DEVELOPMENT AND EVALUATION OF BIFONAZOLE-LOADED TRANSFEROSOMAL TOPICAL GEL FOR DEEPER DERMAL DELIVERY IN THE MANAGEMENT OF TINEA PEDIS AND TINEA CORPORIS

Abstract

The present study aimed to develop and evaluate a Bifonazole-loaded transferosomal gel for enhanced dermal drug delivery in the treatment of superficial fungal infections. Bifonazole exhibits limited skin penetration in conventional topical formulations results in substandard therapeutic results. In this present study Bifonazole Transferosomes were prepared using Soya lecithin phospholipids (vesicle formers) and Tween 80 (edge activator) by the thin-film hydration method. Total of 9 formulations F1-F9 were designed using 3² full factorial design. Two variables are soya lecithin amount and Tween 80 amount. The amount of drug kept constant in all the 9 formulations. All the formulations were evaluated for % entrapment efficiency and in-vitro drug membrane diffusion studies. Among all, F6 showed highest % EE and higher in-vitro drug diffusion. We concluded that F6 is the optimised formulation and further, this F6 optimised formulation was evaluated for vesicle size, PDI, and zeta potential. The best formulation F6 was incorporated into an empty Carbopol gel base to prepare Bifonazole transferosomal gel. This gel was evaluated for pH, spreadability, skin irritation, drug content, and viscosity. Furthermore, % of in-vitro membrane drug diffusion studies was conducted for both prepared Bifonazole transferosomal gel and the marketed Bifonazole (Brand: Bi-fone) gel. The transferosomal gel demonstrated significantly enhanced drug release, achieving 97.03% release at 9 h compared to 49.30% from the marketed gel. The enhancement factor was found to be 4.57 at 1 h and 1.97 at 9 h, indicating improved permeation.