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Purpose <p>Onychomycosis is a persistent fungal infection of the nail that remains difficult to treat using topical therapies due to the dense keratinized nail plate. This study aimed to develop and evaluate a novel ethyl cellulose-based nail lacquer incorporating terbinafine hydrochloride and thyme oil to enhance nail hydration, transungual drug delivery, and antifungal efficacy.</p> Methods <p>A series of medicated nail lacquers were prepared using ethyl cellulose as a film-forming polymer, ethanol-ethyl acetate as volatile solvents, and dibutyl phthalate as plasticizer. Terbinafine hydrochloride (0.1% w/w) and thyme oil (2% v/v) were incorporated into the optimized lacquer formulation. The lacquers were evaluated for physicochemical properties including drying time, viscosity, non-volatile content, spreadability, contact angle, and film appearance. Drug-excipient compatibility was assessed by FTIR spectroscopy. In vitro diffusion was studied using synthetic cellophane membrane in Franz diffusion cell, while transungual permeation and nail hydration were evaluated using hydrated human nail clippings. Antifungal activity was assessed using the agar well diffusion method against <i>Candida albicans</i>. Accelerated stability studies were performed as per ICH Q1A(R2) guidelines.</p> Results <p>The optimized lacquer formulation formed smooth, flexible films with rapid drying (~ 65&#xa0;s), suitable viscosity (24.8 ± 1.6 cP), and optimal non-volatile content (16.9 ± 0.9%). Sustained drug diffusion (71.17% at 24&#xa0;h) was observed. Transungual permeation was significantly enhanced, with cumulative permeation of 28.42 ± 1.95&#xa0;µg cm⁻² and a steady-state flux of 1.21 ± 0.09&#xa0;µg cm⁻² h⁻¹, corresponding to a permeation enhancement ratio of 1.92. Nail hydration increased markedly (hydration enhancement factor = 1.76). The optimized lacquer showed drug and oil contents of 99.3 ± 1.4% and 97.6 ± 1.5%, respectively, and demonstrated synergistic antifungal activity against <i>Candida albicans</i>. The formulation remained stable under accelerated storage conditions for 1 month.</p> Conclusion <p>The developed terbinafine-thyme oil nail lacquer exhibited enhanced transungual delivery, sustained diffusion, and synergistic antifungal efficacy, indicating its potential as a patient-friendly topical alternative for onychomycosis management.</p> Graphical Abstract <p></p>

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Development and Evaluation of a Novel Nail Lacquer Formulation Containing Terbinafine and Thyme Oil for Enhanced Transungual Delivery in Onychomycosis

  • 期刊论文

  • 发表日期：

    2026年3月23日

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  • Diya J. Bhavsar,
  • Dasharath M. Patel

摘要

Purpose

Onychomycosis is a persistent fungal infection of the nail that remains difficult to treat using topical therapies due to the dense keratinized nail plate. This study aimed to develop and evaluate a novel ethyl cellulose-based nail lacquer incorporating terbinafine hydrochloride and thyme oil to enhance nail hydration, transungual drug delivery, and antifungal efficacy.

Methods

A series of medicated nail lacquers were prepared using ethyl cellulose as a film-forming polymer, ethanol-ethyl acetate as volatile solvents, and dibutyl phthalate as plasticizer. Terbinafine hydrochloride (0.1% w/w) and thyme oil (2% v/v) were incorporated into the optimized lacquer formulation. The lacquers were evaluated for physicochemical properties including drying time, viscosity, non-volatile content, spreadability, contact angle, and film appearance. Drug-excipient compatibility was assessed by FTIR spectroscopy. In vitro diffusion was studied using synthetic cellophane membrane in Franz diffusion cell, while transungual permeation and nail hydration were evaluated using hydrated human nail clippings. Antifungal activity was assessed using the agar well diffusion method against Candida albicans. Accelerated stability studies were performed as per ICH Q1A(R2) guidelines.

Results

The optimized lacquer formulation formed smooth, flexible films with rapid drying (~ 65 s), suitable viscosity (24.8 ± 1.6 cP), and optimal non-volatile content (16.9 ± 0.9%). Sustained drug diffusion (71.17% at 24 h) was observed. Transungual permeation was significantly enhanced, with cumulative permeation of 28.42 ± 1.95 µg cm⁻² and a steady-state flux of 1.21 ± 0.09 µg cm⁻² h⁻¹, corresponding to a permeation enhancement ratio of 1.92. Nail hydration increased markedly (hydration enhancement factor = 1.76). The optimized lacquer showed drug and oil contents of 99.3 ± 1.4% and 97.6 ± 1.5%, respectively, and demonstrated synergistic antifungal activity against Candida albicans. The formulation remained stable under accelerated storage conditions for 1 month.

Conclusion

The developed terbinafine-thyme oil nail lacquer exhibited enhanced transungual delivery, sustained diffusion, and synergistic antifungal efficacy, indicating its potential as a patient-friendly topical alternative for onychomycosis management.

Graphical Abstract