EXTEMPORANEOUS COMPOUNDING PREPARATION IN SMALL SCALE

PHARMACY LABORATOY
 PREPARE FOR PRODUCTION PROCESS

• 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
 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.

• - 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
• Compounding also includes the preparation of drugs or devices in
anticipation of prescription drug orders, on the basis of routine, regularly
observed prescribing patterns.
 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
 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 the
products 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 unit.
• The 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.
 Pharmacy Grooming Standards & Dress Code
• 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 safety
Hazard. 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.
 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.
 …cont

• 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
• All labels for labeling compounded medicines
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
Special labeling instructions for particular type of dispensed
dosage form

1 Ointments For external use only

2 Paints For external use only

3 Pastes For external use only

4 solutions For external use only

5 Gargles and Not to be swallowed in large amounts

mouth washes

6 Emulsions Shake the bottle before use

7 Creams For external use only, Store in a cool place

 Beyond-use Dating (BUD)
• Compounding professionals should avoid ingredients and conditions that could
result in excessive physical deterioration 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 is determined 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.
 Compounders should consult and apply drug-specific and general stability
documentation and literature when available, and should consider the nature of the
drug and its degradation mechanism, the container in which it is packaged, the
expected storage conditions, and the intended duration of therapy when assigning
a beyond-use date.
 At all steps in the compounding, dispensing, and storage process, the
compounder should observe the compounded drug preparation for signs of
instability. However, excessive chemical degradation and other drug concentration
loss due to reactions may be invisible more often than they are visible.
 Preparation of iodine solution
There are three types of iodine preparation

1. Weak iodine solution( lugol’s solution)

2. Strong iodine solution and

3. Iodine tincture
 Strong iodine solution
Ingredients M.F R.F
Iodine-------------10g
Potassium iodide—6g
purified water---10ml
Ethanol(90%)----100ml
Send 30ml

N.B: Use C1V1=C2V2 for Ethanol 90%,(Ethanol is

available as 99% or 95%.
 …cont

Compounding:- Dissolve KI2 and I2 in purified

water add sufficient ethanol to produce 30ml.

Use:- Antiseptic
Not to be taken through mouth

Storage:- Must be in well closed container.

* The materials of container should be resistant to

iodine ( the should be ambour in color )
 Preparation of iodine tincture
Ingredients M.F R.F
Iodine--------2g
potassium iodide-2.5ml
purified water--10ml
Ethanol(90%)--100ml

Mitt 30ml
 ….cont

Sig:- Not to be taken by mouth

• Store in a cool place and protect fro sun light

• Compounding:- Mill iodine and [Link] in

glass mortar.
• Add water to powder and mix it add sufficient
ethanol to produce 100ml.
• Transfer to final container and label it.
 …cont
 Action and Use:- Antiseptic
 The material of container should be resistant
to iodine.
 Pharmaceutical solutions
 Solution:-

 Is Liquid preparations that contain one or more

chemical substances dissolved in a suitable

solvent or mixture of miscible solvents.

 Classification of the solutions according to

pharmaceutical use:-

1- Anoral-solution, 2-Oticsolution,3-Ophthalmic
solution

4- Nasal solution 5- Topical solution

6- rectal and vaginal solutions (enema and

douche)
 …cont
 Classification of solutions according to their composition :-

 Syrups aqueous solutions containing a sugar.

 Elixirs sweetened (sugar) hydro alcoholic

(combinations of water and ethanol) solutions.

 Spirits solutions of aromatic materials if the solvent

is alcoholic or aromatic waters if the solvent is

aqueous.

 Tinctures are alcoholic or hydro alcoholic solutions

prepared from vegetable materials or from chemical

substances.
Some Solvents for Liquid Preparations:
1- Alcohol, USP (Ethyl Alcohol, Ethanol, C [Link])
Next to water, Alcohol is the most useful solvent in pharmacy.
• It is used as a primary solvent for many organic compounds
together with water it forms a hydro alcoholic mixture that
dissolves both alcohol- soluble and water-soluble substances
and it is useful in the extraction of active constituents from
crude drugs.

 By varying the proportion of two agents (water and alcohol),

the active constituents may be selectively dissolved and
extracted.

 Alcohol, USP, is 94.9 to 96.0% C2H5OH v/v. Dehydrated Alcohol-

USP, contains not less than 99.5 % C2H5OH by volume.

• N.B. The alcohol has potential toxic effects when ingested in

the products specially by children.
 …cont
2- Diluted Alcohol
• Mixing of equal volumes of Alcohol and Purified
Water.
• The final volume of such mixtures is not the sum
of the individual volumes of the two components,
because the liquids contract upon mixing.
• The final volume is generally 3% less than what
would be expected.

• Then, 50 ml water + 50 ml alcohol = or measures

approx. 97 ml.

3- Alcohol, Rubbing
Rubbing Alcohol contains about 70 % of ethyl
alcohol and water, denaturants with or without
colour additives and perfume oils, and stabilizers.
 …cont
 Each 100 ml must contain not less than 355 mg of
sucrose octa acetate, bitter substances that discourage
abusive oral ingestion.
 The denaturants is composed of 8 parts by volume of
acetone, 1.5 parts by volume of methyl isobutyl ketone,
and 100 parts by volume of ethyl alcohol.

 The use of this denaturant mixture makes the

separation of ethyl alcohol from the denaturants
impossible.

4- Glycerine, (Glycerol), [Link].CH20H

• Glycerine:- is a clear syrup liquid with a sweet taste. It
is miscible both with water and alcohol. As a solvent, it
is comparable with alcohol, but because of its viscosity,
solutes are slowly soluble in it unless it is rendered les
viscous by heating. Glycerine has preservative qualities,
used as stabilizer and as an auxiliary solvent in
conjunction with water or alcohol.
 Preparation of Solutions
 Most pharmaceutical solutions are unsaturated with solute.

 Some chemical agents are only slowly soluble and require an

extended time for dissolving.

 Several techniques used to hasten the dissolution:

1 applying heat
2 reducing the particle size of the solute
3 using a solubilising agent
4 vigorous agitation during the preparation of the solution.

 Most solutions are prepared by simple mixing of the solutes

with the solvent or solvent mixture.

 On an industrial scale, solutions are prepared in large mixing

vessels with ports for mechanical stirrers. When heat is
desired, thermostatically controlled mixing tanks may be
 Preparations of Oral Solution
 The composition:-

 flavorants and colorants to make the drug

more attractive and palatable for the patient.

 Stabilizers are added to maintain the chemical

and physical stability of the drugs.

 preservatives to prevent the growth of

microorganisms.
 Precaution about chemical interactions
between the components of a solution which
may result in an alteration in the
preparation's stability and/or potency must be
considered by the formulation pharmacist.
 Syrups
Definition:- Syrups are concentrated, aqueous preparations of
a sugar or sugar substitute with or without added
flavouring agents and medicinal substances.
Classification of syrups
1) Non-medicated syrups  containing flavouring agents
only.e.g cherry syrup, orange syrup.
2) Medicated syrups  containing sucrose, purified water,
flavouring agents, colouring agents and therapeutic agent
present in the syrup.
 Advantages of syrup:-
1-Can administer a liquid form of a
disagreeable tasting drug.

2-They are effective in the

administration of drugs to young
patients.

3-Syrups contain little or no alcohol.

4-Easy to swallow comparing to solid

dosage forms (children or elderly).
 …cont
Disadvantages:-
1-Care must be exercised to ensure
compatibility between the drug and
the other components of the syrup.

