Ready to Use Ketorolac Formulations

Abstract

Disclosed in certain embodiments is a pharmaceutical composition for parenteral administration comprising: an aqueous solution comprising ketorolac or a pharmaceutically acceptable salt thereof in an amount from about 0.1 mg/mL to about 10 mg/mL; and a pharmaceutically acceptable excipient; wherein the formulation is substantially free of alcohol.

1 . A pharmaceutical composition for parenteral administration comprising:
 an aqueous solution comprising ketorolac or a pharmaceutically acceptable salt thereof in an amount form about 0.1 mg/mL to about 10 mg/mL; and   a pharmaceutically acceptable excipient   wherein the formulation is substantially free of alcohol.   
       a pharmaceutically acceptable excipient selected from the group consisting of anhydrous or hydrous forms of sodium chloride, dextrose, sucrose, xylitol, fructose, glycerol, sorbitol, mannitol, potassium chloride, mannose, calcium chloride, magnesium chloride; 
       wherein the composition is substantially free of alcohol, has a pH from about 4.5 to about 8.5 and maintains at least 90% of the amount of ketorolac or a pharmaceutically acceptable salt thereof after storage for 6 months at 25° C.; and 
       wherein the composition is contained in a pharmaceutically acceptable container selected from the group consisting of intravenous bags and intravenous bottles. 
     
     
         2 . The pharmaceutical composition of  claim 1 , which maintains at least 90% of the amount of ketorolac or a pharmaceutically acceptable salt thereof after storage for 6 months. 
     
     
         3 . The pharmaceutical composition of  claim 1 , which maintains at least 90% of the amount of ketorolac or a pharmaceutically acceptable salt thereof after storage for 1 year. 
     
     
         4 . The pharmaceutical composition of  claim 1 , which maintains at least 90% of the amount of ketorolac or a pharmaceutically acceptable salt thereof after storage for 2 years. 
     
     
         5 . The pharmaceutical composition of  claim 1 , which maintains at least 95% of the amount of ketorolac or a pharmaceutically acceptable salt thereof after storage for 6 months. 
     
     
         6 . The pharmaceutical composition of  claim 1 , which maintains at least 95% of the amount of ketorolac or a pharmaceutically acceptable salt thereof after storage for 1 year. 
     
     
         7 . The pharmaceutical composition of  claim 1 , which maintains at least 95% of the amount of ketorolac or a pharmaceutically acceptable salt thereof after storage for 2 years. 
     
     
         8 . The pharmaceutical composition of  claim 1 , which maintains at least 98% of the amount of ketorolac or a pharmaceutically acceptable salt thereof after storage for 6 months. 
     
     
         9 . The pharmaceutical composition of  claim 1 , which maintains at least 98% of the amount of ketorolac or a pharmaceutically acceptable salt thereof after storage for 1 year. 
     
     
         10 . The pharmaceutical composition of  claim 1 , which maintains at least 98% of the amount of ketorolac or a pharmaceutically acceptable salt thereof after storage for 2 years. 
     
     
         11 . The pharmaceutical composition of  claim 1 , wherein the ketorolac or a pharmaceutically acceptable salt thereof is in an amount from about 0.1 mg/mL to about 5 mg/mL. 
     
     
         12 . The pharmaceutical composition of  claim 1 , wherein the ketorolac or a pharmaceutically acceptable salt thereof is in an amount from about 0.1 mg/mL to about 1 mg/mL. 
     
     
         13 . The pharmaceutical composition of  claim 1 , having a pH from about 4.5 to about 8.5. 
     
     
         14 . The pharmaceutical composition of  claim 1 , having a pH from about 6.9 to about 7.5. 
     
     
         15 . The pharmaceutical composition of  claim 1 , wherein the pharmaceutically acceptable salt is ketorolac tromethamine. 
     
     
         16 . The pharmaceutical composition of  claim 1 , wherein the pharmaceutically acceptable excipient includes a tonicity agent. 
     
     
         17 . The pharmaceutical composition of  claim 16 , wherein the tonicity agent is selected from the group consisting of anhydrous or hydrous forms of sodium chloride, dextrose, sucrose, xylitol, fructose, glycerol, sorbitol, mannitol, potassium chloride, mannose, calcium chloride, magnesium chloride and other inorganic salts. 
     
     
         18 . The pharmaceutical composition of  claim 16 , wherein the tonicity agent is dextrose. 
     
     
         19 . The pharmaceutical composition of  claim 18 , comprising from about 0.1% to about 3% dextrose. 
     
     
         20 . The pharmaceutical composition of  claim 16 , wherein the tonicity agent is sodium chloride. 
     
     
         21 - 110 . (canceled)