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 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”).

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 at least between about 8 weeks and 12 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.   
   
   
       2 . A method of  claim 1 , wherein said formulation is applied for 8 weeks. 
   
   
       3 . A method of  claim 1 , wherein said formulation is applied for 9 weeks. 
   
   
       4 . A method of  claim 1 , wherein said formulation is applied for 10 weeks. 
   
   
       5 . A method of  claim 1 , wherein said formulation is applied for 11 weeks. 
   
   
       6 . A method of  claim 1 , wherein said formulation is applied for 12 weeks. 
   
   
       7 . A method of  claims 1 - 6 , wherein the formulation is applied once a day at least 4 times a week. 
   
   
       8 . A method of  claims 1 - 6 , wherein the formulation is applied once a day at least 5 times a week. 
   
   
       9 . A method of  claims 1 - 6 , wherein the formulation is applied once a day at least 6 times a week. 
   
   
       10 . A method of  claims 1 - 6 , wherein the formulation is applied once a day at least 7 times a week. 
   
   
       11 . A method of  claims 1 - 10 , wherein the formulation contains from greater than about 1% to about 5% imiquimod. 
   
   
       12 . A method of  claim 11 , wherein the formulation contains about 1.25% imiquimod. 
   
   
       13 . A method of  claim 11 , wherein the formulation contains about 1.5% imiquimod. 
   
   
       14 . A method of  claim 11 , wherein the formulation contains about 1.75% imiquimod. 
   
   
       15 . A method of  claim 11 , wherein the formulation contains about 2% imiquimod. 
   
   
       16 . A method of  claim 11 , wherein the formulation contains about 2.25% imiquimod. 
   
   
       17 . A method of  claim 11 , wherein the formulation contains about 2.5% imiquimod. 
   
   
       18 . A method of  claim 11 , wherein the formulation contains about 2.75% imiquimod. 
   
   
       19 . A method of  claim 11 , wherein the formulation contains about 3% imiquimod. 
   
   
       20 . A method of  claim 11 , wherein the formulation contains about 3.25% imiquimod. 
   
   
       21 . A method of  claim 11 , wherein the formulation contains about 3.5% imiquimod. 
   
   
       22 . A method of  claim 11 , wherein the formulation contains about 3.75% imiquimod. 
   
   
       23 . A method of  claim 11 , wherein the formulation contains about 4.0% imiquimod. 
   
   
       24 . A method of  claim 11 , wherein the formulation contains about 4.25% imiquimod. 
   
   
       25 . A method of  claim 11 , wherein the formulation contains about 4.5% imiquimod. 
   
   
       26 . A method of  claims 1 - 25 , wherein the dermatological disorder is a viral disease. 
   
   
       27 . A method of  claim 26 , wherein the viral disease is a Type I Herpes simplex infection. 
   
   
       28 . A method of  claim 26 , wherein the viral disease is a Type II Herpes simplex infection. 
   
   
       29 . A method of  claims 1 - 25 , wherein the dermatological disorder is genital warts. 
   
   
       30 . A method of  claims 1 - 25 , wherein the dermatological disorder is actinic keratosis. 
   
   
       31 . A method of  claims 1 - 25 , wherein the dermatological disorder is superficial basal cell carcinoma. 
   
   
       32 . A method of  claims 1 - 31 , wherein the formulation further includes a fatty acid. 
   
   
       33 . A method of  claim 32 , wherein the fatty acid is isostearic acid. 
   
   
       34 . A method of  claim 32 , wherein the fatty acid is oleic acid. 
   
   
       35 . A method of  claim 32 , wherein the fatty acid is super purified oleic acid. 
   
   
       36 . A method of  claim 32 , wherein the fatty acid is linoleic acid. 
   
   
       37 . A method of  claims 1 - 36 , wherein the formulation is selected from the group consisting of a cream, ointment, gel, foam, lotion and adhesive-coated sheet material. 
   
   
       38 . 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 at least between about 8 weeks and 12 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.   
   
   
       39 . A method of  claim 38 , wherein said formulation is applied for 8 weeks. 
   
   
       40 . A method of  claim 38 , wherein said formulation is applied for 9 weeks. 
   
   
       41 . A method of  claim 38 , wherein said formulation is applied for 10 weeks. 
   
   
       42 . A method of  claim 38 , wherein said formulation is applied for 11 weeks. 
   
   
       43 . A method of  claim 38 , wherein said formulation is applied for 12 weeks. 
   
   
       44 . A method of  claims 38 - 43 , wherein the formulation is applied once a day at least 4 times a week. 
   
   
       45 . A method of  claims 38 - 43 , wherein the formulation is applied once a day at least 5 times a week. 
   
   
       46 . A method of  claims 38 - 43 , wherein the formulation is applied once a day at least 6 times a week. 
   
   
       47 . A method of  claims 38 - 43 , wherein the formulation is applied once a day at least 7 times a week. 
   
   
       48 . A method of  claims 38 - 47 , wherein the formulation contains from greater than about 1% to about 5% imiquimod. 
   
   
       49 . A method of  claim 48 , wherein the formulation contains about 1.25% imiquimod. 
   
   
       50 . A method of  claim 48 , wherein the formulation contains about 1.5% imiquimod. 
   
   
       51  . A method of  claim 48 , wherein the formulation contains about 1.75% imiquimod. 
   
   
       52 . A method of  claim 48 , wherein the formulation contains about 2% imiquimod. 
   
   
       53 . A method of  claim 48 , wherein the formulation contains about 2.25% imiquimod. 
   
   
       54 . A method of  claim 48 , wherein the formulation contains about 2.5% imiquimod. 
   
   
       55 . A method of  claim 48 , wherein the formulation contains about 2.75% imiquimod. 
   
   
       56 . A method of  claim 48 , wherein the formulation contains about 3% imiquimod. 
   
   
       57 . A method of  claim 48 , wherein the formulation contains about 3.25% imiquimod. 
   
   
       58 . A method of  claim 48 , wherein the formulation contains about 3.5% imiquimod. 
   
   
       59 . A method of  claim 48 , wherein the formulation contains about 3.75% imiquimod. 
   
   
       60 . A method of  claim 48 , wherein the formulation contains about 4.0% imiquimod. 
   
   
       61 . A method of  claim 48 , wherein the formulation contains about 4.25% imiquimod. 
   
   
       62 . A method of  claim 48 , wherein the formulation contains about 4.5% imiquimod. 
   
   
       63 . A method of  claims 38 - 48 , wherein the formulation further includes a fatty acid. 
   
   
       64 . A method of  claim 63 , wherein the fatty acid is isostearic acid. 
   
   
       65 . A method of  claim 63 , wherein the fatty acid is oleic acid. 
   
   
       66 . A method of  claim 63 , wherein the fatty acid is super purified or refined oleic acid. 
   
   
       67 . A method of  claim 63 , wherein the fatty acid is linoleic acid. 
   
   
       68 . A method of  claims 38 - 67 , wherein the formulation is selected from the group consisting of a cream, ointment, gel, foam, lotion and adhesive-coated sheet material.