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Controlled release hydrocodone formulations

DC
  • US 9,669,023 B2
  • Filed: 12/13/2016
  • Issued: 06/06/2017
  • Est. Priority Date: 10/30/2000
  • Status: Expired due to Term
First Claim
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1. A hydrocodone formulation comprising:

  • hydrocodone or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable polymer,the pharmaceutically acceptable polymer comprising between 1% and 80% of the formulation by weight,the formulation providing an in-vitro release rate of hydrocodone, 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,wherein the formulation provides a plasma concentration profile of hydrocodone with a ratio of the plasma concentration of hydrocodone at 24 hours after administration to the highest concentration of hydrocodone during the 24 hours of from 0.55 to 1.0,maintains the plasma concentrations of hydrocodone within the therapeutic range over 12 hours or longer after administration to a human and is administrable on a once a day basis.

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