Prediction of dissolution profiles by non-destructive NIR spectroscopy in bilayer tablets.

This study describes how near infrared (NIR) spectroscopy can be used to predict the dissolution of bilayer tablets as a non-destructive approach. Tablets in this study consist of two APIs physically separated in layers and manufactured under three levels of hardness. NIR spectra were acquired for each layer in diffuse reflectance mode. Reference dissolution profile values were obtained using dissolution apparatus & HPLC. A multivariate PLS calibration model was developed for each API relating its dissolution profile with to spectral data. This calibration model was used to predict dissolution profile of an independent test set and results of the prediction were compared using model free approaches i.e. dissimilarity (f1 ) & similarity (f2 ) factor to assure similarity in performance and leads to bioequivalence.