3rd Edition

Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products

Edited By Louis Rey Copyright 2010

    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.

    Glimpses into the Realm of Freeze-Drying: Classical Issues and New Ventures; Louis Rey

    Structural and Dynamic Properties of Bulk and Confined Water; Marie-Claire Bellissent-Funel and Jose Teixeira

    Freezing and Annealing Phenomena in Lyophilization; Jim A. Searles

    Phase Separation of Freeze-Dried Amorphous Solids: The Occurrence and Detection of Multiple Amorphous Phases in Pharmaceutical Systems; Adora M. Padilla and Michael J. Pikal

    The Use of Microscopy, Thermal Analysis, and Impedance Measurements to Establish Critical Formulation Parameters for Freeze-Drying Cycle Development; Kevin R. Ward and Paul Matejtschuk

    The Relevance of Thermal Properties for Improving Formulation and Cycle Development: Application to Freeze-Drying of Proteins; Stéphanie Passot, Ioan Cristian Tréleéa, Michèle Marin, and Fernanda Fonseca

    Freezing- and Drying-Induced Perturbations of Protein Structure and Mechanisms of Protein Protection by Stabilizing Additives; John F. Carpenter, Ken-ichi Izutsu, and Theodore W. Randolph

    Mechanisms of Protein Stabilization During Freeze-Drying Storage: The Relative Importance of Thermodynamic Stabilization and Glassy State Relaxation Dynamics; Michael J. Pikal

    Formulation Characterization; D. Q. Wang

    Practical Aspects of Freeze-Drying of Pharmaceutical and Biological Products Using Nonaqueous Cosolvent Systems;

    Dirk L. Teagarden, Wei Wang, and David S. Baker

    Regulatory Control of Freeze-Dried Products: Importance and Evaluation of Residual Moisture;

    Joan C. May

    Freeze-Drying of Biological Standards; Paul Matejtschuk, Michelle Stanley, and Paul Jefferson

    Molecular Mobility of Freeze-Dried Formulations as Determined by NMR Relaxation Times, and Its Effect on Storage Stability; Sumie Yoshioka and Yukio Aso

    Scanning Electron Microscopy: A Powerful Tool for Imaging Freeze-Dried Material; Tauno Jalanti

    Pharmaceutical Packaging for Lyophilization Applications; Claudia Dietrich, Florian Maurer, Holger Roehl, and Wolfgang Frieß

    Closure and Container Considerations in Lyophilization; Fran L. DeGrazio

    Extractables and Leachables as Container Closure Considerations in Lyophilization; Diane Paskiet and Fran L. DeGrazio

    Optimizing the Throughput of Freeze-Dryers Within a Constrained Design Space; Jim A. Searles

    Monitoring and Control of Industrial Freeze-Drying Operations: The Challenge of Implementing Quality-by-Design (QbD); Miquel Galan

    Process Analytical Technology in Industrial Freeze-Drying; Antonello A. Barresi, Davide Fissore, and Daniele L. Marchisio

    Practical Considerations for Freeze-Drying in Dual Chamber Package Systems; Dirk L. Teagarden, Stanley M. Speaker, Susan W. H. Martin, and Thomas Österberg

    Lyophilization and Irradiation as an Integrated Process; Dalal Aoude-Werner and Florent Kuntz

    Appendix: Table, Saturation Vapor Pressure of Ice



    Rey, Louis