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Pharmaceutical Dosage Forms
and Drug Delivery
Completely revised and updated, this fourth edition elucidates the principles of pharmaceutics,
biopharmaceutics, dosage form design, and drug delivery— including emerging new biotechnologybased treatment modalities. The authors integrate aspects of physical pharmacy, chemistry, biology, and
biopharmaceutics into drug delivery.
With the expiration of older patents and generic competition, the biopharmaceutical industry is
evolving faster than ever. Consequently, this edition of the book emphasizes the heightened focus that
the recent remarkable progress in gene editing, immunotherapy, and nanotechnology has brought to the
design of new drugs, diagnostic approaches, and novel dosage forms.
ligence (AI) in drug discovery, messenger ribose nucleic acid (mRNA) and antibody- based therapies,
genome editing, immunotherapy, chemical kinetics, and the stability of drug products.
Features:
• Includes new chapters on antibody therapeutics, gene editing, and immunotherapy.
•
• Updated sections on pharmacy mathematics, chemical kinetics, and the stability of medicinal
products.
• Important updates on parenteral drug products, protein and peptide treatments, and biotechnologybased pharmaceuticals to provide a contemporary perspective on drug development, delivery, and
pharmaceutical sciences.
• Expansion of review questions and answers to clarify concepts for students and add to their grasp
of key concepts covered in this book.
Although there are numerous books on pharmaceutics and dosage forms, most cover different areas
of the discipline and do not provide an integrated approach. The integrated approach of this book not
students, instructors, and professionals, saving their time and money.
Pharmaceutical Dosage
Forms and Drug Delivery
Revised and Expanded
Fourth Edition
Ram I. Mahato, Ajit S. Narang, and Virender Kumar
https://t.me/med1917
Fourth edition published 2025
by CRC Press
2385 NW Executive Center Drive, Suite 320, Boca Raton FL 33431
and by CRC Press
4 Park Square, Milton Park, Abingdon, Oxon, OX14 4RN
CRC Press is an imprint of Taylor & Francis Group, LLC
© 2025 Ram I. Mahato, Ajit S. Narang, and Virender Kumar
First edition published by CRC Press 2007
Third edition published by CRC Press 2022
Reasonable efforts have been made to publish reliable data and information, but the author and publisher cannot assume
responsibility for the validity of all materials or the consequences of their use. The authors and publishers have attempted
to trace the copyright holders of all material reproduced in this publication and apologize to copyright holders if permission
to publish in this form has not been obtained. If any copyright material has not been acknowledged, please write and let us
know so we may rectify it in any future reprint.
Except as permitted under U.S. Copyright Law, no part of this book may be reprinted, reproduced, transmitted, or utilized
in any form by any electronic, mechanical, or other means, now known or hereafter invented, including photocopying,
For permission to photocopy or use material electronically from this work, access www.copyri ght.com or contact the
Copyright Clearance Center, Inc. (CCC), 222 Rosewood Drive, Danvers, MA 01923, 978- 750- 8400. For works that are not
available on CCC please contact mpkbookspermissions@tandf.co.uk
Trademark notice
and explanation without intent to infringe.
Library of Congress Cataloging-in-Publication Data
Names: Mahato, Ram I., author. | Narang, Ajit S., author. | Kumar, Virender (Professor of pharmaceutics) author.
Title: Pharmaceutical dosage forms and drug delivery / Ram I. Mahato, Ajit S. Narang, Virender Kumar.
Description: Fourth edition, revised and expanded. | Boca Raton, FL : CRC Press, 2025. |
Includes bibliographical references and index.
ISBN 9781032485034 (paperback) | ISBN 9781003389378 (ebook)
Subjects: MESH: Dosage Forms | Drug Delivery Systems | Pharmacokinetics | Biopharmaceutics
LC record available at https://lccn.loc.gov/2024022100
LC ebook record available at https://lccn.loc.gov/202402210
ISBN: 9781032485034 (pbk)
ISBN: 9781003389378 (ebk)
DOI: 10.1201/ 9781003389378
Typeset in Times New Roman
by Newgen Publishing UK
https://t.me/med1917
I dedicate this book to my wife Subhashini, my children Kalika and Vivek for their love and support, my
mother Sarswati for believing in me, and my students and mentors who have always helped me in my
quest for learning and achieving higher goals.
Ram I. Mahato
I dedicate this book to the sacrices of my parents, Mr. Tirath Singh and Mrs. Gurdip Kaur, and my wife,
Swayamjot; to the love of my brother, Supreet, and sons, Manvir and Arjun; and to the encouragement
and condence bestowed on me by my teachers and mentors that have always inspired me to be and do
the very best.
Ajit S. Narang
This book is affectionally dedicated to my parents, Mr. Bahadur Singh and Mrs. Sharda Rani, who taught
me how to be a man, and my wife, Bharti Sethi; my loving brother, Jitender, and my wonderful children,
Kanishk and Gia; and to the support and condence put upon me by my teachers and mentors.
