Delayed release oral dosage forms for treatment of intestinal disorders

An orally administrable pharmaceutical dosage form for selectively administering a drug to the intestine comprising a plurality of granules of the drug contained in an enterically coated capsule which releases the granules in the small intestine, wherein said granules are coated with a coating comprising an anionic polymer which is insoluble in gastric juice and in intestinal juice below pH 7 but is soluble in colonic intestinal juice whereby the coating on the released coated granules remains substantially intact until the granules reach at least the ileum.

An orally administrable pharmaceutical dosage form for selectively administering a drug to the intestine comprising a plurality of granules of the drug contained in a capsule coated with a coating comprises a partly methyl esterified methacrylic acid polymer having a ratio of free acid groups to ester groups of about 1:1 whereby the granules are released in the small intestine, wherein said granules are coated with a coating comprising a partly methyl esterified methacrylic acid polymer having a ratio of free acid groups to ester groups of about 1:2 and which is insoluble in gastric juice and in intestinal juice below pH 7 but is soluble in colonic intestinal juice whereby the coating on the released coated granules remains substantially intact until the granules reach at least the ileum.

An orally administrable pharmaceutical dosage form for selectively administering a drug, selected from the group consisting of 5-aminosalicylic acid and a pharmaceutically acceptable salt or ester thereof;

• topically active steroids;
• and bismuth salts and complexes, to the intestine comprising a plurality of granules of the drug contained in an enterically coated capsule which releases the granules in the small intestine, wherein said granules are coated with a coating which remains substantially intact until the coated granules reach at least the ileum.

An orally administrable pharmaceutical dosage form for selectively administering a drug, selected from the group consisting of 5-aminosalicylic acid and a pharmaceutically acceptable salt or ester thereof;

• topically active steroids;
• and bismuth salts and complexes, to the intestine comprising a plurality of granules of the drug contained in an enterically coated capsule which releases the granules in the small intestine, wherein said granules are coated with a coating comprising an anionic polymer which is insoluble in gastric juice and in intestinal juice below pH 7 but is soluble in colonic intestinal juice whereby the coating on the released coated granules remains substantially intact until the granules reach at least the ileum.

An orally administrable pharmaceutical dosage form for selectively administering a drug, selected from the group consisting of 5-aminosalicylic acid and a pharmaceutically acceptable salt or ester thereof;

• topically active steroids;
• and bismuth salts and complexes, to the intestine comprising a plurality of granules of the drug contained in a capsule coated with a coating comprises a partly methyl esterified methacrylic acid polymer having a ratio of free acid groups to ester groups of about 1:1 whereby the granules are released in the small intestine, wherein said graules are coated with a coating comprising a partly methyl esterified methacrylic acid polymer having a ratio of free acid groups to ester groups of about 1:2 and which is insoluble in gastric juice and in intestinal juice below pH 7 but is soluble in colonic intestinal juice whereby the coating on the released coated granules remains substantially intact until the granules reach at least the ileum.

A method of treating ulcerative colitis or Crohn's disease comprising orally administering to a person suffering therefrom a pharmaceutically effective amount for the treatment of ulcerative colitis or Crohn's disease of a drug selected from the group consisting of 5-aminosalicylic acid and a pharmaceutically acceptable salt or ester thereof;

• topically active steroids;
• and bismuth salts and complexes, in an pharmaceutical dosage form comprising a plurality of granules of the drug contained in an enterically coated capsule which releases the granules in the small intestine, wherein said granules are coated with a coating which remains substantially intact until the coated granules reach at least the ileum.

A method of treating ulcerative colitis or Crohn's disease comprising orally administering to a person suffering therefrom a pharmaceutically effective amount for the treatment of ulcerative colitis or Crohn's disease of a drug selected from the group consisting of 5-aminosalicylic acid and a pharmaceutically acceptable salt or ester thereof;

• topically active steroids;
• and bismuth salts and complexes, in a pharmaceutical dosage form comprising a plurality of granules of the drug contained in an enterically coated capsule which releases the granules in the small intestine, wherein said granules are coated with a coating comprising an anionic polymer which is insoluble in gastric juice and in intestinal juice below pH 7 but is soluble in colonic intestinal juice whereby the coating on the released coated granules remains substantially intact until the granules reach at least the ileum.

A method of treating ulcerative colitis or Crohn's disease comprising orally administering to a person suffering therefrom a pharmaceutically effective amount for the treatment of ulcerative colitis or Crohn's disease of a drug selected from the group consisting of 5-aminosalicylic acid and a pharmaceutically acceptable salt or ester thereof;

• topically active steroids;
• and bismuth salts and complexes, in a pharmaceutical dosage form comprising a plurality of granules of the drug contained in a capsule coated with a coating comprises a partly methyl esterified methacrylic acid polymer having a ratio of free acid groups to ester groups of about 1:1 whereby the granules are released in the small intestine, wherein said granules are coated with a coating comprising a partly methyl esterified methacrylic acid polymer having a ratio of free acid groups to ester groups of about 1:2 and which is insoluble in gastric juice and in intestinal juice below pH 7 but is soluble in colonic intestinal juice whereby the coating on the released coated granules remains substantially intact until the granules reach at least the ileum.