Dosage Forms, Formulation Developments and Regulations
Recent and Future Trends in Pharmaceutics, Volume 1
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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
Readership
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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