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) and other CNS stimulant responsive conditions 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 an extended release.

主权项

1. A solid, oral pharmaceutical composition comprising a plurality of particles, each comprising:
a core comprising an inert bead coated with a layer comprising an amphetamine or a pharmaceutical salt thereof,an extended release layer enclosing the core; anda 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 5% of the total amphetamine 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 4 hours in sodium phosphate buffer at pH 6.0; followed by 14 hours in sodium phosphate buffer, pH 7.2 at 37° C.±0.0.5° C., measured by the USP Apparatus I.