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Methods for treatment of attention deficit hyperactivity disorder

  • US 8,916,588 B2
  • Filed: 03/31/2014
  • Issued: 12/23/2014
  • Est. Priority Date: 03/23/2011
  • Status: Active Grant
First Claim
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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.

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