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<p>The oral administration of quercetin dihydrate (QUE) demonstrates limited bioavailability due to its low solubility. To enhance therapeutic efficacy, the local application of QUE was explored by developing novel QUE-loaded nanostructured lipid carriers (QUE-NLCs) for the treatment of androgenetic alopecia (AGA). QUE-NLCs were formulated by solvent evaporation method and optimized using a 3<sup>3</sup>-Box Behnken design. The optimized QUE-NLCs depicted spherical morphology, optimum particle size (335&#xa0;nm), polydispersity index (0.241), zeta potential (− 24&#xa0;mV), and higher encapsulation efficiency (~ 94.56%). Characterization techniques like XRD, DSC, and FTIR confirmed the drug’s amorphous state and encapsulation within the lipid matrix. QUE-NLCs were incorporated into Carbopol 934 gel and characterized based on rheology and viscosity. Further, developed QUE-NLC-GEL exhibited sustained release of ~ 76.75% after 72&#xa0;h and excellent stability at ambient and refrigerated storage conditions, promising a safety profile in in vivo skin irritation testing and histopathological analysis. Coumarin 6 dye-conjugated NLC-GEL formulations depicted superior penetrability in CLSM studies. In the testosterone-induced AGA mice model, QUE-NLC-GEL exhibited comparable efficacy with a commercial 2% MNX solution. These findings suggest that QUE-NLC-GEL is an effective alternative to the marketed topical formulation for treating AGA. However, these preclinical studies must be corroborated with the efficacy assessment in clinical situations.</p>

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QbD-Enabled Development of Quercetin Dihydrate-Loaded Nanostructured Lipid Carriers: In vitro Characterization, Safety and Efficacy Assessment in Androgenetic Alopecia Mice Model

  • 期刊论文

  • 发表日期：

    2025年2月3日

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  • Meenaz M. Sayyed,
  • Tulshidas S. Patil,
  • Tanaya D. Khairnar,
  • Nayan A. Gujarathi,
  • Abhijeet Aher,
  • Yogeeta O. Agrawal

摘要

The oral administration of quercetin dihydrate (QUE) demonstrates limited bioavailability due to its low solubility. To enhance therapeutic efficacy, the local application of QUE was explored by developing novel QUE-loaded nanostructured lipid carriers (QUE-NLCs) for the treatment of androgenetic alopecia (AGA). QUE-NLCs were formulated by solvent evaporation method and optimized using a 33-Box Behnken design. The optimized QUE-NLCs depicted spherical morphology, optimum particle size (335 nm), polydispersity index (0.241), zeta potential (− 24 mV), and higher encapsulation efficiency (~ 94.56%). Characterization techniques like XRD, DSC, and FTIR confirmed the drug’s amorphous state and encapsulation within the lipid matrix. QUE-NLCs were incorporated into Carbopol 934 gel and characterized based on rheology and viscosity. Further, developed QUE-NLC-GEL exhibited sustained release of ~ 76.75% after 72 h and excellent stability at ambient and refrigerated storage conditions, promising a safety profile in in vivo skin irritation testing and histopathological analysis. Coumarin 6 dye-conjugated NLC-GEL formulations depicted superior penetrability in CLSM studies. In the testosterone-induced AGA mice model, QUE-NLC-GEL exhibited comparable efficacy with a commercial 2% MNX solution. These findings suggest that QUE-NLC-GEL is an effective alternative to the marketed topical formulation for treating AGA. However, these preclinical studies must be corroborated with the efficacy assessment in clinical situations.