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PHA-Learning Module-Compounding of Pharmaceuticals I
PHA-Learning Module-Compounding of Pharmaceuticals I
Pharmaceuticals I
Learning Module
December 2017
Learning Module: Compounding of Pharmaceuticals I | ORHB
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Preface
In response to the critical shortage of pharmacy/Medical laboratory personnel in Oromia National
regional state, a group of experts from universities and colleges in the region have developed an
Outcome based TVET Model curriculum for Pharmacy Level II-IV programs in October, 2017
with the initiative of Oromia Regional Health Bureau.
The outcome based curriculum was developed in reference to the level based 2011 Ethiopian
Occupational standard. The guiding principle in the development of the outcome based curriculum
was to train Pharmacy professionals in focused, time efficient and outcome based approach, and
to fill the existing pharmacy works force shortage with competent professionals.
The key features of the outcome based curriculum include: use of variety of teaching/learning
methods, repeated exposure of trainees to skill laboratories, practical attachment/cooperative
training and the delivery of the training in standardized learning modules (information sheets) and
skill lab manual/checklists (Operation sheets).
This learning module was developed by a diverse group of experts from higher teaching
institutions in Oromia region, experts from Oromia Regional health bureau, Oromia TVET,
Oromia COC agency and professional associations.
Dear Trainee, you are expected to read the information presented in the learning module, attempt
all the self-check questions and perform skill activities as per the skill lab learning guide/checklist.
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Acknowledgment
This Compounding of Pharmaceuticals I learning module and skill lab manual for Retail Pharmacy
assisting Level II Program was developed by experts from Universities and Colleges in Oromia
National Regional State.
Oromia Regional Health Bureau and Oromia TVET Bureau would like to acknowledge the
following individuals and their organization for their dedication, kind participation, and expert
contributions in the development of this training material.
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Table of Contents
Preface............................................................................................................................................. 1
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3.6.2. Volume........................................................................................................................ 58
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Dear trainee, in this chapter you will learn on the general processes followed during
pharmaceutical compounding. Please follow your instructor’s interactive presentation attentively
and read this material for further understanding and be competent in preparing the compounding
process.
Objectives:
At the end of this chapter you will be able to:
Describe the importance of extemporaneous compounding
Outline the compounding process in extemporaneous preparations
Clean compounding areas and equipment as per the procedure
Maintain personal hygiene as per the product requirements
Apply right dressing code as per the product and institutional requirement
Identify different equipments used in extemporaneous dispensing
1.1. Introduction
Compounding is the preparation, mixing, assembling, packaging or labeling of a drug in response
to a prescription written by a licensed practitioner.
Extemporaneous compounding is defined as the timely preparation of a drug product according
to a physician’s prescription, a drug formula, or a recipe in which calculated amounts of ingredients
are made into a homogenous (uniform) mixture.
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Because of the diversity of the types and number of preparations that can be formulated
extemporaneously, compounder experience and expertise are significant factors in the production
of safe and effective extemporaneous formulations.
A clean white coat should be worn to protect the compounder from the product and, conversely,
the product from contamination from the compounder. During the compounding process, safety
glasses should always be worn and, depending on the nature of the ingredients to be incorporated
into the preparation, additional safety equipment (e.g. facemasks, gloves) may also be required.
It is the responsibility of the individual compounder to assess the risk posed by any pharmaceutical
ingredient and to ensure that the correct safety equipment is in use. Similarly, long hair should be
tied back and hands washed, ensuring any open cuts are covered.
(For further reference see pharmacy grooming standard and dress code in Box 1 below).
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Dirty or wrinkled smocks are prohibited. Sleeve length of smock will match the sleeve length of shirt,
blouse, or dress.
All clothing:
Clothing must be clean, pressed, properly fitted and in good condition. All dress code deviations
from Classic White or Blue shirt professional attire and tie will be accompanied by a crisp,
white, laundered pharmacist smock.
Conservative holiday accent attire is permitted such as holiday theme ties and/or shirt/blouse
pins.
Male:
A white or solid colored professional, button front, collared dress shirt must be worn. A solid white T‐
shirt may be worn underneath the professional collared dress shirt. No decals or writing are permitted
on the T‐shirt. A white cardigan or sweater may be worn under the smock. No sweatshirts or jackets
are allowed.
Female:
A white or colored professional, button front, collared dress shirt or a dress with long or short sleeves
are acceptable. If the shirt has buttons, it must be buttoned to assure a professional appearance. Avoid
overly bright, potentially distracting colors. Must be accompanied by a crisp, white, laundered
pharmacist smock.
Shoes: Must be polished at all times. Polished, dark leather shoes must be worn. Athletic shoes made
of all polished leather (no fabric) are acceptable. Rubber heels should be worn for safety. No canvas
shoes, saddle shoes, boating shoes, open toe/backless shoes, or sandals are allowed.
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D. Label preparation
The label for any pharmaceutical product must be prepared before starting the compounding
procedure. This will enable the product to be labeled as soon as it has been compounded and
packaged, eliminating the possibility that an unlabeled product will be left on the bench. It also
reduces the possibility of the product being mislabeled and given to the wrong patient.
Reasons for having labels include;
To give the patient clear and complete instructions on how to use the preparations.
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To indicate the storage condition necessary to ensure full potency through the period of
treatment.
To uniquely identify the contents of the container
To increase patients’ compliance by giving clear and concise information about the
preparation
To provide information about some cautions /warnings about the preparations
Requirements for labels
There are both legal and professional requirements, which must be complained between labeling
a dispensed medicine. It is the pharmacist responsibility to ensure that these requirements are
satisfies and that all labeling is accurate. The regulation indicates the standard details which must
appear on label.
Requirements for labeling compounded medicines
All labels must be type written or computer generated. The details, which must appear on the label
of a dispensed medicine, are:
The name and address of the pharmacy
The patient’s name
Name of the preparation
Quantity of the preparation
Formula of the preparation (for unofficial preparations only)
The strength of the preparation
Use of the preparation
Instructions for the patient
The date of compounding
Beyond used date (shelf life)
Storage conditions
Additional label
o Precautions
o Advise
For further details on the preparation of a suitable label, please read the table below.
Table1: Special labeling instructions for particular type of dispensed dosage form
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F. Premises standards
The premises where an extemporaneous product is being prepared needs to be of an appropriate
standard.
Premises’ decoration should be of a good basic standard.
The floor should be covered but in such a manner as to be easily cleaned, surfaces should
be smooth.
Sinks should be clean and have a supply of hot and cold water.
There should be a functioning, clean refrigerator.
There should be a supply of mains (potable) water.
Premises Standards for the establishment and practice of pharmaceutical compounding in Ethiopia
are given below.
• The walls, floor ceilings, and floor of a compounding laboratory shall be smooth, have no
cracks or holes.
• The walls, floor and ceilings shall be painted and/or made of washable material.
• The compounding room shall have adequate light and ventilation (ventilator, etc.)
• The compounding room should be protected from direct sunlight.
• The window(s) of the compounding room shall be high enough and sealed.
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G. Equipment requirements
A dispensary should have sufficient equipment available in order to be able to operate effectively.
Equipment commonly required for extemporaneous compounding are described below under sub title
“Equipments used in pharmaceutical compounding”.
H. Avoidance of contamination
To avoid contamination of any extemporaneously prepared product, compounders should adhere to
the following guidelines:
Ensure all equipment is clean and dry prior to use.
Keep the dispensing area clear of unnecessary items.
Do not leave lids off stock bottles: always replace immediately after use.
Do not return material to stock containers once removed.
Do not leave weighed and measured items unlabeled on the work surface.
Do not allow raw materials or the final product to come in contact with the hands (if necessary
wear gloves).
Compound record
• Name, strength, and dosage form of the compounded preparation (CP)
• Master Formulation Record reference for the CP, when used
• Date and time of preparation of the CP
• Assigned internal identification number (e.g., prescription or lot number)
• Signature or initials of individuals involved in each step (e.g., technician or pharmacist)
• Name, vendor or manufacturer, lot number, and expiration date of each ingredient and
container-closure system
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A master formulation record is recommended when performing batch or high risk compounding.
The following is a Best Practice recommendation on the elements of a master formulation record.
Master formulation record
• Name, strength, and dosage form of the CP
• Physical description of the final preparation
• Identities and amounts of all ingredients and appropriate container-closure systems
• Complete instructions for preparing the CP, including equipment, supplies, and a description
of the compounding steps
• BUD and storage requirements
• Quality control procedures (e.g., pH, filter integrity, and visual inspection)
• Sterilization method, if applicable (e.g., filter, steam, or dry heat)
• Any other information needed to describe the operation and ensure its repeatability (e.g.,
adjusting pH and tonicity and temperature)
In addition to recording the compounding process for extemporaneously dispensed items, other
records (e.g. fridge temperatures) should be routinely recorded. Refrigerators used in pharmacies must
be capable of storing medicines between 2°C and 8°C and must be equipped with a
maximum/minimum thermometer. This should be checked each day the premises are open and the
maximum/minimum temperatures recorded to ensure that the equipment is operating correctly and
that patient safety is not compromised.
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Extemporaneous record sheets should be kept for a minimum of two years, although ideally five years
would be advisable. All records and reports should be readily available in the pharmacy for authorized
inspection during the retention period. The proper recording of information is so vital to ensuring
consistent preparation of a formulation that an entire chapter is devoted to the subject, discussing each
type of record in detail.
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In summary, the steps to be followed before, during, and after compounding can be grouped into five
categories: preparatory, compounding, final check, sign-off, and cleanup steps. These are summarized
in the sidebar below.
Preparatory
Judging the suitability of the prescription in terms of its safety and intended use and the dose
for the patient.
Performing the calculations to determine the quantities of the ingredients needed.
Selecting the proper equipment and making sure it is clean.
Donning the proper attire and washing hands.
Cleaning the compounding area and the equipment, if necessary.
Assembling all the necessary materials and ingredients to compound and package the
prescription.
Compounding
Compounding the prescription according to the formulary record or the prescription, using
techniques of the art and science of pharmacy.
Final Check
Checking, as indicated, the weight variation, adequacy of mixing, clarity, odor, color,
consistency, and pH.
Entering the information in the compounding log.
Labeling the prescription.
Sign-Off
Signing and dating the prescription, affirming that all of the indicated procedures were carried
out to ensure uniformity, identity, strength, quantity, and purity.
Cleanup
Cleaning and storing all equipment.
Cleaning the compounding area.
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Stirring rods
Stirring rods are used to agitate liquids to speed up the process of dissolution of solids. These are
normally between 20 and 30mm in length and made of glass. Care must be taken not to stir too
vigorously as this may cause the stirring rod to break.
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Water baths
A water bath is laboratory equipment made from a container filled with heated water. It is used to melt
or heat reagents as required. The item to be melted or heated is placed in an evaporating basin over a
water bath containing hot water and allowed to melt or get heated.
All water baths have a digital or an analogue interface to allow users to set a desired temperature.
Weighing balances
Balance is one of important equipment used to weigh the required amount of pharmaceutical
ingredients in pharmaceutical extemporaneous preparation. Balances are differentiated each other by
the following parameters.
