title: Modeling of feed-forward control using the partial least squares regression method in the tablet compression process.
abstract: 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.
authors.affiliation: Research Institute of Pharmaceutical Sciences, Faculty of Pharmacy, Musashino University, 1-1-20 Shin-machi, Nishi-tokyo city, Tokyo 202-8585, Japan. Electronic address: yhattori@musashino-u.ac.jp.
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Hattori
authors.affiliation: Research Institute of Pharmaceutical Sciences, Faculty of Pharmacy, Musashino University, 1-1-20 Shin-machi, Nishi-tokyo city, Tokyo 202-8585, Japan.
authors.forename: Makoto
authors.initials: M
authors.lastname: Otsuka
mesh_terms: D016018:Least-Squares Analysis; D019265:Spectroscopy, Near-Infrared; D013607:Tablets; D013678:Technology, Pharmaceutical
chemical_list: D013607:Tablets
keywords: Continuous manufacturing; Feed-forward control compression process; Granule; Near-infrared spectroscopy; Partial least squares regression