FORMULATION DEVELOPMENT OF ORAL FAST-DISSOLVING SUBLINGUAL FILM OF RESVERATROLAbstract
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.
Vaishali Ashish Shirsat *, Anushree Anil Hukeri and Sneha Balu Govind
Department of Pharmaceutical Analysis, Bombay College of Pharmacy, Kalina, Santacruz East, Mumbai, Maharashtra, India.
05 September 2022
18 October 2022
17 November 2022
01 May 2023