Pharmaceutics: A Practical Manual for PHARM & PHARM D Courses

Pharmaceutics

A Practical Manual

Third Edition

(Exclusively for I - B.Pharm and I - Pharm.D course, according to

the syllabus prescribed by the Pharmacy Council of India).

Pharmaceutics

A Practical Manual

Third Edition

(Exclusively for I - B.Pharm and I - Pharm.D course,

according to the syllabus prescribed by the Pharmacy

Council of India).

Sindhu Abraham

Assistant Professor,

Department of Pharmaceutics,

M.S Ramaiah College of Pharmacy,

Bangalore.

Pharmaceutics: A Practical Manual, Third Edition by Sindhu Abraham

© 2019, by Publisher, All rights reserved.

No part of this book or parts thereof may be reproduced, stored in a retrieval system or transmitted in any language or by any means, electronic, mechanical, photocopying, recording or otherwise without the prior written permission of the publishers.

Printed at

Aditya Offset Process (I) Pvt. Ltd.

Hyderabad.

Price: Rs. 295.00

ISBN: 978-93-87593-77-0 (Paperback)

Preface to Third Edition

Pharmaceutics is a branch of pharmacy concerned with the art and science of dosage form design. The word Pharmaceutics comprises varied subject areas that are associated with the steps involved in formulation development.

There are a number of practical manuals in Pharmaceutics which caters to the needs of B.Pharm and D.Pharm students. This comprehensive manual is a sincere effort to provide practical knowledge in Pharmaceutics for Pharm.D, B.Pharm and D. Pharm students and has been prepared in accordance with the syllabus prescribed by the PCI.

The manual encompasses chapters covering all conventional dosage forms such as symps, elixirs, solutions, liniments, suspensions, emulsions, powders, suppositories etc. Experiments on incompatibilities have also been included.

Special emphasis has been laid on:

(a)   Concepts and principles of each experiment.

(b)   Synonym / Latin terms for selected preparations.

(c)   Marketed formulations available for certain preparations

(d)   Appendices as ready reckoner.

(e)   Question bank containing frequently asked questions.

Further suggestions and criticism from teachers and students will be highly appreciated.

- Author

Acknowledgements

I express my deep sense of gratitude to Dr. V. Madhavan. Principal, M. S Ramaiah College of Pharmacy, Bangalore for his constant support and encouragement.

My sincere thanks to Dr. S. Bharath, Professor and HOD, Dr. B. V Basavaraj, Associate Professor, Dr. R. Deveswaran, Associate Professor, Mrs. Sharon Furtado, Assistant Professor and Mrs. Shwetha, Assistant Professor, Department of Pharmaceutics, M. S Ramaiah College of Pharmacy, for their unceasing support, assistance and encouragement in bringing out the revised edition of this book. It is their inspiration that has helped me go ahead with the preparation of this work.

I also thank M/s Pharma Book Syndicate for publishing this book and in particular Mr. Anil Shah and Mr. Naresh Davergave for their enthusiasm and support in printing this book.

