Spectroscopic investigation of the aggregation state of amphotericin B during loading, freeze-drying, and reconstitution of polymeric micelles

J Pharm Pharm Sci. 2004 Nov 22;7(4):1-6.

Abstract

Purpose: To investigate the relative aggregation state of amphotericin B (AmB) during loading and reconstitution of polymeric micelles.

Methods: Hexanoate and stearate derivatives of PEO-b-p (L-Asp) were prepared. The polymers and AmB were dissolved in methanol (MeOH). Milli-Q water was then added slowly, and the MeOH was removed via rotary evaporation. The solutions were freeze-dried in the presence of trehalose. During micelle preparation, the aggregation state of AmB was assessed using absorption spectroscopy. Upon reconstitution, the samples were analyzed using vapor-pressure osmometry, size-exclusion chromatography (SEC), and absorption spectroscopy. The absorption spectrum of AmB in the presence of the block copolymers was compared to that of AmB alone under the same conditions.

Results: AmB was loaded into micelles prepared from acyl derivatives of PEO-b-p (L-Asp). Absorption spectroscopy indicated that the aggregation state was preserved during the loading process. AmB exists in a self-aggregated state in polymeric micelles containing hexanoate ester cores and in a relatively monomeric state in polymeric micelles containing stearate ester cores. Vapor-pressure osmometry confirmed the isotonicity of the formulations, while SEC indicated that the micelles were approximately 10(6) g/mol.

Conclusions: Depending on the polymer structure and assembly conditions, it is possible to encapsulate AmB in a relatively nonaggregated or aggregated state in micelles prepared from acyl derivatives of PEO-b-p (L-Asp). In polymeric micelles containing stearate side chains, AmB was loaded in a nearly monomeric state, possibly due to interaction with the stearate side chains. The final aggregation state of the drug is preserved during lyophilization and reconstitution of polymeric micelles prepared by a novel solvent evaporation procedure.

Publication types

  • Comparative Study
  • Research Support, N.I.H., Extramural
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Amphotericin B / analysis*
  • Amphotericin B / chemical synthesis*
  • Drug Carriers / analysis
  • Drug Carriers / chemical synthesis
  • Freeze Drying / methods
  • Micelles*
  • Polymers / analysis*
  • Polymers / chemical synthesis*
  • Spectrophotometry, Ultraviolet / methods

Substances

  • Drug Carriers
  • Micelles
  • Polymers
  • Amphotericin B