Developing Solid Oral Dosage Forms
Pharmaceutical Theory and Practice
- 3rd Edition - January 1, 2026
- Imprint: Academic Press
- Editors: Yihong Qiu, Yisheng Chen, Geoff G.Z. Zhang, Rao V. Mantri, Lawrence Yu
- Language: English
- Hardback ISBN:9 7 8 - 0 - 4 4 3 - 3 4 1 5 6 - 4
- eBook ISBN:9 7 8 - 0 - 4 4 3 - 3 4 1 5 7 - 1
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 aspect… Read more
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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 the development process of oral dosage forms. This new edition reflects the significant impact of AI and ML on pharmaceutical science in recent years, with six new chapters and extensive updates to existing content. The book covers essential principles of physical pharmacy, biopharmaceutics, and industrial pharmacy, as well as their application to the research and development process of oral dosage forms. The Third Edition features new chapters on Evaluation of Drug Absorption from Oral Dosage Forms, Dissolution Evaluation of Enabling Formulations Based on Supersaturation, Patient-Centric Drug Product Design, and Design of Improved and Differentiated Products through 505(b)(2) NDA Pathway. Additionally, existing chapters have been updated, combined, or completely rewritten to provide a well-organized and valuable reference. Topics such as spray drying, amorphous solid dispersion using hot-melt extrusion, modeling and simulation, bioequivalence of complex modified-release dosage forms, biowaivers, and more are covered in this edition. Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Third Edition is an indispensable resource for industry professionals and academics looking to stay current with the latest advancements in solid formulation development. This book not only provides a thorough understanding of the principles and techniques involved in the development process but also offers practical guidance on how to apply these concepts to real-world situations. With its extensive coverage of new topics and updates to existing chapters, this edition is an essential tool for those working in the field of pharmaceutical science.
- Updated with six new chapters, through coverage of the AI and ML impact in oral formulation, and the latest developments in 3D printing, continuous manufacturing and Industry 4.0 in pharma
- Includes practical application, showing how essential principles are applied to real-world situations
- Covers both Industry and Academic content needs, for professionals, researchers, and students alike
- Addresses preformulation, formulation, process design, characterization, scale-up, and production operations
- Introduces the patient-centric drug product design process
Pharmaceutical researchers and development scientists and engineers in industry, academic institutions and regulatory agencies focused on developing and approving solid dosage forms for both new and generic drug products
I: Theories and Techniques in the Characterization of Drug Substances and Excipients
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 Phenomenon
9. The Fundamentals of Diffusion and Dissolution
10. Particle, Powder, and Compact Characterization
II: Biopharmaceutical and Pharmacokinetic Evaluations of Drug Molecules and Dosage Forms
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 Oral Products
14. Bioavailability and Bioequivalence
15. Dissolution Evaluation of Enabling Formulations Based on Supersaturation
16. In Vitro-In Vivo Correlations: Fundamentals, Development Considerations and Applications
III: Design, Development and Scale-up of Formulation and Manufacturing Process
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 Development of Amorphous Solid Dispersions
22. Rational Design of Oral Modified-Release Drug Delivery Systems
23. Basics and Applications of DOE in Product Development, Scale-up and Optimization
24. Modeling of Manufacturing Processes of Solid Drug Products
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 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. Capsule Dosage Forms: 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 Hot Melt Extrusion and Continuous Granulation
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. Commercial Manufacturing and Product Quality
41. New Technologies for Modernizing Pharmaceutical Production: Continuous Manufacturing and 3D printing
42. Machine Learning and Artificial Intelligence in Product & Process Development and Manufacturing Part IV: Regulatory Aspects of Product Development
43. Drug Product Approval in the US and ICH
44. Modern Pharmaceutical Regulations: Quality Assessment for Drug Substance
45. Modern Pharmaceutical Regulations: Quality Assessment for Drug Products
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 Phenomenon
9. The Fundamentals of Diffusion and Dissolution
10. Particle, Powder, and Compact Characterization
II: Biopharmaceutical and Pharmacokinetic Evaluations of Drug Molecules and Dosage Forms
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 Oral Products
14. Bioavailability and Bioequivalence
15. Dissolution Evaluation of Enabling Formulations Based on Supersaturation
16. In Vitro-In Vivo Correlations: Fundamentals, Development Considerations and Applications
III: Design, Development and Scale-up of Formulation and Manufacturing Process
