Cationic antiseptic compositions and methods of use

Abstract

Antimicrobial compositions, especially those useful when applied topically, particularly to mucosal tissues (i.e., mucous membranes), including a cationic antiseptic such as biguanides and bisbiguanides such as chlorhexidine and its various salts including but not limited to the digluconate, diacetate, dimethosulfate, and dilactate salts; polymeric quaternary ammonium compounds such as polyhexamethylenebiguanide; silver and various silver complexes; small molecule quaternary ammonium compounds such as benzalkoium chloride and alkyl substituted derivatives; di-long chain alkyl (C8-C18) quaternary ammonium compounds; cetylpyridinium halides and their derivatives; benzethonium chloride and its alkyl substituted derivatives; and octenidine. The compositions can also include an enhancer component, a surfactant, a hydrophobic component, and/or a hydrophilic component. Such compositions provide effective topical antimicrobial activity and are accordingly useful in the treatment and/or prevention of conditions that are caused, or aggravated by, microorganisms (including viruses).

1 - 21 . (canceled) 
     
     
         22 . An antiseptic composition comprising:
 (a) a polymeric quaternary ammonium compound having the formula
   X—R 1 —NH—C(NH)—NH—C(NH)—NH—R 2 —NHC(NH)—NH—C(NH)—NH—R 3 —X
 
 where R 1 , R 2 , and R 3  are each bridging groups having 2 to 10 methylene groups, and X is selected from the group consisting of an amine, an amine salt, and a dicyandiamide group; 
   (b) a lipid comprising at least one of
 a (C7-C14)saturated fatty acid ester of a polyhydric alcohol, 
 a (C8-C22)unsaturated fatty acid ester of a polyhydric alcohol, 
 a (C7-C14)saturated fatty ether of a polyhydric alcohol, 
 a (C8-C22)unsaturated fatty ether of a polyhydric alcohol, 
 an alkoxylated derivative thereof, and 
 combinations thereof, 
 where the alkoxylated derivative has less than 5 moles of alkoxide per mole of polyhydric alcohol, and 
 where for polyhydric alcohols other than sucrose, the esters comprise monoesters and the ethers comprise monoethers, and for sucrose the esters comprise monoesters, diesters, or combinations thereof, and the ethers comprise monoethers, diethers, or combinations thereof; 
   (c) a hydrophilic component;   (d) a thickener; and   (e) water.   
     
     
         23 . The antiseptic composition of  claim 22 , wherein the polymeric quaternary ammonium compound is polyhexamethylene biguanide. 
     
     
         24 . The antiseptic composition of  claim 22 , wherein the polymeric quaternary ammonium compound comprises 0.05% to 8% by weight of the composition. 
     
     
         25 . The antiseptic composition of  claim 22 , wherein the lipid comprises the (C7-C14)saturated fatty acid ester of a polyhydric alcohol. 
     
     
         26 . The antiseptic composition of  claim 22 , wherein the polymeric quaternary ammonium compound and lipid together comprise 0.2% to 20% by weight of the composition. 
     
     
         27 . The antiseptic composition of  claim 22 , further comprising a non-ionic surfactant. 
     
     
         28 . The antiseptic composition of  claim 27 , wherein the non-ionic surfactant comprises at least one of alkyl glucosides, alkyl polyglucosides, polyhydroxy fatty acid amides, sucrose esters, esters of fatty acids and polyhydric alcohols, fatty acid alkanolamides, ethoxylated fatty acids, ethoxylated aliphatic acids, ethoxylated fatty alcohols, nonyl phenoxy poly(ethyleneoxy) ethanol, ethoxylated and propoxylated aliphatic alcohols, ethoxylated glycerides, ethoxylated/propoxylated block copolymers, ethoxylated cyclic ether adducts, ethoxylated amide and imidazoline adducts, ethoxylated amine adducts, ethoxylated mercaptan adducts, ethoxylated condensates with alkyl phenols, ethoxylated nitrogen-based hydrophobes, ethoxylated polyoxypropylenes, polymeric silicones, fluorinated surfactants, and polymerizable (reactive) surfactants. 
     
     
         29 . The antiseptic composition of  claim 27 , wherein the non-ionic surfactant comprises 0.01% to 10% by weight of the composition. 
     
     
         30 . The antiseptic composition of  claim 22 , wherein the hydrophilic component comprises a polyhydric alcohol. 
     
     
         31 . The antiseptic composition of  claim 22 , wherein the hydrophilic component comprises at least one of glycerol, propylene glycol, dipropylene glycol, tripropylene glycol, polypropylene glycol, polyethylene glycol, diethylene glycol, pentaerythritol, trimethylolpropane, trimethylolethane, trimethylolbutane, sorbitol, mannitol, xylitol, pantothenol, ethylene glycol adducts of polyhydric alcohol, propylene oxide adducts of polyhydric alcohol, 1,3-butanediol, dipropylene glycol, diglycerine, polyglycerine, erythritol, sorbitan, sugars, and sugar alcohols. 
     
     
         32 . The antiseptic composition of  claim 22 , wherein the hydrophilic component comprises the highest amount in % by weight of any component in the composition. 
     
     
         33 . The antiseptic composition of  claim 22 , wherein the thickener comprises at least one of a soluble organic polymeric thickener, a swellable organic polymeric thickener, and an insoluble organic polymeric thickener. 
     
     
         34 . The antiseptic composition of  claim 22 , wherein the thickener comprises a swellable organic polymeric thickener. 
     
     
         35 . The antiseptic composition of  claim 22 , wherein the thickener comprises at least one of silica, fumed silica, precipitated silica and silica aerogels. 
     
     
         36 . The antiseptic composition of  claim 22 , wherein the water is less than 20% by weight of the composition. 
     
     
         37 . The antiseptic composition of  claim 22 , wherein the composition is a gel. 
     
     
         38 . A flexible tube containing the composition of  claim 22 . 
     
     
         39 . A delivery device containing the composition of  claim 22 , wherein the delivery device is selected from the group consisting of a wipe and a pad. 
     
     
         40 . A delivery device containing the composition of  claim 22 , wherein the delivery device is selected from the group consisting of cloth, sponges and paper products. 
     
     
         41 . A method of killing microorganisms in skin, the method comprising applying the composition of  claim 22  to the skin.