Formulations of vancomycin

摘要

Vancomycin-containing compositions substantially free of precipitation after at least about 12 months of storage at refrigerated or ambient conditions are disclosed. The compositions include vancomycin or a pharmaceutically acceptable salt thereof; a polar solvent including propylene glycol, polyethylene glycol and mixtures thereof; lactic acid, a lactate salt, or mixtures thereof; and optionally, a pH adjuster in an amount sufficient to maintain a pH of the compositions at from about 3 to about 8.

主权项

1. A vancomycin-containing composition, comprising:a) about 25 mg/mL to about 150 mg/mL vancomycin or a pharmaceutically acceptable salt thereof; andb) a pharmaceutically acceptable fluid having a pH of about 3 to about 8, comprising:
i) about 25% (v/v) to about 50% (v/v) of a polar solvent comprising propylene glycol, polyethylene glycol or mixtures thereof; and ii) about 0.25 mmole to about 0.94 mmole of lactic acid, lactate or mixtures thereof per mL of pharmaceutically acceptable fluid; wherein the vancomycin-containing composition has less than about 6% degradation of vancomycin B, as determined by HPLC at a wavelength of 280 nm, after at least about 12 months of storage at a temperature of from about 5° C. to about 25° C.; and wherein the lactic acid, lactate or mixtures thereof and the polar solvent are present in the composition in amounts providing the composition with an equivalent of a 1M lactic acid to polar solvent ratio of 75:25 (v/v) to 50:50 (v/v) per 100 mg/mL of vancomycin.