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Controlled release hydrocodone formulations

  • US 8,951,555 B1
  • Filed: 10/21/2014
  • Issued: 02/10/2015
  • Est. Priority Date: 10/30/2000
  • Status: Expired due to Fees
First Claim
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1. A solid oral controlled-release dosage form of hydrocodone, the dosage form comprising an amount of a hydrocodone bitartrate salt equivalent to from about 5 mg to about 60 mg of hydrocodone,the dosage form providinga ratio of a plasma concentration of hydrocodone at the end of a dosing interval to a maximum plasma concentration of hydrocodone during the dosing interval of about 0.55 to about 1, and an effective pain relief over a period of time of about 12 hours or longer after administration to a human patient or a population of patients,an in-vitro release of hydrocodone when measured by the USP Basket method at 100 rpm in 700 ml aqueous buffer at a pH of 1.2 at 37°

  • C. of from 10% to about 45% by weight hydrocodone released at 1 hour,the dosage form is a capsule comprisinga first portion of said amount of the hydrocodone bitartrate salt in an immediate release form andthe remaining portion of said amount of the hydrocodone bitartrate salt and a controlled release material in an extended release form, whereinsaid hydrocodone bitartrate salt is the only active agent in the dosage form.

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