Compositions for the Treatment of Dry Eye and Methods of Use Thereof

Abstract

The disclosure relates to compositions containing allyl isothiocyanate and methods of use thereof for stimulating tearing in a subject to treat dry eye.

1 . A composition for stimulating tearing when orally administered to a subject, the composition comprising: a core comprising water and an amount of allyl isothiocyanate effective for stimulating tearing, and a shell encapsulating the core. 
     
     
         2 . The composition of  claim 1 , wherein the core comprises a hydrated wasabi paste. 
     
     
         3 . The composition of  claim 1 , wherein the shell is water-resistant. 
     
     
         4 . The composition of  claim 1 , wherein the shell comprises hypromellose. 
     
     
         5 . The composition of  claim 1 , wherein the shell comprises one or more layers of a hard candy shell comprising sugar. 
     
     
         6 . (canceled) 
     
     
         7 . The composition of  claim 1 , wherein the core further comprises a flavoring agent. 
     
     
         8 . The composition of  claim 7 , wherein the flavoring agent is menthol or a menthol-containing oil. 
     
     
         9 . The composition of  claim 5 , wherein the hard candy shell further comprises a flavoring agent. 
     
     
         10 . The composition of  claim 1 , wherein the core stimulates tearing that therapeutically treats one or more symptoms of dry eye in the subject. 
     
     
         11 . The composition of  claim 1 , wherein the core stimulates an increase in tear production by over 10 mm in the subject, as measured on a Schirmer’s test. 
     
     
         12 . A method of manufacturing a composition for stimulating tearing when orally administered by a subject, comprising the steps of:
 (a) providing a core comprising water and an amount of allyl isothiocyanate effective for stimulating tearing; and   (b) encapsulating the core in a shell.   
     
     
         13 . The method of  claim 12 , wherein the core comprises a hydrated wasabi paste. 
     
     
         14 . The method of  claim 12 , wherein the shell comprises hypromellose. 
     
     
         15 . The method of  claim 12 , wherein the shell comprises one or more layers of a hard candy shell comprising sugar. 
     
     
         16 . (canceled) 
     
     
         17 . The method of  claim 12 , further comprising adding a flavoring agent to the core or shell. 
     
     
         18 - 23 . (canceled) 
     
     
         24 . A blister pack comprising two or more blisters, wherein each blister contains a composition for stimulating tearing when orally administered by a subject, wherein the composition comprises a core containing an effective amount of allyl isothiocyanate for stimulating tearing, and a shell encapsulating the core. 
     
     
         25 . The blister pack of  claim 24 , wherein the core comprises a wasabi paste hydrated with water. 
     
     
         26 . The blister pack of  claim 24 , wherein the shell comprises hypromellose. 
     
     
         27 . The blister pack of  claim 24 , wherein the shell comprises one or more layers of a hard candy shell comprising sugar. 
     
     
         28 . The blister pack of  claim 24 , wherein the core stimulates tearing that therapeutically treats one or more symptoms of dry eye in the subject.