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Claims for Patent: 7,858,118

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Claims for Patent: 7,858,118

Title:Extended release composition containing Tramadol
Abstract:An oral Tramadol-containing pharmaceutical composition suitable for once daily administration, which contains an amount of Tramadol or a pharmaceutically acceptable salt thereof, providing in vivo, a time of Tramadol peak plasma concentration (T.sub.max) of greater than 10 hours, and peak Tramadol plasma concentration (C.sub.max) which are less than three times the plasma concentration obtained 24 hours after administration (C.sub.24h) of a single dose of the composition.
Inventor(s): Deboeck; Arthur M. (Gurabo, PR), Vanderbist; Francis (Meise, BE), Sereno; Antonio (Melsbroeck, BE)
Assignee: Galephar Pharmaceutical Research, Inc. (Juncos, PR)
Application Number:10/119,939
Patent Claims: 1. A solid pharmaceutical composition in a capsule comprising an effective amount of Tramadol or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier; the composition comprising a fast release Tramadol tablet, and slow release Tramadol beads, said tablet comprising between 10 and 30% by wt. of a unit dose of Tramadol or salt thereof, and said beads being free of binder and comprising a Tramadol salt, sucrose stearate and being coated with a porous membrane from which the Tramadol is liberated slowly and exhibiting an at least biphasic absorption profile in vivo under fed and fasted administration conditions providing a time of Tramadol peak plasma concentration (Tmax) greater than about 10 hours after administration and peak concentration (C.sub.max) which is less than about three times the plasma concentration obtained 24 hours after once daily administration (C.sub.24th) of a single dose of said composition; and wherein a first peak of plasma concentration rise occurs within about 0.5 to 4 hours after administration, and wherein the capsule comprises a gelatine or hydroxypropylmethylcellulose capsule.

2. The pharmaceutical composition of claim 1, which provides, after single administration in vivo, O-desmethyl Tramadol peak plasma concentration (C.sub.max) which is less than about twice the plasma concentration obtained 24 hours after administration (C.sub.24th).

3. The pharmaceutical composition of claim 1, which provides, after single administration in vivo, a time of O-desmethyl Tramadol peak plasma concentration (T.sub.max) greater than about 10 hours.

4. The pharmaceutical composition of claim 1, wherein said pharmaceutical composition provides a pharmacokinetic profile that is unaffected by patient food intake.

5. The pharmaceutical composition of claim 1, wherein said pharmaceutical composition provides effective pain control in humans during a period of about 24 hours after administration.

6. The pharmaceutical composition of claim 5, wherein the pharmaceutical composition provides effective pain control in humans, starting at about 1 to 2 hours after administration and lasting for about 24 hours after administration.

7. The pharmaceutical composition of claim 1, wherein said fast release Tramadol tablet releases about 80% of Tramadol therein within 1 hour.

8. The pharmaceutical composition of claim 1, wherein said beads are free of binder and comprise a mixture of Tramadol hydrochloride, microcrystalline cellulose and sucrose stearate.

9. The pharmaceutical composition of claim 1, wherein the amount of Tramadol or salt thereof in said tablet in such that a peak plasma concentration therefrom is less than a peak plasma concentration from said beads.

10. A method of treating post-surgical pain, which comprises administering an effective amount of the pharmaceutical composition of claim 1, to a mammal in need thereof.

11. The method of claim 10, wherein the mammal is a human.

12. The pharmaceutical composition of claim 1, wherein said porous membrane is a microporous membrane.

13. The pharmaceutical composition of claim 12, wherein said microporous membrane is present in an amount of 2 to 55% by weight of the weight of the beads.

14. The pharmaceutical composition of claim 12, wherein said microporous membrane is made of a water-soluble or dispersible film-forming polymer or copolymer comprising polyacrylates, polymethacrylates, ethylcelluloses, hydroxylpropyleellulose or hydroxypropylmethylcellulose.

15. The pharmaceutical composition of claim 1, which exhibits a biphasic absorption profile in vivo under fed and fasted administration conditions.

16. The pharmaceutical composition of claim 1, wherein said fast release tablet has a diameter of between 3 mm and 5 mm.

17. The pharmaceutical composition of claim 1, wherein a first C.sub.max obtained from said fast release tablet is less than a second C.sub.max obtained from said slow release beads.
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