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Controlled release hydrocodone formulations

  • US 7,514,100 B2
  • Filed: 09/11/2003
  • Issued: 04/07/2009
  • Est. Priority Date: 10/30/2000
  • Status: Expired due to Term
First Claim
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1. A solid oral controlled-release dosage form suitable for 24 hour dosing of an active agent in a human patient comprising a pharmaceutically acceptable matrix comprising an analgesically effective amount of hydrocodone or a pharmaceutically acceptable salt thereof and controlled release material;

  • said dosage form after administration to a human patient, providing a C24/Cmax ratio of 0.55 to about 0.85;

    a therapeutic effect for at least about 24 hours and a dissolution release rate in-vitro of the hydrocodone or salt thereof, when measured by the USP Basket Method at 100 rpm in 700 ml Simulated Gastric Fluid (SGF) at 37°

    C. for 1 hour and thereafter switching to 900 ml with Phosphate Buffer at a pH of 7.5 at 37°

    C., wherein at least 20% by weight hydrocodone or salt thereof is released at 4 hours, from about 20% to about 65% by weight hydrocodone or salt thereof is released at 8 hours, from about 45% to about 85% by weight hydrocodone or salt thereof is released at 12 hours, and at least 80% by weight hydrocodone or salt thereof is released at 24 hours.

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