2-Stability of therapeutic agent may

be changed due to change in pH of
syrup in presence of flavouring
agents (acidic, neutral or basic
syrups).
 Components of Syrups
• Most syrups contain the following components in
addition to purified water and medicinal agents:-
1) The sugar, usually sucrose, or sugar‑ substitutes
used to provide sweetness and viscosity
2) Antimicrobial preservatives
3) Flavorants and
4) Colorants. Also, many syrups, especially those
prepared commercially, contain special solvents,
solubilising agents, thickeners, or stabilizers.
Sucrose and NonSucrose Based Syrups
• Sucrose:- is the sugar most commonly used in
syrups, it may be replaced by other sugars, as
dextrose, or non sugars as sorbitol, glycerine and
propylene glycol (these materials converted to
glucose in the body).
• In some instances, these substances are replaced by
methylcellulose or hydroxy ethyl cellulose (diabetic
 …cont
• It is important that the concentration of sucrose
approach but not quite reach the saturated
point (60 to 80%).

• In dil. Solution---- sucrose provides good

nutrient for growth of microorganisms.

• In conc. Solution---retard the growth of

microorganisms. why?

• Due to unavailability of water required for

growth of microorganism.

• However, a saturated solution may lead to

crystallization of a part of the sucrose under
condition of changing temperature.
 …cont

Syrups

Simple Medicated Flavored

syrup syrup syrup
 Simple syrup
• It is prepared by dissolving 85 g of sucrose in purified water to
make 100 ml of syrup.
• The resulting preparation requires no additional preservation
why? the syrup has a specific gravity of about 1.313.

• If the syrup were completely saturated with sucrose, under cool

storage conditions some sucrose might crystallize from solution.
• The official syrup is both stable and resistant to crystallization as
well as to microbial growth.

 Sucrose ‑based syrup

• Sucrose ‑based syrup may be substituted in whole or in part by

other agents in the preparation of medicated syrups.

• A solution of a polyol, as sorbitol, or a mixture of polyols, as

sorbitol and glycerol, are commonly used.

• Sorbitol Solution, USP, which contains 64 % by weight of the

polyhydric alcohol sorbitol is employed for medicated syrups
 Some ingredients used in syrup
1- Antimicrobial Preservative
• The amount of a preservative required in a syrup varies with the
proportion of water available for growth, the nature and
preservative activity of some materials and the capability of the
preservative itself.
• Preservative commonly used in syrups are: benzoic acid (0.1 to
0.2%), sodium benzoate (0.1 to 0.2%), and various combinations
of methyl‑, propyl‑, and butylparabens (about 0.1%).
• Frequently alcohol is used in the preparation of syrups to assist in
the dissolving of alcohol soluble ingredients and in the final
product in amounts that would be considered to be adequate for
preservation (15 to 20%).
2- Flavorants
• Most syrups are flavoured with synthetic flavorants or with
naturally occurring materials as volatile oils (e.g. orange oil),
vanillin, and others, to render the syrup pleasant tasting.
flavorants must possess sufficient water solubility.

• However, sometimes a small amount of alcohol is added to a syrup

to ensure the continued solution of a poorly water-soluble
flavorant.
 …cont
3- Colorant
• To enhance the appeal of the syrup,
a colouring agent is used that
correlates with the flavorants
employed (i.e. green with mint,
brown with chocolate) is used
• The colorant is generally water
soluble, nonreactive with the other
syrup components and stable at the
pH range used and against light
during the shelf life.
 Ferrous sulphate syrup
Ingredients M.F R.F
Ferrous sulfate------40g
Citric acid-------------30g
Peppermint oil------4ml
Ethanol(90%)--------40ml
Syrup-------------------10ml
Purified water-------1000ml
Send 50ml
 ….cont
 Compounding:- ferrous sulfate plus citric acid
plus syrup while sufficient amount of water in
mortar then transfer in to final container and
add peppermint oil & finally add ethanol.
Use:- Anemia
Finally label
 Solutions used in mouth and throat
 GARGLES
 Are aqueous solutions intended for use in
prevention and/ or treatment of throat
infection gargles usually contain a bactericide
e.g. phenol or thymol or, and are dispensed
in concentrated forms with direction for
dilution with warm water before use,
 …cont
Phenol gargle( carbolic acid )

Ingrid. M.F R.F

Phenol glycerin------50ml
Amaranth solution---10ml
Purified water-------1000ml

Mitt 50ml
 …cont
Sig: Dilute equal volume of warm water before
use. Not to be swallowed in large amounts.

