Description
Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Second Edition illustrates how to develop high-quality, safe, and effective pharmaceutical products by discussing the latest techniques, tools, and scientific advances in preformulation investigation, formulation, process design, characterization, scale-up, and production operations.This book covers the essential principles of physical pharmacy, biopharmaceutics, and industrial pharmacy, and their application to the research and development process of oral dosage forms. Chapters have been added, combined, deleted, and completely revised as necessary to produce a comprehensive, well-organized, valuable reference for industry professionals and academics engaged in all aspects of the development process.New and important topics include spray drying, amorphous solid dispersion using hot-melt extrusion, modeling and simulation, bioequivalence of complex modified-released dosage forms, biowaivers, and much more.- Written and edited by an international team of leading experts with experience and knowledge across industry, academia, and regulatory settings- Includes new chapters covering the pharmaceutical applications of surface phenomenon, predictive biopharmaceutics and pharmacokinetics, the development of formulations for drug discovery support, and much more- Presents new case studies throughout, and a section completely devoted to regulatory aspects, including global product regulation and international perspectives
Table of Contents
Part I: Theories and Techniques in the Characterization of Drug Substances and Excipients1. Solubility of Pharmaceutical Solids2. Crystalline and Amorphous Solids3. Solid-State Characterization and Techniques4. API Solid-Form Screening and Selection5. Drug Stability and Degradation Studies6. Excipient Compatibility and Functionality7. Polymer Properties and Characterization8. Interfacial Phenomena9. Fundamental of Diffusion and Dissolution10. Particle, Powder, and Compact CharacterizationPart II: Biopharmaceutical and Pharmacokinetic Evaluations of Drug Molecules and Dosage Forms11. Oral Absorption Basics: Pathways and Physicochemical and Biological Factors Affecting Absorption12. Oral Drug Absorption: Evaluation and Prediction13. Dissolution Testing of Solid Products14. Bioavailability and Bioequivalence15. Predictive Biopharmaceutics and Pharmacokinetics: Modeling and Simulation16. In Vitro/In Vivo Correlations: Fundamentals, Development Considerations, and ApplicationsPart III: Design, Development and Scale-Up of Formulation and Manufacturing Process17. Oral Formulations for Preclinical Studies: Principle, Design, and Development Considerations18. Rational Design for Amorphous Solid Dispersions19. Rational Design of Oral Modified-Release Drug Delivery Systems20. Product and Process Development of Solid Oral Dosage Forms21. Analytical Development and Validation for Solid Oral Dosage Forms22. Statistical Design and Analysis of Long-Term Stability Studies for Drug Products23. Packaging Selection for Solid Oral Dosage Forms24. Clinical Supplies Manufacture: Strategy, GMP Considerations, and Cleaning Validation25. Specification Setting and Manufacturing Process Control for Solid Oral Drug Products26. Process Development, Optimization, and Scale-Up: Providing Reliable Powder Flow and Product Uniformity27. Capsules Dosage Form: Formulation and Manufacturing Considerations28. Design, Development, and Scale-Up of the High-Shear Wet Granulation Process29. Process Development, Optimization, and Scale-Up: Fluid-Bed Granulation30. Formulation, Process Development, and Scale-Up: Spray-Drying Amorphous Solid Dispersions for Insoluble Drugs31. Process Development and Scale-Up: Twin-Screw Extrusion32. Development, Scale-Up, and Optimization of Process Parameters: Roller Compaction Theory and Practice33. Development, Optimization, and Scale-Up of Process Parameters: Tablet Compression34. Development, Optimization, and Scale-Up of Process Parameters: Pan Coating35. Development, Optimization, and Scale-Up of Process Parameters: Wurster Coating36. Commercial Manufacturing and Product Quality37. Emerging Technology for Modernizing Pharmaceutical Production: Continuous ManufacturingPart IV: Regulatory Aspects of Product Development38. Drug Product Approval in the United States and International Harmonization39. Modern Pharmaceutical Regulations: Quality Assessment for Drug Substances40. Modern Pharmaceutical Regulations: Quality Assessment for Drug Products
