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<p>Naringenin (NGN), a hydrophobic bioactive flavonoid, has demonstrated significant preclinical therapeutic potential. However, its clinical application is restricted because of poor aqueous solubility and limited oral bioavailability. To overcome these limitations, the present study focuses on the development, optimization, and characterization of NGN encapsulated solid self-emulsifying delivery system (SEDS) using maltodextrin as wall material. Initial solubility screening of NGN in different excipients identified Capmul MCM as the ideal lipid phase, while Kolliphor HS15 and PEG 400 were selected as suitable surfactant and co-surfactant, respectively. A pseudo-ternary phase diagram was constructed to determine the ideal component ratios, resulting in a stable nanoemulsion characterized by a mean droplet size of 103.26 ± 0.74&#xa0;nm and a polydispersity index (PDI) of 0.241 ± 0.02. The formulation exhibited good thermodynamic stability and an acceptable cloud point, confirming its robustness. The liquid SEDS was solidified <i>via</i> spray drying using maltodextrin as a carrier, which yielded a Solid–SEDS with 86.83% yield and 76.79% encapsulation efficiency. Solid-state characterization using FT-IR, PXRD and DSC confirmed the amorphous dispersion of NGN and successful entrapment within the maltodextrin matrix. Morphological evaluation using SEM revealed smooth, spherical particles with nano-scale dimensions. The Solid-SEDS exhibited fair flowing property and remained stable under gastric simulation conditions. In vitro dissolution studies in PBS (pH 7.4) demonstrated a better release of NGN (60.7%) as compared to native NGN (30.6%). Our work demonstrates the potential of Solid–SEDS as an effective approach to improve the solubility, stability, and release profile of hydrophobic naringenin, offering a promising platform for oral delivery applications.</p>

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Development and characterization of a solid self-emulsifying delivery system to enhance dissolution of naringenin using maltodextrin as wall material

  • 期刊论文

  • 发表日期：

    2025年11月27日

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  • Nabab Khan,
  • Ankit Saneja

摘要

Naringenin (NGN), a hydrophobic bioactive flavonoid, has demonstrated significant preclinical therapeutic potential. However, its clinical application is restricted because of poor aqueous solubility and limited oral bioavailability. To overcome these limitations, the present study focuses on the development, optimization, and characterization of NGN encapsulated solid self-emulsifying delivery system (SEDS) using maltodextrin as wall material. Initial solubility screening of NGN in different excipients identified Capmul MCM as the ideal lipid phase, while Kolliphor HS15 and PEG 400 were selected as suitable surfactant and co-surfactant, respectively. A pseudo-ternary phase diagram was constructed to determine the ideal component ratios, resulting in a stable nanoemulsion characterized by a mean droplet size of 103.26 ± 0.74 nm and a polydispersity index (PDI) of 0.241 ± 0.02. The formulation exhibited good thermodynamic stability and an acceptable cloud point, confirming its robustness. The liquid SEDS was solidified via spray drying using maltodextrin as a carrier, which yielded a Solid–SEDS with 86.83% yield and 76.79% encapsulation efficiency. Solid-state characterization using FT-IR, PXRD and DSC confirmed the amorphous dispersion of NGN and successful entrapment within the maltodextrin matrix. Morphological evaluation using SEM revealed smooth, spherical particles with nano-scale dimensions. The Solid-SEDS exhibited fair flowing property and remained stable under gastric simulation conditions. In vitro dissolution studies in PBS (pH 7.4) demonstrated a better release of NGN (60.7%) as compared to native NGN (30.6%). Our work demonstrates the potential of Solid–SEDS as an effective approach to improve the solubility, stability, and release profile of hydrophobic naringenin, offering a promising platform for oral delivery applications.