Compounding- Mix the phenol glycerin and the

amaranth solution with portion of the water.
Agitate add water to final volume.

Action and use: Antibacterial and anesthetic.

 …cont
MOUTH WASHES
-Are aqueous preparations pleasant taste and
odor. Used to cleans, rinsing, deodorizing or
refreshing buccal cavity to react infection of
mouth for antiseptic action.

-Medicated mouth washes containing astringents,

antibacterial agents protein precipitants or
agents are also used but they must be used
under supervision of dentist.
 …cont
- Mouth washes are particularly refreshing to bed-
ridden patients.

- Like gargles they are usually after dilution with

warm water and directions for diluting the
mouth washes should be given on the label of
these preparations.
 …cont

Sodium chloride mouth wash.

Ingr M.F R.F
Sodium bicarbonate-------10g
Sodium chloride------------15g
Amaranth solution---------10ml
D.S chloroform--------------500ml
Purified water to-----------100ml
Mitt 50ml

NOTE: D.S- formula is 100ml=5ml

Sig: Dilute with an equal volume of warm water

 …cont
Compounding
-Dissolve sodium bicarbonate and sodium
chloride in the portion of the water. Add
amaranth solution and double strength
chloroform water finally adjust to final volume
with water. Transfer to a bottle , label and
dispense.

Use:- cleansing and deodorizing / the buccal cavity

 …cont
Solutions applied to body surface
-Are liquid preparations intended for external
application to the skin by dabbing or after
spreading on dressing.

-Lotion should be shaken vigorously before each

use to redistribute any separated mater.
Container should be labeled to instruct the
patient to shake thoroughly before use and also
to use externally only.
 …cont
Salicylic acid Lotions
Ingr M.F R.F
Salicylic acid---------20g
Castor oil-------------10ml
Alcohol(95%)--------1000ml

Mitt 50ml

Sig: For external only

 …cont
Compounding
-Dissolve the salicylic acid in portion of
ethanol, Add castor oil and sufficient ethanol
to produce 1000ml and mix.

-Action and uses: Keratolytic

 paints
PAINTS
-Are solutions or dispersions of one or more
active ingredients for application to the skin or
in some cases, mucus membranes. How ever all
the official paints are solutions.

-All paints except throat paints, are labeled “ For

external use only “
 …cont
Crystal Violet paint
Ingr M.F R.F
Crystal violet----5gm
Water to---------1000ml
Mitt 50ml

Sig: For external use only, Apply undiluted

Compounding: dissolve the crystal violet in the water to produce

the required volume.

Action and use: Antiseptic

 Solutions installed in to body cavity
Douches:- Are an aqueous solution used for
rinsing a body cavity and function are as
cleaning agent antiseptic, or astringent.
-The word douches most often used for vaginal
solutions but it is sometimes applied to
solutions for the bladder ( usually called
irrigations ) or the rectum ( usually called
enemas)
 …cont
- Douches usually directed to the appropriate
body part by using bulb syringes.
-Douches are often supplied as liquid concentrates
or powders to be diluted or dissolved in the
appropriate amount of warm water how ever
tablets for preparing solution are also available.
If powders or tablets are supplied, they must be
free from insoluble material in order to produce
a clear solution.
 …cont
Potassium Permanganate Vaginal Douches
Ingr M.F R.F
Potassium permanganate---1gm ---
Purified water-----------------1000ml ---

Mitt 300ml

Sig: dilute with 3 times its volume of warm water

-Discard the remain after one week
-Store in cool place ( not to be taken )
 ….cont
Note:- KMNo4 solution will stain plastic surface,
take appropriate precautions. Care must be
taken to avoid spoilage during weighing and
apparatus should be kept on large glass.

