Impact of Raman mapping area and intra-tablet homogeneity on the accuracy of sustained-release tablet dissolution prediction

[Display omitted] •Investigation of intra-tablet homogeneity is an important step before dissolution prediction.•Intra-tablet homogeneity determines the minimum required mapping area for predicting the dissolution profiles of tablets.•Homogeneous tablets require smaller mapping areas, while increasing accuracy in dissolution profile prediction. This exploratory study investigated the minimum required Raman mapping area for predicting sustained-release tablet dissolution profiles based on intra-tablet homogeneity. The aim was to minimize scanning time while achieving reliable dissolution profile predictions. To construct the sample set, we controlled the blending time to introduce variability in the homogeneity of the tablets. The dissolution prediction models were established using the partial least squares regression under different Raman mapping area. The accuracies of the prediction results were evaluated according to the difference factor f1 and Intersection–Union two one-sided t-tests (IU TOST) methods, and the implications conveyed by the results were discussed. The results showed that the homogeneity of sustained-release tablet affects the minimum required mapping area, and the tablets with higher homogeneity show higher prediction accuracy when using the same mapping area to model the dissolution profiles of tablets.