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Freeze drying/lyophilization of pharmaceutical and biological products /
edited by Louis Rey, Joan C. May.
- 3rd ed.
- New York ; London : Informa Healthcare, 2010.
- xiii, 564 p. : ill ; 24 cm.
- Drugs and the pharmaceutical sciences ; v. 206 .
Includes bibliographical references and index.
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-Funeland, 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 / St�ephanie Passot ... [et al.] -- 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 effecton 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 ... [et al.] -- 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 ... [et al.] -- Lyophilization and irradiation as an integrated process / Dalal Aoude-Werner and Florent Kuntz.
9781439825754 (hbk. : alk. paper)
Freeze-drying.
Drugs--Drying.
Biological products--Drying.
Freeze Drying--methods.
Biological products.
Pharmaceutical Preparations.
615.19 / F857
Includes bibliographical references and index.
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-Funeland, 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 / St�ephanie Passot ... [et al.] -- 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 effecton 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 ... [et al.] -- 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 ... [et al.] -- Lyophilization and irradiation as an integrated process / Dalal Aoude-Werner and Florent Kuntz.
9781439825754 (hbk. : alk. paper)
Freeze-drying.
Drugs--Drying.
Biological products--Drying.
Freeze Drying--methods.
Biological products.
Pharmaceutical Preparations.
615.19 / F857