ENTERIC SUSTAINED-RELEASE FINE PARTICLES FOR TAMSULOSIN OR ITS SALT AND PROCESS FOR PRODUCING THE SAME

摘要

The present invention relates to enteric sustained-release fine particles of tamsulosin or its salt that can be contained in tablets that disintegrate in the buccal cavity and a manufacturing method thereof. In further detail, the present invention relates to enteric sustained-release fine particles for tablets that disintegrate in the buccal cavity, which comprise (1) tamsulosin or its salt and at least (2) an enterosoluble substance, and when necessary contain (3) a water-insoluble substance, and which have the following characteristics: 1) a particle diameter of approximately 5 to 250 mu m 2) when dissolution tests are performed on tablets that disintegrate in the buccal cavity containing these particles by dissolution testing methods cited in the Japanese Pharmacopoeia, a) the dissolution rate of tamsulosin or its salt at a pH of 1.2 two hours after starting tests is 25% or less b) the time when 50% of the tamsulosin or its salt has dissolved at a pH of 6.8 is 0.5 to 5 hours, and a manufacturing method thereof.