- Author

Contents

Preface to Third Edition

Acknowledgements

Format for Record Writing

Syrups

Experiment 1

     Simple Syrup IP

Experiment 2

     Orange Syrup BPC

Experiment 3

     Orange Syrup NF

Experiment 4

     Ephedrine Hydrochloride Syrup NF

Experiment 5

     Vasaka Syrup IP

Experiment 6

     Ferrous Phosphate Syrup IP

Elixirs

Experiment 7

     Piperazine Citrate Elixir BPC

Experiment 8

     Paediatric Paracetamol Elixir BPC

Experiment 9

     Cascara Elixir BP

Linctuses

Experiment 10

     Simple Linctus BPC

Experiment 11

     Paediatric Simple Linctus BPC

Experiment 12

     Codeine Linctus BPC

Experiment 13

     Paediatric Codeine Linctus BPC

Experiment 14

     Diabetic Codeine Linctus BPC

Solutions

Experiment 15

     Cresol with Soap Solution IP

Experiment 16

     Aqueous Iodine Solution IP

Experiment 17

     Strong Iodine Solution IP

Experiment 18

     Weak Iodine Solution BP

Experiment 19

     Weak Iodine Solution IP

Experiment 20

     Strong Ammonium Acetate Solution IP

Experiment 21

     Strong Solution of Ferric Chloride BPC

Experiment 22

     Surgical Chlorinated Soda Solution BPC

Experiment 23

     Chloroxylenol Solution BPC

Experiment 24

     Sodium Chloride Solution IP

Liniments

Experiment 25

     Turpentine Liniment IP

Experiment 26

     Camphor Liniment

Experiment 27

     Soap Liniment BP

Suspensions

Experiment 28

     Calamine Lotion IP

Experiment 29

     Magnesium Hydroxide Mixture BP

Experiment 30

     Aluminium Hydroxide Gel

Experiment 31

     Magnesium Trisilicate Mixture BPC

Experiment 32

     Paediatric Chalk Mixture BPC

Experiment 33

     Zinc Sulphide Lotion BPC

Emulsions

Experiment 34

     Liquid Paraffin Emulsion BP

Experiment 35

     Cod Liver Oil Emulsion BP

Experiment 36

     Castor Oil Emulsion

Experiment 37

     Liquid Paraffin and Magnesium Hydroxide Emulsion BPC

Experiment 38

     Oily Calamine Lotion BPC

Experiment 39

     Calciferol Emulsion

Powders

Experiment 40

     Eutectic Powder

Experiment 41

     Explosive Powder

Experiment 42

     Dusting Powder

Experiment 43

     Insufflation

Experiment 44

     Tooth Powder

Experiment 45

     Face Powder

Experiment 46

     Oral Rehydration Salts (ORS) IP

Experiment 47

     Compound Effervescent Powder BPC

Experiment 48

     Effervescent Granules

Suppositories

Experiment 49

     Boric Acid Suppositories

Experiment 50

     Chloral Hydrate Suppositories

Experiment 51

     Zinc Oxide Suppositories

Experiment 52

     Glycerol Suppositories BP

Collodions

Experiment 53

     Salicylic Acid Collodion BP

Lotions

Experiment 54

     Salicylic Acid Lotion BPC

Experiment 55

     Aminobenzoic Acid Lotion BPC

Mouthwashes and Gargles

Experiment 56

     Compound Sodium Chloride Mouthwash BPC

Experiment 57

     Zinc Sulphate and Zinc Chloride Mouthwash BPC

Experiment 58

     Chlorhexidine Gluconate Mouthwash

Experiment 59

     Phenol Gargle BPC

Experiment 60

     Potassium Permanganate Gargle BPC

Experiment 61

     Povidone- Iodine Gargle

Throat Paints

Experiment 62

     Compound Iodine Paint BPC

Enemas

Experiment 63

     Glycerin Enema

Inhalations

Experiment 64

     Benzoin Inhalation BPC

Experiment 65

     Menthol Inhalation BPC

Experiment 66

     Menthol and Eucalyptus Inhalation BPC

Semisolid Dosage Forms

Experiment 67

     Kaolin Poultice BPC

Experiment 68

     Zinc Gelatin Jelly BPC

Experiment 69

     Sodium Alginate Jelly

Experiment 70

     Lubricating Jelly

Experiment 71

     Simple Ointment BP

Experiment 72

     Sulphur Ointment BP

Experiment 73

     Non Staining Iodine Ointment with Methyl Salicylate BPC

Experiment 74

     Methyl Salicylate Ointment BPC

Experiment 75

     Bentonite Gel

Experiment 76

     Cold Cream

Experiment 77

     Vanishing Cream

Experiment 78

     Compound Zinc Paste BP

Experiment 79

     Diclofenac Gel

Ear Drops

Experiment 80

     Chloramphenicol Ear Drops BPC

Nasal Drops

Experiment 81

     Ephedrine Hydrochloride Nasal Drops BPC

Incompatibilities

Experiment 82

     Mixtures with Physical Incompatibilities

Experiment 83

     Mixtures with Chemical Incompatibilities

Experiment 84

     Therapeutic Incompatibilities

Appendices

Appendix 1

     Definitions of Selected Drug Categories

Appendix 2

     Preparation of Pharmaceutical Ingredients

Appendix 3

     Synonyms of Formulations

Appendix 4

     Categories (uses) of Formulations

Appendix 5

     Examples of Pharmaceutical Ingredients

Appendix 6

     Glossary of Important Pharmaceutical Terms

Appendix 7

     Some Important Latin Terms and Abbreviations

Appendix 8

     Important Conversions

Appendix 9

     Frequently Asked Questions

References

Format for Record Writing

The details to be written in the left hand side of the record include:

1.   Calculations

2.   Label

The details to be written in the right hand side of the record include:

1.   Name of the Preparation

2.   Aim

3.   Synonym (if any)

4.   Formula

5.   Principle

6.   Procedure

7.   Category

8.   Dose

9.   Directions

10.   Auxiliary label

11.   Storage

The format for the label will be as follows

Quantity of the Preparation : in ml /g/ numbers

NAME OF THE PREPARATION ( IP/BP/BPC/NF)

SYNONYM: Another name for the preparation

DRUG Content: Name and quantity of the active ingredient(s)

CATEGORY: Use of the preparation

DOSAGE: ( If any or write As directed by the Physician)

DIRECTIONS: On how to use the preparation

AUXILIARY LABEL: Includes precautions to be taken while administering the preparation.

