Controlled release compositions for treatment of cognitive, emotional and mental ailments and disorders

Abstract

A montelukast composition having a therapeutically effective amount of montelukast in a sustained release is disclosed. A montelukast composition having a therapeutically effective amount of montelukast in an immediate release and sustained release is also disclosed.

1 . A composition comprising:
 a therapeutically effective amount montelukast; and   a rate release modifier.   
     
     
         2 . A modified release tablet having two portions, wherein a first portion comprises a first quantity of montelukast in an immediate release formulation which becomes fully bioavailable in the subject's stomach and a second portion comprises a second quantity of montelukast in a release-delaying matrix. 
     
     
         3 . The modified release tablet of  claim 2 , wherein the first of multiple doses of a standard immediate release formulation having one fraction the amount of montelukast is dosed about every two hours over a 12 hour period, and wherein said tablet also provides therapeutically effective bioavailability for at least twelve hours after a single dose in a human subject. 
     
     
         4 . The modified release tablet of  claim 2 , wherein the total quantity of montelukast is from about 30 mg to about 90 mg. 
     
     
         5 . The modified release tablet of  claim 2 , wherein the total quantity of montelukast in the immediate release formulation is from about 5 mg to about 25 mg. 
     
     
         6 . The modified release tablet of  claim 2 , wherein the total quantity of montelukast in the release-delaying matrix is from about 20 mg to about 90 mg. 
     
     
         7 . The modified release tablet of  claim 2 , wherein the total quantity of montelukast in the immediate release formulation is about 20 mg and wherein the total quantity of montelukast in the release-delaying matrix is about 60 mg. 
     
     
         8 . The modified release tablet of  claim 2 , additionally comprising a vitamin selected from folic acid or a reduced folate, N-acetyl-L-cysteine, vitamin B 12 , vitamin B 6 , or vitamin B 2 . 
     
     
         9 . A multi-particulate pharmaceutical dosage form of a montelukast providing a modified release profile comprising:
 a population of immediate release beads comprising montelukast,   a population of extended release beads, wherein said extended release beads comprise a montelukast core particle and an extended release coating.   
     
     
         10 . The multi-particulate pharmaceutical dosage form of  claim 9 , wherein said dosage form when dissolution tested using United States Pharmacopoeia Apparatus 2 (paddles @ 50 rpm) in 900 mL of 0.1N HC1 at 37° C. exhibits a drug release profile substantially corresponding to the following pattern:
 after about 2 hours, no more than about 40% of the total active is released; 
 after about 4 hours, from about 40-65% of the total active is released after about 8 hours, from about 60-85% of the total active is released; 
 wherein said dosage form provides therapeutically effective plasma concentration over a period of 12 hours to improve memory, mental clarity, mood, attention span, and cognitive function when administered to a patient in need thereof. 
 
     
     
         11 . The multi-particulate pharmaceutical dosage form of  claim 9 , additionally comprising a vitamin selected from folic acid or a reduced folate, N-acetyl-L-cysteine, vitamin B 12 , vitamin B 6 , or vitamin B 2 .