Patent ID: 8142811
Filing Date: 2012-03-27
Classification: A61K,A61P

Abstract:
1. A solid oral controlled-release dosage form comprising a compressed granulation in the form of a controlled release matrix, the compressed granulation comprising an analgesically effective amount of hydrocodone or a pharmaceutically acceptable salt thereof, a controlled release material comprising a methacrylic acid polymer or copolymer, and optionally a therapeutically effective amount of a non-opioid drug; wherein the hydrocodone and the optional non-opioid drug are the only active agents in the dosage form, and the dosage form provides an in-vitro release rate of the hydrocodone or salt thereof when measured b 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 to a pH of 7.5 at 37° C., such that 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, and after a first administration to a human patient, provides a C