Methods of treatment of attention deficit hyperactivity disorder
AssigneeIronshore Pharmaceuticals & Development, Inc.
InventorsDavid Lickrish, Feng Zhang
Life of this patent
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Abstract
Therapeutic compositions and methods for treatment of attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD) include dosage forms that deliver a therapeutic amount of active drug in a delayed and controlled release formulation. The dosage form can be administered at night and drug release is delayed for from 5 to 7 hours or longer, followed by an ascending release rate. When administered at night the composition provides early morning improvement in symptoms of ADHD and sustained improvement over a period of at least 12 hours.
Claims10
A method of treating a subject with a disorder or condition responsive to the administration of a methylphenidate, comprising:
- orally administering an effective amount of a methylphenidate or a pharmaceutical salt thereof in a formulation comprising one or more water soluble capsules containing a unit dose of methylphenidate or a pharmaceutical salt thereof in a solid dosage form that comprises a plurality of beads,
- wherein said beads comprise a sustained release formulation comprising the methylphenidate or a pharmaceutical salt thereof enclosed in a delayed release coating that is insoluble in an aqueous medium at pH below 5.5,
- wherein the sustained release formulation comprises a drug-containing core enclosed in a sustained release coating comprising ethyl cellulose and hydroxypropyl cellulose in a ratio of about 1:3 to 1:5, dibutyl sebacate and from 25% to 50% magnesium stearate, and
- wherein the method comprises administering the unit dose form 5-8 hours prior to the desired treatment period.
Dependencies are inferred from the claim text.