Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Farmers Insurance
Harvard Business School
Boehringer Ingelheim
Argus Health
Cipla
Queensland Health
Federal Trade Commission
Healthtrust
Merck
Chinese Patent Office

Generated: October 23, 2017

DrugPatentWatch Database Preview

Details for Patent: ► Subscribe

« Back to Dashboard

Details for Patent: ► Subscribe

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)
Assignee: Depomed, Inc. (Newark, CA)
Filing Date:Apr 01, 2013
Application Number:13/854,433
Claims:1. An oral dosage form comprising gabapentin or a pharmaceutically acceptable salt thereof, wherein the dosage form comprises (a) at least one component that contains a gas generating agent and the gabapentin, and (b) at least one hydrophilic membrane in the form of a sachet, which contains component (a), and wherein the hydrophilic membrane expands by inflation, floats on the aqueous phase in the stomach, and is permeable to gastric juice, and wherein gabapentin is released from the dosage form into the upper gastrointestinal tract over about 5-12 hours at a rate sufficient to achieve a lower maximum plasma concentration 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.int.

2. The dosage form of claim 1, wherein the gas-generating agent releases carbon dioxide or nitrogen.

3. The dosage form of claim 1, further comprising a second therapeutic agent selected from the group consisting of a hydantoin, an iminostilbene, a valproate, a phenyltriazine, a barbiturate, a dexoybarbiturate, a benzodiazepine, a carbamate, an anticonvulsant other than gabapentin, a tricyclic antidepressant, levadopa, carbidopa, an opioid, lithium, carbamazepine, valproate, trifluoperazine, clonazepam, risperidone, lorazepam, venlafaxine, clozapine, olanzapine, a benzodiazepine, a neuroleptic, a serotonin reuptake inhibitor, buproprion, nefadone, venlaxatine, nefadone, diazepam, oxazepam, a dopaminergic agent, clonazepam, a triptine and ergotamine.

4. A method for administering a therapeutically effective amount of gabapentin or a pharmaceutically acceptable salt thereof to a subject, comprising administering a dosage form comprising the gabapentin, wherein the dosage form comprises (a) at least one component that contains a gas generating agent and the gabapentin, and (b) at least one hydrophilic membrane in the form of a sachet which contains component (a), wherein the hydrophilic membrane expands by inflation, floats on the aqueous phase in the stomach, and is permeable to gastric juice, and wherein gabapentin is released from the dosage form into the upper gastrointestinal tract over about 5-12 hours at a rate sufficient to achieve a lower maximum plasma concentration 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.int.

5. The method of claim 4, wherein the gas-generating agent releases carbon dioxide or nitrogen.

6. The method of claim 4, wherein the at least one hydrophilic membrane is in the form of a microporous membrane.

7. The method of claim 4, wherein the dosage form is administered once-daily.

8. The method of claim 7, wherein the dosage form is administered with a meal.

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

10. The method of claim 9, wherein each dosage form is administered with a meal.

11. The method of claim 4, wherein the dosage form comprises between about 100 mg and 4800 mg gabapentin.

12. The method of claim 4, wherein the dosage form comprises about 300 mg or about 600 mg gabapentin.

13. The method of claim 4, wherein the dosage form further comprises a second therapeutic agent selected from the group consisting of a hydantoin, an iminostilbene, a valproate, a phenyltriazine, a barbiturate, a dexoybarbiturate, a benzodiazepine, a carbamate, an anticonvulsant other than gabapentin, a tricyclic antidepressant, levadopa, carbidopa, an opioid, lithium, carbamazepine, valproate, trifluoperazine, clonazepam, risperidone, lorazepam, venlafaxine, clozapine, olanzapine, a benzodiazepine, a neuroleptic, a serotonin reuptake inhibitor, buproprion, nefadone, venlaxatine, nefadone, diazepam, oxazepam, a dopaminergic agent, clonazepam, a triptine and ergotamine.

14. A method for treating a disorder, comprising administering a dosage form comprising the gabapentin or a pharmaceutically acceptable salt thereof, wherein the dosage forms comprises (a) at least one component that contains a gas generating agent and the gabapentin, and (b) at least one hydrophilic membrane in the form of a sachet which contains component (a), wherein the hydrophilic membrane expands by inflation, floats on the aqueous phase in the stomach, and is permeable to gastric juice, and wherein gabapentin is released from the dosage form into the upper gastrointestinal tract over about 5-12 hours at a rate sufficient to achieve a lower maximum plasma concentration 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.int.

15. The method of claim 14, wherein the dosage form is administered once-daily or twice-daily.

16. The method of claim 14, wherein the disorder is a neuropathic pain, epilepsy, a movement disorder, or a psychiatric disorder.
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Farmers Insurance
Novartis
Baxter
Julphar
Medtronic
AstraZeneca
Harvard Business School
Johnson and Johnson
Mallinckrodt
Chubb

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot