Composition and kits for inhibition of pathogenic microbial infection and methods of using the same

Abstract

Antimicrobial polymer coating formulations are prepared that protect biological surfaces by treating, reducing, ameliorating, preventing or inhibiting pathogenic microorganism ingress to a human or animal host, reducing the potential for infection, particularly by necrotizing fasciitis originating microorganisms, through use of an polymer coating barrier containing antimicrobial agents that facilitates sustained release of biocidal agents active against such opportunistic microorganisms. Such formulations are effective for inhibiting microbial ingress pertaining to soft tissue and skin tears, abrasions, punctures and surgical wounds, and can be used as in water environments and as a skin protectant sunscreen and insect repellent.

1 . An antimicrobial, water-insoluble, polymer coating composition comprising:
 at least one polymeric biguanide in an amount from at least 0.10 wt-% to 10.00 wt-%, and   at least one additional antimicrobial agent in an amount of at least 0.20 wt-% to 10.00 wt-%,   said polymer coating comprising up to 99.7 wt-% of said composition, wherein said polymer coating composition provides biocidal activity for at least 24 hours against at least one opportunistic pathogen that causes necrotizing fasciitis selected from  Vibrio vulnificus  and  Streptococcus pyrogenes.      
     
     
         2 . The composition according to  claim 1 , wherein said polymeric biguanide comprises poly(hexamethylene biguanide) and its salts. 
     
     
         3 . The composition according to  claim 1 , wherein said at least one additional antimicrobial agent comprises a monoacyl glycerol. 
     
     
         4 . The composition according to  claim 1 , wherein said at least one antimicrobial agent comprises a monoacyl glycerol selected from the group consisting of 1-O-decanoylglycerol, monocaprin, 1-O-undecanoylglycerol, 1-O-undecenoylglycerol, 1-O-dodecanoylglycerol, monolaurin, glycerol monolaurate, 1-O-tridecanoylglycerol, 1-O-tetradecanoylglycerol, monomyristin, 1-O-pentadecanoylglycerol, 1-O-hexadecanoylglycerol, 1-O-heptadecanoylglycerol, 1-O-octanoylglycerol, monocaprylin, and combinations thereof. 
     
     
         5 . The composition according to  claim 1 , where said polymeric biguanide is poly(hexamethylene biguanide) hydrochloride and said one additional antimicrobial agent is glycerol monolaurate. 
     
     
         6 . The composition according to  claim 1  further comprising at least one additional additive selected from the group consisting of surfactants, sunscreen agents, insect repelling agents, emollients, active pharmaceutical agents, antibiotics, essential oils, polymer film flexibilizers, plasticizers, compatabilizers, skin care additives, and combinations thereof. 
     
     
         7 . The composition according to  claim 1 , wherein said composition provides a log reduction of at least 2 log orders in 48 hours against  Vibrio vulnificus , and  Streptococcus pyrogenes.    
     
     
         8 . The composition according to  claim 6 , further comprising a surfactant selected from the group consisting of poloxamers, poloxamines, Pluronics, Tetronics, polyethylene glycol esters of fatty acids, polyoxyethylene or polyoxypropylene ethers of higher alkanes (C 12 -C 18 ), polysorbate 20, polysorbate 80, Brij 35, Myrj 52, polyoxyethylene propylene glycol stearate, nonylphenol ethoxylates, Triton X-100, Tween 80, Miranol, cocoamidopropyl betaine, decyl glucoside, lauryl glucoside, sodium N-lauryl-β-iminodipropionate, sodium lauriminodipropionate, disodium lauriminodipropionate, disodium 3,3′-(dodecylimino)dipropanoate, disodium 3-[2-carboxylatoethyl(dodecyl)amino]propanoate, disodium lauroamphodiacetate, sodium-2-ethylhexyliminodipropionate, disodium cocoamphodiacetate, sodium cocoamphoacetate, ammonium lauriminodipropionate, triethanolamine lauraminopropionate, disodium cocaminodipropionate, cocamidopropyl betaine, lauramidopropyl betaine, cocobetaine, laurylbetaine, isostearamidopropyl betaine, cocamidopropyl hydroxysultaine, lauramidopropyl hydroxysultaine, disodium capryloamphodiacetate, sodium lauroamphoacetate, sodium cocaminodipropionate, ammonium cocaminodipropionate, triethanolamine lauriminodipropionate, sodium cocoamphohydroxypropylsulfonate, sodium cocoamphopropionate, sodium cornamphopropionate, sodium lauroamphohydroxypropylsulfonate, sodium lauroamphopropionate, ammonium cocaminopropionate, ammonium cocoamphoacetate, disodium caproamphodiacetate, disodium caproamphoadipropionate, disodium capryloamphodiacetate, disodium capryloamphodipriopionate, disodium cocoamphocarboxyethylhydroxypropylsulfonate, disodium laureth-5 carboxyamphodiacetate, disodium oleoamphodipropionate, disodium PPG-2-isodecethyl-7 carboxyamphodiacetate, lauraminopropionic acid, lauroamphodipropionic acid, lauryl aminopropylglycine, lauryl diethylenediaminoglycine, cocoamidopropyldimethylglycine, cocoamphocarboxypropionate, cocamidopropyl PG-dimonium chloride phosphate, oleamidopropyl betaine, myristamidopropyl betaine, dimethicone propyl PG-betaine, palmitamidopropyl betaine, undecylenamidopropyl betaine, and combinations thereof. 
     
