Comparative evaluation of clove oil and tea tree oil based topical microemulsion gel in modulating delivery of luliconazole through skin: promising approach for antifungal delivery

Luliconazole, BCS class II, has been widely used for topical fungal infections. Conventional Luliconazole topical formulation exhibits poor cutaneous absorption and poor drug retention. We hypothesized that Luliconazole microemulsion-based gel with clove/tea tree oil as an oil phase will exhibit synergistic action, improve Luliconazole solubility and cutaneous absorption. The Luliconazole microemulsion containing clove/tea tree oil was optimized by applying a D-optimal design. The independent variables selected were the oil concentration (X1), Smix concentration (X2), and water concentration (X3) while the dependent variables chosen were the globule size (Y1) and flux at one hour (Y2). The globule size and zeta potential optimized Luliconazole Microemulsion were 59/60.4 nm and −1.4/-8.3 Mv for clove/tea tree oil, respectively. The size and sphericity of globules were further confirmed by transmission electron microscopy (TEM) analyses. The optimized clove oil and tea tree oil based LUL ME was further evaluated against <i>Candida albicans</i> (ATCC 10231) and <i>Aspergillus niger</i> (ATCC 16404) utilizing the disk diffusion method. The results of the study indicate a significant increase in the antifungal activity of both microemulsions in comparison to pure drug and higher activity for clove oil microemulsions. The histopathology images of the Wistar rat skin treated with optimized LCZ microemulsion gel further confirmed that neither of the formulations caused any disturbances to the skin’s epithelial layer. The findings of this study were encouraging for the pharmaceutical industry because it offers a complementary treatment for topical fungal infection.