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Last Updated: October 31, 2020

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Claims for Patent: 10,130,592

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Summary for Patent: 10,130,592
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:14/863,112
Patent Claims: 1. A composition comprising: epinephrine and/or salts thereof, an antioxidant present at a concentration of in the range of about 0.1 to 0.9 mg/mL, a buffer system, the buffer system comprising tartaric acid, sodium chloride as a tonicity regulating agent at a concentration of in the range of about 6 to 7.5 mg/mL, a preservative, and disodium edetate dihydrate as a transition metal complexing agent at a concentration of in the range of about 0.01 to 0.4 mg/mL, wherein the buffer system provides a resistance to a pH change such that the composition has a pH of in the range of about 3.5 and 4.0 after 18 months of shelf life, and wherein after 18 months of storage at between 23.degree. C. and 32.degree. C. and between 55% RH and 70% RH, the composition comprises about 3% or less of D-Epinephrine.

2. The composition of claim 1, wherein the composition has a pH of in the range of about 3.5 and 4.0 after 24 months of shelf life.

3. The composition of claim 1, wherein the composition has a pH of in the range of about 3.5 and 4.0 after 30 months of shelf life.

4. The composition of claim 1, wherein the composition has a pH of in the range of about 3.5 and 4.0 after 36 months of shelf life.

5. The composition of claim 1, wherein the composition has an initial pH of in the range of about 3.5 and 4.5.

6. The composition of claim 1, wherein the composition has a pH after 18 months of shelf life of no more than about 1 unit different than an initial pH of the composition.

7. The composition of claim 1, wherein the composition has a pH after 24 months of shelf life of no more than about 1 unit different than an initial pH of the composition.

8. The composition of claim 1, wherein the composition has a pH after 30 months of shelf life of no more than about 1 unit different than an initial pH of the composition.

9. The composition of claim 1, wherein the composition has a pH after 36 months of shelf life of no more than about 1 unit different than an initial pH of the composition.

10. The composition of claim 1, wherein the buffer system has a pK.sub.a value in the range of about 2 to 5.

11. The composition of claim 1, wherein the buffer system has a pK.sub.a value in the range of about 3 to 4.5.

12. The composition of claim 1, wherein the buffer system has a pK.sub.a value of about 4.

13. The composition of claim 1, wherein the buffer system has a pK.sub.a value that is within 1 unit of an initial pH of the composition without the buffer system.

14. The composition of claim 1, wherein the composition has an initial pH of about 4.

15. The composition of claim 1, wherein after 24 months of storage at between 23.degree. C. and 32.degree. C. and between 55% RH and 70% RH, the composition comprises about 3% or less of D-Epinephrine.

16. The composition of claim 1, wherein 30 months of storage at between 23.degree. C. and 32.degree. C. and between 55% RH and 70% RH, the composition comprises about 3% or less of D-Epinephrine.

17. The composition of claim 1, after 36 months of storage at between 23.degree. C. and 32.degree. C. and between 55% RH and 70% RH, the composition comprises about 3% or less of D-Epinephrine.

18. The composition of claim 1, wherein the composition with the buffer system has a higher pH after 18 months of shelf life than what it would otherwise have without the presence of the buffer system.

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