Composition and method for treating hemorrhoids and/or anorectal disorders

Abstract

The invention provides an oil-in-water emulsion useful in the treatment of anorectal disorders comprising a local anesthetic, vasoconstrictor, glycerin and water, and method of preparation of the emulsion and a method for treating hemorrhoids using the composition of the invention.

1 . A method of treating of hemorrhoids and/or anorectal disorders in humans comprising administering to the anorectal region a safe and effective amount of a pharmaceutical composition, the pharmaceutical composition comprising: pramoxine hydrochloride, phenylephrine hydrochloride, glycerin and water wherein the pharmaceutical composition is an oil-in-water emulsion and the oil-in-water emulsion is a cream, wherein the pramoxine hydrochloride and phenylephrine hydrochloride are solubilized in the water portion of the oil-in-water emulsion, wherein the ratio of the glycerin amount by weight to the sum of the glycerin amount and water amount by weight is about 20% to about 45%, and wherein and wherein the composition provides hydration to hemorrhoid and/or anorectal tissue. 
   
   
       2 . The pharmaceutical composition of  claim 1 , wherein the sum of the glycerin amount and water amount is at least 50% w/w of the pharmaceutical composition. 
   
   
       3 . The pharmaceutical composition of  claim 1 , wherein the vasoconstrictor comprises at least one of phenylephrine hydrochloride, ephedrine sulphate, epinephrine, epinephrine hydrochloride and tetrahydrozoline HCl. 
   
   
       4 . The pharmaceutical composition of  claim 1 , wherein the anesthetic comprises at least one of benzocaine, benzyl alcohol, dibucaine, dibucaine HCl, pramoxine hydrochloride, tetrocaine, tetracaine HCl, dyclonine, and dyclonine HCl. 
   
   
       5 . The pharmaceutical composition of  claim 1 , further comprising at least one non-ionic emulsifier. 
   
   
       6 . The pharmaceutical composition of  claim 1 , wherein the at least one non-ionic emulsifier includes an ethoxylated fatty alcohol that is a solid at room temperature. 
   
   
       7 . The pharmaceutical composition of  claim 1 , further comprising a pH adjusting compound wherein the pH adjusting compound has buffering capacity and wherein the pH is adjusted to less than about pH 6. 
   
   
       8 . The pharmaceutical composition of  claim 1 , further comprising about 12% w/w to about 18% w/w of a semisolid oleaginous protectant.