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Claims for Patent: 8,318,802

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Claims for Patent: 8,318,802

Title:Epoprostenol formulation and method of making thereof
Abstract: This invention relates to a stable epoprostenol composition that can be combined with commercially available IV fluids and can be administered in its reconstituted and/or diluted form under ambient conditions of about 15-30.degree. C. for greater than 24 hours. The composition preferably contains (a) epoprostenol or a salt thereof; (b) a alkalinization agent; and (c) a base, such that when reconstituted or in solution, the solution has a pH>11. Methods for making the lyophilized composition are also disclosed.
Inventor(s): Palepu; Naglesh R. (Southampton, PA)
Assignee: Actelion Pharmaceuticals Ltd. (Altschwil, CH)
Application Number:12/278,061
Patent Claims: 1. A lyophilized pharmaceutical composition comprising: (a) a unit dose of 0.5 mg or 1.5 mg of epoprostenol or a salt thereof; (b) arginine; and (c) sodium hydroxide, wherein said lyophilized pharmaceutical composition is (i) formed from a bulk solution having a pH of 13 or higher and (ii) capable of being reconstituted for intravenous administration with an intravenous fluid.

2. The lyophilized pharmaceutical composition of claim 1, wherein the ratio of the epoprostenol to arginine is about 1:25 to about 1:200 by weight.

3. The lyophilized pharmaceutical composition of claim 1, further comprising a bulking agent.

4. The lyophilized pharmaceutical composition of claim 3, wherein the bulking agent is selected from the group consisting of hydroxyl ethyl starch (HES), sorbitol, lactose, dextran, maltose, mannose, ribose, sucrose, mannitol, trehalose, lactose, dextran, cyclodextrin, glycine, and polyvinylpyrrolidine (PVP).

5. The lyophilized pharmaceutical composition of claim 3, wherein the bulking agent is present at about 1-10%.

6. The lyophilized pharmaceutical composition of claim 1, wherein the epoprostenol salt is epoprostenol sodium.

7. The lyophilized pharmaceutical composition of claim 3, wherein the bulking agent is selected from the group consisting of dextran, sucrose and mannitol.

8. The lyophilized pharmaceutical composition of claim 3, wherein the bulking agent is sucrose.

9. The lyophilized pharmaceutical composition of claim 3, wherein the bulking agent is mannitol.

10. The lyophilized pharmaceutical composition of claim 1, further comprising a sealed sterile vial containing the composition.

11. A lyophilisate formed from a bulk solution comprising: (a) epoprostenol or a salt thereof; (b) arginine; (c) sodium hydroxide; and (d) water, wherein the bulk solution has a pH of 13 or higher, and wherein said lyophilisate is capable of being reconstituted for intravenous administration with an intravenous fluid.

12. The lyophilisate of claim 11, wherein the ratio of epoprostenol sodium to arginine is about 1:25 to about 1:200.

13. The lyophilisate of claim 11, wherein said solution further comprising a bulking agent.

14. The lyophilisate of claim 13, wherein the bulking agent is selected from the group consisting of hydroxyl ethyl starch (HES), sorbitol, lactose, dextran, maltose, mannose, ribose, sucrose, mannitol, trehalose, lactose, dextran, cyclodextrin, glycine, and polyvinylpyrrolidine (PVP).

15. The lyophilisate of claim 13, wherein the bulking agent is present at about 1-10%.

16. The lyophilisate of claim 11, wherein the epoprostenol salt is epoprostenol sodium.

17. The lyophilisate of claim 13, wherein the bulking agent is selected from the group consisting of dextran, sucrose and mannitol.

18. The lyophilisate of claim 13, wherein the bulking agent is sucrose.

19. The lyophilisate of claim 13, wherein the bulking agent is mannitol.

20. The lyophilized pharmaceutical composition of claim 1, wherein the arginine is present in the amount of 50 mg.

21. The lyophilized pharmaceutical composition according to claim 1, comprising: (a) a unit dose of 0.5 mg or 1.5 mg of epoprostenol or a salt thereof; (b) 50 mg of arginine; (c) mannitol; and (d) sodium hydroxide.

22. The lyophilized pharmaceutical composition according to claim 1, comprising: (a) a unit dose of 0.5 mg or 1.5 mg of epoprostenol or a salt thereof; (b) 50 mg of arginine; (c) sucrose; and (d) sodium hydroxide.
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