Abstract
The successful topical therapy of onychomycosis depends on effective drug release and penetration into nail, which can be achieved by using an adequately developed delivery system. This study evaluated and compared effect of film-forming polymers Eudragit RL100, Eudragit RS100, and ethyl cellulose on naftifine hydrochloride release from experimental nail lacquer formulations. Quality of formulations was evaluated by determining drying time and water resistance. Interactions between active pharmaceutical ingredient and excipients were investigated using microcalorimetry and FT-IR. Optimization of nail lacquer formulations was performed by naftifine hydrochloride release testing. Release of naftifine hydrochloride increased with increasing concentration of Eudragit RL100. Plasticizer triacetin affected the release of naftifine hydrochloride, when Eudragit RS100 polymer was used. Ethyl cellulose polymer was determined to be not applicable for naftifine hydrochloride nail lacquer formulations. Two compositions of nail lacquers were optimized and could be used in further development of transungual delivery systems.
Highlights
Onychomycosis is a fungal infection of nails that causes discoloration, thickening, and separation from the nail bed
This study evaluated and compared effect of film-forming polymers Eudragit RL100, Eudragit RS100, and ethyl cellulose on naftifine hydrochloride release from experimental nail lacquer formulations
Film-forming polymers Eudragit RL100 and Eudragit RS100 were kindly gifted by Evonik Industries AG (Essen, Germany), while ethyl cellulose Ethocel Standard 20 Premium was obtained from Colorcon (UK)
Summary
Onychomycosis is a fungal infection of nails that causes discoloration, thickening, and separation from the nail bed. Oral antifungal therapy remains the most often used for onychomycosis treatment; it has significant disadvantages: long systematic treatment can cause serious side effects, liver damage, and only tiny drug fraction could reach a target because of limited blood circulation [2]. Topical delivery systems offer many benefits in dermatology; gel, cream, or liquid formulations are not adequate for the transungual delivery since they are removed by washing or rubbing. This phenomenon at the site of application accounts for their inefficacy [3,4,5,6]
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