Hemorrhoidal compositions and method of use

Abstract

The present invention is directed to gel compositions useful in the preparation of medicated gel products. Such medicated gel products are suitable for use in the treatment of anorectal disorders such as hemorrhoids. Also disclosed is a method for the treatment of such anorectal disorders using the claimed medicated gel products.

1 . A method of treating hemorrhoid and/or anorectal disorders in a human so afflicted, which method comprises administering intrarectally and/or to the anorectal region an aqueous gel composition which contains one or more drugs effective in such treatment and a carrier comprising (i) a gelling agent consisting of one or more water soluble cellulose derivatives in an amount from about 0.2% to about 10% by weight ofthe total composition, (ii) propylene glycol in the amount of from about 5% to about 45% by weight of the total composition and (iii) water in an amount up to about 94% by weight of the total composition.  
     
     
         2 . A method of treating hemorrhoids in a human so afflicted which comprises administering intrarectally and/or to the anorectal region an aqueous gel composition which contains one or more drugs effective in such treatment and a carrier comprising a water soluble cellulose derivative as gelling agent in an amount from about 0.2% to about 10% by weight of the total composition, propylene glycol in an amount of from about 5% to about 45% by weight of the total composition and water in an amount up to about 94% by weight of the total composition.  
     
     
         3 . The method of  claim 2  wherein the drug is selected from one or more of the following: astringents, vasoconstrictors, anti-inflammatories and/or local anesthetics.  
     
     
         4 . The method of  claim 3  in which the drug is hydrophilic.  
     
     
         5 . The method of  claim 3  in which composition comprises a vasoconstrictor selected from phenylephrine hydrochloride, ephedrine sulphate, epinephrine and epinephrine hydrochloride and an optional antioxidant system.  
     
     
         6 . The method of  claim 5  wherein the composition comprises phenylephrine hydrochloride in an amount to about 0.35% w/w of the total composition and the antioxidant system comprises sodium citrate, sodium metabisulphite and disodium edetate.  
     
     
         7 . The method of  claim 2  wherein the cellulose derivative is one of the following: hydroxyethylcellulose, hydroxypropylmethylecellulose, methyl cellulose, methylhydroxyethylcellulose, methylhydroxypropylcelulose and carboxymethylcellulose or a combination thereof.  
     
     
         8 . The method of  claim 7  wherein the cellulose derivative is hydroxyethylcellulose.  
     
     
         9 . The method of  claim 7  wherein the cellulose derivative is present in an amount from about 0.5 to about 5% by weight of the total composition.  
     
     
         10 . The method of  claim 2  wherein the propylene glycol is present in an amount from about 10 to about 20% by weight of the total composition.  
     
     
         11 . The method of  claim 2  wherein composition has a viscosity from about 25000 cps to about 150000 cps at 20° C.  
     
     
         12 . A method of treating hemorrhoids in a human so afflicted which comprises administering inarectally and/or to the anorectal region an aqueous gel composition containing at least one hydrophilic drug selected from the class consisting of astringents, vasoconstrictors, anesthetics and anti-inflammatory agents or a combination thereof and a carrier comprising a water soluble cellulose derivative in an amount of from about 0.2 to about 10% by weight of total composition, propylene glycol in an amount from about 5 to about 45% by weight of total composition and water in an amount up to about 94% by weight of the total composition.  
     
     
         13 . An aqueous gel composition for intrarectal administration in the treatment of hemorrhoids and/or in the treatment of anorectal disease which contains one or more drugs effective in such treatment excluding topical corticosteroids and a carrier comprising a water soluble cellulose derivative as gelling agent in an amount from about 0.2% to about 10% by weight of the total composition, propylene glycol in an amount of from about 5% to about 45% by weight of the total composition and water in an amount up to about 94% by weight of the total composition.  
     
     
         14 . The composition of  claim 13  wherein the drug is selected from the group consisting of astringents, vasoconstrictors, anti-inflammatories and local anesthetics.  
     
     
         15 . The composition of  claim 14  which comprises a vasoconstrictor selected from phenylephrine hydrochloride, ephedrine sulphate, epinephrine and epinephrine hydrochloride and an optional antioxidant system.  
     
     
         16 . The composition of  claim 15  comprising phenylephrine hydrochloride in an amount up to about 0.35% w/w of the total composition and an antioxidant system comprising sodium citrate, sodium metabisulphite and disodium edetate.  
     
     
         17 . The composition of  claim 14  wherein the cellulose derivative is selected from the group consisting of hydroxyethylcellulose, hydroxypropylmethylecellulose, methyl cellulose, methylhydroxyethylcellulose, methylhydroxypropylcelulose and carboxymethylcellulose and combinations thereof.  
     
     
         18 . The composition of  claim 14  wherein the cellulose derivative is hydroxyethylcellulose.  
     
     
         19 . The composition of  claim 18  wherein the cellulose derivative is present in an amount from about 0.5 to about 5% by weight of the total composition.  
     
     
         20 . The composition of  claim 14  wherein the propylene glycol is present in an amount from about 10 to about 20% by weight of the total composition.  
     
     
         21 . The composition of  claim 14  having a viscosity from about 25000 cps to about 150000 cps at 20° C.