Orally effective methylphenidate extended release powder and aqueous suspension product

  • US 8,778,390 B2
  • Filed: 09/03/2013
  • Issued: 07/15/2014
  • Est. Priority Date: 02/15/2011
  • Status: Active Grant
First Claim
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1. A methylphenidate aqueous extended release oral suspension comprising an immediate release methylphenidate component, a sustained release methylphenidate component, and water,wherein said suspension is stable at room temperature for at least one month and provides a single mean average plasma concentration peak and a therapeutically effective plasma profile for about 12 hours for methylphenidate, andwherein the suspension has a pharmacokinetic profile in which the single mean plasma concentration peak for methylphenidate has an area under the curve (AUC)0-∞

  • of about 114 ng-hr/mL to about 180 ng-hr/mL, Cmax of about 11 ng/mL to about 17 ng/mL, Tmax of about 4 hours to about 5.25 hours and T1/2 of about 5 hours to about 7 hours following a single oral administration of an aqueous liquid suspension at a dose equivalent to 60 mg racemic methylphenidate HCl in adults.

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