FORMULATION AND EVALUATION OF POLIHEXANIDE LOADED LIPOSOSMAL GEL FOR THE TREATMENT OF DIABETIC FOOT ULCER

Abstract

Diabetic foot ulcers (DFU) are severe complications of diabetes that often result in delayed wound healing, persistent infection, and an increased risk of lower-limb amputation. Conventional topical therapies frequently fail because they lack adequate drug retention and sustained antimicrobial activity at the wound site. To address these limitations, this study formulated and evaluated a polihexanide-loaded liposomal gel using soya lecithin, cholesterol, and a Carbopol 934 hydrogel base. Five liposomal formulations were prepared via the thin-film hydration method, with the optimized formulation (F5) demonstrating a particle size of 93.26 nm, a polydispersity index of 0.342, and an entrapment efficiency of 92.24%. Scanning electron microscopy confirmed that the vesicles were spherical with a smooth surface morphology. The resulting liposomal gel exhibited favorable physicochemical properties, including a pH of 6.12, a viscosity of 6513 cps, and good spreadability, while showing no signs of skin irritation. Furthermore, the formulation achieved sustained drug release with 97.89% cumulative release over 12 hours, following the Higuchi kinetic model ($R^2 = 0.9778$) to indicate a diffusion-controlled mechanism. Overall, the polihexanide-loaded liposomal gel represents a promising topical drug delivery system capable of providing prolonged antimicrobial action for improved diabetic wound management.