Preparation, characterization and in vivo evaluation of formulation of baicalein with hydroxypropyl-beta-cyclodextrin

Int J Pharm. 2006 Apr 7;312(1-2):137-43. doi: 10.1016/j.ijpharm.2006.01.011. Epub 2006 Feb 3.

Abstract

The interaction of 2-hydroxypropyl-beta-cyclodextrin (HP-beta-CD) and a poorly water-soluble flavonoid, baicalein (Ba), chemically 5,6,7-trihydroxy flavone in solution and solid-state was studied. Ba/HP-beta-CD solid systems were prepared by freeze-drying method. The formation of Ba/HP-beta-CD complex in aqueous solution was demonstrated by UV spectroscopy, while Ba/HP-beta-CD co-lyophilized product was characterized by differential scanning calorimetry (DSC) and X-ray diffractometry (XRD). Through complexation with HP-beta-CD, the solubility of Ba in neutral aqueous solution was improved significantly. The phase-solubility profile was AP-type, indicating the formation of higher-order complexes or complex aggregates. Ba/HP-beta-CD solid powders were amorphous and show a significantly improved dissolution rate in comparison with free Ba. Comparison of the pharmacokinetics between Ba/HP-beta-CD co-lyophilized product and free Ba was also performed in rats. The concentration of Ba and its mainly conjugated metabolite, 7-O-glucuronide of baicalein (BG) in rat plasma was determined by HPLC method. The in vivo results show that Ba/HP-beta-CD co-lyophilized product exhibits the similar pharmacokinetics as that of free Ba after intravenous administration. Ba/HP-beta-CD co-lyophilized product displays earlier tmax and higher Cmax of BG than free Ba after oral dosing. By comparing the AUC0-infinity of BG between oral dosing, the relative bioavailability of Ba/HP-beta-CD co-lyophilized product to free Ba was 165.0%, which highlighted the evidence of significantly improved bioavailability of formulation of Ba with HP-beta-CD.

MeSH terms

  • 2-Hydroxypropyl-beta-cyclodextrin
  • Animals
  • Area Under Curve
  • Biological Availability
  • Calorimetry, Differential Scanning
  • Chemistry, Pharmaceutical
  • Chromatography, High Pressure Liquid
  • Female
  • Flavanones / administration & dosage
  • Flavanones / chemistry*
  • Flavanones / pharmacokinetics*
  • Freeze Drying
  • Rats
  • Rats, Sprague-Dawley
  • Solubility
  • Spectrophotometry, Ultraviolet
  • X-Ray Diffraction
  • beta-Cyclodextrins / chemistry*

Substances

  • Flavanones
  • beta-Cyclodextrins
  • 2-Hydroxypropyl-beta-cyclodextrin
  • baicalein