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Last Updated: October 29, 2020

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Claims for Patent: 10,182,995

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Summary for Patent: 10,182,995
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:15/359,202
Patent Claims: 1. A solid, oral pharmaceutical composition comprising coated particles: said particles comprising: (a) a core comprising methylphenidate or a pharmaceutical salt thereof; (b) a sustained release layer enclosing the core, wherein the sustained release layer comprises a water-insoluble and water-permeable polymer, a water-soluble polymer, a hydrophobic plasticizer, and a hydrophobic binder; and (c) a pH dependent polymer or copolymer that is insoluble in aqueous medium at pH lower than 5.5; wherein the formulation provides at least an 8 hour lag time during which the formulation releases no more than 10% of the total methylphenidate or a pharmaceutical salt thereof; followed by a sustained 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.degree. C..+-.0.5.degree. C., as measured by the USP Apparatus I.

2. The composition of claim 1, wherein the core comprises methylphenidate hydrochloride.

3. The composition of claim 1, wherein the sustained release layer comprises ethyl cellulose, hydroxypropyl cellulose, dibutyl sebacate and a metal stearate.

4. The composition of claim 1, wherein the sustained release layer comprises ethyl cellulose, hydroxypropyl cellulose, dibutyl sebacate and magnesium stearate.

5. The composition of claim 1, wherein the pH dependent copolymer is methacrylic acid copolymer Type B.

6. The composition of claim 1, further comprising mono- and diglycerides, dibutyl sebacate and polysorbate 80.

7. The composition of claim 1, contained in a single dosage form containing 1 mg to 150 mg of methylphenidate or a pharmaceutical salt thereof.

8. The composition of claim 1, contained in a single dosage form containing 1 mg to 80 mg of methylphenidate or a pharmaceutical salt thereof.

9. The composition of claim 1, wherein the sustained release layer comprises ethyl cellulose and hydroxypropyl cellulose in a ratio of about 1:3 to 1:5, dibutyl sebacate and from 25% to 50% by weight magnesium stearate.

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