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A Text Book of Pharmaceutics for I Year

Diploma in Pharmacy

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 A Text Book of
Pharmaceutics for
I Year Diploma in
Pharmacy
Dr. Sowjanya Gurugubelli Mrs. Jhansipriya Marabathuni V

Mr. Prakash Nathaniel Kumar Sarella Mrs. Vinny Therissa Mangam

Mr. Shaikh Samir Karim Karim Mrs. Chollangi Bharghavi

Mrs. Prathyusha Vuddanda Dr. Bala Venkata Sivaram Nallamolu

Mrs. Vijayalakshmi M K Mr. Anilkumar Vadaga

Copyright © 2024 ThinkPlus Pharma Publications

All rights reserved.

ISBN: 9788197973178
 A Text Book of Pharmaceutics for I Year Diploma in Pharmacy

Editors

Dr. Sowjanya Gurugubelli

Mrs. Jhansipriya Marabathuni V
Mr. Prakash Nathaniel Kumar Sarella
Mrs. Vinny Therissa Mangam
Mr. Shaikh Samir Karim Karim

Mrs. Chollangi Bharghavi

Mrs. Prathyusha Vuddanda
Dr. Bala Venkata Sivaram Nallamolu
Mrs. Vijayalakshmi M K
Mr. Anilkumar Vadaga

First Edition: 2024

ISBN: 9788197973178

Maximum Retail Price: Rs. 500/- (Inclusive of all taxes)

Published by ThinkPlus Pharma Publications,

9-15/1, Indrapalem, Kakinada, AP-533006, India.
Website: www.books.jopir.in
Printed at Tarangini Printing Works, Subhadra Arcade,
Bhanugudi, Kakinada, AP-533003, India.

Copyright © 2024 ThinkPlus Pharma Publications

All rights reserved. No part of this publication may be
reproduced or distributed in any form or by any means, or
stored in a database or retrieval system, without the prior
written permission of the publisher

ii
 DEDICATION

We dedicate this textbook to the future generations of

pharmacists who are taking their first steps into the
fascinating world of pharmaceutics. May this work
inspire and guide you through your educational
journey and beyond. We also dedicate this book to our
students, past and present, whose curiosity and
enthusiasm have continually motivated us to strive for
excellence in pharmacy education. Finally, we extend
this dedication to all healthcare professionals who
tirelessly work to improve patient care and advance
the field of pharmacy.
 CONTENTS

Acknowledgments i
1 Historical Background and Development 001
of Profession of Pharmacy
2 Pharmacopoeias 051
3 Packaging materials 070
4 Pharmaceutical Aids 116
5 Size Reduction 144
6 Size Separation 165
7 Mixing 184
8 Filtration 213
9 Drying 245
10 Extraction 271
11 Tablets 306
12 Capsules 368
13 Liquid Oral Preparations 395
14 Topical Preparations 489
15 Nasal and Ear Preparations 555
16 Powders and Granules 570
17 Sterile formulations 598
18 Immunological products 644
19 Pharmaceutical Manufacturing Plant 659
20 Quality Control and Quality Assurance 684
21 Novel Drug Delivery Systems 713
 ACKNOWLEDGMENTS

We, the authors, express our sincere gratitude to the

numerous individuals and institutions that have
supported us throughout the creation of this textbook.
Our deepest thanks go to our colleagues and mentors
in the pharmaceutical sciences, whose expertise and
guidance have been instrumental in shaping this
comprehensive work. We are profoundly grateful to
the faculty and staff of various Diploma in Pharmacy
programs, whose valuable feedback and suggestions
have significantly enhanced the content and structure
of this book. We extend our appreciation to the
pharmaceutical industry professionals and
researchers whose groundbreaking work has
informed and enriched our content. Our heartfelt
thanks go to our families for their unwavering support
and understanding during the writing process. Lastly,
we acknowledge the diligent efforts of our publishing
team, whose expertise has been crucial in bringing this
collaborative project to fruition.

i
CHAPTER 1

HISTORICAL BACKGROUND AND

DEVELOPMENT OF PROFESSION
OF PHARMACY
Author
Dr. Chennupati V Suresh
Professor, Nalanda College of Pharmacy, Nalgonda,
Telangana State, India

Abstract
The profession of pharmacy has evolved significantly from its ancient
roots to its current status as an integral part of modern healthcare. Early
civilizations recognized the medicinal properties of plants, leading to
the development of traditional healing practices. The emergence of
apothecaries in medieval Europe marked a crucial step towards the
formalization of pharmacy as a distinct profession. The Renaissance
period saw advancements in chemical and botanical knowledge,
contributing to the expansion of the pharmacist's role. The 18th and 19th
centuries witnessed the isolation of active compounds from plants and
the birth of synthetic drug manufacturing, revolutionizing
pharmaceutical practice. The 20th century brought about significant
changes, including the industrialization of drug production, the
development of new dosage forms, and the expansion of clinical
pharmacy services. Today, pharmacists play diverse roles in healthcare,
from medication management to patient counseling and public health
initiatives. The profession continues to adapt to technological
advancements, evolving healthcare needs, and the increasing
complexity of drug therapies, emphasizing the importance of lifelong
learning and interprofessional collaboration in modern pharmacy
practice.

