Comparative pharmacokinetics and safety of a novel lyophilized amphotericin B lecithin-based oil-water microemulsion and amphotericin B deoxycholate in animal models

J Antimicrob Chemother. 2003 Jul;52(1):103-9. doi: 10.1093/jac/dkg266. Epub 2003 Jun 12.

Abstract

Amphotericin B (AmB) has been a most effective systemic antifungal agent, but its use is circumscribed by the dose-limiting toxicity of the conventional micellar dispersion formulation Fungizone (D-AmB). To lower AmB-associated toxicity, AmB may be integrated into oil-in-water lecithin-based microemulsions. The present study compares the pharmacokinetic characteristics of D-AmB with the alternative formulation of AmB in microemulsion (M-AmB), which has proved effective in a murine candidiasis model. Both formulations were given by intravenous bolus: D-AmB 1 mg/kg, and M-AmB 0.5, 1 or 2 mg/kg. The pharmacokinetics of D-AmB and M-AmB have several differences, specifically with regard to the respective Cmax and AUC0- infinity values. Elimination of AmB from serum was biphasic for both M-AmB and D-AmB. Single-dose D-AmB (1 mg/kg) achieved a Cmax of 3.89 +/- 0.48 mg/L and an AUC0- infinity of 32.28 +/- 7.31 mg.h/L, whereas single-dose M-AmB (1 mg/kg) by comparison achieved a lower Cmax (2.92 +/- 0.54 mg/L) and a lower AUC0- infinity (21.89 +/- 5.17 mg.h/L). To evaluate the safety of M-AmB, a multiple-dose toxicity study was performed in groups of 10 mice, each receiving D-AmB 1 mg/kg, or M-AmB 1, 1.5, 2 or 3 mg/kg. The findings suggest that, in comparison with D-AmB, M-AmB produces no histologically demonstrable renal lesions, or changes in clinical chemistry.

Publication types

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

MeSH terms

  • Amphotericin B / administration & dosage
  • Amphotericin B / pharmacokinetics*
  • Amphotericin B / toxicity*
  • Animals
  • Area Under Curve
  • Creatinine / blood
  • Deoxycholic Acid / administration & dosage
  • Deoxycholic Acid / analogs & derivatives*
  • Deoxycholic Acid / pharmacokinetics*
  • Deoxycholic Acid / toxicity*
  • Drug Combinations
  • Emulsions
  • Freeze Drying
  • Hemoglobins / metabolism
  • Injections, Intravenous
  • Kidney Diseases / chemically induced
  • Kidney Diseases / pathology
  • Kidney Function Tests
  • Male
  • Mice
  • Oils
  • Rabbits
  • Water

Substances

  • Drug Combinations
  • Emulsions
  • Hemoglobins
  • Oils
  • Deoxycholic Acid
  • Water
  • Amphotericin B
  • amphotericin B, deoxycholate drug combination
  • Creatinine