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|Title:||Treatment of inflammatory bowel disease using oral dosage forms of omega-3 polyunsaturated acids|
|Abstract:||Inflammatory bowel disease, especially Crohn's disease and ulcerative colitis, is treated by administration of an oral dosage form, containing as an active principle an omega-3 polyunsaturated acid in free acid form or as a pharmaceutically acceptable salt thereof, which releases the acid in the ileum. Preferably the oral dosage form is a gelatine capsule coated with a poly(ethylacrylate-methylmethacrylate).|
|Inventor(s):||Buser; Thomas (Ziefen, CH), Camporesi; Emilio P. (Ziefen, CH)|
|Assignee:||Tillotts Pharma AG (Ziefen, CH)|
1. An oral dosage form for treating inflammatory bowel disease, containing an active compound selected from the group consisting of omega-3 polyunsaturated acids and pharmaceutically
acceptable salts thereof and containing a neutral polyacrylate coating which is resistant to release of the active compound for a period of 30 to 60 minutes at pH 5.5 whereby the active compound is released in the ileum.
2. An oral dosage form comprising a coated capsule containing as an active principle an omega-3 polyunsaturated acid in free acid form or a pharmaceutically acceptable salt thereof, wherein the coating is a neutral polyacrylate whereby the active principle is released in the small intestine.
3. An oral dosage form as claimed in claim 2 wherein the coating is resistant to release of the omega-3 polyunsaturated acid for a period of 30 to 60 minutes at pH 5.5.
4. An oral dosage form as claimed in claim 2 wherein the coating is a poly(ethylacrylate-methylmethacrylate).
5. An oral dosage form as claimed in claim 4 wherein the coating comprises iron oxide, titanium dioxide, and talc.
6. An oral dosage form as claimed in claim 5 wherein the coating contains by ratio about 3 mg iron oxide, about 2.35 mg titanium dioxide, and about 10 mg talc to about 60 mg of poly(ethylacrylate-methylmethacrylate).
7. An oral dosage from as claimed in claim 2 wherein said acid is eicosapenta-5,8,11,14,17-enoic acid, docosahexa--4,7,10,13,16,19-enoic acid or a mixture thereof.
8. An oral dosage form as claimed in claim 7 wherein the eicosapenta-5,8,11,14,17-enoic acid, docosahexa-4,7,10,13,16,19-enoic acid or mixture thereof is present in an oil constituent in a percentage of at least 60% w/w.
9. An oral dosage form as claimed in claim 2 wherein said acid is present as the sole active principle.
10. An oral dosage form as claimed in claim 2 wherein said active principle is an omega-3 polyunsaturated acid in free acid form or a pharmaceutically acceptable salt thereof except for a lithium salt thereof.
11. An oral dosage form as claimed in claim 2 wherein the capsule is a hard or soft gelatin capsule.
12. An oral dosage form as claimed in claim 2 containing as an active principle a unit dose of 250 to 1,000 mg.
13. A method of treating inflammatory bowel disease or reducing clinical relapse thereof, which comprises administering to a patient an effective amount of an oral dosage form as claimed in claim 2.
14. A method as claimed in claim 13 wherein the inflammatory bowel disease is Crohn's disease.
15. A method as claimed in claim 14 wherein patients are in clinical remission for less than 24 months prior to treatment.
16. A method as claimed in claim 13 which comprises administering a daily dosage of 20 to 50 mg/kg omega-3 polyunsaturated acid.
17. An oral dosage form comprising a capsule containing eicosapenta-5,8,11,14,17-enoic acid, docosahexa-4,7,10,13,16,19-enoic acid or a mixture thereof, and coated with poly(ethylacrylate-methylmethacrylate).
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