Monitoring and modeling of film coating in a side vented pan coater using near-infrared reflectance spectroscopy, digital video imaging and computational methods
Abstract
The impact of process understanding, continuous improvement and designing quality into products has been a major focus issue within the pharmaceutical industry and regulatory agencies. This thesis explores new tools and methods that can be used for process monitoring and control as well as obtaining enhanced predictive capabilities. One of the main objectives of this study was to monitor a pan coating process in real-time and develop methods for calibration of NIR spectra for the tracking of coating thickness on pharmaceutical tablets and enable end-point determination. A series of methods based on digital video analysis of moving tablet beds were also developed to elucidate tablet bed behavior and dynamics as well as inter-tablet and intra-tablet coating variability in a side-vented perforated coating pan. Results are compared to those obtained using discrete element method (DEM) simulations that model a similar system of tablets inside a coating pan. The study focuses on the effect of coating process variables like pan loading size, and pan speed on the movement of tablets within the coating pan. It was found that information on overall tablet movement and bed dynamics can be obtained by using a combination of experimental and computational tools and can be used for pharmaceutical pan coating process optimization and design.
Degree
Ph.D.
Advisors
Morris, Purdue University.
Subject Area
Pharmaceutical sciences
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