Film-Forming Resins as a Carrier for Topical Application of Pharmacologically Active Agents

Abstract

The invention provides a biological dressing for treatment of a dermatological disease comprised of one or more resins or other film-forming agents, a topically acceptable volatile solvent, and a pharmacologically active agent. The combined one or more resins are present in a suitable amount such that the composition, when the solvent evaporates, will dry to form a solid coating that sticks to the skin, nail or mucosal membrane to which the composition is applied, and maintain the pharmacologically active agent over a sustained period of time in contact with sites on the skin or mucosal membranes exhibiting symptoms of the disease. Methods are provided for treating symptoms of dermatological diseases with such a pharmacological composition.

1 . A pharmacological composition comprising: a) one or more resins;
 b) at least one topically acceptable pharmacologically active agent other than the one or more resins that is effective as a treatment for ameliorating symptoms of a disease of skin or a mucous membrane of a mammal, wherein the pharmacologically active agent can remain in contact with the skin, nail or the mucous membrane for greater than 4 hours without toxic effects to the mammal; and c) a topically acceptable volatile solvent for the one or more resins and the pharmacologically active agent.   
     
     
         2 . The composition according to  claim 1 , wherein the one or more resins are independently selected from the group consisting of a hard resin, an oleoresin, and a gum resin. 
     
     
         3 . The composition according to  claim 2 , wherein the one or more resins are selected from the group consisting of benzoin, mastic gum, elemi gum, and olibanum gum. 
     
     
         4 . The composition according to  claim 1 , wherein the topically acceptable volatile solvent comprises ethanol. 
     
     
         5 . The composition according to  claim 3 , wherein the topically acceptable volatile solvent is ethanol and comprises about 60% to 95% of the composition. 
     
     
         6 . The composition according to  claim 1 , wherein the pharmacologically active agent is an antimicrobial agent. 
     
     
         7 . The composition according to  claim 6 , wherein the antimicrobial agent is an anti-fungal agent. 
     
     
         8 . The composition according to  claim 7 , wherein the anti-fungal agent is clotrimazole. 
     
     
         9 . The composition according to  claim 8 , wherein the clotrimazole is present as 1% of the composition. 
     
     
         10 . The composition according to  claim 1 , wherein the pharmacologically active agent is a steroidal agent. 
     
     
         11 . The composition according to  claim 10 , wherein the steroidal agent is betamethasone. 
     
     
         12 . The composition according to  claim 11 , wherein the betamethasone is present as 0.025-0.05% of the composition. 
     
     
         13 . The composition according to  claim 1 , wherein the pharmacologically active agent comprises both an antimicrobial agent and a steroidal agent. 
     
     
         14 . The composition according to  claim 1 , further comprising a penetration enhancer. 
     
     
         15 . A pharmacological composition comprising: a) one or more resins; b) clotrimazole; and c) ethanol. 
     
     
         16 . The composition according to  claim 15 , wherein the one or more resins are selected from the group consisting of a hard resin, an oleoresin, and a gum resin. 
     
     
         17 . The composition according to  claim 16 , wherein the one or more resins are selected from the group consisting of benzoin, mastic gum, elemi gum, and olibanum gum. 
     
     
         18 . A pharmacological composition comprising: a) one or more resins; b) 1% clotrimazole; and c) 90% ethanol. 
     
     
         19 . The composition according to  claim 18 , wherein the one or more resin are selected from the group consisting of a hard resin, an oleoresin, and a gum resin. 
     
     
         20 . The composition according to  claim 19 , wherein the one or more resins are selected from the group consisting of benzoin, mastic gum, elemi gum, and olibanum gum. 
     
     
         21 . The composition according to  claim 6 , wherein the antimicrobial agent is an anti-viral agent. 
     
     
         22 . The composition according to  claim 6 , wherein the antimicrobial agent is an antibacterial agent. 
     
     
         23 . The composition according to  claim 22 , wherein the antibacterial agent is an antibiotic. 
     
     
         24 . The composition according to  claim 1 , wherein the pharmacological agent is a hormone. 
     
     
         25 . The composition according to  claim 1 , wherein the pharmacological agent is an antihistamine. 
     
     
         26 . The composition according to  claim 7 , wherein the anti-fungal agent is terbinafine. 
     
     
         27 . The composition according to  claim 26 , wherein the terbinafine is present as 1% of the composition. 
     
     
         28 . A pharmacological composition comprising: a) one or more resins; b) terbinafine; and c) ethanol. 
     
     
         29 . The composition according to  claim 28 , wherein the one or more resins are selected from the group consisting of a hard resin, an oleoresin, and a gum resin. 
     
