Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice

The second edition of Developing Solid Oral Dosage Forms illustrates how to develop high-quality, safe and effective pharmaceutical products by discussing the latest techniques, tools and scientific advances in preformulation investigation, formulation and process design, characterization and scale-up and production operations. This book continues to cover 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 and 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, modelling and simulation, bioequivalence of complex modified-released dosage forms, biowaivers and much more. Written and edited by a team of international 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 the book and a section completely devoted to regulatory aspects, including global product regulation and international perspectives INDICE: Part I: Theories and Techniques in the Characterization of Drug Substances and Excipients 1. Solubility of Pharmaceutical Solids 2. Crystalline and Amorphous Solids 3. Analytical Techniques in Solid State Characterization 4. Salt and Solid Form Screening and Selection 5. Drug Stability and Degradation Studies 6. Excipient Functionality and Compatibility 7. Polymer Properties and Characterization 8. Surface phenomenon and pharmaceutical applications 9. The Fundamentals 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, Physicochemical and Biological Factors, and Methods of Stud 12. Oral Absorption Evaluation 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. Development of formulations for drug discovery support 18. Enabling formulation technology for developing solid dosage form of insoluble drugs 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 Dosage Forms 22. Statistical Design and Analysis of Long Term Stability Studies for Drug Products 23. Packaging Selection for Solid Dosage Form 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 and Scale-Up: Powder Handling and Segregation Concerns 27. The Formulation and Manufacturing of Capsules 28. Process Development and Scale-Up: High Shear Wet Granulation (high shear) 29. Process Development and Scale-Up: Fluid-bed Granulation 30. Process Development and Scale-Up: Spray Drying 31. Process Development and Scale-Up: Twin Screw Extrusion 32. Development, Scale-Up and Optimization of Process Parameters: Roller Compaction 33. Development, Scale-Up and Optimization of Process Parameters: Compression 34. Development and Scale-Up of Process Parameters: Pan Coating 35. Development, Scale-Up and Optimization of Process Parameters: Wurster Coating 36. Commercial Manufacturing and Product Quality 37. Emerging Manufacturing Technology and Continuous Manufacturing  Part IV: Regulatory Aspects of Product Development 38. Product Registration and Regulatory Approval Process 39. Question-based Review for Drug Substance 40. Question-based Review for Drug Product

• ISBN: 978-0-12-802447-8
• Editorial: Academic Press
• Encuadernacion: Cartoné
• Páginas: 992
• Fecha Publicación: 31/10/2016
• Nº Volúmenes: 1
• Idioma: Inglés