The impact of the freezing stage in lyophilization: Effects of the ice nucleation temperature on process design and product quality

American Pharmaceutical Review

Volumn 5, Issue 3, 2002, Pages 48-52

  Pikal, Michael J ^a   Rambhatla, Shailaja ^a   Ramot, Roee ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ICE; PROTEIN;

ARTICLE; CONTROLLED STUDY; CRYOPRESERVATION; CRYSTALLIZATION; DESICCATION; DRUG DESIGN; DRUG FORMULATION; DRUG MANUFACTURE; DRUG STABILITY; FREEZE DRYING; LOW TEMPERATURE PROCEDURES; MATHEMATICAL COMPUTING; MOLECULAR DYNAMICS; PH; PROCESS DESIGN; QUALITY CONTROL; SCANNING ELECTRON MICROSCOPY; TEMPERATURE DEPENDENCE; THERMODYNAMICS;

EID: 0036741133     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (11)

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6. T. D. Rowe, " A technique for the nucleation of ice", International Symposium on Biological Product Freeze-Drying and Formulation, 1990.
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9. N. Milton, M.J. Pikal, M.L. Roy, S.L. Nail, "Evaluation of Manometric Temperature Measurement as a method of monitoring product temperature during lyophilization" PDA Journal of Pharmaceutical Science and Technology, 5, 7-16, (1997).
10. T. A. Patapoff, D. E. Overcashier, "The Importance of freezing on lyophilization cycle development", Biopharm, 3, 16- 21, (2002).
11. Pikal M.J., "Use of Laboratory Data in Freeze Drying Process Design: Heat and Mass Transfer Coefficients and the Computer Simulation of Freeze Drying," J. Parenteral Sci., and Tech., 39, 115-138 (1985).