Methods of treatment using a gastric retained gabapentin dosage form
View Patent ↗A method of treatment for epilepsy and other disease states is described, which comprises delivery of gabapentin in a gastric retained dosage form.
1. A method for treating a subject diagnosed with epilepsy, psychiatric disorders, neuropathic pain or movement disorder, comprising
administering to the subject an extended release oral dosage form comprising an osmotic device comprising a core comprising gabapentin and a semipermeable membrane surrounding the core, wherein the semipermeable membrane comprises a plasticizer, is permeable to a fluid in an environment of use and is substantially impermeable to unsolubilized gabapentin,
wherein the oral dosage form as formulated is of sufficient size to promote retention in the stomach of the subject in the fed mode for a period of at least 5 hours, and
wherein the gabapentin is released into the upper gastrointestinal tract over a period of about 5-12 hours at a rate sufficient to achieve a lower maximum plasma concentration (C max ) compared to an equal dose of gabapentin provided by an immediate release dosage form.
2. The method according to claim 1 , wherein the dosage form provides for bioavailability of gabapentin at a level greater than or equal to 80% of that provided by an equal dose of gabapentin released by the immediate release dosage form as measured by the plasma AUC inf .
3. The method according to claim 1 , wherein the osmotic device comprises an elementary pump.
4. The method according to claim 1 , wherein the osmotic device comprises a macroporous membrane.
5. The method according to claim 1 , wherein the dosage form comprises about 100 mg to about 4800 mg gabapentin.
6. The method according to claim 1 , wherein the dosage form comprises about 300 mg or about 600 mg gabapentin.
7. The method according to claim 1 , 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 deoxybarbiturate, 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 neuroleptic, a serotonin reuptake inhibitor, buproprion, nefadone, venlaxatine, nefadone, diazepam, oxazepam, a dopaminergic agent, clonazepam, a triptan and ergotamine.
8. The method according to claim 1 , wherein the osmotic device comprises a push-pull osmotic device comprising a first osmotic composition and a second osmotic composition housed in a compartment of the push-pull osmotic device.
9. The method according to claim 8 , wherein the dosage form provides for bioavailability of gabapentin at a level greater than or equal to 80% of that provided by an equal dose of gabapentin released by the immediate release dosage form as measured by the plasma AUC inf .
10. The method according to claim 8 , wherein the dosage form comprises about 100 mg to about 4800 mg gabapentin.
11. The method according to claim 8 , wherein the dosage form comprises about 300 mg or about 600 mg gabapentin.
12. The method according to claim 8 , 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 deoxybarbiturate, 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 neuroleptic, a serotonin reuptake inhibitor, buproprion, nefadone, venlaxatine, nefadone, diazepam, oxazepam, a dopaminergic agent, clonazepam, a triptan and ergotamine.
13. The method of claim 1 , wherein the subject is a human.