FORMULATION DEVELOPMENT AND OPTIMISATION OF FAST DISSOLVING BUCCAL FILMS LOADED GLIMEPIRIDE SOLID DISPERSION WITH ENHANCED DISSOLUTION PROFILE USING CENTRAL COMPOSITE DESIGN

Abstract

Objective: This study aimed to enhance the solubility and dissolution of Glimepiride, a new-generation hypoglycaemic agent with low water solubility, by preparing Fast dissolving buccal films (FDBFs) containing Glimepiride solid dispersion. Methods: Glimepiride solid dispersions were fabricated using Polyethylene Glycol 4000 as the carrier by Physical mixture, Solvent evaporation, Kneading, and Fusion method. The optimised solid dispersion was selected based on the drug content and in vitro dissolution data. The final films incorporated with solid dispersion were prepared by the solvent casting technique, wherein the film formulation was optimised using the design of experiment (DoE) approach by applying the Central Composite statistical design. The optimised film formulation was then evaluated for various parameters, including weight variation, folding endurance, disintegration time, thickness, surface pH, and dissolution studies. Results: Among the different methods employed, the kneading method using PEG 4000 in a drug-to-polymer ratio of 1:3 exhibited the highest drug content and in vitro drug release, making it the most promising option. The film formulation that was optimised displayed an accelerated in vitro drug dissolution within a time frame of 10 min, with an average disintegration time of 31.33±0.471. Conclusion: The developed FDBFs loaded with Glimepiride solid dispersion demonstrated a markedly improved dissolution profile, avoidance of extensive first-pass metabolism, and improved patient compliance. The results suggest that the developed FDBFs could be a potential alternative to conventional dosage forms of Glimepiride.