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 pre-filled syringe containing a composition, the composition comprising:
epinephrine and/or salts thereof,
a tonicity regulating agent,
a pH raising agent,
an antioxidant comprising methionine,
a pH lowering agent,
a transition metal complexing agent, and
water.
2 . The pre-filled syringe of claim 1 , wherein the tonicity regulating agent comprises sodium chloride.
3 . The pre-filled syringe of claim 1 , wherein the pH raising agent comprises tartaric acid and sodium hydroxide.
4 . The pre-filled syringe of claim 1 , wherein the pH lowering agent comprises hydrochloric acid.
5 . The pre-filled syringe of claim 1 , wherein the transition metal complexing agent comprises EDTA.
6 . The pre-filled syringe according to claim 1 , wherein the composition comprises about 20% or less total impurities after 1 month of storage in accelerated storage conditions.
7 . The pre-filled syringe according to claim 1 , wherein the composition comprises about 20% or less total impurities after 2 months of storage in accelerated storage conditions.
8 . The pre-filled syringe according to claim 1 , wherein the composition comprises about 20% or less total impurities after 3 months of storage in accelerated storage conditions.
9 . The pre-filled syringe according to claim 1 , wherein the composition comprises about 10% or less total impurities after 1 month of storage in accelerated storage conditions.
10 . The pre-filled syringe according to claim 1 , wherein the composition comprises about 10% or less total impurities after 2 months of storage in accelerated storage conditions.
11 . The pre-filled syringe according to claim 1 , wherein the composition comprises about 10% or less total impurities after 3 months of storage in accelerated storage conditions.
12 . A pre-filled syringe containing a composition, the 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 methionine,
a pH lowering agent comprising hydrochloric acid,
a transition metal complexing agent comprising EDTA, and
water.
13 . The pre-filled syringe according to claim 12 , wherein the composition comprises about 20% or less total impurities after 1 month of storage in accelerated storage conditions.
14 . The pre-filled syringe according to claim 12 , wherein the composition comprises about 20% or less total impurities after 2 months of storage in accelerated storage conditions.
15 . The pre-filled syringe according to claim 12 , wherein the composition comprises about 20% or less total impurities after 3 months of storage in accelerated storage conditions.
16 . The pre-filled syringe according to claim 12 , wherein the composition comprises about 10% or less total impurities after 1 month of storage in accelerated storage conditions.
17 . The pre-filled syringe according to claim 12 , wherein the composition comprises about 10% or less total impurities after 2 months of storage in accelerated storage conditions.
18 . The pre-filled syringe according to claim 12 , wherein the composition comprises about 10% or less total impurities after 3 months of storage in accelerated storage conditions.
19 . The pre-filled syringe according to claim 12 , wherein the antioxidant consists of methionine.
20 . A method comprising filling a syringe with a composition, wherein the composition comprises:
epinephrine and/or salts thereof,
a tonicity regulating agent,
a pH raising agent,
an antioxidant comprising methionine,
a pH lowering agent,
a transition metal complexing agent, and
water.