Real-time prediction of dissolution profiles of coated oral dosage forms

Oct. 21, 2024, 2:13 p.m. - by Stephan Sacher , Elisabeth Fink , Carolina Alva , Jesús Alberto Afonso Urich , Aygün Doğan , Vanessa Herndler , Ioannis Koutsamanis , Varun Kushwah , Anna Peter , Sharareh Salar-Behzadi , Katrina Wilfling , Sandra Stranzinger , Manuel Zettl , Xin Feng , Maxwell Korang-Yeboah , Huiquan Wu , Johannes G. Khinast

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Optical coherence tomography (OCT) has become an in-line monitoring method for pharmaceutical coating processes based on a representative sample size. In this study, a method was developed to correlate coating thickness, measured in-line using OCT, with the dissolution profile of the tablet. This approach allows for real-time prediction of the dissolution profile of coated oral dosage forms at each stage of the coating process. Correlation models were created for both a tablet pan coating process and a pellet fluid-bed coating process. The models' feasibility was evaluated using various process parameters and coating formulations. This research showed that utilizing OCT data for dissolution prediction could offer a novel approach to ensuring drug product quality and implementing a control strategy within the real-time release testing (RTRT) framework.

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