Method 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 an amphetamine, comprising orally administering an effective amount of an amphetamine or a pharmaceutical salt thereof in a formulation comprising a core comprising an amphetamine 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 provides an 8 hour lag time during which the formulation releases no more than 10% of the total amphetamine or a pharmaceutical salt thereof followed by a sustained release period of 10-12 hours when the composition is placed in 700 ml aqueous solution of 0.1N HCl pH 1.1, for up to 2 hours followed by hours 2-6 in sodium phosphate buffer at pH 6.0;
followed by hours 6-20 in sodium phosphate buffer, pH 7.2 at 37°
C.±
0.0.5°
C., measured by the USP Apparatus I.
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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 8 hours or longer, followed by a prolonged release.
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Citations
17 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 an amphetamine, comprising orally administering an effective amount of an amphetamine or a pharmaceutical salt thereof in a formulation comprising a core comprising an amphetamine 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 provides an 8 hour lag time during which the formulation releases no more than 10% of the total amphetamine or a pharmaceutical salt thereof followed by a sustained release period of 10-12 hours when the composition is placed in 700 ml aqueous solution of 0.1N HCl pH 1.1, for up to 2 hours followed by hours 2-6 in sodium phosphate buffer at pH 6.0;
followed by hours 6-20 in sodium phosphate buffer, pH 7.2 at 37°
C.±
0.0.5°
C., measured by the USP Apparatus I. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
- a sustained release layer enclosing the core and a delayed release layer enclosing the sustained release layer, wherein when the formulation provides an 8 hour lag time during which the formulation releases no more than 10% of the total amphetamine or a pharmaceutical salt thereof followed by a sustained release period of 10-12 hours when the composition is placed in 700 ml aqueous solution of 0.1N HCl pH 1.1, for up to 2 hours followed by hours 2-6 in sodium phosphate buffer at pH 6.0;
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15. A method of treating a condition in a subject with a disorder or condition responsive to the administration of an amphetamine, comprising orally administering an effective amount of amphetamine or a pharmaceutical salt thereof in a formulation comprising a core comprising amphetamine 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 provides an 8 hour lag time during which the formulation releases no more than 1% of the total amphetamine or a pharmaceutical salt thereof followed by a sustained release period of at least 8 hours when the composition is placed in 700 ml aqueous solution of 0.1N HCl pH 1.1, for 2 hours followed by hours 2-6 in sodium phosphate buffer at pH 6.0;
followed by hours 6-20 in sodium phosphate buffer, pH 7.2 at 37°
C.±
0.0.5°
C., measured by the USP Apparatus I. - View Dependent Claims (16, 17)
- a sustained release layer enclosing the core and a delayed release layer enclosing the sustained release layer, wherein when the formulation provides an 8 hour lag time during which the formulation releases no more than 1% of the total amphetamine or a pharmaceutical salt thereof followed by a sustained release period of at least 8 hours when the composition is placed in 700 ml aqueous solution of 0.1N HCl pH 1.1, for 2 hours followed by hours 2-6 in sodium phosphate buffer at pH 6.0;
Specification