Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products

by Louis Rey (Editor)

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 regulatio

Product Details

ISBN-13:	9781040067529
Publisher:	CRC Press
Publication date:	04/19/2016
Series:	Drugs and the Pharmaceutical Sciences
Sold by:	Barnes & Noble
Format:	eBook
Pages:	584
File size:	9 MB

About the Author

Rey, Louis

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

Editorial Reviews

This is a practical manual for freeze drying pharmaceutical and biological products. The purpose is to provide discussions on the applications in the industry for vaccines and collagen-based devices, management of equipment, and validation procedures. The utility of this volume will be mainly for process engineers and those working in the private sector concerned with the preservation of materials by freeze drying. Although of theoretical interest, the contributors writing the two articles on water structure approach this complex topic from a quantum mechanical orientation, providing the background for molecular dynamics calculations, etc. It is hard to visualize that these theoretical contributions will be of interest to the same readers concerned with process validation. Given that the technique itself remains widely used, those with explicit practical concerns will find useful information here. Water itself has been the subject of several treatises and remains a complex yet simple molecule. The discussions in this volume do not fit well with the bulk of the existing material, which is largely pragmatic.

Eugene A. Davidson

...a good choice for those who wish to learn about recent topics and study trends in the field of freeze—drying from theoretical and industrial viewpoints. The...references cited can be utilized to make the scope of the information wide and deeper....an excellent source of information for those who employ the technology in the field of pharmaceutics, microbiology, biochemistry...as well as those specialized in research/development of pharmaceutical dosage forms. Without a doubt, it can be said helpful towards appropriately validating a diversity of freeze—drying hardware and software, because many point to consider in providing quality assurance in free—drying processes are well addressed. Reading this book is strong recommended.

PDA Journal of GMP and Validation in Japan

...a clear and comprehensive book, readily accessible to the diversified group of potential users of freeze drying in the pharmaceutical industry....It sheds light on some focal areas of the field in which pioneering research has been achieved, and assesses their impact on current manufacturing practices.

Bioseparation

...the editors have largely succeeded in their stated aim of producing a work that touches on the main principles affecting the conduct of lyophilization. The book is a good acquisition for anyone contemplating the development of a lyophilized product, and seasoned freeze—dryers will gain much from reading the sections related to fundamentals.

Pharmaceutical Development and Technology

Highlights the application of freeze-drying to pharmaceuticals, illustrating practical and industry-tested methods of preserving and reactivating delicate biological and biochemicals. Explains the lyophilization process step by step, analyzes the behavior of complex molecules in cryogenic processes, and summarizes research on the role of water in different phases and processes such as macromolecule-water and biopolymer-water interactions. Describes technologies such as X- ray diffraction, nuclear paramagnetic resonance, electron scanning microscopy, and thermogravimetry, and evaluates new designs for semicontinuous and continuous freeze-drying. Annotation c. Book News, Inc., Portland, OR (booknews.com)

Booknews

Reviewer: Eugene A Davidson, PhD (Georgetown University School of Medicine)
Description: This is a practical manual for freeze drying pharmaceutical and biological products.
Purpose: The purpose is to provide discussions on the applications in the industry for vaccines and collagen-based devices, management of equipment, and validation procedures.
Audience: The utility of this volume will be mainly for process engineers and those working in the private sector concerned with the preservation of materials by freeze drying.
Features: Although of theoretical interest, the contributors writing the two articles on water structure approach this complex topic from a quantum mechanical orientation, providing the background for molecular dynamics calculations, etc. It is hard to visualize that these theoretical contributions will be of interest to the same readers concerned with process validation.
Assessment: Given that the technique itself remains widely used, those with explicit practical concerns will find useful information here. Water itself has been the subject of several treatises and remains a complex yet simple molecule. The discussions in this volume do not fit well with the bulk of the existing material, which is largely pragmatic.

Doody's Review Service