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 Development of Amorphous Solid Dispersions
22. Rational Design of Oral Modified-Release Drug Delivery Systems
23. Basics and Applications of DOE in Product Development, Scale-up and Optimization
24. Modeling of Manufacturing Processes of Solid Drug Products
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 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. Capsule Dosage Forms: 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 Hot Melt Extrusion and Continuous Granulation
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. Commercial Manufacturing and Product Quality
41. New Technologies for Modernizing Pharmaceutical Production: Continuous Manufacturing and 3D printing
42. Machine Learning and Artificial Intelligence in Product & Process Development and Manufacturing Part IV: Regulatory Aspects of Product Development
43. Drug Product Approval in the US and ICH
44. Modern Pharmaceutical Regulations: Quality Assessment for Drug Substance
45. Modern Pharmaceutical Regulations: Quality Assessment for Drug Products
- Edition: 3
- Published: January 1, 2026
- Imprint: Academic Press
- Language: English
YQ
Yihong Qiu
Dr. Yihong Qiu is currently a Senior Research Fellow, Oral Drug Products, Science and Technology, AbbVie. His in-depth knowledge and extensive experience encompass various phases of product development, including preformulation, drug delivery technology, product/process design, biopharmaceutics/pharmacokinetics, formulation/process development, scale-up and optimization, manufacturing trouble-shooting, intellectual property and regulatory registration for NCE’s, line-extension and marketed products. He also plays a key role in the product life cycle management, IP strategy, scientific and regulatory assessment of business opportunities. During his 25-year tenure with Abbott/AbbVie, his work has resulted in successful commercial IR and MR products, patented drug delivery technologies, IVIVC’s and biowaivers approved by global regulatory agencies. Dr. Qiu’s research interests include modified-release delivery systems, dissolution, bioavailability, IVIVC, drug delivery technology and science-based regulation. He is an elected fellow of the American Association of Pharmaceutical Scientists (AAPS), a member of 2010-2015 USP Expert Committee and a review committee member of Chang Jiang Scholars Program (2014-15). He has more than 50 publications in journals and books, 30 patents granted or pending, and numerous invited presentations. He is routinely invited to lecture at professional organizations and universities. Dr. Qiu received BS in Pharmacy, MS. in Pharmaceutics from China Pharmaceutical University, and Ph.D. in Pharmaceutics from The University of Iowa.
Affiliations and expertise
PhD, Senior Research Fellow, Oral Drug Products, Manufacturing Science and Technology, AbbVie Inc., North Chicago, IL, USAYC
Yisheng Chen
Dr. Yisheng Chen currently serves as Vice President of Product Development at Novast Laboratories, Ltd, leading the development of pharmaceutical products for global markets. Dr. Chen earned his Ph.D. degree in Pharmaceutics in 1994 from the University of Iowa. He then joined Burroughs Wellcome as a development scientist, and later Abbott Laboratories with increasing responsibilities where he was elected as an Associate Research Fellow, Volwiler Society. Dr. Chen also served as an expert member of both the Product Quality Research Institute (PQRI) and the USP Performance Testing Expert Panel, and as an adjunct professor at the Guangdong Pharmaceutical University. Dr. Chen has in-depth knowledge and extensive experience in various aspects of developing solid pharmaceutical products, ranging from formulation and process development, CMC documentation for regulatory filing, scale-up, and validation for commercialization. His expertise includes the quality by design (QbD) development of modified release (MR) products using traditional delivery technologies, and development of new delivery systems for MR products. Dr. Chen has extensive experience in the development and scale-up of beads coating process using Wurster coating technology for different types of products from lab to commercial scales. He has successfully led the development and secured the approval of more than 30 products approved in the US, EU, Japan and China, including new drug applications (NDAs) and high barrier branded abbreviated new drug applications (ANDAs). Dr. Chen also has the expertise in packaging protection of drug products. He developed a theoretical model for predicting moisture uptake by packaged products during storage. His theory provided the fundamental basis for the development of ASTM D7709 and the revision of USP general chapter on the standard methods for measuring the water vapor transmission rate (WVTR) of containers, as well as the scientific criteria of using MVTR/unit product to evaluate the performance of containers for product protection. Dr. Chen has published over 30 peer-reviewed articles, book chapters, and patents. He is a co-editor of “Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice”. Dr. Chen is a frequent speaker at national and international conferences, and at major universities.
