Claims for Patent: 11,241,392

Summary for Patent: 11,241,392

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:	17/124,102
Patent Claims:	1. A solid, oral pharmaceutical composition comprising: coated particles comprising: a core comprising 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 composition 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 composition 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 solid, oral pharmaceutical composition of claim 1, wherein the composition is contained in a capsule comprising hydroxypropyl methylcellulose. 5. The solid, oral pharmaceutical composition of claim 1, 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. 6. The solid, oral pharmaceutical composition of claim 1, 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. 7. The solid, oral pharmaceutical composition of claim 1, wherein the composition comprises 20 mg, 40 mg, 60 mg, 80 mg or 100 mg of methylphenidate hydrochloride. 8. A solid, oral pharmaceutical composition comprising: coated particles consisting of: a core comprising 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 composition 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 composition 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 solid, oral pharmaceutical composition of claim 8, wherein the composition is contained in a capsule comprising hydroxypropyl methylcellulose. 12. The solid, oral pharmaceutical composition of claim 8, wherein the composition provides a 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. 13. The solid, oral pharmaceutical composition of claim 8, 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. 14. The solid, oral pharmaceutical composition of claim 8, wherein the composition comprises 20 mg, 40 mg, 60 mg, 80 mg or 100 mg of methylphenidate hydrochloride.