Developing Solid Oral Dosage Forms : Pharmaceutical Theory and Practice （3RD）

Qiu, Yihong (EDT)/ Chen, Yisheng (EDT)/ Zhang, Geoff G.Z. (EDT)

Academic Press Inc（2026/01発売）

• ページ数 1300 p.
• 言語 ENG
• 商品コード 9780443341564

Full Description

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 the development process of oral dosage forms. This new edition reflects the significant impact of AI and ML on pharmaceutical science in recent years, with six new chapters and extensive updates to existing content. The book covers essential principles of physical pharmacy, biopharmaceutics, and industrial pharmacy, as well as their application to the research and development process of oral dosage forms. The Third Edition features new chapters on Evaluation of Drug Absorption from Oral Dosage Forms, Dissolution Evaluation of Enabling Formulations Based on Supersaturation, Patient-Centric Drug Product Design, and Design of Improved and Differentiated Products through 505(b)(2) NDA Pathway. Additionally, existing chapters have been updated, combined, or completely rewritten to provide a well-organized and valuable reference. Topics such as spray drying, amorphous solid dispersion using hot-melt extrusion, modeling and simulation, bioequivalence of complex modified-release dosage forms, biowaivers, and more are covered in this edition. Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Third Edition is an indispensable resource for industry professionals and academics looking to stay current with the latest advancements in solid formulation development. This book not only provides a thorough understanding of the principles and techniques involved in the development process but also offers practical guidance on how to apply these concepts to real-world situations. With its extensive coverage of new topics and updates to existing chapters, this edition is an essential tool for those working in the field of pharmaceutical science.

Contents

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 Phenomenon
9. The Fundamentals of Diffusion and Dissolution
10. Particle, Powder, and Compact Characterization

II: Biopharmaceutical and Pharmacokinetic Evaluations of Drug Molecules and Dosage Forms
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 Oral Products
14. Bioavailability and Bioequivalence
15. Dissolution Evaluation of Enabling Formulations Based on Supersaturation
16. In Vitro-In Vivo Correlations: Fundamentals, Development Considerations and Applications

III: Design, Development and Scale-up of Formulation and Manufacturing Process
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 Development of Amorphous Solid Dispersions
22. Rational Design of Oral Modified-Release Drug Delivery Systems
23. Basics and Applications of DOE in Product Development, Scale-up and Optimization
24. Modeling of Manufacturing Processes of Solid Drug Products
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 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. Capsule Dosage Forms: 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 Hot Melt Extrusion and Continuous Granulation
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. Commercial Manufacturing and Product Quality
41. New Technologies for Modernizing Pharmaceutical Production: Continuous Manufacturing and 3D printing
42. Machine Learning and Artificial Intelligence in Product & Process Development and Manufacturing Part IV: Regulatory Aspects of Product Development
43. Drug Product Approval in the US and ICH
44. Modern Pharmaceutical Regulations: Quality Assessment for Drug Substance
45. Modern Pharmaceutical Regulations: Quality Assessment for Drug Products