1. Sensitivity: Is the smallest weight that makes a perceptible change in the pointer which
indicates equilibrium.
2. Sensitivity Requirement (SR): Is the weight necessary to move the pointer of the balance one
division on the index plate against which equilibrium is observed.
3. Capacity: The maximum weight, which a balance can weigh.
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Measuring apparatus
Measuring apparatus are glass or plastic equipments used to measure different volumes of liquid
ingredients.
There are several types of measures. Some of them are the following.
Cylindrical graduates Beakers
Conical graduates Graduated pipettes
Bottles Burette Dropper
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Summary
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 important
when certain medical needs of individual patients cannot be met by the use of an approved
commercial drug product. During the compounding process, the compounder adheres to strict
procedures to ensure the safety of the patient for whom the extemporaneous formulation is
intended. The general procedures for compounding starts with receiving, validating and
interpreting of the prescription as per the Standard Operating Procedures (SOP) for dispensing.
Following different standardized steps, it ends with recording of the prescription on the
Compounding Prescription Registration Book. The products produced in the pharmacy must be
suitable for use, accurately prepared, and prepared in such a way as to ensure the products meet
the required standard for quality assurance.
Self-check questions
Instruction: choose the best answer from the given alternatives
1. The preparation, mixing, assembling, packaging, and labeling of a drug is referred to as:
A. Dispensing
B. Compounding
C. Sorting
D. Selecting
2. Why extemporaneous compounding is required
A. If the dosages are unavailable
B. When dilution is required
C. When dosage form conversion is necessary
D. All of the above
3. One of the following steps in compounding process is concerned with getting the appropriate
amounts of ingredients for compounding?
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A. Personal hygiene
B. Label preparation
C. Weighing and measuring
D. Record keeping
4. The date after which a compounded production is not to be used is called
A. Expiry date
B. Preparation date
C. Beyond use date
D. Dispensing date
5. Which of the following professional people are responsible to select the most appropriate
chemicals to use for compounding?
A. Physicians
B. Pharmacists
C. Pharmacy technicians
D. All of the above
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9. Which one is important for protecting the compounder form chemical damage and product
contamination in compounding?
A. Wearing gloves
B. Wearing gown
C. Eye goggles
D. All of the above
10. Labeling of pharmaceutical preparations is important to give complete information about the
preparation for the patient.
A. True B. False
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Dear trainee, in this chapter you will be introduced about quality control aspects of pharmaceutical
extemporaneous compounding. Please read the content carefully. After completing this chapter,
you are expected to perform quality control checks for extemporaneous preparations.
Objectives:
At the end of this chapter you will be able to:
Define Quality Assurance, Good compounding practice and Quality control
Discuss quality assurance principles
Recognize the essential elements of current good compounding practice
Perform QC checks for extemporaneous preparations
2.1. Introduction
Quality control and assurance is designed to achieve the utmost quality, purity, effectiveness, and
safety concerning drug products. The Food and Drug Administration (FDA) has issued many
guidelines overseeing specific dosage forms and operations that include aseptic manufacturing,
stability testing, and validation. Quality system inspections are a regular part of regulatory pre-
approval programs for new drugs.
Quality control and assurance is designed to achieve the utmost quality, purity, effectiveness, and
safety concerning drug products. Inadequate quality control practices may lead to contamination
of pharmaceuticals as well as medication errors. The pharmacy professional is responsible for the
storage of all pharmaceuticals, for monitoring expiration dates, and for monitoring the temperature
of refrigerators and freezers used to store pharmaceuticals.
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Definitions
Quality Assurance: is all system which ensures activities involving planning, quality
control, quality assessment, reporting and quality improvement to ensure that a product or
service meets defined standards of quality with a stated level of confidence.
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objective of ensuring that pharmaceutical products are of the quality required for their intended
use. Quality assurance therefore incorporates GMP/GCP, QC and other factors, including those
outside the scope of this guide such as product design and development.
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k. Regular evaluations of the quality of pharmaceutical products should be conducted with the
objective of verifying the consistency of the process and ensuring its continuous
improvement.
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and that the quantity and quality of the product are as expected; any significant deviations
are fully recorded and investigated;
g. Records covering manufacture and distribution, which enable the complete history of a
batch to be traced, are retained in a comprehensible and accessible form;
h. The proper storage and distribution of the products minimizes any risk to their quality;
i. A system is available to recall any batch of product from sale or supply
j. Complaints about marketed products are examined; the causes of quality defects
investigated, and appropriate measures taken in respect of the defective products to prevent
recurrence.
Activity: Read the principles of quality assurance and Current Good Compounding Practices
The pharmacy professional then reviews the compounding steps to ensure that the procedures and
techniques used to prepare the formulation were faithfully followed and appropriately
documented. This review also ensures that the formulation is reasonably aesthetic and uniform in
content.
The review of the final check phase should be comprehensive. It is intended to verify the following:
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The compounder may also decide to submit samples of compounded preparations to an analytical
testing laboratory or test it within the pharmacy. Such analytical testing could include dissolution
rates and concentrations of compounded medications. Additional tests, assays, or visual
observations of samples of the preparation may be performed to ensure the content, stability, pH,
sterility, and non pyrogenicity.
Summary
Quality control and assurance is designed to achieve the utmost quality, purity, effectiveness, and
safety concerning drug products. Quality Assurance is all systems which ensure of activities
involving planning, quality control, quality assessment, reporting and quality improvement to
ensure that a product or service meets defined standards of quality with a stated level of confidence.
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As a part of quality assurance GMP ensures products are consistently produced and controlled to
the quality standard appropriate to their intended use. Quality control is overall system of activities
concerned with sampling, specification and testing and organization, documentation and release
of procedure to ensure the quality of the product. Pharmacy technicians participate in quality
control of extemporaneous preparations through inspection and continuous quality improvement.
Self-check Questions
Instruction: Choose the best answer from the given alternatives
1. The process of sampling, specification, testing and release of procedures to ensure the quality
of the product is
A. Quality assurance
B. Good manufacturing practice
C. Quality control
D. None of the above
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Dear trainee, this chapter will give you important knowledge and skill about pharmaceutical
ingredients, weighing and measuring techniques which are important steps in pharmaceutical
compounding. After completing this chapter, you are expected to identify different pharmaceutical
ingredients and packaging materials. You should also acquire basic skills of weighing and
measuring techniques
Objectives:
At the end of this chapter you will be able to:
• Identity the types and uses of pharmaceutical ingredients
• Classify packaging materials based on dosage forms
• Explain the procedures for ordering and receiving pharmaceutical products.
• Derive compounding formula from the master formula
• Perform weighing of solid and semi solid ingredients as per the procedure
• Operate measuring of liquid ingredients following the procedure manual
3.1. Introduction
Drug substances are seldom administered alone; rather they are given as part of a formulation in
combination with one or more non-medicinal agents that serve varied and specialized
pharmaceutical functions. Selective use of these nonmedical agents, referred to as pharmaceutical
ingredients or excipients, produces dosage forms of various types.
Drug = API (Active Pharmaceutical Ingredient) + Non-API (Excipient)
Non-API: Material that is deliberately incorporated into the formulation to aid some
physicochemical process of drug manufacturing. It has no pharmacological action but establish the
primary features of the product Physical form, texture, stability, taste, appearance.
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a. Pharmaceutical solvents:
Dissolve another substance in preparation. The selection of the proper solvent for a particular
solute depends on, knowledge of the chemical characteristics of drugs, Factors of solubility (size,
Temperature, pH, extent of agitation, Clarity, low toxicity, viscosity, compatibility, chemical
inertness, palatability, odor, color, and economy). The most common solvent is water.
b. Preservatives:
Prevents the formulation from chemical, physical and microbial degradation
E.g. Benzoic acid, boric acid, Sorbic acid, Benzalkonium Chloride, Phenols, Alcohols,
c. Anti-oxidant:
Prevent the degradation of a drug by oxidation. Have higher oxidative potential or inhibit free
radical-induced drug decomposition. Employed in low concentrations (<0.2%w/w).
E.g. Ascorbic acid, sodium bisulfate, sodium formaldehyde, sodium meta bisulfite
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g. Colorants:
Colorants are added to impart color to liquid and solid preparations
• For esthetics and patient compliance
• For identification
• To minimize the medication errors
• To protect the contents of the formulation
E.g. Titanium dioxide, Calamine, Azo dye, Nitroso dyes, xanthenes, Nitro dyes,
j. Lubricants:
Reduce friction during tablet compression
Enhance the flow of the material
Minimize wear of the part of the machines
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Packaging is the science, art and technology of enclosing or protecting products for
distribution, storage, sale, and use. This total time scale must be within the shelf-life of the
product, which is controlled by the selection of the right combination of product and pack.
For these reasons packaging technology should be based on the understanding of pharmaceutical
products, characteristics of formulations, and dosage forms, including the physical and chemical
properties of the drug substance.
Packaging involves various types or categories of containers. A container is defined as “that which
holds the article and is or may be in direct contact with the article”. The closure is “a part of the
container”.
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Packages may include authentication seals and use security printing to help indicate that
the package and contents are not counterfeit. Packages also can include anti-theft devices,
such as dye-packs or electronic article surveillance tags that can be activated or detected by
devices at exit points and require specialized tools to deactivate.
Convenience - Packages can have features that add convenience in distribution, handling,
stacking, display, sale, opening, reclosing, use, dispensing and reuse.
Offer consumer safety: warn of hazards due to improper use of dangerous substances (such
as the information on cigarette packaging) or design considerations (such as not standing on
the top step of a ladder).
Because the primary pack also represents the pack of 'use', it must also function in the hands of the
user as a means of drug administration. Primary packages are primarily made of glass, plastic,
single or laminated flexible material, and metal.
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Examples of primary packaging materials include: Containers, Ampoules, Vials, Dosing dropper,
Closures (plastic, metal), Syringe, Strip package, Blister packaging
It may be used for the final market presentation of the product, often used to carry the required
labeling for the product. It can also provide protection against damage in the handling and
distribution system.
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The USP classifies containers according to their ability to protect their contents from external
conditions as follows.
A well-closed container: protects the contents from extraneous solids and from loss of the
article under the ordinary or customary conditions of handling, shipment, storage and
distribution.
A tight container: protects the contents from contamination by extraneous liquids, solids
or vapors, from loss of the article, and from efflorescence, deliquescence, or evaporation
under the ordinary or customary conditions of handling, shipment, storage and distribution
and is capable of tight re-closure.
Hermetic sealed containers: are impervious to air or any other gas under pharmaceutical
preparations. Sterile hermetic containers generally hold preparations intended for injection
or parenteral administration. Hermetic sealed containers may be:
Single dose containers in which the quantity of sterile drug contained is intended as a
single dose and which once opened cannot be resealed with assurance that sterility has
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been maintained. These containers include fusion sealed ampoules and prefilled
syringes and cartridges
Multi dose container permits withdrawal of successive portions of the contents
without changing the strength or endangering the quality or purity of the remaining
portion. These containers are commonly called vials.
