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Advances in Pharmaceutical Product
Development
Keerti Jain • Awesh K. Yadav
Editors
Advances in
Pharmaceutical Product
Development
Editors
Keerti Jain
Drug Delivery and Nanomedicine Research
Laboratory
Department of Pharmaceutics
National Institute of Pharmaceutical
Education and Research (NIPER)
Lucknow, Uttar Pradesh, India
Awesh K. Yadav
Department of Pharmaceutics
National Institute of Pharmaceutical
Education and Research (NIPER)
Lucknow, Uttar Pradesh, India
ISBN 978-981-97-9229-0 ISBN 978-981-97-9230-6 (eBook)
https://doi.org/10.1007/978-981-97-9230-6
© The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Singapore
Pte Ltd. 2025
This work is subject to copyright. All rights are solely and exclusively licensed by the Publisher, whether
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v
Preface
Development of any pharmaceutical product starts with determination of various
physicochemical properties of a new chemical entity having potential to be devel-
oped as a new drug molecule. These physicochemical properties are determined in
the preformulation studies, one of the important stages in the development of phar-
maceutical formulation apart from prototype development, scale up studies, and
commercialization of pharmaceutical formulation. Preformulation studies assist in
identication of possible problems which could be anticipated while developing the
pharmaceutical formulation; further it also helps in determining one of the appropri-
ate dosage forms to develop prototype, which could nally lead to a safe, effective,
and stable pharmaceutical product for a new drug molecule. Optimization for the
scale-up studies facilitates transformation of process to clinical level from preclini-
cal experiments. In this book, we focus on compiling all the stages involved in
pharmaceutical product development including the importance, requirement, and
effect of each stage and process. This book has covered prototype development for
pharmaceutical formulations, scale-up studies, optimization, testing, packaging and
commercialization of different dosage forms like tablets, suspensions, emulsions,
nanocrystals, inhalational products, sterile products, herbal formulations, etc.
This book provides important and informative topics including quality by design,
process analytical technology, perspective related to additives or excipients used in
pharmaceutical product development, advances in tablet formulations, pharmaceu-
tical product development of drug nanocrystals, inhalational drug delivery systems,
herbal formulations and challenges associated with the development of these for-
mulations, drug repositioning and virtual screening, and pharmacovigilance and
pharmacogenomics as well. Chapter 1–3 compiles the information regarding the
pharmaceutical formulation development, design, and optimization for materials
and pharmaceutical products. Chapter 4 provides a detailed account of formulation
additives for pharmaceutical product development. Chapter 5–14 discusses differ-
ent pharmaceutical products and their developments like tablets and other solid dos-
age forms, liquid and poly-disperse systems including suspensions and emulsions,
sterile products, topical and transdermal drug delivery systems, ophthalmic formu-
lations, inhalational drug delivery systems, and drug nanocrystals. Chapter 15 deals
with herbal formulations whereas Chaps. 16 and 17 are focused on drug repurpos-
ing and virtual screening, and preclinical, clinical studies, pharmacogenomics,
pharmacovigilance, and commercialization of pharmaceutical drug products.
vi
We believe that this book will be a valuable source of information to its audience
and will assist in understanding the updates on pharmaceutical formulation devel-
opment. We are thankful to all the contributors for their worthy manuscripts which
helped signicantly in the compilation of this book. We are grateful to our institu-
tion, NIPER-Raebareli, colleagues, students, and family members for their support
and encouragement. We are also thankful to Springer Nature and all the team mem-
bers who worked tirelessly to publish this book and bring it in the market.
