abstract |
The invention is concerned with a Dosage form, comprising a biologically active ingredient, for use in treating or preventing of a disease in the animal or human body, which treatment or prevention requires the release of 50 % or more of the biologically active ingredient in the small intestine within the pH range from 3 up to 5.5, wherein the dosage form comprises: a) a core, comprising the biologically active ingredient, b) an intermediate coating layer (IMC) onto or above the core, comprising an alkaline agent and c) an enteric coating layer (ECL) onto or above the intermediate coating layer, comprising an enteric polymer, wherein the relation of the alkaline agent to the enteric polymer in the dosage form is 5 to 95 % when calculated by the formula: Formula (I) wherein biologically active ingredients which are proton-pump inhibitors belonging to the class of substituted benzimidazole compounds are excepted. |