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Amphotericin B liposomal formulation: applicable preparation methods, challenges, and tips.

Rogayeh Seify1, Fahimeh Zahednezhad1, Parvin Zakeri-Milani2

  • 1Student Research Committee, Tabriz University of Medical Science, Tabriz, Iran.

Drug Development and Industrial Pharmacy
|May 30, 2023
PubMed
Summary

This study evaluated three methods for preparing Amphotericin B (AmB) liposomes, finding the solvent-free method most economical and eco-friendly. The resulting liposomes exhibited favorable characteristics and stability for potential industrial manufacturing.

Keywords:
Amphotericin BLiposomeinjectable formulationnanoparticlephospholipid

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Nanotechnology

Background:

  • Amphotericin B (AmB) is a crucial antifungal agent with significant toxicity.
  • Liposomal formulations offer a strategy to improve AmB's therapeutic index by altering its pharmacokinetic and toxicity profiles.
  • Developing stable and scalable liposomal AmB formulations is essential for its wider clinical application.

Purpose of the Study:

  • To explore and evaluate optimal methods for preparing Amphotericin B (AmB) liposomes.
  • To assess the physicochemical characteristics and stability of AmB-loaded liposomes prepared by different methods.
  • To provide pre-formulations suitable for industrial manufacturing with improved properties and reduced toxicity.

Main Methods:

  • Solubility screening and three liposome preparation techniques: ethanol injection, solvent evaporation, and solvent-free methods.
  • Characterization of liposomes including size, size distribution, zeta potential (ZP), morphology, drug loading, and loading capacity.
  • Physicochemical stability studies and drug-lipid interaction analysis using HPLC for AmB quantification.

Main Results:

  • All three methods yielded AmB-loaded liposomes with acceptable characteristics (size: 150.3–263.9 nm, PDI ≤0.32).
  • Liposomes were spherical and separate, with physical drug loading and no significant drug-lipid interactions.
  • The solvent-free method produced lyophilized powder stable for 6 months, retaining 91.5% drug loading.

Conclusions:

  • Applicable methods for preparing AmB-loaded liposomes were successfully developed.
  • The solvent-free method is identified as the most economical and environmentally friendly approach.
  • These findings support the industrial manufacturing of liposomal AmB with enhanced properties and reduced toxicity.