Compounding:- the solute dissolves slowly in

water and since it may not indicated. The use of
an electric stirrer is recommended as alternative
as a glass mortar may be used.

Action and use:- mild antiseptic and deodorant

 OINTEMENTS

• 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.
 Hydrocarbon bases
 Absorption bases
 Water-miscible bases
 Water soluble bases

Preparation
Since Ointments are applied primary to irritated areas it is an un breakable
rule that these preparations must contain ….
 …cont
…no 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 equipment are available for the preparation of
ointments
[Link] slab and spatula
[Link] and pestle
[Link] fill
 Two techniques are used mixing ointments
[Link] by fusion
On a small scale fusion is usually carried out in an evaporating
basin a water bath
• Fusion is necessary when waxes, hard paraffin, fatty alcohols,
fatty acids or any hard wax- like material is included in the
formula.
 …cont
• Fusion is used also when a medicament is soluble
in the melted base

[Link] by titration

• This method is applicable when the medicament

is a solid insoluble in the bases or liquid present
in small amount

• Trituration may be carried out with an ointment

tile and spatula or using a mortar and pestle
 Packaging of Ointments
• Packaging
• Ointments are dispensed in either ointment or
collapsible tube. However ointments prepared
extemporaneously are usually packed in ointment
jar.
• Procedure will be demon strand
The ointment jars should be packed tidily and the top
surface should be smoothed neatly.

• Ointments jars should be closed tightly when not in

use particularly if the ointment contains water to
prevent loss though evaporation.
 …cont
• Storage
• 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 liquefy.

• Excessive heat or cold may cause an emulsion

base to separate into two phases
 …cont
• Sulphur ointment using simple ointment BP
Simple ointment BP
Ingredients [Link]
Reduc.F
Wool fat 50g
Hard paraffin 30g
Cetostearyl alcohol 50g
Yellow /white soft paraffin 850g

Send 25g
 …cont
• Formulation: 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 there is no dark colored
ingredient to be added. White soft paraffin should be used.

• Compounding: grate the hard paraffin and weigh out the

ingredient for the base. Place to melt an evaporating dish on
water –bath. Stir gently to aid melting and to mix the-
ingredients. When homogenous, remove from the beat and
continue to stir gently until cold.
 …cont

• NB. Weigh the wool fat and the soft paraffin

using waxed papers to allow full recovery of
the materials.

• Storage: store in cool places

• Action and use: ointment base emollient

 …cont

• Sulfur ointment BP
Ingredients master formula red.F
Precipitated sulphur, 100gm
finely sifted
Simple ointment 900g
Send 25 g
• Formulation: the BP directs that the simple
ointment be prepared with white soft paraffin
ointment is adequate to ensure that 22.5g will
be available (to compensate for the
manipulative losses).
 …cont
• compounding: weigh out the amount of precipitate sulphur
required and place it on the center ointment tile, weigh the
required amount of simple ointment (using a piece of waxed paper)
and place it on side of the tile take a portion of the base (about two
to three times the weight of the powder) and levigate it with the
sulphur until there is no sign of any gritty particles (this can checked
for by spreading a thin layer on the tile).
• Gradually incorporate the remaining base in geometrically and
continue levigation until uniformly mixed. Finally, collect the
ointment together the center of the tile using the spatula and pack
into an ointment jar.

• Storage and shelf life: store in a cool place. An expire date of 4

weeks is appropriate.
 ….cont

• For External use only.

• Container: wide–mounted amber jar with a

grease proof paper disc

• Advice for patient when dispensed: the skin

should be cleansed prior to application and
ointment applied sparingly to the affected area.

