Design and evaluation of a novel evodiamine-phospholipid complex for improved oral bioavailability

AAPS PharmSciTech. 2012 Jun;13(2):534-47. doi: 10.1208/s12249-012-9772-9. Epub 2012 Mar 28.

Abstract

A novel evodiamine (EVO)-phospholipid complex (EPLC) was designed to improve the bioavailability of EVO. A central composite design approach was employed for process optimization. EPLC were characterized by differential scanning calorimetry, ultraviolet spectroscopy, Fourier transformed infrared spectroscopy, (1)H-NMR spectroscopy, matrix-assisted laser desorption/ionization time-of-flight spectroscopy, apparent solubility, and dissolution rate. After oral administration of EPLC, the concentrations of EVO at different time points were determined by high-performance liquid chromatography. The optimal formulation for EPLC was obtained where the values of X (1), X (2), and X (3) were 2, 0.5, and 2.5 mg/mL, respectively. The average particle size and zeta potential of EPLC with the optimized formulation were 246.1 nm and -26.94 mV, respectively. The EVO and phospholipids in the EPLC were associated with non-covalent interactions. The solubility of EPLC in water and the dissolution rate of EPLC in phosphate-buffered solution (pH 6.8) were substantially enhanced. The plasma EVO concentration-time curves of EPLC and free EVO were both in accordance with the two-compartment model. The peak concentration and AUC(0-∞) of EPLC were increased, and the relative bioavailability was significantly increased to 218.82 % compared with that of EVO.

Publication types

  • Comparative Study
  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Animals
  • Area Under Curve
  • Biological Availability
  • Calorimetry, Differential Scanning
  • Chemistry, Pharmaceutical
  • Chromatography, High Pressure Liquid
  • Drug Carriers*
  • Drugs, Chinese Herbal / administration & dosage*
  • Drugs, Chinese Herbal / chemistry
  • Drugs, Chinese Herbal / pharmacokinetics*
  • Hydrogen-Ion Concentration
  • Indole Alkaloids / administration & dosage*
  • Indole Alkaloids / blood
  • Indole Alkaloids / chemistry
  • Indole Alkaloids / pharmacokinetics*
  • Magnetic Resonance Spectroscopy
  • Male
  • Microscopy, Electron, Scanning
  • Models, Biological
  • Models, Chemical
  • Particle Size
  • Phospholipids / chemistry*
  • Rats
  • Rats, Sprague-Dawley
  • Solubility
  • Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization
  • Spectrophotometry, Ultraviolet
  • Spectroscopy, Fourier Transform Infrared
  • Technology, Pharmaceutical / methods

Substances

  • Drug Carriers
  • Drugs, Chinese Herbal
  • Indole Alkaloids
  • Phospholipids
  • evodamine