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Purpose <p>Breast cancer is a leading cause of female cancer mortality. Caffeic acid (CA), a plant-derived polyphenol, demonstrates anticancer potential, but has limited clinical utility due to poor solubility, instability, and quick elimination.</p> Methods <p>This study presents the first QbD-based optimization of caffeic acid (CA) cubosomes (CA-CN) for breast cancer. To study the impact of glyceryl monooleate (GMO) concentration, Poloxamer 407 concentration and sonication time on the particle size, zeta potential and entrapment efficiency (EE), a three-factor three-level Box- Behnken Design (BBD) was used.</p> Results <p>The optimized formulation exhibited particle size of 102.9&#xa0;nm, EE of 98.9% and zeta potential of -31 mV showing good colloidal stability. In the design study it was seen that the increase in Poloxamer 407 concentration and sonication time decreased particle size and EE considerably and that the increase in GMO concentration provided larger particle and moderate drug encapsulation. The successful encapsulation and a transition of CA to an amorphous form favoring its solubility enhancement were proved by FTIR, XRD, and DSC researches. CA-CNs showed 87.4%. drug release after 24&#xa0;h. The pharmacokinetic profile in rabbits revealed that CA-CN was associated with 3.08-fold higher bioavailability than pure CA.</p> Conclusion <p>The cubosomal system improved CA’s physicochemical and pharmacokinetic properties, indicating its potential as a nanocarrier for breast cancer. Future research may focus on active targeting and clinical-scale development.</p>

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Quality by Design-Driven Optimization of Caffeic Acid Cubosomes: A Bioavailable Nanoplatform for Breast Cancer Treatment

  • 期刊论文

  • 发表日期：

    2025年11月21日

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  • Amol M. Patil,
  • Durgacharan A. Bhagwat

摘要

Purpose

Breast cancer is a leading cause of female cancer mortality. Caffeic acid (CA), a plant-derived polyphenol, demonstrates anticancer potential, but has limited clinical utility due to poor solubility, instability, and quick elimination.

Methods

This study presents the first QbD-based optimization of caffeic acid (CA) cubosomes (CA-CN) for breast cancer. To study the impact of glyceryl monooleate (GMO) concentration, Poloxamer 407 concentration and sonication time on the particle size, zeta potential and entrapment efficiency (EE), a three-factor three-level Box- Behnken Design (BBD) was used.

Results

The optimized formulation exhibited particle size of 102.9 nm, EE of 98.9% and zeta potential of -31 mV showing good colloidal stability. In the design study it was seen that the increase in Poloxamer 407 concentration and sonication time decreased particle size and EE considerably and that the increase in GMO concentration provided larger particle and moderate drug encapsulation. The successful encapsulation and a transition of CA to an amorphous form favoring its solubility enhancement were proved by FTIR, XRD, and DSC researches. CA-CNs showed 87.4%. drug release after 24 h. The pharmacokinetic profile in rabbits revealed that CA-CN was associated with 3.08-fold higher bioavailability than pure CA.

Conclusion

The cubosomal system improved CA’s physicochemical and pharmacokinetic properties, indicating its potential as a nanocarrier for breast cancer. Future research may focus on active targeting and clinical-scale development.