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|Abstract:||An object of the present invention is to provide an anti-constipation composition containing a halogenated-bi-cyclic compound as an active ingredient in ratio of bi-cyclic/mono-cyclic structure of at least 1:1. The halogenated-bi-cyclic compound is represented by Formula (I): ##STR00001## where X.sub.1 and X.sub.2 are preferably both fluorine atoms. The composition can be used to treat constipation with out substantive side-effects, such as stomachache.|
|Inventor(s):||Ueno; Ryuji (Potomac, MD)|
|Assignee:||Sucampo AG (Zurich, CH)|
1. A liquid dosage form for oral administration comprising: a bi-cyclic compound represented by the formula (I), ##STR00028##
13,14-dihydro-15-keto-16,16-difluoro-prostaglandin E1 a compound which is a mono-cyclic tautomer of formula (I), and a non-aqueous solution or suspension agent, wherein the non-aqueous solvent or suspending agent stabilizes the dosage form in a ratio of
bi-cyclic compound to mono-cyclic tautomer of at least 20:1.
2. The liquid dosage form of claim 1, wherein the non-aqueous solution or suspension agent is propylene glycol, polyethylene glycol, alcohol, or polysorbate.
3. The liquid dosage form of claim 1, wherein the non-aqueous solution or suspension agent is propylene glycol, polyethylene glycol, a fatty acid triglyceride, a vegetable oil, or an alcohol.
4. The liquid dosage form of claim 1, further comprising one or more of a preservative, wetting agent, emulsifier, dispersant, or anti-oxidant.
5. The liquid dosage form of claim 1, wherein the ratio of bi-cyclic compound to mono-cyclic tautomer is at least about 96:4.
6. The liquid dosage form of claim 1, which is formulated in a capsule.
7. The liquid dosage form of claim 6, which is formulated in a soft capsule.