Pellets having a multi-layer structure for delayed release of the active substance in the distal colon

A pellet for the delayed release of an active substance in the distal colon having a multi-layer coating, wherein said pellet is composed of the following components:

• a) a starter pellet consisting only of an inert material, further wherein said starter pellet contains no pharmaceutically active substance,
• b) an active substance layer that is directly applied to said starter pellet a), further wherein said active substance layer contains both an active substance and film-forming excipients,
• c) a swelling layer that is directly applied to said active substance layer b), further wherein said swelling layer contains swelling materials that swell upon contact with intestinal fluid,
• d) a retard layer that is directly applied to said swelling layer c), further wherein said retard layer does not dissolve upon contact with intestinal fluid but rather becomes permeable for all fluids, and
• e) an outermost coating that is directly applied to said retard layer d), further wherein said outermost coating does not dissolve at a pH value <5.5, but dissolves well at a pH value greater than 6.0,
• wherein the active substance is budesonide or a pharmaceutically acceptable salt thereof.