Buccal, polar and non-polar spray containing zolipidem

Abstract

Buccal aerosol sprays or capsules using polar and non-polar solvents have now been developed which provide zolpidem for rapid absorption through the oral mucosa, resulting in fast onset of effect. The buccal polar compositions of the invention comprise formulation I: aqueous polar solvent, zolpidem, and optional flavoring agent; formulation II: aqueous polar solvent, zolpidem, optionally flavoring agent, and propellant; formulation III: non-polar solvent, zolpidem, and optional flavoring agent; formulation IV: non-polar solvent, zolpidem, optional flavoring agent, and propellant; formulation V: a mixture of a polar solvent and a non-polar solvent, zolpidem, and optional flavoring agent; formulation VI: a mixture of a polar solvent and a non-polar solvent, zolpidem, optional flavoring agent, and propellant.

1 - 62 . (canceled) 
     
     
         63 . A pump spray container comprising:
 an oral spray composition and a metered valve suitable for releasing from said container a predetermined amount of said composition,   wherein the composition is propellant free, and wherein the composition comprises an aqueous polar solvent present at about 30% to about 99.69% by weight of the total composition, zolpidem tartrate at about 0.001% to about 60% by weight of the total composition, and a flavoring agent at about 0.1% to about 10% by weight of the total composition.   
     
     
         64 . The pump spray container of  claim 63 , wherein the composition coats the mucosal membrane with fine droplets of spray. 
     
     
         65 . The pump spray container of  claim 64 , wherein the zolpidem tartrate is rapidly absorbed through the oral mucosa. 
     
     
         66 . The pump spray container of  claim 63 , wherein the zolpidem tartrate is present at about 0.01% to about 20%. 
     
     
         67 . The pump spray container of  claim 63 , wherein the zolpidem tartrate is present at about 0.2% to about 10%. 
     
     
         68 . The pump spray container of  claim 63 , wherein the zolpidem tartrate is present at about 4% to about 5%. 
     
     
         69 . The pump spray container of  claim 63 , wherein the aqueous polar solvent is present at about 30% to about 70%. 
     
     
         70 . The pump spray container of  claim 63 , wherein the aqueous polar solvent is present at about 30% to about 60%. 
     
     
         71 . The pump spray container of  claim 63 , wherein the aqueous polar solvent is present at about 30% to about 40%. 
     
     
         72 . The pump spray container of  claim 63 , wherein the flavoring agent is present at about 0.1% to about 5%. 
     
     
         73 . The pump spray container of  claim 63 , wherein the flavoring agent is present at 0.1% to about 2.5%. 
     
     
         74 . The pump spray container of  claim 63 , wherein the flavoring agent is present at 0.1% to about 0.3%. 
     
     
         75 . The pump spray container of  claim 63 , wherein the flavoring agent is selected from the group consisting of synthetic or natural oil of peppermint, oil of spearmint, citrus oil, fruit flavors, sweeteners, and combinations thereof.