• Action and uses: mild antiseptic used in the

treatment of acne and scabies.
 Experiment

Ointment (cont.)
Whitfield ointment using emulsifying ointment Emulsifying
ointment

Ingredients master formula red.F

Emulsifying wax 300g
White soft paraffin 500g
Liquid paraffin 200g
White Beeswax 250g

Send 25g
 …cont
• Compounding:
• place ingriendents of the base in a evaporating
dish on a water – bath and allow it is most
convenient to weight the liquid paraffin directly
in to the dish and to add the other ingredients.
Stir gently to aid melting and to mix the
ingredient .

• When homogenous, remove from heat and

continue to stirr gently until cool.
a. Compound Benzole acid Ointment, BP ( Whitfield’s
Ointment )
Ingredients master formula red .f
• Benzoic acid, in fine powder 60 g
• Salicylic Acid, in fine powder 30g
• Emulsifying ointment 910 g
Compounding: sift the medicament through separate 180µm sieves.
Not that salicylic acid very irritant to the respiratory tract and
precautions should be take to avoid inhalation. Weigh the powders
after sifting and mix them. Then place them on an ointment tile and
levigate with two at times their weight of the base until
homogenous. Gradually incorporate the remaining base.
Storage shelf life: store in a cool place.
 …cont
• Container: wide–mouthed amber jar with a greaseproof paper
disc.

• Advice for patients when dispensed: the ointment should be

applied sparingly to the affected area. Is should not be applied
to the broken or inflamed skin.

• Actions and uses: topical anti fungal preparation

 …cont

b. Methyl salicylate ointment

Ingredients master formula red. formula

• Methyl salicylate 500g

• Hydrous woof fat 250g

Send 20g
 …cont
• Formulation: methyl salicylate is a volatile liquid and
should be added to the base at as low temperature as
possible . Bees wax helps to stiffen the base, which would
otherwise be very soft by the large proportion (50%) of
liquid methyl salicylate.
• Compounding: melt the grated beeswax and hydrous wool
fat in an evaporating dish on a water -bath .Remove from
the heat and cool until about to solidify. Add the methyl
salicylate and stir until cool

• Storage and shelf: store in cool place

• Container: wide mouthed amber glass jar with a

greaseproof paper disc and well- fitting closure at methyl
 …cont

• Advice for patients when dispensed:

• the ointment should be massaged well in to the

skin.
• It not be applied to broken or inflamed skin or
near to the eyes or mucous membranes.
• The container should be kept tightly closed.

• Advice and uses: relief of pain in rheumatic

conditions.
 Experiment
Ointments (cont.)
• Calamine and coal tar ointment
Ingredients master formula [Link]

Calamine, finely sifted 125 g

Zinc oxide, finely sifted 125 g
Strong coal tar solution 25g
Hydrous wool fat 250 g
White soft paraffin 475 g
Send 25g
 …cont
• Formulation: the ointment contains two
insoluble solids and a volatile liquid.
• Compounding: sift the zinc oxide and calamine
through separate 180µm sieves and weigh the
required amounts.
• Melt the soft paraffin and hydrous wool fat at as
low a temperature as possible add small amounts
of each powder alternately to the molten base
and stir thoroughly until homogenous.
• Continue to stir until temperature falls to 400 C
before adding the strong coal tare solution and
stirring until cold.
 …cont
• Note that because coal tar solution is volatile, it should
not be weighed in advance and uncovered on the
benefit to evaporate

• Storage and shelf life: store in a cool place

• Container: wide – mouthed amber jar with grease proof
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 or
near the eye . It stains skin hair and fabrics
• Action and uses: mild astringent and anti-pruritic.
 …cont
• Ichthammol ointment
Ingredients [Link] redu.F
Ichthmmol 100g
Wool fat 450g
Yellow soft paraffin 450g
Send 20g
• Formulation: ichthammol is an almost black viscous
liquid with a strong tarry odor. It consists of the
ammonium salts of the sulfonic acids. It is water –
soluble.
• Incorporation in an ointment base is facilitated if the
base contains a large amount of wool fat, 45 % in this
 …cont

• Compounding: place the ingredients for the base in an

evaporating dish on a water bath and allow melting. stir
gently to aid melting and to mix the ingredients .
• When homogenous remove from the heat and cool to
about 400 C. add the ichthammol and stir until cool.

