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 4 to 6 hours or longer, followed by an ascending release rate.

主权项

1. A solid, oral pharmaceutical composition comprising:
a single population of beads, said beads comprising:a core comprising methylphenidate 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 formulation is administered to a human subject in a fasted state, (i) there is a lag of at least 7 hours during which the plasma concentration of methylphenidate is less than 5% of the maximum plasma (Cmax), (ii) a plasma area under the curve at 10 hours (AUC0-10) after administration that is less than about 7% of AUC0-48; and (iii) wherein the time to Cmax (Tmax) is between 12 and 19 hours after administration, and wherein administration to a population of subjects provides a significant improvement in ADHD related behavior or cognitive ability over a period of at least 12 continuous hours as measured by a validated rating scale.