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Understanding Pharmacopoeia and Formulations

The document outlines regulations and procedures related to the preparation and control of magistral formulas and officinal preparations in pharmacies. It includes true/false statements, differences between types of preparations, labeling requirements, and minimum conditions for preparation areas. Additionally, it details the roles of active ingredients, excipients, and the importance of quality control in pharmaceutical practices.

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0% found this document useful (0 votes)
6 views40 pages

Understanding Pharmacopoeia and Formulations

The document outlines regulations and procedures related to the preparation and control of magistral formulas and officinal preparations in pharmacies. It includes true/false statements, differences between types of preparations, labeling requirements, and minimum conditions for preparation areas. Additionally, it details the roles of active ingredients, excipients, and the importance of quality control in pharmaceutical practices.

Translated by

ScribdTranslations
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

THEME 1.

1.- Indicate true or false


a- The Official Preparations must be listed and described in The Royal Spanish Pharmacopoeia F
b- The National Form will contain only the officially recognized preparations as medications, their categories,
instructions and raw materials involved in its composition or preparation, as well as the correct standards
preparation and control.F
c.- Advertising of their magistral formulas and officinal preparations is allowed in all pharmacy offices. F
d.- The quality control sheet will record the controls carried out by the pharmacy office or service.
pharmacist. The control reference number and the analysis report provided by the
authorized center dependent on the laboratory from which the raw material is acquired. V
e.- Standardized procedure for preparation and control: it will only be necessary for the specified formulas. It will contain
all the necessary information to correctly prepare a specific magistral formula. F
f.- The recipes for magistral formulas and official preparations that do not have to be subjected to further processes
of management, processing, control or those that, due to their composition, require a specific deadline, must be
safeguarded by the pharmacy office or by the pharmaceutical service that dispenses them for a minimum period of six
months. F

2.- Difference between magistral formulas and officinal preparations.


A medicinal preparation is a medication made and guaranteed by a pharmacist or under their direction.
dispensed at your pharmacy or pharmaceutical service, listed and described by the National Formulary (the
Unspecified FM are not included in the national form intended for direct delivery to patients (not only
to a particular patient as in the case of the FM) to whom that pharmacy supplies, and they can be dispensed with or
without a prescription, depending on the active ingredient they contain, and they can be prepared in batches a formula
Magistral is a medication intended for a specific patient and always requires a medical prescription.
included or not in the national form

3.- Difference between normal label and abbreviated label.


The difference is that the normal label includes more data than the abbreviated label (the data in 'italics' is not included).
They would be included in the abbreviated label, but would go in a separate report for the user. In a normal label of an FM.
the following data would be included:
a) Name of the official preparation or, if applicable, the specified magistral formula, which must coincide with the
established in the National Form.
b) Complete qualitative and quantitative composition, at least, of the active ingredients and excipients of
mandatory declaration.
c) Pharmaceutical form, route of administration, and quantity dispensed.
d) Registration number in the Recipe Book or its substitute support, in accordance with current legislation.
e) Batch number, in the case of official preparations.
f) Date of preparation and validity period or expiration date.
g) Storage conditions, if applicable.
h) Name and license number of the prescribing physician for the preparations that require a prescription.
i) Patient's name in the case of magistral formulas.
j) Pharmacy office or dispensing pharmaceutical service: name, address, and phone number.
k) Warning: keep out of reach of children. Therefore, in a shortened label (if the dimension of
the container does not allow a normal label) only the following data appears:
a) Name of the official preparation or, where applicable, of the specified magistral formula, which must correspond to the
established in the National Form.
b) Complete qualitative and quantitative composition, at least, of the active principles and excipients of
mandatory declaration.
c) Route of administration, if confusion may exist.
d) In the case of magistral formulas, registration number of the Recipe Book or the support that replaces it.
compliance with current legislation.
e) Batch number, in the case of official preparations.
f) Fecha de elaboración y plazo de validez o fecha de caducidad. g) Identficación de la oficina de farmacia o servicio
dispensing pharmacist.

4.- El procedimiento de elaboración y control de las fórmulas magistrales presenta una estructura. Enumérala:
Bibliographic References. Patient information. Observations controls. Storage material and
etquetado. Caducidad. Denominación. Condiciones de conservación. Fórmula desarrollada. Modus operandi.
Media and raw materials.
Bibliographic References. 11th
Patient information. 7th
Observations 10th
Controls. 5th
Storage material (packaging) and labeling. 6th
Expiration. 8th
Denomination. 1st
Conservation conditions. 9th
Developed formula. 2nd
Operating mode. 4th
Media and raw materials. 3rd

5.- What procedures are not mentioned in RD 175/2001 but are still required by the F.N?
Royal Decree 175/2001 does not establish these procedures as mandatory, but the National Form does require them.
to have them available.
Standardized weighing procedure.
2. Standardized mixing procedure.
3. Standardized disaggregation procedure.
4. Standardized screening procedure

1.-Difference between pouring instruments and containing instruments


The pouring instruments usually carry the indication 'pour,' Ex, or TD, such as pipettes.
burettes and graduated cylinders. In these, the volume indicated in the calibration corresponds exactly to the amount or to the
volume of liquid poured (since the error in the amount of liquid that is not poured out has been taken into account)
adhered to the walls) And the calibrated instruments to contain, carry the indication cont., In or TC, like the
calibrated flasks, and the indicated volume corresponds to the volume of liquid that is inside the instrument (
not with the volume that would be spilled)

2. Indicate the difference between a graduated pipette and a volumetric pipette.


The graduated pipette is a straight tube made of glass or plastic that has a scale or divisions engraved on its wall.
in volume in ml and in tenths (0.1) or hundredths of a milliliter (0.01), allowing for the measurement of different volumes
of liquid. They are less accurate than calibrated or volumetric ones. At its top, it would indicate the Maximum Volume that
Volumetric pipettes (graduated) are designed to measure a single volume of liquid. They are tubes
long with a widening in their central part, where their capacity and temperature are generally indicated
The volumetric pipette is calibrated to be used under standard conditions, with a specific volume and temperature.
Determined; the temperature is usually 20°C), and with a mark or graduation line. And there are also "double" pipettes.
afore (or double mark) where the capacity of the pipette matches the volume of liquid contained between the two
flow lines

To measure 5 ml of a liquid, it is more accurate to use a 10 ml pipette or one of 4 ml and one of 1 ml.
To make the measurement more accurate, the smaller the volume measurement of the pipette, the better. Therefore,
the option of a 4ml pipette and a 1ml one is the most appropriate. In any case, there are 5ml pipettes and, thus
I would avoid using two pipettes or taking two measurements with the same pipette.

4. Answer true-false
a.- It is recommended to heat the volumetric containers F
b.- Calibrated instruments for containment usually carry the indication Ex Otd F
c.- One should always blow out the last drop that remains in the pipette. F
Graduated pipettes measure a determined volume of liquid F

5. What material is MORE accurate for measuring volumes?


a. Graduated flask.
b. Beaker.
c. Erlenmeyer flask.
d. Test tube.

Porcelain is used as laboratory material:


a. Never because it can be attacked by organic solvents.
b. When materials that can withstand high temperatures are needed.
c. Frequently because they are disposable.
d. Just as decoration.

7. Complete
Name Function
a.- Bureta It is used in volumetric analysis.
b.- Graduated or volumetric pipette They are designed to measure a single volume of liquid
c.-Micropipette They are used to transfer very small amounts of liquid

8.- They are calibrated materials for pouring:


a. Graduated flasks and measuring cylinders.
b. Burettes and pipettes.
c. Beaker and Erlenmeyer
d. a and b are correct

9.- When preparing a solution in the laboratory with a volumetric flask, if the fill level exceeds the mark:
a. The concentration of the solution thus obtained will be lower.
b. The concentration of the solution thus obtained will be higher.
c. The excess must be drawn back with a Pasteur pipette until it is perfectly leveled.
d. Note importance

10.- What are the minimum components of a preparation area?


The size must be sufficient to avoid the risks of confusion and contamination during operations.
of preparation. If sterile preparations are made, it will be necessary for the area designated for this purpose to
found isolated, with floors, ceilings, and walls. The preparation area will have potable water and with the
necessary energy sources. It should be well ventilated and illuminated, and its temperature and relative humidity
Environmental regulations will be established according to the nature of the products to be handled.

11.- The RD. 175/2001 describes the minimum conditions that staff must meet and what else?
Raw materials and packaging materials, preparation and dispensing. Complete the document a
list of minimum tools for the preparation of formulations and control sheet models
quality of raw materials and of magistral formulation record.

12.- What do the initials PNT mean? Are these protocols followed in the cleaning of galenic laboratory materials?
Normalized Work Procedure
Yes.

5.- What material cannot be dried or sterilized in an oven?


a. Graduated pipettes. (as long as they are not high T°C and depending on the type of glass)
Volumetric flasks
c. Precipitate vessels.
d. Erlenmeyer flasks.

