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Claims for Patent: 7,999,007

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Claims for Patent: 7,999,007

Title:Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same
Abstract: Buffer solutions for pharmaceutical preparations that have bactericidal activity preferentially against gram negative bacteria are provided. The buffers have a pH of greater than about 10 or less than about 4.5 with low buffer capacity. Methods of their use in reducing the occurrence of blood stream infections in a mammal is also provided.
Inventor(s): Jeffs; Roger (Chapel Hill, NC), Zaccardelli; David (Cary, NC)
Assignee: United Therapeutics Corporation (Silver Spring, MD)
Application Number:12/276,707
Patent Claims: 1. A method of selectively killing gram negative bacteria and inhibiting the growth of gram positive bacteria in a pharmaceutical preparation comprising an active agent selected from the group consisting of treprostinil and treprostinil sodium, the method comprising supplying the active agent with a buffer comprising glycine and having a pH of greater than 10 with low buffer capacity.

2. The method of claim 1, wherein the active agent is treprostinil sodium.

3. The method of claim 1, wherein the buffer further comprises sodium hydroxide.

4. The method of claim 1, wherein the buffer has a pH between about 10 to about 12 with low buffer capacity.

5. The method of claim 4, wherein the buffer has a pH between about 10.2 to about 10.8 with low buffer capacity.

6. The method of claim 1 further inhibiting the growth of fungus, mold, or both.

7. The method of claim 1, wherein the active agent is supplied at a concentration between about 0.001 mg/mL to about 1 mg/mL.

8. The method of claim 2, wherein the treprostinil sodium is supplied at a concentration between about 0.004 mg/mL to about 0.13 mg/mL.

9. The method of claim 1 further comprising injecting the pharmaceutical preparation into a mammal in need thereof.

10. The method of claim 4, wherein the pharmaceutical preparation is injected intravenously into a mammal in need thereof.

11. A method of reducing the occurrence of blood stream infections in a mammal being treated with an active agent comprising administering to the mammal the active agent with a buffer comprising glycine and having a pH of greater than 10, wherein the active agent is selected from the group consisting of treprostinil and treprostinil sodium, and wherein the administration reduces the gram negative bacteria and inhibits the growth of gram positive bacteria.

12. The method of claim 11, wherein the human subject has pulmonary arterial hypertension.

13. The method of claim 11, where in the active agent is administered intravenously.

14. The method of claim 11, wherein the active agent is treprostinil sodium.

15. The method of claim 11, wherein the buffer further comprises sodium hydroxide and has a pH between about 10.2 to about 10.8.

16. The method of claim 11, wherein the buffer has a pH between about 10 to about 12 with low buffer capacity.

17. The method of claim 16, wherein the buffer has a pH between about 10.2 to about 10.8 with low buffer capacity.

18. The method of claim 11 further inhibiting the growth of fungus, mold, or both.

19. The method of claim 11, wherein the active agent is supplied at a concentration between about 0.004 mg/mL to about 0.13 mg/ml.

20. The method of claim 14, wherein the treprostinil sodium is supplied at a concentration between about 0.004 mg/mL to about 0.13 mg/mL.

21. The method of claim 1 wherein the administering is injecting the pharmaceutical preparation into a mammal in need thereof.

22. A pharmaceutical composition comprising an active agent selected from the group consisting of treprostinil and treprostinil sodium in a solution comprising glycine and having a pH greater than 10.

23. The composition of claim 22, wherein the solution further comprises sodium hydroxide.

24. The composition of claim 22, wherein the solution has a pH between about 10 to about 12.

25. The composition of claim 24, wherein the solution has a pH between about 10.2 to about 10.8.

26. The composition of claim 22, wherein the active agent is treprostinil sodium.
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