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Compositions for treatment of attention deficit hyperactivity disorder

  • US 10,179,108 B2
  • Filed: 12/01/2016
  • Issued: 01/15/2019
  • Est. Priority Date: 03/23/2011
  • Status: Active Grant
First Claim
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1. A solid, oral pharmaceutical composition comprising coated particles:

  • said particles comprising;

    (a) a core comprising dextroamphetamine or a pharmaceutical salt thereof;

    (b) a sustained release layer enclosing the core, wherein the sustained release layer comprises a water-insoluble and water-permeable polymer, a water soluble polymer, a hydrophobic plasticizer, and a hydrophobic binder; and

    (c) a delayed release layer enclosing the sustained release layer, wherein the delayed release layer comprises a pH dependent polymer or copolymer that is insoluble in aqueous medium at pH lower than 5.5;

    wherein the formulation provides at least an 8 hour lag time during which the formulation releases no more than 10% of the total dextroamphetamine or a pharmaceutical salt thereof, followed by a sustained release period of 10-12 hours when the composition is placed in 700 ml aqueous solution of 0.1N HC1 pH 1.1 for up to 2 hours, followed by 4 hours in sodium phosphate buffer at pH 6.0, followed by 14 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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