Compositions and methods for treating pruritis ani and anal fissures

Abstract

Compositions and methods for the treatment of pruritic ani and anal fissures are described. The compositions include one or more of Calamine (USP) or zinc oxide (ZnO), aluminum hydroxide (Al(OH) 3 ) glycerin, and menthol (or any compound which activates the menthol receptor (TRPM8)). The composition does not contain (or contains a limited amount, such as less than 10%) of a hydrocarbon-based pharmaceutical carrier such as petroleum jelly, white petrolatum, mineral oil, hard paraffin, soft paraffin, microcrystalline wax, or ceresine. Methods of treating pruritic ani and anal fissures by topical application(s) of the compositions to affected perianal or anal epidermis are also described.

1 . A composition comprising aluminum hydroxide, zinc oxide, and one or more pharmaceutically acceptable carriers. 
     
     
         2 . The composition of  claim 1 , wherein the composition takes the form of a topical cream. 
     
     
         3 . The composition of  claim 2 , wherein the composition has a viscosity in the range of centipoise to 200,000 centipoise. 
     
     
         4 . The composition of  claim 2 , wherein the composition has a pH in the range of 7.1-9.0. 
     
     
         5 . The composition of  claim 2 , wherein the composition comprises less than 10% of a hydrocarbon-based pharmaceutical carrier. 
     
     
         6 . The composition of  claim 2 , wherein the composition comprises less than 10% petroleum jelly, white petrolatum, mineral oil, hard paraffin, soft paraffin, microcrystalline wax, or ceresine. 
     
     
         7 . The composition of  claim 2 , wherein the composition does not comprise any hydrocarbon-based pharmaceutical carrier. 
     
     
         8 . The composition of  claim 2 , wherein the composition does not comprise petroleum jelly, white petrolatum, mineral oil, hard paraffin, soft paraffin, microcrystalline wax, or ceresine. 
     
     
         9 . The composition of  claim 2 , wherein the composition further comprises a menthol receptor (TRPM8) agonist. 
     
     
         10 . The composition of  claim 9 , wherein the menthol-receptor (TRPM8) agonist is menthol. 
     
     
         11 . The composition of  claim 2 , wherein:
 aluminum hydroxide is present in the composition at a concentration in the range of 0.1-49.9% (w/w); and   zinc oxide is present in the composition at a concentration in the range of 0.1-24.9% (w/w).   
     
     
         12 . The composition of  claim 9 , wherein:
 aluminum hydroxide is present in the composition at a concentration in the range of 0.1-49.9% (w/w);   zinc oxide is present in the composition at a concentration in the range of 0.1-24.9% (w/w); and   the menthol-receptor (TRPM8) agonist is present at a concentration of 0.1-1.0 (w/w).   
     
     
         13 . The composition of  claim 12 , further comprising glycerin at a concentration in the range of 20-45% w/w. 
     
     
         14 . A composition comprising:
 aluminum hydroxide at a concentration in the range of 0.1-49.9% (w/w);   zinc oxide at a concentration in the range of 0.1-24.9% (w/w); and   a menthol-receptor (TRPM8) agonist at a concentration of 0.1-1.0% (w/w); and   one or more pharmaceutically acceptable carriers;   wherein:   the composition does not comprise petroleum jelly, white petrolatum, mineral oil, hard paraffin, soft paraffin, microcrystalline wax, or ceresine; and   the composition takes the form of a topical cream with a viscosity in the range of centipoise to 200,000 centipoise.   
     
     
         15 . The composition of  claim 14 , further comprising glycerin. 
     
     
         16 . The composition of  claim 15 , wherein glycerin is present in the composition at a concentration in the range of 20-45% (w/w). 
     
     
         17 . The composition of  claim 14 , wherein the one or more pharmaceutically acceptable carriers comprise Acrylates/C 10-30 Alkyl Acrylate Crosspolymer, Beeswax, Cetearly Alcohol, Coconut Oil, Deionized Water, Isopropyl Palmitate, Phenoxyethanol, Polysorbate 20, Propylene Glycol, SD Alcohol, or Stearyl Alcohol. 
     
     
         18 . A method for treating pruritus ani or anal fissures comprising:
 applying an effective amount of the composition of  claim 2  to the perianal or anal skin of a patient in need thereof.   
     
     
         19 . The method of  claim 18 , which is a method of treating pruritis ani, comprising:
 cleaning and drying the perianal or anal skin of the patient; and   applying the composition to the perianal or anal skin when itching occurs.   
     
     
         20 . The method of  claim 18 , which is a method of treating anal fissures, comprising:
 applying the composition to the perianal or anal skin of the patient twice a day.