Consulting the UT1 Units of the virtual classroom, answer:


1st What are the minimum components of a preparation area?
The operations of manufacturing, conditioning, labeling, and controlling a pharmaceutical form must
to be carried out in a premises, or in a designated area of the premises, called preparation, designed or conceived for these
ends and located inside the pharmacy office or pharmaceutical service, to allow for effective supervision by
part of the pharmaceutical. The size must be sufficient to avoid the risks of confusion and contamination during the
preparation operations. If sterile preparations are made, it will be necessary for the area designated for this purpose to
found isolated, with floors, ceilings, and walls. The preparation area will have potable water (cold and hot) and
with the necessary energy sources. It should be well ventilated and lit, and its temperature and relative humidity
Environmental regulations will be established according to the nature of the products to be handled.
It should also have a refrigerator with a thermostat (control of maximum and minimum temperature) and cabinets for storage.
materials and raw materials, and area for production with anti-vibration horizontal support and another area for
deposit the dirty material

2nd The RD 175/2001 describes the minimum conditions that the personnel must meet and what else?
Royal Decree 175/2001, of February 23, approving the rules for proper preparation and control of
quality of magistral formulas and officinal preparations.
The quality control and proper preparation standards describe the minimum general conditions that must be
gather the staff, the premises, the tools, the documentation, the raw materials used and the materials of
conditioning, the preparation, quality control, and dispensing. All aspects are considered in them
they influence directly or indirectly the quality of the preparations that are made both in the pharmacy offices
as in pharmaceutical services.
- CHAPTER I Personnel.
- CHAPTER II Locations and tools.
- CHAPTER III Documentation.
- CHAPTER IV Raw materials and packaging materials.
- CHAPTER V Development.
CHAPTER VI Dispensation.
SHEET 1 Quality control sheet for raw materials.
SHEET 2 Master formulation registration form.

3rd What do the initials PNT stand for? Are these protocols followed in the cleaning of the materials in the galenic laboratory?
Standardized work procedures (PNT): These are the written and approved procedures according to the standards of
correct preparation and quality control that specifically describe the activities carried out both
in the preparation of a magistral formula or official preparation as well as in its quality control. - The responsibility of
The application and scope of this procedure falls on all personnel (technical and/or auxiliary) who proceed to the
drafting and completion of a PNT and/or the records it generates
If there are cleaning procedures for premises and materials (within the general documentation) and, furthermore, they are mandatory.

4th Complete the following definition:


A magistral formula is the medication intended for an individualized patient, prepared by the pharmacist.
your address, to precisely complete a detailed facultative prescription of the medicinal substances that
includes according to the technical and scientific standards of pharmaceutical art, dispensed in a pharmacy office or service
pharmacist and with the appropriate information to the user.

TESTS
5th In the FN, the procedure is established as mandatory:
a) pH determination PN
b) Weight and volume verification PN
c) Control plan for weight uniformity
d) All are correct

According to the Medicines Law, the following are recognized as such:


a) the official preparations
b) industrially manufactured veterinary medicines
c) the magistral formulas
d) All are correct

7th The official preparation is listed and described in:


the UN
b) the Spanish Pharmacopoeia FE (or RFE)
The pharmacist prepares it by consulting books.
it is intended for a single individual

8th A masterfully simplified formula:


a) it is included in the FE (or Spanish Royal Pharmacopoeia RFE)
b) they are FM that are frequently used
c) they are the ones collected in the FN
d) b and c are correct

9th Among the quality control tests of the ampoules, the following is conducted:
a) a sterility control
pH study
c) the control of organoleptic characteristics
d) All are correct

10th Among the quality controls of the capsules is


a) the control or study of transparency
b) the variation or uniformity of weight
c) the pH
d) All are correct

11th Indicates the correct statement (V) or incorrect (F):


The maintenance and cleaning of the laboratory must be documented in the form of a PNT.....( V )
Waste will be regularly disposed of in appropriate containers..... ( V )
In the production area, other activities can be carried out, such as clinical analysis, order review.
etc....( F )
The laboratory must be well ventilated and lit.
The PO is dispensed under a trade name... (F)
The RFE includes the analytical methods for excipients and medicinal substances...( V )

12º What do the abbreviations mean:


in equal parts
csp: sufficient amount for
- cap: cápsula
VR: rectal route
oral route
- SSF: solución salina fisiológica
IV: intravenous
- FDA: Food and Drug Administration (USA)

THEME 2

QuestionnaireUTD2Raw materials 1.

Define active principle and raw material: active principle is all matter, regardless of its origin - human, animal, vegetable,
Chemical or other - attributed with an activity suitable for constituting a medication.
Raw material is any substance, active or inactive, used in the manufacture of a medication, whether it remains.
unchanged, be modified or disappear during the course of the process.
What is Opotherapy? It is the treatment of diseases with extracts or parts of animal organs or with the
secretions or hormones isolated from the endocrine glands (such as the thyroid, adrenal glands, testicles,...)

3. Functions of excipients 1. -Facilitate the administration of active principles.


2.- Improve the effectiveness of the active principle.
3.- Ensure stability and preservation until the deadline for its use.

4. Why is glycerin commonly used in suppositories and ovules? Due to its hygroscopicity, to prevent them from drying out.

5. What is saponification? The reaction that produces the formation of soaps. The main cause is the dissociation by
Hydrolysis of fats in an alkaline medium. Vegetable oils and animal fats are triglycerides and, when being
strong bases such as (NaOH) or (KOH) saponify, meaning soap (salt of fatty acid) is produced and
glycerin (glycerol).

4. Why is glycerin commonly used in suppositories and ovules?


Due to its hygroscopicity, so that they do not dry out

5. What is saponification? The reaction that produces the formation of soaps. The main cause is the dissociation by
hydrolysis of fats in an alkaline medium. Vegetable oils and animal fats are triglycerides, and when being
strong bases like (NaOH) or (KOH) saponify, that is, soap (salt of the fatty acid) is produced and
glycerin (glycerol).

1. Indicate the steps to follow from the arrival of raw materials to the pharmacy office or service.
pharmaceutical until they are stored in the appropriate place.
The first thing is to check that the delivery note matches the ordered material (request note).
Then if the condition of containers, packaging and labeling is correct,
and it is verified that the analysis bulletin has been sent with its control (quality) reference number
After this first inspection, the raw materials that meet the aforementioned requirements will
they register and move to the quarantine zone.
The Register contains the minimum data that identifies each raw material that exists in the pharmacy office.
quarantine period and before possible compliance, and are included in the control, recording and specifications guide
raw materials, such as:
Internal registration number.
Product name: expressed in INN or, if not available, in DC.
Provider.
etc.
A computer application will print a label that includes this information and a legend indicating
Raw material in quarantine The label is stuck on the container of the raw material without covering the original label.
provider.
Once the raw materials are registered, they will be placed in the storage area designated for raw materials.
"in quarantine" until its final approval or rejection.
The pharmacist responsible for studying the possible compliance (CONTROL OF
The conformity of the raw material will verify the analysis report and the manufacturer's specifications.
the options available are as follows:
Raw materials controlled by an authorized center:
To ensure product quality, the control reference number and the bulletin will be considered sufficient.
analysis provided by the authorized center, duly signed by the technical director.
2. Raw materials not controlled by an authorized center: The responsible pharmacist must carry out the control.
complete analysis of the raw materials supplied, to verify that they meet the specifications of the Royal
Spanish Pharmacopoeia and prepare the quality control sheet
If the raw material is accepted, it is assigned an internal registration number and a final label will be made with the
Basic data of the guide and signature of the responsible pharmacist for the acceptance. The label, once signed, will be attached.
in the containers of the raw materials located in the quarantine area previously removing the label
of quarantine.
Conversely, if the raw material is rejected, it must be returned to the supplier as soon as possible.

TESTS
According to their function, raw materials are divided into:
packaging material
b) excipients
active principles
d) All are correct

2. Last adventures are


a) plant exudates
It is an extractive preparation from plants.
c) they are vegetable juices
d) they are the same as quetsanas

3. What is an active principle that originated from animals?


a) Heparin
b) Vitamin B12
c) Digitalis
d) Atropine

4. Antibiotics are substances produced by


the minerals
b) microorganisms
c) the blood and the tissues
d) None is correct

5. Purified or distilled water:


It is a colorless, odorless, and tasteless liquid.
b) it is about demineralized water.
c) it is not used to prepare injectables
d) All are correct

6. Propylene glycol is
a) insoluble in ether
b) it is one of the least used excipients
c) it is hygroscopic (which easily absorbs ambient moisture),
d) dissolves the oils.

