Compositions for treatment of attention deficit hyperactivity disorder
First Claim
Patent Images
1. A solid, oral pharmaceutical composition comprising a plurality of particles, each comprising:
- a core comprising dextroamphetamine or a pharmaceutical salt thereof and at least one pharmaceutically acceptable excipient;
a extended release layer enclosing the core; and
a delayed release layer enclosing the extended release layer,wherein the formulation provides at least an 8 hour lag period during which the formulation releases no more than 10% of the total dextroamphetamine or a pharmaceutical salt thereof followed by an extended 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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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.
118 Citations
27 Claims
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1. A solid, oral pharmaceutical composition comprising a plurality of particles, each comprising:
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a core comprising dextroamphetamine or a pharmaceutical salt thereof and at least one pharmaceutically acceptable excipient; a extended release layer enclosing the core; and a delayed release layer enclosing the extended release layer, wherein the formulation provides at least an 8 hour lag period during which the formulation releases no more than 10% of the total dextroamphetamine or a pharmaceutical salt thereof followed by an extended 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, 15, 16, 17, 18, 19, 20)
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21. A solid, oral pharmaceutical composition comprising a plurality of particles, each particle comprising:
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a core comprising dextroamphetamine or a pharmaceutical salt thereof and at least one pharmaceutically acceptable excipient; an extended release layer enclosing the core; and a delayed release layer enclosing the extended release layer, wherein when the composition is administered to a human subject in a fasted state, (i) there is a lag period of at least 8 hours during which the area under the curve of plasma concentration versus time (AUC0-8) of dextroamphetamine or a pharmaceutical salt thereof is no more than 3% of the total area under the curve (AUC0-t); and
(ii) wherein the time to Cmax (Tmax) is between 15 and 24 hours after administration. - View Dependent Claims (22, 23, 24)
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25. A solid, oral pharmaceutical composition comprising a plurality of particles, each particle comprising:
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a substantially spherical core comprising a therapeutic amount of a dextroamphetamine sulfate or a pharmaceutical salt thereof and the pharmaceutically acceptable excipient microcrystalline cellulose; an extended release layer enclosing the core and comprising ethylcellulose, hydroxypropylcellulose, dibutyl sebacate and magnesium stearate; and a delayed release layer enclosing the extended release layer and comprising methacrylic acid copolymer B, mono- and di-glycerides, dibutyl sebacate, and polysorbate 80. - View Dependent Claims (26, 27)
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Specification