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Study of near Infrared Chemometric Models with Low Heterogeneity Films: The Role of Optical Sampling and Spectral Preprocessing on Partial Least Squares Errors
09 Jun 2023 | Contributor(s):: Ortega-Zuñiga, Carlos, Reyes-Maldonado, Kerimar, Méndez, Rafael, Romañach, Rodolfo J.
This study is focused on understanding absorption and scattering effects and their impact on the errors observed in near infrared calibration models developed using partial least squares regression able to predict the number of polypropylene film layers stacked together. The films provided a...
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Model-based analysis of high shear wet granulation from batch to continuous processes in pharmaceutical production - A critical review
09 Jun 2023 | Contributor(s):: Kumar, Ashish, Gernaey, Krist V., De Beer, Thomas, Nopens, Ingmar
The manufacturing of pharmaceutical dosage forms, which has traditionally been a batch-wise process, is now also transformed into a series of continuous operations. Some operations such as tabletting and milling are already performed in continuous mode, while the adaptation towards a complete...
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Development of Near Infrared Spectroscopy-based Process Monitoring Methodology for Pharmaceutical Continuous Manufacturing Using an Offline Calibration Approach
09 Jun 2023 | Contributor(s):: Hetrick, Evan, Barnes, Lukas E, Garrett, Aaron W, Rupard, Robert G, Kramer, Timothy T, Cooper, Tony M, Myers, David P, Shi, Zhenqi, Castle, Bryan C
A near-infrared (NIR) calibration was developed using an efficient offline approach to enable a quantitative partial least-squares (PLS) chemometric model to measure and monitor the concentration of active pharmaceutical ingredients (API) in powder blends in the feed frame (FF) of a tablet press....
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Benchtop NIR method development for continuous manufacturing scale to enable efficient PAT application for solid oral dosage form
09 Jun 2023 | Contributor(s):: Alam, MA, Liu, YADolph, S, Pawliczek, M, Peeters, E, Palm, A
A Near Infrared (NIR) method was developed using a small benchtop feed frame system to quantify Saccharin potency in a powder blend during continuous manufacturing process. A 15-point Design of Experiments (DoE) was created based on the NIR spectral response and compositions of the formulation to...
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Application of Ultra-Performance Liquid Chromatography as an Online Process Analytical Technology Tool in Pharmaceutical Crystallization
09 Jun 2023 | Contributor(s):: Yang, Yang, Zhang, Chuntao Pal, Kanjakha Koswara, Andy, Quon, Justin, Mckeown, Rahn, Goss, Charles, Nagy, Zoltan K
Concentration is often an important process parameter in pharmaceutical crystallization processes. In this work, an ultra-performance liquid chromatography (UPLC) system designed for process monitoring (Waters PATROL UPLC) was applied online as a process analytical technology tool for real-time...