alexa Theoretical approaches to physical transformations of active pharmaceutical ingredients during manufacturing processes.
Chemistry

Chemistry

Modern Chemistry & Applications

Author(s): Morris KR, Griesser UJ, Eckhardt CJ, Stowell JG

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Abstract Processing-induced transformations (PITs) during pharmaceutical manufacturing are well known but difficult to predict and often difficult to control. This review of the concepts of transformations is couched in terms of the issues associated with identifying rate-controlling events from the materials side and the processing side. Specifically, the approach is reconciling the characteristic time scale of the structural change(s) in the material with the time scale of the processing-induced stress. This is definitely a model (or rather a melding of a group of existing theories) in development. This overview is a 'snapshot' of the authors' attempts to identify the categories of existing theories needed to encompass all of the relevant events for each possible PIT. The ultimate goal is to establish a framework of concepts and theories for consideration, discussion, and modeling of PITs as well as to locate much of the relevant literature in the framework.
This article was published in Adv Drug Deliv Rev and referenced in Modern Chemistry & Applications

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