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Claims for Patent: 8,349,892

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Claims for Patent: 8,349,892

Title:Solid formulations of prostacyclin analogs
Abstract: Moderate moisture levels, such as greater than 3% but no greater than 7%, may be beneficial for solid formulations of certain prostacyclin analogs. Accordingly, a solid formulation containing a prostacyclin analog may be packaged inside a pharmaceutical packaging with such amount of a desiccant or a drying agent that after the storage the solid formulation may have a moderate level of moisture in it.
Inventor(s): Phares; Kenneth R. (Hillsborough, NC)
Assignee: United Therapeutics Corporation (Silver Spring, MD)
Application Number:12/775,102
Patent Claims: 1. A pharmaceutical product comprising a pharmaceutical packaging; and a solid formulation inside the packaging, wherein the formulation comprises an active agent that is treprostinil diethanolamine, wherein the packaging is configured to maintain a moisture level in the solid formulation of greater than 3% and no more than 7%.

2. The pharmaceutical product of claim 1, wherein said formulation further comprises at least one pharmaceutically acceptable excipient.

3. The pharmaceutical product of claim 2, wherein said at least one excipient comprises at least one of maltodextrin and xylitol.

4. The pharmaceutical product of claim 1, wherein the packaging in configured to maintain the moisture level of no less than 3.5% and no more than 6%.

5. The pharmaceutical product of claim 1, wherein the packaging in configured to maintain the moisture level of no less than 3.5% and no more than 4.5%.

6. The pharmaceutical product of claim 1, wherein said packaging is a bottle packaging.

7. The pharmaceutical product of claim 1, wherein said packaging is a blister packaging.

8. The pharmaceutical product of claim 1, wherein the packaging does not include a desiccant.

9. A pharmaceutical product comprising: (a) a pharmaceutical packaging; (b) a solid formulation inside the packaging, wherein the formulation comprises a active agent that is treprostinil diethanolamine; and (c) a desiccant inside the packaging, wherein an amount of the desiccant in the packaging is less than an effective amount for maintaining a relative humidity level inside the packaging for a storage time of the formulation below 40%.

10. The pharmaceutical product of claim 9, wherein said formulation further comprises at least one pharmaceutically acceptable excipient.

11. The pharmaceutical product of claim 10, wherein said at least one excipient comprises at least one of maltodextrin and xylitol.

12. The pharmaceutical product of claim 9, wherein the packaging is a bottle.

13. The pharmaceutical product of claim 9, wherein the amount of the desiccant in the packaging is less than an effective amount for maintaining a humidity level in the packaging for 24 months below 40%.

14. The pharmaceutical product of claim 13, wherein the amount of the desiccant in the packaging is at least two times less than an effective amount for maintaining a humidity level in the packaging for 24 months below 40%.

15. A storage method comprising: storing a solid formulation inside a pharmaceutical packaging, wherein the formulation comprises an active agent that is treprostinil diethanolamine; wherein a moisture level in the solid formulation after said storing is greater than 3% and no more than 7%.

16. The storage method of claim 15, wherein said formulation further comprises at least one pharmaceutically acceptable excipient.

17. The storage method of claim 16, wherein said at least one excipient comprises at least one of maltodextrin and xylitol.

18. The storage method of claim 15, wherein the moisture level in the solid formulation after said storing is no less than 3.5% and no more than 6%.

19. The storage method of claim 15, wherein the moisture level in the solid formulation after said storing is of no less than 3.5% and no more than 4.5%.

20. The storage method of claim 15, wherein said storing lasts at least 12 months.

21. The storage method of claim 15, wherein said storing lasts at least 24 months.

22. The storage method of claim 15, wherein the solid formulation is stored inside the packaging together with a desiccant, wherein an amount of the desiccant is less that an effective amount for maintaining a humidity level inside the packaging during said storing below 40%.

23. The storage method of claim 15, wherein said packaging is a bottle packaging.

24. The storage method of claim 15, wherein said packaging is a blister packaging.

25. A storage method comprising: storing a solid formulation and a desiccant inside a pharmaceutical packaging, wherein the formulation comprises an active agent that is treprostinil diethanolamine; wherein an amount of the desiccant is less that an effective amount for maintaining a relative humidity level inside the packaging during said storing below 40%.

26. The storage method of claim 25, wherein said formulation further comprises at least one pharmaceutically acceptable excipient.

27. The storage method of claim 26, wherein said at least one excipient comprises at least one of maltodextrin and xylitol.

28. The storage method of claim 25, wherein a moisture level in the solid formulation after said storing is no less than 3.5% and no more than 6%.

29. The storage method of claim 25, wherein a moisture level in the solid formulation after said storing is of no less than 3.5% and no more than 4.5%.

30. The storage method of claim 25, wherein said storing lasts at least 12 months.

31. The storage method of claim 25, wherein said storing lasts at least 24 months.

32. The storage method of claim 25, wherein said packaging is a bottle packaging.

33. The storage method of claim 25, wherein said packaging is a blister packaging.
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