Lozenge

Abstract

The invention relates to a lozenge comprising micronized benzocaine, at least one dissolution enhancer and one or more excipients as well as the use of the lozenge for the treatment of sore throat.

1 . A lozenge comprising:
 a. micronized Benzocaine;   b. at least one dissolution enhancer, wherein the dissolution enhancer is PEG, and wherein the dissolution enhancer is present in an amount from 1 to 30 mg; and   c. one or more excipients.   
     
     
         2 - 22 . (canceled) 
     
     
         23 . The lozenge according to  claim 1 , wherein the micronized Benzocaine has a mass median particle size of about 5 to about 30 μm. 
     
     
         24 . The lozenge according to  claim 1 , wherein the PEG is polyethylene glycol (PEG) 4000 to 6000. 
     
     
         25 . The lozenge according to  claim 24 , wherein the PEG is PEG 6000. 
     
     
         26 . The lozenge according to  claim 1 , wherein the micronized Benzocaine has a mass median particle size of about 7 to about 18 μm. 
     
     
         27 . The lozenge according to  claim 1 , wherein the micronized Benzocaine is present in an amount from about 2 to about 15 mg. 
     
     
         28 . The lozenge according to  claim 1 , wherein the micronized Benzocaine is present in an amount of about 8 mg. 
     
     
         29 . The lozenge according to  claim 1 , wherein the PEG is present in an amount of about 5 to about 25 mg. 
     
     
         30 . The lozenge according to  claim 1 , wherein the one or more excipients is at least one sweetening agent. 
     
     
         31 . The lozenge according to  claim 30 , wherein the at least one sweetening agent is selected from the group consisting of synthetic or natural sugars; artificial sweeteners including saccharin, sodium saccharin, aspartame, acesulfame, thaumatin, glycyrrhizin, sucralose, cyclamate, dihydrochalcone, alitame, miraculin and monellin; sugar alcohols including sorbitol, mannitol, glycerol, lactitol, maltitol, and xylitol; sucrose, dextrose, fructose and lactose; isomalt, stevia, and mixtures thereof. 
     
     
         32 . The lozenge according to  claim 1 , wherein the one or more excipients is at least one flavoring agent. 
     
     
         33 . The lozenge according to  claim 32 , wherein the at least one flavoring agent is selected from the group consisting of lime, orange, lemon, black current, blood orange, cranberry, cloudberry, goji berry, raspberry, strawberry, wild strawberry, sea buckthorn, cherry, melon, kiwi, papaya, pineapple, passion fruit, coconut, and other flavors such as honey, herbs, tea, anise, water grass, lemon grass, cooling agent ginger, coffee, eucalyptus, mangosten, peppermint, spearmint, wintergreen, cinnamon, cacao/cocoa, vanilla, liquorice, salt, pepper, chili, menthol, aniseeds, mint, natural of synthetic versions and mixtures thereof. 
     
     
         34 . The lozenge according to  claim 1 , further comprising a filler, a binding/gelling agent and a lubricant. 
     
     
         35 . The lozenge according to  claim 34 , wherein the filler is mannitol, the binding/gelling agent is xanthan gum, and the lubricant is magnesium stearate. 
     
     
         36 . The lozenge according to  claim 1 , wherein the lozenge is coated with a film forming agent. 
     
     
         37 . The lozenge according to  claim 36 , wherein the film forming agent is a cellulose ether film forming agent. 
     
     
         38 . The lozenge according to  claim 37 , wherein the cellulose ether film forming agent is selected from the group consisting of hydroxy propyl methyl cellulose (HPMC), methyl hydroxy ethyl cellulose (MHEC), hydroxy propyl cellulose (HPC), hydroxyethyl cellulose (HEC), or ethyl hydroxyl ethyl cellulose (EHEC). 
     
     
         39 . The lozenge according to  claim 1 , wherein the lozenge is direct compressed or granulated and compressed. 
     
     
         40 . A method of treating a sore throat, the method comprising administering a lozenge according to  claim 1 .