently Competently Needs Remark
Performed Performed Improvement
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Tare the bottle to the desired
volume by using purified water
8 Measure peppermint oil and
Add to the tarred bottle
9 Measure Alcohol (90%) and
Dissolve peppermint oil with
small quantity of the alcohol
and then add more of the
alcohol to produce the required
volume.
10 Shake well

83
 Pharmaceutical compounding I

12 Clean the working equipments

and the surroundings
13 Label
14 Complete the Recordings and
documentation
15 Store the preparation to an
appropriate place

Skill practice session 4-8

Preparation of aqueous iodine solution
Purpose: The purpose of this activity is to enable you
 To practice the preparation methods and dissolution techniques in compounding
of Lugol’s solution preparation
 Identify the equipments used in Lugol’s solution preparation

Instruction
Prepare 20 ml of aqueous iodine solution using the following master formula.
Iodine ……………………50 gm
Potassium iodide ………… 100 gm
Purified water q.s …………1000 ml
Send 20 ml
Use: source of iodine in it’s deficiency condition
Storage: stored in well closed and iodine resistant container.

84
 Pharmaceutical compounding I

Direction for use: As directed by the physician

Role of ingredients:
 Iodine: Active ingredient
 Potassium iodide: increase the solubility of Iodine
 Water up:vehicle/solvent

Conditions or situation for the operations

Iodine is practically insoluble in water. Its solubility is 1: 3000 but in the presence of
potassium iodide it becomes soluble due to formation of polyiodides. Eg. KI. I 2, .KI 2I2,
KI. 3I2
KI + I2KI. I2 = KI3
KI + 2I2 KI. 2I2= KI5
Potassium iodide is added only to increase the solubility of iodine

Resources (equipment tools and materials)

 Chemical/Ingredients
o Iodine crystal or powder
o Potassium iodide
o Purified water
 Equipments /Tools
o Watch glass
o Stainless steel spoon spatula
o Weighing paper
o Beam/digital balance
o Glass mortar and pestle
o Amber colored medicinal bottle
o Label –white paper
o Measuring cylinder

85
 Pharmaceutical compounding I

(To be completed by students/Peers)

Rate the performance of each step or task observed using the following rating scale:

1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary),
or is omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if
necessary) but participant/student does not progress from step to step efficiently
3. Proficiently Performed: Step or task performed efficiently and precisely in the proper
sequence (if necessary)

Precautions
o Iodine will stain skin, clothing and plastic surface, take appropriate precautions.
o Care must be taken to avoid spillage during weighing and transfer
o The equipment and container must be spotlessly clean because this solution may stain the
working benches.
Procedure-learning guide/checklist
Rate
[Link] Step/Task
Proficiently Competently Needs Remark
Performed Performed Improvement
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Tare the bottle to the desired
volume by using purified water
8 Measure purified water
9 Weigh potassium iodide
10 Weigh iodine
11 Add potassium iodide and iodine
in to glass mortar and triturate

86
 Pharmaceutical compounding I

together
12 Add sufficient purified water to
the mortar and Dissolve
potassium iodide and iodine
13 Transfer the solution in to the
tarred bottle
14 Make up the volume by rinsing
the mortar and pestle with the
water.
15 Clean the working equipments
and the surroundings
16 Label
17 Complete the recordings and
documentation
18 Store the preparation to an
appropriate place

Skills practice session 4-9

Preparation of iodine tincture, B.P.1988
Purpose:The purpose of this activity is to enable you to practice the preparation methods,
weighing, dissolution techniques and identifying equipments in compounding of Iodine Tincture
Instruction
Prepare and supply 50ml of Iodine Tincture, B.P.1988 (Weak Iodine Solution) using the following formula
Potassium iodide………………..25g
Iodine……………………………25g
Water……………………………..25ml
Ethanol(90%) to………… …….1000ml
Send 50ml
Storage:-Store in a cool place and in airtightcontainer
Use: antiseptic.

Direction for use : Apply with swab to the throat

For external use only

Role of ingredients
 Potassium iodide: Increase the solubility of iodine

87
 Pharmaceutical compounding I

 Iodine: Active ingredient

 Water: solventEthanol (90%):co solvent and vehicle.

Resources (equipment tools and materials)

 Chemicals/Ingredients
o Potassium iodide
o Iodine
o Alcohol (90%)
o Purified water
 Equipments/Tools
o Beam/digital balance
o Spoon spatula
o Amber colored medicinal bottle
o Glass mortar and pestle/Erlenmeyer flask/ conical graduates
o Measuring cylinder
o pipettes
o Label –white paper

(To be completed by students/Peers)

Rate the performance of each step or task observed using the following rating scale:

1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary),
or is omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if
necessary) but participant/student does not progress from step to step efficiently
3. 3. Proficiently Performed: Step or task performed efficiently and precisely in the proper
sequence (if necessary)

Precautions
o Iodine will stain plastic surface, take appropriate precautions.
o Care must be taken to avoid spillage during weighing and transfer

88
 Pharmaceutical compounding I

o The equipment and container must be spotlessly clean because this solution may stain the
working benches

Procedure-learning guide/checklist
Rate
[Link] Step/Task Proficiently Competently Needs Remark
Performed Performed Improvement
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Tare the bottle to the desired
volume by using purified water
8 Weigh potassium iodide, and
iodine
9 Measure Alcohol(90%) and
Water,

10 dissolve the potassium iodide and

the iodide in the purified water
11 Transfer to the final tarred bottle

12 Add sufficient ethanol (90%) to

produce the final amount
13 Clean the working equipments
and the surroundings
14 Label
15 Complete the Recordings and
documentation
16 Store the preparation to an
appropriate place

Skills practice session4-10

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 Pharmaceutical compounding I

Preparation of simple syrup, USP

Purpose: The purpose of this activity is to enable you to practice the preparation methods,
weighing and dissolution techniques in compounding of simple syrups,USP

Instruction
Prepare and supply 100ml of simple syrup, USPusing the following master formula.

Sucrose……667g sucrose…….850g
or
Purified water…to 1000g purified water…..to 1000ml
Send 100ml
Storage: store in well closed airtight container in a moderately cool place.
Use: sweetening and flavoring agent (sweetening vehicle)

Role of ingredients
 Sucrose: Main ingredient as sweetening agent
 Purified water: Vehicle/solvent

Conditions or situation for the operations

Syrups are concentrated aqueous solutions of sucrose, other sugars or sweetening agents,
to which quantities of polyhydric alcohols, may be added to retard crystallization or to
increase the solubility of the other ingredients. Syrup made without heat is practically
colorless while syrups made with heat have pale amber color due to the laevulose formed
as a result of hydrolysis of sucrose.
Resources (equipment tools and materials)
 Chemicals/Ingredients
o Sucrose
o Evaporating dish/beaker
o Water bath
 Equipments/Tools
o Glass rode
o Purified water
o Funnel

90
 Pharmaceutical compounding I

o Fine muslin (for straining)

o Beam/digital balance
o Spoon spatula
o Weighing paper
o Mortar and pestle
o Amber colored medicinal bottle
o Label –white paper
o Measuring cylinder

(To be completed by students/Peers)

Rate the performance of each step or task observed using the following rating scale:

1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary),
or is omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if
necessary) but participant/student does not progress from step to step efficiently
3. 3. Proficiently Performed: Step or task performed efficiently and precisely in the proper
sequence (if necessary)

Procedure-learning guide/checklist
Rate
[Link] Step/Task Proficiently Competently Needs Not
Performed Performed Improvement performed
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula

91
 Pharmaceutical compounding I

7 Calibrate the balance

8 Tare the bottle to the desired
volume by using purified water
9 Weigh sucrose
10 Measure purified water.

11 Place the sucrose in a dish and

add the water
12 Dissolve the sucrose by heating
on a water bath ,stirring
continuously with glass rode
13 When the dissolution of sucrose
is complete, allow the solution
formed to cool add sufficient
boiling purified water to make
up for that loss by evaporation
14 strain the syrup while still warm
,through fine muslin supported
in a funnel in to the tarred
bottle
15 Shake the bottle occasionally
until the content is quite cold.

16 Clean the working equipments

and the surroundings

17 Label
18 Complete the Recordings and
documentation
19 Store the preparation to an
appropriate place

92
 Pharmaceutical compounding I

Skills practice session 4-11

Preparation of ferrous sulphate syrup
Purpose:The purpose of this activity is to enable you to practice the preparation methods,
weighing and dissolution techniques in compounding of Ferrous Sulphate syrups
Instruction
Prepare 50ml of Ferrous Sulfate Syrup using the following formula:
Ferrous sulfate……………..40g
Citric acid, hydrous……….2.1g
Peppermint spirit…………2ml
Sucrose……………………825g
Purified water to…………. 1000ml
Send 50ml
Storage:-well closed container at a temperature not exceeding 30ºC.
Use:-This preparation is used in the treatment of anemia
Direction for use: 2 tsp. TID

Role of ingredients
 Ferrous sulfate: Active ingredient
 Citric acid, hydrous: prevent discoloration of syrup from green to reddish brown
 Peppermint spirit: flavoring agent
 Sucrose: sweetening agent
 Purified water: vehicle

Conditions or situation for the operations

93
 Pharmaceutical compounding I

Syrups are concentrated aqueous solutions of sucrose, other sugars or sweetening agents,
to which quantities of polyhydric alcohols, may be added to retard crystallization or to
increase the solubility of the other ingredients. Peppermint water is a flavoring agent.
Citric acid is added to prevent discoloration of syrup from green to reddish brown.

Resources (equipment tools and materials)

 Chemicals/Ingredients
o Ferrous sulfate
o Citric acid, hydrous
o Peppermint spirit
o Sucrose
 Equipments/Tools
o Evaporating dish/ flask/
o Water bath
o Glass rode
o Purified water
o Beam/digital balance
o Spoon spatula
o Weighing paper
o Amber colored medicinal bottle
o Label –white paper
o Measuring cylinder
o Pipettes

(To be completed by students/Peers)

Rate the performance of each step or task observed using the following rating scale:

1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary), or is

94
 Pharmaceutical compounding I

omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if necessary) but
participant/student does not progress from step to step efficiently
3. 3. Proficiently Performed: Step or task performed efficiently and precisely in the proper sequence (if
necessary)

Procedure-learning guide/checklist
Rate
[Link] Step/Task
Proficiently Competently Needs Remark
Performed Performed Improvement
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Calibrate the balance
8 Tare the bottle to the desired
volume by using purified water
9 Weigh Ferrous sulfate, Citric
acid, hydrous Peppermint spirit
and Sucrose
10 Measure purified water.

11 Dissolve FeSO4. H2O, Citric

acid and sucrose in purified
water using erlyminer
flask/evaporating dish by
stirring and heating on water
bath
12 Allow to cool and add the
peppermint spirit and make up
the final volume.

95
 Pharmaceutical compounding I

Clean the working equipments

and the surroundings
13 Label
14 Write short report/complete the
Recordings and documentation
15 Store the preparation to an
appropriate place

Skills practice session 4-12

Preparation of phenobarbitone elixirs
Purpose: The purpose of this activity is to enable you to practice the preparation methods,
weighing and dissolution techniques in the compounding of Elixir
Instruction
Prepare 25 Phenobarbitone elixirs using the following master formula.
Phenobarbitone……………………………………. 0.4 g
Ethanol (90%) ……………………………………. 40 ml
Compound orange spirit ………………………… 2.5 ml
Glycerol …………………………………………… 40 ml
Amaranth solution ………………………………… 1 ml
Purified water to ………………………………….. 100 ml
Send 25 ml
Use: Anticonvulsant to treat epilepsy
Warning: Phenobarbitone causes drowsiness: alcohol should be avoided
Storage: Store in well closed container and in dark place.

