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 |