Developing Solid Oral Dosage Forms
Pharmaceutical Theory & PracticeEdited by
- Yihong Qiu, Abbott Laboratories, IL, USA
- Yisheng Chen, Novast Laboratories, Nantong, China
- Geoff Zhang, Abbott Laboratories, IL, USA
- Lirong Liu, Pfizer Inc., NJ, USA
- William Porter, Abbott Laboratories, IL, USA
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
PRIMARY MARKET: Pharmaceutical researchers at both pharmaceutical companies & academic institutions focused on developing solid dosage forms fpr drug delivery.
SECONDARY MARKET: Advanced graduate level courses in the pharmaceutical sciences programs in the US and EMEA.
Hardbound, 978 Pages
Published: December 2008
Imprint: Academic Press
- Ch 1 Solubility of Pharmaceutical SolidsCh 2 Crystalline and Amorphous Solids Ch 3 Analytical Techniques in Solid State Characterization Ch 4 Salt Screening and Selection: New Challenges and Considerations in the Modern Pharmaceutical R&D Paradigm Ch 5 Drug Stability and Stability StudiesCh 6 Excipient CompatibilityCh 7 Theory of Diffusion and Pharmaceutical ApplicationsCh 8 Particle, Powder and Compact CharacterizationCh 9 Polymer Properties and Characterization Ch 10 Applied Statistics in Product DevelopmentCh 11 Oral Absorption Basics: Pathways, Physicochemical and Biological Factors, and Methods of StudyCh 12 Oral Absorption Evaluation and PredictionCh 13 Fundamentals of DissolutionCh 14 Dissolution Testing of Solid ProductsCh 15 Bioavailability and BioequivalenceCh 16 In Vivo Evaluation of Dosage Form PerformanceCh 17 In Vitro-In Vivo Correlations: Fundamentals, Applications and Development ConsiderationsCh 18 Integration of physical, chemical, mechanical and biopharmaceutical properties in solid oral dosage form developmentCh 19 Design and Development of Self-Emulsifying Drug Delivery Systems for Enhanced Oral Absorption of Poorly Soluble CompoundsCh 20 Rational Design of Oral Modified-Release Drug Delivery SystemsCh 21 Development of Modified-Releas Oral Dosage FormsCh 22 Analytical Development and Validation for Solid Oral Dosage FormsCh 23 Statistical Design and Analysis of Long Term Stabilty Studies for Drug ProductsCh 24 Packaging selection for solid dosage formsCh 25 Clincial Supplies ManufactureCh 26 Specification Setting and Manufacturing Process Control for Solid Oral Drug ProductsCh 27 Scale-Up Of Pharmaceutical Manufacturing Operation of Solid Dosage FormsCh 28 Process Development, Optimization and Scale-Up: Powder Handling and Segregation ConcernsCh 29 Process Development and Scale-Up of Wet Granulation by High-Shear ProcessCh 30 Development,Scale-Up and Optimization of Fluid-bed GranulationCh 31 Development, Optimization and Scale-Up of Process Parameters: Roller CompactionCh 32 Development, Optimization And Scale-Up Of Process Parameters: CompressionCh 33 Development, Optimization & Scale-Up of Process Parameters: Pan CoatingCh 34 Development, Optimization And Scale-Up Of Process Parameters: Wurster CoatingCh 35 Process Analytical TechnologyCh 36 The Product Development Process Ch 37 Product Registration and Drug Approval ProcessCh 38 Modern Pharmaceutical Development RegulationsCh 39 Intellectual Property in Pharmaceutical DevelopmentCh 40 Product Life-Cycle Management