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

Automated summary

This study investigated the minimum Raman mapping area required for predicting sustained-release tablet dissolution profiles based on intra-tablet homogeneity. The sample set was constructed by controlling the blending time to introduce variability in tablet homogeneity. Dissolution prediction models were established using partial least squares regression under different mapping areas. The accuracy of the prediction results was evaluated and the implications were discussed. The results showed that tablet homogeneity affects the minimum required mapping area, and tablets with higher homogeneity exhibit higher prediction accuracy using the same mapping area.