(643d) Real-Time Monitoring of a Tableting Process Via Optical Coherence Tomography

Tools enabling the real-time monitoring of a tableting process are a crucial part of any strategy aimed at prediction dissolution in real-time release (RTRT strategy). The dissolution behavior of uncoated tablets is determined by the active pharmaceutical ingredient (API), the formulation and structural properties of the tablet, such as hardness or porosity. Several tools for measuring porosity and correlating it with dissolution exist, but generally need offline analysis. This presentation will demonstrate that optical coherence tomography is a suitable tool for closing this gap. It will be demonstrated how OCT images of uncoated tablets can be evaluated in such a way that conclusions about the tablet’s inner morphology can be drawn. A machine learning model further predicts the amount of API from only OCT image evaluation. The developed concept has been applied to an in-line setting for the real-time evaluation of tablets immediately after the tablet press of a ConsiGma 25^TM tableting line. The upscaling from offline to in-line image analysis will be discussed and further directions of this research will be outlined. These results present OCT as a novel real-time in-line monitoring tool for the production of uncoated tablets that can be combined with control strategies for optimal process performance.