• US 20100120822A1
  • Filed: 01/30/2010
  • Published: 05/13/2010
  • Est. Priority Date: 12/17/2004
  • Status: Active Grant
First Claim
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1. A method of controlling formation of 1-(2-methylpropyl)-1H imidazo[4,5-c]quinolin-4-amine (imiquimod) impurities in a pharmaceutical cream formulated with imiquimod during storage of the pharmaceutical cream prior to application of the pharmaceutical cream to a dermal or mucosal surface to treat a dermal or mucosal associated condition, said method comprising:

  • formulating the pharmaceutical cream with imiquimod and a pharmaceutically acceptable vehicle including a refined oleic acid component, wherein the refined 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 the pharmaceutical cream;

    storing the formulated pharmaceutical cream for at least about six months prior to use of the pharmaceutical cream; and

    forming a reduced or similar amount of imiquimod impurities in the pharmaceutical cream during said storing of the pharmaceutical cream, as compared to an amount of imiquimod impurities formed in an identical pharmaceutical imiquimod cream but further formulated with butylated hydroxyanisole (BHA) when the pharmaceutical cream and the identical pharmaceutical imiquimod cream are each stored under identical storage conditions, so that the formation of imiquimod impurities in the pharmaceutical cream is reduced and a therapeutically effective amount of imiquimod can be delivered from the pharmaceutical cream to treat the dermal or mucosal associated condition when the pharmaceutical cream is applied to a dermal or mucosal surface following said storing of the pharmaceutical cream.

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