Controlled release hydrocodone

  • US 8,551,520 B2
  • Filed: 12/20/2012
  • Issued: 10/08/2013
  • Est. Priority Date: 10/30/2000
  • Status: Active Grant
First Claim
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1. A solid oral controlled-release dosage form comprising a matrix comprising an analgesically effective amount of hydrocodone or a pharmaceutically acceptable salt thereof and an amount of a controlled release material sufficient to render the dosage form suitable for once-a-day administration, wherein the matrix is compressed into a tablet, and the dosage form providesan in-vitro release rate of hydrocodone or a pharmaceutically acceptable salt thereof, when measured by the USP Basket Method at 100 rpm in 900 ml aqueous buffer at a pH of between 1.6 and 7.2 at 37°

  • C., of from 0% to about 35% at 1 hour, from about 10% to about 70% at 4 hours, from about 20% to about 75% at 8 hours, from about 30% to about 80% at 12 hours, from about 40% to about 90% at 18 hours, and greater than about 60% at 24 hours, and,after a first administration to an individual patient or a patient population, a C24/Cmax ratio of about 0.55 to about 1.0.

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