| abstract |
Delayed-release oral dosage form of sertraline that decreases Tmax in relation to the Tmax of the currently known immediate-release sertraline tablet dosage forms, which release an equivalent large pill-shaped dose. With regard to the immediate release dosage forms, this also decreases the incidence and / or severity of gastrointestinal effects and / or other side effects. A temporarily delayed dosage form suitable for oral administration to a mammal, characterized in that it comprises (1) an immediate release core comprising sertraline or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier and (2) a surrounding coating said core, not substantially releasing said dosage form, when tested in vitro solution in a USP No. 2 apparatus containing 900 ml of acetic acid / acetate buffer, pH 4.0, which is 0.075M NaCl, sertraline during a first period of approximately 10 minutes, not releasing more than 10% of the sertraline incorporated therein for a second period that lasts up to 2 hours after said period, and then effecting the immediate release of the remaining sertraline incorporated in the same after said second period |