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