Device and method of treating conditions associated with neuroinflammation

Abstract

Disclosed is a device and method for treating a neurodegenerative disease or condition associated with neuroinflammation induced by a leukotriene. The device is a film unit dosage form having a film layer and a safe and effective amount of a leukotriene receptor antagonist or leukotriene synthesis inhibitor. The device is configured and formulated to achieve transmucosal and/or enteral delivery of the leukotriene receptor antagonist or leukotriene synthesis inhibitor. The method includes transmucosally and/or enterally delivering to an animal in need of treatment, a safe and effective amount of a leukotriene blocker capable of crossing the blood-brain barrier.

1 . A method of treating a neurodegenerative disease or neuroinflammatory disorder, comprising:
 delivering to a person or other animal in need of treatment for a neurodegenerative disease or neuroinflammatory disorder via a film dosage form, a safe and effective amount of a leukotriene blocker.   
     
     
         2 . The method of  claim 1 , wherein the film dosage form includes a bioadhesive film layer in which the leukotriene blocker is incorporated. 
     
     
         3 . The method of  claim 1 , wherein the leukotriene blocker is Montelukast. 
     
     
         4 . The method of  claim 1 , wherein the leukotriene blocker is Montelukast present in an amount of from 0.5 mg to 20 mg. 
     
     
         5 . The method of  claim 1 , wherein the leukotriene blocker is zafirlukast. 
     
     
         6 . The method of  claim 2 , wherein the film comprises a pH modifier. 
     
     
         7 . The method of  claim 1 , wherein the amount of leukotriene blocker is 1-20 mg per dosing. 
     
     
         8 . A method of treating a subject in need of treatment for a neurodegenerative disease or neuroinflammatory disorder, comprising:
 administering to the subject a film oral dosage form having a leukotriene blocker in a film layer comprising a film-forming polymer.   
     
     
         9 . The method of  claim 8 , wherein the film oral dosage form includes a bioadhesive polymer to maintain adhesive contact between the film oral dosage form and mucosal tissue to facilitate transmucosal delivery of the leukotriene blocker into a bloodstream of the subject in an amount that is safe and effective. 
     
     
         10 . The method of  claim 9 , wherein the bioadhesive polymer is incorporated in a bioadhesive layer joined to the film layer in which the leukotriene blocker is dispersed. 
     
     
         11 . The method of  claim 9 , wherein the bioadhesive polymer is incorporated in the film layer in which the leukotriene blocker is dispersed. 
     
     
         12 . The method of  claim 10 , wherein the bioadhesive layer further comprises a penetration enhancing agent to increase the rate or extend of transmucosal absorption of the leukotriene blocker. 
     
     
         13 . The method of  claim 11 , wherein the film layer in which the leukotriene blocker is dispersed further comprises a penetration enhancing agent to increase the rate or amount of transmucosal absorption of the leukotriene blocker. 
     
     
         14 . The method of  claim 9 , wherein the leukotriene blocker is present in the form of an electrostatic complex with a cationic biopolymer. 
     
     
         15 . The method of  claim 10 , wherein the oral film dosage form further comprises a barrier layer comprising a high viscosity polymer that prevents or inhibits diffusion of the leukotriene blocker, whereby transmucosal absorption is enhanced. 
     
     
         16 . The method of  claim 11 , wherein the oral film dosage form further comprises a barrier layer joined to a side of the film layer opposite the bioadhesive layer, the barrier layer comprising a water insoluble polymer that prevents or inhibits diffusion of the leukotriene blocker, whereby transmucosal absorption is enhanced. 
     
     
         17 . A method of treating a subject in need of treatment for a neurodegenerative disease or neuroinflammatory disorder, comprising:
 administering to the subject a film oral dosage form having Montelukast dispersed in a film layer comprising a film-forming polymer, wherein the film oral dosage form includes a bioadhesive polymer to maintain adhesive contact between the film oral dosage form and mucosal tissue to facilitate transmucosal delivery of the Montelukast into a bloodstream of the subject in an amount that is safe and effective, wherein the Montelukast is present in the form of an electrostatic complex with a cationic biopolymer.   
     
     
         18 . The method of  claim 17 , wherein the Montelukast is present in an amount of from 0.5 mg to 20 mg. 
     
     
         19 . The method of  claim 18 , wherein the film oral dosage form further comprises a penetration enhancing agent to increase the rate or amount of transmucosal absorption of the leukotriene blocker. 
     
     
         20 . The method of  claim 18 , wherein the oral film dosage form further comprises a barrier layer comprising a water insoluble polymer that prevents or inhibits diffusion of the leukotriene blocker, whereby transmucosal absorption is enhanced.