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Onychomycosis is a persistent fungal nail infection that is often difficult to treat with topical therapies because the dense keratinized nail plate limits drug penetration.
A novel terbinafine-thyme oil nail lacquer improves nail hydration, enhances transungual drug delivery, and demonstrates synergistic antifungal activity against onychomycosis.
Onychomycosis is a persistent fungal nail infection that is often difficult to treat with topical therapies because the dense keratinized nail plate limits drug penetration. Improving nail hydration and transungual drug delivery may enhance the effectiveness of topical antifungal treatment.
This study aimed to develop and evaluate an ethyl cellulose-based nail lacquer containing terbinafine hydrochloride and thyme oil to enhance transungual drug permeation, nail hydration, and antifungal efficacy in onychomycosis.
A series of medicated nail lacquers using ethyl cellulose as a film-forming polymer, ethanol-ethyl acetate as volatile solvents, and dibutyl phthalate as a plasticizer were formulated. Table 1 outlines the composition of the optimized nail lacquer formulation.
These formulations were evaluated for physicochemical characteristics, including drying time, viscosity, non-volatile content, spreadability, contact angle, and film appearance. Drug-excipient compatibility was evaluated through Fourier Transform Infrared Spectroscopy (FTIR) analysis. In vitro diffusion studies were performed using a Franz diffusion cell system, while transungual permeation and nail hydration were evaluated using hydrated human nail clippings. Antifungal activity against Candida albicans was assessed using the agar well diffusion method. Accelerated stability studies were conducted according to International Council for Harmonisation (ICH) Q1A(R2) guidelines.
The optimized nail lacquer produced smooth and flexible films with a rapid drying time of approximately 65 seconds, suitable viscosity (24.8 ± 1.6 centipoise), and optimal non-volatile content (16.9 ± 0.9%) with the key performance outcomes summarized in Table 1.
The formulation also demonstrated synergistic antifungal activity against Candida albicans and remained stable under accelerated storage conditions for one month.
The terbinafine-thyme oil nail lacquer demonstrated enhanced transungual delivery, sustained drug diffusion, improved nail hydration, and synergistic antifungal efficacy, highlighting its potential as a patient-friendly topical treatment option for onychomycosis.
Journal of Pharmaceutical Innovation
Development and evaluation of a novel nail lacquer formulation containing terbinafine and thyme oil for enhanced transungual delivery in onychomycosis
Diya J. Bhavsar & Dasharath M. Patel
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