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Freeze-drying/lyophilization of pharmaceutical and biological products.

Author(s) : REY L. (ed.), MAY J. C. (ed.)

Type of monograph: Book

Summary

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 new edition of the book addresses these changes with updated and new chapters on emerging developments in lyophilization technology, research, and industry procedures. Extract from the table of contents: glimpses into the realm of freeze-drying; structural and dynamic properties of bulk and confined water; freezing and annealing phenomena in lyophilization; phase separation of freeze-dried amorphous solids; 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; freezing- and drying-induced perturbations of protein structure and mechanisms of protein protection by stabilizing additives; mechanisms of protein stabilization during freeze-dried storage; practical aspects of freeze-drying using nonaqueous cosolvent systems; regulatory control of freeze-dried products; molecular mobility of freeze-dried formulation 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 consideration in lyophilization; monitoring and control of industrial freeze-drying operations; lyophilization and irradiation as an integrated process.

Details

  • Original title: Freeze-drying/lyophilization of pharmaceutical and biological products.
  • Record ID : 2010-0994
  • Languages: English
  • Subject: Technology
  • Publication: Informa healthcare - United kingdom/United kingdom
  • Publication date: 2010
  • Collection:
  • ISBN: 9781439825754
  • Source: Source: ed. 3; vol. 206; 580 p.; fig.; photogr.; tabl.; ref.; index; append.
  • Document available for consultation in the library of the IIR headquarters only.

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