Ondansetron sublingual spray formulation

Abstract

The invention is directed to sublingual spray formulations containing ondansetron or a pharmaceutically acceptable salt thereof and water. The invention is further directed to methods for treating or preventing nausea and emesis associated with cancer treatments by administering sublingual spray formulations containing ondansetron or a pharmaceutically acceptable salt thereof to a patient in need thereof.

we claim: 
     
         1 . A sublingual formulation comprising discrete liquid droplets of an effective amount of ondansetron or a salt thereof, in water, the droplets having a mean diameter of greater than 10 microns. 
     
     
         2 . The formulation of  claim 1 , wherein the droplets have a mean diameter of from about 20 to about 200 microns. 
     
     
         3 . The formulation of  claim 1 , wherein the droplets have a mean diameter of about 20 microns. 
     
     
         4 . A sublingual formulation comprising an effective amount of ondansetron or a salt thereof, in water, that is capable of producing a droplet size distribution wherein the mean Dv(10) is from about 10 to about 30 microns during administration, the mean Dv(50) is from about 15 to about 80 microns during administration or the mean Dv(90) is from about 40 to about 200 microns during administration.