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<p>Although fusidic acid (FA) is a potent topical antimicrobial agent, its therapeutic potential is limited by poor aqueous solubility and suboptimal topical delivery. To address these challenges, this study introduces a novel lyotropic liquid crystalline nanoparticle-based hydrogel (FA-LLCNPs-hydrogel) designed to enhance FA’s topical application. To the best of our knowledge, this is the first report employing a Quality by Design (QbD)-driven optimization approach to systematically develop FA-loaded LLCNPs for this indication. The optimized formulation contains a glyceryl monooleate concentration of 4.77% and a poloxamer 407 concentration of 0.1%. The optimised formulation exhibited a particle size (PS) (210.33 ± 3.33&#xa0;nm), PDI (0.256 ± 0.07), Zeta potential (ZeP) (-33.8 ± 1.2 mV), and % entrapment efficiency (%EnE) of 86.56 ± 0.14%. The morphology of the LLCNPs, as observed by Cryo-SEM, was in agreement with the DLS. Sustained drug release of 54.61 ± 1.97% at 24&#xa0;h followed by a Weibull model. The cytotoxicity study on NIH/3T3 cells confirmed that the prepared LLCNPs are non-toxic. The optimized LLCNPs were incorporated into a carbopol 980-based gel system and characterized for their rheological behaviors, spreadability, drug content, antibacterial activity, and skin irritation studies. The antimicrobial study against <i>S. aureus</i> revealed that both FA-LLCNPs and FA dispersion exhibited higher activity against the bacteria. Furthermore, the skin irritation study confirmed that the prepared formulation did not irritate rats, confirming the potential of FA-LLCNPs-hydrogel as a novel localized therapy for topical application with enhanced efficacy and patient safety.</p> Graphical Abstract <p></p>

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Fusidic Acid-Loaded Lyotropic Liquid Crystalline Nanoparticles embedded Gel: Optimization and Characterization for Topical Application

  • 期刊论文

  • 发表日期：

    2026年3月4日

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  • Niketan Naik,
  • Devaraj Yallappa,
  • Sandeep Kr Maharana,
  • Abhishek Devakare,
  • Kunal Gonage,
  • Sapan Borah,
  • Aakanchha Jain

摘要

Although fusidic acid (FA) is a potent topical antimicrobial agent, its therapeutic potential is limited by poor aqueous solubility and suboptimal topical delivery. To address these challenges, this study introduces a novel lyotropic liquid crystalline nanoparticle-based hydrogel (FA-LLCNPs-hydrogel) designed to enhance FA’s topical application. To the best of our knowledge, this is the first report employing a Quality by Design (QbD)-driven optimization approach to systematically develop FA-loaded LLCNPs for this indication. The optimized formulation contains a glyceryl monooleate concentration of 4.77% and a poloxamer 407 concentration of 0.1%. The optimised formulation exhibited a particle size (PS) (210.33 ± 3.33 nm), PDI (0.256 ± 0.07), Zeta potential (ZeP) (-33.8 ± 1.2 mV), and % entrapment efficiency (%EnE) of 86.56 ± 0.14%. The morphology of the LLCNPs, as observed by Cryo-SEM, was in agreement with the DLS. Sustained drug release of 54.61 ± 1.97% at 24 h followed by a Weibull model. The cytotoxicity study on NIH/3T3 cells confirmed that the prepared LLCNPs are non-toxic. The optimized LLCNPs were incorporated into a carbopol 980-based gel system and characterized for their rheological behaviors, spreadability, drug content, antibacterial activity, and skin irritation studies. The antimicrobial study against S. aureus revealed that both FA-LLCNPs and FA dispersion exhibited higher activity against the bacteria. Furthermore, the skin irritation study confirmed that the prepared formulation did not irritate rats, confirming the potential of FA-LLCNPs-hydrogel as a novel localized therapy for topical application with enhanced efficacy and patient safety.

Graphical Abstract