A light–resistant container: protects the contents from the effects of light by virtue of the
specific properties of the material of which it is composed. Another option is to make a
clear and colorless or translucent container light-resistant by an opaque covering. Agents
termed ultraviolet absorbers may be added to plastic to decrease the transmission of short
ultraviolet rays.
Tamper evident containers: are closed containers fitted with a device that irreversibly
indicates if the container has been opened.
A single-unit package: is termed a unit dose package. The single-unit packaging of drugs
may be performed on a large scale by a manufacturer or distributor or on a smaller scale
by the pharmacy dispensing the medication. In either instance, the single-unit package must
be appropriately labeled with the product identity, quality and/or strength, name of
manufacturer, and lot number to ensure positive identification of the medication
Strip packs: have at least one sealed pocket of material with each pocket containing a
single dose of the product. They are common ways of unit packaging of a solid drug
formulation. The packaging materials may be combinations of paper, foil, plastic, or
cellophane.
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Pressurized packs (aerosol containers): are also available which expel the product
through a valve.
Original packs are pharmaceutical packs that are commercially produced and intended for
finite treatment periods. It is always good practice to dispense medication to patients in the
same type and quality of container as that used by the manufacturer.
Returning Items
After checking all items against the orders that you receive, you may find that some items are
defective; some products are expired, or more than needed. The pharmacy technician must use
appropriate return forms when returning goods. On a return form, the following information must
be included:
• Original purchase order (P.O.) number
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• Item number
• Quantity
• Reason for return
Similar procedures are followed for obtaining and returning raw materials for compounding. IFRR
form is used for this purpose.
A master formula sheet may be used to document information about each formulation that is used
in the pharmacy. These sheets commonly contain:
• Information about the ingredients of a formulation
• Its manufacturer
• Lot number(batch number)
• The manufacturer’s expiration date
• The formula quantity
• The quantity used
• Preparation date
• The compounder name and
• The person who checked it for accuracy.
These sheets also usually contain the required equipment for formulating, manufacturing
directions, description of the final appearance of the mixture, information that will appear on its
label, and a description of the length it will be stable.
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Based on the information on the compounding sheet, the pharmacy technician should take
appropriate amounts for compounding, i.e. apply reducing or enlarging formulas to get the required
amount of compounding ingredients.
Exercise: be in groups and practice how to derive working formula for compounding from the
master formula
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3.6.1. Weight
Weight is measured by means of a balance. In dispensing (hospital and community pharmacies)
the type of balance used is called prescription balance.
For compounding purpose, usually we use the following two types of prescription balances.
• Beam balance
• Digital balance
Cares that should be taken in weighing are the following.
• Keep the balance in a place where there is no environmental disturbance (Vibration, dust,
moisture, wind, etc.)
• Keep the balance cover down except when the balance is in use.
• Use powder papers or watch glasses to prevent direct contact of the pan(s) and the material
to be weighted.
• Support the pan(s) when weights and materials are added or removed.
• Handle weights only with forceps
• Adjust the scale to perfect balance (0 positions) before each weighting.
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Purpose: The purpose of this activity is to enable you to practice weighing techniques of solid
and semi-solid ingredients
Instruction
1. Weigh 2.5g and 10g of zinc oxide BP
2. Weigh 5gWhite soft paraffin using beam balance
beam balance
spoon spatula
weighing paper/watch glass/greasy proof paper
** You will only be competent when you efficiently perform all the steps
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Procedure-learning guide/checklist
Rate
Ser.No Step/Task
Improvement
Competently
Proficiently
Performed
Performed
Remark
Needs
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Select a balance with appropriate capacity and
sensitivity
6 Check that the balance is clean and dry
7 Put the balance on a level, non-vibrating and clean
table and
adjust the it
8 put the container for the material to be weighed
and weigh it (to deduct from the final total
weight) or use auto-zero to cancel its weight
9 Using a spatula, transfer, 10 g of Zinc Oxide BP
to the paper/ watch glass. Check the weight, check
the ingredient.
Repeat the same procedure for 10g of white soft
paraffin by using watch glass/greasy proof paper
10 Transfer the weighed zinc oxide and a to its
respective packages and label it(repeat the same
procedure for white soft paraffin )
Return the stock pot to the shelf.
13 Clean the working equipments and the
surroundings
15 Complete recordings and documentation
16 Store the weighed zinc oxide to an appropriate
place
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Learning Module: Compounding of Pharmaceuticals I | ORHB
3.6.2. Volume
An important factor in the accuracy of an instrument used for measuring volume is the surface area
of the liquid in it. Accuracy increases as surface area decreases. However, a decrease in surface
area decreases the convenience of transferring a liquid to and from the instrument. Therefore,
accuracy and convenience should be compromised. Volume is measured by using measures.
Volumetric flasks Meniscus- The volume under the horizontal tangent touching the lowest
point of the surface is the meniscus volume.
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Learning Module: Compounding of Pharmaceuticals I | ORHB
bottom of the meniscus with the desired graduation mark. If the liquid is densely colored or
opaque, such as a suspension, the top of the meniscus should be read.
Transfer the liquid from the graduate to the appropriate vessel or container, allowing about 15
seconds for aqueous and hydro-alcoholic fluids to drain. Approximately 60 seconds (or more)
are required for more viscous liquids such as syrups, glycerin, propylene glycol, and mineral
oil to drain.
Always select the smallest device (graduate, pipette, and syringe) that will accommodate the
desired volume of liquid. This will minimize the potential for errors of measurement associated
with misreading the scale.
Use a graduated pipette, syringe, or calibrated dropper to measure/deliver volumes <1 ml.
Remember that oily and viscous liquids will be difficult to remove from graduates and pipettes,
and at best require long drainage time. Consider using a disposable syringe instead, or better yet,
measuring by weight rather than volume.
NB. Never use prescription bottles, non-volumetric flasks, beakers, or household teaspoons as
measurement devices, unless you calibrate it yourself. When small (<5 ml) or very accurate doses
are required, provide the patient with a calibrated dropper, oral syringe, or similar device to ensure
proper dosing.
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Purpose: The purpose of this activity is to enable you to practice measuring techniques of
liquids
Instruction
a. Measure 1ml, 5ml,25ml,50ml and 100ml of potable water
b. Measure 25ml and 50 ml of liquid paraffin
1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary), or is
omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if necessary) but
participant/student does not progress from step to step efficiently
3. Proficiently Performed: Step or task performed efficiently and precisely in the proper sequence
(if necessary)
** You will only be competent when you efficiently perform all the steps
60
Learning Module: Compounding of Pharmaceuticals I | ORHB
Procedure-learning guide/checklist
Rate
Ser. Step/Task
Improvement
Competently
Proficiently
Performed
Performed
Remark
No
Needs
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Select an appropriately sized conical measure.
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Summary
Drug dosage forms are generally composed of two types of ingredients, active Pharmaceutical
ingredients and none active Pharmaceutical ingredients (excipients). Active Pharmaceutical
ingredients are the main components that are intended to furnish the Pharmaco-therapeutic effect;
while none active ingredients are materials that are deliberately incorporated into the formulation
to aid some physicochemical process of drug manufacturing.
All dispensed medicinal products will need to be dispensed to the patient in a suitable product
container. The function of a container for a medicinal product is to maintain the quality, safety and
stability of its contents. The Primary purposes of packaging and package labels is to protect the
contents of product from physical, mechanical; chemical hazards and microbial contamination. It
also helps to transmit information how to use, transport, recycle, or dispose of the package or
products. Packaging can be categorized by layer or function: "primary", "secondary", or tertiary.
Knowledge and application of accurate pharmaceutical measurements are essential for pharmacy
professionals to practice their profession. Pharmaceutical measurements mostly involved are
Weighing and Measuring Volumes.
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Self-check Questions
Instruction: Match the following questions.
Pharmaceutical ingredient Uses
1. Preservatives A. Promote and maintain dispersion
2. Viscosity inducing agents B. prevent spoilage of the preparation by microbes
3. Emulsifying agents and surfactant C. increase thickness of liquids
4. Flavorants and sweeteners D. vehicle for semisolids
5. Ointment Bases E. impart pleasant taste to the preparation
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Dear trainee, this chapter will give you important knowledge and skill about compounding
methods for preparing extemporaneous preparations. So, please go through the document and
follow your instructor’s lecture and skill lab sessions attentively and be competent in compounding
of extemporaneous preparations.
Objectives:
At the end of this chapter you will be able to:
Discuss different Compounding methods
Explain Storage conditions of compounded products
Apply appropriate Beyond use dates on labels
4.1. Introduction
In previous chapters of this module, you have studied the basic principles and processes of
compounding in pharmacies. Now you will be introduced about different types of formulations
that could be prepared in prescription compounding and the methods for the preparation for these
products. For details of labels and packaging materials, you can refer to chapter one and three of
this module. Storage conditions for pharmaceuticals and shelf life is well explained in other
modules.
Definitions
Levigation: The process of grinding an insoluble substance to a fine powder, while wet.
Trituration: The process of creating fine particles from powders by grinding using mortar and
pestle.
Dissolution: The process of mixing solutes with appropriate solvent to get homogeneous solutions
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Learning Module: Compounding of Pharmaceuticals I | ORHB
The assignment of the terms solute and solvent is sometimes arbitrary. Generally, the solute is the
component present in the smallest amount and the solvent is the larger, liquid component. Water
is nearly always considered the solvent. Pharmaceutical solutes may include active drug
components, flavoring or coloring agents, preservatives, and stabilizers or buffering salts. Water
is the most common solvent for pharmaceutical solutions, but ethanol, glycerin, propylene glycol,
isopropyl alcohol or other liquids may be used, depending on the product requirements. To be an
appropriate solvent, the liquid must completely dissolve the drug and other solid ingredients at the
desired concentration, be nontoxic and safe for ingestion or topical application, and be aesthetically
acceptable to the patient in terms of appearance, aroma, texture, and/or taste.
Solution are homogenous liquid preparation containing one or more dissolved ingredients and are
used for a variety of purposes as both internal and external dosage forms.
In addition to the active ingredient (medicaments), solutions also contain vehicles and adjuncts.
The vehicle is the medium in which the ingredient of a medicine is dissolved or dispersed for
solution this is the solvent.
E.g. water, aromatic waters, alcohol, glycerol, syrup, etc.
Water is the vehicle of choice for the majority of pharmaceutical solution. This is because water
is generally available, relatively inexpensive, palatable, non- toxic for oral use and non-irritant for
external use. It also acts as a solvent for a wide range of substances. The adjuncts are additives that
are added to improve the quality of the preparations.
E.g. Chemical stabilizers, colorants, Flavorants, preservatives, etc.
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Types of solutions
1. Solution taken orally: mixtures, elixirs, syrups, linctuses draughts
2. Solution used in mouth and throat: - mouth washes and gargles, throat paints, throat
sprays.
3. Solution instilled into body cavities: douches, enemas, eardrops, eyes, drops, nasal drops,
nasal sprays.
4. Solution applied to body surface: collodions, liniments, lotion and paints.
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Learning Module: Compounding of Pharmaceuticals I | ORHB
11. Rinse out the beaker in which the solution was made with a portion of the vehicle, and
transfer the rinsing’s to the conical measure.
