EPINEPHRINE COMPOSITIONS AND CONTAINERS
A sterile storage stable ready-to-inject epinephrine composition contained within a flexible container and packaged within a secondary container, the composition including an aqueous pharmaceutically acceptable carrier containing epinephrine and a metal ion chelator, the epinephrine being present in a concentration of equal to or less than 0.07 mg/mL, substantially all of the epinephrine being an R-isomer, the composition having a pH of between 3.5-4.7, and the composition having, after storage of at least one month at 25° C., total impurities of equal or less than 0.7% and equal or less than 4% S-isomer content.
1 . A sterile storage stable ready-to-inject epinephrine composition contained within a flexible container and packaged within a secondary container,
wherein the composition comprises an aqueous pharmaceutically acceptable carrier containing epinephrine and a metal ion chelator,
wherein the epinephrine is present in a concentration of equal to or less than 0.07 mg/ml,
wherein substantially all of the epinephrine is an R-isomer,
wherein the composition has a pH of between 3.5-4.7, and
wherein the composition has, after storage of at least one month at 25° C., total impurities of equal or less than 0.7% and equal or less than 4% S-isomer content.
2 . The composition of claim 1 , wherein the secondary container comprises an aluminum foil overwrap.
3 . The composition of claim 2 , wherein the aluminum foil overwrap comprises an oxygen scavenger.
4 . The composition of claim 1 , wherein at least one of the flexible container and the secondary container has an oxygen transmission rate between 0.0005 to 0.005 cc/100 in2/24 hrs.
5 . The composition of claim 1 , wherein the flexible container is a flexible infusion bag.
6 . The composition of claim 1 , wherein the flexible container has a volume of at least 100 mL.
7 . The composition of claim 1 , wherein the flexible container comprises polyethylene, polypropylene, polyethylene terephthalate, a co-polymer selected from ethylene-propylene copolymers, ethylene vinyl acetate, and copolyester ether polymers, or a combination thereof.
8 . The composition of claim 1 , wherein the epinephrine is present in a concentration of about 8 mcg/mL.
9 . The composition of claim 1 , wherein the epinephrine is present in a concentration of about 16 mcg/mL.
10 . The composition of claim 1 , wherein the epinephrine is present in a concentration of about 20 mcg/mL.
11 . The composition of claim 1 , wherein the epinephrine is present in a concentration of about 32 mcg/mL.
12 . The composition of claim 1 , wherein the epinephrine is present in a concentration of about 40 mcg/mL.
13 . The composition of claim 1 , wherein the metal ion chelator comprises disodium edetate dihydrate.
14 . The composition of claim 1 , further comprising a tonicity agent.
15 . The composition of claim 14 , wherein the tonicity agent comprises sodium chloride.
16 . The composition of claim 1 , further comprising a buffer.
17 . The composition of claim 16 , wherein the buffer comprises tartaric acid.
18 . The composition of claim 1 , further comprising a pH adjusting agent.
19 . The composition of claim 18 , wherein the pH adjusting agent comprises hydrochloric acid, sodium hydroxide, or a combination thereof.
20 . The composition of claim 1 , wherein the composition, after storage of at least one month at 25° C., changes pH no more than 0.5 pH units.