Terbinafine Hydrochloride Loaded Liposome Film Formulations for Onychomycosis: Characterization and Ex Vivo Evaluation

Characterization and Ex Vivo Evaluation S. Tuncay Tanriverdi, O. Ozer Ege University Purpose The aim of this study to prepare Terbinafine hydrochloride (TBF-HCl) loaded liposome included film formulations for ungual therapy of onychomycosis. Ex-vivo nail permeation studies was performed with these formulations to investigate accumulation of TBF-HCl on nail plate. Methods The thin film hydration method was used to prepare the liposomal suspensions. Formulations were chacterized in terms of the z-average mean (Z-size), polydispersity (PI) and zeta potential (æ (mV), the entrapment efficiency (EE), the pH. Film former polymer was dispersed with TBF-HCl loaded liposome suspensions to perform film formulations. Propylene glycol also was added to mixture and heated at 30°C and water content evaporated to form film formulation. Prepared film formulations were analysis macroscopically and weight, bioadhesive properties and breakable of films were tested. Specially modified Franz diffusion cells and human cadaver nail samples were used for ex-vivo permeation experiment. Samples were analyzed by validated method of HPLC. TBF-HCl was extracted from pulverized nails. After centrifugation amount of drug was measured by HPLC. The amount of TBF-HCl remained in the nail plate was presented as a percentage of the drug concentration in donor phase at the beginning of experiment.