12. Add any remaining liquid ingredients to the conical measure and stir.
13. Make up to final volume with remaining vehicle.
14. Transfer to a suitable container, label and dispense to the patient
Aromatic water
Aromatic waters are aqueous solutions usually saturated of volatile oils or other volatile
substances that are characterized by very low water solubilities. E.g. Chloroform.
Aromatic waters are used externally as perfumes (e.g. Rose water) and internally as
flavoring agents (e.g. peppermint water, cinnamon water has been used as carminative and
chloroform water was used in expectorant preparations).
1. Distillation
Place the odoriferous portion of the plant or drug in a suitable still with sufficient purified
water.
Distill most of the water; carefully avoiding the development of an odor of burnt as a
result of decomposition at high temperatures. Separate the excess oil from the distillate.
Then the aqueous phase is the product.
2. Solution
Agitate the volatile substance with purified water for a period of 15 minutes
The mixture is set aside for at least 12 hrs to ensure saturation
Then filter through wetted filter paper. The filter paper must be wet to prevent the passage
of excess oil into the filtrate and to eliminate absorption of dissolved aromatics by the filter.
3. Alternate Solution
Mix thoroughly the volatile material with 15g of purified talc.
Then agitate the mixture with a liter of purified water for 10 min., prior to filtration
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Learning Module: Compounding of Pharmaceuticals I | ORHB
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Tinctures
Tinctures are alcoholic or hydro alcoholic solution of principles extracted from natural
sources or of pure chemical merely dissolved in these solvent systems an example of the
latter being iodine tincture.
Tinctures vary widely in their method of preparation the strength of their volatile ingredients
their alcoholic content and their intended use
Tinctures are prepared by a number of processes: maceration (process M), percolation
(process p), solution and dilution.
Elixirs
An elixir is a liquid oral preparation that usually contains either potent or unpleasant-tasting
drugs.
The formulation is clear and generally contains a high proportion of sugar or other
sweetening agent, included to mask offensive or nauseating tastes.
Pediatric elixirs are usually formulated with fruit syrup as a base flavoring agent.
Linctuses
A linctus is a liquid oral preparation that is chiefly used for a demulcent, expectorant or
sedative purpose, principally in the treatment of cough.
A linctus is intended to be sipped slowly and allowed to trickledown the throat in an
undiluted form.
Consequently, linctuses are formulated as viscous solutions which contain sugars.
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Equipment/Tools
Measuring cylinder
Bottle/Flask
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Procedure-learning guide/checklist
Rate
S.No Step/Task
Improvement
Competently
Proficiently
Performed
Performed
Remark
Needs
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Tare the bottle
8 Measure hydrogen peroxide
9 Add the calculated amount of hydrogen peroxide
to the tarred dispensing bottle
10 Add the purified water to the bottle and adjust to
the final volume
13 Clean the working equipments and the
surroundings
14 Label
15 Complete recordings and documentation
16 Store the preparation to an appropriate place
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Purpose: The purpose of this activity is to enable you to practice the dilution methods of alcohol
solution
Instruction
Prepare 50ml of 70% ethanol from 98% stock solutions and label it.
1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary), or is omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if necessary) but
participant/student does not progress from step to step efficiently
3. Proficiently Performed: Step or task performed efficiently and precisely in the proper sequence (if
necessary)
72
Learning Module: Compounding of Pharmaceuticals I | ORHB
Improvement
Competently
Proficiently
Performed
Performed
Remark
Needs
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Tare the bottle
8 Measure ethanol 98% stock solution
9 Add the calculated amount of Alcohol to the tarred
dispensing bottle
10 Add the purified water to the bottle and adjust to
the final volume
13 Clean the working equipments and the
surroundings
14 Label
15 Complete recordings and documentation
16 Store the preparation to an appropriate place
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Purpose: The purpose of this activity is to enable you to practice the preparation methods and
dissolution techniques of chloroform water.
Instructions
Prepare 100 ml of chloroform water, Bp. 88 using the following master formula.
Chloroform …………..2.5 ml
Purified water q.s. ……1000 ml.
Send 100 ml
Storage: Store in a well closed container in a cool place.
Use: Pharmaceutical Aid (flavoring, sweetening, and preservative)
Instruction
Prepare 100 ml of Double strength chloroform water, Bp. 88 using the following
master formula.
Chloroform …………..5 ml
Purified water q.s. ……1000 ml.
Send 100 ml
Storage: Store in a well closed container in a cool place.
Use: Pharmaceutical Aid (flavoring, sweetening, and preservative)
Role of ingredients
Chloroform: sweetening agent, carminative
Water: Vehicle
Conditions or situation for the operations
In this preparation Chloroform is required to be shaken vigorously to divide the
Chloroform in small globules so as to increase the surface area and hence solubility. It is
to be stored in well closed container as chloroform is volatile in nature and also in amber
color glass bottles as it is light sensitive. In the presence of light it forms a poisonous gas
Phosgene.
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Learning Module: Compounding of Pharmaceuticals I | ORHB
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Improvement
Competently
Proficiently
Performed
Performed
Remark
Needs
1 Wear Gown
2 Wash your hands
3 Glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Tare the bottle to the desired volume by using
purified water
8 Measure Chloroform using pipette/measuring
cylinder
9 Add the Chloroform to the dispensing bottle
10 Close the bottle
11 Measure purified water
12 Add the purified water to the dispensing bottle to
the final volume
13 Shake the bottle vigorously to facilitate the
solubility of chloroform
14 Label
15 Clean the working equipments and the
surroundings
16 Complete recordings and documentation
17 Store the preparation to in appropriate place
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Purpose: The purpose of this activity is to enable you to practice the preparation methods and
dissolution techniques of camphor water
Instructions
Prepare 50 ml of concentrated camphor water BP.1988 using master formula.
Camphor …………………. 40 g
Alcohol (90%)……………. 600 ml
Purified water, qs………… 1000 ml
Send 50 ml
Storage: should be stored in airtight container, in a cool place.
use: Solvent carminative, flavor and mild expectorant)
Direction for use: as directed by the physician
Role of ingredients
Camphor: Main ingredient
Alcohol (90%):solvent of camphor
Purified water: Vehicle
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Equipment /Tools
Amber colored dispensing bottle
Beam /digital balance
Weighing paper
Spoon spatula
Label –white paper
Measuring cylinder
Pipette
1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary), or
is omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if necessary)
but participant/student does not progress from step to step efficiently
3. 3. Proficiently Performed: Step or task performed efficiently and precisely in the proper
sequence (if necessary)
Precautions
1. Water should not be added to the alcoholic solution of camphor because in this case whole of
the camphor will be precipitated out which will not re-dissolve easily on shaking.
2. Camphor is volatile in nature so it should be stored in well closed container to prevent the
volatilization of camphor
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Improvement
Competently
Proficiently
Performed
Performed
Remark
Needs
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Adjust the balance to zero scale
8 Tare the bottle to the desired volume by using
purified water
9 Weigh the desired amount of camphor
10 Measure Alcohol (90%) using measuring
cylinder
11 Add the Alcohol (90%) to the tarred dispensing
bottle
12 Dissolve camphor in the alcohol (90%)
13 Measure purified water
14 Add sufficient water in successive small portions
to produce required volume
15 Shake the bottle vigorously after each addition of
purified water until you get homogeneous
solution
16 Label
17 Clean the working equipments and the
surroundings
18 Complete recording and documentation
19 Store the preparation to an appropriate place
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Instruction
Prepare 50 ml of Peppermint water using the following master formula.
Peppermint oil ----------------0.2 ml
Water, FBC to ----------------100ml
Send 50 ml
Use: Carminative and Flavoring agent
Storage: Store in a well closed container at cool place
Direction for use: As directed by the physician
Role of ingredients:
Peppermint oil: sweetening agent and carminative
Purified water: vehicle/solvent
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Rate
S.No Step/Task
Improvement
Competently
Proficiently
Performed
Performed
Remark
Needs
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Tare the bottle to the desired volume by using purified
water
8 Measure peppermint oil using pipette
9 Add the peppermint oil to the tarred dispensing bottle
10 Close the bottle
11 Measure purified water
12 Add the purified water to the dispending bottle in
small quantities with vigorous shaking after each
addition to produce the final volume
14 Label
15 Complete recordings and documentation
16 Store the preparation to an appropriate place
81
Learning Module: Compounding of Pharmaceuticals I | ORHB
Purpose: The purpose of this activity is to enable you to practice the preparation methods and
dissolution techniques of chloroform Spirits
Instruction
Prepare 40 ml of chloroform spirit using the following master formula.
Chloroform………………………….50ml
Alcohol (90%) q.s…………………...1000ml
Send 40 ml
Use: It is used as a flavoring g agent, carminative and preservative
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Equipment/tools
o Amber colored medicinal bottle
o Label –white paper
o Measuring cylinder
o pipette
1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary), or
is omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if necessary)
but participant/student does not progress from step to step efficiently
3. 3. Proficiently Performed: Step or task performed efficiently and precisely in the proper
sequence (if necessary)
Procedure-learning guide/checklist
Improvement
Competently
Proficiently
Performed
Performed
Remark
Needs
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Tare the bottle to the desired volume by using
purified water
83
Learning Module: Compounding of Pharmaceuticals I | ORHB
84
Learning Module: Compounding of Pharmaceuticals I | ORHB
Purpose: The purpose of this activity is to enable you to practice the preparation methods and
dissolution techniques of peppermint spiritB.P.88 (peppermint Essence)
Instruction
Prepare 30 ml of peppermint spirit, B.P.88 (peppermint Essence) using the following
formula.
Peppermint oil ……………….100ml
Ethanol (90%) to……………..1000ml
Send 20 ml
Use: It is used as a Flavoring agent and carminative
Role of ingredients
Peppermint oil: Flavoring agent
Alcohol 90%: Solvent of Peppermint oil
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Equipment/Tools
o Amber colored medicinal bottle
o Label –white paper
o Measuring cylinder
o pipettes
1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary), or is omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if necessary) but
participant/student does not progress from step to step efficiently
3. Proficiently Performed: Step or task performed efficiently and precisely in the proper sequence (if
necessary)
Procedure-learning guide/checklist
Rate
S.No Step/Task
Improvement
Competently
Proficiently
Performed
Performed
Remark
Needs
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Tare the bottle to the desired volume by using
purified water
8 Measure peppermint oil and Add to the tarred bottle
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Learning Module: Compounding of Pharmaceuticals I | ORHB
87
Learning Module: Compounding of Pharmaceuticals I | ORHB
Instruction
Prepare 20 ml of aqueous iodine solution using the following master formula.
Iodine ……………………50 gm
Potassium iodide ………… 100 gm
Purified water q.s …………1000 ml
Send 20 ml
Use: source of iodine in it’s deficiency condition
Storage: stored in well closed and iodine resistant container.
