Patent ID: 7943173
Filing Date: 2011-05-17
Classification: A61K,A61P

Abstract:
1. An oral pharmaceutical sustained release composition comprising active ingredients consisting essentially of about 10 mg oxycodone hydrochloride and 0.80 to 0.90 mg naloxone hydrochloride, wherein the oxycodone hydrochloride and the naloxone hydrochloride are interdispersed in a matrix comprising a sustained release excipient, and the composition, when tested in-vitro by the USP Apparatus I (Basket) method of U.S. Pharmacopoeia XXIV (2000) at 100 rpm in 900 ml simulated gastric fluid (SGF) at 37° C., provides a dissolution rate of the oxycodone hydrochloride such that from about 20 to about 60% (by weight) oxycodone hydrochloride is released at 1 hour, from about 40 to about 90% (by weight) oxycodone hydrochloride is released at 4 hours, and greater than about 70% (by weight) oxycodone hydrochloride is released at 12 hours, and a dissolution rate of the naloxone hydrochloride which is within about 30% of the dissolution rate of the oxycodone hydrochloride at 1 hour, 4 hours and 12 hours.