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<p>This study aimed to develop and optimize a lutein-loaded in situ ocular gel to enhance aqueous solubility, prolong precorneal retention, and achieve sustained drug release for improved ocular delivery.&#xa0;Lutein solid dispersion was prepared using PVP K30 to improve solubility, followed by incorporation into thermosensitive in situ gels formulated with Carbopol 940 and HPMC E50LV. A 3² factorial design was employed to optimize the formulation based on two independent variables concentrations of Carbopol 940 (A) and HPMC E50LV (B) evaluated against key responses: viscosity at 35&#xa0;°C and in vitro drug release at 6&#xa0;h. The optimized batch (YF7) was selected based on desirability function targeting ideal viscosity and sustained release.&#xa0;The optimized formulation YF7 showed a viscosity of 2104.5 ± 61.7 cP at 35&#xa0;°C and 53.8 ± 2.6% drug release at 6&#xa0;h. Solid dispersion significantly enhanced lutein solubility (22.37 ± 1.36&#xa0;µg/mL), and FTIR, DSC, and XRD analyses confirmed compatibility and partial amorphization. The gel demonstrated rapid gelling (42.1 ± 2.7&#xa0;s), pH within ocular range (6.15 ± 0.04), and good stability over 3 months with minimal changes in key parameters.&#xa0;The optimized in situ gel offers enhanced solubility, controlled release, and favorable physicochemical characteristics, indicating its potential for clinical use in treating ocular disorders. Future in vivo studies are warranted to confirm therapeutic efficacy and ocular safety.</p>

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QbD-Driven Development of a Lutein Solid-Dispersion–Based in Situ Gel for Sustained Ocular Release

  • 期刊论文

  • 发表日期：

    2026年1月16日

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  • Yogeshwari N. Gunjal,
  • Sachin B. Somwanshi,
  • Kaveri T. Vaditake

摘要

This study aimed to develop and optimize a lutein-loaded in situ ocular gel to enhance aqueous solubility, prolong precorneal retention, and achieve sustained drug release for improved ocular delivery. Lutein solid dispersion was prepared using PVP K30 to improve solubility, followed by incorporation into thermosensitive in situ gels formulated with Carbopol 940 and HPMC E50LV. A 3² factorial design was employed to optimize the formulation based on two independent variables concentrations of Carbopol 940 (A) and HPMC E50LV (B) evaluated against key responses: viscosity at 35 °C and in vitro drug release at 6 h. The optimized batch (YF7) was selected based on desirability function targeting ideal viscosity and sustained release. The optimized formulation YF7 showed a viscosity of 2104.5 ± 61.7 cP at 35 °C and 53.8 ± 2.6% drug release at 6 h. Solid dispersion significantly enhanced lutein solubility (22.37 ± 1.36 µg/mL), and FTIR, DSC, and XRD analyses confirmed compatibility and partial amorphization. The gel demonstrated rapid gelling (42.1 ± 2.7 s), pH within ocular range (6.15 ± 0.04), and good stability over 3 months with minimal changes in key parameters. The optimized in situ gel offers enhanced solubility, controlled release, and favorable physicochemical characteristics, indicating its potential for clinical use in treating ocular disorders. Future in vivo studies are warranted to confirm therapeutic efficacy and ocular safety.