Formulation, optimization, and in-vitro diffusion studies of novel niosomal gel of miconazole nitrate

Background: Miconazole Nitrate exhibits potent antifungal activity; its therapeutic potential is restricted by poor skin permeability and low aqueous solubility. To overcome these limitations, the present study aimed to develop and optimize a niosomal gel delivery system using non-ionic surfactant vesicles to enhance dermal diffusion and therapeutic efficacy. Methodology: The ether injection method was used to create niosomes. The results obtained from applying the Box-Behnken design (BBD) were highly instructive for the PDI, droplet size, and drug release profile. DLS was used to quantify particle size and zeta potential, and SEM was used to characterize particle morphology. The stability and compatibility were examined using DSC and FTIR. Results and Discussion: The optimized niosomal formulation exhibited a particle size of 180.9 ± 1.8 nm, a PDI of 0.1533 ± 0.01, and a zeta potential of –27.28 ± 0.2 mV, indicating excellent colloidal stability. The Box–Behnken model exhibited strong statistical significance (R² = 0.9663 for size, 0.9098 for PDI, and 0.9971 for zeta potential; p < 0.05). The encapsulation efficiency was 91%; the in-vitro diffusion profile followed the Hixson–Crowell model (R² = 0.9959), confirming a controlled-release mechanism. Compared with conventional Miconazole formulations, the optimized niosomal gel demonstrated markedly enhanced diffusion and prolonged release over 8 hours. The Carbopol-based gel exhibited suitable viscosity (3250 cP), spreadability, and pH (5.5 ± 0.1), ensuring dermal compatibility. Conclusion: The niosomal gel displayed characteristics that improved its drug loading, stability, and sustained-release properties. These modifications indicate its potential as a transdermal drug delivery system and improved antifungal activity.