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

By Toson, Peter; Lopes, Diogo G. Paus, Raphael Kumar, Ashish; Geens, Jeroen; Stibale, Sandy; Quodbach, Julian; Kleinebudde, Peter; Hsiao, Wen-Kai; Khinast, Johannes

Published on CMKC

Abstract

This work presents a new model based approach to process design and scale-up within the same equipment of a roller compaction process. The prediction of the operating space is not performed fully in-silico, but uses low-throughput experiments as input. This low-throughput data is utilized in an iterative calibration routine to describe the behavior of the powder in the roller compactor and improves the predictive quality of the mechanistic models at low and high-throughput. The model has been validated with an experimental design of experiments of two ibuprofen formulations. The predicted sweet spots in the operating space are in good agreement with the experimental results.

Journal

International Journal of Pharmaceutics: X. Volume 1,, 2019, 100005-

DOI

10.1016/j.ijpx.2019.100005

Type of publication

Peer-reviewed journal

Affiliations

  • Research Center for Pharmaceutical Engineering GmbH

Article Classification

Research Article

Classification Areas

  • Modeling

Tags