• Storage and shelf life: Store in a cool place.

• Advice for patients when dispensed: The ointment should

be rubbed lightly on the affected area. It should not be
applied to the broken skin.
• Actions and uses: mild antibacterial and anti –
inflammatory.
 Compound Benzole acid Ointment, BP
( Whitfield’s Ointment )

Ingredients M.f R.F

Benzoic acid, in fine powder 60 g

Salicylic Acid, in fine powder 30g
Emulsifying ointment 910 g

Send 50g

Compounding: sift the medicament through separate 180µm sieves. Not that salicylic
acid very irritant to the respiratory tract and precautions should be take to avoid
inhalation.
 Weigh the powders after sifting and mix them.
 Then place them on an ointment tile and levigate with two at times their weight of the
base until homogenous.
 Gradually incorporate the remaing base.
 …cont
• Storage shelf life: store in a cool place.

• Container: wide – mouthed amber jar with a

greaseproof paper disc.

• Advice for patients when dispensed: the ointment

should be applied sparingly to the affected area.
Is should not be applied to the broken or
inflamed skin.
•
• Actions and uses: topical anti fungal preparation
 Methyl salicylate ointment
Ingredients master formula Reduced formula
Methyl salicylate 500g
Hydrous woof fat 250g
• Send 20g

• Formulation: methyl salicylate is a volatile liquid and

should be added to the base at as low temperature
as possible. Bees wax helps to stiffen the base, which
would otherwise be very soft by the large proportion
(50%) of liquid methyl salicylate.
•
 …cont
Compounding: melt the grated beeswax and hydrous wool
fat in an evaporating dish on a water -bath .Remove
from the heat and cool until about to solidify. Add the
methyl salicylate and stir until cool
Storage and shelf: store in cool place
Container: wide mouthed amber glass jar with a
greaseproof paper disc and well- fitting closure at
methyl salicylate reacts with some plastics.
Advice for patients when dispensed: the ointment should
be massaged well in to the skin. It not be applied to
broken or inflamed skin or near to the eyes or mucous
membranes. The container should be kept tightly closed.
Advice and uses: relief of pain in rheumatic conditions.
 POWDER DOSAGE FORMS

• Powder may be defined as dry mixtures of

pulverized drug and / or chemicals which are used
internally or externally.
• Depending upon their intended use, powders are
packing and dispensed in two ways as bulk
powders or as divided powders.
• I. Bulk powders
• The substance prescribed in this form are bulky
powder a as light and heavy magnesium
carbonate, magnesium trisllicate etc.
• It is when accuracy of dosage is not critical that
powder may be dispensed in bulk.
 …cont

• II. Divided powder

• This form of powder may contain one or more active
ingredients together with an inert diluents to produce a
minimum quantity ( 120g) that can be weighed by the
dispenser and handled by the patient
• After the powder blend is prepared, it can be subdivided
in to the required number of doses by weighing or by
using the block and divide method.
• The paper for choice for hygroscopic or deliquescent
powders is waxed paper because of it water proof
qualities. Also powders containing volatile ingredients
should be similarly wrapped.
• Method for wrapping divided powders: Demonstration
 …cont

• Compounding
• 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.
• Packing:
• For bulk powders
• For internal powers: wide mouth screw cap glass jars.
• A 5 ml 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, colored glass or plastic jars with
a recloseable perforated lid
 Storage and labeling

