DEVELOPMENT OF TOPICAL NAIL LACQUER FORMULATION FOR THE MANAGEMENT OF ONYCHOMYCOSISAbstract
Nail plate being a formidable barrier, drug permeation through this layer is limited. Taking this as a challenging task, the present study focuses on the formulation of an antifungal topical nail lacquer using Oxiconazole nitrate. The novelty of the studies can be stated as the use of a combination of permeation enhancers like salicylic acid, thioglycolic acid, and urea for effective therapeutic treatment of topical nail infection like Onychomycosis. Results: Optimized formulation F13 was subjected for incompatibility studies followed by post-formulation studies (drying time, water resistance, etc.). Clipping of nail part was examined for in-vitro drug release and anti-microbial activity followed by stability studies of the optimized formulation. The optimized F13 formulation was found to have a thickness (57±0.04µm), folding endurance (183±0.57 mm), and tensile strength (2.62±0.02 Kg/cm2) values, respectively. The FTIR and XRD studies showed no interaction between drug-excipients. Permeation enhancer in the ratio of salicylic acid: thioglycolic acid: urea in hydrogen peroxide (1:1:1) with 5% concentration each showed in-vitro drug release rate of 96.03% at 48 hours both through cellophane membrane as well bovine hooves membrane methods. Antifungal activity exhibit a zone of inhibition of 11±0.03 mm. Conclusion: The present research with an attempt to use combinatorial permeation enhancer (salicylic acid: thioglycolic acid: urea in hydrogen peroxide) showed good permeability and antifungal activity. The F13 formulation possessed all the expected activities and thereof compared with marketed (Lakme) topical nail lacquer. From the above results, it can be concluded that in-vivo studies can be a promising approach in the future.
K. K. Sindhu, P. Biju *, M. Shaik, A. R. Augusthy and V. Revadigar
Department of Pharmaceutics, Yenepoya Pharmacy College and Research Centre, Yenepoya Deemed to be University, Mangalore, Karnataka, India.
07 July 2020
16 October 2020
06 May 2021
01 July 2021