# US 9,872,906 B2 · Ceftolozane antibiotic compositions > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,872,906 B2 - Document ID: US9872906B2 - Status: Granted - Kind: B2 - Application number: 14/856,075 - Filed: 2015-09-16 - Published: 2016-01-07 - Granted: 2018-01-23 - Earliest claimed: 2013-03-15 - Assignees: Merck Sharp & Dohme Corp. - Applicants: Merck Sharp & Dohme Corp. - Inventors: Joseph Terracciano; Nicole Miller Damour; Chun Jiang; Giovanni Fogliato; Giuseppe Alessandro Donadelli; Dario Resemini - Web page: https://patentgrep.com/patent/US9872906B2 ## CPC - A61K 47/02: Inorganic compounds - A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)} - A61K 9/19: lyophilised {, i.e. freeze-dried, solutions or dispersions (lyophilised products with subsequent particle size reduction A61K9/14; granules or pellets made by lyphilisation A61K9/1682; solid oral dosage forms made by lyophilisation A61K9/2095; lyophilisation additives A61K47/00)} - A61K 31/431: containing further heterocyclic rings, e.g. ticarcillin, azlocillin, oxacillin - A61K 31/546: containing further heterocyclic rings, e.g. cephalothin - A61K 47/183: {Amino acids, e.g. glycine, EDTA or aspartame} - A61K 47/12: Carboxylic acids; Salts or anhydrides thereof - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) ## Abstract This disclosure provides pharmaceutical compositions comprising ceftolozane, pharmaceutical compositions comprising ceftolozane and tazobactam, methods of preparing those compositions, and related methods and uses of these compositions. ## Claims ### Claim 1 A solid pharmaceutical composition comprising ceftolozane sulfate and tazobactam sodium, said composition comprising less than 0.15% of a compound of formula (III) relative to ceftolozane sulfate, as determined by high performance liquid chromatography (HPLC) at a wavelength of 254 nm, when stored for 1 month at a temperature of 25° C. and at a relative humidity of 60%, wherein the ceftolozane sulfate and tazobactam sodium provide ceftolozane active and tazobactam active in a ratio of 2:1 by weight. ### Claim 2 (depends on 1) The composition of claim 1, which contains less than 0.1% of the compound of formula (III) relative to ceftolozane sulfate, as determined by high performance liquid chromatography (HPLC) at a wavelength of 254 nm, when stored for 1 month at a temperature of 25° C. and at a relative humidity of 60%. ### Claim 3 (depends on 1) The composition of claim 1, which contains less than 0.03% of the compound of formula (III) relative to ceftolozane sulfate, as determined by high performance liquid chromatography (HPLC) at a wavelength of 254 nm when stored for 1 month at a temperature of 25° C. and at a relative humidity of 60%. ### Claim 4 (depends on 1) The composition of claim 1, wherein the amount of ceftolozane active is 1,000 mg and the amount of tazobactam active is 500 mg. ### Claim 5 (depends on 1) The composition of claim 1, wherein the amount of ceftolozane active is 2,000 mg and the amount of tazobactam active is 1,000 mg. ### Claim 6 (depends on 1) The pharmaceutical composition of claim 1, comprising 1,147 mg ceftolozane sulfate and 537 mg tazobactam sodium. ### Claim 7 (depends on 1) The composition of claim 1, which is provided in a unit dosage form. ### Claim 8 (depends on 1) An injectable composition comprising the pharmaceutical composition of claim 1 dissolved in a pharmaceutically acceptable vehicle. ### Claim 9 A pharmaceutical composition comprising ceftolozane sulfate and tazobactam sodium, said composition comprising less than 0.15% of the compound of formula (III) relative to ceftolozane sulfate, as determined by high performance liquid chromatography (HPLC) at a wavelength of 254 nm, and less than 1.5% of a compound of formula (IV) relative to ceftolozane sulfate, as determined by high performance liquid chromatography (HPLC) at a wavelength of 254 nm, when stored for 3 months at a temperature of 25° C. and at a relative humidity of 60%, wherein the ceftolozane sulfate and tazobactam sodium provide ceftolozane active and tazobactam active in a ratio of 2:1 by weight. ### Claim 10 (depends on 9) The composition of claim 9, which contains less than 0.05% of the compound of formula (III) relative to ceftolozane sulfate, as determined by high performance liquid chromatography (HPLC) at a wavelength of 254 nm, when stored for 3 months at a temperature of 25° C. and at a relative humidity of 60%. ### Claim 11 (depends on 9) An injectable composition comprising the pharmaceutical composition of claim 9 dissolved in a pharmaceutically acceptable vehicle. ### Claim 12 A pharmaceutical composition comprising ceftolozane sulfate and tazobactam sodium, said composition comprising less than 0.15% relative to ceftolozane sulfate of the compound having a mass spectra depicted in FIG. 14, as determined by high performance liquid chromatography (HPLC) at a wavelength of 254 nm, when stored for 1 month at a temperature of 25° C. and at a relative humidity of 60%, wherein the ceftolozane sulfate and tazobactam sodium provide ceftolozane active and tazobactam active in a ratio of 2:1 by weight. ### Claim 13 (depends on 12) The composition of claim 12, which contains less than 0.1% relative to ceftolozane sulfate of the compound with the mass spectra depicted in FIG. 14, as determined by high performance liquid chromatography (HPLC) at a wavelength of 254 nm, when stored for 1 month at a temperature of 25° C. and at a relative humidity of 60%. ### Claim 14 (depends on 12) The composition of claim 12, which contains less than 0.03% relative to ceftolozane sulfate of the compound with the mass spectra depicted in FIG. 14, as determined by high performance liquid chromatography (HPLC) at a wavelength of 254 nm, when stored for 1 month at a temperature of 25° C. and at a relative humidity of 60%. ### Claim 15 (depends on 12) The composition of claim 12, wherein the amount of ceftolozane active is 1,000 mg and the amount of tazobactam active is 500 mg. ### Claim 16 (depends on 12) The composition of claim 12, wherein the amount of ceftolozane active is 2,000 mg and the amount of tazobactam active is 1,000 mg. ### Claim 17 (depends on 12) The pharmaceutical composition of claim 12, comprising 1,147 mg ceftolozane sulfate and 537 mg tazobactam sodium. ### Claim 18 (depends on 12) An injectable composition comprising the pharmaceutical composition of claim 12 dissolved in a pharmaceutically acceptable vehicle. ### Claim 19 A pharmaceutical composition comprising ceftolozane sulfate and tazobactam sodium, said composition comprising less than 0.15% relative to ceftolozane sulfate of a compound having a mass spectra depicted in FIG. 14, as determined by high performance liquid chromatography (HPLC) at a wavelength of 254 nm, and less than 1.5% of a compound of formula (IV): relative to ceftolozane sulfate, as determined by high performance liquid chromatography (HPLC) at a wavelength of 254 nm, when stored for 3 months at a temperature of 25° C. and at a relative humidity of 60%, wherein the ceftolozane sulfate and tazobactam sodium provide ceftolozane active and tazobactam active in a ratio of 2:1 by weight. ### Claim 20 (depends on 19) An injectable composition comprising the pharmaceutical composition claim 19 dissolved in a pharmaceutically acceptable vehicle.