Reference and Formula in Pharmaceutical

Session 6: Reference and Formula in Pharmaceutical

production

Total Session Time: 120 minutes + 4 hours of Practical

Prerequisites

Learning Tasks

By the end of this session students are expected to be able to:

Resources Needed:

SESSION OVERVIEW

Activity/

Step Time Content

Method

1 05 Minutes Presentation Introduction, Learning Tasks

10 Minutes Presentation Definition of Drug Monographs

2

Buzzing

25 Minutes Presentation Types of References Used in Pharmaceutical

3 Production

Demonstration

20 Minutes Presentation Identification of Formula for Pharmaceutical

4

Demonstration Preparations

40 Minutes Reduce or Enlarge Official Formula to Obtain

Presentation

5 Required Formula for Compounding

Group Discussion

6 05Minutes Presentation Key Points

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7 05 Minutes Presentation Evaluation

8 10 Minutes Presentation Take home assignment

SESSION CONTENTS

STEP1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning tasks and clarify

ASK students if they have any questions before continuing

STEP 2: Definition of Drug monographs (10 minutes)

Activity: Buzzing (5 minutes)

ASK students to pair up and buzz on the following question for 2 minutes

ALLOW few pairs to respond and let other pairs to add on points not mentioned

WRITE their response on the flip chart/board

CLARIFY and SUMMARIZE by using the content below

kind and amount of ingredients and may contain the conditions and imitations for which it may be

offered, directions for use, warnings, and other information contained in its label

drugs

STEP 3: Types of References Used in Pharmaceutical Production (25 minutes)

o Book of standards of purity and strength for medical substances, products, dressings, etc.

together with „official‟ assays and tests.

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o Provides a source of standards for some extemporaneous preparations not included in the BP

and is now incorporated into the Pharmaceutical Codex.

o The PC is an encyclopedia of drug information and includes entries on diseases and

conditions, aspects of pharmaceutics, surgical dressings and veterinary information as well as

the formulae for medicines

o Prepared under the auspices of the council of Europe and was created to permit free

circulation of drugs within the European community.

o Publication of the World Health Organization (WHO) providing recommended standards for

international use.

o The official standard reference of the United States of America (USA). There is a companion

volume of dispensing information (USPDI).

o Prepared under the auspices of the council of Europe and was created to permit free

circulation of drugs within the European community.

o Publication of the World Health Organization (WHO) providing recommended standards for

international use.

o The official standard reference of the United States of America (USA). There is a companion

volume of dispensing information (USPDI).

o An authoritative reference book on drugs and medicines in current use throughout the world.

Martindale provides detailed information on nomenclature, physical and pharmaceutical

properties, adverse effects, actions and uses, etc.

o A reference manual for practitioners and students of pharmacy and the allied professions.

Information such as „The preparation and supply of medicines‟, „methods of sterilization,‟

„nomenclature of organic compounds‟, desirable body weights and calculation of body surface

areas which are useful data relevant to pharmacy.

o Provides general guidance for prescribers together with the special requirements of particular

groups of patient, e.g. the very young, the elderly, pregnant women and patient with renal or

hepatic failure.

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o Contains notes on drugs and preparations classified under the diseases and conditions to be

treated.

o Information on indications, contraindications, cautions, side effects and doses are given for

each drug listed.

o A formulary for commonly used „official‟ extemporaneous preparations and information on

drug interactions, cautionary and advisory labels, etc. for the pharmacists are included.

STEP 4: Identification of Formula for Pharmaceutical Preparation (20 minutes)

formula from the reference book

o Find the name of the pharmaceutical preparation to be compounded through table of

contents of the reference book and go to formulation, e.g. solution.

o The formulation in the content indicates the page where the respective formula is

indicated.

o Find the name of the pharmaceutical preparation to be compounded through the index of

the reference book

o The index indicates the number of page where the respective formula is indicated

Below are official formulas obtained from the reference book (TPH) under the indicated table

of content of the book.

Emulsifying ointment …………………………………….. 91.0g

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Activity: Demonstration (10 minutes)

DIVIDE students in small manageable groups.

PREPARE formula from a reference book for demonstration

POSITION students so that everyone can see and hear

REVIEW steps of that skill with students using a reference book

REFER students to the Tanzania Pharmaceutical Handbook (TPH)

DEMONSTRATE the procedure of identifying a formula from a reference book

ALLOW one student from each group to do a return demonstration and let others comment

on it

CLARIFY and SUMMARIZE the procedures to identify a Formula for Pharmaceutical

Preparation

INFORM the students that “every student will practice in the laboratory under supervision

until is competent”

STEP 5: Reduction and Enlarging of Official Formula to Obtain Amount of Each

Ingredient Required for Compounding (40 minutes)

medicines (Prescribed/ordered) deviate from the official formula in a reference book.

o Obtaining the amount of each ingredient required for compounding, the figures of the official

formula are multiplied by a factor which is determined by the following proportion:-

Total amount required x

i.e.

