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Pharmaceutical compositions

  • US 9,789,104 B2
  • Filed: 07/01/2015
  • Issued: 10/17/2017
  • Est. Priority Date: 01/09/2008
  • Status: Active Grant
First Claim
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1. A solid oral pharmaceutical composition for treating pain, and reducing or preventing opioid-induced nausea or vomiting in a subject in need thereof, wherein the solid oral pharmaceutical composition comprises:

  • a first matrix that comprises an antiemetic, wherein the antiemetic is promethazine or a pharmaceutically acceptable salt thereof; and

    a second matrix that comprises an opioid analgesic and a non-opioid analgesic, wherein the opioid analgesic is hydrocodone or a pharmaceutically acceptable salt thereof and is present in an amount of about 5 mg, about 7.5 mg, about 10 mg, about 15 mg, about 20 mg, or about 30 mg, wherein the non-opioid analgesic is acetaminophen or a pharmaceutically acceptable salt thereof and is present in an amount of about 200-600 mg,wherein about 90% of the antiemetic is released in about 1 minute to about 20 minutes following contact of the solid oral pharmaceutical composition with a dissolution fluid as measured by a USP Apparatus 2 (Paddle Apparatus), wherein about 100% of the opioid analgesic is released in about 60 minutes following contact of the solid oral pharmaceutical composition with a dissolution fluid as measured by a USP Apparatus 2 (Paddle Apparatus),wherein the solid oral pharmaceutical composition contains an effective amount of the opioid analgesic and the non-opioid analgesic to treat pain, wherein the solid oral pharmaceutical composition contains an effective amount of the antiemetic to reduce or prevent nausea associated with the opioid analgesic or vomiting associated with the opioid analgesic, and wherein the solid oral pharmaceutical composition is for administration at about every 4, 5, or 6 hours.

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