Buccal, polar and non-polar spray or capsule

Abstract

Buccal aerosol sprays or capsule using polar and non-polar solvent have now been developed which provide biologically active compounds for rapid absorption through the oral mucosa, resulting in fast onset of effect. The buccal polar compositions of the invention comprises formulation I: polar solvent 37-98.58%, active compound 0.005-55%, optionally containing flavoring agent 0.1-10%.

1 - 29 . (canceled) 
   
   
       30 . A method for administering an effective amount of a pharmacologically active compound to a mammal to provide transmucosal absorption of a therapeutically effective amount of the active compound through the oral mucosa of the mammal to the systemic circulatory system of the mammal, comprising:
 spraying the oral mucosa of the mammal with a propellant free buccal spray composition, containing a pharmacologically active compound dissolved in a pharmacologically acceptable solvent, comprising in weight percent of the composition:   a polar solvent in an amount ranging from 30-99.69%; and   an active compound in an amount ranging from 0.005-55% by weight of the total composition; wherein the active compound is selected from the group consisting of a central nervous system active amine, a sulfonyl urea, an antibiotic, an antiviral, a sleep inducer, an antiasthmatic, an antiemetic, a histamine H-2 receptor antagonist, a barbiturate, a prostaglandin or a bronchial dilator.   
   
   
       31 . The method of  claim 30 , wherein the amount of the spray is predetermined. 
   
   
       32 . The method of  claim 30 , further comprising a flavoring agent in an amount ranging from 0.1 to 10 percent by weight of the composition. 
   
   
       33 . The method of  claim 32 , wherein the polar solvent is present in an amount ranging from 60.9-97.06 percent by weight of the composition, the active compound is present in an amount ranging from 0.01 to 40 percent by weight of the composition, and the flavoring agent is present in an amount ranging from 0.75 to 7.5 percent by weight of the composition. 
   
   
       34 . The method of  claim 30 , wherein the polar solvent comprises a low molecular weight polyethylene glycol (PEG) having a molecular weight ranging from 400 to 1,000, a C 2  to C 8  mono- and polyalcohol, or an alcohol of C 7  to C 18  hydrocarbon of linear or branched configuration. 
   
   
       35 . The method of  claim 30 , wherein the solvent comprises aqueous polyethylene alcohol. 
   
   
       36 . The method of  claim 30 , wherein the solvent comprises aqueous ethanol. 
   
   
       37 . The method of  claim 30 , wherein the active compound is selected from the group consisting of cyclosporine, clozapine, zidevudine, ondansetron, carboprost, thromethamine or a pharmaceutically acceptable salt thereof. 
   
   
       38 . A method for administering an effective amount of a pharmacologically active compound to a mammal to provide transmucosal absorption of a therapeutically effective amount of the active compound through the oral mucosa of the mammal to the systemic circulatory system of the mammal, comprising:
 spraying the oral mucosa of the mammal with a propellant free buccal spray composition, containing a pharmacologically active compound dissolved in a pharmacologically acceptable solvent, comprising in weight percent of the composition:   propylene glycol in an amount of about 60%; and   ondansetron hydrochloride in an amount ranging from 2.5 to 15% by weight of the total composition; wherein a therapeutically effective amount of the active compound is absorbed through the oral mucosa to the systemic circulatory system of the mammal.