Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice

Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Second Edition illustrates how to develop high-quality, safe, and effective pharmaceutical products by discussing the latest techniques, tools, and scientific advances in preformulation investigation, formulation, process design, characterization, scale-up, and production operations.

This book covers the essential principles of physical pharmacy, biopharmaceutics, and industrial pharmacy, and their application to the research and development process of oral dosage forms. Chapters have been added, combined, deleted, and completely revised as necessary to produce a comprehensive, well-organized, valuable reference for industry professionals and academics engaged in all aspects of the development process.

New and important topics include spray drying, amorphous solid dispersion using hot-melt extrusion, modeling and simulation, bioequivalence of complex modified-released dosage forms, biowaivers, and much more.

• Written and edited by a international team of leading experts with experience and knowledge across industry, academia, and regulatory settings
• Includes new chapters covering the pharmaceutical applications of surface phenomenon, predictive biopharmaceutics and pharmacokinetics, the development of formulations for drug discovery support, and much more
• Presents new case studies throughout, and a section completely devoted to regulatory aspects, including global product regulation and international perspectives

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.

Dr. Lawrence X. Yu, is an adjunct professor at the University of Michigan and Associate Editor of The AAPS Journal. Dr. Yu has made transformative contributions to pharmaceutical science and regulation. He developed the Compartmental Absorption and Transit (CAT) model, which became the scientific foundation for commercial simulation platforms including GastroPlus™ and Simcyp®. As chair of FDA's Biopharmaceutics Classification System (BCS) Committee from 2000 to 2016, he advanced global acceptance of BCS and contributed to the 2019 ICH M9 guideline. He pioneered Pharmaceutical Quality by Design (QbD) as a regulatory paradigm, emphasizing design, understanding, control, and lifecycle management. Most recently, he originated the Knowledge-aided Assessment and Structured Applications (KASA) initiative to strengthen knowledge management and enable artificial intelligence in regulatory decision-making. Dr. Yu currently leads the ICH Expert Working Group revising the M4Q(R1) guideline to modernize pharmaceutical product registration and lifecycle management. He has authored over 178 scientific publications, delivered more than 400 invited presentations, and co-edited three influential books on biopharmaceutics and drug development.

Dr. Rao V. Mantri is the Chief Manufacturing Officer (CMfgO) at Astellas. Under his leadership, Astellas continues to accelerate product development through launch and ensure a reliable supply, leveraging innovative capabilities across modalities. Rao brings more than 24 years of leadership and experience across the pharmaceutical value chain, including global product development, manufacturing and supply chain management during his tenure at Bristol Myers Squibb. Over his career, he has contributed to the development and commercialization of many innovative pharmaceutical and biologic products. Rao received his B.Tech. in Chemical Engineering from Osmania University, India, M.S. in Chemical Engineering, M.S., and Ph.D.(honors) in Pharmaceutical Chemistry from The University of Kansas, USA. He also holds Executive MBA from MIT Sloan. Rao authored 30 peer-reviewed publications, 13 patents/applications and delivered numerous Keynote/Invited lectures. He also served on USP Expert Committee and was industrial mentor for NSF ERC. Rao’s strong expertise across modalities and technologies is complemented by his strategic insights, focused execution, and ability to build across cultures and functions. He is committed to creating and delivering innovative medicines to patients around the world, with a sense of urgency.