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Claims for Patent: 5,541,170

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Claims for Patent: 5,541,170

Title: Orally administrable pharmaceutical compositions
Abstract:A solid dosage form, such as a capsule or tablet, containing a pharmacologically active agent is coated with an anionic polymer, which is insoluble in gastric juice and in intestinal juice below pH7 but soluble in colonic intestinal juice, in a sufficient amount that the oral dosage form remains intact until it reaches the colon. The preferred anionic polymer is a partly methyl esterified methacrylic acid polymer in which the ratio of free carboxylic groups to ester groups is about 1:2. The invention has particular application to dosage forms of prednisolone and salts thereof, indomethacin, ibuprofen, and, especially, 5-amino-salicylic acid.
Inventor(s): Rhodes; John (Cardiff, GB7), Evans; Brian K. (Dinas Powis, GB7)
Assignee: Tillotts Pharma AG (Ziefen, CH)
Application Number:08/401,696
Patent Claims: 1. An orally administrable pharmaceutical composition for selectively administering 5-amino-salicylic acid, or pharmaceutically acceptable salt or ester thereof, to the large intestine, comprising a solid oral dosage form containing a pharmaceutically effective amount for the treatment of ulcerative colitis or Crohn's disease of the colon of said 5-amino-salicylic acid, salt or ester, said solid oral dosage form being coated with a layer which is insoluble in gastric juice and in intestinal juice below pH 7, but soluble in colonic intestinal juice, whereby the dosage form releases the 5-amino-salicylic acid, salt or ester to the right side of the colon.

2. The composition of claim 1 wherein said layer comprises anionic polymer.

3. The composition of claim 2 wherein said layer has a thickness ranging from 60 to 150 microns,

4. The composition of claim 2 wherein the anionic polymer contains anionic groups which are selected from the group consisting of free carboxylic groups and esterified carboxylic groups.

5. The composition of claim 4 wherein said layer has a thickness ranging from 60 to 150 microns.

6. A method for treating ulcerative colitis or Crohn's disease of the colon comprising orally administering to a person suffering therefrom the composition of claim 1 whereby the 5-amino-salicyclic acid is released to the right side of the colon.

7. An orally administrable pharmaceutical composition for selectively administering 5-amino-salicylic acid, or pharmaceutically acceptable salt or ester thereof, to the large intestine, comprising a solid oral dosage form containing a pharmaceutically effective amount for the treatment of ulcerative colitis or Crohn's disease of the colon of said 5-amino-salicylic acid, salt or ester, said solid oral dosage form being coated so as to release the 5-amino-salicylic acid, salt or ester to the right side of the colon.
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