Keywords: Apothecary, Drug discovery, Professional evolution, Healthcare,

Pharmaceutical science, Clinical pharmacy
 A Text Book of Pharmaceutics for I Year Diploma in Pharmacy

Learning Objectives
After completion of the chapter, the student should be
able to:
• Understand the evolution of pharmacy as a
profession from ancient times to the present day.
• Identify key milestones and influential figures in the
history of pharmacy.
• Explain the transition from traditional apothecaries
to modern pharmaceutical practices.
• Describe the development of pharmacology and its
impact on the pharmacy profession.
• Discuss the role of pharmacy in healthcare systems
throughout history.
• Analyze the changing responsibilities and scope of
practice for pharmacists over time.
• Evaluate the impact of technological advancements
on the pharmacy profession.

INTRODUCTION TO PHARMACEUTICS

P
harmaceutics: Pharmaceutics is a fundamental
discipline within pharmacy that focuses on the
transformation of new chemical entities (NCEs)
or existing drugs into safe and effective medications for
patient use. This field encompasses the science of dosage
form design, which is crucial for optimizing drug delivery
and therapeutic outcomes.
Drug
The term "drug" originates from the French word
'drogue', meaning herb, reflecting the historical roots of
pharmacy in natural remedies. In modern pharmacology, a
drug is defined as any agent used in the treatment,
prevention, mitigation, cure, or diagnosis of diseases or
1
 A Text Book of Pharmaceutics for I Year Diploma in Pharmacy

disorders in humans or animals. Drugs utilized in

contemporary medical practice are either synthetic or
derived from natural sources, including vegetable, animal,
or mineral origins.
Drug sources have diversified significantly over time.
While many pharmaceuticals still originate from natural
sources, such as plants (e.g., morphine from Papaver
somniferum), animals (e.g., heparin from porcine intestinal
mucosa), or minerals (e.g., calcium carbonate), an increasing
number are synthetic or semi-synthetic. Advances in
medicinal chemistry and biotechnology have led to the
development of novel drug entities and biologics,
expanding the therapeutic arsenal available to healthcare
professionals.
Dosage form
A dosage form is the final, administrable presentation of
a drug, created by combining the active pharmaceutical
ingredient (API) with non-drug components known as
excipients or additives. Excipients encompass a wide range
of substances, including binders, disintegrants, lubricants,
preservatives, flavoring agents, and coloring agents. The
selection and proportion of these ingredients are critical in
determining the physicochemical properties, stability, and
therapeutic efficacy of the final dosage form

The desirable properties of dosage forms are:

1. It should be convenient to handle, use and store. For
better compliance it should not disturb his routine lifestyle
as far as possible and should be acceptable aesthetically,
organoleptically, therapeutically and from economic
standpoint.
2. It should be stable during storage and use. During
storage the physical, chemical and therapeutic integrity of
the dosage form should be maintained by assuring freedom

2
 A Text Book of Pharmaceutics for I Year Diploma in Pharmacy

from interaction between components, with packaging

materials and environmental factors (heat, humidity,
oxygen, light). It should also withstand mechanical shock
during transportation. The dosage form should retain its
shape, size, appearance, taste, flavor and therapeutic effect
during the stipulated half life.
3. The dosage form should be represented in different
dosage form strengths providing flexibility of dose to suit
different age groups (50, 100,200mg etc)
4. It should provide anticipated therapeutic effect. The
extent and pattern of drug release from the dosage form
should be predictable.
5. It should protect the drug substance and conceal the
disagreeable taste or odour.
6. It should be economical and presentation should be
elegant.
7. Finally it should permit easy identification through
distinct colour, shape or identification marking.

Classification of Dosage forms:

According to physical state: Solid, semi solid, liquid,
gaseous.
Route of administration: Oral. Parenteral, rectal, nasal
Site of application: Skin, eye, tooth, hand, foot, hair,
nose etc
Use: External, Internal

3
 A Text Book of Pharmaceutics for I Year Diploma in Pharmacy

Figure: Classification of dosage forms according to

physical state
Definitions
Tablets: Tablets are solid unit dosage forms containing
one or more medicaments, with or without appropriate
excipients. They are primarily manufactured through
compression, although molding techniques may also be
employed in some cases. While tablets are predominantly
designed for oral administration, they can be formulated for
other routes as well. The compression process involves the
application of high pressure to a powder mixture, resulting
in a coherent, uniform, and stable product. Tablets offer
several advantages, including precise dosing, ease of
administration, and improved stability compared to liquid
formulations. They can be formulated to provide immediate
release, modified release, or targeted delivery of the active
ingredient(s). Common examples include Aminophylline
tablets for bronchodilation, Chloroquine sulphate tablets for
malaria treatment, and Paracetamol tablets for pain relief
and fever reduction. The formulation of tablets typically
includes the active pharmaceutical ingredient(s) (APIs),
diluents (e.g., lactose, microcrystalline cellulose), binders
(e.g., povidone, hydroxypropyl methylcellulose),
disintegrants (e.g., croscarmellose sodium, sodium starch
4
 A Text Book of Pharmaceutics for I Year Diploma in Pharmacy

