Rey L., May J.C (eds.) Freeze-Drying/Lyophilization of Pharmaceutical & Biological Products

3rd Edition. - Informa Healthcare, 2010. - 580 p.
Highlights the application of freeze-drying to pharmaceuticals, illustrating practical and industry-tested methods of preserving and reactivating delicate biologicals and biochemicals. The text discusses the basic principles and engineering aspects of lyophilization, and also the role of bulking agents, cryoprotectants, antioxidants, free radicals, and other products that protect the biological integrity of active substances during freezing, drying and storage.Glimpses into the Realm of Freeze-Drying: Classical Issues and New Ventures
Structural and Dynamic Properties of Bulk and Confined Water
Freezing and Annealing Phenomena in Lyophilization
Phase Separation of Freeze-Dried Amorphous Solids: The Occurrence and Detection of Multiple Amorphous Phases in Pharmaceutical Systems
The Use of Microscopy, Thermal Analysis, and Impedance Measurements to Establish Critical Formulation Parameters for Freeze-Drying Cycle Development
The Relevance of Thermal Properties for Improving Formulation and Cycle Development: Application to Freeze-Drying of Proteins
Freezing- and Drying-Induced Perturbations of Protein Structure and Mechanisms of Protein Protection by Stabilizing Additives
Mechanisms of Protein Stabilization During Freeze-Drying Storage: The Relative Importance of Thermodynamic Stabilization and Glassy State Relaxation Dynamics
Formulation Characterization
Practical Aspects of Freeze-Drying of Pharmaceutical and Biological Products Using Nonaqueous Cosolvent Systems
Regulatory Control of Freeze-Dried Products: Importance and Evaluation of Residual Moisture
Freeze-Drying of Biological Standards
Molecular Mobility of Freeze-Dried Formulations as Determined by NMR Relaxation Times, and Its Effect on Storage Stability
Scanning Electron Microscopy: A Powerful Tool for Imaging Freeze-Dried Material
Pharmaceutical Packaging for Lyophilization Applications
Closure and Container Considerations in Lyophilization
Extractables and Leachables as Container Closure Considerations in Lyophilization
Optimizing the Throughput of Freeze-Dryers Within a Constrained Design Space
Monitoring and Control of Industrial Freeze-Drying Operations: The Challenge of Implementing Quality-by-Design (QbD)
Process Analytical Technology in Industrial Freeze-Drying
Practical Considerations for Freeze-Drying in Dual Chamber Package Systems
Lyophilization and Irradiation as an Integrated Process