"ENTERIC SUSTAINED-RELEASE FINE PARTICLES OF TAMSULOSIN OR ITS SALT AND MANUFACTURING METHOD THEREOF"
Application 3637/DELNP/2005 published 2007-01-12, filed 2005-08-18
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: a particle diameter of approximately 5 to 250 um 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, the dissolution rate of tamsulosin or its salt at a pH of 1.2 two hours after starting tests is 25% or less 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.
Applicant
1)ASTELLAS PHARMA, INC
:3-11, NIHONBASHI-HONCHO 2-CHOME, CHUO-KU, TOKYO 103-8411, JAPAN. Japan
Inventor
1)YOJI TANIJIRI 2)AKIRA ITO 3)HIROYA SUGAO 4)TETSUYA TAMURA 5)MARE NISHIURA 6)SHIGERU YAMAZAKI 7)TAKAO MIZUMOTO
International Info
Classification: A61K 31/18
Publication Number: WO 2004/066991
Application Date: 2004-01-26
Priority Information
60/442 984 U.S.A. 2003-01-27