Claims for Patent: 9,872,906

Summary for Patent: 9,872,906

Title:	Ceftolozane antibiotic compositions
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.
Inventor(s):	Terracciano; Joseph (Concord, MA), Damour; Nicole Miller (Belmont, MA), Jiang; Chun (Hillsborough, CA), Fogliato; Giovanni (Barzana, IT), Donadelli; Giuseppe Alessandro (Casalpusterlengo, IT), Resemini; Dario (Milan, IT)
Assignee:	Merck Sharp & Dohme Corp. (Rahway, NJ)
Application Number:	14/856,075
Patent Claims:	1. A solid pharmaceutical composition comprising ceftolozane sulfate and tazobactam sodium, said composition comprising less than 0.15% of a compound of formula (III) ##STR00018## 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.degree. 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. 2. 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.degree. C. and at a relative humidity of 60%. 3. 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.degree. C. and at a relative humidity of 60%. 4. The composition of claim 1, wherein the amount of ceftolozane active is 1,000 mg and the amount of tazobactam active is 500 mg. 5. 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. 6. The pharmaceutical composition of claim 1, comprising 1,147 mg ceftolozane sulfate and 537 mg tazobactam sodium. 7. The composition of claim 1, which is provided in a unit dosage form. 8. An injectable composition comprising the pharmaceutical composition of claim 1 dissolved in a pharmaceutically acceptable vehicle. 9. A pharmaceutical composition comprising ceftolozane sulfate and tazobactam sodium, said composition comprising less than 0.15% of the compound of formula (III) ##STR00019## 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) ##STR00020## 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.degree. 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. 10. 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.degree. C. and at a relative humidity of 60%. 11. An injectable composition comprising the pharmaceutical composition of claim 9 dissolved in a pharmaceutically acceptable vehicle. 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.degree. 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. 13. 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.degree. C. and at a relative humidity of 60%. 14. 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.degree. C. and at a relative humidity of 60%. 15. The composition of claim 12, wherein the amount of ceftolozane active is 1,000 mg and the amount of tazobactam active is 500 mg. 16. 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. 17. The pharmaceutical composition of claim 12, comprising 1,147 mg ceftolozane sulfate and 537 mg tazobactam sodium. 18. An injectable composition comprising the pharmaceutical composition of claim 12 dissolved in a pharmaceutically acceptable vehicle. 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): ##STR00021## 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.degree. 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. 20. An injectable composition comprising the pharmaceutical composition claim 19 dissolved in a pharmaceutically acceptable vehicle.