Direction for use: 2 tsp. h .s

Role of ingredients:
 Phenobarbitone: Active ingredient
 Ethanol (90%) : Co-solvents for the phenobarbitone
 Compound orange spirit : Flavorant
 Glycerol: co-solvents for the phenobarbitone
 Amaranth solution: Colorant
 Purified water: vehicle

Resources (equipment tools and materials)

96
 Pharmaceutical compounding I

 Chemicals/ Ingredients
o Phenobarbitone
o Ethanol (90%)
o Compound orange spirit
o Glycerol
o Amaranth solution
o Purified water
 Equipments/Tools
o Beam/digital balance
o Spoon spatula
o Weighing paper
o Amber colored medicinal bottle
o Label –white paper
o Measuring cylinder
o pipettes

(To be completed by students/Peers)

Rate the performance of each step or task observed using the following rating scale:
1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary),
or is omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if
necessary) but participant/student does not progress from step to step efficiently
3. Proficiently Performed: Step or task performed efficiently and precisely in the proper

97
 Pharmaceutical compounding I

sequence (if necessary)

Procedure-learning guide/checklist
S. No Rate
Step/Task
Proficiently Competently Needs Not
Performed Performed Improvement performed
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Calibrate the balance
8 Tare the bottle to the desired
volume by using purified water
9 Weigh Phenobarbitone
10 Measure purified water.

11 Measure ethanol(90%),
compound orange spirit,
glycerol, amaranth solution,

12 Dissolve Phenobarbitone in
ethanol
13 Add the orange spirit, glycerol,
Amaranth solution add water to
adjust the final volume
14 Shake well
15 Clean the working equipments
and the surroundings
16 Label
17 Complete the Recordings and
documentation
18 Store the preparation to an
appropriate place

98
 Pharmaceutical compounding I

Skills practice session 4-13

Preparation of compound sodium chloride
Purpose:The purpose of this activity is to enable you to practice the preparation methods,
weighing and dissolution techniques in compounding ofCompound Sodium Chloride mouth
wash.
Instruction
Prepare 50ml of Compound Sodium Chloride Mouthwashusing the followingformula
Sodium bicarbonate………………………………….10gm
Sodium chloride ……………………………………..15gm
Concentrated Peppermint Emulsion…………………25ml
Double Strength Chloroform Water ………………..500ml
Water to………………………………………………1000ml
Send 50ml
Directions:-
1. Dilute it with equal volume of warm water before use.
2. Rinse the mouth 3-4 times daily.

Storage: well closed, airtight container and in cool place.

Uses: - It is used to cleanse and de-odorize the buccal cavity. It is very refreshing particularly to
the bed- ridden patients.
Caution: Not to be Swallowed

Role of the ingredients

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 Pharmaceutical compounding I

 Sodium chloride: makes the preparation isotonic

 Sodium bicarbonate: Sodium bicarbonate helps in dissolving the mucus
 Concentrated Peppermint Emulsion: flavoring agent
 Double Strength Chloroform Water: preservative, solvent ,and flavoring agent

Resources (equipment tools and materials)

Chemical/Ingredients
 Sodium chloride
 Sodium bicarbonate
 Amaranth solution
 Peppermint water
 Purified water

Equipments/Tools
 Beam/digital balance
 Spoon spatula
 Weighing paper
 Amber colored medicinal bottle
 Erlenmeyer flask/ Conical graduates
 Measuring cylinder
 pipettes
 Label –white paper

(To be completed by students/Peers)

Rate the performance of each step or task observed using the following rating scale:
1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary),
or is omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if
necessary) but participant/student does not progress from step to step efficiently

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 Pharmaceutical compounding I

3. Proficiently Performed: Step or task performed efficiently and precisely in the proper
sequence (if necessary)

Procedure-learning guide/checklist
Rate
[Link] Step/Task Proficiently Competently Needs Remark
Performed Performed Improvement
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Calibrate the balance
8 Tare the bottle to the desired volume
by using purified water
9 Weigh Sodium chloride and Sodium
bicarbonate
10 Measure Double strength chloroform
water and Peppermint emulsion

11 Dissolve the sodium chloride and

sodium bicarbonate in portion of the
water..
12 Add Peppermint emulsion and the
double strength chloroform water
13 Finally adjust to final volume with
water
14 Clean the working equipments and the
surroundings

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 Pharmaceutical compounding I

15 Label
16 Write short report/complete the
Recordings and documentation
17 Store the preparation to an appropriate
place

Skills practice session 4-14

Preparation of alkaline phenol mouth wash
Purpose:The purpose of this activity is to enable you to practice the preparation methods,
weighing and dissolution techniques in compounding of Alkaline Phenol mouth wash.
Instruction
Prepare 50ml of Alkaline Phenol Mouthwashusing the following
formula
Liquefied phenol…………………………………….30ml
Potassium Hydroxide solution 5% ………………….30m
Amaranth Solution…………………………………….1m
Water to……………………………………………1000ml
Send 50ml

Directions:-
1. Dilute it with ten times its volume of warm water before use.
2. Rinse the mouth 3-4 times daily.

Storage:- well closed, airtight container and in cool place.

Uses: - It is used to cleanse and de-odorize the buccal cavity.
Caution: Not to be Swallowed

Role of the ingredients

 Liquefied phenol: Active ingredient
 Potassium Hydroxide solution 5%:Alkalinizing agent
 Amaranth Solution: coloring agent
 Water: vehicle

Resources (equipment tools and materials)

Chemicals/Ingredients

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 Pharmaceutical compounding I

 Liquefied phenol
 Potassium Hydroxide solution 5%:
 Amaranth Solution:
 Water
 Amaranth solution
 Purified water

Equipments/Tools
 Amber colored medicinal bottle
 Erlenmeyer flask/ Conical graduates
 Measuring cylinder
 pipettes
 Label –white paper

(To be completed by students/Peers)

Rate the performance of each step or task observed using the following rating scale:
1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary),
or is omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if
necessary) but participant/student does not progress from step to step efficiently
3. Proficiently Performed: Step or task performed efficiently and precisely in the proper
sequence (if necessary)

Procedure-learning guide/checklist
Rate
S. No Step/Task
Proficiently Competently Needs Remark
Performed Performed Improvement
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula

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 Pharmaceutical compounding I

7 Calibrate the balance

8 Tare the bottle to the desired
volume by using purified water
9 Weigh Sodium chloride and Sodium
bicarbonate
10 Measure Double strength
chloroform water and Peppermint
emulsion
11 Dissolve the sodium chloride and
sodium bicarbonate in portion of the
water.
12 Add Peppermint emulsion and the
double strength chloroform water
13 Finally adjust to final volume with
water
14 Clean the working equipments and
the surroundings
15 Label
16 Complete the Recordings and
documentation
17 Store the preparation to an
appropriate place

Skills practice session 4-15

Preparation of phenol gargle
Purpose:The purpose of this activity is to enable you to practice the preparation methods and
dissolution techniques in compounding of Phenol Gargle.
Instruction
Prepare 50ml of Phenol gargle (Carbolic Acid Gargle) using the following formula
Phenol Glycerin……..50 ml
Amaranth solution……..10 ml
Water q.s …………..1000 ml
Send 50ml
Precautions: - 1. Dilute it with equal volume of warm water before use.

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2. Do not swallow the preparation

Storage: well closed, airtight container and in cool place.

Uses: It is used in the treatment of infections of pharynx and naso-pharynx

Directions for use : As directed by the physician

Role of the ingredients

 Phenol Glycerin: Active ingredients
 Amaranth solution: coloring agent

Conditions or situation for the operations

 Gargles are aqueous solutions used for the treatment of an infection of the throat.
 These are concentrated and must be diluted before use.
 They are brought into intimate contact with the mucous membrane of the throat and are
allowed to remain there for a few moment and then thrown out.
 They should never be swallowed.

Resources (equipment tools and materials)

Chemicals/Ingredients
 Phenol Glycerin
 Amaranth solution
 Purified water

Equipments/Tools
 Amber colored medicinal bottle
 Erlenmeyer flask/ Conical graduates
 Measuring cylinder
 pipettes
 Label –white paper

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 Pharmaceutical compounding I

(To be completed by students/Peers)

Rate the performance of each step or task observed using the following rating scale:
1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary),
or is omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if
necessary) but participant/student does not progress from step to step efficiently
3. 3. Proficiently Performed: Step or task performed efficiently and precisely in the proper
sequence (if necessary)

Procedure-learning guide/checklist
Rate
S. No Step/Task
Proficiently Competently Needs Remark
Performed Performed Improvement
1 Wear Gown
2 Wash your hands

4 Wear glove
5 Clean the working lab bench
6 Clean equipments
7 Develop your working
formula
8 Tare the bottle to the desired
volume by using purified
water
9 Measure Phenol Glycerin and
Amaranth solution

10 Mix amaranth solution with

small amount of water. Add
phenol glycerin (16% w/w
phenol and 84% w/w glycerin)
and mix.
11 To this add more of the
vehicle to produce the
required volume.

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 Pharmaceutical compounding I

12 Clean the working equipments

and the surroundings
13 Label
14 Complete the Recordings and
documentation
15 Store the preparation to an
appropriate place

Skills practice session 4-16

Preparation of camphor liniment
Purpose:The purpose of this activity is to enable you to practice the preparation methods,
weighing, dissolution techniques and equipments in compounding CamphorLiniment.
Instruction
Prepare and supply 10ml of Camphor Liniment using the following formula
Camphor……………200g
Arachis Oil…………800g
Storage:-Store in a cool place and in airtight container
Use: Counterirritant.
Direction for use : As directed
For external use only

Role of the ingredients

 Camphor: Active ingredient
 Arachis Oil: vehicle /solvent

Resources (equipment tools and materials)

Chemicals/Ingredients
 Camphor
 Arachis oil
 Purified water

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 Pharmaceutical compounding I

Equipments/Tools
 Beam/digital balance
 Spoon spatula
 Amber colored medicinal bottle
 Erlenmeyer flask/ Conical graduates
 Weighing paper
 Measuring cylinder
 pipettes
 Label –white paper

(To be completed by students/Peers)

Rate the performance of each step or task observed using the following rating scale:
1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary), or is
omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if necessary) but
participant/student does not progress from step to step efficiently
3. 3. Proficiently Performed: Step or task performed efficiently and precisely in the proper sequence
(if necessary)
Procedure-learning guide/checklist
Rate
[Link] Step/Task
Proficiently Competently Needs Remark
Performed Performed Improvement
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Tare the bottle to the desired volume
by using purified water
8 Weigh potassium camphor and
measure arahis oil
9 Dissolve the camphor in the oil in the
flask

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 Pharmaceutical compounding I

10 Clean the working equipments and the

surroundings
14 Label
15 Complete the Recordings and
documentation
16 Store the preparation to an appropriate
place

Skills practice session 4-17

Preparation of compound iodine paint
Purpose:The purpose of this activity is to enable you to practice the preparation methods,
weighing, dissolution techniques and identifying equipments in compounding of Throat paints
Instruction
Prepare and supply 50ml of compound Iodine paint (mandl’s paint) using the following formula
Potassium iodide……………25g
Iodine……………………………12.5g
Alcohol (90%)………………..40ml
Water…………………………..25ml
Peppermint oil……………………4.0ml
Glycerol to……………………….1000ml
Storage:-Store in a cool place and in airtight container
Use: Used in the case of pharyngitis and tonsillitis. It is an antiseptic.
Precautions: Not to be swallowed in large amount
Direction for use Apply with swab to the throat
For external use only

Role of the ingredients

 Potassium iodide: Increase the solubility of iodine
 Iodine: active ingredient
 Alcohol (90%): solvent for Peppermint oil
 Water: solvent/vehicle
 Peppermint oil: Flavoring agent
 Glycerol: Humectants, Emollient and vehicle

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 Pharmaceutical compounding I

Conditions or situation for the operations

 Throat paints are liquid preparations used for mouth and throat infections by applying to the
mucous surfaces.
 They are usually medicated with substances possessing antiseptic, astringent, caustic, or
analgesic properties.
 They are usually viscous (wide-mouthed containers are better) and patient should have a
throat brush.
 They are made viscous so that drug should remain in contact for longer time.

Resources (equipment tools and materials)

Chemicals/Ingredients
 Potassium iodide
 Iodine
 Alcohol (90%)
 Peppermint oil
 Glycerol.
 Purified water

Equipments/Tools
 Beam/digital balance
 Spoon spatula
 Amber colored medicinal bottle
 Glass mortar and pestle/Erlenmeyer flask/ Conical graduates
 Watch glass
 Weighing paper
 Measuring cylinder
 pipettes
 Label –white paper

110
 Pharmaceutical compounding I

(To be completed by students/Peers)

Rate the performance of each step or task observed using the following rating scale:
1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary), or
is omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if necessary)
but participant/student does not progress from step to step efficiently
3. 3. Proficiently Performed: Step or task performed efficiently and precisely in the proper
sequence (if necessary)

Procedure-learning guide/checklist
Rate
S. No Step/Task Proficiently Competently Competently Remark
Performed Performed Performed
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Tare the bottle to the desired volume by
using purified water
8 Weigh potassium iodide, and iodine
9 Measure Alcohol(90%),Water,
Peppermint oil and Glycerol

10 Put the water in conical flask /Glass

mortar and Dissolve KI, add iodine
11 Mix peppermint oil in alcohol and add
to the previous solution
12 Make up to final volume with glycerol
and mix thoroughly.

