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Extruded extended release abuse deterrent pill

  • US 10,172,797 B2
  • Filed: 12/17/2014
  • Issued: 01/08/2019
  • Est. Priority Date: 12/17/2013
  • Status: Active Grant
First Claim
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1. An oral, extended release, abuse deterrent pill comprising:

  • (i) 4 wt % to 40 wt % oxymorphone HCl or a pharmaceutically acceptable salt thereof;

    (ii) 38 wt % to 42 wt % polyethylene oxide (PEO) having an average molecular weight between 50K Daltons and 150K Daltons;

    (iii) a controlled release agent selected from either 15 wt % to 45 wt % hydroxypropyl methylcellulose or 29 wt % to 60 wt % combination of polyvinyl acetate and polyvinylpyrrolidone; and

    ,(iv) 0.25 wt % to 20 wt % polyethylene glycol;

    wherein the oxymorphone HCl or pharmaceutically acceptable salt thereof has an extended release profile,wherein the pill exhibits less than a 10% increase in the release of the oxymorphone HCl or pharmaceutically acceptable salt thereof in a simulated alcoholic gastric fluid environment,wherein the pill has at least 50 wt % of particles with a particle size greater than 0.5 mm following physical or mechanical manipulation of the pill, andwherein the pill is a formed, uniform extrudate having a uniform blend of said oxymorphone HCl or pharmaceutically acceptable salt thereof, said polyethylene oxide, said controlled release agent and said polyethylene glycol, and is directly formed from an extrusion process.

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