     
         9 . The composition according to  claim 6  wherein the sunscreen agents are selected from the group consisting of avobenzone (butylmethoxydibenzoylmethane; 4-tert-butyl-4′-methoxydibenzoylmethane), homosalate (homomenthyl salicylate; 3,3,5-trimethylcyclohexyl 2-hydroxybenzoate), octisalate (octyl salicylate; 2-ethylhexyl salicylate; 2-ethylhexyl 2-hydroxybenzoate), octocrylene (2-ethylhexyl-2-cyano-3,3-diphenyl-2-acrylate; 2-ethylhexyl-2-cyano-3,3-diphenyl-2-propenoate), oxybenzone (benzophenone-3; (2-hydroxy-4-methoxyphenyl)phenylmethanone; 2-hydroxy-4-methoxybenzophenone), otinoxate (ethylhexyl methoxycinnamate); octyl methoxycinnamate), zinc oxide, titanium dioxide, and combinations thereof. 
     
     
         10 . The composition according to  claim 6 , wherein the insect repelling agents are selected from the group consisting of oil of lemon eucalyptus, p-menthane-3,8-diol, picaridin, icaridin, lemongrass oil, citronella oil, castor oil, cedar oil, clove oil, geraniol oil, peppermint oil, eucalyptus oil, pine oil, rosemary oil, cedarwood oil, lavender oil, spearmint oil, lime oil, bog myrtle, neem oil, soybean oil, N,N-diethyltoluamide, and combinations thereof. 
     
     
         11 . The composition according to  claim 1 , wherein the polymer coating comprises a film-forming polymer selected from the group consisting of acrylate polymers, methacrylate polymers, siloxanyl polymers, dimethicones, acrylamide polymers, octylacrylamide polymers, vinyl acetate polymers, N-vinylpyrollidone polymers, maleate polymers, crotonate polymers, alkene polymers, styrene polymers, butadiene polymers, vinyl methyl ether polymers, vinyl proprionate polymers, urethane polymers, polyesters, quaternary ammonium polymers, N-vinylcaprolactam polymers, and combinations thereof. 
     
     
         12 - 13 . (canceled) 
     
     
         14 . An antimicrobial, liquid coating composition, comprising:
 45.0 to 99.7 wt-% of a volatile polar and/or nonpolar liquid;   0.10 to 50.0 wt-% of a polymer dissolved in said volatile polar and/or nonpolar liquid;   0.10 wt-% (1,000 ppm) to 1.0 wt-% (10,000 ppm) polymeric biguanide, and   0.10 wt-% (1,000 ppm) to 4.0 wt-% (40,000 ppm) of an additional antimicrobial agent, wherein a polymer coating formed from said antimicrobial, liquid coating composition provides biocidal activity for at least 24 hours against at least one opportunistic pathogen that causes necrotizing fasciitis selected from  Vibrio vulnificus  and  Streptococcus pyrogenes.      
     
     
         15 . The composition according to  claim 14 , further comprising an aerosol propellant selected from ethane, propane, n-butane, isobutane, 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3-heptafluoropropane, dimethyl ether, methyl ethyl ether, and compressed gases selected from nitrogen, nitrous oxide, air, and carbon dioxide, and combinations thereof. 
     
     
         16 . The composition according to  claim 14  comprising 0.10 wt-% to 4.0 wt-% of solubilized water as part of the volatile solvent. 
     
     
         17 . A method of inhibiting or preventing pathogenic microbial infection, comprising:
 applying a liquid antimicrobial polymer coating formulation to a biological surface,   wherein said polymer formulation comprises:
 0.10 to 50.0 wt-% of a polymer dissolved in about 45.0 to 99.7 wt-% of a volatile polar and/or nonpolar liquid, 
 0.10 wt-% (1,000 ppm) to 1.0 wt-% (10,000 ppm) polymeric biguanide, and 
 0.10 wt-% (1,000 ppm) to 4.0 wt-% (40,000 ppm) of an additional antimicrobial agent; and 
 evaporating said solvent, wherein a polymer coating formed by said evaporating provides biocidal activity for at least 24 hours against at least one opportunistic pathogen that causes necrotizing fasciitis selected from  Vibrio vulnificus  and  Streptococcus pyrogenes.    
   
     
     
         18 . A method according to  claim 17  wherein said applying step comprises application by at least one of spraying, wiping, dipping, painting, brushing, casting, and aerosolization. 
     
     
         19 . A kit comprising:
 an antimicrobial solution composition according to  claim 14 ; and   instructions for using the antimicrobial composition for inhibition against at least one opportunistic pathogen that causes necrotizing fasciitis selected from  Vibrio vulnificus  and  Streptococcus pyrogenes.      
     
     
         20 . The kit according to  claim 19 , wherein said instructions comprise contacting the antimicrobial solution composition with an area of skin in need of inhibition of opportunistic pathogen infection. 
     
     
         21 . The composition according to  claim 1 , wherein said polymeric biguanide comprises a poly(hexamethylene biguanide) or one of its salts, and said at least one additional antimicrobial agent comprises a monoacyl glycerols. 
     
     
         22 . The composition according to  claim 1 , wherein said at least one additional antimicrobial agent comprises glycerol monolaurate.