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Claims for Patent: 7,332,183

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Claims for Patent: 7,332,183

Title:Multilayer dosage forms containing NSAIDs and triptans
Abstract:The present invention is directed to multilayer pharmaceutical tablets in which an NSAID and a triptan are present in separate and distinct layers. The layers are in a side-by-side configuration, which allows the dissolution of triptan and NSAID to occur independently and immediately.
Inventor(s): Plachetka; John R. (Chapel Hill, NC), Kothapalli; Venkata Markandeya (Cary, NC), Gilbert; Donna L. (Chapel Hill, NC)
Assignee: Pozen Inc. (Chapel Hill, NC)
Application Number:10/741,592
Patent Claims: 1. A multilayer pharmaceutical tablet comprising naproxen and a triptan and, wherein: a) substantially all of said triptan is in a first layer of said tablet and substantially all of said naproxen is in a second, separate layer; and b) said first layer and said second layer are in a side by side arrangement such that the dissolution of said naproxen occurs independently of said triptan.

2. The tablet of claim 1, wherein said naproxen is in the form of naproxen sodium at between 200 and 600 mg.

3. The tablet of claim 1, wherein said triptan is selected from the group consisting of: sumatriptan, eletriptan, rizatriptan, frovatriptan, alniotriptan, zolniitriptan, and naratriptan.

4. The tablet of claim 1, wherein said triptan is sumatriptan.

5. The tablet of claim 4, wherein said sumatriptan is in the form of sumatriptan succinate at between 25 and 100 mg.

6. The tablet of claim 1, wherein said first layer and said second layer are juxtaposed symmetrically along a single planar surface such that essentially all of said first layer is on one side of said planar surface and essentially all of said second layer is on the other side of said planar surface.

7. The tablet of claim 6, wherein said first layer and said second layer contact one another along said single planar surface.

8. The tablet of claim 6, wherein said first layer and said second layer are separated by at least one additional layer.

9. The tablet of any one of claims 1-8, wherein said tablet is a bilayer dosage form.

10. The tablet of any one of claims 1-8, further comprising a coating layer surrounding both said first layer and said second layer.

11. The tablet of any one of claims 2, 3 or 6-8, wherein said triptan is sumatriptan.

12. The tablet of claim 11, wherein said sumatriptan is in the form of sumatriptan succinate at between 25 and 100 mg.

13. A method of treating a patient for headache, comprising administering to said patient the tablet of any one of claims 1-8, wherein said patient is treated at a dosage effective to alleviate the pain associated with said headache.

14. The method of claim 13, wherein said headache is migraine headache.

15. A method of treating a patient for headache, comprising administering to said patient the tablet of claim 9, wherein said patient is treated at a dosage effective to alleviate the pain associated with said headache.

16. The method of claim 15, wherein said headache is migraine headache.

17. A method of treating a patient for headache, comprising administering to said patient the tablet of claim 10, wherein said patient is treated at a dosage effective to alleviate the pain associated with said headache.

18. The method of claim 17, wherein said headache is migraine headache.

19. A multilayer pharmaceutical tablet comprising an NSALD and a triptan, wherein a) substantially all of said triptan is in a first layer of said tablet and substantially all of said NSALD is in a second, separate layer; and b) said first layer and said second layer are in a side by side arrangement such that the dissolution of said NSAID occurs independently of said triptan.

20. A method for rapid release of sumatriptan and naproxen from an oral dosage form in a patient, the method comprising administering to said patient the tablet of claim 4 or claim 5, wherein in said patient, dissolution of sumatriptan and naproxen is faster from said tablet as compared to dissolution of sumatriptan and naproxen from a tablet where sumatriptan and naproxen are in a physical admixture.
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