Novel Polypseudorotaxanes Hydrogel based Nail Lacquer of Efinaconazole for Transungual Drug Delivery

Aim: Due to the various drawbacks associated with current treatment therapy of onychomycosis, the main aim was to develop thermosensitive hydrogels and thermosensitive polypseudorotaxanes hydrogels-based nail lacquer for transungual delivery of Efinaconazole for the management of onychomycosis. The objective is to enhance the permeation and retention of the drug in the nails and improve patient compliance. Methods: Poloxamer 407 and Hydroxy Propyl-β-cyclodextrin were used to prepare the nail lacquers. 2-mercaptoethanol was added as a penetration enhancer to improve the penetration of the drug across the nail plate. The formulations were optimized by varying the concentration of poloxamer and water: ethanol ratio and evaluated based on the basis of drying time, sol-gel transition temperature, ex vivo drug release, and viscosity. The optimized formulation was further evaluated for pH, water resistance, non-volatile content, drug content, blush test, spreadability, and stability studies. Results: The increase in ethanol concentration and reduction in poloxamer proportion led to a reduction in lacquer stickiness thus, improving the lacquer drying time and penetration. The polypseudorotaxanes improved the permeation profile of the drug in comparison to the marketed nail lacquer. The presence of 2-mercaptoethanol also contributed to the transungual delivery of Efinaconazole. Conclusion: The polypseudorotaxanes based nail lacquer with the incorporation of penetration enhancer was able to achieve a high rate of drug penetration and retention, thus supporting the potential use of aqueous based-nail lacquer in transungual drug delivery for the onychomycosis treatment.