7. The most commonly used lubricant in tablet manufacturing is:


cocoa butter
olive oil
c) stearic acid
ethanol oleate

8. Carbopol is a raw material


a) of biological origin
b) that are presented in the form of yellow tablets
c) that swell in water and form transparent gels
they are very soluble in water

9. Which of the following preservative additives are authorized in medications in any concentration and route of administration?
administration
ascorbic acid
b) tocopherols
c) phenol
d) a and b are correct

10. The white beeswax is characterized by:


it is very soluble in water
melts at 50 ºC
melts at 65ºC
it is poorly soluble in essential oils

11. The starch paste is obtained:


a) dissolving starch in alcohol at room temperature
b) in cold aqueous solution
c) with starch in water when it reaches 80ºC
d) None is correct

Vaseline is a type of excipient


they have laxative properties when taken orally
b) it can be used alone in ointments
c) it is a petroleum derivative
d) All are correct

13. Gum arabic and gum tragacanth are used in:


a) the preparation of pasta
b) tablet manufacturing
c) in the formulation of suspensions
d) All are correct

14. Las Tegobetaínas ® is the brand of a surfactant that


a) it is a non-ionic detergent
b) it is mainly used in the manufacturing of shampoos
c) they are used for their bactericidal properties
d) they are derivatives of sorbitan

15. Silicones are:


a) hydrophobic
toxic
c) unstable at high temperatures
d) All are correct

16. The sucrose has the disadvantage that:


a) should be avoided in diabetics
b) its diluted solutions favor the growth of microorganisms
c) its concentrated solutions allow the development of microorganisms
d) a and b are correct

17. Bentonite is an excipient.


a) of kinetic origin
b) that is used in making tablets
c) it swells upon contact with water
d) is known as Venetian talc

18. As excipients in mandatory declaration medications are included:


vitamin E
b) lactose
c) BHT
d) b and c are correct

19. The acronym W is used to designate the excipient for mandatory declaration:
Sacarosa
b) Lidocaine
c) Aspartame
d) Ethanol

20. The CMC is a type of raw material:


a) mineral origin
b) it is obtained from starch
c) it is used as an excipient in ointments
d) All are correct

THEME 3

1. Indicate the steps to follow from the arrival of the raw materials at the pharmacy office.
or pharmaceutical service until they are stored in the appropriate place.
The first thing is to check that the delivery note matches the ordered material (delivery note of
request). ---Then if the condition of containers, packaging, and labeling is correct, and it is verified
the analysis report has been sent with its quality control reference number
After this initial inspection, the raw materials that meet the cited requirements with
previously registered and moved to the quarantine zone.
The registry contains the minimum data that identifies each raw material present in the office.
pharmacy during the quarantine period and before the possible compliance, and are included in the guide of
control, registration and specifications of raw materials, such as:
Internal registration number.
Product name: expressed in INN or, if not available, in DCI.
Supplier. Etc
Through a computer application, a label will be printed that includes that data and a
legend indicating 'Raw material in quarantine' The label is stuck on the container of the material
prima sin tapar la etqueta original del proveedor.
Once the raw materials are registered, they will be placed in the designated storage area.
raw materials "in quarantine" until their final approval or rejection.
El farmacéutco responsable de estudiar la posible conformidad ( CONTROL DE CONFORMIDAD) de la
raw material will check the analysis bulletin and the manufacturer's specifications.
The possibilities offered are as follows:
1. Raw materials controlled by an authorized center: To ensure product quality, it
it will consider the control reference number and the analysis report provided by the
authorized center, duly signed by the technical director.
2. Raw materials not controlled by an authorized center: The responsible pharmacist must
carry out the complete analytical control of the supplied raw materials, to verify that
they comply with the specifications of the Spanish Royal Pharmacopoeia and prepare the control sheet of
quality 1 If the raw material is accepted, it is assigned an internal registration number and will be made a
definitive label with the basic information of the guide and signature of the responsible pharmacist
acceptance The label, once signed, will be affixed to the containers of the raw materials that are
located in the quarantine zone previously removing the quarantine label. . For the
On the contrary, if the raw material is rejected, it must be returned to the supplier as soon as possible.
possible.

1.-DEFINE:
Conditioning: all operations, including packaging and labeling, that a product must undergo.
bulk to be converted into a specific product.
There are two positions:
Primary conditioning: an essential element of the medication, with a mission of protection (it isolates and
keep the medication at the right temperature) and a functional paper (facilitates the use of the medication by
sick; example: the container that holds a syrup.
It is in direct contact with the medication.
Secondary conditioning: It allows the handling, transport of the medication, its identification and the
information to the patient (ensures safety). It is the cardboard packaging in which the conditioning is included
primary.
Cap: in the vials, for the administration of the preparation, the central part of the capsule has a tab.
(called operculum) that can be retracted, exposing the elastomer, and that can be pierced by the
corresponding needle.
Posology: a branch of therapy that deals with the dosing of medications, both in terms of the amount of
medication as the interval of time between successive administrations.
Blister: unit packaging for various small manufactured items that consists of a cardboard or cardstock support over
the one that is attached to a transparent plastic sheet with cavities where the different items are placed. Shape
part of the primary conditioning.

2.-Name all the data included in the conditioning material record sheet.
1. Internal registration number.
2. Product Identification.
3. Provider.
4. Lot number.
5. Date of receipt.
6. Quantity and number of containers.
7. Expiration date, if applicable.
8. Conservation conditions, if applicable.
9. Decision of acceptance or rejection, dated and signed by the pharmacist.

3.- List the functions of secondary packaging.


Secondary conditioning is the case or box that protects the primary one, and it is called packaging.
external. In some cases, conditioning is part of the management system of a
medication: pre-filled syringes Unlike the primary one, sometimes it does not exist, as for example in the
large volume parenteral preparations. It has functions of protection, identification, information, etc. And
It can be divided into two parts: case or box and leaflet.

4.-Draw the symbol that appears in the secondary conditioning of medications that may produce
photosensitivity.

5.- Tras leer el tema . ¿ qué datos mínimos crees que deberían figurar en la etqueta de un frasco ( por ejemplo , un
syrup) of magistral formulation Can you consult the RD 175/2001 for the labeling in the Chapter of
Dispensation.
a) Name of the officinal preparation or, where appropriate, of the specified magistral formula, which must coincide with the
established in the National Form. b) Complete qualitative and quantitative composition, at least, of the principles
active ingredients and excipients with mandatory declaration. c) Pharmaceutical form, route of administration and quantity
exempted. d) Registration number in the Prescription Book or supporting document that replaces it, in accordance with the legislation.
in force. e) Lot number, in the case of official preparations. f) Date of manufacture and validity period or date of
expiration. g) Conservation conditions, if applicable. h) Name and license number of the prescribing physician,
for the preparations that require a prescription. i) Patient's name in the case of compounded formulas. j) Office of
pharmacy or dispensing pharmacy service: name, address, and phone number. k) Warning: keep away
out of reach of children. 2nd When the size of the packaging does not allow for the inclusion of all on its label.
Previous data will include, at a minimum, the following: a) Name of the official preparation or, if applicable, of the
Master formula specified, which must match that established in the National Form. b) Composition
Qualitative and quantitative complete, at least, of the active principles and the excipients of mandatory declaration.
{"c":"Route of administration, if confusion may exist.","d":"In the case of magistral formulas, registration number of the Book"}
Recipe or the support that replaces it in accordance with current legislation. e) Lot number, in case of
prepared prescriptions. f) Date of preparation and validity period or expiration date. g) Identification of the office of
pharmacy or dispensing pharmaceutical service. 3rd The rest of the data that could not be included in the labeling
will be delivered along with the written information or prospectus addressed to the patient that must accompany the
dispensing of the magistral formula or official preparation

7.-Complete: according to the RFE, a SEALED container is a package closed by melting the material it is made of,
while an airtight container is IMPERVIOUS to solids, liquids, and gases under usual conditions.
manipulation, preservation and TRANSPORT.

8.- The inclusion of the leaflet is mandatory in all medications, except…..


If all the required information is included in the outer packaging, or, failing that, in the conditioning.
primary.

9. What is the first step to take in the process of receiving an order of raw materials?
a. Inspect the good condition of the containers.
b. Review the status of the raw material labels.
c. Check that the raw materials listed on the delivery note match those ordered.
d. None of the above answers is correct.

10. When should the quality control sheet of a raw material be prepared?
a. When the raw material is not controlled by an authorized center.
b. When an analytical control is carried out on the raw material to verify that it meets the stipulated conditions.
the RFE.
c. When the raw material is controlled by an authorized center.
d. Answers a and b are correct.

11. What information should the label of a raw material contain?


a. The wealth and the conditions of conservation.
b. The name of the raw material in DOE or in DCI.
c. The internal registration number and the expiration date.
d. All the previous answers are correct

12. What type of conditioning material should be recorded?


None.
b. The high school.
c. Only the primary.
d. All the previous answers are incorrect.

13. The rules for proper preparation and control require that the raw materials meet the requirements of:
Purity.
b. Identity.
c. Acute toxicity.
d. All of the above answers are correct.

14. What procedure should the conditioning material undergo?


a. Verification.
b. A quality control.
c. A registered.
d. All of the previous answers are correct

15. The ampoules are packaging containers


made of glass
b. closed by fusion
c. where one of its parts is the bulb
d. all are correct

16. The packaging of granules is becoming increasingly common in:


a. glass jars
b. multidose envelopes
c. blister
d. metal tubes

17. The cartridges are containers.


a. that contain a large volume of liquid
they have a cylindrical shape
They are used to package local anesthetics.
d. b and c are correct.

