Purpose <p>This study aimed to develop and characterize a fluoxetine-loaded bio-nanoemulgel using Acacia gum as a natural stabilizer to enhance dermal permeation, bypass first-pass metabolism, and achieve sustained transdermal antidepressant delivery.</p> Methods <p>Six formulations (F1–F6) were prepared by varying Acacia gum concentrations. Physicochemical properties, including pH, viscosity, spreadability, conductivity, entrapment efficiency, and short-term stability, were evaluated. Ex vivo permeation was assessed using Franz diffusion cells with goat forehead skin due to its close physiological similarity to human skin. Drug-release kinetics were analyzed using zero-order, first-order, Higuchi, and Korsmeyer–Peppas models.</p> Results <p>All formulations exhibited suitable physicochemical properties, good stability, and dermal compatibility. The optimized formulation demonstrated superior drug entrapment, sustained drug release, and enhanced ex vivo permeation compared with formulations containing higher polymer concentrations. Release behavior was consistent with diffusion-controlled kinetics, and stability and skin-irritation studies confirmed the robustness and safety of the bio-nanoemulgel system.</p> Conclusion <p>The optimized fluoxetine bio-nanoemulgel (F1) demonstrated sustained release, ex vivo enhanced dermal permeation, and robust short-term stability, suggesting strong potential as a transdermal antidepressant delivery system. Incorporation of Acacia gum supports a natural and sustainable formulation strategy. Further in vivo studies and scale-up evaluation are recommended to confirm therapeutic performance and commercial feasibility.</p>

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Formulation and Characterization of a Novel Fluoxetine Bio-Nanoemulgel for Enhanced Transdermal Antidepressant Delivery

  • Vikrant Dandekar,
  • Milind Sathe,
  • Preeti Singh,
  • Sneha Yadav

摘要

Purpose

This study aimed to develop and characterize a fluoxetine-loaded bio-nanoemulgel using Acacia gum as a natural stabilizer to enhance dermal permeation, bypass first-pass metabolism, and achieve sustained transdermal antidepressant delivery.

Methods

Six formulations (F1–F6) were prepared by varying Acacia gum concentrations. Physicochemical properties, including pH, viscosity, spreadability, conductivity, entrapment efficiency, and short-term stability, were evaluated. Ex vivo permeation was assessed using Franz diffusion cells with goat forehead skin due to its close physiological similarity to human skin. Drug-release kinetics were analyzed using zero-order, first-order, Higuchi, and Korsmeyer–Peppas models.

Results

All formulations exhibited suitable physicochemical properties, good stability, and dermal compatibility. The optimized formulation demonstrated superior drug entrapment, sustained drug release, and enhanced ex vivo permeation compared with formulations containing higher polymer concentrations. Release behavior was consistent with diffusion-controlled kinetics, and stability and skin-irritation studies confirmed the robustness and safety of the bio-nanoemulgel system.

Conclusion

The optimized fluoxetine bio-nanoemulgel (F1) demonstrated sustained release, ex vivo enhanced dermal permeation, and robust short-term stability, suggesting strong potential as a transdermal antidepressant delivery system. Incorporation of Acacia gum supports a natural and sustainable formulation strategy. Further in vivo studies and scale-up evaluation are recommended to confirm therapeutic performance and commercial feasibility.