CEFTOLOZANE ANTIBIOTIC COMPOSITIONS
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.
1 - 26 . (canceled)
27 . A solid pharmaceutical composition comprising ceftolozane or a pharmaceutically acceptable salt thereof and tazobactam sodium, said composition comprising less than 0.1% by weight of a compound of formula (III)
when stored for 1 month at a temperature of 25° C. and at a relative humidity of 60%, wherein the ceftolozane or pharmaceutically acceptable salt thereof and tazobactam sodium provide ceftolozane active and tazobactam active in a ratio of 2:1 by weight.
28 . The composition of claim 27 , wherein the pharmaceutically acceptable salt of ceftolozane is ceftolozane sulfate.
29 . The composition of claim 48 , which is provided in a unit dosage form.
30 . The composition of claim 48 , which contains less than 0.05% by weight of the compound of formula (III) when stored for 1 month at a temperature of 25° C. and at a relative humidity of 60%.
31 . The composition of claim 48 , which contains less than 0.03% by weight of the compound of formula (III) when stored for 1 month at a temperature of 25° C. and at a relative humidity of 60%.
32 . The composition of claim 48 , wherein the compound of formula (III) is not present when stored for 1 month at a temperature of 25° C. and at a relative humidity of 60%.
33 . The composition of claim 48 , wherein the amount of ceftolozane active is 1,000 mg and the amount of tazobactam active is 500 mg.
34 . The composition of claim 48 , wherein the amount of ceftolozane active is 2,000 mg and the amount of tazobactam active is 1,000 mg.
35 . The pharmaceutical composition of claim 48 , comprising 1147 mg ceftolozane sulfate and 537 mg tazobactam sodium.
36 . An injectable solution comprising a pharmaceutical composition of claim 48 dissolved in a pharmaceutically acceptable vehicle.
37 . The injectable solution of claim 56 , wherein the pharmaceutically acceptable vehicle is selected from water, 0.9% sodium chloride and 5% Dextrose.
38 . A pharmaceutical composition comprising ceftolozane or a pharmaceutically acceptable salt thereof and tazobactam sodium, said composition comprising less than 0.1% of a material having a mass spectra depicted in FIG. 14 , wherein the ceftolozane or pharmaceutically acceptable salt thereof and tazobactam sodium provide ceftolozane active and tazobactam active in a ratio of 2:1 by weight.
39 . The composition of claim 58 , wherein the pharmaceutically acceptable salt of ceftolozane is ceftolozane sulfate.
40 . The composition of claim 59 , which is provided in a unit dosage form.
41 . The composition of claim 59 , which contains less than 0.05% by weight of the material with the mass spectra depicted in FIG. 14 when stored for 1 month at a temperature of 25° C. and at a relative humidity of 60%.
42 . The composition of claim 59 , which contains less than 0.03% by weight of the material with the mass spectra depicted in FIG. 14 when stored for 1 month at a temperature of 25° C. and at a relative humidity of 60%.
43 . The composition of claim 48 , wherein the material with the mass spectra depicted in FIG. 14 is not present when stored for 1 month at a temperature of 25° C. and at a relative humidity of 60%.
44 . The composition of claim 59 , wherein the amount of ceftolozane active is 1,000 mg and the amount of tazobactam active is 500 mg.
45 . The composition of claim 59 , wherein the amount of ceftolozane active is 2,000 mg and the amount of tazobactam active is 1,000 mg.
46 . The pharmaceutical composition of claim 59 , comprising 1147 mg ceftolozane sulfate and 537 mg tazobactam sodium.
47 . An injectable solution comprising a pharmaceutical composition of claim 59 dissolved in a pharmaceutically acceptable vehicle.
48 . The injectable solution of claim 67 , wherein the pharmaceutically acceptable vehicle is selected from water, 0.9% sodium chloride and 5% Dextrose.