Method of treating actinic keratosis

  • US 7,928,116 B2
  • Filed: 01/29/2010
  • Issued: 04/19/2011
  • Est. Priority Date: 12/17/2004
  • Status: Expired due to Fees
First Claim
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1. A method of treating actinic keratosis 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 actinic keratosis for a period of time sufficient to topically deliver a therapeutically effective amount of imiquimod to the skin to induce a therapeutic effect selected from a group of therapeutic effects consisting of reducing actinic keratosis lesions, reducing pre-actinic keratosis lesions and reducing recurrence of actinic keratosis;

    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 actinic keratosis, 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.

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