Pharmaceutical cream having similar or less levels of imiquimod impurity formation as cream with BHA (comparator)

  • US 7,906,524 B2
  • Filed: 02/01/2010
  • Issued: 03/15/2011
  • Est. Priority Date: 12/17/2004
  • Status: Active Grant
First Claim
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1. A pharmaceutical cream formulated with 1-(2-methylpropyl)-1H imidazo[4,5-c]quinolin-4-amine (imiquimod) for topical application to a dermal or mucosal surface, said pharmaceutical cream comprising:

  • a therapeutically effective amount of imiquimod;

    a pharmaceutically acceptable vehicle including an oleic acid component, where 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

    a level of imiquimod impurities formed during storage of said pharmaceutical cream;

    wherein the level of imiquimod impurities formed in said pharmaceutical cream is less than a level of imiquimod impurities formed in an identical pharmaceutical imiquimod cream but further formulated with butylated hydroxyanisole (BHA) when said pharmaceutical cream and said identical pharmaceutical imiquimod cream are each stored under identical storage conditions for about six months after formulation.

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