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 Pharmaceutical compounding I

13 Clean the working equipments and the

surroundings
14 Label
15 Complete the Recordings and
documentation
16 Store the preparation to an appropriate
place

Skills practice session 4-18

Preparationof sodium bicarbonate ear drops
Purpose:The purpose of this activity is to enable you to practice the preparation methods,
weighing, dissolution techniques and equipments in compounding of ear drops
Prepare and supply 20ml of Sodium Bicarbonate ear drops using the following formula
Sodium Bicarbonate………. 5 gm
Glycerin……………………30 ml
Purified water q.s. …….. 100 ml
Storage: Store in a cool place
Uses: - It is used to relieve itching in the ears.
Direction for use: AS directed by physician
For external use only

Role of the ingredients

 Sodium Bicarbonate: Main ingredient
 Glycerin: Ingredient for softening ear wax
 Purified water: vehicle

Conditions or situation for the operations

 Ear drops are liquid preparations in which the drug is dissolved or suspended in a suitable
vehicle like alcohol, water; glycerine etc. water generally is not used because it would
face in mixing with the secretions of ear which are mainly fatty.
 Ear drops are used for cleansing, softening the wax and for the treatment of mild
infections.

112
 Pharmaceutical compounding I

Resources (equipment tools and materials)

Chemicals/Ingredients
 Sodium Bicarbonate
 Glycerin
 Purified water

Equipments/Tools
 Beam/digital balance
 Spoon spatula
 Amber colored medicinal bottle
 Erlenmeyer flask/ Conical graduates
 Measuring cylinder
 Pipettes
 Beam /digital balance
 Weighing paper
 Label –white paper

(To be completed by students/Peers)

Rate the performance of each step or task observed using the following rating scale:
1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary),
or is omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if
necessary) but participant/student does not progress from step to step efficiently

113
 Pharmaceutical compounding I

1. 3. Proficiently Performed: Step or task performed efficiently and precisely in the proper
sequence (if necessary)

Procedure-learning guide/checklist
Rate
S. No Step/Task Proficiently Competently Needs Remark
Performed Performed Improvement

1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Tare the bottle to the desired volume
by using purified water
8 Weigh sodium Bicarbonate
9 Measure Glycerin and Purified water

10 Dissolve the sodium bicarbonate in

about 60 ml (Use the reduced amount)
of purified water;
11 Add the glycerin and sufficient
purified water to produce the required
volume.
12 Make up to final volume with glycerol
and mix thoroughly.
13 Clean the working equipments and the
surroundings
14 Label
15 Complete the Recordings and
documentation
16 Store the preparation to an appropriate
place

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 Pharmaceutical compounding I

4.2.2. Compounding of pharmaceutical suspension

Suspension are dispersed systems in which finely divided drug practices (called the disperse
phase) are distributed thought out a vehicle (called dispersion medium or continues phase) in
which the drug exhibits a minimum degree of solubility. It in include both powders in dry from
to be place in suspension and drugs suspended in liquid vehicles.
Suspension can be classified in to coarse suspension in which the particles are large than 1um in
diameter.
Major applications: suspension dosage forms can be administered orally injected parentally
(intramuscularly or subcutaneously) or applied externally (topically) to the skin eye ear etc.
The physical properties of suspensions and their design depend upon the nature of the dispersed
phase the dispersion medium and the pharmaceutical adjuncts/additives.
The drug particles (dispersed phase) is suspension could be:
o Diffusible solids

115
 Pharmaceutical compounding I

o In diffusible solids or
o Poorly wettable solids
General methods of preparation of suspension
1. Carefully tare(calibrate) the container to the required volume
2. Finely powder any solid ingredient not already in fine powder
3. Mix the insoluble powders in a mortar adding first the ingredient of
4. Smallest bulk and diluting it with the others in increasing order of bulk using amounts
approximately equal to bulk already in the mortar (geometric dilution).
5. Add enough vehicles to produce a smooth paste.
6. Add non-volatile solid ingredients dissolved in part of the vehicle and mix well
7. Dilute with a vehicle until pourable. Examine the suspension critically and if it contains
foreign particle strain through muslin. (Before use rinse the fabric with a little vehicle to
detach loose fibers).
8. Transfer it to the tarred bottle a measure is not used because complete and accurate
transfer of a suspension is not possible once it has been made up to volume.
9. Add any volatile solid ingredients previously dissolved in some of the vehicle and mix
well.
10. Add any liquid ingredients raise the measures and mix well after each addition.
11. Rinse the mortar and pestle with successive volumes of the vehicle until they are quite
clean transferring the rinsing to the bottle.
12. Make up to volume with the vehicle and shake thoroughly

Suspensions containing diffusible solids

• Diffusible solid (also called dispersible solids) are light and easily wettable solids.
• They readily mix with water and on shaking diffuse evenly through the liquid for long
enough for a dose to be measured. (Ensure even distribution in each dose.)
• Examples of diffusible solids are light kaolin magnesium Trisilicate light magnesium
carbonate and calcium carbonate.

Suspensions containing indiffusible solids

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 Pharmaceutical compounding I

Indiffusible solids will not remain evenly distributed in a vehicle long enough to ensure
uniformity of dose. Examples include chalk, zinc oxide, calamine aspirin and phenobarbitone.
The simplest way of correcting this problem is to increase the viscosity of the formation of
aggregates that settle rapidly.

The thickening agents used to stabilize suspensions is substances that spontaneously

formcolloidal dispersions in aqueous media because of their affinity to water.
There are three major groups of thickening agents:
1. Polysaccharides include acacia, tragacnath, methylcellulose, sodium alginate,
microcrystalline cellulose sodium carboxymethyl cellulose starch etc.
2. Inorganic agents include bentonite veegum hectorite aluminium hydroxide etc
3. Synthetic agents include carboxyvinyl polymer(carbomer) colloidal silicon dioxide etc

Containers and labeling:

 Suspensions are generally packed in well closed containers appropriate to the class of
dispensed medicine be it mixture lotion ear drop, enema etc.
 If the preparation is particularly viscous a wide mouthed container may be used.
 Containers of suspensions should be of suitable size to allow shaking of the products.
 Labels for suspensions includes:
- Shake well before use
- Store in cool place (not refrigerator)
- Also expiry dates for suspensions that should be prepared recently is one month and
if diluted two weeks.

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 Pharmaceutical compounding I

Skills practice session 4-19

Compounding of pediatric kaolin mixture, BP 1988A
Purpose:The purpose of this activity is to enable you to practice the preparation methods,
weighing, dissolution techniques and equipments used in compounding of Pediatric Kaolin
Mixture, BP 1988suspension
Instruction
Prepare and supply 50ml Pediatric Kaolin Mixture, BP 1988 suspension using the following
formula
Light kaolin ………………………………….200 g
Amaranth Solution…………………………….10ml
Benzoic Acid Solution………………………..20ml
Raspberry Syrup……………………………...200ml
Chloroform Water (D.S.)……………………..500ml
Water to ………………………………………1000ml
Send50 ml
Shake well before use
Storage: Unless the kaolin has been sterilized, the preparation should be recently prepared.
Uses:- Anti diarrhea mixture for children. It Maintains fluid intake in diarrhea
Direction for use: 1tsp tid

Role of the ingredients

 Light kaolin: Active ingredients
 Amaranth Solution: Colorant
 Benzoic Acid Solution: Preservatives
 Raspberry Syrup: Flavoring agent
 Chloroform Water (D.S): Preservatives
 Water: Vehicle

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 Pharmaceutical compounding I

Conditions or situation for the operations

 Diffusible solids are those substances which do not dissolve in water but on shaking they
can be mixed with it and remain evenly distributed throughout the liquid.
 On standing these settle at the bottom and requires re shaking of the bottle each time
whenever a dose is to be measured.
 Kaolin is a diffusible solid and therefore no additional suspending agent is required,
although the raspberry syrup increases the viscosity of the vehicle.
Resources (Equipment tools and Materials)
Chemicals/Ingredients
 Light kaolin
 Amaranth Solution
 Benzoic Acid Solution
 Raspberry Syrup
 Chloroform Water (D.S.)
 Purified water
Equipments/Tools
 Beam/digital balance
 Spoon spatula
 Amber colored medicinal bottle
 Mortar and pestle
 Erlenmeyer flask/ Conical graduates
 Measuring cylinder
 Pipettes
 Weighing paper
 Label –white paper

119
 Pharmaceutical compounding I

(To be completed by students/Peers)

Rate the performance of each step or task observed using the following rating scale:
1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary),
or is omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if
necessary) but participant/student does not progress from step to step efficiently
3. Proficiently Performed: Step or task performed efficiently and precisely in the proper
sequence (if necessary)

Procedure-learning guide/checklist
Rate
S. No Step/Task Proficiently Competently Needs Remark
Performed Performed Improvement
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Tare the bottle to the desired volume
by using purified water
8 Weigh Light kaolin
9 Measure
 Amaranth Solution
 Benzoic Acid Solution
 Raspberry Syrup
 Chloroform Water (D.S.)
 Purified water
1 Add the kaolin to the mortar and
prepare a paste with the syrup and a

120
 Pharmaceutical compounding I

0 little of the chloroform water. Add

the amaranth solution and mix well.
1 Dilute the suspension until pourable
1 and transfer to the bottle.
1 Incorporate remaining t chloroform
2 water before making up to volume
with water
1 Add the benzoic acid solution to the
3 bottle and make up to the final
volume and shake thoroughly
1 Clean the working equipments and
4 the surroundings
1 Label
5
1 Complete the Recordings and
6 documentation
1 Store the preparation to an
7 appropriate place

Skills practice session 4-20

Compounding of magnesium sulfate mixture (oral suspension) BP.88

121
 Pharmaceutical compounding I

Purpose:The purpose of this activity is to enable you to practice the preparation methods,
weighing, dissolution techniques and equipments used in compounding of Magnesium Sulfate
mixture (Oral Suspension)BP.88
Instruction
Prepare and supply 20mlMagnesium Sulfate mixture BP.88 (Magnesium Sulfate Oral
Suspension) using the following master formula
Magnesium sulfate……………………………………………….. 400 g
Light magnesium carbonate………………………………………..50g
Concentrated peppermint emulsion……………………………….25g
Double strength chloroform water……………………………….300ml
Water FBC sufficient to produce……………………………….1000ml
Send 20 ml
Advice for patients:Shake well to bottle before use

Actions and uses: as laxative.

Storage and shelf life: the mixture should be recently prepared.

Direction for use:10 ml t.i.d.

