Methylphenidate extended release chewable tablet

摘要

An oral methylphenidate extended release tablet is described, which can be scored and still retain its extended release profile. The tablet contains a combination of an uncoated methylphenidate-ion exchange resin complex, a barrier coated methylphenidate-ion exchange resin complex-matrix, and an uncomplexed methylphenidate active component. Following administration of a single dose of the extended release methylphenidate chewable tablet, a therapeutically effective amount of methylphenidate is reached in less than about 20 minutes and the composition provides a twelve-hour extended release profile.

主权项

1. An extended release chewable tablet having a therapeutically effective immediate release and a 12-hour extended release profile, wherein said chewable tablet is a uniform solid dispersion comprising: (a) a sustained release dexmethylphenidate component comprising a water-insoluble, water-permeable, pH-independent barrier coated, dexmethylphenidate-ion exchange resin complex in a polymeric matrix, wherein said barrier coating is over the dexmethylphenidate-ion exchange resin complex-matrix; (b) a first immediate release component which comprises an immediate release uncoated dexmethylphenidate-ion exchange resin complex; (c) a second immediate release dexmethylphenidate component which comprises an uncomplexed dexmethylphenidate; wherein said first immediate release component (b) has a slower onset of release than (c); wherein about 50% w/w to about 90% w/w of the dexmethylphenidate active component is provided by the sustained release component based on the total amount of dexmethylphenidate in the tablet, and wherein said chewable tablet is capable of being divided and providing tablet portions which retain a therapeutically effective immediate release and a 12-hour extended release profile, and a pharmacokinetic profile in which the dexmethylphenidate has an area under the curve (AUC)0-∞ of about 110 ng-hr/mL to about 140 ng-hr/mL and a Cmax of about 10 ng/mL to about 15 ng/mL following a single oral administration of the chewable tablet comprising the equivalent of 40 mg racemic methylphenidate HCl in adults under fasted and fed conditions.