Use of Pat for Active Pharmaceutical Ingredient Crystallization Process Control
نویسندگان
چکیده
Crystallization of active pharmaceutical ingredient (API) or pharmaceutical drug substances is a crucial unit operation. In this paper challenges and scientific progress over the last two decades in the areas of pharmaceutical crystallization thermodynamics, kinetics, polymorphism, process modeling, and process control were attempted. Effective utilization of such scientific knowledge for optimized control of API crystallization process was discussed. A conceptual PAT framework for API crystallization process control was proposed. Three case studies from the literatures were discussed as hypothetical examples to illustrate the application of PAT framework to pharmaceutical crystallization process. Copyright © 2005 IFAC
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