Abstract

FORMULATION AND EVALUATION OF BI LAYER NAIL LACQUER CONTAINING ANTIFUNGAL DRUG FOR THE TREATMENT OF ONYCHOMYCOSIS

B. Sravan Kumar*, T. Praveen Kumar, V. Himabindu and M. Chinna Eswaraiah

ABSTRACT

Transungual therapy is considered to be highly desirable to treat nail diseases owing to its localized effects, improved adherence and minimal adverse systemic events compared to oral therapy. The aim of present investigation was to formulate and evaluate terbinafine hydrochloride bilayer nail lacquer for treatment of onychomycosis. Nail lacquer was prepared by using HPMC as film forming agent. Salycylic acid, Thioglycolic acid and urea were selected as kerotolytic agents. Diethyl Pthalate and polyvinyl phenol were used as plasticizer in backing layer. Total 9 formulations were prepared with 5%, 10% and 15% concentration of kerotolytic agents. Prepared nail lacquers were evaluated for non volatile content, drying time, % adhesion, water resistance, Hydration enhancement factor, drug content, in vitroc permeation studies and in vitro antifungal activity. The drying time in all the formulation was found to be between 64- 90secs. It was observed that thioglycolic acid had higher hydration enhancement efficiency, adhesion, and water resistance than urea and salicylic acid. The drug content was found to be in 85 to 97 % in all the formulations. The results obtained from in-vitro diffusion studies showed that formulation F6 has completed drug release of 79.2μg/ml over 24 hrs. From diffusion studies, it was concluded that thioglycolic acid containing formulation have better penetration enhancement as compared to salicylic acid and urea containing formulation. The best formulation was selected based on permeation studies and antifungal activity against the Candida albicans.

Keywords: Lacquer, Nail Plate, Onychomycosis, Terbinafine Hydrochloride, thioglycolic acid, Urea.