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Details for Patent: 6,277,412

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Details for Patent: 6,277,412

Title: Pellet-type formulation intended for treating the intestinal tract
Abstract:An orally adminsterable pharmaceutical pellet formulation for the treatment of the intestinal tract is disclosed, which comprises a core and an enteric coating, the core including, as a pharmaceutical active compound, aminosalicyclic acid or a pharmaceutically tolerable salt or a derivative thereof.
Inventor(s): Otterbeck; Norbert (Uberlingen, DE)
Assignee: Dr. Falk Pharma GmbH (DE)
Filing Date:Aug 30, 1999
Application Number:09/194,213
Claims:1. An orally administrable pharmaceutical pellet formulation having a controlled release profile for the treatment of the intestinal tract, which comprises a core and an enteric coating, the core including, as a pharmaceutically active compound, 5-aminosalicylic acid, or a pharmaceutically tolerable salt thereof, homogeneously dispersed in a non gel-forming polymer matrix which extends through the entire core and which is essentially insoluble in the intestinal tract and permeable to intestinal fluids;

wherein the matrix is a poly(ethyl acrylate, methyl methacrylate) 2:1 matrix; and

wherein the matrix-forming polymer makes up at least 1% by weight of the total weight of the core; and

wherein the enteric coating comprises poly(methacrylic acid, methyl methacrylates) 1:1 or 1:2; and

wherein the release of said active compound in 0.1 M HCl after 2 hours is <10%; the release of said active compound in artificial gastric juice at pH=6.8 after 0.5 hours is 10-30%, after 2 hours is 40-60% and after 6 hours is at least 80%.
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