Summary: The solubility and stability of amphotericin B in human serum in vitro was assessed using a sensitive high performance liquid chromatographic technique. The solubility of amphotericin B at concentrations ranging from 0.5 mUg/ml to 10 mUg/ml in human serum at pH 7.4, at 37dGC, and in 5percnt; CO2(simulated in vivo conditions) showed no significant difference compared with the solubility at 23dGC in room air after a 1 h incubation period. Dissolution of the colloidal suspension at a concentration of 2 mUg/ml reached 81percnt; in 3 min with a small increase in solubility by 60 min. Amphotericin B was very stable (5percnt; loss) in human serum at minus;20dGC for up to 14 days with only a 10percnt; loss of drug at 6 months. In dimethylsulfoxide, however, losses at 6 months were 60percnt;. We conclude that amphotericin B solubilizes, but not completely, from a colloidal form in human serum under simulated in vivo conditions at 37dGC and at 23dGC in room air over 1 hour. Additionally, amphotericin B is stable in frozen serum for 6 months.
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