glycolate), lubricants (e.g., magnesium stearate), and

sometimes other functional excipients such as glidants or
colorants
Capsules: Capsules are solid dosage forms in which the
medicament is enclosed within a soluble container or shell,
typically made of gelatin. This shell serves to mask the taste
of the drug and facilitate swallowing. Capsules are
classified into two main types: hard gelatin capsules and
soft gelatin capsules.
Hard gelatin capsules consist of two parts - a body and
a cap - and are primarily used for encapsulating solid or
semi-solid formulations. They are filled with powders,
granules, or pellets containing the active ingredient(s) and
necessary excipients. Examples include Amoxicillin
capsules for bacterial infections and Ampicillin capsules for
various infectious diseases. Soft gelatin capsules, also
known as softgels, are one-piece capsules that can
encapsulate liquids, semi-solids, or solids. They are
particularly useful for poorly water-soluble drugs or those
that require protection from oxidation. Soft gelatin capsules
are often used for vitamins, minerals, and some antibiotics.
Powders: Powders represent a versatile solid dosage
form that can be used for both internal (oral) and external
applications. Oral powders are designed for internal use
and may be administered directly or reconstituted with
water before ingestion. These can be simple (containing a
single active ingredient) or compound (containing multiple
active ingredients). Examples include Compound rhubarb
powder, used as a laxative, and Compound sodium
chloride and dextrose oral powder, used for oral
rehydration therapy. Dusting powders, on the other hand,
are intended for external use and are applied topically to the
skin. They often contain ingredients like talc, zinc oxide, or
starch and may be medicated or non-medicated. Talc

5
 A Text Book of Pharmaceutics for I Year Diploma in Pharmacy

dusting powder is a common example, used to absorb

moisture and reduce friction on the skin.
Pills: Pills are an antiquated solid dosage form that
predates tablets in the evolution of unit dosage forms. They
were developed to address the inconvenience associated
with administering loose powders. Pills are spherical in
shape, which was thought to facilitate swallowing. The
manufacturing process typically involved mixing the
medicinal powder with a suitable excipient to form a plastic
mass, which was then rolled into a cylinder and divided
into sections of equal weight. These sections were then
rolled between the fingers to produce spherical pills.
While pills were once a popular dosage form, they have
largely been supplanted by tablets and capsules in modern
pharmaceutical practice. This is due to several factors,
including:
• Difficulty in achieving content uniformity
• Lack of precision in dosing
• Challenges in large-scale manufacturing
• Potential for variability in disintegration and
dissolution.
Granules: Granules are a solid dosage form of
medicaments that serve as an intermediate product in tablet
manufacturing or as a final dosage form for direct
administration. The process of granulation involves mixing
powdered drug(s) with excipients, including sweetening,
flavoring, and coloring agents, to improve taste and
appearance. A granulating agent, typically a liquid binder,
is added to moisten the powder mixture and facilitate
particle agglomeration.
The wet mass is then passed through a sieve to create
uniformly sized granules, which are subsequently dried at
a controlled temperature, often around 60°C. This drying
process is crucial to remove excess moisture and ensure
stability. Granules are commonly supplied in glass
6
 A Text Book of Pharmaceutics for I Year Diploma in Pharmacy

containers with instructions for the patient to reconstitute

them with freshly boiled and cooled water, creating a liquid
preparation at the time of use.
Granules offer several advantages:
• Improved flow properties compared to powders
• Enhanced content uniformity
• Reduced dust formation during handling
• Increased stability and shelf life
• Potential for controlled release formulations.
Effervescent Granules: Effervescent Granules are a
specialized solid dosage form designed for internal use.
They typically contain a combination of acids (such as citric
acid and tartaric acid) and a carbonate or bicarbonate salt
(usually sodium bicarbonate), along with the active
medicament. A sweetening agent like saccharin or sucrose
may be added to improve palatability

The effervescent reaction occurs when these granules are

added to water. This reaction produces carbon dioxide gas,
creating a pleasant, fizzy sensation and often enhancing the
dissolution of the active ingredient. Effervescent granules
are commonly used for:
• Antacid preparations
• Analgesics and antipyretics
• Vitamin and mineral supplements
• Oral rehydration therapies
The effervescence can mask unpleasant tastes, improve
dissolution rates, and potentially enhance absorption of
certain drugs. Patients are typically instructed to consume
the preparation while effervescing or immediately
afterward for optimal effect
Dusting powders: Dusting Powders are topical
formulations intended for external application to the skin.
7
 ENDOFPREVI
EW

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