Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products (eBook, PDF)

Redaktion: Rey, Louis

• Format: PDF

Produktbeschreibung

Freeze-drying, or lyophilization, is a well established technology used in the preservation of numerous pharmaceutical and biological products. This highly effective dehydration method involves the removal of water from frozen materials via the direct sublimation of ice. In recent years, this process has met with many changes, as have the regulations that impact lyophilization practices. This volume addresses these changes with revised chapters on emerging developments in lyophilization technology, research, and industry procedures. Providing both a scientific and industrial perspective, this comprehensive text is a valuable resource for all those who use freeze-drying technology.

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Produktdetails

• Verlag: Taylor & Francis
• Seitenzahl: 584
• Erscheinungstermin: 19. April 2016
• Englisch
• ISBN-13: 9781439825761
• Artikelnr.: 56957811

Autorenporträt

Rey, Louis

Inhaltsangabe

Foreword
Preface
Contributors
1. Glimpses into the Realm of Freeze-Drying: Classical Issues and New Ventures
2. Structural and Dynamic Properties of Bulk and Confined Water
3. Freezing and Annealing Phenomena in Lyophilization
4. Phase Separation of Freeze-Dried Amorphous Solids: The Occurrence and Detection of Multiple Amorphous Phases in Pharmaceutical Systems
5. The Use of Microscopy
Thermal Analysis
and Impedance Measurements to Establish Critical Formulation Parameters for Freeze-Drying Cycle Development
6. The Relevance of Thermal Properties for Improving Formulation and Cycle Development: Application to Freeze-Drying of Proteins
7. Freezing- and Drying-Induced Perturbations of Protein Structure and Mechanisms of Protein Protection by Stabilizing Additives
8. Mechanisms of Protein Stabilization During Freeze-Drying Storage: The Relative Importance of Thermodynamic Stabilization and Glassy State Relaxation Dynamics
9. Formulation Characterization
10. Practical Aspects of Freeze-Drying of Pharmaceutical and Biological Products Using Nonaqueous Cosolvent Systems
11. Regulatory Control of Freeze-Dried Products: Importance and Evaluation of Residual Moisture
12. Freeze-Drying of Biological Standards
13. Molecular Mobility of Freeze-Dried Formulations as Determined by NMR Relaxation Times
and Its Effect on Storage Stability
14. Scanning Electron Microscopy: A Powerful Tool for Imaging Freeze-Dried Material
15. Pharmaceutical Packaging for Lyophilization Applications
16. Closure and Container Considerations in Lyophilization
17. Extractables and Leachables as Container Closure Considerations in Lyophilization
18. Optimizing the Throughput of Freeze-Dryers Within a Constrained Design Space
19. Monitoring and Control of Industrial Freeze-Drying Operations: The Challenge of Implementing Quality-by-Design (QbD)
20. Process Analytical Technology in Industrial Freeze-Drying
21. Practical Considerations for Freeze-Drying in Dual Chamber Package Systems
22. Lyophilization and Irradiation as an Integrated Process
Appendix: Table
Saturation Vapor Pressure Of Ice
Index