Methods for 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 a methylphenidate, comprising orally administering to the subject an effective amount of methylphenidate or a pharmaceutical salt thereof in a formulation 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 formulation is administered to said subject it provides;
(i) 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);
(ii) a plasma area under the curve at 10 hours (AUC0-10) after administration of less than about 7% of AUC0-48; and
(iii) wherein the time to Cmax (Tmax) is between 12 and 19 hours after administration.
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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 4 to 6 hours or longer, followed by an ascending release rate.
107 Citations
29 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 a methylphenidate, comprising orally administering to the subject an effective amount of methylphenidate or a pharmaceutical salt thereof in a formulation 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 formulation is administered to said subject it provides;
(i) 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);
(ii) a plasma area under the curve at 10 hours (AUC0-10) after administration of less than about 7% of AUC0-48; and
(iii) 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)
- a sustained release layer enclosing the core and a delayed release layer enclosing the sustained release layer, wherein when the formulation is administered to said subject it provides;
- 17. A method of treating attention deficit disorder or attention deficit hyperactivity disorder in a subject comprising orally administering to the subject a unit dose of methylphenidate or a pharmaceutical salt thereof in a unit dose that comprises a sustained release formulation comprising the methylphenidate or a pharmaceutical salt thereof enclosed in an outer coating that is insoluble in an aqueous medium at pH below 5.5, wherein the unit dose provides a lag period of at least 5 hours during which the subject'"'"'s plasma concentration of methylphenidate or a pharmaceutical salt thereof is less than 10% of the maximum concentration (Cmax), wherein the plasma area under the curve at 10 hours (AUC0-10) after administration is less than about 7% of AUC0-48 and wherein the time to Cmax (Tmax) is between 12 and 19 hours after administration.
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24. A method of treating attention deficit disorder or attention deficit hyperactivity disorder in a subject comprising orally administering to the subject a unit dose of methylphenidate or a pharmaceutical salt thereof in a unit dose that comprises:
- a water soluble capsule containing a plurality of beads, the beads comprising;
(a) a core comprising methylphenidate or a pharmaceutical salt thereof and at least one pharmaceutically acceptable excipient;
(b) a sustained release layer enclosing the core and comprising ethyl cellulose and hydroxypropyl cellulose in a ratio of about 1;
3 to 1;
5, dibutyl sebacate and from 25% to 50% magnesium stearate; and
(c) a delayed release layer enclosing the sustained release layer and comprising methacrylic acid copolymer type-B, mono- and di-glycerides and polysorbate 80. - View Dependent Claims (25, 26, 27, 28, 29)
- a water soluble capsule containing a plurality of beads, the beads comprising;
Specification