Full Description
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.
Contents
Part 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 Phenomena
9. Fundamental of Diffusion and Dissolution
10. Particle, Powder, and Compact Characterization
Part II: Biopharmaceutical and Pharmacokinetic Evaluations of Drug Molecules and Dosage Forms
11. Oral Absorption Basics: Pathways and Physicochemical and Biological Factors Affecting Absorption
12. Oral Drug Absorption: Evaluation and Prediction
13. Dissolution Testing of Solid Products
14. Bioavailability and Bioequivalence
15. Predictive Biopharmaceutics and Pharmacokinetics: Modeling and Simulation
16. In Vitro/In Vivo Correlations: Fundamentals, Development Considerations, and Applications
Part III: Design, Development and Scale-Up of Formulation and Manufacturing Process
17. Oral Formulations for Preclinical Studies: Principle, Design, and Development Considerations
18. Rational Design for Amorphous Solid Dispersions
19. Rational Design of Oral Modified-Release Drug Delivery Systems
20. Product and Process Development of Solid Oral Dosage Forms
21. Analytical Development and Validation for Solid Oral Dosage Forms
22. Statistical Design and Analysis of Long-Term Stability Studies for Drug Products
23. Packaging Selection for Solid Oral Dosage Forms
24. Clinical Supplies Manufacture: Strategy, GMP Considerations, and Cleaning Validation
25. Specification Setting and Manufacturing Process Control for Solid Oral Drug Products
26. Process Development, Optimization, and Scale-Up: Providing Reliable Powder Flow and Product Uniformity
27. Capsules Dosage Form: Formulation and Manufacturing Considerations
28. Design, Development, and Scale-Up of the High-Shear Wet Granulation Process
29. Process Development, Optimization, and Scale-Up: Fluid-Bed Granulation
30. Formulation, Process Development, and Scale-Up: Spray-Drying Amorphous Solid Dispersions for Insoluble Drugs
31. Process Development and Scale-Up: Twin-Screw Extrusion
32. Development, Scale-Up, and Optimization of Process Parameters: Roller Compaction Theory and Practice
33. Development, Optimization, and Scale-Up of Process Parameters: Tablet Compression
34. Development, Optimization, and Scale-Up of Process Parameters: Pan Coating
35. Development, Optimization, and Scale-Up of Process Parameters: Wurster Coating
36. Commercial Manufacturing and Product Quality
37. Emerging Technology for Modernizing Pharmaceutical Production: Continuous Manufacturing
Part IV: Regulatory Aspects of Product Development
38. Drug Product Approval in the United States and International Harmonization
39. Modern Pharmaceutical Regulations: Quality Assessment for Drug Substances
40. Modern Pharmaceutical Regulations: Quality Assessment for Drug Products
