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Controlled release hydrocodone formulations

  • US 10,179,130 B2
  • Filed: 03/15/2013
  • Issued: 01/15/2019
  • Est. Priority Date: 10/29/1999
  • Status: Expired due to Term
First Claim
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1. A twice-a-day solid oral controlled-release dosage form comprising a gum and two types of multiparticulates, the multiparticulates collectively comprising from about 5 mg to about 60 mg of a pharmaceutically acceptable organic salt of hydrocodone,the gum and two types of multiparticulates compressed into a tablet,a first type of multiparticulates comprising microcrystalline cellulose and a first portion of said 5 mg to 60 mg of the pharmaceutically acceptable organic salt of hydrocodone, each multiparticulate individually coated with a controlled release coating comprising an acrylic polymer,a second type of multiparticulates in the form of uncoated granules, spheroids, or pellets comprising a remaining portion of said 5 mg to 60 mg of the pharmaceutically acceptable organic salt of hydrocodone,said dosage form providing an in-vitro release of from 18% to about 42.5% by weight of hydrocodone from the dosage form at one hour when measured by the USP Basket Method at 100 rpm in 700 ml of Simulated Gastric Fluid (SGF) for 55 minutes at 37°

  • C. and thereafter switching to 900 ml of Simulated Intestinal Fluid (SIF) at 37°

    C., and, after a first administration to a human patient population, providing a plasma concentration of hydrocodone of at least 8 ng/ml at from about 2 to about 8 hours after said administration and a plasma concentration of hydrocodone of at least 6 ng/ml at about 12 hours after said administration, based on oral administration of a dosage form containing 15 mg hydrocodone bitartrate, a mean C12/Cmax hydrocodone ratio of 0.55 to 0.85, a mean Tmax of hydrocodone from about 2 to 8 hours, and a therapeutic effect for about 12 hours.

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