A novel nanoemulgel formulation of Luliconazole with augmented antifungal efficacy: In-vitro, in-silico, ex-vivo, and in-vivo studies

Luliconazole has been a wonder drug for treating superficial fungal infections. Current formulations are limited by very poor and slow skin absorption, requiring long-term, repetitive dosing to completely cure the condition. Nanoemulgel formulation (1% w/w) has been formulated and comprehensively tested, with the results compared to the commercially available formulation. The optimized formulation has an ideal pH, nanometric globular size (86.62 nm), 99.6% transmittance, and zeta potential (-0.386 mV), and has no signs of instability on freeze-thaw cycle, centrifugation, and storage. In silico studies validated the drug molecule's interactions with nanoemulsion (NE) components in an optimum molecular conformation. Additionally, ex vivo skin permeation and deposition tests on biological membranes and a synthetic membrane show increased drug permeation. As well, cell line studies demonstrated higher drug uptake through NE formulation. A Confocal Laser Scanning Microscopy study confirms twice the permeation of nanoemulgel into skin layers as opposed to pure drug. When tested in vivo for topical treatment of fungal infections on Sprague Dawley rats, the nanoemulgel formulation was found to be safe, non-irritant, and more effective with no drug reaching the systemic circulation. Therefore, employing an NE as a carrier for enhanced topical delivery of Luliconazole is a viable option.