Claims for Patent: 11,241,391

Summary for Patent: 11,241,391

Title:	Compositions for treatment of attention deficit hyperactivity disorder
Abstract:	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.
Inventor(s):	Lickrish; David (Camana Bay, KY), Zhang; Feng (Pflugerville, TX)
Assignee:	IRONSHORE PHARMACEUTICALS & DEVELOPMENT, INC. (Camana Bay, KY)
Application Number:	17/108,710
Patent Claims:	1. A method of treating a pediatric or adolescent subject having Attention Deficit Hyperactivity Disorder (ADHD), comprising: orally administering a composition comprising coated particles, said particles comprising: a core comprising an effective amount of methylphenidate hydrochloride; a sustained release layer enclosing the core; and a delayed release layer enclosing the sustained release layer; wherein the coated particles further comprise microcrystalline cellulose, dibutyl sebacate, diglycerides, ethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, methacrylic acid copolymer Type B, monoglycerides, polysorbate 80 and talc; and 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.sub.max of about 12-16 hours when administered to healthy adults. 2. The method of claim 1, 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. 3. The method of claim 1, 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. 4. The method of claim 1, wherein the composition is contained in a capsule comprising hydroxypropyl methylcellulose. 5. The method of claim 1, wherein: the administering is in the evening; and the method provides the 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 the administering in the evening. 6. The method of claim 1, wherein: the administering is in the evening; and the method 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. 7. The method of claim 1, wherein the effective amount is 20 mg, 40 mg, 60 mg, 80 mg or 100 mg. 8. A method of treating a pediatric or adolescent subject having Attention Deficit Hyperactivity Disorder (ADHD), comprising: orally administering a composition comprising coated particles, said particles consisting of: a core comprising an effective amount of methylphenidate hydrochloride; a sustained release layer enclosing the core; and a delayed release layer enclosing the sustained release layer; wherein the coated particles further consist of microcrystalline cellulose, dibutyl sebacate, diglycerides, ethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, methacrylic acid copolymer Type B, monoglycerides, polysorbate 80 and talc; and 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.sub.max of about 12-16 hours when administered to healthy adults. 9. The method of claim 8, 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. 10. The method of claim 8, 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. 11. The method of claim 8, wherein the composition is contained in a capsule comprising hydroxypropyl methylcellulose. 12. The method of claim 8, wherein: the administering is in the evening; and the method provides the 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 the administering in the evening. 13. The method of claim 8, wherein: the administering is in the evening; and the method 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. 14. The method of claim 8, wherein the effective amount is 20 mg, 40 mg, 60 mg, 80 mg or 100 mg.