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ISCRIVITI ALLA NEWSLETTER

An Integrated Real-time Monitoring and Statistical Process Control Approach for Coating Process and Product Quality via In-line Optical Coherence Tomography | Journal of Pharmaceutical Innovation

Volume 18, pages 1870–1878, (2023)
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Abstract

Purpose

The thickness and other quality aspects of pharmaceutical coatings can be significantly impacted by coating process conditions. Under certain circumstances, they can notably influence the drug product performance such as dissolution profiles. Typically, a target coating thickness range is defined in the coating process. The coating thickness is conventionally measured off-line via weight or diameter gain. However, these established methods do not allow real-time monitoring of the product quality during the coating process. Further, options to react to any deviations are limited due to the lack of real-time information on the actual process and product state. The focus of this study was the development of a data-driven approach for real-time process control.

https://link.springer.com/article/10.1007/s12247-023-09750-5