To be written in red, bold letters

Storage: Condition at which the preparation should be stored

Syrups

Syrups are sweet, viscous, concentrated solutions of sucrose or other sugars in water or any other suitable aqueous vehicle. The pharmacopoeial syrups have a high concentration of sucrose (66.7%w/w according to IP and 85%w/v according to USP) which is necessary for stability. Stronger solutions tend to crystallize and more dilute solutions support microbial growth.

The aqueous sugar medium of dilute sucrose solutions is an efficient nutrient medium for the growth of microorganisms, particularly yeasts and moulds whereas, concentrated sugar solutions are quite resistant to microbial growth because of their high osmotic pressure.

Simple syrup requires no additional preservative if it is to be used soon. Preservatives are added if the syrup is to be stored. When properly prepared and maintained, the syrup is inherently stable and resistant to the growth of microorganisms. As formulated, the official syrup is both stable and resistant to microbial growth & crystallization. However commercial syrups must employ preservatives to prevent microbial growth and to ensure their stability during their period of use and storage.

Syrups should be stored at constant temperature, since fluctuations encourage crystallization and in well closed containers to prevent entry of moisture. Moisture can dilute the surface layer, allow' microorganisms to multiply and fermentation occurs.

There are two types of syrups:

1.   Non medicated or Flavoured syrups: These symps contain flavouring agents but not medicinal substances. They are intended to serve as pleasant tasting vehicles for medicated symps.

E.g. Orange symp. Lemon symp, Cocoa symp. Raspberry symp, Cherry symp.

2.   Medicated syrups: These preparations contain medicinal substance/s along with the other additives.

E.g. Ephedrine hydrochloride syrup. Paracetamol syrup.

Syrups provide a pleasant means of administering a liquid preparation containing a disagreeable tasting drug. They are particularly effective in the administration of drugs to children.

Syrups may contain a small concentration of alcohol as a preservative or as a solvent to incorporate flavouring agents.

Preparation of Syrups

Syrups may be prepared by one of the following methods, depending on the physical and chemical character of the ingredients:

1.   Solution with the aid of heat: This method is used when the ingredients of the syrup are not volatile in nature and are heat stable. The sugar is added to the purified water and heated until is completely dissolved. Other heat stable ingredients are then mixed with the hot syrup and made upto volume. The use of heat facilitates faster solution of sugar and other ingredients.

The disadvantage of this method is that heating may lead to the inversion of sucrose. The sweetness of the syrup will be altered, because invert sugar is sweeter than sucrose. The decomposed syrup attains a dark coloration due to caramellization and is more susceptible to fermentation and microbial growth.

2.   Solution by agitation without the aid of heat: this method is used when the ingredients are heat sensitive and to prevent heat induced inversion of sucrose.

All the ingredients are dissolved in purified water by continuous agitation.

3.   Addition of sucrose to a medicated or flavoured liquid: In this method, sucrose is added to the medicated liquid, which may be a tincture or an extract.

4.   Percolation: In the percolation method, the medicinal agent may be percolated to form an extract, to which sucrose or syrup is added.

E.g. Ipecac syrup is prepared by adding glycerin and syrup to an extractive of powdered ipecac obtained by percolation.

EXPERIMENT 1

Simple Syrup IP

Aim

To prepare and submit 20 g of Simple syrup.

Formula

Principle

Syrups are sweet, viscous, concentrated solutions of sucrose or other sugars in water or any other suitable aqueous vehicle. The pharmacopoeial syrups have a high concentration of sucrose (66.7 % WAV according to IP or approx 85%W/V according to U.S.P), which is necessary for stability.

Stronger solutions tend to crystallize and dilute solutions can support microbial growth. Therefore at 66.7%WAV, simple syrup acts as a selfpreservative. The self-preservative activity of syrup is attributed to the high osmotic pressure.

Syrups should be stored at a constant temperature to prevent crystallization and in well-closed containers to prevent entry of moisture.

Moisture can dilute the surface layer and may allow microorganisms to multiply and fermentation may occur.

Procedure

1.   A 100ml empty beaker was weighed and the weight was noted.

2.   Half the quantity of purified water was placed in to