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US 6,254,887 B1Granted
Controlled release tramadol
AssigneeEuro-Celtique S.A.
InventorsRonald Brown Miller, Stewart Thomas Leslie, Sandra Therese Antoinette Malkowska, Kevin John Smith, Walter Wimmer, Horst Winkler, Udo Hahn, Derek Allan Prater
Life of this patent
Estimating the term…
Abstract
A controlled release preparation for oral administration contains tramadol, or a pharmaceutically acceptable salt thereof, as active ingredient.
Claims33
A controlled release oral pharmaceutical preparation suitable for dosing every 24 hours comprising
- a 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° 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.
7 more elements
A controlled release preparation suitable for dosing every twelve hours comprising
- a substrate comprising an effective amount of tramadol or pharmaceutically acceptable salt thereof and said substrate coated wit a controlled release coating;
- said preparation exhibiting an in vitro dissolution rate when measured by the Ph. Eur. Paddle method at 100 rpm in 900 ml 0.1 N hydrochloric acid at 37° C. and using UV detection at 270 mm, such that between 5 and 50% (by weight) tramadol is released after 1 hour, between 10 and 75% by weight) tramadol is released after 2 hours, between 20 and 95% (by weight) tramadol is released after 4 hours, between 40 and 100% (by weight) tramadol is released after 8 hours, more than 50% (by weight) tramadol is released after 12 hours, more than 70% (by weight) tramadol is released after 18 hours and more than 80% (by weight) tramadol is released after 24 hours said preparation providing a therapeutic effect for at least about 12 hours after oral administration.
A controlled release oral pharmaceutical tablet suitable for dosing every 24 hours comprising
- a tablet containing a pharmaceutically effective amount of tramadol or a salt thereof;
- said tablet coated with a controlled release coating;
- said coated tablet 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° 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, and providing a W50 in the range of 10 to 33 hours when orally administered, said coated tablet providing a therapeutic effect for about 24 hours after oral administration.
7 more elements
A controlled release oral pharmaceutical tablet suitable for dosing every 24 hours comprising
- a tablet containing a pharmaceutically effective amount of tramadol or a salt thereof;
- said tablet coated with a controlled release coating;
- said coated tablet providing a therapeutic effect for about 24 hours after oral administration and having an in vitro dissolution rate (measured by the Ph. Eur. Paddle method at 100 rpm in 900 ml 0.1 N hydrochloric acid at 37° C. and using UV detection at 270 mm) as set forth below:
- TIME (H) % RELEASED 1 20-50 2 40-75 4 60-95 8 80-100 12 90-100.
1 more element
A controlled release oral pharmaceutical tablet in accordance with claim 15 which has
- an in vitro dissolution rate (measured by the Ph. Eur. Paddle method at 100 rpm in 900 ml 0.1 N hydrochloric acid at 37° C. using UV detection at 27 mm) as set forth below:
- TIME (H) % RELEASED 1 0-50 2 0-75 4 10-95 8 35-100 12 55-100 16 70-100 24 >90.
A controlled release oral pharmaceutical preparation suitable for dosing every 24 hours comprising
- a substrate comprising a pharmaceutically effective amount of an opioid analgesic consisting essentially 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° 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 hour, after oral administration.
7 more elements
Dependencies are inferred from the claim text.