Methods of treatment of attention deficit hyperactivity disorder
First Claim
1. 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 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, there is (i) 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) a time to Cmax (Tmax) between 12 and 19 hours after administration, and wherein administration to a population of subjects with ADHD 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.
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Accused Products
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.
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Citations
28 Claims
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1. 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 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, there is (i) 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) a time to Cmax (Tmax) between 12 and 19 hours after administration, and wherein administration to a population of subjects with ADHD 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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18)
- 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, there is (i) 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
- 19. A method of treating AHDH in a subject in need thereof, said method comprising orally administering an effective amount of methylphenidate or a pharmaceutical salt thereof in a formulation that provides a lag of at least 7 hours during which the plasma concentration of methylphenidate is less than 5% of the maximum plasma (Cmax), followed by a period of sustained release including a time to Cmax (Tmax) between 12 and 19 hours after administration, and wherein administration in the evening provides an improvement in early morning ADHD symptoms compared to a control as measured by the BSFQ test, when the formulation is administered to a human subject in a fasted state.
Specification