Glycopeptide antibiotics liquid formulations and methods and uses thereof
AssigneeSomerset Therapeutics, LLC
InventorsMandar V. Shah, Ilango Subramanian, Veerappan Subramanian
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Abstract
The invention relates to formulations and compositions comprising one or more glycopeptide antibodies or a pharmaceutically acceptable salt thereof for parenteral administration. In particular, stable liquid formulations and compositions comprising vancomycin or a pharmaceutically acceptable salt thereof, N-acetyl-methionine and one or more pharmaceutically acceptable excipients. The invention also relates to a process of preparing such compositions and methods and uses thereof.
Claims24
A method of treating one or more bacterial infections in a subject in need thereof, the method comprising administering to the subject a liquid formulation that comprises:
- (a) a therapeutically effective amount of a vancomycin antibiotic or a pharmaceutically acceptable salt thereof, (b) N-acetyl-methionine and (c) one or more pharmaceutically acceptable excipients, wherein the liquid formulation does not include N-acetyl D-alanine or polyethylene glycol-400 or both N-acetyl D-alanine and polyethylene glycol-400.
A method of treating an infectious disease in a subject in need thereof, the method comprising administering to the subject a liquid formulation that comprises:
- (a) therapeutically effective amount of a vancomycin antibiotic or a pharmaceutically acceptable salt thereof, (b) N-acetyl-methionine, and (c) one or more pharmaceutically acceptable excipients, wherein the liquid formulation does not include N-acetyl D-alanine or polyethylene glycol-400 or both N-acetyl D-alanine and polyethylene glycol-400.
A method of treating a subject suffering from an infection caused by Gram-positive organisms, the method comprising administering to the subject in need thereof a liquid formulation that comprises:
- (a) a therapeutically effective amount of a vancomycin antibiotic or a pharmaceutically acceptable salt thereof, (b) N-acetyl-methionine, and (c) one or more pharmaceutically acceptable excipients, wherein the liquid formulation does not include N-acetyl D-alanine or polyethylene glycol-400 or both N-acetyl D-alanine and polyethylene glycol-400.
A method of treating a subject suffering from an inflammatory disease, the method comprising administering to the subject in need thereof a liquid formulation that comprises:
- (a) a therapeutically effective amount of a vancomycin antibiotic or a pharmaceutically acceptable salt thereof, (b) N-acetyl-methionine, and (c) one or more pharmaceutically acceptable excipients, wherein the liquid formulation does not include N-acetyl D-alanine or polyethylene glycol-400 or both N-acetyl D-alanine and polyethylene glycol-400.
A process for preparing a liquid composition for parenteral administration, the process comprising:
- (a) adding a vancomycin antibiotic or pharmaceutically acceptable salt to sterilized water;
- (b) stirring the solution until the vancomycin antibiotic or pharmaceutically acceptable salt is fully dissolved by visual inspection;
- (c) adding N-acetyl-D-methionine (NADM) to the solution and stirring until the NADM is fully dissolved by visual inspection;
- (d) adding sodium chloride and stirring until the components of the solution are fully dissolved by visual inspection;
- (e) adjusting the pH to about 5.0 using hydrochloric acid, sodium hydroxide, or both;
- (f) QS with sterilized water suitable for injection to a selected total volume;
- and (g) stirring for an additional selected amount of time to form a prepared composition.
Dependencies are inferred from the claim text.