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

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 material...

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Bibliographic Details
Published in:Advanced drug delivery reviews 2001-05, Vol.48 (1), p.91-114
Main Authors: Morris, Kenneth R., Griesser, Ulrich J., Eckhardt, Craig J., Stowell, Joseph G.
Format: Article
Language:English
Subjects:
Active Pharmaceutical Ingredient
Amorphous
Crystallization
Drug Industry
Drying
Freeze Drying
Hydrate
Lyophilization
Models, Chemical
Phonon
Polymorph
Process-induced transformation
Solvate
Tablets
Tabletting
Technology, Pharmaceutical
Wet Granulation
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Summary: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.
ISSN:0169-409X
1872-8294
DOI:10.1016/S0169-409X(01)00100-4