Developing Solid Oral Dosage Forms. Pharmaceutical Theory and Practice

Table of Contents

1. Solubility of Pharmaceutical Solids 2. Crystalline and Amorphous Solids� 3. Analytical Techniques in Solid State Characterization� 4. Salt Screening and Selection: New Challenges and Considerations in the Modern Pharmaceutical R&D Paradigm� 5. Drug Stability and Stability Studies 6. Excipient Compatibility 7. Theory of Diffusion and Pharmaceutical Applications 8. Particle, Powder and Compact Characterization 9. Polymer Properties and Characterization� 10. Applied Statistics in Product Development 11. Oral Absorption Basics: Pathways, Physicochemical and Biological Factors, and Methods of Study 12. Oral Absorption Evaluation and Prediction 13. Fundamentals of Dissolution 14. Dissolution Testing of Solid Products 15. Bioavailability and Bioequivalence 16. In Vivo Evaluation of Dosage Form Performance 17. In Vitro-In Vivo Correlations: Fundamentals, Applications and Development Considerations 18. Integration of physical, chemical, mechanical and biopharmaceutical properties in solid oral dosage form development 19. Design and Development of Self-Emulsifying Drug Delivery Systems for Enhanced Oral Absorption of Poorly Soluble Compounds 20. Rational Design of Oral Modified-Release Drug Delivery Systems 21. Development of Modified-Releas Oral Dosage Forms 22. Analytical Development and Validation for Solid Oral Dosage Forms 23. Statistical Design and Analysis of Long Term Stabilty Studies for Drug Products 24. Packaging selection for solid dosage forms 25. Clincial Supplies Manufacture 26. Specification Setting and Manufacturing Process Control for Solid Oral Drug Products 27. Scale-Up Of Pharmaceutical Manufacturing Operation of Solid Dosage Forms 28. Process Development, Optimization and Scale-Up: Powder Handling and Segregation Concerns 29. Process Development and Scale-Up of Wet Granulation by High-Shear Process 30. Development,Scale-Up and Optimization of Fluid-bed Granulation 31. Development, Optimization and Scale-Up of Process Parameters: Roller Compaction 32. Development, Optimization And Scale-Up Of Process Parameters: Compression 33. Development, Optimization & Scale-Up of Process Parameters: Pan Coating 34. Development, Optimization And Scale-Up Of Process Parameters: Wurster Coating 35. Process Analytical Technology 36. The Product Development Process� 37. Product Registration and Drug Approval Process 38. Modern Pharmaceutical Development Regulations 39. Intellectual Property in Pharmaceutical Development 40. Product Life-Cycle Management

Authors

Yihong Qiu PhD, Senior Research Fellow, Oral Drug Products, Manufacturing Science and Technology, AbbVie Inc., North Chicago, IL, USA. 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. Yisheng Chen Vice President, Novast Laboratories, Nantong, China. 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. Geoff G.Z. Zhang Senior Research Fellow, Drug Product Development, Abbvie, Inc., North Chicago, IL, USA. 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. Lirong Liu Pfizer Inc., NJ, USA. William Porter Abbott Laboratories, IL, USA.