Methods of treatment of anorectal and genital disorders

Abstract

A topical anorectal or genital composition includes at least one film forming ingredient; at least one surfactant; at least one non-polar volatile siloxane solvent; at least 15% (w/w) water; and a therapeutically effective concentration of at least one pharmaceutical agent, wherein the composition is sufficiently designed to dry within 60 seconds after application to the anorectal or genital surface to form a dried composition, and wherein the dried composition forms: a flexible film, wherein the flexible film closely follows irregularities of the body surface as well as movement of the body surface, and (ii) a durable film, wherein the durable film does not crack or flake off and remains intact for more than 12 hours giving release of the pharmaceutical agent for an extended period of time.

What is claimed is: 
     
         1 . A method of treating an anorectal or genital disorder comprising:
 topically applying to the anorectal or genital surface of a subject in need of such treatment a therapeutically effective amount of a topical anorectal or genital composition comprising:
 from 10.0% (w/w) to 30.0% (w/w) of trimethylsiloxysilicate; 
 from 1.0% (w/w) to 5.0% (w/w) of at least one surfactant; 
 from 30.0% (w/w) to 75.0% (w/w) of at least one non-polar volatile siloxane solvent; 
 from about 15% (w/w) to about 40% (w/w) of water; and 
 a therapeutically effective concentration of at least one pharmaceutical agent, selected from the group consisting of pramoxine, phenylephrine, hydrocortisone, salicylic acid, nitroglycerine, sildenafil, nifedipine, diltiazem, verapamil, procaine, lidocaine, tetracaine, dibucaine, prilocaine, phenacaine, benzyl alcohol, benzocaine, diperodon, dyclonine, dimethisoquin, epinephrine, tetrahydrozoline hydrochloride, an amphetamine, an antihistamine, methylphenidate, mephedrone, oxymetazoline, pseudoephedrine, psilocybin, ephedrine sulphate, imiquimod, podophyllin, podophylotoxin, trichloroacetic acid, bichloroacetic acid, formic acid, fluorouracil, sinecatechins, plant extracts, acyclovir, penciclovir, famciclovir, docosanol or their salts and combinations thereof, 
 wherein the composition is sufficiently designed to dry within 60 seconds after application to the anorectal or genital surface to form a dried composition, and wherein the dried composition forms:
 (i) a flexible film, wherein the flexible film closely follows irregularities of the surface as well as movement of the surface, and 
 (ii) a durable film, wherein the durable film does not crack or flake off and remains intact for more than 12 hours giving release of the pharmaceutical agent for an extended period of time. 
 
   
     
     
         2 . The method of  claim 1 , comprising topically applying twice weekly to the anorectal or genital surface of the subject in need of such treatment the therapeutically effective concentration of the composition. 
     
     
         3 . The method of  claim 1 , comprising topically applying once daily to the anorectal or genital surface of the subject in need of such treatment the therapeutically effective concentration of the composition. 
     
     
         4 . The method of  claim 1 , wherein, after a period of time post topical application of the composition, a similar or better therapeutic effect is observable than a commercially available composition comprising the same active ingredient(s) in the same concentrations wherein applied several times daily. 
     
     
         5 . The method of  claim 1 , wherein the genital disorder is genital warts or herpes. 
     
     
         6 . The method of  claim 1 , wherein the anorectal disorder is anal warts or herpes. 
     
     
         7 . The method of  claim 1 , wherein the anorectal disorder is selected from the group consisting of hemorrhoid anal fissures, anal cracks, anal fistulas, anal abscesses and anal pruritus. 
     
     
         8 . The method of  claim 1 , wherein the composition is in the form of a gel. 
     
     
         9 . The method of  claim 1 , wherein the composition is in the form of an oil-in-water emulsion. 
     
     
         10 . The method of  claim 1 , wherein in the composition, the at least one surfactant is a polysorbate. 
     
     
         11 . The method of  claim 1 , wherein in the composition, the at least one non-polar volatile siloxane solvent is selected from the group consisting of methylsiloxane, hexamethyldisiloxane, and combinations thereof. 
     
     
         12 . The method of  claim 1 , wherein the composition further comprises an additive selected from the group consisting of a dimethicone/vinyl dimethicone crosspolymer, a silicone gum blend, a gelling agent, and a combination thereof. 
     
     
         13 . The method of  claim 1 , wherein the composition further comprises a buffer to adjust the pH of the composition to a pH of about 4.2-4.4. 
     
     
         14 . The method of  claim 1 , wherein the composition further comprises an organosilicone surfactant. 
     
     
         15 . The method of  claim 1 , wherein the composition further comprises a viscosity modifier. 
     
     
         16 . The method of  claim 1 , wherein the composition comprises:
 about 25.0% (w/w) of trimethylsiloxysilicate;   from about 1.0% (w/w) to about 5.0% (w/w) of polyoxyethylene sorbitan monooleate; and   from about 30.0% (w/w) to about 50.0% (w/w) of a non-polar volatile siloxane solvent.   
     
     
         17 . The method of  claim 1 , wherein the genital or anorectal disorder is anal or genital warts and wherein the composition comprises 4.0% (w/w) to 5.0% (w/w) imiquimod. 
     
     
         18 . The method of  claim 1 , wherein the genital or anorectal disorder is anal or genital warts and wherein the composition comprises 0.5% (w/w) podophyllotoxin. 
     
     
         19 . The method of  claim 1 , wherein the genital or anorectal disorder is anal or genital warts and wherein the composition comprises 1.0% (w/w) to 20% (w/w) salicylic acid, 0.1% (w/w) to 10% (w/w) 5-fluorouracil or a combination thereof. 
     
     
         20 . The method of  claim 1 , wherein the genital or anorectal disorder is anal or genital herpes and wherein the composition comprises an antiviral selected from the group consisting of acyclovir, penciclovir, famciclovir, docosanol and combinations thereof.