18. A star-shaped symbol on the packaging means


inflammable
b. it must be stored in the refrigerator
c. caution when operating heavy machinery
d. expires before 5 years

19. A jar for infusion


it is opened using a metal file
It has a plastic system for hanging.
they have a closed stopper by an aluminum capsule
d. b and c are correct

20. The metal tubes


they always maintain the same shape
they have great chemical inertia
they have a lower risk of contamination of the residue
d. they are lightweight
21. If there is a pictogram on the packaging of a raw material, it means

a. medicinal comburant gas


b. photosensitive material
c. radioactive
d. flammable medicinal gas

22. The outer packaging of the medication may come in Braille:


a. the composition
b. the denomination
c. the name of the excipients
d. the warnings

23. Regarding the pre-filled syringes


they are usually plastic syringes
b. they require prior manipulation before administration
they are used for heparin injection
they have an aluminum capsule

TOPIC 4

1.- Specify whether the following material is sterilized or disinfected:


Canvas bases STERILIZE
Erlenmeyer STERILIZATION
3. Petri dishes STERILIZE
4. WATERSTERILIZE
5. graduated flasks DISINFECT
6. Laboratory coats DISINFECT
7. Precipitate glasses STERILIZE

2.- Which of the following procedures is NOT used in crushing?


Shear
b. Percussion.
c. Digestion
d. Compression.

3.- Is condensation a step of the?


a. Distillation.
b. Percolation.
c. Digestion.
d. Filtration
4.- When is the drug brought into contact with the solvent at a temperature of 100° C during an extraction?
(holding it for a few moments) is called?
a. Maceration.
b. Digestion.
c. Infusion.
d. Diacolación.

5.- What of the following can speed up the evaporation process?:


a rise in temperature.
b. A decrease in temperature.
c. An increase in pressure.
d. An increase in pH.

6.- What is the process called when a solid turns into a gas?
a. Crystallization.
b. Desiccation.
c. Sublimation.
d. Collimation.

7.- It is FALSE that regarding sieving?


a. It is used to separate large particles from finer ones.
b. It is used to determine the size of the particles.
c. It is used to fractionate solid substances and transform them into smaller particles.
d. It is used to classify powder types into coarse, fine, very fine, extra fine, and micro fine.
Answer true or false
8.- When is the flame of a lighter yellow with more calorific power?....NO...the blue has more power.
caloric
9.- Is maceration a mechanical extraction?......NO ..maceration is an extraction using a solvent.
(discontinuous static)......

10.- Name laboratory devices that are used for pulverization or grinding.
Mortars: The most used. They can be made of porcelain, Screw and blade grinders: Coffee grinder type or blender.
kitchen. Mills: Type of pepper grinders.

11.- Define maceración, digestón e infusión.


Maceration: It consists of the prolonged contact for a certain time of the drug (divided into small
fragments) with the solvent
Digestion: It is a maceration placing the container in which it is practiced at a temperature higher than the ambient one and always
constant (a bath with a thermostat is used)
Infusion: It consists of placing the divided drug in an empty container that will be filled with boiling water, then letting it steep until
reach the ambient temperature

12.- What types of filtrations do you know? 1.- Gravity filtration: As filter material, it is usedreplace the filter paper that is
Place in a funnel in a vertical position, and the liquid descends by the action of gravity. 2.- Filtration by suction: As a medium
A filter is used with filter paper in a funnel or a filter plate mounted in a funnel or a crucible.
What advantages and disadvantages does the use of plastic material have compared to glass material?
Advantages: - Plastic containers do not break as easily as glass material - They are more stable against
Acids, with exceptions such as fuming sulfuric acid, and concentrated nitric and perchloric acids) - They are more
stable against alkalis. - They can be disposable - They are lighter (weigh less)
Disadvantages: - The plastic material is porous to carbon dioxide (CO2), so the solutions
that remain stored in these containers for long periods of time end up becoming carbonated.
They cannot heat above 70ºC.

2. When would the process of removing moisture from a solid in the oven be finalized?
When after having weighed the solid substance (P) and putting it back in the oven for a while longer, it is weighed again.
new (P ¨) and this weight is equal to the previous one. That is, if it remains constant (in reality it is allowed that if they are not
exactly the same, only varying by a +-0.05% both weights

What precaution should be taken when heating test tubes?


They should not be heated from the bottom, but rather near the surface of the liquid (from the side of the tube), and thus it will not spill out.
projected. And be careful that the mouth of the tube does not point at any colleague.

1. A desiccator consists of.


a round-bottom flask
a refrigerant
c) a perforated metal plate
d) None is correct

2. The 'porosity' of a filter refers to:


its speed to filter
b) type of material it is made of
c) the diameter of the pore
d) None is correct

3. During the use of the pipettes


a) do not touch the tip to the wall of the container so that the liquid drains
b) the small remaining volume from the tip can be poured by blowing
c) a rubber pear can be adjusted
d) All are correct

4. The chromatic mixture allows for the removal of embedded dirt, organic matter, or grease in the material and is made with:
nitric acid
b) sulfuric acid
hydrochloric acid
d) All are correct

5. A heating blanket
a) does not allow regulating the Tª
b) uses water as a source of heating
c) it is an electric heating equipment
d) None is correct

In the evaporation of liquids, the use of is useful


a container such as beakers or watch glasses
b) a volumetric flask
glass pearls
d) a and c are correct

7. The top edge of the filter must maintain a distance (below) from the edge of the funnel of:
a) 1 cm
b) 2 cm
0.5 cm
d) No distance

8. In a suction filtration
a) they use filtering plates
b) Buchner funnels are used->
c) filter paper is used
d) All are correct
TOPIC 5
1. - It is not an absorption area of the digestive tube
Duodenum
b. Stomach
c. Íleon
d. Oral mucosa and esophagus

2.- What happens to the M that are absorbed through the sublingual mucosa?
They go directly into the bloodstream through the capillaries and veins, and by not passing through the
stomach prevents its acidity and gastric enzymes, and by not being absorbed at the intestinal level, they avoid the Effect of
First Step (arrival at the Liver through the Portal vein) Hence they are emergency medications such as the
Active principle nitroglycerin for angina pectoris attacks or heart attacks.

3.- The main advantages of hard gelatin capsules are all except.
a. Easy swallowing
b. The cover does not allow for the transportation of certain active principles.
c. Protection of the active principle
d. Ease of identification by color

4.- Relate:
Moisturizer a.- They must be soluble in water, harmless to the body, and should never interact with the
medications.
2.- Absorbents They are used for the production of hard gelatin capsules when necessary.
3.- Dilutents c.- They facilitate the preparation of the capsule
4.- Adjuvants They help to encapsulate liquid or semi-solid substances
5.- Lubricants They are not usually used in pharmacy offices due to the difficulty of controlling their effects.

5.- Answer true or false regarding gastro-resistant or enteric capsules.


etquetado. Caducidad. Denominación. Condiciones de conservación. Fórmula desarrollada. Modus operandi.
Media and raw materials.
Bibliographic References. 11th
Patient information. 7th
Observations 10th
Controls. 5th
Storage material (packaging) and labeling. 6th
Expiration. 8th
Denomination. 1st
Conservation conditions. 9th
Developed formula. 2nd
Operating mode. 4th
Media and raw materials. 3rd

5.- What procedures are not mentioned in RD 175/2001 but are still required by the F.N?
Royal Decree 175/2001 does not establish these procedures as mandatory, but the National Form does require them.
to have them available.
Standardized weighing procedure.
2. Standardized mixing procedure.
3. Standardized disaggregation procedure.
4. Standardized screening procedure

1.-Difference between pouring instruments and containing instruments


The pouring instruments usually carry the indication 'pour,' Ex, or TD, such as pipettes.
burettes and graduated cylinders. In these, the volume indicated in the calibration corresponds exactly to the amount or to the
volume of liquid poured (since the error in the amount of liquid that is not poured out has been taken into account)
adhered to the walls) And the calibrated instruments to contain, carry the indication cont., In or TC, like the
calibrated flasks, and the indicated volume corresponds to the volume of liquid that is inside the instrument (
not with the volume that would be spilled)

2. Indicate the difference between a graduated pipette and a volumetric pipette.


The graduated pipette is a straight tube made of glass or plastic that has a scale or divisions engraved on its wall.
in volume in ml and in tenths (0.1) or hundredths of a milliliter (0.01), allowing for the measurement of different volumes
of liquid. They are less accurate than calibrated or volumetric ones. At its top, it would indicate the Maximum Volume that
Volumetric pipettes (graduated) are designed to measure a single volume of liquid. They are tubes
long with a widening in their central part, where their capacity and temperature are generally indicated
The volumetric pipette is calibrated to be used under standard conditions, with a specific volume and temperature.
Determined; the temperature is usually 20°C), and with a mark or graduation line. And there are also "double" pipettes.
afore (or double mark) where the capacity of the pipette matches the volume of liquid contained between the two
flow lines

To measure 5 ml of a liquid, it is more accurate to use a 10 ml pipette or one of 4 ml and one of 1 ml.
To make the measurement more accurate, the smaller the volume measurement of the pipette, the better. Therefore,
the option of a 4ml pipette and a 1ml one is the most appropriate. In any case, there are 5ml pipettes and, thus
I would avoid using two pipettes or taking two measurements with the same pipette.

