Abstract
The aim of this study was to prepare and incorporate TBH-loaded spanlastics into different delivery systems for treatment of onychomycosis via the trans-ungual route. Two drug delivery dosage forms; the in-situ gel and the nail lacquer, were developed and evaluated for their ability to deliver TBH encapsulated in spanlastic carriers to the nail plate. In-situ gel formulations were prepared using different Pluronics® in different concentrations using the cold method, and evaluated for sol-gel transition temperature, viscosity, and in-vitro release studies. The nail lacquer formulation were prepared using Eudragit® RLPO as a film forming polymer in different concentrations, and evaluated for drying time, non-volatile content, water resistance and in-vitro release studies. Finally, an ex vivo human cadaver nail permeation study with the optimized formulations was employed in order to assess TBH permeation and retention in the nails compared to the commercially available TBH cream (Lamisil® 1% cream). The optimized in-situ gel formulation G6, showed higher amounts of retained TBH in the nails (2.05 ± 0.008 mg/cm2) compared to the marketed product Lamisil® cream 1% (1.36 ± 0.03 mg/cm2), by an increase of 51%, indicating successful trans-ungual delivery of TBH from the prepared in-situ gels.
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