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Claims for Patent: 7,417,067

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Claims for Patent: 7,417,067

Title:Composition and method for stabilizing the same
Abstract:Disclosed is a novel composition comprising a novel bi-cyclic compound, which is expected to be pharmaceutically active, and a glyceride. The stability of the bi-cyclic compound can be improved significantly by dissolving the same in a glyceride.
Inventor(s): Ueno; Ryuji (Montgomery, MD), Habe; Tsuyoshi (Sasayami, JP)
Assignee: Sucampo AG (Zurich, CH)
Application Number:10/383,581
Patent Claims: 1. A composition comprising: i: the following bi-cyclic compound ##STR00021## 7-[(1R,3R,6R,7R)-3-(1,1-difluoropentyl)-3-hydroxy-2-oxabicyclo[4.3.0]nona- ne-8-one-7-yl]heptanoic acid, ii. the mono-cyclic tautomer of said compound; and iii. at least one glyceride, wherein the ratio of the bi-cyclic compound to mono-cyclic tautomer is at least 90:10.

2. The composition according to claim 1, wherein the ratio of bi-cyclic compound to mono-cyclic tautomer is substantially 100:0.

3. The composition according to claim 1, wherein said glyceride has between 6 and 24 carbon atoms.

4. The composition according to claim 1, wherein said glyceride has between 6 and 20 carbon atoms.

5. The composition according to claim 1, in which the glyceride is a mixture of 2 or more glycerides.

6. The composition according to claim 1, wherein at least one glyceride is a triglyceride.

7. The composition according to claim 2, wherein at least one glyceride is a triglyceride.

8. The composition according to claim 6, wherein said triglyceride is caprylic acid triglyceride and/or capric acid triglyceride.

9. The composition according to claim 6, wherein the triglyceride is present in an amount of 1-5,000,000 parts by weight based on one part by weight of the bi-cyclic structure.

10. The composition according to claim 6, wherein the triglyceride is present in an amount of 5-1,000,000 parts by weight based on one part by weight of the bi-cyclic structure.

11. The composition according to claim 6, wherein the triglyceride is present in an amount of 10-500,000 parts by weight based on one part by weight of the bi-cyclic structure.

12. The composition according to claim 1, wherein said glyceride is admixed with other oil solvent.

13. The composition according to claim 12, wherein said other oil solvent is mineral oil.

14. The composition according to claim 1, which is in a dosage form suitable for oral administration.

15. The composition according to claim 14, which is formulated as a capsule.

16. The composition according to claim 1, which is in a dosage form suitable for topical administration.

17. The composition according to claim 16, which is formulated as an eye drop.

18. A composition comprising: i. the following bi-cyclic compound ##STR00022## 7-[(1R,6R,7R)-3-[(3S)-1,1-difluoro-3-methylpentyl]-3-hydroxy-2-oxabicyclo- [4.3.0]nonane-8-one-7-yl]heptanoic acid, ii. the mono-cyclic tautomer of said compound; and iii. at least one glyceride, wherein the ratio of the bi-cyclic compound to mono-cyclic tautomer is at least 1:1.

19. The composition according to claim 18, wherein the ratio of bi-cyclic compound to mono-cyclic tautomer is at least 90:10.

20. The composition according to claim 18, wherein the ratio of bi-cyclic compound to mono-cyclic tautomer is substantially 100:0.

21. The composition according to claim 18, wherein said glyceride has between 6 and 24 carbon atoms.

22. The composition according to claim 18, wherein said glyceride has between 6 and 20 carbon atoms.

23. The composition according to claim 18, in which the glyceride is a mixture of 2 or more glycerides.

24. The composition according to claim 18, wherein at least one glyceride is a triglyceride.

25. The composition according to claim 24, wherein said triglyceride is caprylic acid triglyceride and/or capric acid triglyceride.

26. The composition according to claim 24, wherein the triglyceride is present in an amount of 1-5,000,000 parts by weight based on one part by weight of the bi-cyclic structure.

27. The composition according to claim 24, wherein the triglyceride is present in an amount of 5-1,000,000 parts by weight based on one part by weight of the bi-cyclic structure.

28. The composition according to claim 24, wherein the triglyceride is present in an amount of 10-500,000 parts by weight based on one part by weight of the bi-cyclic structure.

29. The composition according to claim 24, wherein said glyceride is admixed with other oil solvent.

30. The composition according to claim 29, wherein said other oil solvent is mineral oil.

31. The composition according to claim 18, which is in a dosage form suitable for oral administration.

32. The composition according to claim 31, which is formulated as a capsule.

33. The composition according to claim 18, which in a dosage form suitable for topical administration.

34. The composition according to claim 33, which is formulated as an eye drop.
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