Role of ingredients:
Iodine: Active ingredient
Potassium iodide: increase the solubility of Iodine
Water up: vehicle/solvent
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Learning Module: Compounding of Pharmaceuticals I | ORHB
1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary), or
is omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if necessary)
but participant/student does not progress from step to step efficiently
3. Proficiently Performed: Step or task performed efficiently and precisely in the proper
sequence (if necessary)
Precautions
o Iodine will stain skin, clothing and plastic surface, take appropriate precautions.
o Care must be taken to avoid spillage during weighing and transfer
o The equipment and container must be spotlessly clean because this solution may stain the
working benches.
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Procedure-learning guide/checklist
Rate
S.No Step/Task
Improvement
Competently
Proficiently
Performed
Performed
Remark
Needs
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Tare the bottle to the desired volume by using purified
water
8 Measure purified water
9 Weigh potassium iodide
10 Weigh iodine
11 Add potassium iodide and iodine in to glass mortar
and triturate together
12 Add sufficient purified water to the mortar and
Dissolve potassium iodide and iodine
13 Transfer the solution in to the tarred bottle
14 Make up the volume by rinsing the mortar and pestle
with the water.
15 Clean the working equipments and the surroundings
16 Label
17 Complete the recordings and documentation
18 Store the preparation to an appropriate place
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Role of ingredients
Potassium iodide: Increase the solubility of iodine
Iodine: Active ingredient
Water: solvent Ethanol (90%):co solvent and vehicle.
91
Learning Module: Compounding of Pharmaceuticals I | ORHB
1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary), or
is omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if necessary)
but participant/student does not progress from step to step efficiently
3. 3. Proficiently Performed: Step or task performed efficiently and precisely in the proper
sequence (if necessary)
Precautions
o Iodine will stain plastic surface, take appropriate precautions.
o Care must be taken to avoid spillage during weighing and transfer
o The equipment and container must be spotlessly clean because this solution may stain the
working benches
92
Learning Module: Compounding of Pharmaceuticals I | ORHB
Procedure-learning guide/checklist
Rate
S.No Step/Task
Improvement
Competently
Proficiently
Performed
Performed
Remark
Needs
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Tare the bottle to the desired volume by using purified
water
8 Weigh potassium iodide, and iodine
9 Measure Alcohol(90%) and Water,
14 Label
15 Complete the Recordings and documentation
16 Store the preparation to an appropriate place
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Instruction
Prepare and supply 100ml of simple syrup, USP using the following master formula.
Sucrose……667g sucrose…….850g
or
Purified water…to 1000g purified water…..to 1000ml
Send 100ml
Storage: store in well closed airtight container in a moderately cool place.
Use: sweetening and flavoring agent (sweetening vehicle)
Role of ingredients
Sucrose: Main ingredient as sweetening agent
Purified water: Vehicle/solvent
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Equipments/Tools
o Glass rode
o Purified water
o Funnel
o Fine muslin (for straining)
o Beam/digital balance
o Spoon spatula
o Weighing paper
o Mortar and pestle
o Amber colored medicinal bottle
o Label –white paper
o Measuring cylinder
1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary), or
is omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if necessary)
but participant/student does not progress from step to step efficiently
3. 3. Proficiently Performed: Step or task performed efficiently and precisely in the proper
sequence (if necessary)
95
Learning Module: Compounding of Pharmaceuticals I | ORHB
Procedure-learning guide/checklist
Rate
S.No Step/Task
Improvement
Competently
Proficiently
Performed
Performed
Remark
Needs
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Calibrate the balance
8 Tare the bottle to the desired volume by using purified
water
9 Weigh sucrose
10 Measure purified water.
11 Place the sucrose in a dish and add the water
12 Dissolve the sucrose by heating on a water bath ,stirring
continuously with glass rode
13 When the dissolution of sucrose is complete, allow the
solution formed to cool add sufficient boiling purified
water to make up for that loss by evaporation
14 strain the syrup while still warm ,through fine muslin
supported in a funnel in to the tarred bottle
15 Shake the bottle occasionally until the content is quite
cold.
17 Label
18 Complete the Recordings and documentation
19 Store the preparation to an appropriate place
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Role of ingredients
Ferrous sulfate: Active ingredient
Citric acid, hydrous: prevent discoloration of syrup from green to reddish brown
Peppermint spirit: flavoring agent
Sucrose: sweetening agent
Purified water: vehicle
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Learning Module: Compounding of Pharmaceuticals I | ORHB
1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary), or is omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if necessary) but
participant/student does not progress from step to step efficiently
3. 3. Proficiently Performed: Step or task performed efficiently and precisely in the proper sequence (if
necessary)
98
Learning Module: Compounding of Pharmaceuticals I | ORHB
Procedure-learning guide/checklist
Rate
S.No Step/Task
Improvement
Competently
Proficiently
Performed
Performed
Remark
Needs
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Calibrate the balance
8 Tare the bottle to the desired volume by using
purified water
9 Weigh Ferrous sulfate, Citric acid, hydrous
Peppermint spirit and Sucrose
10 Measure purified water.
99
Learning Module: Compounding of Pharmaceuticals I | ORHB
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Learning Module: Compounding of Pharmaceuticals I | ORHB
o Amaranth solution
o Purified water
Equipments/Tools
o Beam/digital balance
o Spoon spatula
o Weighing paper
o Amber colored medicinal bottle
o Label –white paper
o Measuring cylinder
o pipettes
101
Learning Module: Compounding of Pharmaceuticals I | ORHB
Procedure-learning guide/checklist
S. No Rate
Step/Task
Improvement
Competently
Proficiently
Performed
Performed
Remark
Needs
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Calibrate the balance
8 Tare the bottle to the desired volume by using
purified water
9 Weigh Phenobarbitone
10 Measure purified water.
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Sodium bicarbonate………………………………….10gm
Sodium chloride ……………………………………..15gm
Concentrated Peppermint Emulsion…………………25ml
Double Strength Chloroform Water ………………..500ml
Water to………………………………………………1000ml
Send 50ml
Directions:-
1. Dilute it with equal volume of warm water before use.
2. Rinse the mouth 3-4 times daily.
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Equipments/Tools
Beam/digital balance
Spoon spatula
Weighing paper
Amber colored medicinal bottle
Erlenmeyer flask/ Conical graduates
Measuring cylinder
pipettes
Label –white paper
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Procedure-learning guide/checklist
Rate
Ser.No Step/Task
Improvement
Competently
Proficiently
Performed
Performed
Remark
Needs
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Calibrate the balance
8 Tare the bottle to the desired volume by using
purified water
9 Weigh Sodium chloride and Sodium bicarbonate
10 Measure Double strength chloroform water and
Peppermint emulsion
15 Label
16 Write short report/complete the Recordings and
documentation
17 Store the preparation to an appropriate place
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Directions:-
1. Dilute it with ten times its volume of warm water before use.
2. Rinse the mouth 3-4 times daily.
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Water
Amaranth solution
Purified water
Equipments/Tools
Amber colored medicinal bottle
Erlenmeyer flask/ Conical graduates
Measuring cylinder
pipettes
Label –white paper
Procedure-learning guide/checklist
Rate
S. No Step/Task
Improvement
Competently
Proficiently
Performed
Performed
Remark
Needs
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
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Learning Module: Compounding of Pharmaceuticals I | ORHB
15 Label
16 Complete the Recordings and documentation
17 Store the preparation to an appropriate place
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Learning Module: Compounding of Pharmaceuticals I | ORHB
109
Learning Module: Compounding of Pharmaceuticals I | ORHB
Equipment’s/Tools
Amber colored medicinal bottle
Erlenmeyer flask/ Conical graduates
Measuring cylinder
pipettes
Label –white paper
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Procedure-learning guide/checklist
Rate
S. No Step/Task
Improvement
Competently
Proficiently
Performed
Performed
Remark
Needs
1 Wear Gown
2 Wash your hands
4 Wear glove
5 Clean the working lab bench
6 Clean equipments
7 Develop your working formula
8 Tare the bottle to the desired volume by using
purified water
9 Measure Phenol Glycerin and Amaranth solution
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Equipments/Tools
Beam/digital balance, Spoon spatula
Amber colored medicinal bottle
Erlenmeyer flask/ Conical graduates
Weighing paper
Measuring cylinder
pipettes
Label –white paper
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Rate the performance of each step or task observed using the following rating scale:
1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary), or is
omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if necessary) but
participant/student does not progress from step to step efficiently
3. 3. Proficiently Performed: Step or task performed efficiently and precisely in the proper sequence
(if necessary)
Procedure-learning guide/checklist
Rate
S.No Step/Task
Improvement
Competently
Proficiently
Performed
Performed
Remark
Needs
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Tare the bottle to the desired volume by using purified
water
8 Weigh potassium camphor and measure arahis oil
9 Dissolve the camphor in the oil in the flask
14 Label
15 Complete the Recordings and documentation
16 Store the preparation to an appropriate place
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Learning Module: Compounding of Pharmaceuticals I | ORHB
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Learning Module: Compounding of Pharmaceuticals I | ORHB
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
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Procedure-learning guide/checklist
Rate
S. No Step/Task
improvement
Competently
Proficiently
Performed
Performed
Remark
Needs
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Tare the bottle to the desired volume by using
purified water
8 Weigh potassium iodide, and iodine
9 Measure Alcohol(90%),Water, Peppermint oil and
Glycerol
10 Put the water in conical flask /Glass mortar and
Dissolve KI, add iodine
11 Mix peppermint oil in alcohol and add to the previous
solution
12 Make up to final volume with glycerol and mix
thoroughly.
13 Clean the working equipments and the surroundings
14 Label
15 Complete the Recordings and documentation
16 Store the preparation to an appropriate place
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Learning Module: Compounding of Pharmaceuticals I | ORHB
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Equipments/Tools
Beam/digital balance
Spoon spatula
Amber colored medicinal bottle
Erlenmeyer flask/ Conical graduates
Measuring cylinder
Pipettes
Beam /digital balance
Weighing paper
Label –white paper
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Procedure-learning guide/checklist
Rate
S. No Step/Task
Improvement
Competently
Proficiently
Performed
Performed
Remark
Needs
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Tare the bottle to the desired volume by using
purified water
8 Weigh sodium Bicarbonate
9 Measure Glycerin and Purified water
14 Label
15 Complete the Recordings and documentation
16 Store the preparation to an appropriate place
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Learning Module: Compounding of Pharmaceuticals I | ORHB
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Learning Module: Compounding of Pharmaceuticals I | ORHB
11. Rinse the mortar and pestle with successive volumes of the vehicle until they are quite
clean transferring the rinsing to the bottle.
12. Make up to volume with the vehicle and shake thoroughly
The thickening agents used to stabilize suspensions is substances that spontaneously form colloidal
dispersions in aqueous media because of their affinity to water.
There are three major groups of thickening agents:
1. Polysaccharides include acacia, tragacnath, methylcellulose, sodium alginate,
microcrystalline cellulose sodium carboxymethyl cellulose starch etc.
