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Claims for Patent: 8,026,393

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Claims for Patent: 8,026,393

Title:Soft-gelatin capsule formulation
Abstract: The present invention discloses a soft gelatin capsule formulation of a 15-keto-prostaglandin compound, which comprises: a soft gelatin capsule shell comprising gelatin and sugar alcohol as a plasticizer, and a mixture comprising a 15-keto-prostaglandin compound and a pharmaceutically acceptable vehicle which is filled in the shell. By encapsulating the 15-keto-prostaglandin compound in the specified soft gelatin capsule shell, stability of the compound is significantly improved.
Inventor(s): Hashitera; Yukiko (Kobe, JP), Hirata; Ryu (Sanda, JP), Harada; Yasuhiro (Sanda, JP), Ueno; Ryuji (Potomac, MD)
Assignee: Sucampo AG (Zug, CH) R-Tech Ueno, Ltd. (Tokyo, JP)
Application Number:11/656,476
Patent Claims: 1. A soft gelatin capsule formulation of a 15-keto-prostaglandin compound, which comprises: a soft gelatin capsule shell comprising gelatin and a sugar alcohol as a plasticizer, and a mixture comprising a 15-keto-prostaglandin compound and a pharmaceutically acceptable vehicle, which is filled in the shell.

2. The formulation of claim 1, wherein the 15-keto-prostaglandin compound is a compound of the formula (I): ##STR00010## wherein L, M and N are hydrogen, hydroxy, halogen, lower alkyl, hydroxy(lower)alkyl, lower alkanoyloxy or oxo, wherein at least one of L and M is a group other than hydrogen, and the five-membered ring may have at least one double bond; A is --CH.sub.3, or --CH.sub.2OH, --COCH.sub.2OH, --COOH or a functional derivative thereof; B is --CH.sub.2--CH.sub.2--, --CH.dbd.CH-- or --C.ident.C--; R.sub.1 is a saturated or unsaturated bivalent lower or medium aliphatic hydrocarbon residue, which is unsubstituted or substituted with halogen, lower alkyl, hydroxy, oxo, aryl or heterocyclic group, and at least one of carbon atom in the aliphatic hydrocarbon is optionally substituted by oxygen, nitrogen or sulfur; and Ra is a saturated or unsaturated lower or medium aliphatic hydrocarbon residue, which is unsubstituted or substituted with halogen, oxo, hydroxy, lower alkyl, lower alkoxy, lower alkanoyloxy, cyclo(lower)alkyl, cyclo(lower)alkyloxy, aryl, aryloxy, heterocyclic group or heterocyclicoxy group; lower alkoxy; lower alkanoyloxy; cyclo(lower)alkyl; cyclo(lower)alkyloxy; aryl; aryloxy; heterocyclic group; heterocyclicoxy group.

3. The formulation of claim 1, wherein the 15-keto-prostaglandin compound is a 13,14-dihydro-15-keto-prostaglandin compound.

4. The formulation of claim 1, wherein the 15-keto-prostaglandin compound is a 15-keto-16-mono or 16,16-di-halogen-prostaglandin compound.

5. The formulation of claim 1, wherein the 15-keto-prostaglandin compound is a 13,14-dihydro-15-keto-16-mono- or 16,16-di-halogen-prostaglandin compound.

6. The formulation of claim 1, wherein the 15-keto-prostaglandin compound is a 15-keto-16-mono- or 16,16-di-fluoro-prostaglandin compound.

7. The formulation of claim 1, wherein the 15-keto-prostaglandin compound is a 13,14-dihydro-15-keto-16-mono- or 16,16-di-fluoro-prostaglandin compound.

8. The formulation of claim 1, wherein the 15-keto-prostaglandin compound is a 15-keto-prostaglandin E compound.

9. The formulation of claim 1, wherein the 15-keto-prostaglandin compound is a 13,14-dihydro-15-keto-16,16-difluoro-prostaglandin E.sub.1.

10. The formulation of claim 1, wherein the 15-keto-prostaglandin compound is a 13,14-dihydro-15-keto-16,16-difluoro-18S-methyl-prostaglandin E.sub.1.

11. The formulation of claim 1, wherein the sugar alcohol is selected from the group consisting of sorbitol, maltitol, sugar alcohol solution derived from corn starch, hydrogenated maltose syrup and a mixture thereof.

12. The formulation of claim 1, wherein the sugar alcohol comprises sorbitol and sorbitan as its major component.

13. A method for stabilizing a 15-keto-prostaglandin compound, which comprises: dissolving, dispersing or mixing the 15-keto-prostaglandin in a pharmaceutically acceptable vehicle to give a liquid mixture, and incorporating the liquid mixture in a soft gelatin capsule which comprises gelatin and a sugar alcohol as a plasticizer such that a soft gelatin capsule formulation of claim 1 is prepared.

14. A method for stabilizing a 15-keto-prostaglandin compound, which comprises encapsulating the compound together with a glyceride in a soft gelatin capsule shell comprising gelatin and a sugar alcohol as a plasticizer such that a soft gelatin capsule formulation of claim 1 is prepared.

15. The formulation of claim 1, wherein the pharmaceutically acceptable vehicle is a medium chain fatty acid triglyceride.

16. The method of claim 14, wherein the glyceride is a medium chain fatty acid triglyceride.

17. The formulation of claim 1, wherein the pharmaceutically acceptable vehicle is a fatty acid ester or a polyol.

18. The formulation of claim 1, wherein the pharmaceutically acceptable vehicle is glycerin or propylene glycol.

19. The formulation of claim 1, wherein the pharmaceutically acceptable vehicle is a fatty acid ester or glycerin.

20. The formulation of claim 1, wherein the pharmaceutically acceptable vehicle is a glyceride.

21. The formulation of claim 1, wherein the pharmaceutically acceptable vehicle is a fatty acid ester.

22. The formulation of claim 1, wherein the pharmaceutically acceptable vehicle is glycerin.
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