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Orally effective methylphenidate extended release powder and aqueous suspension product

DC CAFC
  • US 9,040,083 B2
  • Filed: 11/26/2014
  • Issued: 05/26/2015
  • Est. Priority Date: 02/15/2011
  • Status: Active Grant
First Claim
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1. A powder which when admixed with water forms an aqueous oral suspension, said powder comprising (i) an immediate release methylphenidate component, (ii) a sustained release water-insoluble, water-permeable, pH-independent, barrier coated methylphenidate-ion exchange resin complex, and (iii) a buffering agent which adjusts the pH of the oral aqueous suspension comprising the powder to a pH of about 4.2,wherein the oral aqueous suspension provides a pharmacokinetic profile in which d-methylphenidate has an area under the curve (AUC)0-∞

  • of about 114 ng-hr/mL to about 180 ng-hr/mL and a Cmax of about 11 ng/mL to about 17 ng/mL following a single oral administration of the oral aqueous suspension to adult subjects under fasted conditions at a dose equivalent to 60 mg racemic methylphenidate HCl.

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