4. Answer true-false
a.- It is recommended to heat the volumetric containers F
b.- Calibrated instruments for containment usually carry the indication Ex Otd F
c.- One should always blow out the last drop that remains in the pipette. F
Graduated pipettes measure a determined volume of liquid F

5. What material is MORE accurate for measuring volumes?


a. Graduated flask.
b. Beaker.
c. Erlenmeyer flask.
a capsule could deviate by 10% from the theoretical weight (average weight in
this case)
As we see, 100%-10.52% = 89.48%
y 89.48%> 10% for capsule number 7
The deviation of the average weight of this batch of capsules could be studied.
adding the weights of all the capsules and dividing by 20caps →
16.14g/20 = 0.807
and compare it with what we have called Reference Average Weight (1.15g)
But as we have already seen, a capsule does not meet the
required criterion, we know that the batch is not valid

1. Gelatin capsules can be classified according to the type of coating as:


a. Soft gelatin capsules.
b. Hard shell capsules.
c. Gastro-resistant capsules.
d. All are correct

2. The disintegration test for capsule control


a. sirve para validar un lote de cápsulas duras.
b. it is used to validate the enteric coating method
c. use the method that the Spanish Pharmacopoeia describes for pills
d. All are correct

3. What is the number of capsules that will be made according to the prescription?
500mg P.A/12h/20d
20 capsules.
b. 40 capsules.
c. 1 capsule / day.
d. 10 capsules

4. Lactose is an excipient that is used to


a. Increase the volume and completely fill the body of the capsule.
b. Eliminate moisture in hygroscopic products.
c. Facilitate the filling operation of the capsule by making the powder slide more easily.
d. Adsorb the moisture of semi-liquid products.

5. Indicate the True statement regarding the handling of the capsulator:


a. Before filling the capsules, only the lids are placed in the capsule machine.
b. The transparent plates all have 30 holes
c. The plates are numbered and there are always three, two black and one white.
d. It is necessary to compact when filling the capsules.

6. The main function of lubricants is:


a. Increase the volume to completely fill the capsule body.
b. Facilitate the capsule filling operation by making the powder slide more easily and not
I remained adhered.
c. Remove moisture from hygroscopic products, extracts, or semi-liquid products.
d. Help to disaggregate the capsule to release the active ingredient more quickly.

7. Regarding solid oral forms, their preparation can be by:


a. Conglutination
b. Molding
c. Compression
d. All are correct
8. What controls are indicated in the National Form for a medicinal preparation of capsules or for
Batches of capsules (consult PN Preparation of capsules PN / L/FF/001 /00)?
a. Mass uniformity.
b. Disintegration test.
c. Microbiological assay.
d. All are correct.

9. What is the name of the graph that can be used to determine the appropriate capsule number according to the
volume occupied by the active ingredient?
capsule maker
b. nomogram
c. capsugrama
d. microcaps

10. One of the drawbacks of capsules is that


They are difficult to manufacture in O.F.
b. They produce intolerance.
c. They require careful storage and preservation.
They do not mask unpleasant flavors and odors.

11. Among the advantages of capsules, it is found that:


a. The cover is water permeable
The cost of the cover is low
c. Its preparation is simple
d. All are correct

12. In the homogenization control in the capsules:


It is advisable to weigh all the capsules
b. 20 capsules are selected at random
c. The content in p.a. is measured by ultraviolet spectrophotometry
d. It is only observed if they are well closed

13. To obtain a gastro-resistant granulate


a. the capsule is submerged in acetone
b. Eudragit is added slowly
c. they use granules called diffucaps
blue neutral granules are used

14. The pills


a. they usually contain binders like gum arabic
b. does not contain sucrose
c. they dissolve quickly in the oral cavity
d. a and c are correct

[Link] tablets are made


a. through pill pushers
b. are dispersions of the p.a. in syrups
c. with a large amount of sucrose
d. b and c are correct

16. The appropriate capsule size for children is usually:


a. 00
b. 2
c. 1
d. 0

17. Gastro-resistant or enteric capsules are used when:


a. the active principle is emetic
b. the active ingredient is destroyed in the stomach
c. the active principle must be absorbed in the intestine
d. All are correct

18. To obtain dry powder:


a. the dried plant drug is sprayed
b. the plant drug is previously chopped
c. it is not processed for sieving
d. a and b are correct

19. Cryomilled powder:


a. allows obtaining particle sizes on the order of microns
b. change the thermolabile active principles
c. reduces the bioavailability of the product
d. none is correct

True (T) or false (F) questions.


The tablets can be coated in order to mask unpleasant tastes.
the capsule must be transparent in the case of inhalers... ( V )
The granules have a weight of up to 3 g.
Most tablets are swallowed or chewed.
In the case of diabetics, powdered sucrose can be used as a diluent to prepare the
capsules
The hydroalcoholic extracts of fresh state plants are obtained without freezing the plant.
With the term 'galenic form' we refer to the route of administration of the medication.
The obtaining of granules also requires the steps of drying and sieving.
THEME 6

1.- Solutions with a particle size greater than 0.1 microns are:
a. True solution
b. Colloidal solution
c. Suspension
d. There is no solution with that particle size

2.- The speed of dissolution is influenced by:


a. pH and temperature
b. Temperature
c. Pressure
d. Temperature and pressure

3.- What solution is suitable for use as a topical?


a. Sheltered
Lotions
c. Mouthwashes
d. Oiled

4.- Answer true or false


a. A syrup is a nearly saturated alcoholic solution of sucrose.
b. The person responsible for preparing a magistral formula is always the pharmacist.
c. The essences are obtained by distillation of dry material F
d. In the acetic extracts, the extractive liquid is the wine F

5 Complete:
1. Solubility: The solubility coefficient is……THE AMOUNT OF SOLUTE DISSOLVED…. that constitutes…
A saturated solution... The amount of solute that can be dissolved in a given amount...
OF SOLVENT... therefore the... SOLUBILITY.. is the ease with which a substance dissolves in
another.
2. Suspensions... ARE UNSTABLE... by their very nature, they tend to separate into two phases. The more
the larger the particle size, the less stable the suspension will be...
The principles act... THEY ARE ABSORBED. worse than dissolved, but in the
in the case of the topical route, the suspensions add an effect …ANTI-INFLAMMATORY..

6.- Relate:
1. Enemas a.- Used to treat the larynx and nasopharynx
2. Vaginal douches b.- Used for mouth rinses.
3. Mouthwashes They are generally used for washes
4. Gargling They are applied in the ear.
Optical drops It is administered in the form of drops or by nebulization.
Nasal preparations They are liquid forms for rectal use

7.-Name the factors on which solubility depends.


Temperature, solute physical state, impurities, presence of other solutes, pH, surfactants, ...

8.- Why does condensation in the case of syrups favor microbial growth?
If there is condensation of water vapor on the cap of the syrup bottle, the water (condensed vapor) falls.
about the syrup and, as it does not mix well with it due to its high viscosity, a more diluted solution is formed
at the top of the syrup, with the possibility of contamination occurring

9.- In a linear arrangement, which is the solvent? The oil.

TESTS:
In solutions, the solute can be:
solid
b) liquid
gaseous
d) All are correct

[Link] are obtained by:


a) Percolation
b) Maceration
c) By distillation
d) None is correct

3. Milk of magnesia
a) it is an antiseptic suspension
b) contains zinc oxide
c) it contains magnesium hydroxide
is preserved at high temperatures

4. The factors that influence the rate of dissolution are:


a) The temperature
b) The particle size
c) The stirring speed
d) All are correct

5. Dissolutions are characterized by:


a) The solvent is usually solid
b) They can be simple and extractive
c) Its components can be separated by decantation
They tend to settle over time.

