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Claims for Patent: 8,658,694

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Claims for Patent: 8,658,694

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 Andrew (Chapel Hill, NC), Zaccardelli; David (Cary, NC)
Assignee: United Therapeutics Corporation (Silver Spring, MD)
Application Number:13/022,005
Patent Claims: 1. A method of treating pulmonary arterial hypertension comprising diluting a starting solution of treprostinil or treprostinil sodium with a buffer comprising glycine and having a pH of greater than 10 to provide a final solution with a pH of greater than 10 and an effective amount of treprostinol or treprostinil sodium for treating pulmonary arterial hypertension, and administering said final solution to a human subject in need thereof.

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

3. The method of claim 1, wherein the buffer has a pH between 10 and 12.

4. The method of claim 3, wherein the buffer has a pH between 10.2 and 10.8.

5. The method of claim 1, wherein the final solution is administered at a concentration between about 0.004 mg/mL to about 0.13 mg/mL.

6. The method of claim 1, wherein the administering is by injection.

7. The method of claim 6, wherein the injection is intravenous injection.

8. The method of claim 6, wherein the active pharmaceutical ingredient is treprostinil sodium.

9. The method of claim 4, wherein the final solution is administered intravenously.

10. The method of claim 1, wherein the buffer is a 50 mL solution of 94 mg of glycine, 73.3 mg of sodium chloride, and sodium hydroxide.

11. A method of reducing occurrence of a bacterial infection in a human suffering from pulmonary arterial hypertension, who is undergoing treatment for said pulmonary hypertension, comprising diluting a starting solution of treprostinil or treprostinil sodium with a buffer comprising glycine and having a pH of greater than 10 to provide a final solution with a pH of greater than 10 and an amount of treprostinil or treprostinil sodium effective for treating pulmonary arterial hypertension, and administering said final solution to the human subject in need thereof.

12. The method of claim 11, wherein the buffer further comprises sodium hydroxide.

13. The method of claim 11, wherein the buffer has a pH between 10 and 12.

14. The method of claim 13, wherein the buffer has a pH between 10.2 and 10.8.

15. The method of claim 11, wherein the final solution is administered at a concentration between about 0.001 mg/mL to about 1 mg/mL.

16. The method of claim 11, wherein the final solution is administered at a concentration between about 0.004 mg/mL to about 0.13 mg/mL.

17. The method of claim 11, wherein the administering is by injection.

18. The method of claim 17, wherein the injection is intravenous injection.

19. The method of claim 17, wherein the active pharmaceutical ingredient is treprostinil sodium.

20. The method according to claim 11, wherein the administration reduces the growth of gram negative bacteria.

21. The method of claim 14, wherein the final solution is administered intravenously.

22. The method of claim 11, wherein the buffer is a 50 mL solution of 94 mg of glycine, 73.3 mg of sodium chloride, and sodium hydroxide.

23. The method of claim 22, wherein the administering is by injection.

24. The method of claim 23, wherein the injection is intravenous injection.

25. The method of claim 10, wherein the administering is by injection.

26. The method of claim 25, wherein the injection is intravenous injection.
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