# US 2013/0253003 A1 · Methods of treating dermatological disorders and inducing interferon biosynthesis with shorter durations of imiquimod therapy > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2013/0253003 A1 - Document ID: US20130253003A1 - Status: Published application - Kind: A1 - Application number: 13/895,305 - Filed: 2013-05-15 - Published: 2013-09-26 - Earliest claimed: 2007-02-08 - Assignees: Medicis Pharmaceutical Corporation - Applicants: Medicis Pharmaceutical Corporation - Inventors: Jefferson J. Gregory; Michael T. Nordsiek - Web page: https://patentgrep.com/patent/US20130253003A1 ## CPC - A61K 9/0014: {Skin, i.e. galenical aspects of topical compositions (non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00)} - A61K 9/7061: {Polyacrylates} - A61K 31/437: the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline - A61K 31/4745: condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines (yohimbine derivatives, vinblastine A61K31/475; ergoline derivatives A61K31/48) - A61P 31/12: Antivirals - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## 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 warts, actinic keratosis and superficial basal cell carcinoma, and to induce interferon biosynthesis, with shorter durations of therapy, than currently approved for imiquimod by the Food & Drug Administration (“FDA”). ## Claims ### Claim 1 A method of topical and/or transdermal administration of imiquimod for treating a dermatological disorder in a mammal, which method comprises: (a) applying an effective amount of a formulation containing imiquimod on the skin of a mammal once a day at least 3 times a week on 3 different days for between about 8 consecutive weeks and 12 consecutive weeks, not exceeding 12 consecutive weeks; and (b) allowing said imiquimod to remain in contact with the skin for a sufficient time following said application to permit an effective amount of the imiquimod to penetrate the skin to achieve the antiviral effect. ### Claim 2 (depends on 1) The method of claim 1, wherein said formulation is applied for a duration of not more than one of the group consisting of: 8 weeks, 9 weeks, 10 weeks, 11 weeks, and 12 weeks. ### Claim 3 (depends on 1) The method of claim 1, wherein the formulation is applied once a day for at a frequency selected from the group consisting of: 4 times a week, 5 times a week, 6 times a week, and every day of the week. ### Claim 4 (depends on 1) The method of claim 1, wherein the formulation contains an amount of imiquimod selected from the group consisting of: about 1%, about 1.25%, about 1.5%, about 1.75%, about 2%, about 2.25%, about 2.5%, about 2.75%, about 3%, about 3.25%, about 3.5%, about 3.75%, about 4%, about 4.25%, about 4.5%, about 4.75%, and about 5%. ### Claim 5 (depends on 1) The method of claim 1, wherein the dermatological disorder is a viral disease selected from the group consisting of: Type I Herpes simplex, Type II Herpes simplex, genital warts, actinic keratosis, and superficial basal cell carcinoma. ### Claim 6 (depends on 1) The method of claim 1, wherein the formulation further includes a fatty acid selected from the group consisting of: isostearic acid, oleic acid, super purified oleic acid, and linoleic acid. ### Claim 7 (depends on 1) The method of claim 1, wherein the formulation is selected from the group consisting of a cream, ointment, gel, foam, lotion, and adhesive-coated sheet material. ### Claim 8 A method of topical and/or transdermal administration of imiquimod to induce interferon biosynthesis in a mammal, which method comprises: (a) applying an effective amount of a formulation containing imiquimod on the skin of a mammal once a day at least 3 times a week on 3 different days for between about 8 consecutive weeks and 12 consecutive weeks, not exceeding 12 consecutive weeks; and (b) allowing said imiquimod to remain in contact with the skin for a sufficient time following said application to permit an effective amount of the imiquimod to penetrate the skin to achieve the antiviral effect. ### Claim 9 (depends on 8) The method of claim 8, wherein said formulation is applied for a duration of not more than one of the group consisting of: 8 weeks, 9 weeks, 10 weeks, 11 weeks, and 12 weeks. ### Claim 10 (depends on 8) The method of claim 8, wherein the formulation is applied once a day for at a frequency selected from the group consisting of: 4 times a week, 5 times a week, 6 times a week, and every day of the week. ### Claim 11 (depends on 8) The method of claim 8, wherein the formulation contains an amount of imiquimod selected from the group consisting of: about 1%, about 1.25%, about 1.5%, about 1.75%, about 2%, about 2.25%, about 2.5%, about 2.75%, about 3%, about 3.25%, about 3.5%, about 3.75%, about 4%, about 4.25%, about 4.5%, about 4.75%, and about 5%. ### Claim 12 (depends on 8) The method of claim 8, wherein the dermatological disorder is a viral disease selected from the group consisting of: Type I Herpes simplex, Type II Herpes simplex, genital warts, actinic keratosis, and superficial basal cell carcinoma. ### Claim 13 (depends on 8) The method of claim 8, wherein the formulation further includes a fatty acid selected from the group consisting of: isostearic acid, oleic acid, super purified oleic acid, and linoleic acid. ### Claim 14 (depends on 8) The method of claim 8, wherein the formulation is selected from the group consisting of a cream, ointment, gel, foam, lotion, and adhesive-coated sheet material.