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US 9,283,214 B2Granted
Compositions 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 solid, oral pharmaceutical composition comprising:
- a single population of beads, said beads comprising:
- a core comprising methylphenidate or a pharmaceutical salt thereof and at least one pharmaceutically acceptable excipient;
- a sustained release layer enclosing the core;
- and
- a delayed release layer enclosing the sustained release layer, wherein when the formulation is administered to a human subject in a fasted state, (i) there is a lag of at least 7 hours during which the plasma concentration of methylphenidate is less than 5% of the maximum plasma (Cmax), (ii) a plasma area under the curve at 10 hours (AUC0-10) after administration that is less than about 7% of AUC0-48;
- and (iii) wherein the time to Cmax (Tmax) is between 12 and 19 hours after administration, and wherein administration to a population of subjects provides a significant improvement in ADHD related behavior or cognitive ability over a period of at least 12 continuous hours as measured by a validated rating scale.
3 more elements
Dependencies are inferred from the claim text.