Compositions for Treatment of Attention Deficit Hyperactivity Disorder
Therapeutic compositions deliver a therapeutic amount of methylphenidate in a delayed and extended release formulation. The dosage form exhibits a lag time prior to release of from 6 to 8 hours or longer, followed by a sustained release period.
1 - 9 . (canceled)
10 . A solid, oral pharmaceutical composition comprising:
methylphenidate hydrochloride;
a sustained release layer; and
a delayed release layer;
wherein the composition provides at least a 6 hour lag time during which the composition releases no more than 5% of the total methylphenidate hydrochloride followed by a sustained release period with a median T max of about 12-16 hours when administered to healthy adults.
11 . The composition of claim 10 , wherein the composition provides at least an 8 hour lag time during which the composition releases no more than about 5% of the total methylphenidate hydrochloride.
12 . The composition of claim 10 , wherein the composition provides at least a 10 hour lag time during which the composition releases no more than 10% of the total methylphenidate hydrochloride.
13 . The solid, oral pharmaceutical composition of claim 10 , wherein the composition is contained in a capsule.
14 . The solid, oral pharmaceutical composition of claim 10 , wherein the composition provides pediatric or adolescent subjects having Attention Deficit Hyperactivity Disorder (ADHD) with a significant improvement compared to a placebo in Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale (SKAMP) combined scores for a period from about 11 hours through about 23 hours after administration in the evening.
15 . The solid, oral pharmaceutical composition of claim 10 , wherein the composition provides pediatric or adolescent subjects having Attention Deficit Hyperactivity Disorder (ADHD) with a significant improvement compared to a placebo in ADHD Rating Scale (ADHD-RS-IV) Total Score, Before School Functioning Questionnaire (BSFQ) score, and/or Parent Rating of Evening and Morning Behavior-Revised (PREMB-R AM) score when administered in the evening.
16 . The solid, oral pharmaceutical composition of claim 10 , wherein the composition comprises 20 mg, 40 mg, 60 mg, 80 mg or 100 mg of methylphenidate hydrochloride.
17 . The solid, oral pharmaceutical composition of claim 10 , wherein, following the lag time, the remaining methylphenidate hydrochloride that is released from the composition is released during the sustained release period.