Correlation of Drug Substance Bulk Properties to Predict and Troubleshoot the Formulation of Drug Products: The API Camera

Presented herein is an approach for correlating active pharmaceutical ingredient (API) bulk properties such as particle size, surface area, powder flow, morphology, and dissolution in order to provide an understanding of their collective impact on the formulation and manufacturing of drug products....

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Bibliographic Details
Published inOrganic process research & development Vol. 25; no. 4; pp. 1036 - 1046
Main Authors Morrison, Henry, Osan, Remus, Horstman, Elizabeth, Lee, Ernest, Ritchie, Sean, Payne, Philippa, Scott, Mark E, Geier, Michael J, Wang, Xiaotian
Format Journal Article
LanguageEnglish
Published American Chemical Society 16.04.2021
Subjects
surface area
particle size
microscopy
ring shear flow
bulk properties
dissolution
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Summary:Presented herein is an approach for correlating active pharmaceutical ingredient (API) bulk properties such as particle size, surface area, powder flow, morphology, and dissolution in order to provide an understanding of their collective impact on the formulation and manufacturing of drug products. This methodology, termed the API Camera, shows the significance of understanding the relationship of the various bulk properties to each other rather than monitoring them independently to draw conclusions. Three case studies are provided of which two show how the API Camera was utilized to troubleshoot issues that arose during drug product manufacturing, while the third focuses on how the methodology was proactively used during process development to guide decisions for an early-stage program.
ISSN:1083-6160
1520-586X
DOI:10.1021/acs.oprd.1c00043