Freeze drying/lyophilization of pharmaceutical and biological products için kapak resmi
Başlık:
Freeze drying/lyophilization of pharmaceutical and biological products
Yazar:
Rey, Louis.
ISBN:
9781439825761
Basım Bilgisi:
3rd ed.
Yayın Bilgileri:
New York ; London : Informa Healthcare, 2010.
Fiziksel Tanımlama:
xiii, 564 p. : ill.
Seri:
Drugs and the pharmaceutical sciences ; v. 206
Seri Başlığı:
Drugs and the pharmaceutical sciences ; v. 206
İçerik:
1. Glimpses into the realm of freeze-drying : classical issues and new ventures / Louis Rey -- 2. Structural and dynamic properties of bulk and confined water / Marie-Claire Bellissent-Funel and, Jose Teixeira -- 3. Freezing and annealing phenomena in lyophilization / Jim A. Searles -- 4. 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 -- 5. 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 -- 6. The relevance of thermal properties for improving formulation and cycle development : application to freeze-drying of proteins / Stp̌hanie Passot ... [et al.] --

7. 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 -- 8. Mechanisms of protein stabilization during freeze-drying storage : the relative importance of thermodynamic stabilization and glassy state relaxation dynamics / Michael J. Pikal -- 9. Formulation characterization / D.Q. Wang -- 10. Practical aspects of freeze-drying of pharmaceutical and biological products using nonaqueous cosolvent systems / Dirk L.Teagarden, Wei Wang, and David S. Baker --

11. Regulatory control of freeze-dried products : importance and evaluation of residual moisture / Joan C. May -- 12. Freeze-drying of biological standards / Paul Matejtschuk, Michelle Stanley, and Paul Jefferson -- 13. Molecular mobility of freeze-dried formulations as determined by NMR relaxation times, and its effecton storage stability / Sumie Yoshioka and Yukio Aso -- 14. Scanning electron microscopy : a powerful tool for imaging freeze-dried material / Tauno Jalanti -- 15. Pharmaceutical packaging for lyophilization applications / Claudia Dietrich ... [et al.] -- 16. Closure and container considerations in lyophilization / Fran L. DeGrazio -- 17. Extractables and leachables as container closure considerations in lyophilization / Diane Paskiet and Fran L. DeGrazio -- 18. Optimizing the throughput of freeze-dryers within a constrained design space / Jim A. Searles -- 19. Monitoring and control of industrial freeze-drying operations : the challenge of implementing quality-by-design (QbD) / Miquel Galan -- 20. Process analytical technology in industrial freeze-drying / Antonello A. Barresi, Davide Fissore, and Daniele L. Marchisio -- 21. Practical considerations for freeze-drying in dual chamber package systems / Dirk L.Teagarden ... [et al.] -- 22. Lyophilization and irradiation as an integrated process / Dalal Aoude-Werner and Florent Kuntz.
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