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Claims for Patent: 9,119,876

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Claims for Patent: 9,119,876

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. (Woodcliff Lake, NJ)
Application Number:14/657,990
Patent Claims: 1. 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.

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

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

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

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

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

7. The composition of claim 1, further comprising a preservative.

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

9. The composition of claim 8, wherein the preservative is present at a concentration of in the range of about 4.75 to 5.75 mg/mL.

10. The composition of claim 1, further comprising a solvent.

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

12. The composition 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 composition 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 composition 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 composition 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 composition 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 composition 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 composition 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 composition 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.
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