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|Title:||Gastric retentive gabapentin dosage forms and methods for using same|
|Abstract:||Provided is a method of treating a patient suffering from a pain state by administering to the patient a gastric retentive dosage form of gabapentin that is capable of administration in once-daily or twice daily dosing regimens. By reducing the need to administer gabapentin from the thrice-daily administrations characteristic of immediate release gabapentin, the gastric retentive gabapentin dosage forms provided herein have the advantages of improving patient compliance for gabapentin treatment. In addition to the foregoing, the gastric retentive gabapentin dosages forms also exhibit decreased blood plasma concentrations and increased bioavailability throughout the dosing regimen.|
|Inventor(s):||Berner; Bret (Half Moon Bay, CA), Hou; Sui Yuen Eddie (Foster City, CA), Gana; Theophilus J. (Leesburg, VA), Cramer; Marilou S. (Redwood City, CA)|
|Assignee:||Depomed, Inc. (Newark, CA)|
|Filing Date:||Dec 07, 2012|
|Claims:||1. A method of treating a symptom associated with menopause in a subject experiencing said symptom, comprising: administering to the subject a daily dose of 100 mg gabapentin in a gastric retentive dosage form comprising a hydrophilic polymer that upon ingestion swells to a size sufficient to achieve retention of the dosage form in the stomach in a fed mode for a period of at least about five hours, wherein the daily dose is administered as a 600 mg dose with a morning meal and a 1200 mg dose with an evening meal, and wherein the subject is experiencing hot flashes. |
2. The method of claim 1, wherein the subject is a menopausal female.
3. The method of claim 1, wherein the hydrophilic polymer comprises polyethylene oxide.
4. The method of claim 1, wherein the hydrophilic polymer comprises hydroxypropylmethylcellulose.
5. A method for treating hot flash in a subject comprising: administering to the subject in need thereof gabapentin in a gastric retentive dosage form comprising a hydrophilic polymer that upon ingestion swells to a size sufficient to achieve retention of the dosage form in the stomach in a fed mode for a period of at least about five hours, wherein said daily dose is administered as a 600 mg dose with a morning meal and a 1200 mg dose with an evening meal.
6. The method of claim 5, wherein the subject is a human.
7. The method of claim 6, wherein the human is a female.
8. The method of claim 7, wherein the female is a menopausal female.
9. The method of claim 6, wherein the human is a male.
10. The method of claim 5, wherein the subject has undergone or is undergoing chemotherapy.
11. The method of claim 5, wherein the hydrophilic polymer comprises polyethylene oxide.
12. The method of claim 5, wherein the hydrophilic polymer comprises hydroxypropylmethylcellulose.
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