<p>Kaempferol, a phytomolecule currently in Phase I clinical trials, is also being explored for its nutraceutical potential. However, its clinical utility is limited due to poor bioavailability. Previous studies suggest that intravenous administration of PEGylated liposomes can markedly improve the pharmacokinetic profile and systemic availability of phytochemicals, while enabling controlled release through the enhanced permeability and retention (EPR) effect. In the present study, we prepared and validated polyethylene glycol (PEG) modified Kaempferol liposome which possess a particle size, polydispersity index (PDI) and zeta potential of <b>136.60 ± 0.37&#xa0;nm</b>, <b>0.1540 ± 0.020</b> and <b>-37.0 ± 8.19&#xa0;mV</b> respectively. PEG-LP-KP exhibited an entrapment efficiency of ~ 92% and shows a sustained Kaempferol release upon 24&#xa0;h at pH <b>5.5</b>. Our study indicates that intravenous administration of PEG-LP-KP significantly improves the pharmacokinetic parameters such as AUC<sub>(</sub><sub>0-24)</sub>, Cmax and Vd compared with pure Kaempferol at three different doses (10&#xa0;mg/kg, 20&#xa0;mg/kg &amp; 30&#xa0;mg/kg). The biodistribution study indicated that Kaempferol encapsulated into the liposome shows a high accumulation in the <Emphasis Type="BoldItalic">liver</Emphasis><Emphasis Type="BoldItalic">, </Emphasis><Emphasis Type="BoldItalic">followed by spleen, lungs, heart, and kidneys</Emphasis> of healthy SD rats. The biodistribution pattern of PEG-LP-KP was significantly improved compared with that of pure Kaempferol. PEG-LP-KP exhibited significant cytotoxicity in HepG2 cells with an IC<sub>50</sub> of <b>153.57&#xa0;μM</b> as assessed by the MTT assay. PEG-LP-KP demonstrated a favorable safety profile, as evidenced by both acute and sub-acute toxicity assessments. We also found a significant tumor reduction in PEG-LP-KP treated animal groups compared to vehicle control as assessed by Orthotopic syngeneic N1S1 rat model.</p>

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PEGylated liposomes enhance the pharmacokinetics, biodistribution, anticancer efficacy, and safety of Kaempferol, a phytomolecule enrolled in clinical trials

  • Ayana R. Kumar,
  • M. Divya Dharshini,
  • Aswathy R. Devan,
  • Ashok R. Unni,
  • M. S. Sithara,
  • Bhagyalakshmi Nair,
  • Adithya Jayaprakash Kamath,
  • Sunil Kumar Sah,
  • K. Pavithran,
  • M. Sabitha,
  • M. S. Sudheesh,
  • Lekshmi R. Nath

摘要

Kaempferol, a phytomolecule currently in Phase I clinical trials, is also being explored for its nutraceutical potential. However, its clinical utility is limited due to poor bioavailability. Previous studies suggest that intravenous administration of PEGylated liposomes can markedly improve the pharmacokinetic profile and systemic availability of phytochemicals, while enabling controlled release through the enhanced permeability and retention (EPR) effect. In the present study, we prepared and validated polyethylene glycol (PEG) modified Kaempferol liposome which possess a particle size, polydispersity index (PDI) and zeta potential of 136.60 ± 0.37 nm, 0.1540 ± 0.020 and -37.0 ± 8.19 mV respectively. PEG-LP-KP exhibited an entrapment efficiency of ~ 92% and shows a sustained Kaempferol release upon 24 h at pH 5.5. Our study indicates that intravenous administration of PEG-LP-KP significantly improves the pharmacokinetic parameters such as AUC(0-24), Cmax and Vd compared with pure Kaempferol at three different doses (10 mg/kg, 20 mg/kg & 30 mg/kg). The biodistribution study indicated that Kaempferol encapsulated into the liposome shows a high accumulation in the liver, followed by spleen, lungs, heart, and kidneys of healthy SD rats. The biodistribution pattern of PEG-LP-KP was significantly improved compared with that of pure Kaempferol. PEG-LP-KP exhibited significant cytotoxicity in HepG2 cells with an IC50 of 153.57 μM as assessed by the MTT assay. PEG-LP-KP demonstrated a favorable safety profile, as evidenced by both acute and sub-acute toxicity assessments. We also found a significant tumor reduction in PEG-LP-KP treated animal groups compared to vehicle control as assessed by Orthotopic syngeneic N1S1 rat model.