|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 (Potomac, MD), Habe; Tsuyoshi (Sasayama, JP) |
|Assignee:|| Sucampo AG (Zurich, CH) |
1. A pharmaceutical composition for oral administration comprising: i. the following bicyclic compound, ##STR00022##
7-[1R,3R,6R,7R)-3-(1,1-difluoropentyl)-3-hydroxy-2-oxabicycl[4.3.0]nonane- -8-one-7-yl]heptanoic acid ii. the monocyclic tautomer of said compound, and iii. an oil solvent, wherein the composition is suitable for oral administration, wherein the ratio
of the bicyclic compound to the monocyclic tautomer in the pharmaceutical composition is at least 90:10, wherein the composition is substantially free of water.
2. The composition according to claim 1, wherein the ratio of bi-cyclic compound to mono-cyclic tautomer is at least about 96:4.
3. The composition according to claim 1, wherein the ratio of bi-cyclic compound to mono-cyclic tautomer is substantially 100:0.
4. The composition according to claim 1, which is formulated as a capsule.
5. The composition according to claim 1, wherein said solvent is an oil solvent other than glyceride.
6. The composition according to claim 5, wherein said oil solvent is mineral oil.