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US 10,881,618 B2Granted
Compositions for treatment of attention deficit hyperactivity disorder
AssigneeIronshore Pharmaceuticals & Development, Inc.
InventorsDavid Lickrish, Feng Zhang
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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.
Claims7
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 hydroxypropyl methylcellulose and microcrystalline cellulose, and an effective amount of methylphenidate hydrochloride;
- a sustained release layer enclosing the core, wherein the sustained release layer comprises dibutyl sebacate, ethyl cellulose, hydroxypropyl cellulose, and magnesium stearate;
- and
- a delayed release layer enclosing the sustained release layer, wherein the delayed release layer comprises dibutyl sebacate, methacrylic acid copolymer Type B, monoglycerides, diglycerides and polysorbate 80;
- 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 Tmax of about 12-16 hours when administered to healthy adults.
3 more elements
Dependencies are inferred from the claim text.