Lucknow, Uttar Pradesh, India KeertiJain
Lucknow, Uttar Pradesh, India AweshK.Yadav
Preface
vii
Contents
1 Advances in Development of Pharmaceutical Products . . . . . . . . . . . . 1
Keerti Jain, Soya Tarannum, Gijith K. Mohan, Manisha Patel,
Anchal Pathak, Parth Patel, Vineet K. Jain, Ashish Baldi,
and Harvinder Popli
2 Design of Materials and Product Specifications
for Pharmaceutical Dosage Forms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Ankita Kishore, Neeraj Mishra, Jovita Kanoujia,
Prem Prakash Singh, and Alok Kumar Mahor
3 Optimization Techniques for the Development of Pharmaceutical
Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Sunny Rathee, Shivani Saraf, Pritish Kumar Panda, Sarjana Raikwar,
Pooja Das Bidla, and Sanjay K. Jain
4 Pharmaceutical Product Development: Formulation Additives . . . . . . 83
Meenakshi Patel, Dhruvi Patel, Hitarthi Mayur Patel,
and Lalit Lata Jha
5 Advances in Pharmaceutical Oral Solid Dosage Forms . . . . . . . . . . . . 111
P. Saikiran, T. Pawan Kumar, Shristi Arya, Darshana Tijare,
Soham Loharkar, Gopal Bajad, Deepankar Bahuguna,
Pawan Devangan, Atul Mourya, Harithasree Veerabromma,
Chantibabu Katta, and Jitender Madan
6 Advances in Tablet Production and Tablet Coating. . . . . . . . . . . . . . . . 143
Nagphase Nakshatra Jitendra, Rohit Garg, Md Imtiyaz Alam,
and Awesh K. Yadav
7 Formulation Evaluation and Development of Specialized Tablets . . . . 175
Soya Tarannum and Keerti Jain
8 Suspensions: Theory, Formulation Considerations, Flocculated
and Deflocculated Suspensions, and Evaluation of Suspension
Stability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199
Anjali Rajora and Kalpana Nagpal
viii
9 Liquid and Polydisperse Systems: Emulsions . . . . . . . . . . . . . . . . . . . . 219
K. Shubham, B. Behera, and Meenakshi K. Chauhan
10 Sterile Products and Admixtures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 245
Satish Shilpi, Amit K. Dubey, Shalini Bajaj,
Shashank Shekar Mishra, Chetan Ram, Debasis Gantayat,
Vibhooti Pippola, and Khyati Saini
11 Challenges and Advances in Pharmaceutical Development
of Topical and Transdermal Dosage Forms . . . . . . . . . . . . . . . . . . . . . . 269
Jaspreet Kaur, Manju, Amanjot Kaur, Monu Yadav,
Neha Raina, Sumit Kumar, Akhilesh Kumar, and Madhu Gupta
12 Advances in Ophthalmic Formulation Development . . . . . . . . . . . . . . . 289
Rohit Bhawale, Vaibhavi Srivastava, and Neelesh Kumar Mehra
13 Advances and Developments in Formulation
of Drug Nanocrystals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 321
Manshi, Sonal Setya, and Sushama Talegaonkar
14 A Technological Update on Inhalation Drug Delivery Devices . . . . . . . 355
Ankaj Kumar, Ishwar Chandra, V. Rajesh, Sourabh Jadhav,
Harshita Krishnatreyya, and Arvind Gulbake
15 Herbal Formulations: Development, Challenges, Testing,
Stability, and Regulatory Guidelines. . . . . . . . . . . . . . . . . . . . . . . . . . . . 379
Shivam Ramdas Pawar, Parth Patel, and Keerti Jain
16 Drug Repurposing and Virtual Screening . . . . . . . . . . . . . . . . . . . . . . . 399
Ruchika Sharma, Sweta Roy, and Anoop Kumar
17 Pre-clinical and Clinical Studies, Pharmacovigilance,
Pharmacogenomics, and Commercialization of Pharmaceutical
Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 423
Mit Joshi and Bhoomika M. Patel
Contents
ix
Editors and Contributors
About the Editors
Keerti Jain is presently working as Assistant Professor in Department of
Pharmaceutics, National Institute of Pharmaceutical Education and Research
(NIPER)—Raebareli. She earned her M. Pharm. and Doctorate degree from
Department of Pharmaceutical Sciences, Dr. H.S. Gour Central University, Sagar.
