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<p>Nanostructured lipid carriers (NLC) have emerged as promising systems for enhancing the solubility, stability, and bioavailability of poorly water-soluble drugs. Their biocompatibility and ability to offer controlled drug release make them ideal for various delivery routes, including intranasal administration. In this study, a Quality by Design (QbD) approach was used to develop and optimize tetrahydrocurcumin-loaded NLC (THC-NLC), aiming to overcome THC’s limited aqueous solubility and bioavailability. Compritol 888 ATO and Labrafil were selected as solid lipid and liquid lipid respectively based on solubility studies. Tween 80 was used as a surfactant. THC-NLC were prepared by high shear homogenization and optimized using a Box–Behnken Design by evaluating the effects of solid lipid (X1), liquid lipid (X2), and surfactant (X3) on particle size (Y1) and entrapment efficiency (Y2). The optimized formulation showed a particle size of 131.1&#xa0;nm and 87.9% entrapment efficiency. DSC and TEM confirmed crystalline nature and morphology. In-vitro studies demonstrated sustained release following the Higuchi model (R² = 0.891). Optimized THC-NLC were proved safe with enhanced absorption during ex-vivo nasal permeation study and nasal ciliotoxicity studies. Overall, the study supports optimized THC-NLC obtained by utilizing quality by design approach could be an effective lipid-based formulation for improved and safe nasal delivery of THC. Future animal studies on optimized formulation could facilitate the determination of brain uptake via nose to brain delivery thus may offer potential benefits for neurodegenerative diseases.</p> Graphical Abstract <p></p>

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Design and Optimization of Tetrahydrocurcumin-Loaded Nanostructured Lipid Carriers for Intranasal Delivery: A Box–Behnken Approach

  • 期刊论文

  • 发表日期：

    2025年12月20日

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  • Pranjal Sharma,
  • Jai Bharti Sharma,
  • Manisha Bhatia,
  • Vishal Sharma,
  • Devesh U. Kapoor

摘要

Nanostructured lipid carriers (NLC) have emerged as promising systems for enhancing the solubility, stability, and bioavailability of poorly water-soluble drugs. Their biocompatibility and ability to offer controlled drug release make them ideal for various delivery routes, including intranasal administration. In this study, a Quality by Design (QbD) approach was used to develop and optimize tetrahydrocurcumin-loaded NLC (THC-NLC), aiming to overcome THC’s limited aqueous solubility and bioavailability. Compritol 888 ATO and Labrafil were selected as solid lipid and liquid lipid respectively based on solubility studies. Tween 80 was used as a surfactant. THC-NLC were prepared by high shear homogenization and optimized using a Box–Behnken Design by evaluating the effects of solid lipid (X1), liquid lipid (X2), and surfactant (X3) on particle size (Y1) and entrapment efficiency (Y2). The optimized formulation showed a particle size of 131.1 nm and 87.9% entrapment efficiency. DSC and TEM confirmed crystalline nature and morphology. In-vitro studies demonstrated sustained release following the Higuchi model (R² = 0.891). Optimized THC-NLC were proved safe with enhanced absorption during ex-vivo nasal permeation study and nasal ciliotoxicity studies. Overall, the study supports optimized THC-NLC obtained by utilizing quality by design approach could be an effective lipid-based formulation for improved and safe nasal delivery of THC. Future animal studies on optimized formulation could facilitate the determination of brain uptake via nose to brain delivery thus may offer potential benefits for neurodegenerative diseases.

Graphical Abstract