Journal
INTERNATIONAL JOURNAL OF PHARMACEUTICS
Volume 524, Issue 1-2, Pages 407-413Publisher
ELSEVIER
DOI: 10.1016/j.ijpharm.2017.04.004
Keywords
Feed-forward control compression process; Continuous manufacturing; Granule; Near-infrared spectroscopy; Partial least squares regression
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In the pharmaceutical industry, the implementation of continuous manufacturing has been widely promoted in lieu of the traditional batch manufacturing approach. More specially, in recent years, the innovative concept of feed-forward control has been introduced in relation to process analytical technology. In the present study, we successfully developed a feed-forward control model for the tablet compression process by integrating data obtained from near-infrared (NIR) spectra and the physical properties of granules. In the pharmaceutical industry, batch manufacturing routinely allows for the preparation of granules with the desired properties through the manual control of process parameters. On the other hand, continuous manufacturing demands the automatic determination of these process parameters. Here, we proposed the development of a control model using the partial least squares regression (PLSR) method. The most significant feature of this method is the use of dataset integrating both the NIR spectra and the physical properties of the granules. Using our model, we determined that the properties of products, such as tablet weight and thickness, need to be included as independent variables in the PLSR analysis in order to predict unknown process parameters. (C) 2017 Elsevier B.V. All rights reserved.
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