Role of the ingredients

 Magnesium sulfate:active ingredient
 Light magnesium carbonate: active ingredient
 Concentrated peppermint emulsion: flavoring and acts as a carminative
 Double strength chloroform water: acts as flavoring, preservative and vehicle
 Water FBC: Vehicle/solvent
Resources (equipment tools and materials)
Chemicals/Ingredients
o Magnesium sulfate
o Light magnesium carbonate
o Concentrated Peppermint emulsion

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 Pharmaceutical compounding I

o Double strength Chloroform water

o Purified water

Equipments/Tools
o Beam/digital balance
o Spoon spatula
o Amber colored medicinal bottle
o Mortar and pestle
o Measuring cylinder
o Pipettes
o Weighing paper
o Label –white pipettes
(To be completed by students/Peers)
Rate the performance of each step or task observed using the following ratingscale:
1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary), or is
omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if necessary) but
participant/student does not progress from step to step efficiently
3. Proficiently Performed: Step or task performed efficiently and precisely in the proper sequence
(if necessary)

123
 Pharmaceutical compounding I

Procedure-learning guide/checklist
Rate
S. No Step/Task Proficiently Competently Needs Remark
Performed Performed Improvement
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench

5 Clean equipments
6 Develop your working formula
7 Tare the bottle to the desired
volume by using purified water
8 Weigh Magnesium sulfate and
Light magnesium carbonate
9 Measure Concentrated Peppermint
emulsion and Double strength
Chloroform water
10 Mix the magnesium sulfate and
light magnesium carbonate in the
mortar
11 Add enough vehicle to make a
smooth paste and dilute with the
vehicle unit sufficiently pour able to
transfer to the bottle
12 Transfer into the tarred Bottle; the
volatile peppermint emulsion and
adjust to the final volume
13 Clean the working equipments and
the surroundings
14 Label

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 Pharmaceutical compounding I

15 Complete the Recordings and

documentation
16 Store the preparation to an
appropriate place

Skills practice session 4-21

Compounding of phenolated calamine lotion,USP

Purpose:The purpose of this activity is to enable you to practice the preparation methods,
weighing, dissolution techniques and equipments used in compounding of Phenolated Calamine
Lotion, USP
Instruction
Prepare and supply 50ml of phenolated Calamine Lotion B.P using the following master
formula
Calamine powder………………… 80 g
Zinc oxide powder…………………85g
Bentonite powder………………….20g
Liquid phenole……………………10ml
Glycerin………………………….20ml
Calcium Hydroxide solution to…1000ml

Send 50 ml
Direction for use: As directed
Storage and shelf life: The preparation is stable, cool storage is advised because of the
volatile preservative.
Advice for patients when dispensed: Shake the bottle; For external use only. The lotion
is applied to the skin as required and allowed to dry.
Actions and Uses: Cooling lotion useful for treating mild sunburn.

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 Pharmaceutical compounding I

Role of the ingredients

 Calamine powder:Active ingredient, astringent and soothing to the skin
 Zinc oxide powder: Active ingredient, astringent and soothing to the skin
 Bentonite powder: Thickening agent
 Liquid phenol: Preservative
 Glycerin: emollient (assists application) miscible with the aqueous vehicle
 Calcium Hydroxide solution : cause partial deflocculating of the calamine and so
make the preparation more pourable
Resources (equipment tools and materials)
Chemicals/Ingredients
 Calamine powder
 Zinc oxide powder
 Bentonite powder
 Liquid phenol
 Glycerin
 Calcium Hydroxide solution
Equipments/Tools
 Beam/digital balance
 Spoon spatula
 Amber colored medicinal bottle
 Mortar and pestle
 Measuring cylinder
 Pipettes
 Weighing paper
 Label –white paper

(To be completed by students/Peers)

126
 Pharmaceutical compounding I

Rate the performance of each step or task observed using the following rating scale:
1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary),
or is omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if
necessary) but participant/student does not progress from step to step efficiently
3. Proficiently Performed: Step or task performed efficiently and precisely in the proper
sequence (if necessary)

Precaution: Liquefied phenol is very caustic so do not use mouth to pipette the liquid. Use a
small measuring cylinder or a treated pipette
Procedure-learning guide/checklist
Rate
S. No Step/Task Proficiently Competently Needs Remark
Performed Performed Improvement
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Tare the bottle to the desired volume
by using purified water
8 Weigh Calamine powder, Zinc oxide
powder and Bentonite powder
9 Measure Liquefied Phenol,Glycerin
and Calcium Hydroxide solution
10 Mix the dry powders in the mortar
until evenly dispersed
11 Add bentonite in to powders and
Triturate well to distribute

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throughout the indiffusible powders

12 Add calcium hydroxide solution to
make a smooth paste and to dilute
the formed paste for transfer to the
bottle
13 Transfer in to the tarred bottle

14 Add Liquid phenol, the Glycerin and

sufficient quantity of water to make
up the required volume.

15 Clean the working equipments and

the surroundings
16 Label
17 Complete the Recordings and
documentation
18 Store the preparation to an
appropriate place

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4.2.3. Compounding of Emulsions

 An emulsion is a disperse system consisting of two immiscible liquids, usually water and
oil, one of which (the disperse phase) is distributed throughout the other (the continuous
phase) as small globules.
 Since this type of dispersion is inherently unstable, the system is stabilized by the
presence a third component, the emulsifying agent (emulgent, emulsifier).

Common types of Emulsions

Emulsions can be classified into:
1. Oil in water (O/W), in which the oil is dispersed in the water, i.e. the continuous phase is
aqueous).
2. Water in oil (W/O) in which the water is dispersed in the oil, i.e. the continuous phase is
oily.

Determination of Emulsion Type

Tests for distinguishing between O/W and W/O emulsions include:
1. Dilution Test (Miscibility Test): It involves dilution of an emulsion with water or oil.
2. Dye-solubility Test (Staining Test): It involves the use of dyes soluble only in either the
aqueous or the oil phase of an emulsion, but not in both phases, e.g. Scarlet red, Sudan
III.
3. Conductivity Test: It uses the fact that an O/W emulsion possesses a much higher
conductivity that a W/O emulsion.
Stability of Emulsions
A stable emulsion is one in which the globules
o Retain their initial character (i.e., mean size and size distribution); and
o Remain uniformly distributed throughout the continuous phase.

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Instability in emulsion includes:

1. Cracking (Breaking) coalescence of the dispersed globules and separation of the
disperse Phase as a separate layer. In an emulsion, this has broken; simple mixing
fails to re-establish the stable emulsion.
2. Creaming-the formation of a layer of relatively concentrated emulsion.
3. It is a less serious type of instability than cracking because a creamed emulsion may
be made homogenous again by shaking. Nevertheless, it is undesirable because the
closeness of the globules in the cream favors breakdown of interface and consequent
coalescence of the globules. Large droplets cream more rapidly coalesce more
readily in the cream; therefore, the emulsion may eventually crack.
Phase inversion-the change of an emulsion from O/W to W/O emulsion or vice versa.

Small-Scale Preparation an Emulsion

 Good emulsions can be prepared on a small scale using a mortar and pestle although its
efficiency is limited and the globule size may be larger than 10µm.
 Electric Mixer may also be used on a small scale although entrapped air may be a
problem.
 Since the quality and stability of the product is improved by decreasing globule size
and by reducing the size range of globules in the disperse phase the use of
homogenizers recommended.
 When using may of the highly active synthetic agents, it is possible to obtain excellent
preparations by simply adding the warmed phases to a beaker and stirring until cool. In
place of a beaker, the phases can sometimes be placed into a bottle, which is then
shaken.

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A. Mortar and pestle: This approach is used for those emulsions that are stabilized by the
presence of a multimolecular film (e.g., Acacia, tragacanth and agar) at the interface.
There are two basic methods.
i) The Wet Gum (or so-called English) Method. In this method, the emulsifying agent is
placed in the mortar and dispersed in water to form mucilage. The oil is added in
small amounts with continuous trituration, each portion of the oil being emulsified
before adding the next increment.
ii) The Dry Gum (or so-called continental) Method. In this method, preferred by most
pharmacists, the gum is added to the oil, rather than the water as with the wet gum
method.
In both the Dry Gum and the Wet Gum methods, a primary, or concentrated, emulsion is first
prepared using a set ratio of oil, water, and gum (emulsifying agent) from which the final product
is obtained by dilution with the continuous phase.

Acacia Emulsions
Unless otherwise specified, extemporaneously prepared emulsions for internal use are made with
acacia gum. To prepare acacia emulsions using a pestle and mortar, a thick (primary) emulsion
must be made first. The quantities for primary emulsions have been determined by experience.
‘Parts’ is interpreted as parts by volume for fixed, mineral, and volatile oils, and part by weight
for oleoresins and acacia.
Quantities for Primary Emulsions
Types of oil Examples Quantities for primary emulsions (Parts)
Almond oil oil Water Gum (Acacia) Tragacanth
Fixed oil Arachis oil
Castor oil 4 2 1 0.1
Cod-liver oil
Mineral oil Liquid paraffin 3 2 1 0.1
Volatile oil Turpentine oil
Cinnamon oil 2 2 1 0.1
Peppermint oil
Oleo-resin Male fern extract 1 2 1 0.1

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NB. The amount of trangacanth needed is only one-tenth of the acacia amount.
When an emulsion contains two or more oily liquids the quantity of acacia for each is calculated
separately and the sum of these quantities used.

The method is as follows:

1. Measure the oil very accurately in a dry measure: pour it into the bottom of a large,
perfectly dry, flat bottomed mortar and allow the measure to drain by resting it against
the head of a dry flat-headed pestle placed in the mortar.
2. While the oil is draining, measures the quantity of water or aqueous vehicle required for
the primary emulsion in a clean measure and place this within easy reach.
3. Weigh the acacia powder.
4. Remove the oily measure from the mortar: place the gum on the oil and mix lightly for
just long enough to disperse the Jumps. Take care to keep the suspension in the bottom
of the mortar. Do not over mix.
5. Immediately add all the previously measured water and stir continuously but lightly in
one direction until the mixture thickens under the pestle. Then triturate vigorously (i.e.,
Stir and mix vigorously in the mortar).
6. When the primary emulsion is well formed there is usually a characteristic ‘Cracking’
sound. Continue to triturate for a further 2-3 minutes to produce a white, stable emulsion.
The finer the dispersion the whiter the product.
7. Gradually dilute the primary emulsion with small volumes of the vehicle ensuring
complete mixing between additions.
8. Transfer to a measure and make up to final volume.
9. If necessary, decant through a muslin strainer into a calibrated bottle.

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Problems:
Sometimes the primary emulsion does not form properly and the contents of the mortar become
oily, thin and translucent. This is due to phase inversion, the product, which has become a W/O
emulsion cannot be diluted with water and must therefore be discarded.

Possible causes are:

 Insufficient shear between the mortar base and the pestle head.
 Inaccurate measurement of water or oil.
 Cross contamination of water or oil.
 Excessive mixing of oil and gum.
 Too early or too rapid dilution of the primary emulsion.
 Poor quality acacia.

B. Other Methods
An increasing number of emulsions are being formulated with synthetic emulsifying
agents,especially of the non-ionic type.
 When using many of these highly active synthetic agents, it is possible to obtain
excellent preparations by simply adding the warmed phases to a beaker and stirring
until cool. In place of a beaker, the phases can sometimes be placed into a bottle,
which is then shaken.
 With hand homogenizers an initial rough emulsion is formed by titration in a mortar
or shaking in a bottle. The rough emulsion is then passed several times through the
homogenizer.
Containers and Labeling
Emulsions should be supplied in well-filled containers with airtight closures. For viscous
preparations wide-mouthed amber glass bottles are most appropriate.
Labeling: shake the bottle, store in cool place but avoid freezing.

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Skills practice session 4-22

Compounding of pharmaceutical castor oilemulsion

Purpose: The purpose of this activity is to enable you to practice the preparation methods,
weighing and dissolution techniques in the compounding of castor oil emulsion
Instruction
Prepare and supply 20ml of castor oil emulsion using the following master formula

Castor oil……………. 8 ml
Acacia in powder………2gm
Water q.s……………… 20 ml
Send 20 ml
Advice for patients:Shake well to bottle before use
Storage and shelf life: the mixture should be recently prepared and should be stored in a cool place.
Actions and uses: This emulsion is used as a purgative since castor oil is purgative in nature
Direction for use: Three 5ml spoonfuls to be taken three times a day with meals

Role of the ingrsdients

 Castor oil: Active ingredient
 Acacia in powder: Emulsifying agent
 Purified water: vehicle

Conditions or situation for the operations

Here wet gum method is used for the preparation of emulsion. Castor oil is a fixed oil and is
immiscible with water. To make it miscible a third substance known as emulsifying agent is
added in the ratio of oil: water : gum 4 : 2 : [Link] the preparation of the primary emulsion. Here in
this preparation gum acacia is used as emulsifying agent. Emulsions prepared with gum acacia
remain stable for sufficiently long time. It is an o/w type of emulsion for internal use.

