Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice

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 settingsIncludes new chapters covering the pharmaceutical applications of surface phenomenon, predictive biopharmaceutics and pharmacokinetics, the development of formulations for drug discovery support, and much morePresents new case studies throughout, and a section completely devoted to regulatory aspects, including global product regulation and international perspectives

Part I: Theories and Techniques in the Characterization of Drug Substances and Excipients 1. Solubility of Pharmaceutical Solids 2. Crystalline and Amorphous Solids 3. Solid-State Characterization and Techniques 4. API Solid-Form Screening and Selection 5. Drug Stability and Degradation Studies 6. Excipient Compatibility and Functionality 7. Polymer Properties and Characterization 8. Interfacial Phenomena 9. Fundamental of Diffusion and Dissolution 10. Particle, Powder, and Compact Characterization

Part II: Biopharmaceutical and Pharmacokinetic Evaluations of Drug Molecules and Dosage Forms 11. Oral Absorption Basics: Pathways and Physicochemical and Biological Factors Affecting Absorption 12. Oral Drug Absorption: Evaluation and Prediction 13. Dissolution Testing of Solid Products 14. Bioavailability and Bioequivalence 15. Predictive Biopharmaceutics and Pharmacokinetics: Modeling and Simulation 16. In Vitro/In Vivo Correlations: Fundamentals, Development Considerations, and Applications

Part III: Design, Development and Scale-Up of Formulation and Manufacturing Process 17. Oral Formulations for Preclinical Studies: Principle, Design, and Development Considerations 18. Rational Design for Amorphous Solid Dispersions 19. Rational Design of Oral Modified-Release Drug Delivery Systems 20. Product and Process Development of Solid Oral Dosage Forms 21. Analytical Development and Validation for Solid Oral Dosage Forms 22. Statistical Design and Analysis of Long-Term Stability Studies for Drug Products 23. Packaging Selection for Solid Oral Dosage Forms 24. Clinical Supplies Manufacture: Strategy, GMP Considerations, and Cleaning Validation 25. Specification Setting and Manufacturing Process Control for Solid Oral Drug Products 26. Process Development, Optimization, and Scale-Up: Providing Reliable Powder Flow and Product Uniformity 27. Capsules Dosage Form: Formulation and Manufacturing Considerations 28. Design, Development, and Scale-Up of the High-Shear Wet Granulation Process 29. Process Development, Optimization, and Scale-Up: Fluid-Bed Granulation 30. Formulation, Process Development, and Scale-Up: Spray-Drying Amorphous Solid Dispersions for Insoluble Drugs 31. Process Development and Scale-Up: Twin-Screw Extrusion 32. Development, Scale-Up, and Optimization of Process Parameters: Roller Compaction Theory and Practice 33. Development, Optimization, and Scale-Up of Process Parameters: Tablet Compression 34. Development, Optimization, and Scale-Up of Process Parameters: Pan Coating 35. Development, Optimization, and Scale-Up of Process Parameters: Wurster Coating 36. Commercial Manufacturing and Product Quality 37. Emerging Technology for Modernizing Pharmaceutical Production: Continuous Manufacturing

Part IV: Regulatory Aspects of Product Development 38. Drug Product Approval in the United States and International Harmonization 39. Modern Pharmaceutical Regulations: Quality Assessment for Drug Substances 40. Modern Pharmaceutical Regulations: Quality Assessment for Drug Products