Formulations of vancomycin
AssigneeScidose LLC
InventorNagesh R. PALEPU
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Abstract
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.
Claims25
A vancomycin-containing composition, comprising:
- a) about 25 mg/mL to about 150 mg/mL vancomycin or a pharmaceutically acceptable salt thereof;
- and
- b) 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.
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A vancomycin-containing composition, comprising:
- a) vancomycin or a pharmaceutically acceptable salt thereof, in an amount of about 100 mg/mL;
- and
- b) a pharmaceutically acceptable fluid having a pH of about 3 to about 8, comprising:
- i) about 50% (v/v) polyethylene glycol;
- ii) about 0.5 mmole of lactic acid or lactate or mixtures thereof per mL of pharmaceutically acceptable fluid;
- and
- iii) optionally, a pH adjuster in an amount sufficient to maintain the pH of the vancomycin-containing composition at about 5.5;
- 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.
A vancomycin-containing composition, comprising:
- a) vancomycin or a pharmaceutically acceptable salt thereof, in an amount of about 50 mg/mL;
- and
- b) a pharmaceutically acceptable fluid having a pH of about 3 to about 8, comprising:
- i) about 50%) (v/v) polyethylene glycol;
- ii) about 0.5 mmole of lactic acid, lactate or mixtures thereof per mL of pharmaceutically acceptable fluid;
- and
- iii) optionally, a pH adjuster in an amount sufficient to maintain the pH of the vancomycin-containing composition at about 5.5;
- 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.
A vancomycin-containing composition, comprising:
- a) vancomycin or a pharmaceutically acceptable salt thereof, in an amount of about 2.5 mg/mL to about 10 mg/mL;
- and
- b) a pharmaceutically acceptable fluid having a pH of about 3 to about 8, comprising:
- i) about 1.25% (v/v) to about 5% (v/v) of a polar solvent comprising propylene glycol, polyethylene glycol, or mixtures thereof;
- ii) about 0.04 mmole to about 1 mmole of lactic acid, lactate or mixtures thereof per mL of pharmaceutically acceptable fluid;
- and
- iii) optionally, a pH adjuster in an amount sufficient to maintain the pH of the vancomycin-containing composition at from about 3 to about 8;
- 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 15° C.
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Dependencies are inferred from the claim text.