Patent ID: 8980314
Filing Date: 2015-03-17
Classification: A61K,A61P

Abstract:
1. A medicine core of duloxetine enteric formulation, consisting of pharmaceutical active ingredient duloxetine or its salt and pharmaceutically acceptable excipient; wherein the pharmaceutically acceptable excipient contains water-soluble hot melt materials, the content of which is 10% to 40% by mass relative to the total mass of the medicine core; the content of pharmaceutical active ingredient duloxetine or its salt is 15% to 60% by mass relative to the total mass of the medicine core; and the rest is at least one other pharmaceutically acceptable excipient; wherein the softening or melting temperature of the said water-soluble hot melt material is 40 to 65° C., wherein the medicine core of the duloxetine enteric formulation is prepared by a manufacturing process comprising: mixing duloxetine or its salt, water-soluble hot melt material and pharmaceutically acceptable excipient, heating the water-soluble hot melt materials until they are softened or melted; and granulating in the state that the water-soluble hot melt materials are softened or melted, and then cooling down.