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The comparative drug dispositions, urinary pharmacokinetics, and effects on renal function of multilamellar liposomal nystatin (LNYS; Nyotran) and amphotericin B deoxycholate (DAMB; Fungizone) were studied in rabbits. Drug concentrations were determined by high-performance liquid chromatography as total concentrations of LNYS and DAMB. In comparison to a standard dose of 1 mg of DAMB/kg of body weight, therapeutic dosages of LNYS, i.e., 2, 4, and 6 mg/kg, resulted in escalating maximum concentrations (Cmax) (17 to 56 microg/ml for LNYS versus 3.36 microg/ml for DAMB; P&lt;0.001) and values for the area under the concentration-time curve from 0 to 24 h (AUC(0-24)) (17 to 77 microg.h/ml for LNYS versus 12 microg.h/ml for DAMB; P&lt;0.001) in plasma but a significantly faster total clearance from plasma (0.117 to 0.080 liter/h/kg for LNYS versus 0.055 liter/h/kg for DAMB; P=0.013) and a &lt; or =8-fold-smaller volume of distribution at steady state (P=0.002). Urinary drug concentration data revealed a &gt; or =10-fold-higher Cmax (16 to 10 microg/ml for LNYS versus 0.96 microg/ml for DAMB; P=0.015) and a 4- to 7-fold-greater AUC(0-24) (63 to 35 microg.h/ml for LNYS versus 8.9 microg.h/ml for DAMB; P=0.015) following the administration of LNYS, with a dose-dependent decrease in the dose-normalized AUC(0-24) in urine (P=0.001) and a trend toward a dose-dependent decrease in renal clearance. Except for the kidneys, the mean concentrations of LNYS in liver, spleen, and lung 24 h after dosing were severalfold lower than those after administration of DAMB (P, &lt;0.002 to &lt;0.001). Less than 1% each of the total dose of LNYS was recovered from the kidneys, liver, spleen, and lungs; in contrast, a quarter of the total dose was recovered from the livers of DAMB-treated animals. LNYS had dose-dependent effects on glomerular filtration and distal, but not proximal, renal tubular function which did not exceed those of DAMB at the highest investigated dosage of 6 mg/kg. The results of this experimental study demonstrate fundamental differences in the dispositions of LNYS and DAMB. Based on its enhanced urinary exposure, LNYS may offer a therapeutic advantage in systemic fungal infections involving the upper and lower urinary tracts that require therapy with antifungal polyenes.

Comparative Drug Disposition, UrinaryPharmacokinetics, and Renal Effects of Multilamellar Liposomal Nystatinand Amphotericin B Deoxycholate inRabbits