Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia

  • US 8,992,975 B2
  • Filed: 12/17/2013
  • Issued: 03/31/2015
  • Est. Priority Date: 05/17/2011
  • Status: Active Grant
First Claim
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1. A pharmaceutical composition comprising:

  • (a) at least one immediate release portion comprising about 125 mg to about 325 mg of acetaminophen and oxycodone or a pharmaceutically acceptable salt thereof in an amount selected from the group consisting of about 1 mg, 1.25 mg, 1.3 mg, 1.325 mg, 1.35 mg, 1.375 mg, 1.4 mg, 1.425 mg, 1.45 mg, 1.475 mg, 1.5 mg, 1.525 mg, 1.55 mg, 1.575 mg, 1.6 mg, 1.625 mg, 1.65 mg, 1.675 mg, 1.7 mg, 1.725 mg, 1.75 mg, 1.775 mg, 1.8 mg, 1.825 mg, 1.85 mg, 1.875 mg, 1.9 mg, 1.925 mg, 1.95 mg, 1.975 mg, 2.0 mg, 2.25 mg, 2.5 mg, 2.75 mg, 3.0 mg, 3.25 mg, 3.5 mg, 3.75 mg, and 4.0 mg; and

    (b) at least one extended release portion comprising about 125 mg to about 325 mg of acetaminophen and about 4.5 mg to about 6.5 mg oxycodone or a pharmaceutically acceptable salt thereof, and an extended release component;

    wherein the total amount of acetaminophen in the composition is 325 mg and the total amount of oxycodone or a pharmaceutically acceptable salt in the composition is about 7.5 mg; and

    wherein upon oral administration of a single dose of the composition to a subject, the composition provides a Cmax for oxycodone from about 0.9 ng/mL/mg to about 1.6 ng/mL/mg, a Cmax for acetaminophen from about 4.0 ng/mL/mg to about 11.0 ng/mL/mg, a Tmax for oxycodone from about 2 hours to about 7 hours, and a Tmax for acetaminophen from about 0.5 hour to about 6 hours.

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