Water-soluble pharmaceutical compositions of hops resins

Abstract

The present invention is drawn to water-soluble compositions for providing hops constituents, particularly alpha acids, iso-alpha acids, and beta acids. A pharmaceutical gel composition can comprise a hops extract and a surfactant. Such compositions can be formulated into products for various therapeutic applications, including oral and topical uses. Such compositions can also be dissolved in water to yield a clear solution containing more dilute hops acids. The invention also provides methods of treatment comprising administering water-soluble hops compositions. The present invention is also drawn to methods for making water-soluble preparations of hops constituents.

What is claimed is: 
     
         1 . A pharmaceutical composition of hops extract, comprising:
 water;   non-ionic surfactant selected from the group consisting of monoglycerides, diglycerides, triglycerides, mono-fatty acid esters of polyethylene glycol, di-fatty acid esters of polyethylene glycol, sorbitan fatty acid esters, polyglycolyzed glycerides, triblock copolymers, and mixtures thereof; and   hops extract including from 0.0005 wt % to 24.5 wt % alpha acids and from 0.0001 wt % to 12.5 wt % beta acids,   wherein the composition is free of visible particles and clear.   
     
     
         2 . A composition as in  claim 1 , wherein the non-ionic surfactant includes a member selected from the group consisting of monoglycerides, diglycerides, triglycerides, and mixtures thereof. 
     
     
         3 . A composition as in  claim 1 , wherein the non-ionic surfactant includes polyoxyl castor oil. 
     
     
         4 . A composition as in  claim 1 , wherein the composition is formulated into a product form selected from the group consisting of toothpastes, creams, ointments, lotions, salves, nasal mists, and oral rinses. 
     
     
         5 . A composition as in  claim 1 , further comprising an additive selected from the group consisting of flavoring agents, sweeteners, coloring agents, odorants, and mixtures thereof. 
     
     
         6 . A composition as in  claim 1 , wherein the composition comprises at least 2.5 wt % non-ionic surfactant. 
     
     
         7 . A method of making a clear pharmaceutical composition of hops extract, comprising:
 heating a water-soluble non-ionic surfactant in a container to a temperature of about 90° F. to about 250° F., wherein the non-ionic surfactant is selected from the group consisting of monoglycerides, diglycerides, triglycerides, mono-fatty acid esters of polyethylene glycol, di-fatty acid esters of polyethylene glycol, sorbitan fatty acid esters, polyglycolyzed glycerides, triblock copolymers, and mixtures thereof;   heating a hops extract to a temperature of about 90° F. to 250° F.;   mixing an amount of the hops extract with the non-ionic surfactant so that the hops extract is sufficiently dispersed or dissolved in the non-ionic surfactant to yield the water-soluble pharmaceutical gel composition; and   dissolving or finely dispersing the water-soluble pharmaceutical gel composition in water such that the clear pharmaceutical composition is formed comprising   (a) from 0.0005 wt % to 24.5 wt % alpha acids; and   (b) from 0.0001 wt % to 12.5 wt % beta acids.   
     
     
         8 . A method as in  claim 7 , wherein the water-soluble pharmaceutical gel composition, prior to dissolving or finely dispersing in water, comprises from 0.2 wt % to 70 wt % hops extract and from 30 wt % to 99.8 wt % non-ionic surfactant. 
     
     
         9 . A method as in  claim 7 , wherein the clear pharmaceutical composition comprises at least 2.5 wt % non-ionic surfactant. 
     
     
         10 . A method as in  claim 7 , wherein the step of heating the water-soluble non-ionic surfactant includes the step of stirring or mixing during the heating step, or wherein the step of heating the hops extract includes the step of stirring or mixing during the heating step, or both. 
     
     
         11 . A method as in  claim 7 , wherein the non-ionic surfactant is selected from the group consisting of monoglycerides, diglycerides, triglycerides, and mixtures thereof. 
     
     
         12 . A method as in  claim 7 , wherein the non-ionic surfactant includes polyoxyl castor oil. 
     
     
         13 . A method as in  claim 7 , wherein the water-soluble pharmaceutical gel composition is formulated into a product from selected from the group consisting of toothpastes, creams, ointments, lotions, salves, nasal mists, and oral rinses. 
     
     
         14 . A method as in  claim 7 , further comprising the step of including an additive selected from the group consisting of flavoring agents, sweeteners, coloring agents, odorants, and mixtures thereof. 
     
     
         15 . A method as in  claim 7 , wherein the clear pharmaceutical composition is pale in color.