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Claims for Patent: 9,066,856

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Claims for Patent: 9,066,856

Title:Stable preservative-free mydriatic and anti-inflammatory solutions for injection
Abstract: The present invention relates to stable, preservative- and antioxidant-free liquid formulations of phenylephrine and ketorolac for injection.
Inventor(s): Demopulos; Gregory A. (Mercer Island, WA), Shen; Hui-rong (Bothell, WA), Tedford; Clark E. (Poulsbo, WA)
Assignee: Omeros Corporation (Seattle, WA)
Application Number:14/061,039
Patent Claims: 1. A sterile liquid pharmaceutical formulation consisting essentially of phenylephrine, ketorolac and a buffer system in an aqueous carrier, wherein the formulation is stable for at least six months when stored at a temperature of from 5+/-3.degree. C. to 25+/-2.degree. C.

2. The pharmaceutical formulation of claim 1, wherein the buffer system comprises a sodium citrate buffer system.

3. The pharmaceutical formulation of claim 1, wherein the pharmaceutical formulation has a pH of from 5.8 to 6.8.

4. The pharmaceutical formulation of claim 1, wherein formulation is stable for a period of at least 24 months when stored at a temperature of from 5+/-3.degree. C. to 25+2.degree. C.

5. The pharmaceutical formulation of claim 1, wherein the formulation is contained within a single-use container.

6. The pharmaceutical formulation of claim 1, wherein the formulation comprises about 60.75 mM phenylephrine and about 11.25 mM ketorolac.

7. The pharmaceutical formulation of claim 1, further comprising an irrigation carrier into which the formulation is injected, wherein after injection the phenylephrine is present at a concentration of from 240 to 72 .mu.M and the ketorolac is present at a concentration of from 10 to 270 .mu.M.

8. The pharmaceutical formulation of claim 1, wherein the phenylephrine and ketorolac are included at a molar ratio of from 3:1 to 10:1 phenylephrine to ketorolac.

9. A sterile liquid pharmaceutical formulation comprising phenylephrine, ketorolac and a buffer system in an aqueous carrier, wherein the formulation is stable in the absence of preservatives and antioxidants for at least six months when stored at a temperature of from 5+/-3.degree. C. to 25+/-2.degree. C.

10. The pharmaceutical formulation of claim 9, wherein the buffer system comprises a sodium citrate buffer system.

11. The pharmaceutical formulation of claim 9, wherein the pharmaceutical formulation has a pH of from 5.8 to 6.8.

12. The pharmaceutical formulation of claim 9, wherein formulation is stable for a period of at least 24 months when stored at a temperature of from 5+/-3.degree. C. to 25+2.degree. C.

13. The pharmaceutical formulation of claim 9, wherein the formulation is contained within a single-use container.

14. The pharmaceutical formulation of claim 9, wherein the formulation comprises about 60.75 mM phenylephrine and about 11.25 mM ketorolac.

15. The pharmaceutical formulation of claim 9, further comprising an irrigation carrier into which the formulation is injected, wherein after injection the phenylephrine is present at a concentration of from 240 to 720 .mu.M and the ketorolac is present at a concentration of from 10 to 270 .mu.M.

16. The pharmaceutical formulation of claim 9, wherein the phenylephrine and ketorolac are included at a molar ratio of from 3:1 to 10:1 phenylephrine to ketorolac.
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