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 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 composition is orally administered to a human subject,(i) there is a lag period of at least 6 hours during which the area under the curve of plasma concentration versus time (AUC0-6) of amphetamine or a pharmaceutical salt thereof is less than 10% of the total area under the curve at Tmax (AUC0-Tmax); and
(ii) the time to Cmax (Tmax) is between 12 and 19 hours after administration.
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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.
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Citations
29 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 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 composition is orally administered to a human subject, (i) there is a lag period of at least 6 hours during which the area under the curve of plasma concentration versus time (AUC0-6) of amphetamine or a pharmaceutical salt thereof is less than 10% of the total area under the curve at Tmax (AUC0-Tmax); and (ii) the time to Cmax (Tmax) is between 12 and 19 hours after administration. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24)
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- 25. A water soluble capsule containing a unit dose of an amphetamine or a pharmaceutical salt thereof, wherein when the composition is orally administered to a human subject, there is a lag period of at least 5 hours during which the plasma concentration of amphetamine or a pharmaceutical salt thereof is less than 10% of the maximum concentration (Cmax), and wherein the time to Cmax (Tmax) is between 12 and 19 hours after administration.
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27. 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 or a pharmaceutical salt thereof and at least one pharmaceutically acceptable excipient; a sustained release layer enclosing the core and comprising ethylcellulose, hydroxypropylcellulose, dibutyl sebacate and from 25-50% magnesium stearate; and a delayed release layer enclosing the sustained release layer and comprising methacrylic acid copolymer B, mono- and di-glycerides and polysorbate 80. - View Dependent Claims (28)
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29. A solid, oral pharmaceutical composition comprising a plurality of particles, each comprising:
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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 the particles release no more than 5% of the total amphetamine or a pharmaceutical salt thereof from hour 0 to hour 6; and
release no more than 10% of the total amphetamine or a pharmaceutical salt thereof from hour 0 to hour 8; and
, exhibit sustained release over the following 10 hours when the composition is placed in 700 ml aqueous solution of 0.1N HCl pH 1.1, for 2 hours followed by 4 hours in sodium phosphate buffer at pH 6.0;
followed by 6-20 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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Specification