ASCENDING-DOSE DOSAGE FORM

摘要

PROBLEM TO BE SOLVED: To provide a dosage form and a method for delivering to a human patient a drug in an ascending amount over time. SOLUTION: The dosage form contains methylphenidate or a pharmaceutically acceptable salt thereof and has a length greater than its width. The dosage form includes first layer containing 10 ng to 700 mg of a drug selected from methylphenidate or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier; a second layer containing 60 to 95% of a hydrophilic-expandable polymer based on the total weight of the second layer; a semipermeable composition layer surrounding the first layer and the second layer; a coating composition on the external surface of the semipermeable composition layer containing 10 ng to 100 mg of methylphenidate or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier; and a path in the semipermeable composition layer communicating with the first layer at an end of the dosage form for releasing methylphenidate or a pharmaceutically acceptable salt thereof from the first layer. The drug is released in an ascending amount over 2 to 8 hours following the release of the drug at the start. COPYRIGHT: (C)2010,JPO&INPIT