Methods of treating dermatological disorders and inducing interferon biosynthesis with shorter durations of imiquimod therapy

Abstract

Pharmaceutical formulations and methods for the topical and/or transdermal delivery of imiquimod, including creams, ointments and pressure-sensitive adhesive compositions to treat dermatological disorders, namelyl, viral infections, such as Type I or Type II Herpes simplex infections and genital and perianal warts, actinic deratosis and superficial basal cell carcinoma, and to induce interferon biosynthesis to achieve an antiviral effect, with shorter durations of therapy, than currently approved for imiquimod by the Food & Drug Administration (“FDA”).

1 . A method for treating genital or perianal warts in a subject, the method comprising:
 applying an imiquimod pharmaceutical cream formulated with 3.75% by weight imiquimod to the warts, once per day, each day, for up to about 8 consecutive weeks or until clearance is observed, whichever occurs earlier, to treat the warts.   
     
     
         2 . The method of  claim 1 , wherein the imiquimod pharmaceutical cream further comprises a pharmaceutically acceptable vehicle. 
     
     
         3 . The method of  claim 2 , wherein the pharmaceutically acceptable vehicle comprises a member selected from the group consisting of a fatty acid, an emollient, an emulsifier, a thickener, a preservative, a humectant, water, or a combination thereof. 
     
     
         4 . The method of  claim 3 , wherein the fatty acid is selected from the group consisting of isostearic acid, linoleic acid, oleic acid, super purified oleic acid, and a combination thereof 
     
     
         5 . The method of  claim 3 , wherein the fatty acid is isostearic acid. 
     
     
         6 . The method of  claim 3 , wherein the fatty acid is present in an amount of between about 5% to about 25% by weight. 
     
     
         7 . The method of  claim 3 , wherein the emollient is selected from the group consisting of cetyl alcohol, stearyl alcohol, petrolatum, and a combination thereof. 
     
     
         8 . The method of  claim 3 , wherein the emollient is present in an amount of between about 5% to about 10% by weight. 
     
     
         9 . The method of  claim 3 , wherein the emulsifier is selected from the group consisting of polysorbate 60, sorbitan monostearate, and a combination thereof 
     
     
         10 . The method of  claim 3 , wherein the emulsifier is present in an amount of between about 2% to about 6% by weight. 
     
     
         11 . The method of  claim 3 , wherein the preservative is selected from the group consisting of methylparaben, propylparaben, benzyl alcohol, and a combination thereof 
     
     
         12 . The method of  claim 3 , wherein the humectant is glycerin. 
     
     
         13 . The method of  claim 3 , wherein the water is present in an amount of between about 45% to about 85% by weight. 
     
     
         14 . The method of  claim 2 , wherein the pharmaceutically acceptable vehicle consists of isostearic acid, cetyl alcohol, stearyl alcohol, white petrolatum, polysorbate 60, sorbitan monostearate, glycerin, xanthan gum, water, benzyl alcohol, methylparaben, and propylparaben. 
     
     
         15 . The method of  claim 1 , wherein the imiquimod pharmaceutical cream is selected from the group of 3.75% imiquimod pharmaceutical creams listed in Example 29.