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Developing Solid Oral Dosage Forms (2nd Ed.) Pharmaceutical Theory and Practice

Langue : Anglais

Auteur :

Couverture de l’ouvrage Developing Solid Oral Dosage Forms

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.



  • Written and edited by an international team of leading experts with experience and knowledge across industry, academia, and regulatory settings
  • Includes new chapters covering the pharmaceutical applications of surface phenomenon, predictive biopharmaceutics and pharmacokinetics, the development of formulations for drug discovery support, and much more
  • Presents new case studies throughout, and a section completely devoted to regulatory aspects, including global product regulation and international perspectives

Part I: Theories and Techniques in the Characterization of Drug Substances and Excipients

Chapter 1. Solubility of Pharmaceutical Solids

Chapter 2. Crystalline and Amorphous Solids

Chapter 3. Solid-State Characterization and Techniques

Chapter 4. API Solid-Form Screening and Selection

Chapter 5. Drug Stability and Degradation Studies

Chapter 6. Excipient Compatibility and Functionality

Chapter 7. Polymer Properties and Characterization

Chapter 8. Interfacial Phenomena

Chapter 9. Fundamental of Diffusion and Dissolution

Chapter 10. Particle, Powder, and Compact Characterization

Part II: Biopharmaceutical and Pharmacokinetic Evaluations of Drug Molecules and Dosage Forms

Chapter 11. Oral Absorption Basics: Pathways and Physicochemical and Biological Factors Affecting Absorption

Chapter 12. Oral Drug Absorption: Evaluation and Prediction

Chapter 13. Dissolution Testing of Solid Products

Chapter 14. Bioavailability and Bioequivalence

Chapter 15. Predictive Biopharmaceutics and Pharmacokinetics: Modeling and Simulation

Chapter 16. In Vitro/In Vivo Correlations: Fundamentals, Development Considerations, and Applications

Part III: Design, Development and Scale-Up of Formulation and Manufacturing Process

Chapter 17. Oral Formulations for Preclinical Studies: Principle, Design, and Development Considerations

Chapter 18. Rational Design for Amorphous Solid Dispersions

Chapter 19. Rational Design of Oral Modified-Release Drug Delivery Systems

Chapter 20. Product and Process Development of Solid Oral Dosage Forms

Chapter 21. Analytical Development and Validation for Solid Oral Dosage Forms

Chapter 22. Statistical Design and Analysis of Long-Term Stability Studies for Drug Products

Chapter 23. Packaging Selection for Solid Oral Dosage Forms

Chapter 24. Clinical Supplies Manufacture: Strategy, GMP Considerations, and Cleaning Validation

Chapter 25. Specification Setting and Manufacturing Process Control for Solid Oral Drug Products

Chapter 26. Process Development, Optimization, and Scale-Up: Providing Reliable Powder Flow and Product Uniformity

Chapter 27. Capsules Dosage Form: Formulation and Manufacturing Considerations

Chapter 28. Design, Development, and Scale-Up of the High-Shear Wet Granulation Process

Chapter 29. Process Development, Optimization, and Scale-Up: Fluid-Bed Granulation

Chapter 30. Formulation, Process Development, and Scale-Up: Spray-Drying Amorphous Solid Dispersions for Insoluble Drugs

Chapter 31. Process Development and Scale-Up: Twin-Screw Extrusion

Chapter 32. Development, Scale-Up, and Optimization of Process Parameters: Roller Compaction Theory and Practice

Chapter 33. Development, Optimization, and Scale-Up of Process Parameters: Tablet Compression

Chapter 34. Development, Optimization, and Scale-Up of Process Parameters: Pan Coating

Chapter 35. Development, Optimization, and Scale-Up of Process Parameters: Wurster Coating

Chapter 36. Commercial Manufacturing and Product Quality

Chapter 37. Emerging Technology for Modernizing Pharmaceutical Production: Continuous Manufacturing

Part IV: Regulatory Aspects of Product Development

Chapter 38. Drug Product Approval in the United States and International Harmonization

Chapter 39. Modern Pharmaceutical Regulations: Quality Assessment for Drug Substances

Chapter 40. Modern Pharmaceutical Regulations: Quality Assessment for Drug Products

Pharmaceutical researchers in industry and at academic institutions focused on developing solid dosage forms for drug delivery; professors and students involved in advanced graduate level courses in pharmaceutical sciences programs

Date de parution :

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Disponible chez l'éditeur (délai d'approvisionnement : 14 jours).

Prix indicatif 236,94 €

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