Freeze-drying/lyophilization of pharmaceutical and biological products

著者

    • Rey, Louis
    • May, Joan C. (Joan Christine)

書誌事項

Freeze-drying/lyophilization of pharmaceutical and biological products

edited by Louis Rey, Joan C. May

（Drugs and the pharmaceutical sciences, v. 96）

M. Dekker, c1999

  • hbk.

大学図書館所蔵 件 / 全6件

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注記

Includes bibliographical references and index

内容説明・目次

内容説明

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.

目次

  • Glimpses into the realm of freeze-drying - classical issues and new ventures
  • potential energy surfaces, computer simulations, and the structure of water
  • structural and dynamic properties of bulk and confined water
  • experimental freeze-drying procedures and equipment
  • freezing and drying-induced perturbations of protein structure and mechanisms of protein protection by stabilizing additives
  • mechanisms of protein stabilization during freeze-drying and storage - the relative importance of thermodynamic stabilization and glassy state relaxation dynamics
  • the regulatory control of freeze-dried products - importance and evaluation of residual moisture
  • basic aspects and industrial strategies for the preservation of microorganisms by freezing and drying
  • industrial freeze-drying for pharmaceutical applications
  • industrial freeze-drying of vaccines destined for veterinary purposes - an overview
  • manufacturing principles of freeze-dried collagen sponges - characteristics and applications
  • lyophilization process validation
  • critical steps in the preparation of elastomeric closures for biopharmaceutical freeze-dried products
  • technical procedures for operation of cleaning in place and sterilization in place process for production freeze-drying equipment
  • studies on the development of manufacturing processes for pharmaceutical freeze-dried products
  • potential prospects in freeze-drying.

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