• Store in a cool dry place

• Powders intended to be used externally or

locally or should always bear for external use
or for local use auxiliary labels’
 Compound magnesium trisllicate oral powder
• Ingredients master formula reduced
• Magnesium trisilicate 250g
• Chalk in powder 250g
• Sodium Bicarbonate 250g
• Heavy magnesium carbonates 250g

• Send 20g

• Formulation; the ingredients are all ‘active’

Compounding: mix the powders in a mortar in order of increasing bulk volume
pass the resulting mix through a 250 um sieve lightly re-mix and pack
• Storage: store in a dry place
• Container: amber glass screw- capped jar or plastic pot
• Advice for patients when dispensed: the powder should be take mixed with a
should be discouraged without medical advice
• Actions and uses: adsorbent and antacid.
• Dose: 1-5 grams
 Phenolated calamine lotion
• Ingredients master formula reduced
• Calamine 80 g
• Zinc Oxide 80g
• Glycerin 20ml
• Liquefied phenol 10ml
• Bentonite 20g
• Purified water 1000ml
Send 50 ml
 …cont
• Formulation: calamine basic ZnCO3 suitably
colored with Fe2O3 ) and Zinc oxide are both in
diffusible solids and therefore bentonite
included as a thickening agent

• Actions and uses: Cooling lotion useful for

treating mild sun burn
 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.
• When applied to the skin they adhere well. forming a thick coat
protects and soothes inflamed and raw surfaces and in particular,
minimizes the damage done by scratching in itchy conditions such
as chronic eczema, most pastes are unsuitable for treating hair parts
such as the scalp because they are very difficult to remove from the
hair as they formed a densely matted mass.
 Zinc oxide paste

Ingredients master formula reduced

• Zinc oxide, finely sifted 250g

• Starch, finely sifted 250g
• White petrolatum 500g
•
• Send 20g
 …cont
• Compounding: melt the base with a minimum of heat
and sift the powders through separate 180 µm sieves.
Mix the required weight of powders in a warm mortar.
Triturate with a little melted base until smooth,
gradually adding the rest of the base and until cooled.
• NB. The paste is much easier to manipulate in a warm
mortar
• Storage: store in a cool place
• Container: wide – mouthed amber jar with grease
proof paper disc.
• Advice for patient when dispensed: the paste should
be spread thickly on white lint and applied to the
affected area.
• 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 phenol……………………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.
•
• 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
• 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 ingredients
•  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.
 Prepare and supply 25g of Benzoic acid Ointment,(BP) using the
following master formula
Instruction
• 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
•  Glass rode
•  Water bath/hotplate
•  Spoon spatula
•  180m sieves
•  Ointment Jars
•  Label –white paper
 Self-check Questions
Instruction: choose the best answer from the given alternatives
1. Which of the following dosage forms is prepared by the heat method?
• A. Syrups
• B. Emulsions
• C. Suspensions
• D. Elixirs
2. Which term means “reducing to a fi ne powder by grinding”?
• A. Trituration
• B. Suspension
• C. Emulsion
• D. Solution
3. Which of the following are not semisolid drugs?
• A. Pastes
• B. Creams
• C. Suspension
• D. Ointments
 Cont…

[Link] of the following are the simplest dosage forms

compounded extemporaneously?
• A. Solutions
• B. Suspensions
• C. Emulsions
• D. Suppositories
[Link] of the following must be shaken well before being
administered?
• A. Solutions
• B. Suspensions
• C. Emulsions
• D. Elixir
 Prepare and supply 25g of Benzoic acid Ointment,(BP) using the
following master formula
• Instruction
• 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
•  Glass rode
•  Water bath/hotplate
•  Spoon spatula
•  180m sieves
•  Ointment Jars
•  Label –white paper
 Prepare compound of Iodine paint (mandl’s paint) using the following formula
• 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
• 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
THANK YOU!