Epinephrine formulations
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.
1. A composition comprising:
in the range of about 0.75 to 1.25 mg/mL of epinephrine and/or salts thereof,
in the range of about 6 to 8 mg/mL of a tonicity regulating agent,
in the range of 2 and 15 mg/mL of tartaric acid,
in the range of 1 and 5 mg/mL of sodium hydroxide,
in the range of about 0.4 and 0.5 mg/mL of an antioxidant,
in the range of about 0.001 to 0.010 mL/mL of a pH lowering agent,
wherein the antioxidant comprises sodium bisulfite and/or sodium metabisulfite, and
wherein the composition comprises about 3% or less total impurities after 6 months of storage at between 23° C. and 32° C. and between 55% RH and 70% RH.
2. The composition of claim 1 , wherein the tonicity regulating agent comprises sodium chloride.
3. The composition of claim 1 , wherein the pH lowering agent comprises hydrochloric acid.
4. The composition of claim 1 , further comprising a solvent.