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 dextroamphetamine or a pharmaceutical salt thereof and at least one pharmaceutically acceptable excipient; a extended release layer enclosing the core; and a delayed release layer enclosing the extended release layer,wherein the formulation provides at least an 8 hour lag period during which the formulation releases no more than 10% of the total dextroamphetamine or a pharmaceutical salt thereof followed by an extended 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.±0.0.5° C., measured by the USP Apparatus I.