Stabilized composition comprising at least one adrenergic compound

1. A liquid pharmaceutical composition comprising an adrenergic compound and at least one antioxidant that is a member selected from the group consisting of a bisulfite and, a metabisulfite, wherein the molar ratio of the adrenergic compound to the at least one antioxidant, measured as sulfite-equivalents, is 1.31-2.20, and wherein the pH of said liquid composition is between about pH 2.0-4.0.

2. The pharmaceutical composition according to claim 1 , wherein the adrenergic compound is a member selected from the group consisting of epinephrine, norepinephrine, phenylephrine, α-methylnorepinephrine, dopamine, methoxamine, dobutamine, prenalterol, isoproterenol, fenoterol, albuterol, terbutaline, metaproterenol, and physiologically acceptable salts thereof.

3. The pharmaceutical composition according to claim 1 , wherein the adrenergic compound is a member selected from the group consisting of epinephrine, norepinephrine, isoproterenol and dopamine, and physiologically acceptable salts thereof.

4. The pharmaceutical composition according to claim 1 , wherein the adrenergic compound is epinephrine or a physiologically acceptable salt thereof.

5. The pharmaceutical composition according to claim 1 , wherein the antioxidant is sodium metabisulfite.

6. The pharmaceutical composition according to claim 1 , wherein the molar ratio of the at least one adrenergic compound to the at least one antioxidant is 1.31 to 2.00.

7. The pharmaceutical composition according to claim 1 , having a pH in the range of pH 2.5-4.0.

8. The pharmaceutical composition according to claim 7 , wherein the pH is in the range of pH 3.3-3.5.

9. The pharmaceutical composition according to claim 1 , further comprising one or more excipients or additives.

10. The pharmaceutical composition according to claim 2 , comprising:

Epinephrine acid tartrate

2.0

mg/ml

Sodium chloride

6.0

mg/ml

Sodium metabisulfite

0.57

mg/ml

HCl/NaoH

q.s. pH 3.4

Water for injection

q.s. 1.0

ml.

11. A method for stabilizing a liquid pharmaceutical composition comprising an adrenergic compound, comprising the steps of i) providing a solution of an adrenergic compound, ii) adding at least one antioxidant selected from the group consisting of a bisulfite, and a metabisulfite, iii) adjusting the pH of the composition to a value in the range of pH 2.0-4.0 optionally by addition of an acid or a base, wherein the molar ratio of the adrenergic compound to the at least one antioxidant, measured as sulfite-equivalents, is in the range of 1.31-2.20.

12. A kit comprising:

v) a liquid pharmaceutical composition comprising an adrenergic compound and at least one antioxidant selected from the group consisting of a bisulfite, and a metabisulfite, wherein the molar ratio of the adrenergic compound to the at least one antioxidant, measured as sulfite-equivalents, is in the range of 1.31-2.20, and wherein the pH of said liquid composition is in the range of about 2.0-4.0, and

vi) an administration device.

13. The kit according to claim 12 wherein the administration device is an ampoule or an auto-injector.

14. A method of improving at least one symptom of a medical condition requiring an adrenergic compound in an individual in need thereof, comprising administering to the individual a liquid pharmaceutical composition comprising an adrenergic compound and at least one antioxidant that is a member selected from the group consisting of a bisulfite, and a metabisulfite, wherein the molar ratio of the adrenergic compound to the at least one antioxidant, measured as sulfite-equivalents, is 1.31-2.20, and wherein the pH of said liquid composition is in the range of about pH 2.0-4.0.

15. A method of treating anaphylaxis in an individual comprising administering to the individual a liquid pharmaceutical composition comprising an adrenergic compound and at least one antioxidant member selected from the group consisting of a bisulfite, and a metabisulfite, wherein the molar ratio of the adrenergic compound to the at least one antioxidant, measured as sulfite-equivalents, is 1.31-2.20, and wherein the pH of said liquid composition is in the range of about pH 2.0-4.0.

16. A liquid pharmaceutical composition for use in improving at least one symptom of a medical condition requiring an adrenergic compound in an individual in need thereof, comprising an adrenergic compound and at least one antioxidant selected from the group consisting of a bisulfite, and a metabisulfite, wherein the molar ratio of the adrenergic compound to the at least one antioxidant, measured as sulfite-equivalents, is 1.31-2.20, and wherein the pH of said liquid composition is in the range of about pH 2.0-4.0.