Formula for the primary emulsion

Oil water gum

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 Pharmaceutical compounding I

4 2 1
8 ml 4 ml 2 gm

Resources (equipment tools and materials)

Chemicals/Ingredients
 Castor oil
 Acacia in powder
 Purified water
Equipments/Tools
 Beam/digital balance
 Spoon spatula
 Amber colored medicinal bottle
 Mortar and pestle
 Measuring cylinder
 Pipettes
 Weighing paper
 Label –white paper
(To be completed by students/Peers)
Rate the performance of each step or task observed using the following rating scale:
1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary),
or is omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if
necessary) but participant/student does not progress from step to step efficiently
3. 3. Proficiently Performed: Step or task performed efficiently and precisely in the proper
sequence (if necessary)

Procedure-learning guide/checklist
Rate
[Link] Step/Task
Proficiently Competently Needs Remark

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 Pharmaceutical compounding I

Performed Performed Improvement

1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Tare the bottle to the desired
volume by using purified water
8 Weigh Acacia in powder

9 Measure Liquid phenol ,Glycerin

and purified water

10 Thoroughly clean and dry a pestle

and mortar
11 Transfer the weighed acacia powder
in to the mortar
12 4 ml of water and triturate it with
gum so as to form mucilage
13 To this add 8 ml of castor oil in
small quantities at a time with
thorough Trituration after each
addition
14 Triturate briskly without ceasing
until a clicking sound is produced
and the product becomes white or
nearly white
15 Add more of the vehicle in small
quantities with constant Trituration
so as to get a homogenous product
and transfer in to the bottle
16 Add more of the vehicle to produce
the required volume.
17 Clean the working equipments and
the surroundings

18 Label

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 Pharmaceutical compounding I

19 Complete the Recordings and

documentation
20 Store the preparation to an
appropriate place

Skills practice session 4-23

Preparation of concentrated peppermint emulsion

Purpose: The purpose of this activity is to enable you to practice the preparation methods and
dissolution techniques in the compounding of concentrated peppermintEmulsion

Instruction
Prepare 50 ml of Concentrated Peppermint Emulsion using the following formula
Peppermint Oil ……………………………………………20ml
Polysorbate 20 …………………………………………..1ml
Chloroform Water (DS)………………………………500ml
Water to…………………………………………………….1000ml
Send 50 ml
Actions and uses: Flavoring agent
Storage: store at cool place

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Purpose of the ingredients

 Peppermint Oil: Oily component f the emulsion
 Polysorbate 20: emulsifying agents
 Chloroform Water (DS): flovorant
 Water: Aqueous phase of the emulsion

Resources (equipment tools and materials)

Chemicals/Ingredients
 Peppermint Oil
 Polysorbate 20
 Chloroform Water (DS
 Water

Equipment/Tools
 Measuring cylinder
 Dropper/pipette
 Dispensing bottle

(To be completed by students/Peers)

Rate the performance of each step or task observed using the following rating scale:
1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary), or is
omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if necessary) but
participant/student does not progress from step to step efficiently
3. Proficiently Performed: Step or task performed efficiently and precisely in the proper sequence
(if necessary)
** You will only be competent when you efficiently perform all the steps

Procedure-learning guide/checklist
Rate

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 Pharmaceutical compounding I

[Link] Step/Task Proficiently Competently Needs Remark

Performed Performed Improvement
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Tare the final bottle
6 Measure all the ingredients and
put on working bench
7 Add Peppermint Oil to the
tarred bottle and add poly
Sorbate 20 to the peppermint
oil gradually, shaking well
after each addition
8 Add the (DS) chloroform water
and sufficient water to produce
1000ml ;shake well after each
addition.
9 Label
10 Clean the working equipments
and the surroundings
11 Complete recordings and
documentation
12 Store the weighed zinc oxide
to an appropriate place

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4.2.4. Compounding of Semisolid dosage forms

Ointments
Ointments are semisolid preparations intended for external application to the skin or mucous
membranes. Ointments may be medicated or non- medicated the later type being commonly
referred to as ointment bases and are used as such for their emollient or lubricant effect of used
as vehicles in preparation of medicated ointments. There are four main classes of ointment bases.
 Hydrocarbon bases:
Hydrocarbon bases are composed of oleaginous compounds having low water content
and hydrophobic. On application to the skin, they have an emollient effect, protect
against the escape of moisture, are effective as occlusive dressings, can remain on the
skin for long periods without drying out, and because of their immiscibility with water
are difficult to wash off.
Example: white petrolatrum and white ointment,USP

 Absorption bases
Absorption bases are hydrophilic,anhydrous materials or hydrous bases that have the
ability to absorb additional water. The former are anhydrous bases, which absorb water to
become W/O emulsions; the latter are W/O emulsions, which have the ability to absorb
additional water. The word absorption in this context refers only to the ability of the base
to absorb water.
Examples: hydrophilic petrolatum and anhydrous lanolin,

 Water-miscible bases:
These bases are O/W emulsion bases, commonly referred to as creams, and represent the
most commonly used type of ointment base. By far the majority of commercial
dermatologic drug products are formulated in an emulsion (or cream) base. Emulsion
bases are washable and removed easily from skin or clothing.
Example:Hydrophilic Ointment,USP
 Water soluble bases:
Soluble ointment bases, as name implies, are made up of soluble components or may
include gelled aqueous solutions

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Example:Polyethylene glycol (PEG) ointment,NF

Preparation of ointments
Ointments are not applied primary to irritated areas it is an on broken wound rule that these
preparations must contain granular or gritty particles, which might cause further irritation
regardless of the condition of the skin. Ointments must be smooth and free from granular or
gritty particles.

Three types of equipments are available for the preparation of ointments

1. Ointment slab and spatula
2. Mortar and pestle
3. Ointment fill

Two techniques are used in mixing ointments

a) Mixing by fusion
On a small scale, fusion is usually carried out in an evaporating basin water bath. Fusion
is necessary when waxes, hard paraffin, fatty alcohols, fatty acids or any hard wax- like
material is included in the formula. Fusion is used also when a medicament is soluble in
the melted base.
b) Mixing by trituration
This method is applicable when the medicament is a solid insoluble in the bases or liquid
present in small amount. Trituration may become out with an ointment tile and spatula or
using a mortar and pestle.

Packaging of ointments:
 Ointments are dispensed in either ointment or collapsible tube. However, ointments
prepared extemporaneously are usually packed in ointment jar.
 The ointment should be packed and the top surface should be smoothed neatly.
 Ointments jars should be closed tightly when not in use particularly if the ointment
consisting water to prevent loss though operation.
Storage of ointments:
Ointments should be stored in a cool place to prevent softening and eventually liquefiable in the
base. Insoluble medicament may settle to the bottom of the container if the ointment is permit to

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liquefy. Excessive heat or cold may cause an emulsion base to separate into two phases.

Pastes
Pastes are ointment-like preparations intended for external application. Most paste differ from
ointments in containing large amounts of finely powdered solids, thus they are usually stiffer
than ointments, less greasy and more absorptive.
They are applied generously, either with a spatula or spread on lint or other dressing and are not
removed for long periods.

Compounding and packaging of pastes:

For all practical purposes, pastes are prepared in the same manner as ointments
Pastes are generally packed in glass ointment jars. They are often too viscous for easy extrusion
from tubes.

Gels
Jellies are transparent or translucent, non-greasy, semisolid gels generally applied externally
Jellies are used for medication (Medicated jellies), lubrication (Lubricating jellies) and some
miscellaneous applications

Formulation of Gels

Gelling agents are usually organic hydrocolloids but, occasionally, hydrophilic inorganic
substances
Organic hydrocolloids: Tragacanth, Sodium alginate, Pectin, Starch, Gelatin, Cellulose
derivatives (Methylcellulose, Sodium carboxymethylcellulose, Hydrroxypropyl methylcellulose),
Carbomer, Polyvinyl alcohols, and others
Hydrophilic inorganic substances: Clays like bentonite

Other additives for gels

 Humectants:a substance used to reduce the loss of moisture from the preparation. Loss
of water can quickly lead to coarsening of the matrix and humectants such as glycerol,

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propylene glycol or Sorbitol Solution may be added to retain water

 Preservatives: Gels have high water content and therefore are liable to support microbial
growth unless a suitable preservative is added
NB The chosen preservative must be compatible with the gelling agent
 Chelating agents:are ingredients that bind with metal ions or metallic compounds,
preventing contamination or discoloration Bases and medicaments sensitive to heavy
metals are sometimes protected by chelating agents such as EDTA
Packaging
Lubricating jellies should be packed in collapsible tubes. However, stiffer gels for application to
the skin may be supplied in ointment jars
Containers should be well filled and airtight to prevent evaporation
Storage
Jellies should be stored in a cool place to prevent loss of water via evaporation

General method of compounding for gels

1. Heat all components of the gel (with the exception of water) to approximately 90°C.
2. Heat water to approximately 90°C.
3. Add water to oil, stirring continuously.
Avoid vigorous stirring as this will introducebubbles.
Creams
 In pharmacy the term ‘cream’ is reserved for external preparations.
 Creams are viscous semi-solid emulsionsfor external use.
 Medicaments can be dissolved orsuspended in creams.
 A cream may be ‘water-in-oil’ or ‘oil-in-water’ depending on the emulsifying agent used.
 A cream isalways miscible with its continuous phase.
o Water-in-oil creams (oily creams) as bases – Theseare produced by the
emulsifying agents of naturalorigin (e.g. beeswax, wool alcohols or wool fat).
o Oil-in-water creams (aqueous creams) as bases –These are produced by the
synthetic waxes ([Link] and cetomacrogol). They are the bestbases to use
for rapid absorption and penetrationof drugs. They are thin, white and smooth
inconsistency.

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Preparation of creams
 Creams may contain one or more medicaments in solution in one or other of the phases.
Finely powdered insoluble medicaments may also be dispersed in a cream base
 Generally, creams are prepared as follows
 The components of the oily phase (usually including the emulgent) are heated until
molten and the temperature rises to 75oc
 The components of the aqueous phase are mixed in a separate vessel and also heated to
75oc
 The aqueous phase is then added to the oily phase at the same temperature and the
resulting emulsion is stirred gently until cool
o Thermometer should be used to control the temperatures of the two phases
o Rapid cooling may result in separation of high melting point components
o Excessive aeration caused by vigorous stirring may also lead to a granular product

Packaging
 Wide-mouthed jars may be used for creams where the risk of contamination in use is
considered to be minimal, e.g. oily creams. The containers must be well closed and
prevent water evaporation. The mouth of the jar should be covered with a disc of
greaseproof paper
 Collapsible metal or flexible plastic tubes, however, are to be preferred since these reduce
the risk of contamination in use
o NB. Most proprietary cream products are packed in tubes

Storage
 Creams should be stored in a cool place but should not be allowed to freeze

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Skills practice session 4-24

Compounding of simple ointment
Purpose: The purpose of this activity is to enable you to practice the weighing mixing, melting,
and packing techniques of Simple Ointment
Instruction
Prepare and supply 25g of simple ointment(BP) using the following master formula
Wool fat……………………………………50 g
Hard paraffin………………………………50 g
Cetostearyl alcohol…………………….50 g
Yellow or White soft paraffin…………850 g
Send 25g
Storage: store in a cool place
Action and uses: Ointment base emollient

Role of the ingredients

 All are components of ointment base

Conditions or situation for the operations

Simple Ointment is an absorption base prepared by fusion. Yellow or white soft paraffin is
chosen according to the color of the finished product. In this case, since there is no dark colored
ingredient to be added, white soft paraffin should be used

Resources (equipment tools and materials)

Chemicals/Ingredients
 Wool fat
 Hard paraffin
 Cetostearyl acohol
 Yellow or White soft paraffin
Equipments/Tools
 Beam/digital balance
 Flexible spatula
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 Pharmaceutical compounding I

 Ointment slab/tile
 Waxed papers /watch glass
 Glass rode
 Water bath/hotplate
 Spoon spatula
 Ointment Jars
 Evaporating dish
 Weighing paper
 Label –white paper

(To be completed by students/Peers)

Rate the performance of each step or task observed using the following rating scale:
1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary), or is
omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if necessary) but
participant/student does not progress from step to step efficiently
3. 3. Proficiently Performed: Step or task performed efficiently and precisely in the proper sequence
(if necessary)

Procedure-learning guide/checklist
Rate
S. No Step/Task
Proficiently Competently Needs Remark
Performed Performed Improvement
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Weigh wool fat, hard paraffin(after
grating), Cetoctearyl alcohol and
Yellow or White soft paraffin

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 Pharmaceutical compounding I

8 Place the ingredient in an

evaporating dish on a water-bath
from high melting point to low
melting point to melt them all
9 Stir gently to aid melting and to mix
the ingredient

