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US 2010/0136125 A1Published application
Method of treating inflammatory bowel disease
AssigneeJacobus Pharmaceutical Company, Inc.
InventorsDavid P. Jacobus, Guy Alan Schiehser, Kathy Lynne Ales, Laura Ransom Jacobus
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Abstract
Methods are disclosed for treating patients suffering from inflammatory bowel disease, including ulcerative colitis or Crohn's disease, by administering an oral or enema dosage form containing at least one aminosalicylate active ingredient. Granular dosage forms and kits are also disclosed.
Claims53
A method of treating inflammatory bowel disease in a patient, comprising the step of:
- administering orally or by enema to said patient for a treatment period sufficient to control acute flares of said inflammatory bowel disease a solid dosage form comprising:
- a therapeutically effective amount of an aminosalicylate active ingredient selected from the group consisting of 4-aminosalicylic acid, 5-aminosalicylic acid, a pharmaceutically acceptable salt thereof, or a combination thereof;
- a first rate-controlling polymer that forms a pH labile enteric coating for administration of said solid dosage form orally;
- optionally, a first rate-controlling polymer that forms a pH labile enteric coating for administration of said solid dosage form by enema;
- wherein said dosage form releases drug at a therapeutically effective rate and in a region of the intestinal tract of said patient where said acute flares are present.
2 more elements
A granular dosage form, comprising:
- generally spherical particles comprising:
- an active ingredient selected from the group consisting of 4-aminosalicylic acid, 5-aminosalicylic acid, a pharmaceutically acceptable salt thereof, or a combination thereof;
- a first rate controlling polymer that forms a pH labile enteric coating;
- and
- at least one second rate-controlling polymer;
- wherein said particles have a diameter of about 1.3 mm to about 3.5 mm;
- and
- wherein said dosage form releases in USP 23-NF 18:
- less than about 5%, by weight, of said active ingredient over 2 hours at pH 1.0;
- and
- about 40%, by weight, to about 60%, by weight, of said active ingredient in about 1 hour at pH 7.2.
8 more elements
Dependencies are inferred from the claim text.