Developing Solid Oral Dosage Forms
Pharmaceutical Theory and Practice
3. Auflage
Erschienen am 24. April 2026
1300 Seiten
978-0-443-34157-1 (ISBN)
Beschreibung
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.
- Expanded and updated content: Includes 13 new or extensively rewritten chapters covering topics such as supersaturation, oral absorption, DoE, and its applications in product development, and the latest advancements in 3D printing, continuous manufacturing, modeling, machine learning, and Industry 4.0
- Practical focus: Demonstrates the importance and application of essential pharmaceutical principles to real- world product development challenges
- Comprehensive audience coverage: Serves as a valuable reference for industry product development scientists and engineers, academic researchers, regulatory reviewers, and graduate students
- End-to-end development coverage: Addresses preformulation and biopharmaceutics studies, formulation and process design, characterization, development, scale-up, and commercial manufacturing operations
- Patient-centered design: Introduces patient-centric drug product design processes to support improved therapeutic outcomes
Weitere Details
Weitere Ausgaben
Andere Ausgaben
Yihong Qiu | Yisheng Chen | Geoff G.Z. Zhang
Developing Solid Oral Dosage Forms
Pharmaceutical Theory and Practice
Buch
ca. 03/2026
3. Auflage
Academic Press
340,29 €
Noch nicht erschienen
Inhalt
1. 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. The Fundamentals of Diffusion and Dissolution10. Particle, Powder, and Compact Characterization11. Oral Drug Absorption: Pathways, Physicochemical and Biological Factors, and Methods of Study12. Evaluation of Drug Absorption from Oral Dosage Forms13. Dissolution Testing of Solid Products14. Bioavailability and Bioequivalence15. In Vitro-In Vivo Correlations: Fundamentals, Development Considerations, and Applications16. Oral Delivery of Challenging Poorly Soluble Drugs via Supersaturation: Principles and Applications17. Patient-centric Drug Product Design: Rational and Practical Considerations18. Design of Improved and Differentiated Products through 505(b)(2) NDA Pathway19. Oral Formulations for Preclinical Studies: Principle, Design, and Development20. Product and Process Development of Solid Oral Dosage Forms21. Rational design of Amorphous Solid Dispersions22. Rational Design of Oral Modified-Release Drug Delivery Systems23. Basic Principles of The Design of Experiments24. Established unit operation models for solid oral dosage forms from an industrial perspective25. Analytical Method Development of Solid Dosage Forms26. Statistical Design and Analysis of Long-Term Stability Studies for Drug Products27. Packaging Selection for Solid Oral Dosage Forms28. Clinical Supplies Manufacture: Strategy, GMP Considerations, and Cleaning Validation29. Specification Setting and Manufacturing Process Control for Solid Oral Drug Products30. Process Development and Scale-Up: Providing Reliable Powder Flow and Product Uniformity31. Capsules Dosage Form: Formulation and Manufacturing Considerations32. Process Development and Scale-Up: High Shear Wet Granulation process33. Process Development and Scale-Up: Fluid-bed Granulation34. Process Development and Scale-Up: Spray-Drying Amorphous Solid Dispersions for Insoluble Drugs35. Process development and scale-up: Twin screw extrusion36. Development, Scale-Up, and Optimization of Process Parameters: Roller Compaction Theory and Practice37. Development, Scale-Up and Optimization of Process Parameters: Tablet Compression38. Development and Scale-Up of Process Parameters: Pan Coating39. Development, Scale-Up and Optimization of Process Parameters: Wurster Coating40. Ensuring Commercial Manufacturing and Product Quality Through Science- and AI-Driven Approaches41. Continuous Manufacturing: Modernizing Pharmaceutical Manufacturing with Advanced Technologies and 3D Printing42. Drug Product Approval in the United States and International Harmonization43. Modern Pharmaceutical Regulations: Quality Assessment for Drug Substances44. Modern Pharmaceutical Regulations: Quality Assessment for Drug Products
