Developing Solid Oral Dosage Forms

Name: Developing Solid Oral Dosage Forms
Author: Yihong Qiu

Pharmaceutical Theory and Practice

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Paperback, blz. | Engels

Elsevier Science | e druk, 2026

ISBN13: 9780443341564

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Elsevier Science e druk, 2026 9780443341564

€ 389,79

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Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Third Edition is a comprehensive and up-to-date guide for professionals and academics engaged in all aspects of oral dosage form development, from discovery support through commercial manufacturing. This new edition features 13 new or rewritten chapters, along with significant updates to existing content, reflecting the latest advancements in the field, including new theories, scientific findings, approaches, techniques, modeling, and the emerging opportunities offered by AI.
This book consists of 44 chapters covering in-depth principles of physical pharmacy, biopharmaceutics, and industrial pharmacy, and their applications throughout the R&D process and commercial production of oral dosage forms. New chapters address topics such as absorption evaluation of oral dosage forms, formulation principles, and applications based on supersaturation, patient-centric product design, product design through the 505(b)(2) NDA pathway, design of experiments (DoE), process modeling, 3D printing, and machine learning applications in commercial manufacturing. Existing chapters have been updated or completely rewritten to provide advanced information and include practical case studies. Important topics such as amorphous solid dispersions, modified-release delivery, manufacturing technologies, modeling and simulation, fundamentals of dissolution and bioequivalence, IVIVC, biowaivers, regulatory frameworks, and many others are covered.
The new edition of this book is an indispensable resource for industry professionals, academic institutions, and regulatory bodies seeking to stay current with advances in solid dosage form development and manufacturing. It offers a thorough understanding of fundamental principles and techniques, along with practical guidance on applying these concepts to real-world challenges.

Specificaties

ISBN13:9780443341564

Taal:Engels

Bindwijze:paperback

Uitgever:Elsevier Science

Inhoudsopgave

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. The Fundamentals of Diffusion and Dissolution 10. Particle, Powder, and Compact Characterization 11. Oral Drug Absorption: Pathways, Physicochemical and Biological Factors, and Methods of Study 12. Evaluation of Drug Absorption from Oral Dosage Forms 13. Dissolution Testing of Solid Products 14. Bioavailability and Bioequivalence 15. In Vitro-In Vivo Correlations: Fundamentals, Development Considerations, and Applications 16. Oral Delivery of Challenging Poorly Soluble Drugs via Supersaturation: Principles and Applications 17. Patient-centric Drug Product Design: Rational and Practical Considerations 18. Design of Improved and Differentiated Products through 505(b)(2) NDA Pathway 19. Oral Formulations for Preclinical Studies: Principle, Design, and Development 20. Product and Process Development of Solid Oral Dosage Forms 21. Rational design of Amorphous Solid Dispersions 22. Rational Design of Oral Modified-Release Drug Delivery Systems 23. Basic Principles of The Design of Experiments 24. Established unit operation models for solid oral dosage forms from an industrial perspective 25. Analytical Method Development of Solid Dosage Forms 26. Statistical Design and Analysis of Long-Term Stability Studies for Drug Products 27. Packaging Selection for Solid Oral Dosage Forms 28. Clinical Supplies Manufacture: Strategy, GMP Considerations, and Cleaning Validation 29. Specification Setting and Manufacturing Process Control for Solid Oral Drug Products 30. Process Development and Scale-Up: Providing Reliable Powder Flow and Product Uniformity 31. Capsules Dosage Form: Formulation and Manufacturing Considerations 32. Process Development and Scale-Up: High Shear Wet Granulation process 33. Process Development and Scale-Up: Fluid-bed Granulation 34. Process Development and Scale-Up: Spray-Drying Amorphous Solid Dispersions for Insoluble Drugs 35. Process development and scale-up: Twin screw extrusion 36. Development, Scale-Up, and Optimization of Process Parameters: Roller Compaction Theory and Practice 37. Development, Scale-Up and Optimization of Process Parameters: Tablet Compression 38. Development and Scale-Up of Process Parameters: Pan Coating 39. Development, Scale-Up and Optimization of Process Parameters: Wurster Coating 40. Ensuring Commercial Manufacturing and Product Quality Through Science- and AI-Driven Approaches 41. Continuous Manufacturing: Modernizing Pharmaceutical Manufacturing with Advanced Technologies and 3D Printing 42. Drug Product Approval in the United States and International Harmonization 43. Modern Pharmaceutical Regulations: Quality Assessment for Drug Substances 44. Modern Pharmaceutical Regulations: Quality Assessment for Drug Products

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