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.

1 . A method for treating a symptom associated with menopause, comprising:
 administering to a subject 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, and   wherein bioavailability of gabapentin from the gastric retentive dosage form, as measured by area under the curve (AUC), is between about 70% to about 130% of the bioavailability of a comparable immediate release dose of gabapentin.   
   
   
       2 . The method of  claim 1 , wherein the subject is a menopausal female. 
   
   
       3 . The method of  claim 1 , wherein said administering comprises once daily administration. 
   
   
       4 . The method of  claim 1 , wherein said administering comprises twice daily administration. 
   
   
       5 . The method of  claim 4 , wherein said twice daily administration comprises administering a total daily dose of between about 300 mg to about 9600 mg gabapentin. 
   
   
       6 . The method of  claim 4 , wherein said twice daily administration comprises administering at least one dosage form comprising a dose of gabapentin with an evening meal. 
   
   
       7 . The method of  claim 6 , wherein said twice daily administration comprises administering at least one dosage form comprising a dose of gabapentin with a morning meal. 
   
   
       8 . The method of  claim 7 , wherein the dose of gabapentin administered with the morning meal is less than the dose of gabapentin administered with the evening meal. 
   
   
       9 . The method of  claim 1 , wherein said administering comprises administering a total daily dose of between about 300 mg to about 9600 mg gabapentin. 
   
   
       10 . The method of  claim 1 , wherein the hydrophilic polymer comprises polyethylene oxide. 
   
   
       11 . The method of  claim 1 , wherein the hydrophilic polymer comprises hydroxypropylmethylcellulose. 
   
   
       12 . The method of  claim 1 , wherein the symptom associated with menopause is a hot flash. 
   
   
       13 . A method for treating hot flash in a subject comprising:
 administering to the subject 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, and   wherein bioavailability of gabapentin from the gastric retentive dosage form, as measured by area under the curve (AUC), is between about 70% to about 130% of the bioavailability of a comparable immediate release dose of gabapentin.   
   
   
       14 . The method of  claim 13 , wherein the subject is a human. 
   
   
       15 . The method of  claim 14 , wherein the human is a female. 
   
   
       16 . The method of  claim 15 , wherein the female is a menopausal female. 
   
   
       17 . The method of  claim 14 , wherein the human is a male. 
   
   
       18 . The method of  claim 13 , wherein the subject has undergone or is undergoing chemotherapy. 
   
   
       19 . The method of  claim 13 , wherein said administering comprises once daily administration. 
   
   
       20 . The method of  claim 13 , wherein said administering comprises twice daily administration. 
   
   
       21 . The method of  claim 20 , wherein said twice daily administration comprises administering a total daily dose of between about 300 mg to about 9600 mg gabapentin. 
   
   
       22 . The method of  claim 20 , wherein said twice daily administration comprises administering at least one dosage form comprising a dose of gabapentin with an evening meal. 
   
   
       23 . The method of  claim 22 , wherein said twice daily administration comprises administering at least one dosage form comprising a dose of gabapentin with a morning meal. 
   
   
       24 . The method of  claim 23 , wherein the dose of gabapentin administered with the morning meal is less than the dose of gabapentin administered with the evening meal. 
   
   
       25 . The method of  claim 13 , wherein said administering comprising administering a total daily dose of between about 300 mg to about 9600 mg gabapentin. 
   
   
       26 . The method of  claim 13 , wherein the hydrophilic polymer comprises polyethylene oxide. 
   
   
       27 . The method of  claim 13 , wherein the hydrophilic polymer comprises hydroxypropylmethylcellulose.