Description
Developing Solid Oral Dosage Forms 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- It 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
Table of Contents
1. Solubility of Pharmaceutical Solids2. 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 Studies6. Excipient Compatibility7. Theory of Diffusion and Pharmaceutical Applications8. Particle, Powder and Compact Characterization9. Polymer Properties and Characterization 10. Applied Statistics in Product Development11. Oral Absorption Basics: Pathways, Physicochemical and Biological Factors, and Methods of Study12. Oral Absorption Evaluation and Prediction13. Fundamentals of Dissolution14. Dissolution Testing of Solid Products15. Bioavailability and Bioequivalence16. In Vivo Evaluation of Dosage Form Performance17. In Vitro-In Vivo Correlations: Fundamentals, Applications and Development Considerations18. Integration of physical, chemical, mechanical and biopharmaceutical properties in solid oral dosage form development19. Design and Development of Self-Emulsifying Drug Delivery Systems for Enhanced Oral Absorption of Poorly Soluble Compounds20. Rational Design of Oral Modified-Release Drug Delivery Systems21. Development of Modified-Releas Oral Dosage Forms22. Analytical Development and Validation for Solid Oral Dosage Forms23. Statistical Design and Analysis of Long Term Stabilty Studies for Drug Products24. Packaging selection for solid dosage forms25. Clincial Supplies Manufacture26. Specification Setting and Manufacturing Process Control for Solid Oral Drug Products27. Scale-Up Of Pharmaceutical Manufacturing Operation of Solid Dosage Forms28. Process Development, Optimization and Scale-Up: Powder Handling and Segregation Concerns29. Process Development and Scale-Up of Wet Granulation by High-Shear Process30. Development,Scale-Up and Optimization of Fluid-bed Granulation31. Development, Optimization and Scale-Up of Process Parameters: Roller Compaction32. Development, Optimization And Scale-Up Of Process Parameters: Compression33. Development, Optimization & Scale-Up of Process Parameters: Pan Coating34. Development, Optimization And Scale-Up Of Process Parameters: Wurster Coating35. Process Analytical Technology36. The Product Development Process 37. Product Registration and Drug Approval Process38. Modern Pharmaceutical Development Regulations39. Intellectual Property in Pharmaceutical Development40. Product Life-Cycle Management
