Combination therapy using Ciclopirox and Salicylic acid incorporated Chitosan lotion for onychomycosis treatment.

Onychomycosis is a prevalent nail infection, caused by dermatophytes, leading to nail thickening, discolouration, pain and discomfort. Existing topical therapies show limited efficacy due to poor nail penetration and inadequate drug release at the infection site. Current treatment methods include nail removal or laser therapy. To overcome these limitations, we formulated a Ciclopirox-Salicylic acid incorporated Chitosan lotion with penetration enhancers to eliminate the fungal pathogen from the nail bed. Ciclopirox (CX) exhibits both fungicidal and fungistatic activity by inhibiting fungal DNA, RNA and protein synthesis, while salicylic acid (SA) acts as a keratolytic agent that facilitates drug permeation through the nail layers. Tween-80 and poly ethylene glycol (PEG-400) is used as permeation enhancers to improve drug penetration and prevent drug precipitation, thereby enhancing formulation stability. The prepared lotion was characterized using FE-SEM, FT-IR and rheological analyses. The developed CSL-SA-CX shown effective antifungal activity against Candida albicans and Aspergillus niger. Ex vivo porcine skin and goat nail permeation study demonstrated significantly enhanced ciclopirox permeation compared to commercial formulation. In vivo antifungal activity in Drosophila melanogaster fly model validated the in vivo safety of the developed CSL-SA-CX against C. albicans. Thus, the prepared CSL-SA-CX lotion can be used to treat Onychomycosis as well as a wide range of nail fungal infections.