Patent ID: 9320717
Filing Date: 2016-04-26
CPC Classification: A61K,A61P

Claim Text:
1. A twice-a-day solid oral controlled-release dosage form of a pharmaceutically acceptable salt of hydrocodone, the dosage form comprising: a therapeutically effective amount of a pharmaceutically acceptable salt of hydrocodone, and two different types of multiparticulates in the form of granules, spheroids, or pellets, a first type of said multiparticulates comprising a first portion of the pharmaceutically acceptable salt of hydrocodone and providing an immediate release of hydrocodone, a second type of said multiparticulates comprising a remaining portion of the pharmaceutically acceptable salt of hydrocodone and at least one pharmaceutically acceptable excipient and providing a controlled release of hydrocodone, the dosage form providing an in-vitro release of from at least 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, providing a plasma concentration of hydrocodone of at least 8 ng/ml at from about 2 to about 8 hours after administration and a plasma concentration of hydrocodone of at least 6 ng/ml at about 12 hours after administration, based on oral administration of a dosage form containing 15 mg hydrocodone bitartrate, a C a T the therapeutically effective amount of the pharmaceutically acceptable salt of hydrocodone is from about 5 mg to about 60 mg, and the salt of hydrocodone is an inorganic salt of hydrocodone or a bitartrate salt of hydrocodone.