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,   a pH raising agent,   an antioxidant,   a pH lowering agent, and   a transition metal complexing agent,   wherein the antioxidant comprises a thiol-containing organic compound.   
     
     
         2 . The composition according to  claim 1 , wherein the thiol-containing organic compound comprises glutathione. 
     
     
         3 . The composition according to  claim 1 , wherein the epinephrine and/or salts thereof is present at a concentration of in the range of about 0.1 to 2 mg/m L. 
     
     
         4 . The compositions according to  claim 1 , wherein the tonicity regulating agent is present at a concentration of in the range of about 6 to 8 mg/m L. 
     
     
         5 . The compositions according to  claim 1 , wherein the pH raising agent is present at a concentration of in the range of about 2.8 to 3.8 mg/m L. 
     
     
         6 . The compositions according to  claim 1 , wherein the transition metal complexing agent is present at a concentration of in the range of about 0.01 to 0.4 mg/mL. 
     
     
         7 . The composition according to  claim 1 , further comprising a solvent. 
     
     
         8 . The composition according to  claim 7 , wherein the solvent is water. 
     
     
         9 . The composition of  claim 1 , wherein the pH raising agent comprises a buffer system comprising at least two compounds. 
     
     
         10 . The composition of  claim 1 , wherein the pH raising agent comprises at least one of tartaric acid and sodium hydroxide. 
     
     
         11 . The composition of  claim 1 , wherein the pH lowering agent comprises hydrochloric acid. 
     
     
         12 . The composition of  claim 1 , wherein the transition metal complexing agent comprises EDTA. 
     
     
         13 . The composition according to  claim 1 , wherein the composition comprises about 5% or less total impurities after 3 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 2 months of storage in accelerated 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 3 months of storage in long term storage conditions. 
     
     
         18 . The composition according to  claim 17 , wherein the total impurities comprise D-epinephrine. 
     
     
         19 . The composition according to  claim 1 , wherein the composition comprises about 5% or less total impurities after 2 months of storage in long term storage conditions. 
     
     
         20 . The composition according to  claim 19 , wherein the total impurities comprise D-epinephrine.