Topical antifungal compositions and methods of use thereof

Abstract

Described herein are topical anti-fungal pastes and methods that treat fungal infections of the skin, reduce the severity and duration of symptoms of fungal infections of the skin, and prevent recurrence of fungal infections. The topical pastes described herein are composed of an admixture of one or more antifungal agents, excipient inert powder, and a pharmaceutically acceptable topical carrier. The compositions and methods described herein minimize fungal resistance and maximize the number of targeted fungal strains. Additionally, the compounds and methods do not suppress the body's immune system either locally or systemically, thus allowing for a faster restoration of normal skin flora. The compositions and methods described herein are particularly suitable for use in infants and children as well as in immunocompromised individuals, diabetics, and the obese.

What is claimed: 
     
         1 . A topical paste comprising
 a. one or more antifungal agents,   b. an excipient inert powder, and   c. a pharmaceutically acceptable topical carrier,   wherein the excipient inert powder is in a sufficient amount to form a topical paste.   
     
     
         2 . The paste of  claim 1 , wherein the antifungal agent is clotrimazole, ketoconazole, miconazole, oxiconazole, econazole, luliconazole, terbinafine, nystatin, fluconazole, voriconazole, itraconazole, caspofungin, micafungin, naftifine, butenafine, amorolfine, ravuconazole, posaconazole, flucytosine, sertaconazole, efinaconazole, enilaconazole, saperconazole, sulconazole, terconazole, tioconazole, nikkomycin Z, anidulafungin (LY303366), pimaricin, griseofulvin, ciclopirox, haloprogin, tolnaftate, undecylenate, or any combination thereof. 
     
     
         3 . The paste of  claim 1 , wherein the antifungal agent is a single agent. 
     
     
         4 . The paste of  claim 3 , wherein the antifungal agent is from 0.25 to 5% by weight of the paste. 
     
     
         5 . The paste of  claim 3 , wherein the antifungal agent is from 0.5 to 3% by weight of the paste. 
     
     
         6 . The paste of  claim 3 , wherein the antifungal agent is clotrimazole, nystatin, ketoconazole, miconazole, oxiconazole, luliconazole, or terbinafine. 
     
     
         7 . The paste of  claim 1 , wherein the excipient inert powder comprises talc, starch, zinc oxide, zinc carbonate, magnesium oxide, magnesium carbonate, calamine, calcium carbonate, kaolin, titanium dioxide, or any combination thereof. 
     
     
         8 . The paste of  claim 1 , wherein the paste comprises from 10% to 80% by weight granular particles, where the source of the granular particles is the excipient inert powder alone or in combination with the antifungal agent. 
     
     
         9 . The paste of  claim 1 , wherein the pharmaceutically acceptable topical carrier comprises a gel, lotion, or cream. 
     
     
         10 . The paste of  claim 1 , wherein the pharmaceutically acceptable topical carrier comprises an oil-in-water cream base. 
     
     
         11 . The paste of  claim 10 , wherein the oil-in-water cream base comprises Dermabase, Velvachol, or Aquaphilic®. 
     
     
         12 . The paste of  claim 1 , wherein the pharmaceutically acceptable topical carrier comprises an oil-free cream, lotion, or gel. 
     
     
         13 . The paste of  claim 12 , wherein the oil-free cream, lotion, or gel comprises VersaBase®. 
     
     
         14 . A method for treating or preventing a fungal disease, the method comprising applying the paste of  claim 1  to the subject. 
     
     
         15 . The method of  claim 14 , wherein the fungal disease comprises tinea cruris, tinea corporis, tinea versicolor, candidiasis, tinea pedis, intertrigo, seborrhoeic dermatitis, diaper rash, tinea capitis, tinea barbae, thrush, diaper dermatitis, or a combination thereof. 
     
     
         16 . The method of  claim 14 , wherein the fungal disease is intertrigo. 
     
     
         17 . The method of  claim 14 , wherein the fungal disease is diaper rash. 
     
     
         18 . The method of  claim 14 , wherein the composition treats at least one symptom comprising itching, a burning sensation, flaking skin, peeling skin, rash, redness, cracking skin, scaly skin, blisters, macerated skin, odor, or a combination thereof. 
     
     
         19 . The method of  claim 14 , wherein the subject has a weakened immune system resulting from HIV, AIDS, chemotherapy or radiation.