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 racemic methylphenidate component comprising a water-insoluble, water-permeable, pH-independent barrier coated, racemic methylphenidate-ion exchange resin complex in a polymeric matrix, wherein said barrier coating which provides a sustained release profile to the racemic methylphenidate is over the racemic methylphenidate-ion exchange resin complex-matrix; (b) a first immediate release component which comprises an immediate release uncoated racemic methylphenidate-ion exchange resin complex; (c) a second immediate release racemic methylphenidate component which comprises an uncomplexed racemic methylphenidate; 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 racemic methylphenidate active component is provided by the sustained release component based on the total amount of racemic methylphenidate 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 12 hour extended release profile, and a pharmacokinetic profile in which the methylphenidate has a geometric mean for area under the curve (AUC)0-∞ of about 110 ng-hr/mL to about 140 ng-hr/mL and a geometric mean Cmax of about 10 ng/mL to about 15 ng/mL under fasted and fed conditions following a single oral administration of an chewable tablet comprising 40 mg racemic methylphenidate HCl in adults.