Total amount of official formula

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Thus the factor is determined by the ratio:

Total amount required .

Total amount of official formula

Summary on obtaining the amount for each ingredient in the required amount (x):

To Determine Amount of Each Ingredient Required for Compounding

Activity: Small Group Discussion ( 20 minutes)

DIVIDE students in small manageable groups

ASK students to discuss in groups on the following questions

PCx?

REFER Students to Tanzania Pharmaceutical Handbook (2011): Chapter 2,

Formulary and list of alternatives for Pharmaceutical ingredients including water, for

reference

ALLOW students to discuss for 20 minutes

ALLOW each groups to present for 5 minutes

CLARIFY and SUMMARIZE by using the contents below

o Salicylic acid, finely sifted…. ……………………………………… 2.0g

o Wool alcohols………………….. …………………………………. 98.0g

Thus:

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Official amount

100gm

Then, amount of each ingredient can be obtained as summarized in table below,

Formula Official amount Factor Required amount

o Wool alcohols ………………………….. ……………………………49.0g

o Starch, finely sifted ……………………..…………………………… 25.0g

Official amount

100gm

Then, amount of each ingredient can be obtained as summarized in table below,

Formula Official amount Factor Required amount

Zinc oxide, finely sifted 25gm 5.0 gm

White soft paraffin 50gm 10.0gm

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o Zinc oxide, finely sifted……………….. 5.0 gm

o Starch, finely sifted …………………… 5.0gm

o White soft paraffin ……………..……… 10.0 gm

STEP 6: Key Points (5 minutes)

an aspect of a subject, often by a single author, and usually on a scholarly subject.

in one volume (book) or a definite number of volumes. Thus it differs from a serial publication

such as a magazine, journal, or newspaper.

STEP 7: Evaluation (5 minutes)

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STEP 9: Take Home Assignment (10 minutes)

Activity: Take home Assignment (10 minutes)

DIVIDE students in groups or individual.

ASK the students to work on the following assignment

2 of the worksheet 6.1.

ALLOCATE time for students to do the assignment and submit

REFER students to worksheet 6.1: Take Home Assignment

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References

Pharmaceutical Society of Great Britain., & . Department of Pharmaceutical Sciences. (1994). The

Pharmaceutical Codex, Principles and Practice of Pharmaceutics (W. Lund Ed. 12th ed.).

London,: Pharmaceutical .

Senya, S. S., Mwasha, C. Y. S., Muyinga, A. M., Amiri, R. I., & Mauga, E. A. S. K. (2011). Tanzania

Pharmaceutical Handbook (2nd ed.). Dar es salaam.

United States Pharmacopeial Convention. Committee of Revision. (2013). The United States

pharmacopeia (pp. v.). Rockville, Md.: United States Pharmacopeial Convention, Inc.

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Worksheet 6.1: Take Home Assignment

Take home Assignment

Practice Calculations of amounts required for compounding from the official formula in the

following exercise

Questions / Instructions

ointment PCx

Hydrous wool fat …………………………………………… 50g

Yellow soft paraffin …………………………………………. 50g

2. From the following formula, calculate the quantities required to make 5g of Paraffin ointment

PCx

Cetostearyl alcohol ……………………………………………. 5.0g

White soft paraffin …………………………………………… 90.0

3. From the following formula, calculate the quantities required to make 50g of Salicylic acid and

sulphur ointment PCx

Compound benzoic acid ointment PCx

Benzoic acid, in fine powder ………………………………………… 6.0g

Salicylic acid, in fine powder ………………………………………….3.0g

Emulsifying ointment ………………………………………………… 91.0g

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Calamine ointment PCx

Calamine, finely sifted ………………………………………. 15.0g

White soft paraffin …………………………………………… 85.0g

Zinc and salicylic acid ointment PCx

Salicylic acid, finely sifted ………………………………………………….. 2.0g

Starch, finely sifted ……………………………………………….. ………… 24.0g

Zinc oxide, finely sifted ……………………………………………………… 24.0g

White soft paraffin…………………………………………………………… 50.0g

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ANSWERS

1. Hydrous wool fat ……………………………………………… 75.0g

Yellow soft paraffin ……………………………………………75.0g

White beeswax …………………………………………….. 0.1g

Cetostearyl alcohol ……………………………………………. 0.25g

White soft paraffin …………………………………………… 4.5g

3. Salicylic acid, finely sifted………………………………………1.5g

4. Benzoic acid, in fine powder ……………………………………90.0g

Salicylic acid, in fine powder ……………………………………45.0g

Emulsifying ointment ……………………………………………1365.0g

5. Calamine, finely sifted ………………………………………. 37.5g

White soft paraffin …………………………………………… 212.5g

6. Salicylic acid, finely sifted ………………………………………2.0g

Starch, finely sifted …………………………………………… 24.0g

Zinc oxide, finely sifted …………………………………………24.0g

White soft paraffin………………………………………………50.0g

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