2. Inorganic agents include bentonite veegum hectorite aluminium hydroxide etc
3. Synthetic agents include carboxyvinyl polymer(carbomer) colloidal silicon dioxide etc
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Learning Module: Compounding of Pharmaceuticals I | ORHB
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Learning Module: Compounding of Pharmaceuticals I | ORHB
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Learning Module: Compounding of Pharmaceuticals I | ORHB
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Procedure-learning guide/checklist
Rate
S. No Step/Task
Improvement
Competently
Proficiently
Performed
Performed
Remark
Needs
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Tare the bottle to the desired volume by using purified
water
8 Weigh Light kaolin
9 Measure
Amaranth Solution
Benzoic Acid Solution
Raspberry Syrup
Chloroform Water (D.S.)
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Purified water
15 Label
16 Complete the Recordings and documentation
Store the preparation to an appropriate place
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Purpose: The purpose of this activity is to enable you to practice the preparation methods,
weighing, traturation techniques and equipments used in compounding of Magnesium Sulfate
mixture (Oral Suspension) BP.88
Instruction
Prepare and supply 20mlMagnesium Sulfate mixture BP.88 (Magnesium Sulfate Oral
Suspension) using the following master formula
Magnesium sulfate……………………………………………….. 400 g
Light magnesium carbonate………………………………………..50g
Concentrated peppermint emulsion……………………………….25g
Double strength chloroform water……………………………….300ml
Water FBC sufficient to produce……………………………….1000ml
Send 20 ml
Advice for patients: Shake well to bottle before use
Equipments/Tools
o Beam/digital balance
o Spoon spatula
o Amber colored medicinal bottle
o Mortar and pestle
o Measuring cylinder
o Pipettes
o Weighing paper
o Label –white pipettes
(To be completed by students/Peers)
Rate the performance of each step or task observed using the following ratingscale:
1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary), or is
omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if necessary) but
participant/student does not progress from step to step efficiently
3. Proficiently Performed: Step or task performed efficiently and precisely in the proper sequence
(if necessary)
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Procedure-learning guide/checklist
S. No Step/Task Rate
Improvement
Competently
Proficiently
Performed
Performed
Remark
Needs
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Tare the bottle to the desired volume by using purified
water
8 Weigh Magnesium sulfate and Light magnesium
carbonate
9 Measure Concentrated Peppermint emulsion and Double
strength Chloroform water
14 Label
15 Complete the Recordings and documentation
16 Store the preparation to an appropriate place
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Purpose: The purpose of this activity is to enable you to practice the preparation methods,
weighing, traturation techniques and equipments used in compounding of Phenolated Calamine
Lotion, USP
Instruction
Prepare and supply 50ml of phenolated Calamine Lotion B.P using the following master
formula
Calamine powder………………… 80 g
Zinc oxide powder…………………85g
Bentonite powder………………….20g
Liquid 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.
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Learning Module: Compounding of Pharmaceuticals I | ORHB
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Precaution: Liquefied phenol is very caustic so do not use mouth to pipette the liquid. Use a
small measuring cylinder or a treated pipette
Procedure-learning guide/checklist
Rate
S. No Step/Task
Improvement
Competently
Proficiently
Performed
Performed
Remark
Needs
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Tare the bottle to the desired volume by using
purified water
8 Weigh Calamine powder, Zinc oxide powder and
Bentonite powder
9 Measure Liquefied Phenol,Glycerin and Calcium
Hydroxide solution
10 Mix the dry powders in the mortar until evenly
dispersed
11 Add bentonite in to powders and Triturate well to
distribute throughout the indiffusible powders
12 Add calcium hydroxide solution to make a smooth
paste and to dilute the formed paste for transfer to
the bottle
13 Transfer in to the tarred bottle
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Learning Module: Compounding of Pharmaceuticals I | ORHB
16 Label
17 Complete the Recordings and documentation
18 Store the preparation to an appropriate place
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Learning Module: Compounding of Pharmaceuticals I | ORHB
An emulsion is a disperse system consisting of two immiscible liquids, usually water and
oil, one of which (the disperse phase) is distributed throughout the other (the continuous
phase) as small globules.
Since this type of dispersion is inherently unstable, the system is stabilized by the presence
a third component, the emulsifying agent (emulgent, emulsifier).
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Learning Module: Compounding of Pharmaceuticals I | ORHB
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Learning Module: Compounding of Pharmaceuticals I | ORHB
A. Mortar and pestle: This approach is used for those emulsions that are stabilized by the
presence of a multimolecular film (e.g., Acacia, tragacanth and agar) at the interface.
There are two basic methods.
i) The Wet Gum (or so-called English) Method. In this method, the emulsifying agent is
placed in the mortar and dispersed in water to form mucilage. The oil is added in
small amounts with continuous trituration, each portion of the oil being emulsified
before adding the next increment.
ii) The Dry Gum (or so-called continental) Method. In this method, preferred by most
pharmacists, the gum is added to the oil, rather than the water as with the wet gum
method.
In both the Dry Gum and the Wet Gum methods, a primary, or concentrated, emulsion is first
prepared using a set ratio of oil, water, and gum (emulsifying agent) from which the final product
is obtained by dilution with the continuous phase.
Acacia Emulsions
Unless otherwise specified, extemporaneously prepared emulsions for internal use are made with
acacia gum. To prepare acacia emulsions using a pestle and mortar, a thick (primary) emulsion
must be made first. The quantities for primary emulsions have been determined by experience.
‘Parts’ is interpreted as parts by volume for fixed, mineral, and volatile oils, and part by weight for
oleoresins and acacia.
Quantities for Primary Emulsions
Types of oil Examples Quantities for primary emulsions (Parts)
Almond oil oil Water Gum (Acacia) Tragacanth
Fixed oil Arachis oil
Castor oil 4 2 1 0.1
Cod-liver oil
Mineral oil Liquid paraffin 3 2 1 0.1
Volatile oil Turpentine oil
Cinnamon oil 2 2 1 0.1
Peppermint oil
Oleo-resin Male fern extract 1 2 1 0.1
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Learning Module: Compounding of Pharmaceuticals I | ORHB
NB. The amount of trangacanth needed is only one-tenth of the acacia amount.
When an emulsion contains two or more oily liquids the quantity of acacia for each is calculated
separately and the sum of these quantities used.
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Problems:
Sometimes the primary emulsion does not form properly and the contents of the mortar become
oily, thin and translucent. This is due to phase inversion, the product, which has become a W/O
emulsion cannot be diluted with water and must therefore be discarded.
B. Other Methods
An increasing number of emulsions are being formulated with synthetic emulsifying agents,
especially of the non-ionic type.
When using many of these highly active synthetic agents, it is possible to obtain
excellent preparations by simply adding the warmed phases to a beaker and stirring
until cool. In place of a beaker, the phases can sometimes be placed into a bottle,
which is then shaken.
With hand homogenizers an initial rough emulsion is formed by titration in a mortar
or shaking in a bottle. The rough emulsion is then passed several times through the
homogenizer.
Containers and Labeling
Emulsions should be supplied in well-filled containers with airtight closures. For viscous
preparations wide-mouthed amber glass bottles are most appropriate.
Labeling: shake the bottle, store in cool place but avoid freezing.
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Purpose: The purpose of this activity is to enable you to practice the preparation methods,
weighing and dissolution techniques in the compounding of castor oil emulsion
Instruction
Prepare and supply 20ml of castor oil emulsion using the following master formula
Castor oil……………. 8 ml
Acacia in powder………2gm
Water q.s……………… 20 ml
Send 20 ml
Advice for patients: Shake well to bottle before use
Storage and shelf life: the mixture should be recently prepared and should be stored in a cool
place.
Actions and uses: This emulsion is used as a purgative since castor oil is purgative in nature
Direction for use: Three 5ml spoonfuls to be taken three times a day with meals
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Learning Module: Compounding of Pharmaceuticals I | ORHB
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Procedure-learning guide/checklist
Rate
S.No Step/Task
Improvement
Competently
Proficiently
Performed
Performed
Remark
Needs
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Tare the bottle to the desired volume by using
purified water
8 Weigh Acacia in powder
9 Measure Liquid phenol ,Glycerin and purified water
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Learning Module: Compounding of Pharmaceuticals I | ORHB
18 Label
19 Complete the Recordings and documentation
20 Store the preparation to an appropriate place
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Purpose: The purpose of this activity is to enable you to practice the preparation methods and
dissolution techniques in the compounding of concentrated peppermint Emulsion
Instruction
Prepare 50 ml of Concentrated Peppermint Emulsion using the following formula
Peppermint Oil ……………………………………………20ml
Polysorbate 20 ……………………………………………1ml
Chloroform Water (DS)……………………………………500ml
Water to…………………………………………………….1000ml
Send 50 ml
Actions and uses: Flavoring agent
Storage: store at cool place
Equipment/Tools
Measuring cylinder
Dropper/pipette
Dispensing bottle
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Procedure-learning guide/checklist
Rate
Ser.No Step/Task
Improvement
Competently
Proficiently
Performed
Performed
Remark
Needs
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Tare the final bottle
6 Measure all the ingredients and put on working
bench
7 Add Peppermint Oil to the tarred bottle and add poly
Sorbate 20 to the peppermint oil gradually, shaking
well after each addition
8 Add the (DS) chloroform water and sufficient water to
produce 1000ml; shake well after each addition.
9 Label
10 Clean the working equipments and the surroundings
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Absorption bases: Absorption bases are hydrophilic, anhydrous materials or hydrous bases
that have the ability to absorb additional water. The former are anhydrous bases, which absorb
water to become W/O emulsions; the latter are W/O emulsions, which have the ability to absorb
additional water. The word absorption in this context refers only to the ability of the base to
absorb water.
Examples: hydrophilic petrolatum and anhydrous lanolin,
Water-miscible bases: These bases are O/W emulsion bases, commonly referred to as creams,
and represent the most commonly used type of ointment base. By far the majority of
commercial dermatologic drug products are formulated in an emulsion (or cream) base.
Emulsion bases are washable and removed easily from skin or clothing.
Example: Hydrophilic Ointment, USP
Water soluble bases: Soluble ointment bases, as name implies, are made up of soluble
components or may include gelled aqueous solutions
Example: Polyethylene glycol (PEG) ointment, NF
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Preparation of ointments
Ointments are not applied primary to irritated areas it is an on broken wound rule that these
preparations must contain granular or gritty particles, which might cause further irritation
regardless of the condition of the skin. Ointments must be smooth and free from granular or gritty
particles.
Packaging of ointments:
Ointments are dispensed in either ointment or collapsible tube. However, ointments
prepared extemporaneously are usually packed in ointment jar.
The ointment should be packed and the top surface should be smoothed neatly.
Ointments jars should be closed tightly when not in use particularly if the ointment
consisting water to prevent loss though operation.
Storage of ointments:
Ointments should be stored in a cool place to prevent softening and eventually liquefiable in the
base. Insoluble medicament may settle to the bottom of the container if the ointment is permit to
liquefy. Excessive heat or cold may cause an emulsion base to separate into two phases.
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Learning Module: Compounding of Pharmaceuticals I | ORHB
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.
