Patent ID: 7674480
Filing Date: 2010-03-09
Classification: A61K,A61P

Abstract:
1. A pharmaceutical dosage form for oral administration to a patient providing pulsed gastric release of methylphenidate comprising: a) a gastric retention vehicle composition comprising about 10 wt-% to about 75 wt-% superdisintegrant, about 2 wt-% to about 12 wt-% tannic acid, and about 20 to about 70 wt-% of a hydrogel, whereby the gastric retention vehicle composition is a homogenous solid matrix and the percentages are calculated with respect to the matrix exclusive of other excipients and the methylphenidate, b) a plurality of first particles containing methylphenidate that are dispersed in the matrix, wherein the methylphenidate is released from the first particles into the stomach upon contact with gastric fluid, and c) a plurality of second particles containing methylphenidate that are dispersed in the matrix, wherein each of the second particles is coated with a coating that is impermeable to methylphenidate and dissolves in gastric fluid, and, after a sufficient amount of the coating is dissolved, the methylphenidate is released from the second particles into the stomach, wherein, upon contact with gastric fluid the gastric retention vehicle composition expands to a sufficient degree such that the dosage form is retained in the stomach at least until methylphenidate is released from the second particles.