Dr. Jain previously worked as Associate Professor in ISF College of Pharmacy,
Moga, India and as Assistant Professor in Delhi Pharmaceutical Sciences and
Research University (DPSRU), New Delhi. She did her Post Doctorate from
M.S. University of Vadodara, India as SERB-National Post-Doctoral Fellow. She
has about 15years of research experience on Nanomedicine based drug delivery
systems. Dr. Jain has led six patents from her innovative research and received
funding for research projects from CSIR, ICMR and SERB, New Delhi. She has
edited several books and contributed to a few book chapters. She has been awarded
with various research fellowships including SERB–NPDF, CSIR-SRF, UGC-JRF
and awarded with many awards for her research work including Pharmaceutical
Science Alumni Award-2006, most innovative Idea award in LUFTHANSA impact
week, SPER Women Forum—Young Scientist Award and prestigious ICMR—
Shakuntala Amir Chand Prize for the year 2019. She has been invited to present her
research work at several national and seven international conferences and enlisted
among World’s Top 2% Scientists, consecutively for year 2020, 2021, 2022 and
2023 in the eld of Pharmacology and Pharmacy, a list created by Stanford
University, USA.Dr. Jain has published more than 70 research papers in many pres-
tigious international journals and also served as a reviewer for several reputed inter-
national journals.
Awesh K. Yadav is currently working as Assistant Professor of Pharmaceutics,
National Institute of Pharmaceutical Education and Research (NIPER)—Raebareli
(A Transit Campus at Lucknow) India, Dr. Yadav has completed his B. Pharm,
M.Pharm and Ph.D. degree from Dr. Hari Singh Gour University, Sagar (MP) India.
Dr. Yadav served as Principal at Bhagyoday Tirth Pharmacy College Sagar (MP)
India. Earlier, he served as Assistant Manager in R&D (Formulation) at Ipca
Laboratories Limited Mumbai India. Then, he worked as Research Scientist at
Himalaya Drug Company Bangalore, India and as a Research Assistant at Sun
Pharm Advanced Research Centre (SPARC), Vadodara (GJ). His research interest is
x
in drug delivery and drug targeting using various drug delivery systems and ligands
i.e., Nanoparticles, Nanodiamonds, fullerenes etc. He has been conferred with vari-
ous prestigious awards notably, Outstanding Teacher award by APTI MP State
Branch. He has received various research fellowships including ICMR-SRF, UGC-
JRF and awarded for his research work and has served as a reviewer for several
international journals. He has also published various research articles in the peer-
reviewed international journal and authored or co-authored a few books and book
chapters. He is a of several international scientic societies and organiza-
tions importantly, Association of Pharmaceutical Teachers of India (APTI), Society
of ethnopharmacology, Society of Pharmaceutical Education and Research, India.
Contributors
Md Imtiyaz Alam Department of Pharmaceutics, National Institute of
Pharmaceutical Education and Research (NIPER) Raebareli, Lucknow, Uttar
Pradesh, India
ShristiArya Department of Pharmaceutics, National Institute of Pharmaceutical
Education and Research, Hyderabad, Telangana, India
Deepankar Bahuguna Department of Pharmaceutics, National Institute of
Pharmaceutical Education and Research, Hyderabad, Telangana, India
GopalBajad Department of Pharmaceutics, National Institute of Pharmaceutical
Education and Research, Hyderabad, Telangana, India
Shalini Bajaj School of Pharmaceuticals Sciences, Jaipur National University,
Jaipur, Rajasthan, India
AshishBaldi Pharma Innovation Lab, Department of Pharmaceutical Sciences and
Technology, Maharaja Ranjit Singh Punjab Technical University, Bathinda,
Punjab, India
B.Behera Delhi Institute of Pharmaceutical Sciences and Research, DPSRU, New
Delhi, Delhi, India
RohitBhawale Pharmaceutical Nanotechnology Research Laboratory, Department
of Pharmaceutics, National Institute of Pharmaceutical Education and Research
(NIPER), Ministry of Chemical and Family Welfare, Hyderabad, Telangana, India
Pooja Das Bidla Pharmaceutics Research Projects Laboratory, Department of
Pharmaceutical Sciences, Dr. Harisingh Gour Vishwavidyalaya, Sagar, Madhya
Pradesh, India
Ishwar Chandra Department of Pharmaceutics, National Institute of
Pharmaceutical Education and Research Guwahati, Guwahati, Assam, India
Editors and Contributors