Delayed release oral dosage forms for treatment of...

A - Human Necessities – 61 – K

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A61K 9/58 (2006.01) A61K 9/48 (2006.01) A61K 9/50 (2006.01) A61K 31/415 (2006.01) A61K 31/65 (2006.01) A61K 33/24 (2006.01) A61K 47/48 (2006.01)

Patent

CA 2104686

An orally administrable pharmaceutical dosage form for selectively administering a drug to the intestine comprises a plurality of enteric coated granules of the drug contained in an enterically coated capsule which releases the granules in the small intestine. The granules are preferably coated with a coating which remains intact until the coated granules reach at least the ileum and thereafter provide a sustained release of the drug in the colon. Suitable coating materials are selected from the Eudragit range of (meth)acrylate and (meth)acrylic acid polymers. The invention has particular application to topically active drugs such as topically active steroids, bismuth salts and complexes, and especially, 5- amino-salicylic acid.

Forme pharmaceutique s'administrant oralement et servant à libérer sélectivement un médicament dans l'intestin. Ladite forme pharmaceutique comprend une pluralité de granules à délitage intestinal contenus dans une capsule à délitage intestinal libérant lesdits granules de médicaments dans l'intestin grêle. Les granules sont, de préférence, recouverts d'un revêtement restant intact jusqu'à ce qu'ils arrivent dans l'ilion, au moins, et ils effectuent, ensuite, une libération prolongée du médicament dans le colon. Les matériaux de revêtement adéquates sont sélectionnés à partir de la gamme Eudragit de polymères de méthacrylate et d'acide méthacrylique. L'invention s'applique particulièrement à des médicaments à action locale tels que des stéroïdes à action locale, des sels et des complexes de bismuth et, particulièrement, des acides 5-amino-salicyliques.

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