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

Optical coherence tomography (OCT) has emerged as an in-line monitoring technique for pharmaceutical coating processes based on a representative number of samples. In this study, an approach was developed to correlate the coating thickness measured in-line via OCT with the resultant tablet dissolution profile. This strategy enables prediction of the dissolution profile of coated oral dosage forms for each individual state of the coating process in real-time. Correlation models were developed for a tablet pan coating process and for a pellet fluid-bed coating process. The feasibility of the correlation models was tested using different process parameters and types of coating formulations. This work demonstrated that using the OCT data to predict dissolution could possibly form a unique way of assuring drug product quality and establishing a control strategy within the real-time release testing (RTRT) concept.