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Details for Patent: 5,013,727

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Details for Patent: 5,013,727

Title: Pharmaceutical composition and method for the treatment of colitis ulcerosa and Crohn's disease by oral administration
Abstract:A pharmaceutical composition containing as active ingredient 5-aminosalicylic acid or a pharmaceutically acceptable salt or ester thereof allow the treatment of colitis ulcerosa or Crohn's disease by oral administration. A particular slow-release tablet formation and its preparation is disclosed.
Inventor(s): Halskov; Soren (Helsinge, DK)
Assignee: Farmaceutisk Laboratorium Ferring A/S (Vanlose, DK)
Filing Date:Jun 26, 1989
Application Number:07/371,123
Claims:1. A method for the treatment of ulcerative colitis or Crohn's disease comprising orally administering an effective amount of a composition consisting essentially of a salt of 5-aminosalicylic acid in admixture with a pharmaceutically acceptable carrier so as to delay the release of said effective amount of 5-aminosalicylic acid to be administered essentially until the colon of the patient is reached.

2. A method according to claim 1, wherein the delayed release is dependent on the prevailing pH in the colon.

3. A method according to claim 1, wherein the carrier comprises a coating capable of delaying the release of said effective amount essentially until the colon is reached.

4. A method for the treatment of ulcerative colitis or Crohn's disease comprising orally administering an effective amount of a composition consisting essentially of a salt of 5-aminosalicylic acid in admixture with a pharmaceutically acceptable carrier so as to gradually release said effective amount of 5-aminosalicylic acid throughout the small intestine and continuously throughout the colon of the patient.

5. A method according to claim 4 wherein the 5-aminosalicylic acid is in the form of particles coated with a pharmaceutically acceptable coating material which will gradually release the 5-aminosalicylic acid upon arrival at the small intestine.

6. A method according to claim 5 wherein the coating material is ethyl cellulose.

7. A method according to claim 4, wherein the gradual release is brought about by establishing suitable pH conditions in the composition.

8. A method for the treatment of Crohn's disease comprising orally administering an effective amount of a composition consisting essentially of a salt of 5-aminosalicylic acid in admixture with a pharmaceutically acceptable carrier which will secure an early release of said effective amount of 5-aminosalicylic acid upon arrival in the small intestine.

9. A method according to claim 8, wherein the early release is dependent on the prevailing pH in the small intestine.

10. A method for the treatment of ulcerative colitis or Crohn's disease consisting essentially of orally administering an effective amount of a composition consisting essentially of a salt of 5-aminosalicylic acid in admixture with a pharmaceutically acceptable carrier so as to delay the release of said effective amount of 5-aminosalicylic acid to be administered essentially until the colon of the patient is reached.

11. A method for the treatment of ulcerative colitis or Crohn's disease consisting essentially of orally administering an effective amount of a composition consisting essentially of a salt of 5-aminosalicylic acid in admixture with a pharmaceutically acceptable carrier so as to gradually release said effective amount of 5-aminosalicylic acid throughout the small intestine and continuously throughout the colon of the patient.

12. A method for the treatment of Crohn's disease consisting essentially of orally administering an effective amount of a composition consisting essentially of a salt or 5-aminosalicylic acid in admixture with a pharmaceutically acceptable carrier which will secure an early release of said effective amount of 5-aminosalicylic acid upon arrival in the small intestine.
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