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Purpose <p>Psoriatic Arthritis (PsA) remains challenging to manage due to limitations of systemic therapies such as Apremilast (APT),including poor solubility, low permeability, and dose-related adverse effects. This study aimed to develop a topical niosomal gel for localizeddelivery of APT to enhance therapeutic efficacy while minimizing systemic exposure.</p> Methods <p>APT-loaded niosomes were prepared using thethin-film hydration method and optimized via Box–Behnken design to achieve minimal vesicle size and polydispersity index (PDI) with maximumentrapment efficiency (EE). The optimized formulation was incorporated into Carbopol 934 gel and evaluated for physicochemical properties, invitro release, stability, and dermal safety.</p> Results <p>The optimized formulation (21.55 mg APT; cholesterol:Span 80 ratio 1.61:1; total lipid 251.5mg) produced vesicles with size 378.8 ± 3.2 nm, PDI 0.153 ± 0.01, and EE 80.5 ± 1.1%. The gel showed suitable pH (5.0 ± 0.4), spreadability, andviscosity. Sustained drug release (85.0 ± 3.4% at 12 h) was observed compared to drug suspension. Stability studies confirmed no significantchanges over 90 days. The formulation was non-irritant and followed Higuchi release kinetics (R² = 0.9867).</p> Conclusion <p>The APT-loadedniosomal gel demonstrates a stable, safe, and effective topical delivery system, offering a promising approach for localized management of PsA.</p> Graphical abstract <p></p>

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Box–Behnken Design-Assisted Formulation of Apremilast-Loaded Niosomes: Characterization and In Vitro Evaluation for Targeted Management of Psoriatic Arthritis

  • 期刊论文

  • 发表日期：

    2026年4月11日

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  • Sonam M. Gandhi,
  • Ronak Dedania

摘要

Purpose

Psoriatic Arthritis (PsA) remains challenging to manage due to limitations of systemic therapies such as Apremilast (APT),including poor solubility, low permeability, and dose-related adverse effects. This study aimed to develop a topical niosomal gel for localizeddelivery of APT to enhance therapeutic efficacy while minimizing systemic exposure.

Methods

APT-loaded niosomes were prepared using thethin-film hydration method and optimized via Box–Behnken design to achieve minimal vesicle size and polydispersity index (PDI) with maximumentrapment efficiency (EE). The optimized formulation was incorporated into Carbopol 934 gel and evaluated for physicochemical properties, invitro release, stability, and dermal safety.

Results

The optimized formulation (21.55 mg APT; cholesterol:Span 80 ratio 1.61:1; total lipid 251.5mg) produced vesicles with size 378.8 ± 3.2 nm, PDI 0.153 ± 0.01, and EE 80.5 ± 1.1%. The gel showed suitable pH (5.0 ± 0.4), spreadability, andviscosity. Sustained drug release (85.0 ± 3.4% at 12 h) was observed compared to drug suspension. Stability studies confirmed no significantchanges over 90 days. The formulation was non-irritant and followed Higuchi release kinetics (R² = 0.9867).

Conclusion

The APT-loadedniosomal gel demonstrates a stable, safe, and effective topical delivery system, offering a promising approach for localized management of PsA.

Graphical abstract