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Claims for Patent: 9,295,657

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Claims for Patent: 9,295,657

Title: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.
Inventor(s): Kannan; Vinayagam (Rochester, MI), Irish; Patrick (Sterling Heights, MI), Bergren; Michael (Henderson, NV)
Assignee: Par Pharmaceutical, Inc. (Chestnut Ridge, NY)
Application Number:14/818,121
Patent Claims: 1. A method of treating a condition comprising administering to a patient in need thereof a composition comprising: in the range of about 0.5 to 1.5 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 about 2.8 to 3.8 mg/mL of a pH raising agent, in the range of about 0.1 to 1.1 mg/mL of an antioxidant, in the range of about 0.001 to 0.010 mL/mL of a pH lowering agent, and in the range of about 0.01 to 0.4 mg/mL of a transition metal complexing agent; wherein the antioxidant comprises sodium bisulfite and/or sodium metabisulfite, and wherein the condition is selected from the group consisting of anaphylaxis, bronchospasm, sensitivity reactions, cardiac arrhythmias, GI and renal hemorrhage, superficial bleeding, premature labor, hypoglycemia, and cardiogenic, hemorrhagic, and traumatic shock.

2. The method of claim 1, wherein the tonicity regulating agent comprises sodium chloride.

3. The method of claim 1, wherein the pH raising agent comprises a buffer system comprising at least two compounds.

4. The method of claim 1, wherein the pH raising agent comprises at least one of tartaric acid and sodium hydroxide.

5. The method of claim 1, wherein the pH lowering agent comprises hydrochloric acid.

6. The method of claim 1, wherein the transition metal complexing agent comprises EDTA.

7. The method of claim 1, wherein the composition further comprises a preservative.

8. The method of claim 7, wherein the preservative comprises chlorobutanol.

9. The method of claim 7, wherein the preservative is present at a concentration of in the range of about 4.75 to 5.75 mg/mL.

10. The method of claim 1, wherein the composition further comprises a solvent.

11. The method of claim 10, wherein the solvent comprises water.

12. The method according to claim 1, wherein the composition comprises about 17% or less total impurities after 18 months of storage at between 23.degree. C. and 32.degree. C. and between 55% RH and 70% RH, wherein the impurities comprise epinephrine sulfonic acid (ESA), D-epinephrine, Impurity A, Impurity B, and Unknown C.

13. The method according to claim 1, wherein the composition comprises about 16% or less total impurities after 18 months of storage at between 23.degree. C. and 32.degree. C. and between 55% RH and 70% RH, wherein the impurities comprise epinephrine sulfonic acid (ESA), D-epinephrine, Impurity A, Impurity B, and Unknown C.

14. The method of claim 1, wherein the composition comprises about 11% or less of ESA after 18 months of storage at between 23.degree. C. and 32.degree. C. and between 55% RH and 70% RH.

15. The method of claim 1, wherein the composition comprises about 3% or less of D-Epinephrine after 18 months of storage at between 23.degree. C. and 32.degree. C. and between 55% RH and 70% RH.

16. The method of claim 1, wherein the composition comprises about 1% or less of Impurity A after 18 months of storage at between 23.degree. C. and 32.degree. C. and between 55% RH and 70% RH.

17. The method of claim 1, wherein the composition comprises about 1% or less of Impurity B after 18 months of storage at between 23.degree. C. and 32.degree. C. and between 55% RH and 70% RH.

18. The method of claim 1, wherein the composition comprises about 1% or less of Unknown C after 18 months of storage at between 23.degree. C. and 32.degree. C. and between 55% RH and 70% RH.

19. The method of claim 1, wherein the composition does not undergo unacceptable color change after 18 months of storage at between 23.degree. C. and 32.degree. C. and between 55% RH and 70% RH.

20. A method for treating Type 1 allergic reactions comprising administering to a patient in need thereof a composition comprising: in the range of about 0.5 to 1.5 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 about 2.8 to 3.8 mg/mL of a pH raising agent, in the range of about 0.1 to 1.1 mg/mL of an antioxidant, in the range of about 0.001 to 0.010 mL/mL of a pH lowering agent, and in the range of about 0.01 to 0.4 mg/mL of a transition metal complexing agent; wherein the antioxidant comprises sodium bisulfite and/or sodium metabisulfite.

21. A method for the induction and maintenance of mydriasis during intraocular surgery comprising administering to a patient in need thereof a composition comprising: in the range of about 0.5 to 1.5 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 about 2.8 to 3.8 mg/mL of a pH raising agent, in the range of about 0.1 to 1.1 mg/mL of an antioxidant, in the range of about 0.001 to 0.010 mL/mL of a pH lowering agent, and in the range of about 0.01 to 0.4 mg/mL of a transition metal complexing agent; wherein the antioxidant comprises sodium bisulfite and/or sodium metabisulfite.
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