10 When homogenous, remove from the

heat and continue to stir gently until
cold
11 Transfer in to ointment Jars

12 Clean the working equipments and

the surroundings
13 Label
14 Complete the Recordings and
documentation
15 Store the preparation to an
appropriate place

Skills practice session 4-25

Compounding of Sulphur ointments

Purpose: The purpose of this activity is to enable you to practice the weighing mixing, melting,
levigating and packing techniques in compounding of Sulphur Ointment using Simple Ointment

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 Pharmaceutical compounding I

Instruction
Prepare and supply 25g of Sulfur Ointment, BP (BP) using the following master formula
Precipitated Sulfur, finely sifted………100 g
Simple ointment……………………………900 g

Send 25
Storage and Shelf life: Store in a cool place. An expiry date of 4 weeks is appropriate. For external use
only
Container: Wide-mouthed amber jar with a greaseproof paper disc
Advice for patient when dispensed: The skin should be cleansed prior to application and the ointment
applied sparingly to the affected area
Action and uses: Mild antiseptic used in the treatment of acne and scabies

Role of the ingredients

 Precipitated Sulfur:Active ingredients
 Simple ointment:Ointment base(vehicle)

Conditions or situation for the operations

The BP directs that the simple ointment be prepared with white soft paraffin. 25g of simple
ointment is adequate to ensure that 22.5g will be available (to compensate for the manipulative
losses)

Resources (Equipment tools and Materials)

Chemicals/Ingredient
 Precipitated Sulfure,
 Simple ointment
Equipment/Tools
 Beam/digital balance
 Flexible spatula
 Ointment slab/tile
 Waxed papers /watch glass

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 Pharmaceutical compounding I

 Glass rode
 Water bath/hotplate
 Spoon spatula
 Ointment Jars
 Weighing paper
 Label –white paper
(To be completed by students/Peers)
Rate the performance of each step or task observed using the following rating scale:
1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary),
or is omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if
necessary) but participant/student does not progress from step to step efficiently
3. 3. Proficiently Performed: Step or task performed efficiently and precisely in the proper
sequence (if necessary)

Procedure-learning guide/checklist
[Link] Step/Task Rate

Competently Competently Needs Remark

Performed Performed Improvement

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 Pharmaceutical compounding I

1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7
8 Weigh precipitated Sulfur required
and place it on the center of the
ointment tile
9 Weigh the required amount of
simple ointment (using a piece of
waxed paper), and place it on one
side of the tile
10 Take a portion of the base (about
two to three times the weight of the
power) and levigate it with the
sulfur until there is no sign of any
gritty particles (This can be checked
for by spreading a thin layer on the
tile).
11 Gradually incorporate the remaining
base in portions geometrically and
continue levigation until uniformly
mixed
12 Finally, collect the ointment
together to the center of the tile
using the spatula and pack into an
ointment jar
13 Clean the working equipments and
the surroundings
14 Label

15 Complete the Recordings and

documentation
16 Store the preparation to an
appropriate place

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 Pharmaceutical compounding I

Skills practice session 4-26

Compounding of emulsifying ointment, BP

Purpose: The purpose of this activity is to enable you to practice the weighing mixing, melting,
and packing techniques in compounding of Emulsifying Ointment BP
Instruction
Prepare and supply 25g of Emulsifying Ointment, BP) using the following master formula
Ingredients
Emulsifying Wax……………………………..30
White soft paraffin……………………………500 g
Liquid paraffin………………………………..200 g
Send 25g
Storage: store in a cool place
Action and uses: Ointment base emollient

Role of the ingredients

 All are components of ointment base

Resources (equipment tools and materials)

Chemicals/Ingredients
 Emulsifying Wax
 White soft paraffin
 Liquid paraffin

Equipments//Tools
 Beam/digital balance  Spoon spatula
 Flexible spatula  Ointment Jars
 Ointment slab/tile  Measuring cylinder
 Waxed papers /watch glass  Label –white paper
 Glass rode  Beaker
 Water bath/hotplate  Evaporating dish
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 Pharmaceutical compounding I

 Weighing paper
(To be completed by students/Peers)
Rate the performance of each step or task observed using the following rating scale:

1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary),
or is omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if
necessary) but participant/student does not progress from step to step efficiently
3. 3. Proficiently Performed: Step or task performed efficiently and precisely in the proper
sequence (if necessary)

Procedure-learning guide/checklist
[Link] Step/Task Rate

Proficiently Competently Needs Not

Performed Performed Improvement performed
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working
formula
7 Weigh Emulsifying Wax,
White soft paraffin, Liquid
paraffin
8 Place the ingredient in an
evaporating dish on a water-
bath from high melting point
to low melting point to melt
them all

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 Pharmaceutical compounding I

9 Stir gently to aid melting and

to mix the ingredient
10 When homogenous, remove
from the heat and continue to
stir gently until cold
11 Transfer in to ointment Jars

12 Clean the working

equipments and the
surroundings
13 Label

14 Complete the Recordings and

documentation
15 Store the preparation to an
appropriate place

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 Pharmaceutical compounding I

Skills practice session 4-27

Compounding of Benzoic acid ointment BP
Instruction
Prepare and supply 25g of Benzoic acid Ointment,(BP) using the following master formula
Benzoic acid………………………….60 g
Salicylic acid…………………………30 g
Emulsifying ointment……………….910g
Send 25

Storage and Shelf life: Store in a cool place

Container: Wide-mouthed amber jars with a greaseproof paper disc
Advice for patients when dispensed: The ointment should be applied sparingly to the affected area. It should not
be applied to the broken or inflamed skin
Action and uses: Topical antifungal preparation

Role of the ingredients

 Benzoic acid: active ingredient
 Salicylic acid: active ingredient
 Emulsifying ointment:ointment base

Resources (equipment tools and materials)

Chemical/Ingredients
 Benzoic acid
 Salicylic acid
 Emulsifying ointment
Equipments/Tools
 Beam/digital balance
 Flexible spatula
 Ointment slab/tile
 Waxed papers /watch glass
 Weighing paper

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 Pharmaceutical compounding I

 Glass rode
 Water bath/hotplate
 Spoon spatula
 180m sieves
 Ointment Jars
 Label –white paper

(To be completed by students/Peers)

Rate the performance of each step or task observed using the following rating scale:
1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary), or is
omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if necessary) but
participant/student does not progress from step to step efficiently
3. Proficiently Performed: Step or task performed efficiently and precisely in the proper sequence
(if necessary)

Precautions: Salicylic acid irritates the respiratory tract, so precautions should be taken to avoid
inhalation

Procedure-learning guide/checklist
[Link] Step/Task Rate

Proficiently Competently Needs Remark

Performed Performed Improvement
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working
formula
7 Sift the medicaments through
separate 180m sieves

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 Pharmaceutical compounding I

8 Weigh Benzoic acid and

Salicylic acid powder after
sifting and mix them
9 Place the mixed Benzoic acid
and Salicylic acid on one side
of the tile
10 Weigh the required amount of
Emulsifying Ointment (using a
piece of waxed paper), and
place it on one side of the tile
11 Take a portion of the base
(about two to three times the
weight of the power) and
levigate it with the powder
mixture until there is no sign
of any gritty particles (This
can be checked for by
spreading a thin layer on the
tile).
12 Gradually incorporate the
remaining base in portions
geometrically and continue
levigation until uniformly
mixed
13 Finally, collect the ointment
together to the center of the
tile using the spatula and pack
into an ointment jar
14 Clean the working equipments
and the surroundings
15 Label

16 Write short report/complete

the Recordings and
documentation
17 Store the preparation to an
appropriate place

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 Pharmaceutical compounding I

Skills practice session 4-28

Compounding of zinc oxide paste, U.S.P. 1990

Purpose:The purpose of this activity isto enable you to practice the preparation methods,
weighing, mixing, levitation and packing techniques in compounding of pastes
Instruction
Prepare and supply 20g of Zinc Oxide Paste, U.S.P. 1990 using the following master formula
Zinc oxide ,finely sifted……………………………..250g
Starch, finely sifted…………………………………..250
White petrolatum……………………………………500g
Send 25g
Storage: Store in a cool place
Container: Wide-mouthed amber jar with greaseproof paper disc
Advice for patient when dispensed: The paste should be spread thickly on white lint and applied to the affected
area
Action and Uses: Absorbent, protectant and mild astringent used for variety of dermatological conditions including
eczema and psoriasis either alone or with additional medicaments

Role of the ingredients

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 Pharmaceutical compounding I

 Zinc oxide, finely sifted :active ingredients

 Starch, finely sifted; Stiffening agent
 White petrolatum: Base
Resources (equipment tools and materials)
Chemicals/Ingredients
 Zinc oxide, finely sifted
 Starch, finely sifted
 White petrolatum

Equipments/Tools
 Beam/digital balance
 Flexible spatula
 Ointment slab/tile
 Waxed papers /watch glass
 Weighing paper
 180m sieves
 Glass rode
 Mortar and pestle
 Water bath/hotplate
 Spoon spatula
 Ointment Jars
 Label –white paper

(To be completed by students/Peers)

Rate the performance of each step or task observed using the following rating scale:
1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary),
or is omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if
necessary) but participant/student does not progress from step to step efficiently

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 Pharmaceutical compounding I

1. 3. Proficiently Performed: Step or task performed efficiently and precisely in the proper
sequence (if necessary)

Procedure-learning guide/checklist
S Rate
No Step/Task
Proficiently Competently Needs Remark
Performed Performed Improvement
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Sift the powders through separate
180m sieves
8 Weigh zinc oxide and starch
powder after sifting them

9 Weigh white petrolatum and Melt the

base with a minimum of heat on
water bath.
10 Mix the required weights of powders
in a warm mortar

11 Triturate the powder mixture with a

little melted base until smooth,
gradually adding the rest of the base

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 Pharmaceutical compounding I

mix until cooled

12 Finally, pack the paste in an ointment
jar
13 Clean the working equipments and
the surroundings
14 Label

15 Write short report/complete the

Recordings and documentation
16 Store the preparation to an
appropriate place

Skills practice session 4-29

Compounding of lubricating sodium carboxy methyl cellulose jellies

Purpose:The purpose of this activity is to enable you to practice the preparation methods,
weighing, mixing, and packing techniques in compounding of Jellies
Instruction
Prepare and supply 40g of Lubricating Jelly with Sodium Carboxy Methyl Cellulose (Na [Link] the
following master formula
Sodium Carboxy Methyl Cellulose ………………….....5g
glycerol………………………………………………….15
Methyl Hydroxybenzoate……………………………….01g
Patent Blue V…………………………………………..0.0001
Purified Water ,FBC to………………………………..100g

Send 40
Storage: Store in a cool place
Container: Collapsible metal tube
Advice for patients when dispensed: Not applicable
Actions and uses: Non-sterile lubricating jelly for lubricating rubber gloves for rectal examination

Role of the ingredients

 Sodium Carboxy Methyl Cellulose: Gelling agent

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 Pharmaceutical compounding I

 Glycerol: Humectant
 Methyl Hydroxybenzoate: preservative
 Patent Blue V: colorant as a warning that the preparation is not sterile and so
unsuitable for lubricating articles used in sterile regions of the body
 Purified Water: vehicle

Resources (equipment tools and materials)

Chemical/Ingredients
 Sodium Carboxy Methyl Cellulose
 glycerol
 Methyl Hydroxybenzoate
 Patent Blue V
 Purified Water
Equipments/Tools
 Beam/digital balance
 Weighing paper
 Glass rode
 Evaporating dish/Beaker
 Graduated cylinder
 Dropper
 Water bath/hotplate
 Spoon spatula
 Ointment Jars
 Label –white paper
(To be completed by students/Peers)
Rate the performance of each step or task observed using the following rating scale:
1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary), or is
omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if necessary) but
participant/student does not progress from step to step efficiently
3. 3. Proficiently Performed: Step or task performed efficiently and precisely in the proper sequence

161
 Pharmaceutical compounding I

(if necessary)
Procedure-learning guide/checklist
Ser. Step/Task Rate
No Proficiently Competently Needs Remark
Performed Performed Improvement
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Sift the powders through separate 180m sieves
8 Weigh All ingredients

9 Dissolve the methyl hydroxybenzoate in the

glycerol and add the sodium carboxymethyl
cellulose.
10 Heat the water to boiling separately
12 Triturate the powder mixture with a little melted
base until smooth, gradually adding the rest of
the base mix until cooled
13 Add the glycerol mixture to the hot water and
stir until a clear gel is formed
14 Add the dye solution, adjust to weight with hot
water and stir until cold
15 Label

16 Clean the working equipments and

surroundings
17 Complete the Recordings and documentation
18 Store the preparation to an appropriate place

Skills practice session 4-30

Compounding of bees’ wax-borax cold cream

162
 Pharmaceutical compounding I

Purpose:The purpose of this activity is to enable you to practice the preparation methods,
weighing, mixing, and packing techniques in compounding of Bees Wax-Borax Cold cream.
Instruction
Prepare and supply 20g ofBees Wax-Borax Cold cream the following master formula
Purified water…………………………………24g
Borax…………………………………………1.19g
Olive oil…………………………………………..50g
Bees Wax………………………………………..12g
White Soft Paraffin…………………………….12.5g
Send 20g
Storage: Store in a cool place but don’t allow to freeze
Container: Collapsible metal tube or wide mouthed jar
Action and Uses: Emollient cream base
 Note: the cooling effect in cold cream is caused due to the slow evaporation of water present in the internal phase

Role of the ingredients

 Purified water: The internal phase of the emulsioncream
 Borax: Component of emulsifing agent
 Olive oil: External (continuous phase of the emulsion cream, Component of
emulsifing agent
 Bees Wax: Component of emulsifing agentand oily phase
 White Soft Paraffin: Emmolient

Conditions or situation for the operations

 Cold cream is a water-in-oil emulsion
 The cream is self-emulsifying i.e., the emulgent is a product of reaction between borax
and free fatty acids of the oil and the wax.

