Qiu Y., Chen Y. et al. (eds.) Developing Solid Oral Dosage Forms. Pharmaceutical Theory & Practice

Academic Press, 2009. — 978 p.This book 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, t 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.Solubility of Pharmaceutical Solids
Crystalline and Amorphous Solids
Analytical Techniques in Solid State Characterization
Salt Screening and Selection: New Challenges and Considerations in the Modern Pharmaceutical R&D Paradigm
Drug Stability and Stability Studies
Excipient Compatibility
Theory of Diffusion and Pharmaceutical Applications
Particle, Powder and Compact Characterization
Polymer Properties and Characterization
Applied Statistics in Product Development
Oral Absorption Basics: Pathways, Physicochemical and Biological Factors, and Methods of Study
Oral Absorption Evaluation and Prediction
Fundamentals of Dissolution
Dissolution Testing of Solid Products
Bioavailability and Bioequivalence
In Vivo Evaluation of Dosage Form Performance
In Vitro-In Vivo Correlations: Fundamentals, Applications and Development Considerations
Integration of physical, chemical, mechanical and biopharmaceutical properties in solid oral dosage form development
Design and Development of Self-Emulsifying Drug Delivery Systems for Enhanced Oral Absorption of Poorly Soluble Compounds
Rational Design of Oral Modified-Release Drug Delivery Systems
Development of Modified-Releas Oral Dosage Forms
Analytical Development and Validation for Solid Oral Dosage Forms
Statistical Design and Analysis of Long Term Stabilty Studies for Drug Products
Packaging selection for solid dosage forms
Clincial Supplies Manufacture
Specification Setting and Manufacturing Process Control for Solid Oral Drug Products
Scale-Up Of Pharmaceutical Manufacturing Operation of Solid Dosage Forms
Process Development, Optimization and Scale-Up: Powder Handling and Segregation Concerns
Process Development and Scale-Up of Wet Granulation by High-Shear Process
Development, Scale-Up and Optimization of Fluid-bed Granulation
Development, Optimization and Scale-Up of Process Parameters: Roller Compaction
Development, Optimization And Scale-Up Of Process Parameters: Compression
Development, Optimization & Scale-Up of Process Parameters: Pan Coating
Development, Optimization And Scale-Up Of Process Parameters: Wurster Coating
Process Analytical Technology
The Product Development Process
Product Registration and Drug Approval Process
Modern Pharmaceutical Development Regulations
Intellectual Property in Pharmaceutical Development
Product Life-Cycle Management