CPC A61K 31/145 (2013.01) [A61K 9/2054 (2013.01); A61K 9/2813 (2013.01); A61K 9/2826 (2013.01); A61K 9/2846 (2013.01); A61K 9/2866 (2013.01); A61K 31/137 (2013.01); A61K 31/155 (2013.01); A61K 31/404 (2013.01); A61K 31/405 (2013.01); A61K 31/4402 (2013.01); A61K 31/4706 (2013.01); A61K 31/496 (2013.01); A61K 31/55 (2013.01); A61K 31/58 (2013.01); A61K 31/635 (2013.01); A61K 31/7048 (2013.01)] | 15 Claims |
1. A dosage form, comprising:
a core, comprising a biologically active ingredient,
an intermediate coating layer (ICL) onto the core, comprising an alkaline agent, wherein the alkaline agent is selected from the group consisting of calcium oxide, calcium carbonate, magnesium carbonate, magnesium oxide, sodium carbonate, sodium bicarbonate, sodium hydroxide, and a combination thereof, and
an enteric coating layer (ECL) onto the intermediate coating layer, comprising an enteric polymer, the enteric layer forming an outer layer of the dosage form,
wherein a relation of the alkaline agent to the enteric polymer is 5 to 95% when calculated by the formula:
wherein the biologically active ingredient is not a proton-pump inhibitor belonging to a class of substituted benzimidazole compounds,
wherein the biologically active ingredient is released in an amount of 10% or less at a pH of 1.2 for 120 min, and in an amount of 50% or more at a pH from 3 to 5.5 for 45 min in the small intestine, and
wherein the intermediate coating layer is present in an amount of 7.5 to 50% by weight, calculated based on the weight of the core,
wherein the dosage form is suitable for the treatment of a disease requiring release of 50% or more of the biologically active ingredient.
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