     
         30 . The composition according to  claim 29 , wherein the one or more resins are selected from the group consisting of benzoin, mastic gum, elemi gum, and olibanum gum. 
     
     
         31 . A pharmacological composition comprising: a) one or more resins; b) 1% terbinafine; and c) 90% ethanol. 
     
     
         32 . The composition according to  claim 31 , wherein the one or more resins are selected from the group consisting of a hard resin, an oleoresin, and a gum resin. 
     
     
         33 . The composition according to  claim 32 , wherein the one or more resins are selected from the group consisting of benzoin, mastic gum, elemi gum, and olibanum gum. 
     
     
         34 . A pharmacological composition comprising: a) one or more resins; b) ciclopirox olamine; and c) ethanol. 
     
     
         35 . The composition according to  claim 34 , wherein the one or more resins are selected from the group consisting of a hard resin, an oleoresin, and a gum resin. 
     
     
         36 . The composition according to  claim 35 , wherein the one or more resins are selected from the group consisting of benzoin, mastic gum, elemi gum, and olibanum gum. 
     
     
         37 . A pharmacological composition comprising: a) one or more resins; b) 1% ciclopirox olamine; and c) 90% ethanol. 
     
     
         38 . The composition according to  claim 37 , wherein the one or more resins are selected from the group consisting of a hard resin, an oleoresin, and a gum resin. 
     
     
         39 . The composition according to  claim 38 , wherein the one or more resins are selected from the group consisting of benzoin, mastic gum, elemi gum, and olibanum gum. 
     
     
         40 . The composition according to  claim 2 , wherein the one or more resins are selected from the group consisting of an exudate from  Burserceae  trees,  Eucalyptus  species, and  Myrtaceae  species. 
     
     
         41 . The composition according to  claim 1 , wherein the one or more resins are selected from the group consisting of an adhesive polymer, a hydrogel polymer, a cellulose bioadhesive, a synthetic lattice, and a mucosal adhesive. 
     
     
         42 . The composition according to  claim 41 , wherein the adhesive polymer is an acrylic polymer, a polyisobutylene, or a silicone. 
     
     
         43 . The composition according to  claim 23 , wherein the antibiotic is clindamycin, erythromycin, tetracycline, mupirocin, gentamycin, metronidizole, bacitracin, neomycin, or polymyxin B. 
     
     
         44 . The composition according to  claim 23 , wherein the antibiotic is a mixture of one or more of clindamycin, erythromycin, tetracycline, mupirocin, gentamycin, metronidizole, bacitracin, neomycin, and polymyxin B. 
     
     
         45 . The composition according to  claim 1 , further comprising silver sulfadiazine. 
     
     
         46 . The composition according to  claim 1 , wherein the pharmacologically active agent is a miticide or pediculocide. 
     
     
         47 . The composition according to  claim 1 , wherein the pharmacologically active agent is an anesthetic. 
     
     
         48 . The composition according to  claim 1 , further comprising an oil. 
     
     
         49 . A pharmacological composition comprising: a) one or more resins; b) naftifine; and c) ethanol. 
     
     
         50 . The composition according to  claim 49 , wherein the one or more resins are selected from the group consisting of a hard resin, an oleoresin, and a gum resin. 
     
     
         51 . The composition according to  claim 50 , wherein the one or more resins are selected from the group consisting of benzoin, mastic gum, elemi gum, and olibanum gum. 
     
     
         52 . The composition according to  claim 49 , further comprising a penetration enhancer. 
     
     
         53 . The composition according to  claim 52 , wherein the penetration enhancer is DMSO. 
     
     
         54 . A pharmacological composition comprising: a) one or more resins; b) 1% to 10% naftifine; and c) 90% ethanol. 
     
     
         55 - 56 . (canceled) 
     
     
         57 . A pharmacological composition comprising: a) one or more resins; b) ciclopirox; and c) ethanol. 
     
     
         58 . The composition according to  claim 57 , wherein the one or more resins are selected from the group consisting of a hard resin, an oleoresin, and a gum resin. 
     
     
         59 . The composition according to  claim 58 , wherein the one or more resins are selected from the group consisting of benzoin, mastic gum, elemi gum, and olibanum gum. 
     
     
         60 . The composition according to  claim 57 , further comprising a penetration enhancer. 
     
     
         61 . The composition according to  claim 60 , wherein the penetration enhancer is DMSO. 
     
     
         62 . A pharmacological composition comprising: a) one or more resins; b) 8% ciclopirox; and c) 90% ethanol. 
     