6. As solutions with topical administration route, we have:


the enolates
b) the mouthwashes
c) the lotions
d) the enemas

7. One way to express the concentration of a solution is in ppm, what does it mean?
a) Molarity
b) Percentage
mg/Kg
d) None is correct

8.A solution where the solute is about to precipitate or form crystals is said to be:
diluted
b) very diluted
c) slightly diluted
d) saturated

9. When preserving while preparing syrups, you can use:


hectorita
b) sorbitol
c) benzoic acid
d) Alginates

10. In the case of topical suspensions:


a) the p.a.s are better absorbed
b) they have an anti-inflammatory effect
they tend to dry out the skin
d) b and c are correct

[Link] sulfate enemas:


a) they are used to achieve a laxative effect
b) they are a type of retention enema
c) they are used for radiological diagnosis
they are used for a local topical effect

12. The problem of fermentation in syrups occurs due to:


a) package them in transparent glass jars
b) the sucrose precipitate when the syrup cools
c) package the syrup hot
d) packaging in jars that are not properly dried

[Link] jarabestenen ventajas como:


a) they have high conservation power
b) delay the precipitation of solutes
c) they mask the unpleasant flavors
d) all are correct

14. To make an oily suspension, the suspending agent used is:


aluminum monoester
acetic acid
c) glucose
methylcellulose

[Link] elixirs are:


a) oily pharmaceutical forms
b) mixtures of alcohol, water, and sugar
c) mixtures that do not require filtration for their preparation
d) they are mixtures of alcohol and sugar only
16. In simple syrups:
a) water is mixed with glucose
b) water, alcohol, and sucrose are mixed
640 g of sucrose is added to 360 g of distilled water.
d) sugar is added in hot to make the solution

17. The suspensions:


they have a transparent appearance
b) they are unstable
they have a dispersed liquid phase
d) the solute has a particle size of less than 0.1 microns

18. The aluminum chloride solution


a) it is a hydroalcoholic solution
b) it is used for excessive sweating
c) it is prepared using a magnetic stirrer
d) b and c are correct

19. As suspending agents for making suspensions, the following are used:
alginate
sucrose
c) carbomer
d) a and c are correct

20. If I need 100ml of 20% Glutaraldehyde to carry out my formula and I have in the laboratory a
25% glutaraldehyde bottle, how many ml should I take from this bottle, to then be able to complete with
water in a 100 ml volumetric flask?
80 ml
40 ml
60 ml
d) None is correct

True (T) or False (F) questions:


The size of the solid particles in suspensions does not affect sedimentation.
heterogeneous dispersed systems are solutions
Simple dissolutions are those in which a residue remains.
The solutions should be shaken before use.
In exothermic reactions, higher temperature means lower solubility.
syrups are just suspensions
The emulsions are preparations whose vehicle is oil.
In solutions, the most commonly used excipient is hydroalcoholic.
bentonite provides a grayish color to the suspensions
The gum arabic precipitates in the presence of alcohol.
THEME 7
1.-It is an emulsion, what is the external or continuous phase called? Dispersant.

2.- What type of equipment is used to make large quantities of emulsion?


Helical, paddle or turbine agitators (or emulsifiers). For example, Unguator.

3.- What drawbacks do anionic and cationic surfactants present?


They are irritating, multiple, incompatible
They present multiple incompatibilities.
Anionic surfactants are only effective in alkaline medium.
Catholics are only effective in acidic medium.
Anionic and cationic substances are incompatible with each other.
Alkaline soaps are particularly sensitive to the action of calcium salts present in hard water.
which transform into calcium soaps that have very different properties.
Skin and mucous membrane irritants. The most irritating are the anionic ones. Within this group, however, the salts of
Organic bases are better tolerated than the rest.

4.- Define:
Thixotropy: TheThixotropy is the property exhibited by some gelatinous fluids of having the power
lose their viscosity when pressure is applied to them or when they are agitated (that is, they can transition from semisolids to
liquids
Evanescence: it is a characteristic that some creams have and that consists of leaving no greasy residue behind.
apply them on the skin (o/w emulsions are more evanescent than w/o ones)
HLB: it is the hydrophilic/lipophilic balance that is used to determine if an emulsifier has more characteristic.
hydrophilic or lipophilic. If the emulsifier has a low HLB, it is suitable for water in oil emulsions
(W/O), and if the emulsifier has a high HLB, it is better for oil in water (O/W) emulsions.

TESTS:
1. Microemulsions are characterized by:
a) the size of the globules is less than 0.1 microns
b) they are thermodynamically unstable
they are opaque
d) all are correct

2. Among the secondary components of an emulsion, we find:


a) the preservatives
the colorants
the flavorings
d) all are correct

3. An emulsion is:
a) a homogeneous system
b) a mixture of solid and liquid
c) a dispersed system
a mixture of two miscible liquids

4. A characteristic of the SPAN® emulsifiers is that:


a) its activity depends on the pH of the solution
b) they are soluble in oils
c) they are practically insoluble in water
they rust easily

5. To incorporate insoluble p.a. in O/W emulsions


a) it is made with propylene glycol
b) it is done with liquid petroleum jelly
c) are directly incorporated into the aqueous phase
d) it is incorporated into the oily phase
6. If methylene blue is added to a W/O emulsion, it occurs that:
a) extends in the emulsion
b) it does not extend
c) increases the viscosity of the emulsion
d) None is correct

7. For the control of homogeneity, the RFE recommends the use of:
a test tube
b) a viscometer
c) cytometer
d) None is correct

8. The more consistent emulsions are called:


milks
lotions
c)ung entos
d) creams

9. The stability test of emulsions can be done with:


a stove
b) penetrometers
c) test tubes
d) a and c are correct

10. The fatty alcohol Lauric, what type of emulsifier is it?


cationic
b) amphoteric
c) anionic
non-ionic

11. Sorbitan monopalmitate (a fatty acid ester with sorbitol) is known as:
a) Tween
Triethanolamine
c) Span
Sudan III

12. The types of containers in which emulsions can be packaged are:


jars
b) tubes
bottles
d) all are correct

13. Coalescence in the case of emulsions refers to:


a) the inversion of the phases
b) sedimentation
c) the formation of a layer on the surface of the emulsion
d) when larger globules are formed by the union of other globules from the dispersed liquid

14. The temperature when making emulsions


it has to be at 70 ºC in the oily phase
b) it must always be ambient temperature in both phases (oily and aqueous)
c) it is usually at 70ºC in both phases
they have to be heated only the aqueous phase to 80ºC

15. The bases of commercial emulsions:


a) they are made up of fat, emulsifier, and water
b) they are formed solely by fat
c) consist of fat and emulsifier
d) it is not necessary to add water to prepare the emulsion

16. The Neo PCL is:


a) an emulsion base that is prepared in pharmacies
b) an industrial emulsion base
c) an emulsion base only W/O
d) a type of anionic emulsifier

17. The organoleptic tests performed on the prepared emulsions consist of


a) observe the coloring
b) measure its pH
c) carry out the weight verification
d) determine the external phase

18. In a W/O emulsion


a) the dispersing phase is water
b) the dispersed phase is oily
c) the continuous phase is oily
d) the external phase is water

19. The non-thermolabile fat-soluble p.a.


a) are incorporated directly into the aqueous phase
b) they are incorporated with the help of a mineral oil
c) is directly incorporated into the oily phase
d) it is added at the end of the emulsion, as it is affected by high temperatures

20. Which of the following substances is commonly added as an active ingredient in creams to treat skin blemishes?
a) hydroquinone
b) sorbitol
nipasol
d) None is correct

21. Which of the following components is usually present in the emulsion base known as Beeler?
sodium lauryl sulfate
b) wax
c) Celtic alcohol
d) All are correct
Contesta si es Verdadero (V) o Falso (F) :
Lecithin can be used as an amphoteric emulsifier…(V)
Cold cream is a type of O/W emulsion.....(F)
When making a W/O emulsion, the emulsifier or emulsifying agent is added beforehand to the dispersed phase...(F)
Emulsifiers with a high HLB are suitable for water in oil (W/O) emulsions....(F)
With the inversion of phases, the dispersed phase becomes continuous and vice versa (V)
Before packaging it is advisable to let the emulsion formula rest for a short period of time ... (V)
For the quality control of emulsions, pH measurement is usually performed.
When the small aqueous phase is included in a larger one, which in turn is dispersed in an aqueous phase, we are
in the presence of a multiple emulsion W/O/W...(V)
Questionnaire on Topic 8: SILICONE EMULSIONS

1. What advantages do W/O emulsions offer over O/W in sunscreen products?


They allow for a better distribution of sunscreen over the skin surface. They are more
substances because they remain longer in contact with the skin, which improves their protective power, and their
great water repellency, making them useful in protective hand preparations and sunscreen products
water resistant.

2. ¿En qué 4 puntos básicos se fundamenta el uso como alternatva tecnológica de las emulsiones silicónicas?

El uso de dimetcona copolioles como emulgentes


The use of cyclosiloxanes as a possible sole lipid component.
The use of high percentages of water.
Cold manufacturing

3... DEFINE: emoliente y queratolítco. Pon un ejemplo de p.a. que ejerza función queratolítca
An emollient is a substance that soothes and softens the skin like ceramides, lanolin,......
A keratolytic is any substance that removes dead cells from the epidermis (from the stratum corneum) such as the
urea, salicylic acid..

4. How are the poorly soluble active ingredients incorporated into the silicone emulsion?
They should be dispersed with drops of cyclosilicone (dispersant), subsequently adding the W/S emulsion in
small portions.
This dispersion can also be added to the W/O emulsion when half of the water has yet to be added.

5. Why do cyclosiloxanes not leave a cold sensation when evaporating on the skin, like ethanol?
Because they have a lower evaporation heat than water and ethanol, which means that their evaporation from the skin
is not accompanied by the feeling of cold that characterizes the evaporation of those.

