Warming and nonirritating lubricant compositions and method of comparing irritation

Abstract

This invention relates to substantially anhydrous warming, non-toxic and nonirritating lubricating compositions containing polyhydric alcohols and an insulating agent as well as gel and jelly compositions related thereto. The invention also relates to methods of using such compositions for lubrication, administration of active ingredients and for preventing or treating dysmenorrhea.

What is claimed is:  
     
         1 . A substantially anhydrous lubricant composition comprising at least one polyol and a gelling agent, wherein said composition increases in temperature by at least about 5° C. upon exposure to moisture and which has a Maximum Energy Release Index of at least about 11 mJ/mg.  
     
     
         2 . A composition according to  claim 1  wherein said composition further comprises a pH adjustment agent.  
     
     
         3 . A composition according to  claim 1  wherein said polyol is a polyhydric alcohol selected from the group consisting of: glycerin, alkylene glycol, polyethylene glycol, polypropylene glycol, PEGylated compounds, block copolymers comprising polyalkylene glycol and a mixture thereof.  
     
     
         4 . A composition according to  claim 1  wherein said gelling agent is hydroxypropylcellulose.  
     
     
         5 . A composition according to  claim 3  wherein said alkylene glycol is selected from the group consisting of: propylene glycol, butylene glycol and hexalene glycol.  
     
     
         6 . A composition according to  claim 4  wherein said polyethylene glycol is selected from the group consisting of polyethylene glycol 300, polyethylene glycol 400 and a mixture thereof.  
     
     
         7 . A composition according to  claim 1  wherein said gelling agent is lactic acid.  
     
     
         8 . A composition according to  claim 5  wherein said composition comprises from about 75% to about 99% by weight of polyhydric alcohol, from about 0.1% to about 4% by weight of hydroxypropylcellulose and from about 0.1% to about 1% by weight of lactic acid.  
     
     
         9 . A composition according to  claim 1  wherein said composition has a viscosity from about 1,000 cps to about 7,000 cps.  
     
     
         10 . A composition according to  claim 1  wherein said composition has a viscosity from about 60,000 cps to about 500,000.  
     
     
         11 . A composition according to  claim 1  which further comprises an antimicrobial agent.  
     
     
         12 . A composition according to  claim 11  wherein said antimicrobial agent is an antifungal agent.  
     
     
         13 . A composition according to  claim 11  wherein said antimicrobial agent is an antibacterial agent.  
     
     
         14 . A composition according to  claim 11  wherein said antimicrobial agent is an antiviral agent.  
     
     
         15 . A composition according to  claim 1  wherein said composition further comprises a spermicide.  
     
     
         16 . A composition according to  claim 1  wherein said composition further comprises a local anesthetic.  
     
     
         17 . A method of treating or preventing dysmenorrhea comprising applying a composition according to  claim 1  intravaginally.  
     
     
         18 . A composition according to  claim 1  wherein said composition increases in temperature upon exposure to moisture.  
     
     
         19 . A composition according to  claim 7  wherein the pH of said composition is adjusted to between about 2 and about 6.  
     
     
         20 . A method of increasing intimacy comprising applying a composition comprising at least one polyol, which increases in temperature by at least about 5° C. upon exposure to moisture and which has a Maximum Energy Release Index of at least about 11 mJ/mg to a skin or mucosal surface.  
     
     
         21 . A method of enhancing relaxation comprising applying a composition comprising at least one polyol, which increases in temperature by at least about 5° C. upon exposure to moisture and which has a Maximum Energy Release Index of at least about 11 mJ/mg to a skin or mucosal surface.  
     
     
         22 . A method of treating female sexual dysfunction comprising applying a composition comprising at least one polyol, which increases in temperature by at least about 5° C. upon exposure to moisture and which has a Maximum Energy Release Index of at least about 11 mJ/mg to a skin or mucosal surface.  
     
     
         23 . A method of treating vulvodynia comprising applying a composition comprising at least one polyol and an analgesic agent, which increases in temperature by at least about 5° C. upon exposure to moisture and which has a Maximum Energy Release Index of at least about 11 mJ/mg to a skin or mucosal surface.  
     
     
         24 . A method of treating frostbite comprising applying a composition comprising at least one polyol, which increases in temperature by at least about 5° C. upon exposure to moisture and which has a Maximum Energy Release Index of at least about 11 mJ/mg to skin on a frostbitten extremity.  
     
     
         25 . A method of treating dysmenorrhea comprising applying a composition comprising at least one polyol and an anti-inflammatory agent, which increases in temperature by at least about 5° C. upon exposure to moisture and which has a Maximum Energy Release Index of at least about 11 mJ/mg to a tampon and inserting said tampon vaginally.