Methods for Treatment of Attention Deficit Hyperactivity Disorder
AssigneeIronshore Pharmaceuticals & Development, Inc.
InventorsDavid Lickrish, Feng Zhang
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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 4 to 6 hours or longer, followed by an ascending release rate.
Claims29
A method of treating a condition in a subject with a disorder or condition responsive to the administration of a methylphenidate, comprising orally administering an effective amount of methylphenidate or a pharmaceutical salt thereof in a formulation that provides a lag period of at least 5 hours during which the plasma concentration of methylphenidate or a pharmaceutical salt thereof is less than 10% of the maximum concentration (Cmax) and wherein the time to Cmax (Tmax) is between 12 and 19 hours after administration.
A method of treating attention deficit disorder or attention deficit hyperactivity disorder in a subject comprising orally administering to the subject a unit dose of methylphenidate or a pharmaceutical salt thereof in a unit dose that comprises a sustained release formulation comprising the methylphenidate or a pharmaceutical salt thereof enclosed in an outer coating that is insoluble in an aqueous medium at pH below 5.5, wherein the unit dose provides a lag period of at least 5 hours during which the subject's plasma concentration of methylphenidate or a pharmaceutical salt thereof is less than 10% of the maximum concentration (Cmax) and wherein the time to Cmax (tmax) is between 12 and 19 hours after administration.
A method of treating attention deficit disorder or attention deficit hyperactivity disorder in a subject comprising orally administering to the subject a unit dose of methylphenidate or a pharmaceutical salt thereof in a unit dose that comprises:
- a water soluble capsule containing a plurality of beads, the beads comprising:
- (a) a core comprising methylphenidate or a pharmaceutical salt thereof and at least one pharmaceutically acceptable excipient;
- (b) a sustained release layer enclosing the core and 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
- (c) a delayed release layer enclosing the sustained release layer and comprising methacrylic acid copolymer type-B, mono- and di-glycerides and polysorbate 80.
Dependencies are inferred from the claim text.