Gels
Jellies are transparent or translucent, non-greasy, semisolid gels generally applied externally
Jellies are used for medication (Medicated jellies), lubrication (Lubricating jellies) and some
miscellaneous applications
Formulation of Gels
Gelling agents are usually organic hydrocolloids but, occasionally, hydrophilic inorganic
substances
Organic hydrocolloids: Tragacanth, Sodium alginate, Pectin, Starch, Gelatin, Cellulose derivatives
(Methylcellulose, Sodium carboxymethylcellulose, Hydrroxypropyl methylcellulose), Carbomer,
Polyvinyl alcohols, and others
Hydrophilic inorganic substances: Clays like bentonite
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Preservatives: Gels have high water content and therefore are liable to support microbial
growth unless a suitable preservative is added
NB The chosen preservative must be compatible with the gelling agent
Chelating agents: are ingredients that bind with metal ions or metallic compounds,
preventing contamination or discoloration Bases and medicaments sensitive to heavy
metals are sometimes protected by chelating agents such as EDTA
Packaging
Lubricating jellies should be packed in collapsible tubes. However, stiffer gels for application to
the skin may be supplied in ointment jars
Containers should be well filled and airtight to prevent evaporation
Storage
Jellies should be stored in a cool place to prevent loss of water via evaporation
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Preparation of creams
Creams may contain one or more medicaments in solution in one or other of the phases.
Finely powdered insoluble medicaments may also be dispersed in a cream base
Generally, creams are prepared as follows
The components of the oily phase (usually including the emulgent) are heated until molten
and the temperature rises to 75oc
The components of the aqueous phase are mixed in a separate vessel and also heated to
75oc
The aqueous phase is then added to the oily phase at the same temperature and the resulting
emulsion is stirred gently until cool
o Thermometer should be used to control the temperatures of the two phases
o Rapid cooling may result in separation of high melting point components
o Excessive aeration caused by vigorous stirring may also lead to a granular product
Packaging
Wide-mouthed jars may be used for creams where the risk of contamination in use is
considered to be minimal, e.g. oily creams. The containers must be well closed and prevent
water evaporation. The mouth of the jar should be covered with a disc of greaseproof paper
Collapsible metal or flexible plastic tubes, however, are to be preferred since these reduce
the risk of contamination in use
o NB. Most proprietary cream products are packed in tubes
Storage
Creams should be stored in a cool place but should not be allowed to freeze
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Learning Module: Compounding of Pharmaceuticals I | ORHB
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Ointment slab/tile
Waxed papers /watch glass
Glass rode
Water bath/hotplate
Spoon spatula
Ointment Jars
Evaporating dish
Weighing paper
Label –white paper
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Procedure-learning guide/checklist
Rate
S. No Step/Task
Needs Improvement
Competently
Proficiently
Performed
Performed
Remark
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Weigh wool fat, hard paraffin(after grating),
Cetoctearyl alcohol and Yellow or White soft paraffin
8 Place the ingredient in an evaporating dish on a water-
bath from high melting point to low melting point to melt
them all
9 Stir gently to aid melting and to mix the ingredient
13 Label
14 Complete the Recordings and documentation
15 Store the preparation to an appropriate place
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Purpose: The purpose of this activity is to enable you to practice the weighing mixing, melting,
levigating and packing techniques in compounding of Sulphur Ointment using Simple Ointment
Instruction
Prepare and supply 25g of Sulfur Ointment, BP (BP) using the following master formula
Precipitated Sulfur, finely sifted………100 g
Simple ointment……………………………900 g
Send 25
Storage and Shelf life: Store in a cool place. An expiry date of 4 weeks is appropriate.
For external use only
Container: Wide-mouthed amber jar with a greaseproof paper disc
Advice for patient when dispensed: The skin should be cleansed prior to application
and the ointment applied sparingly to the affected area
Action and uses: Mild antiseptic used in the treatment of acne and scabies
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Learning Module: Compounding of Pharmaceuticals I | ORHB
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Procedure-learning guide/checklist
S.No Step/Task Rate
Needs Improvement
Competently
Competently
Performed
Performed
Remark
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7
8 Weigh precipitated Sulfur required and place it on
the center of the ointment tile
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Learning Module: Compounding of Pharmaceuticals I | ORHB
14 Label
15 Complete the Recordings and documentation
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Purpose: The purpose of this activity is to enable you to practice the weighing mixing, melting,
and packing techniques in compounding of Emulsifying Ointment BP
Instruction
Prepare and supply 25g of Emulsifying Ointment, BP) using the following master formula
Ingredients
Emulsifying Wax……………………………..30
White soft paraffin……………………………500 g
Liquid paraffin………………………………..200 g
Send 25g
Storage: store in a cool place
Action and uses: Ointment base emollient
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Learning Module: Compounding of Pharmaceuticals I | ORHB
1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary), or
is omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if necessary)
but participant/student does not progress from step to step efficiently
3. 3. Proficiently Performed: Step or task performed efficiently and precisely in the proper
sequence (if necessary)
Procedure-learning guide/checklist
S.No Step/Task Rate
Improvement
Competently
Proficiently
Performed
Performed
Remark
Needs
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Weigh Emulsifying Wax, White soft paraffin,
Liquid paraffin
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Learning Module: Compounding of Pharmaceuticals I | ORHB
13 Label
14 Complete the Recordings and documentation
15 Store the preparation to an appropriate place
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Instruction
Prepare and supply 25g of Benzoic acid Ointment,(BP) using the following master formula
Benzoic acid………………………….60 g
Salicylic acid…………………………30 g
Emulsifying ointment……………….910g
Send 25
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Ointment slab/tile
Waxed papers /watch glass
Weighing paper
Glass rode
Water bath/hotplate
Spoon spatula
180m sieves
Ointment Jars
Label –white paper
Precautions: Salicylic acid irritates the respiratory tract, so precautions should be taken to avoid
inhalation
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Procedure-learning guide/checklist
S.No Step/Task Rate
Improvement
Competently
Proficiently
Performed
Performed
Remark
Needs
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Sift the medicaments through separate 180m sieves
8 Weigh Benzoic acid and Salicylic acid powder after
sifting and mix them
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Learning Module: Compounding of Pharmaceuticals I | ORHB
15 Label
16 Write short report/complete the Recordings and
documentation
17 Store the preparation to an appropriate place
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Purpose: The purpose of this activity is to enable you to practice the preparation methods,
weighing, mixing, levitation and packing techniques in compounding of pastes
Instruction
Prepare and supply 20g of Zinc Oxide Paste, U.S.P. 1990 using the following master
formula
Zinc oxide ,finely sifted……………………………..250g
Starch, finely sifted…………………………………..250
White petrolatum……………………………………500g
Send 25g
Storage: Store in a cool place
Container: Wide-mouthed amber jar with greaseproof paper disc
Advice for patient when dispensed: The paste should be spread thickly on white lint and
applied to the affected area
Action and Uses: Absorbent, protectant and mild astringent used for variety of dermatological
conditions including eczema and psoriasis either alone or with additional medicaments
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Equipments/Tools
Beam/digital balance
Flexible spatula
Ointment slab/tile
Waxed papers /watch glass
Weighing paper
180m sieves
Glass rode
Mortar and pestle
Water bath/hotplate
Spoon spatula
Ointment Jars
Label –white paper
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Procedure-learning guide/checklist
S Rate
No Step/Task
Improvement
Competently
Proficiently
Performed
Performed
Remark
Needs
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Sift the powders through separate 180m sieves
8 Weigh zinc oxide and starch powder after sifting
them
14 Label
15 Write short report/complete the Recordings and
documentation
16 Store the preparation to an appropriate place
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Purpose: The purpose of this activity is to enable you to practice the preparation methods,
weighing, mixing, and packing techniques in compounding of Jellies
Instruction
Prepare and supply 40g of Lubricating Jelly with Sodium Carboxy Methyl Cellulose (Na
C.M.C. using the following master formula
Sodium Carboxy Methyl Cellulose ………………….....5g
glycerol………………………………………………….15
Methyl Hydroxybenzoate……………………………….01g
Patent Blue V…………………………………………..0.0001
Purified Water ,FBC to………………………………..100g
Send 40
Storage: Store in a cool place
Container: Collapsible metal tube
Advice for patients when dispensed: Not applicable
Actions and uses: Non-sterile lubricating jelly for lubricating rubber gloves for rectal
examination
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Procedure-learning guide/checklist
S.No Step/Task Rate
Improvement
Competently
Proficiently
Performed
Performed
Remark
Needs
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Sift the powders through separate 180m sieves
8 Weigh All ingredients
9 Dissolve the methyl hydroxybenzoate in the glycerol
and add the sodium carboxymethyl cellulose.
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Purpose: The purpose of this activity is to enable you to practice the preparation methods,
weighing, mixing, and packing techniques in compounding of Bees Wax-Borax Cold cream.
Instruction
Prepare and supply 20g of Bees Wax-Borax Cold cream the following master formula
Purified water……………………………………24g
Borax…………………………………………….1.19g
Olive oil…………………………………………..50g
Bees Wax…………………………………………12g
White Soft Paraffin………………………………12.5g
Send 20g
Storage: Store in a cool place but don’t allow to freeze
Container: Collapsible metal tube or wide mouthed jar
Action and Uses: Emollient cream base
Note: the cooling effect in cold cream is caused due to the slow evaporation of water present in
the internal phase
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Procedure-learning guide/checklist
S.No Step/Task Rate
Competently
Competently
Proficiently
Performed
Performed
Performed
Remark
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Weigh All ingredients
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Procedure-learning guide/checklist
Ser. Step/Task Rate
No
Improvement
Competently
Proficiently
Performed
Performed
Remark
Needs
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Weigh All ingredients
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Divided Powders
This form of powder may contain one or more active ingredients together with an inert diluents to
produce a minimum quantity (120mg) that can be weighed by the dispenser and handled by the
patient. After the powder blend is prepared, it can be subdivided into the required number of doses
by weighing or by using the block and divide method. The papers in which divided powders are
traditionally folded are called powder papers. The paper of choice for hygroscopic or deliquescent
powders is waxed paper because of its waterproof qualities. Also powders containing volatile
ingredients should be similarly wrapped.
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Packaging:
For bulk powders
For internal powders: Wide-mouth screw cap glass jars
o A 5ml spoon should be supplied for measuring dose
For dusting powders: Colored glass or plastic jars with a reclose able perforated lid
For Divided powders
Folded powder paper packets, Aluminum foils, Heat-sealed plastic bags
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Purpose: The purpose of this activity is to enable you to practice the preparation methods,
weighing, mixing, and packing techniques of Oral Rehydration Salts, BP 1988 (O.R..S)
Instruction
Prepare and supply Oral Rehydration Salts, BP 1988 (O.R.S) using the following master formula
Sodium Chloride………………………….1.0 g
Potassium chloride………………………..1.50g
Sodium Bicarbonate……………………..1.5g
Anhydrous Glucose…………………….36.4g
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Equipment/Tools
250m sieve
Beam/digital balance
Weighing paper
Mortar and pestle
Spoon spatula
Powder papers
Label –white paper
(To be completed by students/Peers)
Rate the performance of each step or task observed using the following rating scale:
1. Needs Improvement: Step or task not performed correctly, out of sequence (if necessary), or
is omitted
2. Competently Performed: Step or task performed correctly in proper sequence (if necessary)
but participant/student does not progress from step to step efficiently
3. 3. Proficiently Performed: Step or task performed efficiently and precisely in the proper
sequence (if necessary)
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Procedure-learning guide/checklist
Improvement
Competently
Proficiently
Performed
Performed
Remark
Needs
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Weigh All ingredients, make a small excess to allow for
losses in the mortar
10 Label
11 Clean the working equipments and the surroundings
12 Complete the Recordings and documentation
13 Store the preparation to an appropriate place
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Prepare and supply Zinc, Starch and Talc Dusting Powder, BPC 1973 the following master formula
Zinc oxide………………………….250 g
Starch, in fine powder……………250g
Purified talc, sterilized…………..500g
Send 15g
Storage: store in a dry place
Container: amber glass screw-capped jar or plastic pot with re closeable perforated lid
Advice for patients when dispensed: The powder should be dusted lightly on to the affected area.
