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<p>Emulgels, hybrid semisolid formulations combining the benefits of emulsions and gels, have emerged as an innovative drug delivery system for topical administration of hydrophobic active pharmaceutical ingredients (APIs). This study developed and optimised a Ruxolitinib Phosphate (RXP-loaded emulgel for the treatment of vitiligo, leveraging a design of experiments (DoE) approach to evaluate critical formulation variables, including emulsifier ratios (Tween 20/Span 80), oil phase composition (medium-chain triglycerides/isopropyl myristate), and gelling agent (Carbomer 980). The optimized emulgel exhibited desirable physicochemical properties, including a skin-compatible pH (5.0–5.6), high viscosity (~ 21,048 cP), and excellent drug content (98.7%). In vitro release studies demonstrated superior drug release kinetics compared to Sepineo-based formulations, while in vitro permeation testing confirmed effective epidermal localization without systemic absorption. Biological evaluations on B16F10 melanoma cells revealed enhanced melanin synthesis (270% of control) and tyrosinase activity (212%), outperforming conventional cream formulations. Stability studies indicated robustness under accelerated conditions (40&#xa0;°C/75% RH for 3 months), with no significant changes in critical quality attributes. These findings highlight the emulgels potential as a stable, efficacious, and patient-friendly topical delivery system for RXP in vitiligo therapy, warranting further clinical validation.</p>

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Enhancing topical ruxolitinib delivery via emulgel for vitiligo: formulation development, in vitro release, skin permeation, and mechanistic effects on melanogenesis

  • 期刊论文

  • 发表日期：

    2026年2月14日

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  • Om Sambhaji Shelke,
  • Seema Amar Gadge,
  • Sanakausar Nadaf,
  • Kshama Nimse,
  • Rupesh Pingale

摘要

Emulgels, hybrid semisolid formulations combining the benefits of emulsions and gels, have emerged as an innovative drug delivery system for topical administration of hydrophobic active pharmaceutical ingredients (APIs). This study developed and optimised a Ruxolitinib Phosphate (RXP-loaded emulgel for the treatment of vitiligo, leveraging a design of experiments (DoE) approach to evaluate critical formulation variables, including emulsifier ratios (Tween 20/Span 80), oil phase composition (medium-chain triglycerides/isopropyl myristate), and gelling agent (Carbomer 980). The optimized emulgel exhibited desirable physicochemical properties, including a skin-compatible pH (5.0–5.6), high viscosity (~ 21,048 cP), and excellent drug content (98.7%). In vitro release studies demonstrated superior drug release kinetics compared to Sepineo-based formulations, while in vitro permeation testing confirmed effective epidermal localization without systemic absorption. Biological evaluations on B16F10 melanoma cells revealed enhanced melanin synthesis (270% of control) and tyrosinase activity (212%), outperforming conventional cream formulations. Stability studies indicated robustness under accelerated conditions (40 °C/75% RH for 3 months), with no significant changes in critical quality attributes. These findings highlight the emulgels potential as a stable, efficacious, and patient-friendly topical delivery system for RXP in vitiligo therapy, warranting further clinical validation.