Abstract

FORMULATION, DEVELOPMENT AND CHARACTERIZATION OF FILM FORMING GELS OF EFINACONAZOLE

Saveetha S. V.*, Shafin Ahamed S. M., Naveenakash M., Kayathri R., Deepika Devaraj, Grace Rathnam

Abstract

The overall core of the present study was to formulate and evaluate the film-forming gels of Efinaconazole using the polymeric blend of Eudragit RL-100 and Ethyl cellulose. Polyethylene Glycol-400 is used as a plasticizer. The drug release profile of Efinaconazole was identified to be burst release (18% - 39%) during initial 4 h period, which later sustained its release up to a mark of 24 h. The drug was determined by performing pre-formulation studies, including the solubility test and the melting point test (81°C-86°C), which correlated with the standard values. Three formulations were prepared and named F1, F2 and F3, which were prepared by the solvent dissolution method by altering the concentration of the polymer and the co-polymer and were evaluated for their pH, weight of dry spray, percentage purity and in vitro drug release. Physicochemical parameters like drying time (56–57 s), density (0.759-0.885ρ), viscosity (6.75-9.98 cP) and pH of 6 were recorded. Initially, the burst release was found for all three formulations at the starting four hours, which after became a sustained release with over 97% of drug release for 24 hours in F3. From this, it is concluded that F3 showed promising results, and Efinaconazole film-forming gels were prepared successfully using the polymeric blend of Eudragit RL-100 and Ethyl Cellulose.

Keywords: Efinaconazole, Film-Forming System, Onychomycosis, Eudragit RL-100, Ethyl Cellulose, Polyethylene glycol-400.