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Claims for Patent: 7,074,430

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Claims for Patent: 7,074,430

Title:Controlled release tramadol tramadol formulation
Abstract:A controlled release preparation for oral administration contains tramadol, or a pharmaceutically acceptable salt thereof, as active ingredient.
Inventor(s): Miller; Ronald Brown (Basel, CH), Malkowska; Sandra Therese Antoinette (Cambridgeshire, GB), Wimmer; Walter (Limburg, DE), Hahn; Udo (Nentershausen, DE), Leslie; Stewart Thomas (Cambridge, GB), Smith; Kevin John (Cambridge, GB), Winkler; Horst (Linter, DE), Prater; Derek Allan (Cambridge, GB)
Assignee: Euro-Celtique S.A. (Luxembourg, LU)
Application Number:09/800,204
Patent Claims: 1. A solid controlled release oral dosage form, comprising, a therapeutically effective amount of tramadol or a pharmaceutically acceptable salt thereof incorporated into a normal release matrix, said matrix overcoated with a controlled release coating comprising a polymethacrylate or a water insoluble cellulose, said dosage form providing a therapeutic effect for at least about 24 hours.

2. The controlled release dosage form as claimed in claim 1, wherein said controlled release coating comprises a polymethacrylate.

3. The controlled release dosage form as claimed in claim 1, wherein said controlled release coating comprises a water insoluble cellulose.

4. The controlled release dosage form as claimed in claim 2, wherein said controlled release coating further comprises a water soluble cellulose.

5. The controlled release dosage form as claimed in claim 3, wherein said controlled release coating further comprises a polyvinylpyrrolidone.

6. The controlled release dosage form as claimed in claim 1, containing from about 50 to 800 mg of tramadol or a pharmaceutically acceptable salt thereof, calculated as the hydrochloride salt.

7. The controlled release dosage form as claimed in claim 1, 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 10 to about 95% tramadol released after 4 hours; from about 35 to about 100% after 8 hours; from about 55 to about 100% tramadol released after 12 hours; from about 70 to about 100% tramadol released after 16 hours; and greater than 90% tramadol released after 24 hours, by weight.

8. The controlled release dosage form as claimed in claim 1, 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 30% tramadol released after 1 hour; from about 0 to about 40% tramadol released after 2 hours; from about 3 to about 55% tramadol released after 4 hours; from about 10 to about 65% after 8 hours; from about 20 to about 75% tramadol released after 12 hours; from about 30 to about 88% 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.

9. The controlled release dosage form as claimed in claim 1, 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 15 to about 25% tramadol released after 1 hour; from about 25 to about 35% tramadol released after 2 hours; from about 30 to about 45% tramadol released after 4 hours; from about 40 to about 60% after 8 hours; from about 55 to about 70% tramadol released after 12 hours; and from about 60 to about 75% tramadol released after 16 hours, by weight.

10. The dosage form according to claim 1, which provides a t.sub.max from about 3 to about 6 hours.

11. The dosage form according to claim 1, which provides a W.sub.50 from about 10 to about 33 hours.

12. The dosage form according to claim 3 wherein said water insoluble cellulose comprises ethylcellulose.

13. The dosage form of claim 1, comprising 100 mg tramadol hydrochloride.

14. The dosage form of claim 1, comprising 200 mg tramadol hydrochloride.

15. The dosage form of claim 1, comprising 300 mg tramadol hydrochloride.

16. The dosage form of claim 1, comprising 400 mg tramadol hydrochloride.

17. The dosage form of claim 1, comprising 600 mg tramadol hydrochloride.
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