Methylphenidate extended release chewable tablet

  • US 9,844,545 B2
  • Filed: 04/19/2017
  • Issued: 12/19/2017
  • Est. Priority Date: 08/15/2012
  • Status: Active Grant
First Claim
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1. An extended release racemic methylphenidate chewable tablet, wherein the chewable tablet is a solid dispersion comprising:

  • (a) a sustained release, racemic methylphenidate component comprising a water-insoluble, water-permeable, pH-independent barrier coated, racemic methylphenidate-cation exchange resin complex which comprises;

    (i) a racemic methylphenidate-cation exchange resin complex comprising racemic methylphenidate and a pharmaceutically acceptable cation ion exchange resin, wherein the racemic methylphenidate is bound to the pharmaceutically acceptable cation exchange resin;

    (ii) a water-insoluble, water-permeable, pH-independent, barrier coating comprising cellulose acetate and a plasticizer;

    wherein the barrier coating provides a sustained release profile to the racemic methylphenidate as defined in (a); and

    wherein about 50% w/w to about 90% w/w of total racemic methylphenidate in the chewable tablet is provided by the sustained release component; and

    (b) an immediate racemic methylphenidate component comprising racemic methylphenidate-cation exchange resin complex which provides a release of the racemic methylphenidate in less than about 30 minutes as determined in an in vitro dissolution assay, wherein the methylphenidate-cation exchange resin complex comprises racemic methylphenidate bound to a pharmaceutically acceptable cation exchange resin;

    wherein the chewable tablet is capable of being divided and providing tablet portions which retain a therapeutically effective extended release profile, and a pharmacokinetic profile in which the racemic methylphenidate has at least one of;

    a geometric mean for area under the curve (AUC)0-∞

    of about 110 ng-hr/mL to about 140 ng-hr/mL or a geometric mean Cmax of about 10 ng/mL to about 15 ng/mL, under fasted conditions in adults following a single oral administration of the chewable tablet which has a total amount of racemic methylphenidate which is the equivalent of 40 mg racemic methylphenidate HCl.

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