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.
Table of Contents
1. New drug discovery and development2. 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
Authors
Amit Kumar Nayak Department of Pharmaceutics, School of Pharmaceutical Sciences, Siksha 'O' Anusandhan (Deemed to be University), Bhubaneswar, Odisha, India.Dr. Amit Kumar Nayak (MPharm, PhD) is working as a professor, at the Department of Pharmaceutics, School of Pharmaceutical Sciences, Siksha 'O' Anusandhan (Deemed to be University), Odisha, India. He has earned his PhD from IFTM University, Moradabad, Uttar Pradesh, India. He has over 14 years of research experiences in the field of pharmaceutics, especially in the development and characterization of novel biopolymeric and nanostructured drug delivery systems. Till date, he has authored more than 138 research and review publications in various high-impact peer-reviewed journals and 135 book chapters. He has edited/authored 23 international books to his credit. Dr. Nayak has presented his research work at several conferences. He has received University Foundation Day Research Award, 2019 and 2022 by Biju Patnaik University of Technology, Odisha. Dr. Nayak is a life member of the Association of Pharmaceutical Teachers of India (APTI) and a registered pharmacist.
Kalyan Kumar Sen Department of Pharmaceutics, Principal of Gupta College of Technological Sciences, Asansol, W.B, India. Dr. Kalyan Kumar Sen (MPharm, PhD) has over 38 years of teaching and industrial and research experience in the field of pharmaceutics, especially in the development and characterization of novel drug delivery systems. He has earned his PhD in pharmacy from Jadavpur University, India. Currently, Dr. Sen is working as a principal and professor of Gupta College of Technological Sciences, Asansol, India. Till date, he has authored several publications in various journals of international repute. He has authored several book chapters. He already has edited two books and co-authored one 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. Dr. Sen is a life member of the APTI and several professional bodies.
