Controlled release formulation
AssigneeEuro-Celtique S.A.
InventorsRonald B. Miller, Stewart T. Leslie, Sandra T. A. Malkowska, Kevin J. Smith, Walter Wimmer, Horst Winkler, Udo Hahn, Derek A. Prater
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Abstract
A controlled release preparation for oral administration contains tramadol, or a pharmaceutically acceptable salt thereof, as active ingredient.
Claims39
A controlled release oral pharmaceutical preparation suitable for dosing every 24 hours containing from about 50 mg to about 800 mg of tramadol or a pharmaceutically acceptable salt thereof, calculated as hydrochloride salt, in a controlled release matrix, the matrix comprising from about 1 to about 80% w/w of one or more hydrophilic or hydrophobic polymers, and having a dissolution rate in vitro when measured using the Ph. Eur. Paddle Method at 100 rpm in 900 ml 0.1N hydrochloric acid at 37.degree. C. and using UV detection at 270 nm, from about 0 to about 50% tramadol released after 1 hour;
- from about 0 to about 75% tramadol released after 2 hours;
- from about 3 to about 95% tramadol released after 4 hours;
- from about 10 to about 100% after 8 hours;
- from about 20 to about 100% tramadol released after 12 hours;
- from about 30 to about 100% tramadol released after 16 hours;
- from about 50 to about 100% tramadol released after 24 hours;
- and greater than 80% tramadol released after 36 hours, by weight.
A controlled release preparation suitable for dosing every twelve hours containing from about 50 to about 400 mg tramadol or pharaceutically acceptable salt thereof, calculated as the hydrochloride salt, in a controlled release matrix containing from about 1 to about 80% w/w of one or more hydrophilic or hydrophobic polymers, said preparation exhibiting an in vitro dissolution rate when measured by the Ph. Eur. Paddle method at 100 rpm in 900 ml 0.1N hydrochloric acid at 37.degree. 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.
Dependencies are inferred from the claim text.