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.

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), wherein the hydrophilic membrane expands by inflation, floats on the aqueous phase in the stomach, and is permeable to gastric juice.   
     
     
         2 . The dosage form of  claim 1 , further comprising a capsule which contains components (a) and (b) and which disintegrates upon oral administration of the dosage form. 
     
     
         3 . The dosage form of  claim 1 , wherein the gas-generating agent releases carbon dioxide or nitrogen. 
     
     
         4 . 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. 
     
     
         5 . 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.   
     
     
         6 . The method of  claim 5 , wherein upon ingestion of the dosage form bioavailability of gabapentin released over 5-12 hours is at least about 80% of that provided by an immediate release dosage form comprising an equal amount of gabapentin as measured by the area under the plasma concentration-time, AUC inf . 
     
     
         7 . The method of  claim 5 , wherein the gas-generating agent releases carbon dioxide or nitrogen. 
     
     
         8 . The method of  claim 5 , wherein the at least one hydrophilic membrane is in the form of a microporous membrane. 
     
     
         9 . The method of  claim 5 , wherein the dosage form further comprises a capsule which contains components (a) and (b) and which disintegrates upon oral administration of the dosage form. 
     
     
         10 . The method of  claim 5 , wherein the dosage form is administered once-daily. 
     
     
         11 . The method of  claim 10 , wherein the dosage form is administered with a meal. 
     
     
         12 . The method of  claim 5 , wherein the dosage form is administered twice-daily. 
     
     
         13 . The method of  claim 12 , wherein each dosage form is administered with a meal. 
     
     
         14 . The method of  claim 5 , wherein the dosage form comprises between about 100 mg and 4800 mg gabapentin. 
     
     
         15 . The method of  claim 5 , wherein the dosage form comprises about 300 mg or about 600 mg gabapentin. 
     
     
         16 . The method of  claim 5 , 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. 
     
     
         17 . A method for treating a disorder, comprising administering a 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), wherein the hydrophilic membrane expands by inflation, floats on the aqueous phase in the stomach, and is permeable to gastric juice.   
     
     
         18 . The method of  claim 17 , wherein upon ingestion of the dosage form bioavailability of gabapentin released over 5-12 hours is at least about 80% of that provided by an immediate release dosage form comprising an equal amount of gabapentin as measured by the area under the plasma concentration-time, AUC inf . 
     
     
         19 . The method of  claim 17 , wherein the dosage form is administered once-daily or twice-daily. 
     
     
         20 . The method of  claim 17 , wherein the disorder is a neuropathic pain, epilepsy, a movement disorder, or a psychiatric disorder.