COMBINATION COMPOSITION COMPRISING OXYCODONE AND ACETAMINOPHEN FOR RAPID ONSET AND EXTENDED DURATION OF ANALGESIA

  • US 20140170217A1
  • Filed: 12/17/2013
  • Published: 06/19/2014
  • 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 about 1.0 mg to about 4.0 mg oxycodone or a pharmaceutically acceptable salt thereof; 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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