Multilayer dosage forms containing NSAIDs and triptans

• US 7,332,183 B2
• Filed: 12/22/2003
• Issued: 02/19/2008
• Est. Priority Date: 12/26/2002
• Status: Active Grant

• Current Assignee: Nuvo Pharmaceuticals (Ireland) Designated Activity Company
• Original Assignee: Pozen Incorporated (Aralez Pharmaceuticals Inc.)
• Inventors: Gilbert, Donna L., Kothapalli, Venkata Markandeya, Plachetka, John R.
• Primary Examiner(s): Kennedy; Sharon
• Application Number:
  US10/741,592
• Publication Number:
  US 20040180089A1
• Time in Patent Office: 1,520 Days
• Field of Search: 424/472, 424/473, 424/474
• US Class Current: 424/472
• CPC Class Codes: A61K 31/00 Medicinal preparations containing organic active ingredients
• CPC Class Codes: A61K 31/167 having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
• CPC Class Codes: A61K 31/19 Carboxylic acids, e.g. valproic acid salicylic acid A61K31/60
• CPC Class Codes: A61K 31/192 having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid cannabinoids A61K31/658
• CPC Class Codes: A61K 31/40 having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
• CPC Class Codes: A61K 31/405 Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin
• CPC Class Codes: A61K 31/495 having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazinesA61K31/48 takes precedence ; with three nitrogen atoms A61K31/53
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/2009 Inorganic compounds
• CPC Class Codes: A61K 9/2054 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
• CPC Class Codes: A61K 9/2077 Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
• CPC Class Codes: A61K 9/209 containing drug in at least two layers or in the core and in at least one outer layer
• CPC Class Codes: A61K 9/2866 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 25/06 Antimigraine agents
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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.

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.

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.

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.