It should not be applied to broken skin or to raw surfaces of large area
Actions and Uses: Adsorbent dusting powder
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Procedure-learning guide/checklist
Rate
S.No Step/Task
Improvement
Competently
Proficiently
Performed
Performed
Remark
Needs
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Weigh All ingredients,
8 Mix the powders in a mortar in order of increasing
bulk
9 Pass the resulting mix through a 180m sieve, lightly
remix and pack
10 Label
11 Clean the working equipments and the surroundings
12 Complete the Recordings and documentation
13 Store the preparation to an appropriate place
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Formulation
There are two main classes of suppository base
1. Fatty bases: designed to melt at body temperature
o Examples: Theobroma oil (cocoa butter), synthetic fats (Witepsols)
2. Water-soluble or water-miscible bases: designed to dissolve or disperse within the body
o Examples: Glycerogelatin bases, macrogol bases
Compounding
Suppository and Pessary moulds
The normal capacities of commonly used moulds. 1g (15 gr), 2g (30 gr), 4g (60 gr), and 8g
(120 gr)
The nominal capacity of mould implies a calibration using oil of theobroma and therefore will
vary with different bases depending upon their density
o NB. The capacity of moulds should be confirmed by filling each mould with base
alone, weighing the products and taking the mean weight as the true capacity
Displacement Value
Displacement value: the number of parts by weight of medicament that displaces one part
by weight of the base
Displacement values for fatty bases are similar to those for Theobroma oil
NB. When the medicament is prescribed as a percentage, the displacement value is irrelevant; to
use it would make the percentage incorrect
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Mould Lubrication
Base Lubricant
Theobroma Soap spirit (soft soap 10g), glycerol (10ml) and 90% alcohol (50ml)
Glycerol-gelatin bases Liquid paraffin or Arachis oil
Synthetic fats No lubricant required
Macrogol bases No lubricant required
NB. The chosen lubricant must be immiscible with the base and compatible with the medicament
and any other formulation additives
Preparation of Suppositories
Two methods mainly are used:
1. Compression or cold process: the drug is mixed with shredded vehicle and the mixture then
is forced into a mould and subsequently extruded
2. Fusion or hot process:- the drug is incorporated into the melted base and the mass is poured
into the mould just before it congeals (Principal method for the preparation of suppositories)
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5. Melt the base. Place the dish containing the shredded base on a water bath and heat until about
two-thirds of the content has melted. Remove from the heat and stir gently with a small spatula to
allow the residual heat in the dish to melt the remainder of the base. (Overheating may occur if the
base is left over the heat until completely melted)
6. Incorporate the medicament
Insoluble solids
Heat a small tile until it is comfortably warm to the hand
Mix the powders on the tile with a flexible spatula
Pour about half of the melted base on to the mixed medicaments and work into a smooth
dispersion as quickly as possible by levigating with the spatula. If the base solidifies it can
be softened by holding the tile over the water bath for a few seconds
Transfer the dispersion to the dish, leaving virtually none on the tile, and stir to form a
homogenous mixture
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Shelf life: Most suppositories and pessaries are stable preparations provided that the packaging
provides adequate protection and that the storage temperature is low
Containers: Extemporaneously prepared suppositories and pessaries should be individually
wrapped in metal foil or waxed paper (if the medicament interacts with metals). Glass or plastic
screw-cap jars are suitable containers, particularly for products that are hygroscopic
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Purpose: The purpose of this activity is to enable you to practice the preparation methods,
weighing, mixing, molding and packing techniques in compounding of Glycerol suppositories BP
1988
Instruction
Prepare and supply 6g child’s size of Glycerol suppositories BP 1988the following master formula
Gelatin………………………..414g
Glycerol………………………..70g
Purified water…q.s (to produce 100g)
Send 20g
Storage: Store in a cool place
Container: Amber glass screw-capped jar or plastic pot
Advice for Patients when dispensed: After unwrapping, moisten with a little water and insert the
suppository as high as possible into the rectum
Actions & Uses: Promotes peristalsis and bowel evacuation in the treatment of constipation
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Procedure-learning guide/checklist
Rate
S.No Step/Task
Competently
Improvemen
Proficiently
Performed
Performed
Remark
Needs
t
1 Wear Gown
2 Wash your hands
3 Wear glove
4 Clean the working lab bench
5 Clean equipments
6 Develop your working formula
7 Weigh and measure All ingredients
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Summary
There are different types of formulations that could be prepared in prescription compounding.
These include; solution, suspension, emulsion, ointments, pastes, creams, gels and powders.
Solution are homogenous liquid preparation containing one or more dissolved ingredients and are
used for a variety of purposes as both internal and external dosage forms. Solutions are usually
prepared by using appropriate dissolution techniques like checking solubility of the solute.
Agitation, shaking, stirring and heating may be applied for facilitating solution formation process.
Suspension are dispersed systems in which finely divided drug practices (called the disperse phase)
are distributed thought out a vehicle (called dispersion medium or continues phase) in which the
drug exhibits a minimum degree of solubility. Compounding methods for suspensions include
fining the solid ingredients, mixing and triturating the insoluble powders using geometric dilution
method.
An emulsion is a disperse system consisting of two immiscible liquids, usually water and oil, one
of which (the disperse phase) is distributed throughout the other (the continuous phase) as small
globules. Most extemporaneously prepared emulsions are made with acacia gum. To prepare
acacia emulsions using a pestle and mortar a thick (primary) emulsion must be made first. Then
other excipients are added and diluted with vehicle to the required volume.Ointments, creams,
pastes and jellies are Semisolid preparations intended for external application to the skin or mucous
membrane. Different preparation methods are used for compounding semisolids like mixing by
fusion and trituration for ointments and pastes, dissolution heating for gels and creams.
Self-check Questions
Instruction: choose the best answer from the given alternatives
1. A type of suspension that consists of two different liquids that are held together by a specific
agent is known as:
A. a gel
B. an elixir
C. an emulsion
D. a magma
2. To grind a powder into a smoother mixture, using moisture, is a process called:
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Learning Module: Compounding of Pharmaceuticals I | ORHB
A. pasteurization
B. agitation
C. suspension
D. levigation
3. Which of the following dosage forms is prepared by the heat method?
A. syrups
B. emulsions
C. suspensions
D. elixirs
4. Which term means “reducing to a fi ne powder by grinding”?
A. trituration
B. suspending
C. agitation
D. atomization
5. Which of the following are not semisolid drugs?
A. pastes
B. creams
C. suspension
D. ointments
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12. What are basic equipments used for the preparation of ointments?
A. ointment slab and spatula
B. mortar and pestle
C. ointments jar or fill
D. all of the above
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References
1. Jahangir Moini, Laboratory Procedures for Pharmacy Technicians. (2010), 1st ed.Delamar.
2. John F Marriot et.al pharmaceutical compounding and dispensing. (2010), 2nd ed. The
pharmaceutical press
3. Loyd V. et.al Ansel’s pharmaceutical dosage forms and drug delivery systems (2011), 9th ed.
Lippincott Williams and Wilkins.
4. Allen LV Jr, The Art, Science, and Technology of Pharmaceutical Compounding. 1998,
American Pharmaceutical Association
5. Ethiopian Hospital Services Transformation Guidelines volume 1, September 2016
6. Drug Administration and Control Authority (DACA) of Ethiopia, standards for the
establishment and practice of pharmaceutical compounding laboratory. September 2002
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Module Syllabus
Module title: Pharmaceutical Compounding I
Module code: PHA M4 1017
Nominal duration: 240 hrs. (45 hrs. theory, 195 hrs. practical) 5 weeks
Module Description: This module aims to provide the learners with the knowledge, skills and
right attitudes required to prepare extemporaneous non-sterile pharmaceutical products from fixed
formulas
Unit of Competencies: HLT PHA 3 04 0611 Compound Small Scale Pharmaceutical Products
Module Outcomes
At the end of the module the learner will be able to:
Prepare for production process
Participate in quality control
Obtain and process raw materials
Manufacture/compound products
Complete production process
Teaching/learning methods
o Lecture
o Demonstration and coaching
o Guided reading
o Case study
o Group discussion
Teaching/learning materials
o Ppt slides
o Lecture note
o Compounding lab
o Cleaning materials
o Reference book
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Learning Module: Compounding of Pharmaceuticals I | ORHB
o Learning module
o Checklist
o IFRR format
o Case scenario o Lab manual
o Procedure manual o Packaging and labeling materials
o Balance and pan o Compounding sheet
o Audiovisuals o Compounding sheet SOP
o Sample packages for liquids, solids o Sample preparations
and semisolids
Methods of assessment
o Oral exam o MCQ
o Essay o Group/individual assignment
o Short answer o Workout
o Structured observation o Observation of product
Module Schedule
Week Learning Activity Required Reading /
Assignment
Day 1
Interactive presentation (4 hours)
Importance of compounding
Compounding area
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Day 3
Interactive Lecture (2 hrs.)
Safety and personal hygiene in compounding
Dressing code
Individual reading
Day 6
• Exam /Assessment: written, oral and practical on
prepare for production process
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Day 1
Interactive lecture (4 hours)
Pharmaceutical ingredients (active ingredients;
excipients for solid dosage forms
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Day 5
Interactive lecture (3 hours)
Deriving working formula
Day 1
Lecture (2 hrs.)
Weighing and measuring pharmaceutical ingredients
Day 4
Skills lab (8 hrs.)
• Preparing tinctures and syrups
Day 5
Skills lab (8 hrs.)
• Preparing elixirs and linctuses
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Day 6
Skills lab (4 hrs.)
• Independent practice on weighing and measuring
Day 1
Skills lab (8 hrs.)
Paints, gargles and mouth washes
Day 2
Skills lab (8 hrs.)
• Preparing douches, enemas and liniments
Day 3
Review Compounding of solution dosage forms (8hr)
Independent practice on compounding solution
Day 4
Interactive Lecture (4 hrs.)
Preparing pharmaceutical suspensions
Exam/ assessment(4hrs)
preparing solutions
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Learning Module: Compounding of Pharmaceuticals I | ORHB
Day1
Skills lab (4 hrs.)
Preparing castor oil emulsion, mineral oil emulsion
Day 4
Skills lab (4 hrs.)
Preparing zinc oxide paste