Compositions for treatment of attention deficit hyperactivity disorder

摘要

Therapeutic compositions and methods for treatment of attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD) include dosage forms that deliver a therapeutic amount of active drug in a delayed and controlled release formulation. The dosage form can be administered at night and drug release is delayed for from 5 to 8 hours or longer, followed by a prolonged release.

主权项

1. A solid, oral pharmaceutical composition comprising a plurality of particles, each comprising:
a core comprising an amphetamine or a pharmaceutical salt thereof and at least one pharmaceutically acceptable excipient; a sustained release layer enclosing the core; and a delayed release layer enclosing the sustained release layer, wherein when the composition is orally administered to a human subject, (i) there is a lag period of at least 6 hours during which the area under the curve of plasma concentration versus time (AUC0-6) of amphetamine or a pharmaceutical salt thereof is less than 10% of the total area under the curve at Tmax (AUC0-Tmax); and (ii) the time to Cmax (Tmax) is between 12 and 19 hours after administration.