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Purpose <p>This study focuses on the development and optimization of a sertaconazole-loaded nanoemulgel (SER-NEG) using a quality by design (QbD) approach for improved topical antifungal therapy. The goal was to formulate a stable nanoemulsion (NE) using the low Energy spontaneous emulsification method, followed by its incorporation into a gel matrix for enhanced drug retention and efficacy.</p> Methods <p>A pseudoternary phase diagram was constructed to determine the optimal ratio of oleic acid (oil), S<sub>mix</sub> (surfactant-co-surfactant), and aqueous phase for a stable NE. Box-Behnken Design (BBD) was applied to optimize critical material attributes (CMAs) affecting critical quality attributes (CQAs) like globule size (GS) and entrapment efficiency (EE). The optimized NE was incorporated into an HPMC-Carbopol gel to form a NEG. The formulation was evaluated for in vitro drug release, release kinetics, morphology, stability, antifungal efficacy, and rheological properties.</p> Results <p>The optimized SER-NEG were evaluated for GS (111 nm), EE (99.7%), viscosity (2682 ± 96.77 cP), and spreadability (7.03 ± 0.98&#xa0;cm). In vitro release studies showed sustained release (77.00% ± 4.28% over 8&#xa0;h), following the Higuchi diffusion model (R² = 0.977). SEM analysis confirmed a uniform, spherical morphology, while stability studies showed excellent physical stability. Antifungal efficacy demonstrated a superior zone of inhibition against <i>Candida albicans</i> (1.1 ± 0.1&#xa0;cm) and <i>Aspergillus niger</i> (0.6 ± 0.1&#xa0;cm) compared to marketed formulations.</p> Conclusion <p>The QbD-optimized SER-NEG displayed enhanced stability, controlled drug release, and better antifungal activity. It ensures smooth application thereby could improve patient compliance. With these many advantages, this carrier system becomes a promising candidate for topical antifungal therapy.</p>

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Development of Sertaconazole Loaded Nanoemulgel Using Quality by Design Approach for Enhanced Antifungal Drug Delivery

  • 期刊论文

  • 发表日期：

    2025年9月9日

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  • Shalini Pandey,
  • Sourav Paul,
  • Krishna Kant Jangde,
  • Dinesh Kumar Mishra

摘要

Purpose

This study focuses on the development and optimization of a sertaconazole-loaded nanoemulgel (SER-NEG) using a quality by design (QbD) approach for improved topical antifungal therapy. The goal was to formulate a stable nanoemulsion (NE) using the low Energy spontaneous emulsification method, followed by its incorporation into a gel matrix for enhanced drug retention and efficacy.

Methods

A pseudoternary phase diagram was constructed to determine the optimal ratio of oleic acid (oil), Smix (surfactant-co-surfactant), and aqueous phase for a stable NE. Box-Behnken Design (BBD) was applied to optimize critical material attributes (CMAs) affecting critical quality attributes (CQAs) like globule size (GS) and entrapment efficiency (EE). The optimized NE was incorporated into an HPMC-Carbopol gel to form a NEG. The formulation was evaluated for in vitro drug release, release kinetics, morphology, stability, antifungal efficacy, and rheological properties.

Results

The optimized SER-NEG were evaluated for GS (111 nm), EE (99.7%), viscosity (2682 ± 96.77 cP), and spreadability (7.03 ± 0.98 cm). In vitro release studies showed sustained release (77.00% ± 4.28% over 8 h), following the Higuchi diffusion model (R² = 0.977). SEM analysis confirmed a uniform, spherical morphology, while stability studies showed excellent physical stability. Antifungal efficacy demonstrated a superior zone of inhibition against Candida albicans (1.1 ± 0.1 cm) and Aspergillus niger (0.6 ± 0.1 cm) compared to marketed formulations.

Conclusion

The QbD-optimized SER-NEG displayed enhanced stability, controlled drug release, and better antifungal activity. It ensures smooth application thereby could improve patient compliance. With these many advantages, this carrier system becomes a promising candidate for topical antifungal therapy.