Pharmaceutical compositions for extended release of oxycodone and acetaminophen resulting in a quick onset and prolonged period of analgesia

  • US 9,050,335 B1
  • Filed: 05/16/2012
  • Issued: 06/09/2015
  • Est. Priority Date: 05/17/2011
  • Status: Expired due to Fees
First Claim
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1. A pharmaceutical composition for extended release of oxycodone and acetaminophen, comprising:

  • at least one extended release portion comprising oxycodone or a pharmaceutically acceptable salt of oxycodone, acetaminophen, and an extended release component;

    wherein the total amount of acetaminophen in the composition is about 325 mg to about 650 mg, and the total amount of oxycodone or salt in the composition is about 7.5 mg to about 15 mg;

    wherein upon oral administration of the composition to a subject in a fasted state, the composition provides an AUC0-1.7h for acetaminophen of about 5 ng·

    h/ml/mg to about 13 ng·

    h/ml/mg;

    an AUC1.7-48h for acetaminophen of about 25 ng·

    h/ml/mg to about 75 ng·

    h/ml/mg;

    an AUC0-2.8h for oxycodone or salt of about 1 ng·

    h/ml/mg to about 3 ng·

    h/ml/mg; and

    AUC2.8-48h for oxycodone or salt of about 7.5 ng·

    h/ml/mg to about 15 ng·

    h/ml/mg.

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