Affiliations and expertise
Vice President, Novast Laboratories, Nantong, ChinaGZ
Geoff G.Z. Zhang
Dr. Geoff G. Z. Zhang is a Senior Research Follow at AbbVie Inc., an adjunct professor of the Department of Industrial and Physical Pharmacy at Purdue University, and a Fellow of the American Association of Pharmaceutical Scientists. He received his B.Sc. in Physical Chemistry from Fudan University, China, and Ph.D. in Pharmaceutics from the University of Minnesota, USA. He has contributed broadly to Physical Pharmacy, specifically in the areas of crystal engineering, polymorphism, characterization and crystallization of amorphous solids and amorphous solid dispersions, as well as delivery of poorly water soluble compounds. He has published over 70 peer-reviewed articles, reviews, and book chapters, given over 170 podium and poster presentations. During his 18-year tenure with Abbott/AbbVie, he has more than 120 granted patents and patent applications. He interacts and collaborates extensively with academic institutes and has mentored 40 graduate students on their thesis and summer research projects. He has received 2012 AAPS Pharmaceutical Research Meritorious Manuscript Award, and serves on the United State Pharmacopeia Physical Analysis Expert Committee.
Affiliations and expertise
Senior Research Fellow, Drug Product Development, Abbvie, Inc., North Chicago, IL, USARM
Rao V. Mantri
Dr. Rao V. Mantri is currently working as Executive Director in Drug Product Science & Technology at Bristol-Myers Squibb Company. He received his B.Tech. in Chemical Engineering from Osmania University, India, M.S. in Chemical Engineering, M.S. in Pharmaceutical Chemistry and Ph.D. in Pharmaceutical Chemistry with honors from The University of Kansas, USA. Since joining BMS R&D in 2000, he has held positions of increasing responsibility in design, development and technology transfer of small molecules as well as biologics drug products. He has broad experience in formulation development, process engineering, materials science, analytical sciences, CMC regulatory filing strategy and leading multi-disciplinary CMC teams. His research interests include solubilization, drug delivery, materials science, drug-excipient interactions, drug stability, biopharmaceutics modeling, formulation development and process scale-up. He has 29 manuscripts, 8 patents and numerous invited talks and presentations. He also served on the 2010-2015 USP Excipients Expert Committee.
Affiliations and expertise
Executive Director, Drug Product Science and Technology, Bristol-Myers Squibb, New Brunswick, NJ, USALY
Lawrence Yu
Lawrence X. Yu, Ph.D., is the Deputy Director, Office of Pharmaceutical Quality, Food and Drug Administration, where he oversees new, generic, and biotechnology product quality review and inspection functions as well as the FDA CDER quality labs. He is also adjunct Professor of Pharmaceutical Engineering at the University of Michigan. Prior to joining the FDA, Dr. Yu had worked at Pfizer (Upjohn) and GlaxoWellcome for 8 years. Dr. Yu joined the FDA in 1999 and has served as Team Leader, Deputy Division Director, Division Director, Deputy Office Director, and Office Director. Dr. Yu’s research interests have centered on the prediction of oral drug delivery and the development of pharmaceutical Quality by Design. His compartmental absorption and transit (CAT) model has laid the foundation for the commercial software, GastroPLUSTM and Simcyp®, which are being widely used in the pharmaceutical industry. Dr. Yu is a fellow and the past section Chair of the American Association of Pharmaceutical Scientists and an Associate Editor of the AAPS Journal. Dr. Yu has authored/co-authored over 140 papers, and presented over 100 abstracts, and given over 200 invited presentations. He is a co-editor of the books entitled “Biopharmaceutics Applications in Drug Development , “FDA Bioequivalence Standards , and “Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, 2nd Ed. Dr. Yu is the winner of numerous awards including AAiPS distinguished Scientist Award, AAPS Regulatory Science Achievement award, AIChE PD2M Drug Product QbD Achievement Award, Japan Naigai Foundation Distinguished Lectureship, China Beijing University IPEM graduation commencement address, Department of Health and Human Service Outstanding Leadership Award, FDA Commissioner’s Special Citation, Outstanding Achievement, Group Recognition, and Team Excellence awards.
Affiliations and expertise
Deputy Director, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA