Patent ID: 7906526
Filing Date: 2011-03-15
Classification: A61K,A61P

Abstract:
1. A method of treating a dermal and/or mucosal associated condition with a pharmaceutical cream formulated with 1-(2-methylpropyl)-1H imidazo[4,5-c]quinolin-4-amine (imiquimod) and an oleic acid component and having enhanced imiquimod stability, said method comprising: applying the pharmaceutical cream following storage of the pharmaceutical cream to skin of a subject diseased with a dermal and/or mucosal associated condition for a period of time sufficient to topically deliver a therapeutically effective amount of imiquimod to the skin to induce a therapeutic effect to treat the dermal and/or mucosal associated condition; wherein the dermal and/or mucosal associated condition is selected from a group of dermal and/or mucosal associated conditions consisting of a wart, a post surgical scar, a lesion caused by a herpes virus and an epidermal neoplasia; wherein the pharmaceutical cream comprises the imiquimod and a pharmaceutically acceptable vehicle containing an oleic acid component; wherein said oleic acid component contains at least about 80% oleic acid by weight as a fatty acid and has a peroxide value of no more than about 5 milliequivalents of oxygen per kilogram and contains less than about 1% by weight polar impurities at or prior to formulation of said pharmaceutical cream; and wherein the pharmaceutical cream, at the time of said applying, contains a greater amount of imiquimod by weight to treat the dermal and/or mucosal associated condition, as compared to an amount of imiquimod by weight present in an identical pharmaceutical imiquimod cream but formulated with a compendial grade oleic acid component, when the pharmaceutical cream and the identical pharmaceutical imiquimod cream are each stored under identical storage conditions for about an equal period of time after formulation and prior to said application of the pharmaceutical cream.