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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 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.
Contents
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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