Pullulan as Film-Forming Polymer for Hydrophilic Nail Lacquer Formulations

Abstract

Abstract Nail lacquers are topical solutions intended for use on nails and have been found to be useful in the treatment of onychomycosis [1]. The film acts a drug reservoir from which drug releases slowly and penetrates into and through the nail [2]. The type of the polymer affects the reservoir properties and releasing properties of the film [3]. The aim of this study was to evaluate pullulan as the film-forming polymer for hydrophilic nail lacquer formulations. To achieve this goal, experimental planning and optimization of hydrophilic nail lacquer compositions were performed based on physical properties of nail lacquers and in vitro release results. For ex vivo permeation and penetration study, human nail clippings were used as nail model and “wetted cotton ball” to mimic nail bed system. Quantitative analysis of antifungal agent was done by UPLC.Two optimized hydrophilic nail lacquers were formulated with the solvent system (purified water:ethanol: butyl acetate), Transcutol P and Pullulan. Hydrophilic nail lacquer OPT 1 with Transcutol Pas plasticizer had the highest released amount of antifungal agent in in vitro release testing; and the hydrophilic nail lacquer OPT 2 with Triacetin as plasticizer had the highest accumulated amount of antifungal agent in the nail clippings and acceptor medium in ex vivo transungual permeation study. Pullulan was found to be a suitable polymer for hydrophilic nail lacquer formulation. It was determined that the plasticizer nature has a statistically significant (p < 0.05) influence on the penetration of active substance to the acceptor media from hydrophilic nail lacquer formulations; and that hydrophilic film-forming polymer exhibit high penetration properties of antifungal drug into the nail model.