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.

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.