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Background <p>Topical treatment with chemotherapeutic agents are widely used to manage squamous cell carcinoma (SCC) of the skin. This study aimed to formulate a dual-drug micellar system of 5-Fluorouracil (5-FU) and Genistein to enhance anti-cancer efficacy while minimizing some therapeutic challenges like increased systemic toxicity, and limited drug bioavailability.</p> Methods <p>Individual micelles of 5-FU and Genistein were prepared followed by mixing of the two systems to develop a final carbopol-based hydrogel product. Labrasol®, Transcutol® P, and Soluplus®, were used to prepare the drug micelles via thin-film hydration method followed by sonication. The formulations were characterized for particle size, polydispersity index, entrapment efficiency and in vitro cytotoxicity. The finished dual-drug loaded micellar gel was characterized for physical properties, in vitro and ex-vivo drug release properties.</p> Results <p>The optimized formulations exhibited nanoscale particle sizes of both the drugs and the mixed micellar gel combination (113.2 ± 34.67&#xa0;nm). It also exhibited low polydispersity, high entrapment efficiencies, and spherical morphology confirmed by transmission electron microscopy. The mixed micelles co-delivering 5-FU and Genistein demonstrated synergistic cytotoxic (combination index &lt; 1) efficacy on A431 cells. Physicochemical characterization revealed suitable pH, viscosity, and spreadability for topical use. In vitro release and ex vivo permeation studies showed sustained and near-complete release of both drugs and enhanced skin permeation.</p> Conclusion <p>This co-delivery system harnesses the advantages of nanotechnology and develops a topical therapy with improved efficacy, sustained drug release and ease of application, which will be useful in management of pre-neoplastic and neoplastic lesions of the epidermis.</p>

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Synergistic Topical Therapy for Squamous Cell Carcinoma via Mixed Micelles Co-delivering 5-Fluorouracil and Genistein

  • 期刊论文

  • 发表日期：

    2026年3月23日

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  • Vidhi Sharma,
  • Sinjini Sarkar,
  • Kavita Singh

摘要

Background

Topical treatment with chemotherapeutic agents are widely used to manage squamous cell carcinoma (SCC) of the skin. This study aimed to formulate a dual-drug micellar system of 5-Fluorouracil (5-FU) and Genistein to enhance anti-cancer efficacy while minimizing some therapeutic challenges like increased systemic toxicity, and limited drug bioavailability.

Methods

Individual micelles of 5-FU and Genistein were prepared followed by mixing of the two systems to develop a final carbopol-based hydrogel product. Labrasol®, Transcutol® P, and Soluplus®, were used to prepare the drug micelles via thin-film hydration method followed by sonication. The formulations were characterized for particle size, polydispersity index, entrapment efficiency and in vitro cytotoxicity. The finished dual-drug loaded micellar gel was characterized for physical properties, in vitro and ex-vivo drug release properties.

Results

The optimized formulations exhibited nanoscale particle sizes of both the drugs and the mixed micellar gel combination (113.2 ± 34.67 nm). It also exhibited low polydispersity, high entrapment efficiencies, and spherical morphology confirmed by transmission electron microscopy. The mixed micelles co-delivering 5-FU and Genistein demonstrated synergistic cytotoxic (combination index < 1) efficacy on A431 cells. Physicochemical characterization revealed suitable pH, viscosity, and spreadability for topical use. In vitro release and ex vivo permeation studies showed sustained and near-complete release of both drugs and enhanced skin permeation.

Conclusion

This co-delivery system harnesses the advantages of nanotechnology and develops a topical therapy with improved efficacy, sustained drug release and ease of application, which will be useful in management of pre-neoplastic and neoplastic lesions of the epidermis.