Design and Formulation of Cyclodextrin based Nano-sponges Loaded Topical Hydrogel with Enhanced Skin Permeation and Effectiveness of Luliconazole

Objective The purpose of this work was to develop an effective luliconazole topical formulation. Cyclodextrin-based nanosponges loaded hydrogel of Carbopol 934 was formulated and characterized for its in-vitro and ex-vivo permeation study. Methods Cyclodextrin-based nanosponges were prepared in a 1:3 ratio using the dispersion-sonication method. The effectivity of topical formulation is based on its spreadability and diffusion flux. 33 Factorial design was utilized for the optimization of the hydrogel formulation using spreadability and diffusion flux as dependent variables. Optimization was done by response surface methodology by keeping the constraint constant. The optimized batch was evaluated for ex vivo skin permeation and in vitro antifungal assay in comparison to marketed and plain drug-loaded hydrogel. Result The prepared nanosponges were of nano size and had more than 80% drug content. Powder characterization confirms the compatibility between drug and excipients and the formation of inclusion complex with cyclodextrin. Based on desirability, optimized hydrogel follows the Higuchi kinetic model of drug release with better ex vivo diffusion compared to the marketed formulation. In vitro, antifungal assay showed better effectivity of hydrogel against Candida albicans. The topography of the gel showed an irregular spherical shape. Accelerated stability studies also confirmed the stabilization of the complex in the hydrogel. Conclusion The prepared formulation shows better effectivity and penetrability due to spherical shape and presence of penetration enhancer and can improve patient compliance.