Method of treatment and device for the improved bioavailability of leukotriene receptor antagonists

Abstract

Disclosed is a method of administration and device for the improved bioavailability of leukotriene receptor antagonists. This method and device involve an alkaline surface pH oral film dosage form designed to deliver leukotriene receptor antagonists, such as Montelukast, to the stomach in an amorphous precipitate suspended in aqueous medium. Also disclosed is a device and method for treating a disease, such as a neurodegenerative disease or condition associated with neuroinflammation induced by a leukotriene. The device is a film unit dosage form having an alkaline surface pH film layer and a safe and effective amount of Montelukast. The device is configured and formulated to predominantly achieve enteral delivery of the Montelukast. The method includes enterally delivering to a human or an animal in need of treatment, a safe and effective amount of Montelukast capable of crossing the blood-brain barrier.

1 . A method of treating conditions where leukotriene inhibition is desired comprising administering to a patient in need thereof an oral film dosage form having an alkaline surface pH containing about 10 to about 75 mg of Montelukast, as needed, up to a total dose of 75 mg per day for the treatment of neuroinflammation, for a continuous period of at least 30 days. 
     
     
         2 . The method of  claim 1 , wherein the oral film dosage form is administered for a period of at least 60 days. 
     
     
         3 . The method of  claim 1 , wherein the oral film dosage form is administered for a period of at least 90 days. 
     
     
         4 . The method of  claim 1 , wherein the oral film dosage form has a surface pH greater than pH 7. 
     
     
         5 . The method of  claim 1 , wherein the oral film dosage form has a surface pH greater than pH 7.5. 
     
     
         6 . The method of  claim 1 , wherein the oral film dosage form has a surface pH greater than pH 8. 
     
     
         7 . The method of  claim 1 , wherein the oral film dosage form has a surface pH greater than pH 8.5. 
     
     
         8 . The method of  claim 1 , wherein the oral film dosage form has a surface pH greater than pH 9. 
     
     
         9 . The method of  claim 1 , wherein the oral film dosage form comprises between 30 and 50 mg of Montelukast. 
     
     
         10 . The method of  claim 1 , wherein the oral film dosage form has a surface pH between pH 8.5 and 9.5. 
     
     
         11 . The method of  claim 1 , wherein the oral film dosage form is unbuffered. 
     
     
         12 . The method of  claim 1 , wherein the oral film dosage form comprises a plurality of stabilizers. 
     
     
         13 . The method of  claim 1 , wherein the leukotriene receptor antagonist is incorporated into the oral film dosage form in an amorphous form. 
     
     
         14 . The method of  claim 1 , wherein the leukotriene receptor antagonist is solubilized in the oral film dosage form. 
     
     
         15 . The method of  claim 1 , wherein the Montelukast comprises 40% to 99% of the oral film dosage form (w/w). 
     
     
         16 . A film oral dosage form for treating conditions where leukotriene inhibition is desired, comprising:
 a combination of at least one film former polymer, at least one plasticizer, and from 10 mg to 75 mg of Montelukast, wherein the oral film dosage form has a surface pH greater than 7.5.   
     
     
         17 . The film oral dosage form of  claim 16 , comprising from 20 mg to 60 mg Montelukast. 
     
     
         18 . The film oral dosage form of  claim 16 , wherein the surface pH is greater than 8.5. 
     
     
         19 . The film oral dosage form of  claim 18 , wherein the surface pH is greater than 8.5.