Controlled release hydrocodone formulations

  • US 8,361,499 B2
  • Filed: 06/28/2012
  • Issued: 01/29/2013
  • Est. Priority Date: 10/30/2000
  • Status: Active Grant
First Claim
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1. A solid oral controlled-release dosage form comprising an analgesically effective amount of hydrocodone or a pharmaceutically acceptable salt thereof and a controlled release material selected from the group consisting of hydrophobic polymers, hydrophilic polymers, gums, protein derived materials, waxes, shellac, oils and mixtures thereof, the dosage form providinga controlled release of the hydrocodone or the pharmaceutically acceptable salt thereof for a time period of from 8 to at least about 24 hours,an 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 administration to a human patient or a population of patients and after the maximum plasma concentration of the hydrocodone is reached, providing a relatively flat serum plasma profile of the hydrocodone meaning that the plasma level of the hydrocodone provides a C24/Cmax ratio of about 0.55 to about 1.0.

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