     
         63 . The composition according to  claim 62 , wherein the one or more resins are selected from the group consisting of a hard resin, an oleoresin, and a gum resin. 
     
     
         64 . The composition according to  claim 63 , wherein the one or more resins are selected from the group consisting of benzoin, mastic gum, elemi gum, and olibanum gum. 
     
     
         65 . The composition according to  claim 62 , further comprising a penetration enhancer. 
     
     
         66 . The composition according to  claim 62 , further comprising a penetration enhancer. 
     
     
         67 . A pharmacological composition comprising: a) one or more resins; b) terbinafine; and c) ethanol. 
     
     
         68 . The composition according to  claim 67 , wherein the one or more resins are selected from the group consisting of a hard resin, an oleoresin, and a gum resin. 
     
     
         69 . The composition according to  claim 68 , wherein the one or more resins are selected from the group consisting of benzoin, mastic gum, elemi gum, and olibanum gum. 
     
     
         70 . The composition according to  claim 67 , further comprising a penetration enhancer. 
     
     
         71 . The composition according to  claim 70 , wherein the penetration enhancer is DMSO. 
     
     
         72 . A pharmacological composition comprising: a) one or more resins; b) clotrimazole; and c) ethanol. 
     
     
         73 . The composition according to  claim 72 , wherein the one or more resins are selected from the group consisting of a hard resin, an oleoresin, and a gum resin. 
     
     
         74 . The composition according to  claim 73 , wherein the one or more resins are selected from the group consisting of benzoin, mastic gum, elemi gum, and olibanum gum. 
     
     
         75 . A pharmacological composition comprising: a) one or more resins; b) Bacitracin; c) Polymysin B; and d) ethanol. 
     
     
         76 . The composition according to  claim 75 , wherein the one or more resins are selected from the group consisting of a hard resin, an oleoresin, and a gum resin. 
     
     
         77 . The composition according to  claim 76 , wherein the one or more resins are selected from the group consisting of benzoin, mastic gum, elemi gum, and olibanum gum. 
     
     
         78 . A pharmacological composition comprising: a) one or more resins; b) 500 units/cc Bacitracin; c) 10,000 units/cc Polymyxin B; and d) 90% ethanol. 
     
     
         79 . A pharmacological composition comprising: a) one or more resins; b) 500 units/cc Bacitracin; and c) 90% ethanol. 
     
     
         80 . A pharmacological composition comprising: a) one or more resins; b) 0.025 Retin-A; and c) 90% ethanol. 
     
     
         81 . A pharmacological composition comprising: a) one or more resins; b) 0.5% to 1.8% Salicylic Acid, and c) 90% ethanol. 
     
     
         82 . A pharmacological composition comprising: a) one or more resins; b) 7.5% meradimate; c) 7.5% octinoxate; d) 10% homosalate; e) 10% sulisobenzone; and 90% ethanol. 
     
     
         83 . A pharmacological composition comprising: a) one or more resins; b) 500 units/cc Bacitracin; c) 10,000 units/cc Polymyxin B; d) 3.5 mg/cc Neomycin; and e) 90% ethanol. 
     
     
         84 . A pharmacological composition comprising: a) one or more resins; b) 500 units/cc Bacitracin; c) 3.5 mg/cc Neomycin; and d) 90% ethanol. 
     
     
         85 . A method of treating a subject having onychomycosis comprising contacting a nail of a subject having onychomycosis with a biological dressing comprising:
 (a) one or more resins;   (b) at least one topically acceptable pharmacologically active agent other than the one or more resins that is effective as a treatment for ameliorating symptoms of onychomycosis, wherein the pharmacologically active agent can remain in contact with the skin or nail for greater than 4 hours without toxic effects to the mammal; and   c) a topically acceptable volatile solvent for the one or more resins and the pharmacologically active agent.   
     
     
         86 . The method of  claim 85 , wherein the one or more resins are selected from the group consisting of a hard resin, an oleoresin, and a gum resin. 
     
     
         87 . The method of  claim 85 , wherein the one or more resins are selected from the group consisting of benzoin, mastic gum, elemi gum, and olibanum burn. 
     
     
         88 . The method of  claim 85 , wherein the pharmacologically active agent is ciclopirox, naftifine or terbinafine. 
     
     
         89 . The method of  claim 85 , wherein the solvent is ethanol, ethyl acetate, or n-propyl acetate. 
     
     
         90 . The composition according to  claim 54 , further comprising a penetration enhancer. 
     
     
         91 . The composition according to claim  55 , wherein the penetration enhancer is DMSO.