Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice

Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Third Edition is a comprehensive and up-to-date guide for professionals and academics engaged in all aspects of oral dosage form development, from discovery support through commercial manufacturing. This new edition features 13 new or rewritten chapters, along with significant updates to existing content, reflecting the latest advancements in the field, including new theories, scientific findings, approaches, techniques, modeling, and the emerging opportunities offered by AI. This book consists of 44 chapters covering in-depth principles of physical pharmacy, biopharmaceutics, and industrial pharmacy, and their applications throughout the R&D process and commercial production of oral dosage forms. New chapters address topics such as absorption evaluation of oral dosage forms, formulation principles, and applications based on supersaturation, patient-centric product design, product design through the 505(b)(2) NDA pathway, design of experiments (DoE), process modeling, 3D printing, and machine learning applications in commercial manufacturing. Existing chapters have been updated or completely rewritten to provide advanced information and include practical case studies. Important topics such as amorphous solid dispersions, modified-release delivery, manufacturing technologies, modeling and simulation, fundamentals of dissolution and bioequivalence, IVIVC, biowaivers, regulatory frameworks, and many others are covered. The new edition of this book is an indispensable resource for industry professionals, academic institutions, and regulatory bodies seeking to stay current with advances in solid dosage form development and manufacturing. It offers a thorough understanding of fundamental principles and techniques, along with practical guidance on applying these concepts to real-world challenges.

Table of Contents:
1. Solubility of Pharmaceutical Solids 2. Crystalline and Amorphous Solids 3. Solid-State Characterization and Techniques 4. API Solid-Form Screening and Selection 5. Drug Stability and Degradation Studies 6. Excipient Compatibility and Functionality 7. Polymer Properties and Characterization 8. Interfacial Phenomena 9. The Fundamentals of Diffusion and Dissolution 10. Particle, Powder, and Compact Characterization 11. Oral Drug Absorption: Pathways, Physicochemical and Biological Factors, and Methods of Study 12. Evaluation of Drug Absorption from Oral Dosage Forms 13. Dissolution Testing of Solid Products 14. Bioavailability and Bioequivalence 15. In Vitro-In Vivo Correlations: Fundamentals, Development Considerations, and Applications 16. Oral Delivery of Challenging Poorly Soluble Drugs via Supersaturation: Principles and Applications 17. Patient-centric Drug Product Design: Rational and Practical Considerations 18. Design of Improved and Differentiated Products through 505(b)(2) NDA Pathway 19. Oral Formulations for Preclinical Studies: Principle, Design, and Development 20. Product and Process Development of Solid Oral Dosage Forms 21. Rational design of Amorphous Solid Dispersions 22. Rational Design of Oral Modified-Release Drug Delivery Systems 23. Basic Principles of The Design of Experiments 24. Established unit operation models for solid oral dosage forms from an industrial perspective 25. Analytical Method Development of Solid Dosage Forms 26. Statistical Design and Analysis of Long-Term Stability Studies for Drug Products 27. Packaging Selection for Solid Oral Dosage Forms 28. Clinical Supplies Manufacture: Strategy, GMP Considerations, and Cleaning Validation 29. Specification Setting and Manufacturing Process Control for Solid Oral Drug Products 30. Process Development and Scale-Up: Providing Reliable Powder Flow and Product Uniformity 31. Capsules Dosage Form: Formulation and Manufacturing Considerations 32. Process Development and Scale-Up: High Shear Wet Granulation process 33. Process Development and Scale-Up: Fluid-bed Granulation 34. Process Development and Scale-Up: Spray-Drying Amorphous Solid Dispersions for Insoluble Drugs 35. Process development and scale-up: Twin screw extrusion 36. Development, Scale-Up, and Optimization of Process Parameters: Roller Compaction Theory and Practice 37. Development, Scale-Up and Optimization of Process Parameters: Tablet Compression 38. Development and Scale-Up of Process Parameters: Pan Coating 39. Development, Scale-Up and Optimization of Process Parameters: Wurster Coating 40. Ensuring Commercial Manufacturing and Product Quality Through Science- and AI-Driven Approaches 41. Continuous Manufacturing: Modernizing Pharmaceutical Manufacturing with Advanced Technologies and 3D Printing 42. Drug Product Approval in the United States and International Harmonization 43. Modern Pharmaceutical Regulations: Quality Assessment for Drug Substances 44. Modern Pharmaceutical Regulations: Quality Assessment for Drug Products

About the Author :
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. 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. 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.