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Details for Patent: 8,409,613

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Details for Patent: 8,409,613

Title:Gastric retained gabapentin dosage form
Abstract: A method of treatment for epilepsy and other disease states is described, which comprises the delivery of gabapentin in a gastric retained dosage form.
Inventor(s): Berner; Bret (Half Moon Bay, CA), Hou; Sui Yuen Eddie (Foster City, CA), Gusler; Gloria M. (Cupertino, CA)
Assignee: Depomed, Inc. (Newark, CA)
Filing Date:Feb 14, 2012
Application Number:13/396,441
Claims:1. A method for the prophylactic treatment of migraine headaches comprising administering a gastric retained dosage form comprising a therapeutically effective amount of gabapentin or a pharmaceutically acceptable salt thereof to a mammal in need of such treatment, wherein the dosage form comprises a matrix and the gabapentin is dispersed in the matrix, and wherein upon ingestion of the dosage form the gabapentin is released from the matrix into the upper gastrointestinal tract over about 5-12 hours at a rate sufficient to achieve a lower maximum plasma concentration (C.sub.max) than that provided by an immediate release dosage form comprising an equal amount of gabapentin, and bioavailability of the gabapentin is at least 80% of that provided by the immediate release dosage form comprising an equal amount of gabapentin as measured by the area under the plasma concentration-time curve, AUC.sub.inf.

2. The method of claim 1, wherein the dosage form is administered once-daily.

3. The method of claim 2, wherein the dosage form is administered with a meal.

4. The method of claim 1, wherein the dosage form is administered twice-daily.

5. The method of claim 4, wherein each dosage form is administered with a meal.

6. The method of claim 1, which further comprises administering one or more therapeutic agents selected from the group consisting of tricyclic antidepressants, selective serotonin reuptake inhibitors, triptans, and ergotamine.

7. The method of claim 1, wherein the dosage form is administered once- or twice-daily and the total a mount of gabapentin the daily dosage is from about 200 mg to about 4000 mg.

8. The method of claim 1, wherein the dosage form is an extended release oral drug, dosage form for releasing gabapentin into the stomach, duodenum and small intestine of the mammal.

9. The method of claim 1, wherein the dosage form is a bilayered or multilayered tablet.

10. The method of claim 1, wherein the dosage form is a film coated dosage form or a capsule dosage form that allows for the extended release of the gabapentin in the stomach, duodenum and small intestine.

11. The method of claim 1, wherein the matrix comprises a hydrophilic polymer that swells to a size sufficient to promote retention in the stomach, duodenum and small intestine in a fed mode, and wherein the dosage form provides extended release of the gabapentin.

12. The method of claim 11, wherein the polymer is selected from the group consisting of polyethylene oxides, alkyl substituted cellulose materials, and combinations thereof.

13. The method of claim 11, wherein the dosage form is a tablet.

14. The method of claim 11, wherein the dosage form is a bilayered or multilayered tablet.

15. The method of claim 11, wherein the dosage form is a film coated dosage form or a capsule dosage form.

16. The method of claim 11, wherein the matrix comprises poly(ethyleneoxide) and hydroxypropylmethylcellulose.

17. The method of claim 1, wherein the dosage form further comprises a gas generating agent.

18. The method of claim 17, wherein the gabapentin is contained in a hydrophilic membrane with the gas generating agent.

19. The method of claim 1, wherein the mammal is a human.

20. A method of treating psychiatric disorders comprising administering a gastric retained dosage form comprising a therapeutically effective amount of gabapentin or a pharmaceutically acceptable salt thereof to a mammal in need of such treatment, wherein the dosage form comprises a matrix and the gabapentin is dispersed in the matrix, and wherein upon ingestion of the dosage form the gabapentin is released from the matrix into the upper gastrointestinal tract over about 5-12 hours at a rate sufficient to achieve a lower maximum plasma concentration (Cmax) than that provided by an immediate release dosage form comprising an equal amount of gabapentin, and bioavailability of the gabapentin is at least 80% of that provided by the immediate release dosage form comprising an equal amount of gabapentin as measured b the area under the plasma concentration-time curve, AUC.sub.inf.

21. A method of treating movement disorders comprising administering a gastric retained dosage form comprising a therapeutically effective amount of gabapentin or a pharmaceutically acceptable salt thereof to a mammal in need of such treatment, wherein the dosage form comprises a matrix and the gabapentin is dispersed in the matrix, and wherein upon ingestion of the dosage form the gabapentin is released from the matrix into the upper gastrointestinal tract over about 5-12 hours at a rate sufficient to achieve a lower maximum plasma concentration (Cmax) than that provided by an immediate release dosage form comprising an equal amount of gabapentin, and bioavailability of gabapentin is at least 80% of that provided by the immediate release dosage form comprising an equal amount of gabapentin as measured by the area under the plasma concentration-time curve, AUC.sub.inf.

22. The method of claim 21, wherein the movement disorder is restless leg syndrome, periodic movement disorder of sleep, essential tremor or acquired nystagmus.

23. The method of claim 21, which further comprises administering one or more therapeutic agents selected from the group consisting of opioids, benzodiazepines, and dopaminergic agents.

24. The method of claim 21, wherein the dosage form is administered once- or twice-daily and the total amount of gabapentin in the daily dosage is from about 100 mg to about 4000 mg.

25. A method for administering a therapeutically effective amount of gabapentin to a mammal in need thereof, the method comprising administering gabapentin or a pharmaceutically acceptable salt thereof in a gastric retained dosage form comprising a matrix, wherein the gabapentin is dispersed in the matrix, and wherein the mammal is being treated for movement disorders, psychiatric disorders, or wherein the mammal is receiving prophylactic treatment for migraine headaches, and wherein upon ingestion of the dosage form the gabapentin is released from the matrix into the upper gastrointestinal tract over about 5-12 hours at a rate sufficient to achieve a lower maximum plasma concentration (C.sub.max) than that provided by an immediate release dosage form comprising an equal amount of gabapentin, and bioavailability of the gabapentin is at least 80% of that provided by the immediate release dosage form comprising an equal amount of gabapentin as measured by the area under the plasma concentration-time curve, AUC.sub.inf.

26. The method of claim 20, wherein the mammal is a human.

27. The method of claim 21, wherein the mammal is a human.
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