Compositions for Treatment of Attention Deficit Hyperactivity Disorder
First Claim
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1. A solid, oral pharmaceutical composition comprising a plurality of particles, each 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 composition is orally administered to a human subject, there is a lag period of at least 5 hours during which the plasma concentration of methylphenidate 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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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 4 to 6 hours or longer, followed by an ascending release rate.
21 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 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 composition is orally administered to a human subject, there is a lag period of at least 5 hours during which the plasma concentration of methylphenidate 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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 24, 25)
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- 26. A water soluble capsule containing a unit dose of methylphenidate 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 methylphenidate 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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28. 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 methylphenidate 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 (29)
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Specification