Topiramate pharmaceutical composition

• US 20060121112A1
• Filed: 12/08/2005
• Published: 06/08/2006
• Est. Priority Date: 12/08/2004
• Status: Abandoned Application

• Current Assignee: Alkermes Pharma Ireland Limited (Alkermes plc)
• Original Assignee: Elan Corporation PLC (Perrigo Company PLC)
• Inventors: Liversidge, Gary, Jenkins, Scott A.
• Application Number:
  US11/297,737
• Publication Number:
  US 20060121112A1
• Time in Patent Office: Days
• US Class Current: 424/468
• CPC Class Codes: A61K 31/7008 Compounds having an amino group directly attached to a carbon atom of the saccharide radical, e.g. D-galactosamine, ranimustine
• CPC Class Codes: A61K 9/5084 Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs tablets containing such a mixture A61K9/2077

Abstract

A once daily controlled-release pharmaceutical formulation which contains therapeutic amounts of topiramate and which is capable of being administered to specific regions along the gastrointestinal tract used to treat various types of conditions, for example, partial seizures with or without secondarily generalized seizures, primary generalized tonic-clonic seizures, seizures associated with Lennox Gastaut Syndrome, migraines, and obesity.

Claims

1. A controlled-release pharmaceutical composition comprising topiramate which is capable of delivering therapeutic amounts of topiramate to a specific region of the gastrointestinal tract of an animal.

2. The composition of claim 1 wherein the animal is a human.

3. The composition of claim 1 wherein the specific region of the gastrointestinal tract is the proximal small bowel, distal small bowel or colon.

15. A method of treating an animal for partial seizures with or without secondarily generalized seizures, primary generalized tonic-clonic seizures, seizures associated with Lennox Gastaut Syndrome or migraines comprising the step of administering the composition of claim 1.

16. The composition of claim 1 further comprising a sympathomimetic agent.

17. The composition of claim 16 wherein the sympathomimetic agent is phentermine.

4. A controlled-release pharmaceutical composition comprising:

(A) an immediate-release component comprising from about 5 mg to about 250 mg of topiramate which is released in the body within about 1 hour after administration; and

(B) a delayed-release component comprising from about 5 mg to about 250 mg of topiramate which is released in the body over a period of time of about 6 hours to 24 hours after administration.

5. An oral dosage form comprising the composition of claim 4.

6. The oral dosage form of claim 5 wherein the dosage is designed to be administered as a once-daily formulation.

7. The composition of claim 4 wherein the delayed-release component is achieved by the use of pharmaceutically acceptable erodable formulation.

8. The composition of claim 4 wherein the delayed-release component is achieved by the use of a pharmaceutically acceptable diffusion controlled formulation.

9. The composition of claim 4 wherein the delayed-release component is achieved by the use of a pharmaceutically acceptable osmotically controlled formulation.

11. The composition of claim 8 which comprises the following components, each of which includes topiramate:

(A) an immediate-release component comprising from about 5 mg to about 250 mg of topiramate which is released as a pulse within about 1 hour after ingestion; and

(B) a delayed-release component comprising from about 5 mg to about 250 mg of topiramate which is released as a pulse at about 6 hours, about 9 hours, about 12 hours or about 18 hours after the release of the immediate-release component.

12. The composition of claim 9 which further comprises at least one additional delayed-release component comprising from about 5 mg to about 250 mg of topiramate which is released as a pulse at about 6 hours, about 9 hours, about 12 hours or about 18 hours after the release of the first delayed-release component.

13. A solid oral dosage form comprising the composition of claim 8.

18. The composition of claim 4 further comprising a sympathomimetic agent.

19. An oral dosage form comprising the composition of claim 18.

20. The oral dosage form of claim 19 wherein the dosage is designed to be administered as a once-daily formulation.

10. An oral controlled-release pharmaceutical composition comprising topiramate which is designed to deliver therapeutic amounts of topiramate to the colonic region of a gastrointestinal tract at lower doses than other regions of the gastrointestinal tract with substantially equal bioavailability.

14. The solid oral dosage form of claim 10 wherein the dosage is administered as a once-daily formulation.