TESTS:
The condensation of alkyl polysiloxanes with polyols such as PEG (polyethylene glycol) allows for their use.
like:
dyes
b) emulsifiers
c) preservatives
d) desiccants

2. The dimethicone copolyols are characterized because:


they have lubricating properties
b) prevent the formation of foam along with surfactants
c) they cause more irritation than other surfactants
d) All are correct

3. The phenildimetconas:
they have a slight perfumed smell
they have little lubricating ability
they are poorly soluble in alcohol
d) All are correct

4. The applications of cyclomethicones are found in products such as:


deodorants
b) bars or sticks
c) moisturizing creams
d) All are correct
5. Silicone emulsions have applications for the preparation of:
solar filters
syrups
c) mosquito repellent lotions
d) a and c are correct

The use of silicon emulsifiers allows


a) prepare emulsions only at a temperature of 70ºC
b) prepare emulsions with a high proportion of water
c) formulate emulsions with low extensibility
d) None of the above is correct

7. Dimethicone has properties such as:


they are fluid
they have a great solvent action
c) allow to reduce the greasiness of the lipids when applied
d) a and c are correct

8. Cyclometalones are characterized by:


a) they do not produce a softening effect
b) They have good compatibility with many cosmetics
c) and give rise to transparent, odorless, and colorless products
d) they are not volatile

9. An antiperspirant is:
a product that gives a good body scent
a product that leaves little greasy residue
a product that reduces sweating
a product that eliminates the hardness from the stratum corneum of the skin

10. Cosmetic forms made with silicones have characteristics such as:
a) the hydrophobicity.
b) the adhesiveness
c) allow sweating
d) a and c are correct

11. In silicone emulsions (W/S):


a) the viscosity of the emulsion is proportional to the water phase content
b) if its water content is less than 70%, they acquire a creamy texture
c) if its water content is over 80% they have a lotion-like appearance
d) All are correct

12. Among the tests that can be performed in a quality control of silicone emulsions, the following can be found:
a) the organoleptics
b) control of pH
c) study of the presence of air bubbles
d) All are correct

13. The applications of phenyl dimethyl siloxanes are:


a) in stocks
b) in insect repellents
nail polish
in low-lubrication hand preparations
14. The use of silicone emulsifiers allows for greater acceptance within the world of cosmetics, due to the fact that
their finished products present:
a bright color
a larger residue
c) less extensibility
d) All are correct

15. What skin types are W/S emulsions indicated for?


oily skin
b) dry skins
c) mixed skin
d) a and c are correct

16. To incorporate a p.a. such as ketoconazole (antifungal) into a silicone emulsion, it is usually done:
a) pulverize in a mortar and mix withCyclomethicone, before adding the emulsion
b) pulverize in a mortar and add to the already made emulsion
c) use glycerin to incorporate it
d) dissolve in the aqueous phase

17. Silicone emulsions are not compatible with:


sodium chloride
iron oxide
with a low HLB
d) None is correct

18. In dermopharmacy, silicone emulsions are being used to treat:


acne-prone skin
b) skin with rosacea
c) skin aging
d) All are correct

True (T) or False (F) Questions

The dimethicone copolyol emulsifier sometimes requires the presence of a co-emulsifier of the O/W type.
The dimethylsiloxane copolyols are easy to handle in pure state.
Silicones are very safe products from a toxicological point of view.
The water-soluble p.a. can dissolve in the silicic phase.
The initial addition of the aqueous phase onto the silicate (priming) must be done very quickly.
the bioavailability of the active ingredients decreases when applied with silicone emulsions
Both dimethicones and phenyl dimethicones are not biodegradable products.
To increase the viscosity of silicone emulsions, the amount of cyclosilicone can be reduced.
TOPIC 9

1.- What 4 aspects can gels be classified into:


1.- According to the nature of the gelling polymer.
2.- According to the number of the phase in which they are constituted.
3.- According to the affinity between the phases.
4.- According to its origin.

2.- Name the plant extracts used in the production of gels.


Starch
-2) Pectna
-3) Guar gum
-4) Alginates
Agar-agar

3.- How are harmful active principles incorporated in an acidic medium when making a gel? And how do
do they incorporate p.a. acid?
Dissolved in neutralizing bases
The acidic p.a. must be neutralized beforehand so that the gel does not lose viscosity, unless it should not be.
change the acidity of the p.a. because it loses its action

4.- Write the galenic and dermocosmetic characteristics of Anionic-Amphoteric Base shampoos (like the one)
Texapon 40 and Tegobetaine.
Medium-high viscosity shampoo, with good foaming, cleansing, conditioning qualities; with low
incidence of irritation on the scalp and good cosmetic appearance.

5.- How do the following substances affect their viscosity: alcohol, oil, sodium chloride, strong acids?
- All decrease it, except for NaCl which increases it.

TEST
1. Among the tests carried out on a gel for quality control, there is:
a. study of aspects
b. pH
if there are bubbles present
d. all are correct

2. As an inconvenience the gelestenen:


a. incompatibility with numerous active principles.
b. under penetration power
c. tendency to desiccation
d. All are correct

3. The TAS gels are:


a. monophase gels
b. transparent biphasic gels
c. they are used to formulate water-repellent gels
d. b and c are correct

4. Which of the following plant extracts or exudates can originate


mucilages after dispersing in hot water?
a. acacia gum
b. pectnas
c. agar-agar
d. a and c are correct

5. Triethanolamine (TEA) is a neutralizing base for gels.


of inorganic nature
b. in the form of sodium salt
c. detpo amina
d. All are correct

6. Gels, in general, are incompatible with:


a. metallic ions such as Fe
b. with UV radiation.
c. a and b are correct
sodium hydroxide

7. Which of the following components is a pH regulator?


a. K0H at 10%
b. colloidal silica
c. gum arabic
d. None is correct

8. When are the active soluble principles incorporated into the diluent in the preparation of gels?
a. It doesn’t matter at what stage they join.
b. Whenever possible, before preparing the gel.
c. It is added once the gel is prepared.
d. None of them is true.

9. In the preparation of the gel, if the gelling agent is Carbopol, it is necessary to adjust the pH:
a. Between 4.5 - 5.5.
b. Between 7 - 7.5.
c. Between 5 - 6.
d. Between 3 - 3.5.

10. The main advantage of gels is:


a. They tend to be opaque
b. What are xotropic.
c. They are unstable in the face of pH changes.
that do not get contaminated easily

11. Bentonite magma is a type of gel


lionphobic
b. single-phase
c. reversible
d. None are correct
12. When neutralizing non-polar systems, if we have more than one solvent
a. TEA is added to the less polar solvent
b. the resin is dispersed in the more polar solvent
c. Add TEA to the more polar solvent
d. under strong agitation, the resin dispersion is added to the mixture
amine-solvent

13. The lyophilic gels are


a. they are irreversible systems
b. they are unstable
c. they change from sol to gel due to changes in temperature and pH
d. All are correct

14. When it comes to water or a polar solvent, it is used as a neutralizer.


for thickening gels
a. sodium hydroxide,
b. TEA
c. ammonium hydroxide
d. All are correct

15. CMCNa (sodium carboxymethyl cellulose) is a gelling agent.


of natural origin
b. that increases its viscosity at high pH
c. compatible with strong acids
in hot water forms mucilage

16. Among the quality control tests for shampoos are:


a. study of pH
b. study of viscosity
c. study of foam persistence
[Link] of them are correct

17. To control the acidic pH in shampoos, the following is used:


lactic acid
b. TEA
c. Sodium chloride
d. Tegobetaine

18. Viscosit15 is the trade name of:


a re-greaser
a surfactant
a thickening agent
d. a and c are correct

19. It is used as a foam stabilizing substance in shampoos.


a. EDTA
b. Espesamida (diethanolamide of coconut fatty acid)
c. menthol
D. Sodium naproxen

20. Most shampoos should have a pH close to


5.5
b. 8
c. 4
d. 3
21. As auxiliary substances in the preparation of shampoo, the following are used:
a. preservatives
b. perfumes
c. chelating substances
d. All are correct

22. To increase the viscosity of the shampoo, one can use:


sodium chloride
b. urea
c. citric acid
d. a and b are correct

23. The water-soluble thermolabile p.a can be incorporated in the preparation of


shampoo
a. directly in the aqueous phase
b. grinding it in a mortar beforehand and incorporating it at the end of its preparation
c. is incorporated into ambient temperature dissolved in a little water and at the end
d. it is added to the surfactant phase before adding it to the aqueous phase

24. The recommended containers, in the case of cream shampoos, are:


a. plastic bottles
b. glass jars
c. aluminum tubes
jars

25. To incorporate a p.a. like zinc pyrithione in shampoos, the following is done:
a. incorporate it at the end after grinding it
dissolve it in water at the beginning of the shampoo preparation
c. dissolve it in 96º alcohol and incorporate it at the end
d. None is correct

26. An amphoteric soap solution -non-ionic contains:


a. Texapon N40 and Tween
b. Tegobetaine L-7 and Texapon N40
c. only Texapón N40
d. Tween and Tegobetaine L-7

True (T) or False (F) questions:


Triethanolamine creates less viscous gels than sodium hydroxide.
The viscosity in Carbomer gels is influenced by temperature.
"The TOW gels are biphasic gels that vibrate upon percussion"....(V)
Veegum is a colloid based on magnesium and aluminum silicate.
Calcium ions (Ca2+) can increase the viscosity of alginates.
"The clarifying substances in shampoos are what give them their milky and shiny appearance."
The detergent power of the surfactant in shampoos should be maximum.
The p.a. ketoconazole requires an antioxidant like BHT when used in shampoos.
sodium chloride does not increase the viscosity of shampoos made with ionic surfactants.
Non-ionic shampoos have low foaming power.
Review questionnaire of UT10 Ointments and Pastes
1. What serves to differentiate emulsions from ointments?
2. Occlusivity is the property that some excipients have to prevent water loss and
_________ through the skin

3. Traditional anhydrous lanolin has been replaced by derivatives such as deodorized lanolin.
____________ or hydrogenated.

