发明名称 NIFEDIPINE-CONTAINING PRESS COATED TABLET AND METHOD OF PREPARING THE SAME
摘要 PROBLEM TO BE SOLVED: To provide a sustained release tablet which is miniaturized as compared to the currently-used nifedipine-containing tablets but the dissolution properties and bioavailability of nifedipine therein are not changed. SOLUTION: A sustained release nifedipine-containing press coated tablet, which comprises (A) a core comprising nifedipine and a hydrophilic gel-forming polymer substance, wherein the dissolution of the nifedipine from the core is designed to be delayed: and (B) an outer shell coating the core, which comprises (i) (a) nifedipine and (b) a disintegration suppression substance comprising a pH-independent water-insoluble polymer, wherein the combined contents of (a) and (b) are in the range of 8 to 22% by weight based on the total weight of the outer shell, and (ii) a hydrophilic gel-forming polymer substance selected from cellulose derivatives and polyvinyl alcohol, wherein the content thereof is in the range of 76 to 95% by weight based on the total weight of the outer shell, which is characterized in that the diameter of the tablet is 7.5 to 8.5 mm, and the thickness thereof is 4.5 to 5.2 mm, and further characterized in that the dissolution rate of nifedipine from the tablet is controlled within a specific range. COPYRIGHT: (C)2009,JPO&INPIT
申请公布号 JP2009120600(A) 申请公布日期 2009.06.04
申请号 JP20080273941 申请日期 2008.10.24
申请人 BAYER YAKUHIN LTD 发明人 YAMANOUCHI YUKA;FUKUI KOSUKE
分类号 A61K31/4422;A61K9/24;A61K9/30;A61K47/32;A61K47/38;A61P9/12;C07D211/90 主分类号 A61K31/4422
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