LAPSE:2024.1527
Published Article
LAPSE:2024.1527
Design Space Identification of the Rotary Tablet Press
Mohammad Shahab, Sunidhi Bachawala, Marcial Gonzalez, Gintaras Reklaitis, Zoltan Nagy
August 15, 2024. Originally submitted on July 9, 2024
The determination of the design space (DS) in a pharmaceutical process is a crucial aspect of the quality-by-design (QbD) initiative which promotes quality built into the desired product. This is achieved through a deep understanding of how the critical quality attributes (CQAs) and process parameters (CPPs) interact that have been demonstrated to provide quality assurance. For computational inexpensive models, the original process model can be directly deployed to identify the design space. One such crucial process is the Tablet Press (TP), which directly compresses the powder blend into individual units of the final product or adds dry or wet granulation to meet specific formulation needs. In this work, we identify the design space of input variables in a TP such that there is a (probabilistic) guarantee that the tablets meet the quality constraints under a set of operating conditions. A reduced-order model of TP is assigned for this purpose where the effects of lubricants and glidants are used to characterize the design space to achieve the desired tablet CQAs. The probabilistic design space, which takes into account interactions between crucial process parameters and important quality characteristics including model uncertainty, is also approximated because of the high cost associated with the comprehensive experiments.
Keywords
design space, direct compression, Optimization, pharmaceutical process, tablet press
Suggested Citation
Shahab M, Bachawala S, Gonzalez M, Reklaitis G, Nagy Z. Design Space Identification of the Rotary Tablet Press. (2024). LAPSE:2024.1527
Author Affiliations
Shahab M: Davidson School of Chemical Engineering, Purdue University, West Lafayette, IN-47907, USA
Bachawala S: School of Mechanical Engineering, Purdue University, West Lafayette, IN 47907, USA
Gonzalez M: School of Mechanical Engineering, Purdue University, West Lafayette, IN 47907, USA
Reklaitis G: Davidson School of Chemical Engineering, Purdue University, West Lafayette, IN-47907, USA
Nagy Z: Davidson School of Chemical Engineering, Purdue University, West Lafayette, IN-47907, USA
Journal Name
Systems and Control Transactions
Volume
3
First Page
194
Last Page
200
Year
2024
Publication Date
2024-07-10
Version Comments
DOI Assigned
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PII: 0194-0200-676122-SCT-3-2024, Publication Type: Journal Article
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LAPSE:2024.1527
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https://doi.org/10.69997/sct.156711
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[v2] (DOI Assigned)
Aug 15, 2024
[v1] (Original Submission)
Jul 9, 2024
 
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