A novel approach for the treatment of oral ulcerative lesion using mucoadhesive proniosome gel

Abstract

A mucoadhesive proniosome gel containing a potent corticosteroid drug (fluticasone propionate) was formulated for the local treatment of oral ulcerative lesions. The formula was made-up in an attempt to avoid the drug's severe systemic adverse effects, moreover, ensuring both efficacy and safety. Full factorial design was employed to prove the significant effect of surfactant type and cholesterol concentration on entrapment efficiency and vesicle size of the formulated proniosome gels. The optimum formula with an entrapment efficiency of 85.5 ± 2.4% was incorporated into mucoadhesive gels using different mucoadhesive polymers, namely, xanthan gum or sodium alginate. The effects of the polymer type and its concentration on the quantity of fluticasone propionate release as well as on the mucoadhesion force were studied. The optimum formula was found to possess a mucoadhesion force of 14425 ± 5.4 dyne/cm2 and maximum quantity of drug release of 89 ± 0.09% which showed to follow Higuchi diffusion model of release. High-resolution transmission electron micrographs revealed that the chosen formula was smooth, homogenous and in nano size range. Cytotoxicity assay test was conducted to ensure the safety of the optimum formula. Curing of oral ulcerative lesions using an animal model was assessed and emphasized by the histopathological findings.