Virender Kumar
https://t.me/med1917
https://t.me/med1917
Contents
Foreword ................................................................................................................................................... ix
Preface ....................................................................................................................................................... xi
About the Authors ................................................................................................................................... xiii
Part I Introductory Chapters
1. Drug Discovery ................................................................................................................................. 3
2. Drug Development .......................................................................................................................... 23
3. Pharmaceutical Considerations .................................................................................................... 39
4. Biopharmaceutical Considerations ............................................................................................... 53
5. Pharmacy Math and Statistics ...................................................................................................... 70
Part II Physicochemical Principles
6. Complexation and Protein Binding ............................................................................................ 117
7. Chemical Kinetics and Stability .................................................................................................. 134
8. Interfacial Phenomena .................................................................................................................
9. Colloidal Dispersions .................................................................................................................... 179
10. Surfactants and Micelles .............................................................................................................. 192
11. Pharmaceutical Polymers ............................................................................................................ 207
12. Rheology ........................................................................................................................................ 223
13. Radiopharmaceuticals.................................................................................................................. 231
14. Drug Delivery Systems ................................................................................................................. 240
15. Organ-SpecicDrugDelivery ..................................................................................................... 255
Part III Dosage Forms
16. Suspensions ................................................................................................................................... 291
17. Emulsions ...................................................................................................................................... 304
18. Pharmaceutical Solutions ............................................................................................................
19. Powders and Granules ................................................................................................................. 325
20. Tablets ............................................................................................................................................353
21. Capsules ......................................................................................................................................... 373
22. Parenteral Drug Products ............................................................................................................ 389
23. Semisolid Dosage Forms .............................................................................................................. 403
24. Inserts, Implants, and Devices..................................................................................................... 414
vii
https://t.me/med1917
viii
Contents
Part IV Pharmaceutical Biotechnology
25. Protein and Peptide Drug Delivery ............................................................................................. 429
26. Antibody Therapeutics ................................................................................................................. 451
27. Biotechnology- Based Drugs .........................................................................................................
28. Genome Editing for Therapeutic Applications .......................................................................... 479
29. Immunotherapy ............................................................................................................................ 495
Answers to Review Questions ............................................................................................................. 509
Index ...................................................................................................................................................... 533
https://t.me/med1917
Foreword
technological advancements and the advent of new medicines and modalities of drug therapy. Though
much of the basic sciences and the fundamental principles of pharmaceutical sciences remain sound,
there is an increasing need to integrate the education of pharmaceutical dosage forms and drug delivery
with current research and contemporary practices in the current biopharmaceutical industry. It is here
that this book— coauthored by leading scientists from academia and industry— makes a strong impact by
presenting the basic principles in a succinct manner that affords an in- depth understanding of their relation to modern- day research and practice in the pharmaceutical sciences.
The revised and updated Fourth Edition of Pharmaceutical Dosage Forms and Drug Delivery provides
greater emphasis on the multidisciplinary nature of drug discovery and development. The Fourth Edition
drug products, protein and peptide therapeutics, and biotechnology- based drugs. These revised chapters
provide a current practice in drug development, delivery, and pharmaceutical sciences, as well as the
interdisciplinary nature of “what it takes to discover and bring a new drug modality to the market.”
Until recently, drug discovery has faced increasing challenges in identifying new drug targets and
cellular and cell surface targets. Still, recent efforts have sharpened their focus on new mechanisms of
involved in diseases and then design drugs that selectively target these proteins or pathways.
Further, AI can analyze large population data to identify trends, predict drug effectiveness, and tailor
treatments to individual patient needs. The latest example of an AI- discovered drug is INS018_ 055,
strategies to address challenges inherent to evolving targets and the increasingly complex nature of therapeutic moieties.
Chapter 7 about chemical kinetics.
Chapter 22 on parenteral drug products now includes sustained- release injectable formulations. Sustained
cacy. It reduces side effects, lowers plasma levels, and reduces injection frequency. Clinical advantages
include longer action duration, reduced injection frequency, improved patient compliance, and enhanced
Chapter 25
have been thoroughly reviewed.
antibodies. Further, it includes a section on various strategies commonly used to overcome the limitations
added to familiarize the students with the basic concepts of antibodies, their utilization embedded in
the current practice of diagnostic and therapeutic medicine, and emerging paradigms for their use in
new drugs. The messenger RNA (mRNA)- based gene therapy discussion has been added to Chapter 27.
mRNA therapy offers increased hope for treating several incurable medical conditions. As a vaccination
or therapeutic agent, mRNA may produce practically any functional protein/ peptide in the body due to
fast technological and molecular medicine breakthroughs. These are invaluable tools for preventing and
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