Synthesis and evaluation of styrene-maleic acid copolymer conjugated amphotericin B

Int J Pharm. 2019 Dec 15:572:118719. doi: 10.1016/j.ijpharm.2019.118719. Epub 2019 Oct 22.

Abstract

Amphotericin B (AmB), which plays a central role in the treatment of systemic fungal infections, is difficult to formulate because it's sparingly soluble in water and organic solvents. We previously prepared AmB-loaded micelles using styrene-maleic acid copolymer (SMA). Although solubilization was achieved by this formulation, stability in the blood circulation was as insufficient as that of Fungizone®, which is a conventional formulation of AmB. Meanwhile, it is well known that polymer-drug conjugates are more stable in circulation than drug-loaded micelles. Therefore, in this study, we developed covalently conjugated SMA-AmB (SMA-AmB conjugate). The SMA-AmB conjugate was found to be soluble and present as micelles in aqueous solution. Furthermore, it was revealed that this micelle behaves as a larger molecule by forming a complex with albumin. The circulation in the blood increased significantly compared to that of Fungizone®, which was suggested to be due to this complex-forming ability. Although in vitro and in vivo antifungal activity of the SMA-AmB conjugate against Saccharomyces cerevisiae was reduced by 1/3 compared to that of Fungizone®, hemolysis decreased to 1/40 or less, and the LD50 decreased to 1/10. In conclusion, it is expected that the SMA-AmB conjugate can be a polymer-therapeutic agent with high antifungal selectivity.

Keywords: Amphotericin B; Antifungal selectivity; Polymer-drug conjugates; Styrene-maleic acid copolymer; Water soluble.

MeSH terms

  • Amphotericin B* / administration & dosage
  • Amphotericin B* / blood
  • Amphotericin B* / chemistry
  • Amphotericin B* / pharmacokinetics
  • Animals
  • Antifungal Agents* / administration & dosage
  • Antifungal Agents* / blood
  • Antifungal Agents* / chemistry
  • Antifungal Agents* / pharmacokinetics
  • Drug Liberation
  • Erythrocytes / drug effects
  • Hemolysis / drug effects
  • Lethal Dose 50
  • Male
  • Maleates* / administration & dosage
  • Maleates* / blood
  • Maleates* / chemistry
  • Maleates* / pharmacokinetics
  • Mice
  • Micelles
  • Saccharomyces cerevisiae / drug effects
  • Saccharomyces cerevisiae / growth & development
  • Solubility
  • Styrene* / administration & dosage
  • Styrene* / blood
  • Styrene* / chemistry
  • Styrene* / pharmacokinetics

Substances

  • Antifungal Agents
  • Maleates
  • Micelles
  • Styrene
  • Amphotericin B
  • maleic acid