Details for Patent: 9,271,973

Title:	Methods of treating dermatological disorders and inducing interferon biosynthesis with shorter durations of imiquimod therapy
Abstract:	Pharmaceutical formulations and methods for the topical and/or transdermal delivery of imiquimod, including creams, ointments and pressure-sensitive adhesive compositions to treat dermatological disorders, namely, viral infections, such as Type I or Type II Herpes simplex infections and genital and perianal warts, actinic deratosis and superficial basal cell carcinoma, and to induce interferon biosynthesis to achieve an antiviral effect, with shorter durations of therapy, than currently approved for imiquimod by the Food & Drug Administration ("FDA").
Inventor(s):	Gregory; Jefferson J. (Bristol, TN), Nordsiek; Michael T. (Wayne, PA)
Assignee:	Medicis Pharmaceutical Corporation (Bridgewater, NJ)
Filing Date:	Nov 27, 2013
Application Number:	14/091,589
Claims:	1. A method for treating an external genital or perianal wart in a subject comprising: (a) applying a 3.75% w/w imiquimod pharmaceutical cream formulation to a dermatological area of the subject having the wart; and (b) allowing the 3.75% imiquimod cream formulation to remain in contact with the dermatological area for a sufficient time following the application whereby an effective amount of the imiquimod composition penetrates the dermatological area; and wherein the 3.75% w/w imiquimod cream formulation is applied to the dermatological area of the subject once daily for up to 8 consecutive weeks or until clearance is observed, whichever occurs earlier, to treat the wart. 2. The method of claim 1, wherein imiquimod is the sole active pharmaceutical ingredient in the 3.75% w/w imiquimod cream formulation applied to the dermatological area of the subject. 3. The method of claim 1, wherein the 3.75% w/w imiquimod cream formulation further comprises a pharmaceutically acceptable vehicle. 4. The method of claim 3, wherein the pharmaceutically acceptable vehicle comprises a member selected from the group consisting of a fatty acid, an emollient, an emulsifier, a thickener, a preservative, a humectant, water, or a combination thereof. 5. The method of claim 4, wherein the fatty acid is selected from the group consisting of isostearic acid, linoleic acid, oleic acid, super purified oleic acid, and a combination thereof. 6. The method of claim 5, wherein the fatty acid is isostearic acid. 7. The method of claim 4, wherein the fatty acid is present in an amount of between about 5% to about 25% by weight. 8. The method of claim 4, wherein the emollient is selected from the group consisting of cetyl alcohol, stearyl alcohol, petrolatum, and a combination thereof. 9. The method of claim 4, wherein the emollient is present in an amount of between about 5% to about 10% by weight. 10. The method of claim 4, wherein the emulsifier is selected from the group consisting of polysorbate 60, sorbitan monostearate, and a combination thereof. 11. The method of claim 4, wherein the emulsifier is present in an amount of between about 2% to about 6% by weight. 12. The method of claim 4, wherein the preservative is selected from the group consisting of methylparaben, propylparaben, benzyl alcohol, and a combination thereof. 13. The method of claim 4, wherein the humectant is glycerin. 14. The method of claim 4, wherein the water is present in an amount of between about 45% to about 85% by weight. 15. The method of claim 3, wherein the pharmaceutically acceptable vehicle consists of isostearic acid, cetyl alcohol, stearyl alcohol, white petrolatum, polysorbate 60, sorbitan monostearate, glycerin, xanthan gum, water, benzyl alcohol, methylparaben, and propylparaben. 16. The method of claim 1, wherein the 3.75% w/w imiquimod cream formulation is selected from the group of 3.75% imiquimod formulations set forth in the tables below: TABLE-US-00033 Excipients % w/w % w/w % w/w % w/w % w/w % w/w Isostearic Acid 20.00 20.00 25.00 18.75 20.00 21.25 Cetyl alcohol 4.00 2. 20 2.20 2.20 2.20 2.20 Stearyl alcohol 2.40 3.10 3.10 3.10 3.10 3.10 White 3.40 3.00 3.00 5.00 5.00 3.75 petroleum Polysorbate 60 3.80 3.40 3.40 3.00 3.40 3.40 Sorbitan 1.00 0.60 0.60 1.00 0.60 0.60 Monostearate Glycerin 3.00 2.00 2.00 5.00 5.00 5.00 Xanthan gum 0.70 0.50 0.50 0.50 0.50 0.50 Purified water 55.73 59.23 54.23 55.48 54.23 54.23 Benzyl alcohol 2.00 2.00 2.00 2.00 2.00 2.00 Methylparaben 0.20 0.20 0.20 0.20 0.20 0.20 Propylparaben 0.02 0.02 0.02 0.02 0.02 0.02 Imiquimod 3.75 3.75 3.75 3.75 3.75 3.75 Total: 100.00 100.00 100.00 100.00 100.00 100.00 TABLE-US-00034 Excipients % w/w % w/w % w/w % w/w % w/w % w/w Isostearic Acid 20.00 20.00 20.00 25.00 18.75 25.00 Cetyl alcohol 2.20 2.20 2.20 2.20 2.20 2.70 Stearyl alcohol 3.10 3.10 3.10 3.10 3.10 3.80 White 3.00 6.00 6.00 3.00 5.00 3.00 petroleum Polysorbate 60 3.40 3.40 3.00 3.40 3.00 3.40 Sorbitan 0.60 0.60 1.00 0.50 1.00 0.60 Monostearate Glycerin 2.00 5.00 5.00 2.00 5.00 2.00 Xanthan gum 0.50 0.50 0.50 0.50 0.50 0.50 Purified water 59.23 53.23 53.23 54.23 55.48 53.03 Benzyl alcohol 2.00 2.00 2.00 2.00 2.00 2.00 Methylparaben 0.20 0.20 0.20 0.20 0.20 0.20 Propylparaben 0.02 0.02 0.02 0.02 0.02 0.02 Imiquimod 3.75 3.75 3.75 3.75 3.75 3.75 Total: 100.00 100.00 100.00 100.00 100.00 100.00 TABLE-US-00035 Excipients % w/w % w/w % w/w % w/w % w/w % w/w Isostearic Acid 25.00 20.00 20.00 20.00 20.00 21.00 Cetyl alcohol 2.20 4.00 2.20 2.20 2.20 2.20 Stearyl alcohol 3.10 2.40 3.10 3.10 3.10 3.10 White 3.00 3.40 5.00 3.00 5.00 5.00 petroleum Polysorbate 60 3.40 3.80 3.40 3.40 3.40 3.40 Sorbitan 0.60 1.00 0.60 0.60 0.60 0.60 Monostearate Glycerin 2.00 3.00 2.00 5.00 5.00 5.00 Xanthan gum 1.00 0.70 0.50 0.50 0.50 0.50 Purified water 53.73 55.73 57.23 56.23 54.23 53.23 Benzyl alcohol 2.00 2.00 2.00 2.00 2.00 2.00 Methylparaben 0.20 0.20 0.20 0.20 0.20 0.20 Propylparaben 0.02 0.02 0.02 0.02 0.02 0.02 Imiquimod 3.75 3.75 3.75 3.75 3.75 3.75 Total: 100.00 100.00 100.00 100.00 100.00 100.00.