Overview

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.

Full Product Details

Author:   Louis Rey ,  Joan C. May
Publisher:   Taylor & Francis Inc
Imprint:   CRC Press Inc
Edition:   3rd edition
Volume:   137
Dimensions:   Width: 15.20cm , Height: 3.60cm , Length: 22.90cm
Weight:   0.952kg
ISBN:  

9781439825754

ISBN 10:   1439825750
Pages:   584
Publication Date:   15 June 2010
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Hardback
Publisher's Status:   Active
Availability:   In Print  
This item will be ordered in for you from one of our suppliers. Upon receipt, we will promptly dispatch it out to you. For in store availability, please contact us.

Table of Contents

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

Reviews

Author Information

Rey, Louis

Tab Content 6

Author Website:  

Customer Reviews

Recent Reviews

No review item found!

Add your own review!

Countries Available

All regions