Resources (equipment tools and materials)

Chemicals/Ingredients
 Purified water
 Borax

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 Pharmaceutical compounding I

 Olive oil
 Bees Wax
 White Soft Paraffin
Equipment/Tools
 Thermometer
 Beam/digital balance
 Waxy paper
 Weighing paper
 Glass rode
 Evaporating dish
 Beaker
 Water bath/hotplate
 Spoon spatula
 Ointment Jars
 Label –white paper

(To be completed by students/Peers)

Rate the performance of each step or task observed using the following rating scale:
1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary),
or is omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if
necessary) but participant/student does not progress from step to step efficiently
3. 3. Proficiently Performed: Step or task performed efficiently and precisely in the proper
sequence (if necessary)

Procedure-learning guide/checklist

164
 Pharmaceutical compounding I

Ser. Step/Task Rate

No Proficiently Competently Competently Remark
Performed Performed Performed
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Weigh All ingredients

8 Melt the beeswax and soft paraffin

on a water bath and then Add the
olive oil and continue heating to
75oC.
9 Dissolve the sodium borate (borax)
in the purified water and warm to
the same temperature (75oC)
10 Then, gradually add the aqueous
phase to the oil phase with gently
stirring
11 Maintain the temperature to 75oC
for about 10 minutes while stirring
On water bath
12 Take out from the water bath and
continue the stirring until cold
13 Transfer in to ointment jar

14 Label it

15 Clean the working equipments and

surroundings
16 Complete the Recordings and
documentation
17 Store the preparation to an
appropriate place

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 Pharmaceutical compounding I

Skills practice session 4-31

Compounding of vanishing cream
Instruction
Prepare and supply 30g of Vanishing Cream the following master formula
Purified water…………………………………79g
Stearic acid……………………………………15g
Potassium Hydroxide…………………………1.04g
Glycerin………………………………………..5g
Send 30g
Storage: Store in a cool place but don’t allow to freeze
Container: Collapsible metal tube
Actions and Uses: Hand or foundation cream
 Note: ‘Vanishing Creams’, because it leaves a very matt (dull), non-greasy residue on the hand to the
extent that the cream appears to vanish during application

Role of the ingredients

 Purified water: External phase of the emulsion cream
 Stearic acid: Part of emulsifying agents
 Potassium Hydroxide: part of emulsifying agent
 Glycerin: Humectant

Conditions or situation for the operations

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 Pharmaceutical compounding I

Cold cream is a water-in-oil emulsion

The cream is self-emulsifying i.e., the emulgent is a product of reaction between borax and free
fatty acids of the oil and the wax

Resources (equipment tools and materials)

Chemicals/Ingredients
 Purified water
 Stearic acid
 Potassium Hydroxide
 Glycerin
Equipments/Tools
 Beam/digital balance
 Waxy paper/watch glass
 Weighing paper
 Glass rode
 Evaporating dish
 Beaker
 Water bath/hotplate
 Spoon spatula
 Ointment Jars
 Label –white paper
(To be completed by students/Peers)
Rate the performance of each step or task observed using the following rating scale:
1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary),
or is omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if
necessary) but participant/student does not progress from step to step efficiently
1. 3. Proficiently Performed: Step or task performed efficiently and precisely in the proper
sequence (if necessary)

Procedure-learning guide/checklist

167
 Pharmaceutical compounding I

Ser. Step/Task Rate

No Proficiently Competently Needs Remark
Performed Performed Improvement
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Weigh All ingredients

8 Melt and heat the stearic acid to

75oC.

9 Dissolve the potassium

hydroxide in the purified water,
add the glycerin and warm to the
same temperature
10 Then, gradually add the aqueous
phase to the oil phase with
gently stirring
11 Maintain the temperature to
75°C for about 10 minutes while
stirring
On water bath
12 Take out from the water bath
and continue the stirring until
cold
13 Transfer in to ointment jar

14 Label it

15 Clean the working equipments

and the surrounding
16 Complete the Recordings and
documentation
17 Store the preparation to an
appropriate place
4.2.5. Compounding of Powders

168
 Pharmaceutical compounding I

Powders are solid preparations intended for either internal or external [Link] following typesof
preparation will be considered:
 Bulk powders for external use – termed dusting powders
 Bulk oral powders
 Individual unit dose powders
Bulk powders for external use
These are dry, free-flowing preparations consisting of one or a mixture of finely powdered
substances and intended for external application.

Bulk oral powders

Bulk oral powders resemble dusting powders with the exception that they are intended for oral
[Link] dose to be taken is measured with a 5 ml spoon, stirred into a quantity of
water and then [Link], this method of measurementcreates considerable
problems with regard to theexpected standards of precision of dosage.

Divided Powders
This form of powder may contain one or more active ingredients together with an inert diluents
to produce a minimum quantity (120mg) that can be weighed by the dispenser and handled by
the patient. After the powder blend is prepared, it can be subdivided into the required number of
doses by weighing or by using the block and divide method. The papers in which divided
powders are traditionally folded are called powder papers. The paper of choice for hygroscopic
or deliquescent powders is waxed paper because of its waterproof qualities. Also powders
containing volatile ingredients should be similarly wrapped.

Compounding method of powders

The basic techniques for the compounding of powders are weighing Size Reduction and Mixing
On a small scale the powdered ingredients may be mixed with a mortar and pestle using the
geometric dilution method.

Packaging:

169
 Pharmaceutical compounding I

For bulk powders

 For internal powders: Wide-mouth screw cap glass jars
o A 5ml spoon should be supplied for measuring dose
 For dusting powders: Colored glass or plastic jars with a reclose able perforated lid
For Divided powders
 Folded powder paper packets, Aluminum foils, Heat-sealed plastic bags

Storage and labeling:

 Store in a cool, dry place
 Powders intended to be used externally or locally should always bear “for external use”
or “For local use” auxiliary labels

Skills practice session 4-32

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 Pharmaceutical compounding I

Preparation of oral rehydration salts, BP 1988 (O.R.S)

Purpose: The purpose of this activity is to enable you to practice the preparation methods,
weighing, mixing, and packing techniques of Oral Rehydration Salts, BP 1988 (O.R..S)
Instruction
Prepare and supply Oral Rehydration Salts, BP 1988 (O.R.S) using the following master formula
Sodium Chloride………………………….1.0 g
Potassium chloride………………………..1.50g
Sodium Bicarbonate……………………..1.5g
Anhydrous Glucose…………………….36.4g

Send for two separate 100 ml doses

Storage: store in a dry place
Container: Wrap each dose (4.04 g) in powder papers, or supply each dose in an individual amber glass screw
capped jar or plastic pot
Advice for Patients when dispensed: Each dose of the powder should be dissolved in sufficient freshly boiled and
cooled water to make 100ml of solution taking hygienic precautions. After reconstitution any unused solution
should be discarded after 1 hour unless refrigerated when it may be kept for 12-24 hours
Actions and Uses: Rehydration and electrolyte replacement in the treatment of diarrhea

Purpose of the ingredients

 All are active for Rehydration and electrolyte replacement

Resources (equipment tools and materials)

Chemicals/Equipments
 Sodium Chloride
 Potassium chloride
 Sodium Bicarbonate
 Anhydrous Glucose
Equipment/Tools
 250m sieve
 Beam/digital balance
 Weighing paper
 Mortar and pestle
171
 Pharmaceutical compounding I

 Spoon spatula
 Powder papers
 Label –white paper
(To be completed by students/Peers)
Rate the performance of each step or task observed using the following rating scale:
1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary),
or is omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if
necessary) but participant/student does not progress from step to step efficiently
3. 3. Proficiently Performed: Step or task performed efficiently and precisely in the proper
sequence (if necessary)

Procedure-learning guide/checklist
Rate
Ser. Step/Task
Proficiently Competently Needs Remark
No
Performed Performed Improvement

1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Weigh All ingredients, make a small
excess to allow for losses in the
mortar

8 Mix the powders in a mortar in order

of increasing bulk

9 Pass the resulting mix through a

250m sieve, lightly remix and pack

10 Label

11 Clean the working equipments and

172
 Pharmaceutical compounding I

the surroundings
12 Complete the Recordings and
documentation
13 Store the preparation to an appropriate
place

Skills practice session 4-33

Preparation of zinc, starch and talc dusting powder, BPC 1973
Prepare and supply Zinc, Starch and Talc Dusting Powder, BPC 1973 the following master formula
Zinc oxide………………………….250 g
Starch, in fine powder……………250g
Purified talc, sterilized…………..500g
Send 15g
Storage: store in a dry place
Container: amber glass screw-capped jar or plastic pot with re closeable perforated lid
Advice for patients when dispensed: The powder should be dusted lightly on to the affected area. It should not be
applied to broken skin or to raw surfaces of large area
Actions and Uses: Adsorbent dusting powder

Role of the ingredients

 All are used as Adsorbent dusting powder

Resources (equipment tools and materials)

Chemicals/Ingredients
 Zinc oxide
 Starch, in fine powder
 Purified talc, sterilized
Equipments/tools
 180m sieve
 Beam/digital balance
 Weighing paper
 Mortar and pestle

173
 Pharmaceutical compounding I

 Spoon spatula
 Powder papers
 Label –white paper

(To be completed by students/Peers)

Rate the performance of each step or task observed using the following rating scale:
1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary),
or is omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if
necessary) but participant/student does not progress from step to step efficiently
3. 3. Proficiently Performed: Step or task performed efficiently and precisely in the proper
sequence (if necessary)

Procedure-learning guide/checklist
Rate
Ser. Step/Task Proficiently Competently Needs Remark
No Performed Performed Improvement
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Weigh All ingredients,
8 Mix the powders in a mortar in order
of increasing bulk

9 Pass the resulting mix through a

180m sieve, lightly remix and pack

10 Label

11 Clean the working equipments and

the surroundings
12 Complete the Recordings and

174
 Pharmaceutical compounding I

documentation
13 Store the preparation to an appropriate
place

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 Pharmaceutical compounding I

4.2.6. Compounding of Suppositories

 Suppositories are solid medicated preparations designed for insertion into the rectum to
exert local or systemic effect.
 Pessaries are similar solid medicated preparations designed for insertion into the vagina,
usually to exert local effect.

