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A pharmaceutical composition comprising 1-(2-methylpropyl)-1H-imidazo4,5-cquinolin-4-amine that is stable to sterilization and suitable for topical application directly to tissue sites where the dermis has been breached, and has been sterilized, packaged compositions that have been sterilized, and m

A pharmaceutical composition comprising 1-(2-methylpropyl)-1H-imidazo4,5-cquinolin-4-amine that is stable to sterilization and suitable for topical application directly to tissue sites where the dermis has been breached, and has been sterilized, packaged compositions that have been sterilized, and methods of sterilizing these compositions are disclosed.

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1. A topical pharmaceutical composition comprising an immune response modifier drug compound that is stable to sterilization and suitable for topical application directly to tissue sites where the dermis has been breached; wherein the drug compound is 1-(2-methylpropyl)-1H-imidazo[4,5-c]quinolin-4-a

1. A topical pharmaceutical composition comprising an immune response modifier drug compound that is stable to sterilization and suitable for topical application directly to tissue sites where the dermis has been breached; wherein the drug compound is 1-(2-methylpropyl)-1H-imidazo[4,5-c]quinolin-4-amine; andwherein the composition has been sterilized. 2. The pharmaceutical composition of claim 1, wherein the composition has been sterilized by exposure to electron beam radiation. 3. The pharmaceutical composition of claim 1, wherein any single drug impurity is present in an amount not more than 0.3 percent of the weight of the 1-(2-methylpropyl)-1H-imidazo[4,5-c]quinolin-4-amine, and the total weight of the drug impurities is not more than 1 percent of the weight of the 1-(2-methylpropyl)-1H-imidazo[4,5-c]quinolin-4-amine. 4. The pharmaceutical composition of claim 3, wherein the total weight of the drug impurities is not more than 0.5 percent of the weight of the 1-(2-methylpropyl)-1H -imidazo[4,5-c]quinolin-4-amine. 5. The pharmaceutical composition of claim 4, wherein the total weight of the drug impurities is not more than 0.3 percent of the weight of the 1-(2-methylpropyl)-1H -imidazo[4,5-c]quinolin-4-amine. 6. The pharmaceutical composition of claim 3, wherein any single drug impurity is present in an amount not more than 0.1 percent of the weight of the 1-(2-rnethylpropyl)-1H-imidazo[4,5-c]quinolin-4-amine. 7. The pharmaceutical composition of claim 1, wherein the total amount of 1-(2-methylpropyl)-1H-imidazo[4,5-c]quinolin-4-amine is at least 0.5 percent by weight, based on the total weight of the composition. 8. The pharmaceutical composition of claim 7 wherein the total amount of 1-(2-methylpropyl)-1H-imidazo[4,5-c]quinolin-4-amine is at least 1 percent by weight, based on the total weight of the composition. 9. The pharmaceutical composition of claim 7 wherein the total amount of 1-(2-methylpropyl)-1H-imidazo[4,5-c]quinolin-4-amine is at least 4.5 percent by weight, based on the total weight of the composition. 10. The pharmaceutical composition of claim 1, wherein the total amount of 1-(2-methylpropyl)-1H-imidazo[4,5-c]quinolin-4-amine is no more than 9 percent by weight, based on the total weight of the composition. 11. The pharmaceutical composition of claim 10 wherein the total amount of 1-(2-methylpropyl)-1H-imidazo[4,5-c]quinolin-4-amine is no more than 5.5 percent by weight, based on the total weight of the composition. 12. The pharmaceutical composition of claim 1, wherein the composition further comprises a preservative. 13. The pharmaceutical composition of claim 12 wherein the preservative is selected from the group consisting of methylparaben, propylparaben, benzyl alcohol, and mixtures thereof. 14. The pharmaceutical composition of claim 1, wherein the composition is a cream, comprising an oil phase and a water phase in admixture, the composition comprising about 4.5 to about 5.5 percent 1-(2-methylpropyl)-1H-imidazo[4,5-c]quinolin-4-amine, about 20 to about 30 percent isostearic acid, about 1.0 percent to about 2.1 percent benzyl alcohol, about 0.5 percent to about 2.5 percent actyl alcohol, about 1 percent to about 3.5 percent stearyl alcohol, about 2 percent to about 4 percent petrolatum, about 3 percent to about 4 percent polysorbate 60, about 0.4 percent to about 0.8 percent of sorbitan monostearate, about 1 percent to about 3 percent of glycerin, about 0.18 to about 0.22 percent methylparaben, about 0.018 percent to about 0.022 percent propylparaben, about 0.0 to about 1.0 percent xanthan gum and about 50 to about 55 percent purified water; all percentages being based upon the total weight of the composition. 15. The pharmaceutical composition of claim 1, wherein the viscosity is at least 2,000 cps and not more than 35,000 cps. 16. The pharmaceutical composition of claim 1, wherein the pH is stable. 17. The pharmaceutical composition of claim 1, wherein the pH is not less than 4 and not more than 5.5. 18. A packaged composition that includes a packaging material and the pharmaceutical composition of claim 1, enclosed within the packaging material wherein the packaged composition has been terminally sterilized. 19. The packaged composition of claim 18, wherein the packaging material is a multi-layer laminate. 20. The packaged composition of claim 19, wherein the multi-layer laminate comprises a contact layer; an outer layer; and a moisture barrier layer disposed between the contact layer and outer layer. 21. The packaged composition of claim 20, wherein the moisture barrier layer comprises a metal foil. 22. The packaged composition of claim 20, wherein the contact layer comprises an acrylonitrile-methyl acrylate copolymer. 23. The packaged composition of claim 18, wherein the packaging material is in the form of a single-use sachet. 24. The packaged composition of claim 18, wherein the packaged composition is a 5% imiquimod cream in a single-use sachet. 25. The packaged composition of claim 18, wherein the packaging material is a tube. 26. The packaged composition of claim 25, wherein the tube is single-use. 27. The packaged composition of claim 25, wherein the tube is multi-use. 28. The packaged composition of any one of claims 25, 26, and 27, wherein the tube is an aluminum tube. 29. The packaged composition of claim 28, wherein the aluminum tube has an epoxy phenolic lacquer liner. 30. The packaged composition of any one of claims 25, 26, and 27, wherein the tube is comprised of a multi-layer laminate, the multi-layer laminate comprising a contact layer, an outer layer, and a moisture barrier layer disposed between the contact layer and outer layer. 31. A method of sterilizing the pharmaceutical composition of claim 1, comprising the step of irradiating the composition with electron beam radiation at a sterilizing dose sufficient to achieve a sterility assurance level of at least 10−3. 32. The method of claim 31, wherein the sterility assurance level is 10−6. 33. The method of claim 31 or claim 32, wherein the sterilizing dose is at least 10 kGy. 34. The method of claim 31 or claim 32, wherein the sterilizing dose is at least 25 kGy. 35. A method of sterilizing the packaged composition of claim 18, comprising the step of irradiating the composition with electron beam radiation at a sterilizing dose sufficient to achieve a sterility assurance level of at least 10−3. 36. The method of claim 35, wherein the sterility assurance level is 10−6. 37. The method of claim 35 or claim 36, wherein the sterilizing dose is at least 10 kGy. 38. The method of claim 35 or claim 36, wherein the sterilizing dose is at least 25 kGy.