Developing Solid Oral Dosage Forms Pharmaceutical Theory and Practice

Yihong Qiu , Yisheng Chen , Geoff G.Z. Zhang , Lawrence Yu , Rao V. Mantri 지음

elsevier 2016년 11월 08일 출간

작품소개

책소개

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

목차

Part I: Theories and Techniques in the Characterization of Drug Substances and Excipients Chapter 1. Solubility of Pharmaceutical Solids Chapter 2. Crystalline and Amorphous Solids Chapter 3. Solid-State Characterization and Techniques Chapter 4. API Solid-Form Screening and Selection Chapter 5. Drug Stability and Degradation Studies Chapter 6. Excipient Compatibility and Functionality Chapter 7. Polymer Properties and Characterization Chapter 8. Interfacial Phenomena Chapter 9. Fundamental of Diffusion and Dissolution Chapter 10. Particle, Powder, and Compact Characterization Part II: Biopharmaceutical and Pharmacokinetic Evaluations of Drug Molecules and Dosage Forms Chapter 11. Oral Absorption Basics: Pathways and Physicochemical and Biological Factors Affecting Absorption Chapter 12. Oral Drug Absorption: Evaluation and Prediction Chapter 13. Dissolution Testing of Solid Products Chapter 14. Bioavailability and Bioequivalence Chapter 15. Predictive Biopharmaceutics and Pharmacokinetics: Modeling and Simulation Chapter 16. In Vitro/In Vivo Correlations: Fundamentals, Development Considerations, and Applications Part III: Design, Development and Scale-Up of Formulation and Manufacturing Process Chapter 17. Oral Formulations for Preclinical Studies: Principle, Design, and Development Considerations Chapter 18. Rational Design for Amorphous Solid Dispersions Chapter 19. Rational Design of Oral Modified-Release Drug Delivery Systems Chapter 20. Product and Process Development of Solid Oral Dosage Forms Chapter 21. Analytical Development and Validation for Solid Oral Dosage Forms Chapter 22. Statistical Design and Analysis of Long-Term Stability Studies for Drug Products Chapter 23. Packaging Selection for Solid Oral Dosage Forms Chapter 24. Clinical Supplies Manufacture: Strategy, GMP

작가정보

저자(글) Yihong Qiu

저자(글) Yisheng Chen

저자(글) Geoff G.Z. Zhang

저자(글) Lawrence Yu

저자(글) Rao V. Mantri