Formulation
 There are two main classes of suppository base
1. Fatty bases: designed to melt at body temperature
o Examples: Theobroma oil (cocoa butter), synthetic fats (Witepsols)
2. Water-soluble or water-miscible bases: designed to dissolve ordispersewithin the body
o Examples: Glycerogelatin bases, macrogol bases

Compounding
Suppository and Pessary moulds
 The normal capacities of commonly used moulds. 1g (15 gr), 2g (30 gr), 4g (60 gr), and 8g
(120 gr)
 The nominal capacity of mould implies a calibration using oil of theobroma and therefore
will vary with different bases depending upon their density
o NB. The capacity of moulds should be confirmed by filling each mould with base
alone, weighing the products and taking the mean weight as the true capacity

Displacement Value
 Displacement value:the number of parts by weight of medicament that displaces one part
by weight of the base
 Displacement values for fatty bases are similar to those for Theobroma oil
NB. When the medicament is prescribed as a percentage, the displacement value is irrelevant; to
use it would make the percentage incorrect

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 Pharmaceutical compounding I

Mould Lubrication
Base Lubricant
Theobroma Soap spirit (soft soap 10g), glycerol (10ml) and 90% alcohol (50ml)
Glycerol-gelatin bases Liquid paraffin or Arachis oil
Synthetic fats No lubricant required
Macrogol bases No lubricant required

NB. The chosen lubricant must be immiscible with the base and compatible with the medicament
and any other formulation additives

Preparation of Suppositories
Two methods mainly are used:
1. Compression or cold process: the drug is mixed with shredded vehicle and the mixture
then is forced into a mould and subsequently extruded
2. Fusion or hot process:- the drug is incorporated into the melted base and the mass is poured
into the mould just before it congeals (Principal method for the preparation of suppositories)

Preparation of Suppositories with Fatty Base

1. Calculate the required amounts
 It is usual to prepare for at least two more suppositories than are ordered to compensate
for the manipulation losses
2. Prepare the mold: Select a clean dry mould and place it on a clean tile
 The mould should be carefully washed in warm, soapy water and thoroughly dried
 Care should be taken not to scratch the internal surface
 Make sure that the two halves fit correctly to ensure that there is no leakage of material
3. Prepare the base. Weight shredded base into an evaporating basin
 Shredding the base speeds melting and helps to avoid over-heating
 Porcelain basins are to be preferred for fatty bases since their relatively poor heat
conductivity reduces the risk of over-heating
4. Prepare the medicament: Insoluble solids should be powdered if necessary and sieved before
weighing (180m). Other ingredients should be weighed or measured
5. Melt the base. Place the dish containing the shredded base on a water bath and heat until
about two-thirds of the content has melted. Remove from the heat and stir gently with a small

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 Pharmaceutical compounding I

spatula to allow the residual heat in the dish to melt the remainder of the base. (Overheating may
occur if the base is left over the heat until completely melted)
6. Incorporate the medicament
Insoluble solids
 Heat a small tile until it is comfortably warm to the hand
 Mix the powders on the tile with a flexible spatula
 Pour about half of the melted base on to the mixed medicaments and work into a smooth
dispersion as quickly as possible by levigating with the spatula. If the base solidifies it
can be softened by holding the tile over the water bath for a few seconds
 Transfer the dispersion to the dish, leaving virtually none on the tile, and stir to form a
homogenous mixture

Soluble solids, semisolids and liquids

 Incorporate directly into the molten base and stir to form a homogenous mixture
7. Fill the mould: The homogenous mixture in the dish should be stirred until the base begins to
thicken. Then fill each cavity in the mould to overflowing to allow for contraction on cooling. If
the consistency of the base is correct, the ‘overflow’ should remain above each cavity. If setting
occurs during pouring, the base can be very briefly re-heated to restore flow
NB The base should be stirred throughout to prevent sedimentation of insoluble solids
[Link] the excess. When the mass has set (2-3 minutes under normal circumstances),
contraction of the base will have occurred and the excess may be removed. Please the blade of a
firm spatula on the excess at one end of the mould and draw it across the mould pressing down at
the same [Link] process will tend to fill any holes in the suppositories, which may have
resulted from pouring too cold
 Reserve the excess together with the surplus mass in case there is a need to re-melt and
re-pour any failures
[Link] the mould: After 10 minutes standing in a cool place the suppositories may be removed
from the mould, inspected and packed

Additional Precautions for Theobroma Oil Suppositories

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1. Thoroughly lubricate the mould: Lubricant should be applied to all the inner surfaces
including the flat faces of the mould (Do not use cotton wool because it leaves fibers)
 After lubrication, close the mould and invert it on a clean paper or tile to allow any
excess lubricant to drain and cool it in a refrigerator or icebox
NB: Cooling hastens setting of the base and reduces sedimentation of suspended solids
2. Take particular care not to overheat the base (polymorphism)
 If melted at not more than 36oC and slowly cooled, it forms stable beta () crystals with
normal melting point
 If over-heated, it may produce, on cooling, unstable gamma () crystals which melt at
about 15oC or alpha () crystals melting at about 20oC
3. After pouring put the mould in an icebox or refrigerator and leave it for about 30min
4. If, through inadequate lubrication or though pouring too hot, the products adhere to the mould
on opening, push them out by their flat ends, to avoid damaging the tips.

Shelf life: Most suppositories and pessaries are stable preparations provided that the packaging
provides adequate protection and that the storage temperature is low
Containers: Extemporaneously prepared suppositories and pessaries should be individually
wrapped in metal foil or waxed paper (if the medicament interacts with metals). Glass or plastic
screw-cap jars are suitable containers, particularly for products that are hygroscopic

Special Labels and Advice

 Store in a cool place
 For rectal use only (suppositories) or for vaginal use only (pessaries)
 If appropriate, the patient should be advised to unwrap the product before use

Skills practice session 4-34

Compounding of glycerol suppositories BP 1988purpose:

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Purpose: The purpose of this activity is to enable you to practice the preparation methods,
weighing, mixing, molding and packing techniques in compounding of Glycerol suppositories
BP 1988
Instruction
Prepare and supply 6g child’s size of Glycerol suppositories BP 1988the following master formula
Gelatin………………………..414g
Glycerol………………………..70g
Purified water…………………..q.s (to produce 100g)
Send 20g
Storage: Store in a cool place
Container: Amber glass screw-capped jar or plastic pot
Advice for Patients when dispensed: After unwrapping, moisten with a little water and insert the suppository as high
as possible into the rectum
Actions & Uses: Promotes peristalsis and bowel evacuation in the treatment of constipation

Role of the ingredients

 Gelatin: Promotes peristalsis and bowel evacuation, base
 Glycerol: Promotes peristalsis and bowel evacuation, emollient
 Purified water: Vehicle

Conditions or situation for the operations

The usual size of a glycerol suppository for a child is 2g (1g for infants and 4g for adults)
Prepare sufficient base for 10 suppositories to allow for relatively large manipulative losses
The quantity of mass for 10 suppositories is
o 10x2x1.2 = 24g
In this case make 25g because that is a more convenient fraction of the master formula quantities
100 gram of base require 30ml of water, 25gram of base, therefore, require
o 30x25/100 = 7.5ml of water initially
Resources (equipment tools and materials)
Chemicals/Ingredients
 Gelatin
 Glycerol

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 Purified water
Equipments/tools
 Thermometer
 Suppository moulds
 Beam/digital balance
 Weighing paper
 Glass rode
 Evaporating dish
 Beaker
 Water bath/hotplate
 Spoon spatula
 Ointment Jars
 Label –white paper
(To be completed by students/Peers)
Rate the performance of each step or task observed using the following rating scale:
1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary), or is
omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if necessary) but
participant/student does not progress from step to step efficiently
3. Proficiently Performed: Step or task performed efficiently and precisely in the proper sequence
(if necessary)
** You will only be competent when you efficiently perform all the steps

Procedure-learning guide/checklist
Rate
Ser.N Step/Task
Proficiently Competently Needs Remark
o
Performed Performed Improvement
1 Wear Gown

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2 Wash your hands

3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Weigh and measure All ingredients

8 Boil purified water and Add the gelatin to it

is on water bath.

9 Add the glycerol previously heated to

100oC to the gelatin solution while it is on
water bath.
10 Heat the mixture on a water bath for 15
minutes or until solution is complete with
stirring
11 Adjust the weight of the product by the
addition of hot purified water or by
evaporation on a water bath.
12 Pour the solution in to an appropriate
suppository mould cavities carefully
13 Put in refrigerator until it gets chilled,
remove from the mould
14 Pack and Label

15 Clean the working equipments and

surroundings
16 Complete the Recordings and
documentation
17 Store the preparation to an appropriate place

Summary
There aredifferent types of formulations that could be prepared in prescription compounding.
These include; solution, suspension, emulsion, ointments, pastes, creams, gels and powders.

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Solution are homogenous liquid preparation containing one or more dissolved ingredients and
are used for a variety of purposes as both internal and external dosage forms. Solutions are
usually prepared by using appropriate dissolution techniques like checking solubility of the
solute. Agitation, shaking, stirring and heating may be applied for facilitating solution formation
process.
Suspension are dispersed systems in which finely divided drug practices (called the disperse
phase) are distributed thought out a vehicle (called dispersion medium or continues phase) in
which the drug exhibits a minimum degree of solubility. Compounding methods for suspensions
include fining the solid ingredients, mixing and triturating the insoluble powders using geometric
dilution method.

An emulsion is a disperse system consisting of two immiscible liquids, usually water and oil, one
of which (the disperse phase) is distributed throughout the other (the continuous phase) as small
globules. Most extemporaneously prepared emulsions are made with acacia gum. To prepare
acacia emulsions using a pestle and mortar a thick (primary) emulsion must be made first. Then
other excipients are added and diluted with vehicle to the required [Link], creams,
pastes and jellies are Semisolid preparations intended for external application to the skin or
mucous membrane. Different preparation methods are used for compounding semisolids like
mixing by fusion and trituration for ointments and pastes, dissolution heating for gels and
creams.
Self-check Questions
Instruction: choose the best answer from the given alternatives
1. A type of suspension that consists of two different liquids that are held together by a specific
agentis known as:
A. a gel
B. an elixir
C. an emulsion
D. a magma
2. To grind a powder into a smoother mixture, using moisture, is a process called:
A. pasteurization
B. agitation

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C. suspension
D. levigation
3. Which of the following dosage forms is prepared by the heat method?
A. syrups
B. emulsions
C. suspensions
D. elixirs
4. Which term means “reducing to a fi ne powder by grinding”?
A. trituration
B. suspending
C. agitation
D. atomization
5. Which of the following are not semisolid drugs?
A. pastes
B. creams
C. suspension
D. ointments

6. Which of the following can be used as an ointment base?

A. oil-in-water emulsions
B. water-in-oil emulsions
C. absorption and water-soluble bases
D. all of the above
7. Pastes are different from ointments, creams, and gels because:
A. They contain a higher content of solids.
B. They contain a lower content of solids.
C. They are compounded in a different manner than ointments.
D. none of the above
8. Which of the following bases is used for compounding suppositories?

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A. cocoa butter
B. polyethylene glycol
C. glycerinated gelatin
D. all of the above
9. Which of the following are the simplest dosage forms compounded extemporaneously?
A. solutions
B. suspensions
C. emulsions
D. suppositories
10. Which of the following must be shaken well before being administered?
A. solutions
B. suspensions
C. emulsions
D. elixir
11. A master formula sheet contains which of the following information?
A. the ingredients of a formulation
B. the manufacturer’s expiration date
C. the date it was prepared
D. all of the above

12. What are basic equipments used for the preparation of ointments?
A. ointment slab and spatula
B. mortar and pestle
C. ointments jar or fill
D. all of the above

Instruction: answer the following questions.

13. Creams differ from lotions in that lotions contain more _________________.
14. Describe general compounding methods of each liquid and semisolid preparation.
15. Discuss the role of pharmaceutical ingredients used in preparing suspensions and
emulsions.

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References
1. Jahangir Moini, Laboratory Procedures for Pharmacy Technicians. (2010), 1st [Link].
2. John F Marriot [Link] pharmaceutical compounding and dispensing. (2010), 2 nd ed. The
pharmaceutical press
3. Loyd V. [Link] Ansel’s pharmaceutical dosage forms and drug delivery systems (2011), 9 th ed.
Lippincott Williams and Wilkins.
4. Allen LV Jr, The Art, Science, and Technology of Pharmaceutical Compounding. 1998,
American Pharmaceutical Association
5. Ethiopian Hospital Services Transformation Guidelines volume 1, September 2016
6. Drug Administration and Control Authority (DACA) of Ethiopia, standards for the
establishment and practice of pharmaceutical compounding laboratory. September 2002

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