Epinephrine formulations

Abstract

Pharmaceutical compositions comprising epinephrine, methods of administration, and methods of making the same. Compositions may comprise at least one of an active agent, a pH raising agent, an antioxidant, a transition metal complexing agent, a pH lowering agent, a tonicity regulating agent, optionally a preservative, and optionally a solvent.

What is claimed is: 
     
         1 . A composition comprising:
 epinephrine and/or salts thereof,   a tonicity regulating agent comprising sodium chloride,   a pH raising agent comprising tartaric acid and sodium hydroxide,   an antioxidant comprising sodium metabisulfite,   a pH lowering agent comprising hydrochloric acid,   a transition metal complexing agent comprising EDTA, and   water.   
     
     
         2 . The composition according to  claim 1 , wherein the epinephrine and/or salts thereof is present at a concentration of 0.114 mg/mL. 
     
     
         3 . The composition according to  claim 1 , wherein the sodium chloride is present at a concentration of 9 mg/mL. 
     
     
         4 . The composition according to  claim 1 , wherein the tartaric acid is present at a concentration of 0.225 mg/mL. 
     
     
         5 . The composition according to  claim 1 , wherein the sodium hydroxide is present at a concentration of 0.1 mg/mL. 
     
     
         6 . The composition according to  claim 1 , wherein the sodium metabisulfite is present at a concentration of 0.0457 mg/mL. 
     
     
         7 . The composition according to  claim 1 , wherein the hydrochloric acid is present at a concentration of 0.025 mg/mL. 
     
     
         8 . The composition according to  claim 1 , wherein the EDTA is present at a concentration of 0.02 mg/mL. 
     
     
         9 . The composition according to  claim 1 , wherein the composition comprises about 15% or less total impurities after 6 months of storage in accelerated storage conditions. 
     
     
         10 . The composition according to  claim 9 , wherein the total impurities comprise D-epinephrine. 
     
     
         11 . The composition according to  claim 1 , wherein the composition comprises about 10% or less total impurities after 3 months of storage in accelerated storage conditions. 
     
     
         12 . The composition according to  claim 11 , wherein the total impurities comprise D-epinephrine. 
     
     
         13 . The composition according to  claim 1 , wherein the composition comprises about 5% or less total impurities after 2 months of storage in accelerated storage conditions. 
     
     
         14 . The composition according to  claim 13 , wherein the total impurities comprise D-epinephrine. 
     
     
         15 . The composition according to  claim 1 , wherein the composition comprises about 5% or less total impurities after 3 months of storage in long term storage conditions. 
     
     
         16 . The composition according to  claim 15 , wherein the total impurities comprise D-epinephrine. 
     
     
         17 . The composition according to  claim 1 , wherein the composition comprises about 5% or less total impurities after 6 months of storage in long term storage conditions. 
     
     
         18 . The composition according to  claim 17 , wherein the total impurities comprise D-epinephrine. 
     
     
         19 . A composition consisting of:
 epinephrine and/or salts thereof at a concentration of 0.114 mg/mL,   a tonicity regulating agent comprising sodium chloride at a concentration of 9 mg/mL,   a pH raising agent comprising tartaric acid at a concentration of 0.225 mg/mL and sodium hydroxide at a concentration of 0.1 mg/mL,   an antioxidant comprising sodium metabisulfite at a concentration of 0.0457 mg/mL,   a pH lowering agent comprising hydrochloric acid at a concentration of 0.025 mg/mL,   a transition metal complexing agent comprising EDTA at a concentration of 0.02 mg/mL, and   water.