Model-based approach to the design of pharmaceutical roller-compaction processes

Dec. 1, 2019, midnight - by Peter Toson , Diogo G. Lopes , Raphael Paus , Ashish Kumar , Jeroen Geens , Sandy Stibale , Julian Quodbach , Peter Kleinebudde , Wen-Kai Hsiao , Johannes Khinast

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This study introduces a novel model-based strategy for the design and scale-up of a roller compaction process within the same equipment. Instead of relying solely on in-silico predictions, the model integrates low-throughput experiments as input. An iterative calibration routine utilizes this low-throughput data to characterize the powder behavior in the roller compactor, enhancing the predictive accuracy of mechanistic models across varying throughput levels. Validation of the model was conducted using an experimental design of two ibuprofen formulations. The predicted optimal operating regions within the process space closely aligned with the experimental outcomes, confirming the model's reliability.

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