Glycopeptide antibiotics liquid formulations and methods and uses thereof
Inventors
Shah, Mandar V. • Subramanian, Ilango • Subramanian, Veerappan
Assignees
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Publication Number
US-12343373-B2
Publication Date
2025-07-01
Expiration Date
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.
Core Innovation
The invention relates to stable ready-to-use liquid parenteral formulations of glycopeptide antibiotics, particularly vancomycin or a pharmaceutically acceptable salt thereof. The liquid composition includes vancomycin together with N-acetyl-L-methionine and one or more pharmaceutically acceptable excipients, and it is adapted only to be suitable for intravenous, subcutaneous, or intramuscular administration to human patients.
A central aspect is the stable maintenance of vancomycin in the liquid composition for a period of at least about 3 months. The liquid composition further has a viscosity of about 1 centipoise, and in specific embodiments excludes N-acetyl-D-alanine and polyethylene glycol-400.
In certain formulations, the vancomycin content and N-acetyl-L-methionine content are defined by weight or by a molar ratio, and the composition includes excipients and, in some cases, pH adjustment agents and water. The formulations are positioned for use as pharmaceutical products provided in acceptable containers for sterile administration.
Claims Coverage
The provided partial claims include three independent claims. Across these independent claims, the inventive coverage is concentrated on a liquid composition with vancomycin or a pharmaceutically acceptable salt, N-acetyl-L-methionine, stable maintenance for at least about 3 months, suitability only for intravenous, subcutaneous, or intramuscular administration to human patients, and a viscosity of about 1 centipoise, with additional exclusions and composition ranges.
Stable liquid vancomycin with N-acetyl-L-methionine and excipients at about 1 cP with exclusions
A liquid composition comprising vancomycin or a pharmaceutically acceptable salt thereof, N-acetyl-L-methionine, and one or more pharmaceutically acceptable excipients, wherein the liquid composition is capable of stably maintaining the vancomycin or a pharmaceutically acceptable salt thereof for a period of at least about 3 months, is adapted only to be suitable for intravenous, subcutaneous, or intramuscular administration to human patients, has a viscosity of about 1 centipoise, and does not include N-acetyl-D-alanine or polyethylene glycol-400.
Specific vancomycin, N-acetyl-L-methionine, sodium chloride, and pH about 5 liquid composition
A liquid composition comprising vancomycin or a pharmaceutically acceptable salt thereof, N-acetyl-L-methionine, sodium chloride, sodium hydroxide or hydrochloride to adjust the composition pH of about 5.0, and water, wherein the liquid composition is capable of stably maintaining the vancomycin or the pharmaceutically acceptable salt thereof for a period of at least about 3 months, is adapted only to be suitable for intravenous, subcutaneous, or intramuscular administration to human patients, and has a viscosity of about 1 centipoise.
Vancomycin and N-acetyl-L-methionine with defined molar ratio and about 1 cP
A liquid composition comprising vancomycin or a pharmaceutically acceptable salt thereof and N-acetyl-L-methionine, wherein the liquid composition is capable of stably maintaining the vancomycin or the pharmaceutically acceptable salt thereof for a period of at least about 3 months, is adapted only to be suitable for intravenous, subcutaneous, or intramuscular administration to human patients, the molar ratio of vancomycin or the pharmaceutically acceptable salt thereof to N-acetyl-L-methionine is about 1:5 to about 1:50, and the liquid composition has a viscosity of about 1 centipoise.
Collectively, the independent claims define a stable liquid parenteral system built around vancomycin or a pharmaceutically acceptable salt thereof and N-acetyl-L-methionine, with stability for at least about 3 months, suitability only for intravenous, subcutaneous, or intramuscular administration to human patients, and a viscosity of about 1 centipoise. Additional claim-specific constraints include exclusion of N-acetyl-D-alanine and polyethylene glycol-400, pH adjustment to about 5.0 with sodium hydroxide or hydrochloride, and a defined vancomycin-to-N-acetyl-L-methionine molar ratio.
Stated Advantages
Stable maintenance of vancomycin or a pharmaceutically acceptable salt thereof for a period of at least about 3 months.
Adapted only for intravenous, subcutaneous, or intramuscular administration to human patients.
Viscosity of about 1 centipoise.
Excludes N-acetyl-D-alanine and polyethylene glycol-400 in the covered embodiments.
Documented Applications
Pharmaceutical products for sterile intravenous, subcutaneous, or intramuscular administration to a patient using an acceptable container such as a vial, syringe, infusion container, infusion bottle, or infusion bag.
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