FORMULATION DEVELOPMENT OF ORAL FAST-DISSOLVING SUBLINGUAL FILM OF RESVERATROL

This research aimed to develop an inclusion complex of resveratrol (RSV)/hydroxypropyl-β-cyclodextrin (HP-β-CD) using a quality-by-design (QbD) approach to improve the solubility and stability of RSV and formulate it into a fast-dissolving sublingual film (FDSF). The RSV/HP-β-CD inclusion complex was prepared by the kneading method using a Box–Behnken Design to assess the effect of the molar ratio of RSV and HP-β-CD, reaction time, and drying time as independent variables on the % entrapment efficiency and % yield. FTIR, DSC, Powder XRD, NMR, and SEM were performed to evaluate the formed complexes. The RSV/HP-β-CD complexation was successful in enhancing RSV solubility and stability. Furthermore, the inclusion complex was incorporated into a fast-dissolving sublingual film. The prepared films were evaluated for a folding endurance test, tensile strength, disintegration time, drug content, thickness, and SEM. The sublingual route of administration was found to be beneficial for films, as it provided 80% permeation of RSV in 60 minutes and no damage to the epithelial tissues was observed in the histopathological study performed on the porcine tongue. Therefore, the developed fast-dissolving sublingual films of the RSV/HP-β-CD inclusion complex were effective for oral administration.