Developing Solid Oral Dosage Forms: Pharmaceutical Theory & Practice

Developing Solid Oral Dosage Forms is intended for pharmaceutical professionals engaged in research and development of oral dosage forms. It covers essential principles of physical pharmacy, biopharmaceutics and industrial pharmacy as well as various aspects of state-of-the-art techniques and approaches in pharmaceutical sciences and technologies along with examples and/or case studies in product development. The objective of this book is to offer updated (or current) knowledge and skills required for rational oral product design and development. The specific goals are to provide readers with:

• Basics of modern theories of physical pharmacy, biopharmaceutics and industrial pharmacy and their applications throughout the entire process of research and development of oral dosage forms
• Tools and approaches of preformulation investigation, formulation/process design, characterization and scale-up in pharmaceutical sciences and technologies
• New developments, challenges, trends, opportunities, intellectual property issues and regulations in solid product development

• The first book (ever) that provides comprehensive and in-depth coverage of what's required for developing high quality pharmaceutical products to meet international standards
• It covers a broad scope of topics that encompass the entire spectrum of solid dosage form development for the global market, including the most updated science and technologies, practice, applications, regulation, intellectual property protection and new development trends with case studies in every chapter
• A strong team of more than 50 well-established authors/co-authors of diverse background, knowledge, skills and experience from industry, academia and regulatory agencies

Dr. Yihong Qiu currently serves as a technical advisor to pharmaceutical companies globally, providing a broad range of scientific expertise, technical know-how, and training across product and process development, regulatory filing, and commercial manufacturing. Prior to 2023, Dr. Qiu was a Senior Research Fellow in Formulation Sciences at AbbVie, where he spent over 30 years at Abbott and AbbVie. His expertise and experience covered the full drug product lifecycle, including preformulation, biopharmaceutics, pharmacokinetics, drug delivery research, product and process development, scale-up, technology transfer, manufacturing troubleshooting, regulatory filing, and intellectual property. His work has led to numerous successful products and processes, patented technologies, in vitro–in vivo correlations (IVIVC), and biowaivers. Dr. Qiu’s research interests include modified-release drug delivery, dissolution, enhancement of oral bioavailability, IVIVC development, and science-based regulatory approaches. He is an elected Fellow of the American Association of Pharmaceutical Scientists (AAPS) and has authored more than 70 publications in journals and books, holds over 40 granted or pending patents, provides training lectures on various aspects of product development, and has delivered numerous invited presentations at conferences. He earned his B.S. in Pharmacy and M.S. in Pharmaceutics from China Pharmaceutical University, and his Ph.D. in Pharmaceutics from the University of Iowa.

Dr. Yisheng Chen is the Senior Vice President of Product Development at Novast Laboratories, Ltd., where he oversees the development of pharmaceutical products for global markets. He earned his Ph.D. in Pharmaceutics from the University of Iowa in 1994 and began his career at Burroughs Wellcome as a development scientist. He later joined Abbott Laboratories, rising through positions of increasing responsibility and being elected Associate Research Fellow of the Volwiler Society. Dr. Chen is recognized for his deep expertise in solid oral pharmaceutical development, spanning formulation and process design, CMC documentation for regulatory submissions, scale‑up, and commercial validation. His technical strengths include quality‑by‑design (QbD) approaches for solid oral dosage forms, with particular emphasis on modified‑release (MR) products. He has led the development and approval of numerous products in the U.S., EU, Japan, and China, including NDAs and complex, high‑barrier ANDAs. Dr. Chen has extensive experience with Wurster coating technology in the development, scale‑up, and troubleshooting of bead‑coating processes. He is widely known for his contributions to packaging protection for drug products. His theoretical model for predicting moisture uptake in packaged products provided the scientific foundation for ASTM D7709 and informed revisions to the USP general chapter on water vapor transmission rate (WVTR). His work also established the scientific rationale for evaluating container performance using MVTR per unit product. Dr. Chen has published more than 30 peer‑reviewed articles, book chapters, and patents. He has served as an expert member of the Product Quality Research Institute (PQRI) and the USP Performance Testing Expert Panel, and he has been an adjunct professor at Guangdong Pharmaceutical University. He is a frequent speaker at national and international conferences and at major universities.

Dr. Geoff G. Z. Zhang, FAAPS, is the Founder and Chief Technical Director of ProPhysPharm; an adjunct professor of the Department of Industrial and Molecular Pharmaceutics at Purdue University; and a Fellow of American Association of Pharmaceutical Scientists. He has contributed broadly to Physical Pharmacy, specifically in the areas of salt and polymorph screening, co-crystallization and crystal engineering, characterization and crystallization of amorphous solids, physical chemistry of supersaturated solutions and the design of amorphous solid dispersions. He has published over 130 peer-reviewed articles, reviews, and book chapters; given 80 invited talks at conferences, universities, pharmaceutical companies, and FDA; and presented more than 150 posters. Prior to founding ProPhysPharm in 2024, he spent 26 years at Abbott/AbbVie. He is a co-inventor of over 170 patents/applications including composition of matter, crystal form, formulation, processing, and method of use on clinical candidates and marketed products. He received his B.Sc. in Physical Chemistry from Fudan University, and Ph.D. in Pharmaceutics from University of Minnesota Twin Cities.