Extended release pharmaceutical compositions of levetiracetam

Abstract

This invention relates to novel extended release pharmaceutical compositions of levetiracetam and preparations and characterizations thereof. This invention further relates to using these extended release pharmaceutical compositions of levetiracetam for the treatment of cognitive impairment associated with central nervous system (CNS) disorders in a subject in need or at risk thereof.

1 .- 7 . (canceled) 
     
     
         8 . An extended release pharmaceutical composition comprising:
 a) 190 mg of levetiracetam;   b) 300 mg of hydroxypropyl methylcellulose;   c) 1.2 mg of colloidal silicon dioxide;   d) 102.8 mg of anhydrous dicalcium phosphate;   
       and
 e) 6 mg of magnesium stearate. 
 
     
     
         9 . The pharmaceutical composition of  claim 8 , wherein the hydroxypropyl methylcellulose is hypromellose 2208. 
     
     
         10 . (canceled) 
     
     
         11 . The pharmaceutical composition of  claim 8 , wherein the silicified microcrystalline cellulose is silicified microcrystalline cellulose SMCC 90. 
     
     
         12 . The pharmaceutical composition of  claim 8 , wherein the composition is formulated for once daily administration. 
     
     
         13 . The pharmaceutical composition of  claim 8 , wherein the composition is formulated for one-unit-dosage-form-once-daily administration. 
     
     
         14 . The pharmaceutical composition of  claim 8 , wherein the composition is in the form of a tablet. 
     
     
         15 . The pharmaceutical composition of  claim 14 , wherein the composition is formulated for one-tablet-once-daily administration. 
     
     
         16 . The pharmaceutical composition of  claim 15 , wherein the composition is formulated for oral administration. 
     
     
         17 . The pharmaceutical composition of  claim 8 , wherein the composition does not comprise a hydrophobic rate controlling polymer. 
     
     
         18 . The pharmaceutical composition of  claim 8 , wherein the composition does not comprise a functional coating. 
     
     
         19 . A method of improving cognition in a subject suffering from cognitive impairment or at risk thereof, wherein the method comprises administering the pharmaceutical composition of  claim 8 . 
     
     
         20 . The method of  claim 19 , wherein the subject suffers from cognitive impairment associated with a central nervous system (CNS) disorder, or at risk thereof. 
     
     
         21 . The method of  claim 20 , wherein the cognitive impairment is associated with age-related cognitive impairment. 
     
     
         22 . The method of  claim 20 , wherein the cognitive impairment is Mild Cognitive Impairment. 
     
     
         23 . The method of  claim 22 , wherein the Mild Cognitive Impairment is amnestic Mild Cognitive Impairment. 
     
     
         24 . The method of  claim 20 , wherein the cognitive impairment is associated with dementia, Alzheimer's disease, schizophrenia, amyotrophic lateral sclerosis, post traumatic stress disorder, cancer therapy, bipolar disorder mental retardation, Parkinson's disease, autism, compulsive behavior, or substance addiction. 
     
     
         25 . A method of treating mild cognitive impairment or amnestic mild cognitive impairment due to Alzheimer's disease or slowing the progression of mild cognitive impairment or amnestic mild cognitive impairment due to Alzheimer's disease in a human subject in need thereof, wherein the method comprises administering the pharmaceutical composition of  claim 8 . 
     
     
         26 .- 28 . (canceled) 
     
     
         29 . An extended release pharmaceutical composition comprising 125 mg to 250 mg levetiracetam, wherein the composition at steady state provides a plasma concentration of levetiracetam in a human subject of between 1.9 μg/ml and 4.4 μg/ml for at least 12 consecutive hours of the 14 hours after administration, and wherein the composition is formulated for once daily administration. 
     
     
         30 . The pharmaceutical composition according to  claim 29 , wherein the composition is formulated for oral administration. 
     
     
         31 . A method of treating a method of treating cognitive impairment or slowing the progression of cognitive impairment in a human subject in need or at risk thereof, wherein the method comprises administering the pharmaceutical composition of  claim 29 .