Patent ID: 6254887
Filing Date: 2001-07-03
Classification: A61K,A61P

Abstract:
A controlled release oral pharmaceutical preparation suitable for dosing every 24 hours comprisinga substrate comprising a pharmaceutically effective amount of tramadol or a salt thereof;said substrate coated with a controlled release coating;said preparation having a dissolution rate in vitro when measured using the Ph. Eur. Paddle Method at 100 rpm in 900 ml 0,1 N hydrochloric acid at 37.degree. C. and using UV detection at 270 nm, between 0 and 50% tramadol released after 1 hour; between 0 and 75% tramadol released after 2 hours; between 3 and 95% tramadol released after 4 hours; between 10 and 100% tramadol released after 8 hours; between 20 and 100% tramadol released after 12 hours; between 30 and 100% tramadol released after 16 hours; between 50 and 100% tramadol released after 24 hours; and greater than 80% tramadol released after 36 hours, by weight, said preparation providing a therapeutic effect for about 24 hours after oral administration.