Abstract
Study objectives: Abelcet® is an amphotericin B (AmB) lipid complex administrated within 24 hours after dilution in Dextrose 5% (D5). In order to increase the delay before administration we have investigated the chemical and physical stability of Abelcet® diluted in D5 bags at different AmB concentrations and temperatures over a one-week period. Methods: Evolution of the concentration of AmB was measured by High Performance Liquid Chromatography (HPLC) as a function of these incubation conditions in order to check the chemical stability of AmB. Physical stability of Abelcet® has been followed by laser diffraction particle size analyser. UV spectroscopy and Circular Dichroism (CD) spectra were achieved to determine the evolution of AmB aggregation state. Results: It appears that AmB concentrations were stable, that no major change in the aggregation state of AmB in Abelcet® were observed in CD spectra, while particle size distribution have not shown any evolution. Conclusion: It is concluded that Abelcet® after dilution in D5 at concentration between 0.4 to 2 mg/mL is stable and may be stored during one week at 4 and 25°C.