Design, Fabrication, in Vitro, and Ex-Vivo Permeation Study of Micro-Emulsified Hydrogel of Fluconazole (Mhg-Flcz) Using a Central Composite Design (Ccd)

Abstract

Objective: The current study's objective was to develop and characterize a micro-hydrogel-based fluconazole (FLCZ) gel. A micro-hydrogel (Mhg) was prepared using different concentrations of Carbopol 940 (CP) and NaCMC using the modified swelling hydrogel method. Methods: A Preformulation study was performed using FTIR to confirm the drug and polymers were compatible with each other based on the functional group determination. 32 optimization procedures were used to develop formulations based on the response surface methodology. The prepared formulations were evaluated for entrapment efficiency, spreadability, viscosity, and visual examination using binocular microscopy and in vitro drug release using Franz diffusion cells. Results: The optimized formulation F2 reported entrapment efficiency of 65.09±0.41%, and viscosity of 11100±1.21 cps. The in vitro release of drug for the prepared formulations was performed for 8 h. and the optimized formulation showed better-controlled drug release compared to other formulations. It was observed that the optimized batch, percentage of drug permeability through the skin at 8 h of ex-vivo study shows 84.67±0.67% and in vitro drug release study (93.22%) through Franz diffusion cell, which suggests that the drug (Optimum batch) can easily penetrate through the skin and showed the highest drug release in a stipulated time interval. Conclusion: The use of an optimized Mhg-FLCZ gel formulation as it has excellent homogeneity, a pH that is close to that of the skin, and suitable thixotropic characteristics relates to that much more convenience than the conventional dosage form. The in vitro and ex-vivo study data proved its suitability as a better alternative to conventional products in the effective treatment of skin infections.