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Purpose <p>Atopic dermatitis (AD) is a chronic, recurrent inflammatory skin disorder frequently observed in infants, where safe and effective therapies remain a clinical challenge. Methylprednisolone aceponate (MPA), a fourth-generation corticosteroid, is widely preferred due to its favorable risk–benefit profile and pediatric approval from four months of age. This study aimed to develop and evaluate novel MPA-loaded microemulsions (MEs) as safe topical formulations for infantile AD.</p> Methods <p>Oil-in-water (O/W) MEs containing 0.1% MPA were prepared using different oils and surfactant/cosurfactant (Smix) ratios. Pseudo-ternary phase diagrams were constructed to identify appropriate component ranges. The optimized ME was characterized by FTIR spectroscopy, viscosity, droplet size (DS), polydispersity index (PDI), and zeta potential (ZP). In vitro drug release was performed, and cytotoxicity was assessed by MTT assay using L929 fibroblast cells.</p> Results <p>The optimized ME formulations exhibited nano-sized droplets with low PDI, negative ZP, and suitable viscosity, indicating high stability. MPA release was 3.69 times higher in formulation A3 and 4.12 times higher in formulation A4 compared to the MPA suspension. In cell culture studies, approximately 90% cell viability was maintained after 24&#xa0;h of incubation, and MTT assays confirmed that the formulations provided high biocompatibility without inducing cytotoxicity in fibroblast cells.</p> Conclusion <p>The formulated MPA-loaded ME is a secure, stable, and novel topical delivery method with significant promise for addressing infantile AD. This is, to our knowledge, the first report of an MPA-ME particularly formulated for newborns, substantiated by physicochemical characterisation and in vitro biocompatibility assessments.</p>

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Formulation and Cytotoxicity Assessment of Methylprednisolone Aceponate Microemulsions for Topical Delivery

  • 期刊论文

  • 发表日期：

    2025年11月25日

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  • Özlem Kral,
  • Gülser Hennep,
  • Esma Nur Uslu,
  • Çiğdem Yücel

摘要

Purpose

Atopic dermatitis (AD) is a chronic, recurrent inflammatory skin disorder frequently observed in infants, where safe and effective therapies remain a clinical challenge. Methylprednisolone aceponate (MPA), a fourth-generation corticosteroid, is widely preferred due to its favorable risk–benefit profile and pediatric approval from four months of age. This study aimed to develop and evaluate novel MPA-loaded microemulsions (MEs) as safe topical formulations for infantile AD.

Methods

Oil-in-water (O/W) MEs containing 0.1% MPA were prepared using different oils and surfactant/cosurfactant (Smix) ratios. Pseudo-ternary phase diagrams were constructed to identify appropriate component ranges. The optimized ME was characterized by FTIR spectroscopy, viscosity, droplet size (DS), polydispersity index (PDI), and zeta potential (ZP). In vitro drug release was performed, and cytotoxicity was assessed by MTT assay using L929 fibroblast cells.

Results

The optimized ME formulations exhibited nano-sized droplets with low PDI, negative ZP, and suitable viscosity, indicating high stability. MPA release was 3.69 times higher in formulation A3 and 4.12 times higher in formulation A4 compared to the MPA suspension. In cell culture studies, approximately 90% cell viability was maintained after 24 h of incubation, and MTT assays confirmed that the formulations provided high biocompatibility without inducing cytotoxicity in fibroblast cells.

Conclusion

The formulated MPA-loaded ME is a secure, stable, and novel topical delivery method with significant promise for addressing infantile AD. This is, to our knowledge, the first report of an MPA-ME particularly formulated for newborns, substantiated by physicochemical characterisation and in vitro biocompatibility assessments.