Selection and Characterization of a Nanoemulsion of Poorly Soluble Drug by Applying Box-Behnken Design and Converting it into a Nanoemulgel for Topical Application

In the present work, nanoemulsion (NE) based hydrogel, i.e., nanoemulgel (NEG) of Itraconazole, an antifungal drug was prepared and investigated to study its potential in delivering a drug topically. NE of Itraconazole was prepared by high energy emulsification method employing anise oil as lipid phase; Gelucire 44/14 and PEG 400 are surfactant and co-surfactants, respectively. The construction of ternary phase diagrams determined the concentration of the ingredients. The prepared NE’s were thus assessed for various parameters such as pH, electric conductivity, refractive index, viscosity, spreadability, poly-dispersity index (PDI), particle size, zeta potential etc and then distributed into suitable gel bases such as Carbopol 934P and Guar gum to obtain nanoemulsion based hydrogel. Therefore, various quality control tests such as pH, electric conductivity, refractive index, viscosity, spreadability, poly-dispersity index (PDI), particle size, zeta potential, swelling index, drug content estimation, in-vitro diffusion and ex-vivo permeation studies, antifungal studies etc were tested on the formulated NEG’s. The optimized formulation FI2 released 98.09 ± 0.84% of the active ingredient in 12 hours and the pH, viscosity, and spreadability were found to suit the skin requirements. The results prove that topical administration of Itraconazole NEG increases the permeability and diffusibility of the drug.