421912 In-Line Monitoring of a Pharmaceutical Fluid-Bed and Pan Coating Process By Optical Coherence Tomography

Wednesday, November 11, 2015: 4:35 PM
Ballroom D (Salt Palace Convention Center)
Daniel Markl1, Stephan Sacher1 and Johannes G. Khinast2, (1)Research Center Pharmaceutical Engineering GmbH, Graz, Austria, (2)Institute of Process and Particle Engineering, Graz University of Technology, Graz, Austria

This study demonstrates a new in-line measurement technique for monitoring coating processes. Process monitoring is performed by an optical coherence tomography (OCT) sensor providing cross-sectional images of film-coatings in a non-destructive and contactless manner. Typically tablets or pellets are coated. Tablets are mostly coated in (perforated) pans or drums, whereas pellet coating is typically carried out in a fluid-bed. However, the monitoring of the coating growth as a function of process time is a key issue for both processes. This study shows results of coating thickness measurements from in-line OCT data for pellets and tablets coated in a fluid-bed and pan coater, respectively.

The coating thickness can be determined directly and automatically from OCT images and without the need of chemometric calibration models. Results of the in-line OCT measurements were validated by analyzing samples that were periodically removed from the process during the production. These samples were characterized off-line by OCT and dynamic image analysis in case of pellets or dimension measurements in case of tablets. Moreover, this methodology enables a multiple direct measurement of the coating thickness on individual pellets/tablets rather than providing the temporal and spatial average of a large number of pellets/tablets. This gives substantially more information about the coating quality, i.e., intra- and inter-particle coating variability, than standard quality control methods. The information about those parameters specifically emphasizes the high capability of the OCT technology to improve process understanding and to assure a high product quality. Specifically, the additional information as intra- and inter-particle coating variability as captured with the OCT sensor could be a valuable critical quality attribute (CQA). An in-line OCT system could act as a key tool for the development and control of coating processes within the process analytical technology (PAT) and quality by design (QbD) framework.

Extended Abstract: File Not Uploaded