Method of 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 method of treating a condition in a subject with a disorder or condition responsive to the administration of an amphetamine, comprising orally administering an effective amount of an amphetamine or a pharmaceutical salt thereof in a formulation 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 formulation provides an 8 hour lag time during which the formulation releases no more than 10% of the total amphetamine or a pharmaceutical salt thereof followed by a sustained release period of 10-12 hours when the composition is placed in 700 ml aqueous solution of 0.1N HCl pH 1.1, for up to 2 hours followed by hours 2-6 in sodium phosphate buffer at pH 6.0; followed by hours 6-20 in sodium phosphate buffer, pH 7.2 at 37° C.±0.5° C., measured by the USP Apparatus I.