LAPSE:2019.0933
Published Article
LAPSE:2019.0933
Advantages of Utilizing Population Balance Modeling of Crystallization Processes for Particle Size Distribution Prediction of an Active Pharmaceutical Ingredient
Tamar Rosenbaum, Li Tan, Joshua Engstrom
August 8, 2019
Active pharmaceutical ingredient (API) particle size distribution is important for both downstream processing operations and in vivo performance. Crystallization process parameters and reactor configuration are important in controlling API particle size distribution (PSD). Given the large number of parameters and the scale-dependence of many parameters, it can be difficult to design a scalable crystallization process that delivers a target PSD. Population balance modeling is a useful tool for understanding crystallization kinetics, which are primarily scale-independent, predicting PSD, and studying the impact of process parameters on PSD. Although population balance modeling (PBM) does have certain limitations, such as scale dependency of secondary nucleation, and is currently limited in commercial software packages to one particle dimension, which has difficulty in predicting PSD for high aspect ratio morphologies, there is still much to be gained from applying PBM in API crystallization processes.
Keywords
active pharmaceutical ingredient, crystallization, particle size control, population balance modeling
Subject
Suggested Citation
Rosenbaum T, Tan L, Engstrom J. Advantages of Utilizing Population Balance Modeling of Crystallization Processes for Particle Size Distribution Prediction of an Active Pharmaceutical Ingredient. (2019). LAPSE:2019.0933
Author Affiliations
Rosenbaum T: Drug Product Science and Technology, Bristol-Myers Squibb, 1 Squibb Drive, New Brunswick, NJ 08903, USA [ORCID]
Tan L: Drug Product Science and Technology, Bristol-Myers Squibb, 1 Squibb Drive, New Brunswick, NJ 08903, USA
Engstrom J: Drug Product Science and Technology, Bristol-Myers Squibb, 1 Squibb Drive, New Brunswick, NJ 08903, USA
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Journal Name
Processes
Volume
7
Issue
6
Article Number
E355
Year
2019
Publication Date
2019-06-10
Published Version
ISSN
2227-9717
Version Comments
Original Submission
Other Meta
PII: pr7060355, Publication Type: Journal Article
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LAPSE:2019.0933
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doi:10.3390/pr7060355
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Aug 8, 2019
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CC BY 4.0
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Aug 8, 2019
 
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Original Submitter
Calvin Tsay
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