9th Annual WML Academic Symposium

Presenter(s): Sukanya Nagfernandes
Title: Formulation, Optimization of an Antifungal Nail Polish containing Itraconazole 1% and Evaluation for its Transungual Penetration
Developed under the guidance of Dr. Mali R.Gupta , College of Pharmacy & Health Sciences

The aim of the study is to achieve transungual penetration of an optimized Itraconazole (1%w/w) nail lacquer and thus pave way for a reduction in onychomycosis. A medicated nail lacquer serves as an efficient, effective, patient compliant and aesthetic drug delivery system to treat nail disorders. The proposed study aims at formulating an antifungal Itraconazole (1%w/w) nail lacquers with a combination of penetration agents, Papain, Urea and Salicylic acid and drawing a comparison based on drug diffusion through nail plate. The formulation strategy would be based on the outcome of the preformulation studies conducted for solubility, pH stabilization and compatibility between drug and excipient. Upon the success of the expected results, four sets of Itraconazole (1%w/w) nail lacquer formulations will be prepared and compared. The formulations are, Itraconazole nail lacquer, Itraconazole lacquer containing Urea, Itraconazole with Papain and Salicylic acid in lacquer and finally Urea, Salicylic acid and Papain in an Itraconazole lacquer. Formulation process would include preparing a solution of the penetration enhancers and drug in a set volume of solvent system of butyl acetate, ethyl acetate and 70% Isopropyl alcohol (adjusted to a pH within 5-6) and eventually making up the weight using a marketed top coat lacquer (Sally Hansen Ultimate Shield Base & Top Coat™). Optimization of Papain and Salicylic acid composition will be performed in accordance with a DoE table (JMP®). The product will be evaluated for transungual diffusion and quality parameters like drug content, spreadability, precipitation and for accelerated stability. In addition, a transungual diffusion study will be conducted using a custom-made nail Franz cell apparatus. Data will be statistically analyzed using the one-way analysis of various technique (ANOVA) and a post hoc test (Tukey’s HSD) using the JMP® software. The results will be noted as mean ± standard deviation. A comparison will be drawn with a 5% level of significance.