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

著者名：Nayak PhD, Amit Kumar (EDT)/Sen, Kalyan Kumar (EDT)

Academic Press（2023/12/09発売）

• 言語：ENG
• ISBN：9780323918176
• eISBN：9780323972468

Description

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.- 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

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 system6. WHO and ICH Guidelines for 'Good Manufacturing Practices'7. Introduction to pharmaceutical validation8. Design of dosage forms: influences of anatomy and administration routes9. Formulation strategies to improve the bioavailability of poorly absorbed drugs10. Optimization techniques in pharmaceutical formulation and processing11. Pharmaceutical product development: A 'Quality by Design' (QbD) approach12. Pharmaceutical excipients13. Pharmaceutical calculations14. Preformulation considerations in pharmaceutical formulation process15. Biopharmaceutical classification system (BCS): A strategic tool in pharmaceutical formulation16. Pilot plant scale up techniques in pharmaceutical product development17. Technology development and transfer in pharmaceutical product development18. Recent developments in pharmaceutical liquids19. Advances in solid dosage forms20. Advances in semi-solid dosage forms21. Pharmaceutical sterilization22. Pharmaceutical sterile formulations23. Challenges in development and manufacturing for dermatological formulations24. Pharmaceutical aerosols25. Pharmaceutical packaging: Recent trends and challenges