[Link] with Orabase, ____________ or any other hydrophilic excipient should never be used.
it would favor the dissolution in saliva.

5. In water pastas it is the _______________ of this that makes it absorb heat from
the skin

6. Advantages and disadvantages of using hydrophobic excipient ointments


7. Tests:
7.1 Ointments that have low penetration capacity are called:
a) Epidermal
b) Endodermic
c) Hypodermic
d) Diadermic

7.2 As an example of hydrophilic ointment excipients we have:


a) Silicones
b) White petroleum jelly
whale sperm
d) Lanolin

7.3 A petroleum derivative used as an excipient in ointments is:


glycerin
b) the petroleum jelly
c) lanolin
beeswax

7.4 As characteristics of ointments, we can mention:


a) low occlusivity
b) little evanescence
c) they usually do not stain the clothes that come into contact with them
d) All are correct
7.5 The packaging of the ointments is done:
a) normally in jars
b) right after finishing the formulation
c) usually in tubes
in glass jars

7.6 Which of the following is an effective antimicrobial preservative against fungi?


a) Citric acid
b) Sodium nipagin
c) Vaseline
d) Vitamin E

7.7 In the preparation of ointments according to PN/L/FF/006/00 what is done beforehand:


a) Add the p.a. until achieving its correct dispersion
b) Fundir conjuntamente todos los componentes, excepto el p.a
c) Dissolve the active ingredient in a solvent of appropriate polarity
d) Incorporate the thermolabile p.a. in cold

7.8 Among the disadvantages of Lanolin as an excipient in ointments are:


a) It is very sticky.
b) What produces allergies.
c) That oxidizes easily.
d) All are correct

7.9 Cetyl alcohol is an excipient used in ointments that:


It is derived from petroleum.
b) Decreases the viscosity of the ointment
It is a vegetable oil.
It can be used as an emulsifier in emulsions.

7.10 According to the PNT for the preparation of ointments, which of these statements about the 'Controls' is not
correct?
a) microbiological control is done in a magistral formula
b) in the official preparations and specified magistral formulas, the weight verification is carried out.
c) if batches are made, the extensibility determination is carried out
d) the evaluation of organoleptic characteristics is carried out in magistral formulas, prepared
medicinal and batches

7.11 The synthetic lipids that can be excipients for ointments are prepared by unions of acids.
fats with trioles such as:
olive oil
b) Glycerin
c) Vaseline
d) Stearyl alcohol

7.12 Which of the following excipients is a natural lipid from the ester group?
beeswax
b) Lanolin
c) Silicone oil
mouse sperm

7.13 Pasta cooked in water is characterized by:


They are very occlusive.
They have fatty excipients like oils
They are removed with difficulty.
They have excipients such as Polyethylene glycol.

7.14 The Dalibour Ointment


a) it is used as an astringent
b) contains copper and zinc sales
c) it is used in exudative processes
d) All are correct

7.15 Lassar Paste is a:


a) Pasta in water
Thin paste for eczema
Fat pasta
d) b and c are correct
7.16 The Collodion

contains copper sulfate and alcohol


it is used to treat lesions in the oral cavity
c) it is prepared in its original bottle which is given to the patient
d) according to the U.S.P. it contains only official collodion and castor oil

7.17 Orabase is an excipient that is applied to the oral mucosa and is:
grayish in color
adhesive
c) with the scent of vanilla
d) very soluble in saliva

17.18 According to the definitions of the PNT Preparation of Ointments, the "Ointments that emulsify water"
a) they can contain adequate amounts of water
b) they are prepared with water-miscible excipients
c) W/O emulsifying agents such as lanolin and fatty alcohols.
d) they frequently use substances like petroleum jelly, paraffin, and waxes

True (T) or False (F) Questions:


Vegetable oils have less covering capacity than other fats.
The "suspension ointments" are those in which the active ingredients are liposoluble.
The 'solution ointments' are always prepared in a mortar and at room temperature.
Silicones are obtained from the sebaceous secretion of sheep.
"Lassar paste with hydrocortisone is prescribed for dermatological issues on the skin in the case of
ostomized
Pastes are more indicated for exudative lesions than ointments.
Questionnaire review UT11: pharmaceutical forms/routes of administration
[Link] the technique of iontophoresis

2. What disadvantages does the administration of a drug by oral route present?

3. The ___________________ are devices that pass a current through them


from air they generate uniform and very fine particles of the active principle (liquid) in
a gas

4. The 3 main routes of administration of injectable preparations are:


the intravenous route, intramuscular route, and ___________ route

5. The ___________ are liquid pharmaceutical forms, resulting from mixing


gum substances in water, used to prepare suspensions and emulsions
[Link]:

6.1. Among the disadvantages of transdermal drug administration


(patches), is located:
a) it can only be used for chronic patients
b) the inactivation of the drug by digestive enzymes
c) it is only useful for administering water-soluble drugs
d) it is only useful for administering lipophilic drugs

6.2. The sublingual route is recommended for:


a) drugs that degrade in gastric juice
b) potent action drugs such as nifedipine
c) achieve a late therapeutic action
d) drugs such as antibiotics

6.3 The capsules may have


a pasty content
a solid content
c) a liquid content
d) All are correct

6.4 Among the semi-solid pharmaceutical forms for topical use, there is:
the gels
the ointments
c) ointments
d) all are correct
6.5 Tablets are a pharmaceutical form of oral administration. Among them are the
special tablets, like the...
a) Effervescent tablets.
b) Effervescent tablets.
sublingual tablets.
d) All answers are correct.

6.6 When tablets are made, it is "necessary" to use a series of excipients, such as:
a) Sweeteners, flavorings, preservatives, and colorants.
b) Dilutants, lubricants, and absorbers.
c) Binders and diluents.
d) Responses b) and c) are correct.

6.7 The tablets can be controlled release, and they are the ones that...
They resist the pH of the stomach and are absorbed in the intestine.
They allow to modify the speed or place of release of the active ingredient.
c) They resist the pH of the intestine where they are absorbed.
d) Responses b) and c) are correct.

6.8 What pharmaceutical form is used for administration via the respiratory route at the level
pulmonary?
a) Aerosoles.
b) Drops.
c) Gargling.
d) All answers are correct.

6.9 Pellets are a type of pharmaceutical form that is administered via...


a) Oral.
b) Parenteral.
c) Topic.
d) Respiratory.

Among the excipients that can be part of the suppositories are


a) PEG
cocoa butter
c) glycerides
d) all are correct

6.11 With dry powder inhalers


a) solid-state medications are administered
b) one can access the circulatory system
c) they can be used to treat asthma (pulmonary pathological process)
d) All are correct

6.12 The "multiple layer tablets" are characterized by:


a) are obtained after a simple compression
they are coated with sugar
c) it serves to protect the drug from gastric juice
d) se usan para obtener una acción prolongada de uno de los p.a.
6.13 The official pills
they have sucrose as the main component
b) are used to vehicle antitussive drugs
c) obtained by lyophilization
d) None is correct
6.14 The bioavailability of a drug administered parenterally depends on:
the dose
b) the injection area
c) its physicochemical characteristics
d) b and c are correct

6.15 As pharmaceutical forms for administration via the rectum, it is known:


the suppositories
ointments
c) solutions
d) all are correct

6.16 The intramuscular route is usually employed


a) to administer insulin
b) to administer small pills
c) in chemotherapy treatment

d) to administer slow-absorbing drugs such as hormones


6.17 The granules are:
a) covered
b) effervescent
c) gastro-resistant
d) All are correct

6.18 Injectable preparations for infusion:


a) they are usually oil external phase emulsions
b) they can carry pyrogenic substances
c) are isotonic with respect to blood
d) are administered topically

True (T) or False (F) tests:


"ointments are not administered through the ocular route".....( )
The percutaneous or transdermal route is used to administer antihypertensives.
the rectal route is a complete and regular absorption route
The receptacle of the capsules is usually made of gelatin.
There are capsules that are administered vaginally.
The eye drops are hypertonic preparations with a pH of 3.

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