Dosage Forms, Formulation Developments and Regulations

Dosage Forms, Formulation Developments and Regulations

Recent and Future Trends in Pharmaceutics, Volume 1

1st Edition - October 1, 2023

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  • Editors: Amit Kumar Nayak, Kalyan Kumar Sen
  • Paperback ISBN: 9780323918176

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Dosage Forms, Formulation Developments and Regulations, Volume One in the Recent and Future Trends in Pharmaceutics series, explores aspects of pharmaceutics, with an original approach focused on technology, novelties and future trends in the field. The book discusses the most recent developments in pharmaceutical preformulation and formulation studies, biopharmaceutics and novel pharmaceutical formulations, regulatory affairs, and good manufacturing practices. Exciting areas such as formulation strategies, optimization techniques, the biopharmaceutical classification system, and pharmaceutical aerosols are included. The field of pharmaceutics is highly dynamic and rapidly expanding day-by-day, so it demands a variety of amplified efforts for designing and developing pharmaceutical processes and formulation strategies. This is an essential reference for researchers in academia and industry as well as advanced graduate students in pharmaceutics.

Key Features

  • Examines trends and recent technologies in dosage, formulation and regulation
  • Contains contributions from leading experts in academia, research, industry and regulatory agencies
  • Includes high-quality illustrations, flow charts and tables for easy understanding of concepts
  • Discusses practical examples and research case studies


Postgraduate pharmacy students, doctoral and postdoctoral research fellows, pharmaceutical formulators, scientists, researchers, and regulatory scientists, Researchers and postgraduate students in biotechnology, biomedical sciences and engineering, bioengineering sciences, chemical engineering

Table of Contents

  • 1. New drug discovery and development
    2. Introduction to drugs and different types of dosage forms.
    3. Pharmacopoeias, National Formulary and Extra Pharmacopoeias
    4. Regulatory affairs: historical overview, authorities and role in drug approval
    5. Introduction to intellectual property and patent system
    6. WHO and ICH Guidelines for ‘Good Manufacturing Practices’
    7. Introduction to pharmaceutical validation
    8. Design of dosage forms: influences of anatomy and administration routes
    9. Formulation strategies to improve the bioavailability of poorly absorbed drugs
    10. Optimization techniques in pharmaceutical formulation and processing
    11. Pharmaceutical product development: A ‘Quality by Design’ (QbD) approach
    12. Pharmaceutical excipients
    13. Pharmaceutical calculations
    14. Preformulation considerations in pharmaceutical formulation process
    15. Biopharmaceutical classification system (BCS): A strategic tool in pharmaceutical formulation
    16. Pilot plant scale up techniques in pharmaceutical product development
    17. Technology development and transfer in pharmaceutical product development
    18. Recent developments in pharmaceutical liquids
    19. Advances in solid dosage forms
    20. Advances in semi-solid dosage forms
    21. Pharmaceutical sterilization
    22. Pharmaceutical sterile formulations
    23. Challenges in development and manufacturing for dermatological formulations
    24. Pharmaceutical aerosols
    25. Pharmaceutical packaging: Recent trends and challenges

Product details

  • No. of pages: 575
  • Language: English
  • Copyright: © Academic Press 2023
  • Published: October 1, 2023
  • Imprint: Academic Press
  • Paperback ISBN: 9780323918176

About the Editors

Amit Kumar Nayak

Dr. Amit Kumar Nayak is currently working as a Professor at Seemanta Institute of Pharmaceutical Sciences, Odisha, India. He earned his Ph.D. in Pharmaceutical Sciences from IFTM University, India. He worked as Senior Research Associate at IIT, Kanpur in a CSIR sponsored project. Dr. Nayak has over 13 years of research experiences in the field of pharmaceutics, especially in the development and characterization of novel biopolymeric and nanostructured drug delivery systems made of natural biopolymers. He has authored over 130 research and review articles in various high impact peer-reviewed journals and 135 book chapters in various international books. In addition, he has authored 2 books and edited 17 books published by International publisher(s). He has received University Foundation Day Research Award-2019 by Biju Patnaik University of Technology, Odisha. He serves as a reviewer for several reputed journals and is a life member of Association of Pharmaceutical Teachers of India (APTI).

Affiliations and Expertise

Professor at Seemanta Institute of Pharmaceutical Sciences, Odisha, India.

Kalyan Kumar Sen

Dr. Kalyan Kumar Sen (M. Pharm, Ph.D) has over 30 years of teaching and research experience in the field of Pharmaceutics, especially in the development and characterization of novel drug delivery systems. He has earned his Ph. D. in Pharmacy from Jadavpur University, India. Currently, Dr. Sen is working as Principal of Gupta College of Technological Sciences, Asansol, India. Till date, he has authored over several publications in various journals of International repute. He has been a reviewer of several journals of high repute. He already has edited 1 book. He has been the permanent reviewer of many international journals of high repute. Dr. Sen has participated and presented his research work at several conferences in India.

Affiliations and Expertise

Department of Pharmaceutics, Principal of Gupta College of Technological Sciences, Asansol, W.B, India

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