Compositions for treatment of attention deficit hyperactivity disorder
First Claim
Patent Images
1. A solid, oral pharmaceutical composition comprising coated particles:
- said particles comprising;
(a) a core comprising dextroamphetamine or a pharmaceutical salt thereof;
(b) a sustained release layer enclosing the core, wherein the sustained release layer comprises a water-insoluble and water-permeable polymer, a water soluble polymer, a hydrophobic plasticizer, and a hydrophobic binder; and
(c) a delayed release layer enclosing the sustained release layer, wherein the delayed release layer comprises a pH dependent polymer or copolymer that is insoluble in aqueous medium at pH lower than 5.5;
wherein the formulation provides at least an 8 hour lag time during which the formulation releases no more than 10% of the total dextroamphetamine 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 HC1 pH 1.1 for up to 2 hours, followed by 4 hours in sodium phosphate buffer at pH 6.0, followed by 14 hours in sodium phosphate buffer, pH 7.2 at 37°
C.±
.0.5°
C., as measured by the USP Apparatus I.
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Abstract
Therapeutic compositions and methods for treatment of attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD) and other CNS stimulant responsive conditions 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 an extended release.
120 Citations
8 Claims
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1. A solid, oral pharmaceutical composition comprising coated particles:
-
said particles comprising; (a) a core comprising dextroamphetamine or a pharmaceutical salt thereof; (b) a sustained release layer enclosing the core, wherein the sustained release layer comprises a water-insoluble and water-permeable polymer, a water soluble polymer, a hydrophobic plasticizer, and a hydrophobic binder; and (c) a delayed release layer enclosing the sustained release layer, wherein the delayed release layer comprises a pH dependent polymer or copolymer that is insoluble in aqueous medium at pH lower than 5.5;
wherein the formulation provides at least an 8 hour lag time during which the formulation releases no more than 10% of the total dextroamphetamine 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 HC1 pH 1.1 for up to 2 hours, followed by 4 hours in sodium phosphate buffer at pH 6.0, followed by 14 hours in sodium phosphate buffer, pH 7.2 at 37°
C.±
.0.5°
C., as measured by the USP Apparatus I. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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Specification