Stable hydroalcoholic compositions

Abstract

Disclosed is a composition including a lower alcohol and water in a weight ratio of about 35:65 to 100:0, between at least 0.5% and 8.0% by weight thickener system comprised of at least two emulsifiers, each emulsifier present in at least 0.05% by weight and wherein each emulsifier is comprised of at least one hydrophobic group and at least one hydrophilic group. The composition is useful as a presurgical scrub replacement, a lotion or other hand preparation.

What is claimed is:  
     
         1 . A hydroalcoholic skin disinfection composition comprising: 
 a) a lower alcohol and water in a weight ratio of about 35:65 to about 95:5; and    b) at least two emulsifiers, wherein at least one of the emulsifiers is solid at ambient temperature and each is present in an amount of at least about 0.05% by weight, based on the total weight of the composition; wherein at least one emulsifier comprises a quaternary amine group and a hydrophobic group comprised of an alkyl chain of at least 20 carbon atoms.    
     
     
         2 . The composition of  claim 1  further comprising at least one emulsifier comprising: 
 (i) at least one hydrophobic group selected from the group consisting of: 
 (A) an alkyl group of at least 18 carbon atoms:  
 (B) an alkenyl group of at least 18 carbon atoms; and  
 (C) an aralkyl or an aralkenyl group of at least 18 carbon atoms; and  
 
 (ii) at least one hydrophilic group selected from the group consisting of: 
 (A) an amide group;  
 (B) a short chain ester of a long chain alcohol or acid;  
 (C) a polyglucoside group having 1-10 glucose units;  
 (D) a polyglycerol ester group having 1-15 glycerol units;  
 (E) a secondary amine group;  
 (F) a tertiary amine group;  
 (G) a quaternary amine group;  
 (H) a zwitterionic group;  
 (I) an ethylene oxide- and/or propylene oxide containing group bonded to the hydrophobic group through an ether or ester bond and optionally terminated with a C1-C36 alkyl ester, C2-C36 alkenyl ester, or a(C6-C36)alkaryl ester;  
 (J) an alcohol group;  
 (K) a polyhydric alcohol group;  
 (L) an ester or ether group of a polyhydric alcohol or polyalkoxylated derivative thereof having 2-150 moles of alkylene oxide per mole of hydrophobic group; and  
 (M) combinations of these groups.  
 
 
     
     
         3 . The composition of  claim 2  wherein the amide group has the structure —NHC(O)R′″ or —C(O)NHR′″, wherein R′″ is hydrogen or an alkyl group of 1-10 carbon atoms optionally substituted with N, O, or S atoms; the anionic group is selected from the group consisting of a sulfate, a sulfonate, a phosphate, a phosphonate, and a carboxylate group; and the zwitterionic group has the formula:  
       —N + (R″) 2 (CHQ) x L′or                    
       wherein: 
 each R″ is independently hydrogen, an alkyl group, an alkenyl group, an alkyl carboxyl group, or an alkenyl carboxyl group, which alkyl or alkenyl groups are optionally substituted with N, O, or S atoms;  
 Q is hydrogen or hydroxyl;  
 x is 1 to 4; and  
 L′ is —CO 2   − , —OP(O)(O − )(O − M + ), —(O)P(OR′″)(O)(O − M + ), —SO 2 O − , or —OSO 2 O −  wherein: 
 R′″ is hydrogen or an alkyl group of 1-10 carbon atoms optionally substituted with N, O, or S atoms;  
 M +  is a positively charged counterion present in a molar ratio necessary to 
 achieve a net neutral charge on the emulsifier and is selected from the group consisting of hydrogen, sodium, potassium, lithium, ammonium, calcium, magnesium, and N + R″ 4 .  
 
 
 
     
     
         4 . The composition of  claim 2  wherein the zwitterionic group has the formula:  
       —N + (R″) 2 (CHQ) x L′or                    
       wherein: 
 each R″ is independently hydrogen, an alkyl group, an alkenyl group, an alkyl carboxyl group, or an alkenyl carboxyl group, which alkyl or alkenyl groups are optionally substituted with N, O, or S atoms;  
 Q is hydrogen or hydroxyl;  
 x is 1 to 4; and  
 L′ is —CO 2   − , —OP(O)(O − )(O − M + ), —(O)P(OR′″)(O)(O − M + ), —SO 2 O − , or —OSO 2 O −  wherein: 
 R′″ is hydrogen or an alkyl group of 1-10 carbon atoms optionally substituted with N, O, or S atoms;  
 M +  is a positively charged counterion present in a molar ratio necessary to achieve a net neutral charge on the emulsifier and is selected from the group consisting of hydrogen, sodium, potassium, lithium, ammonium, calcium, magnesium, and N + R″ 4 .  
 
 
     
     
         5 . The composition of  claim 1  wherein the composition when used as a presurgical scrub replacement achieves bacterial kill equal or better than a traditional soap and water scrub in a shorter period of time.  
     
     
         6 . The composition of  claim 1  wherein the composition maintains or improves the skins natural barrier to microbial and chemical contaminants.  
     
     
         7 . The composition of  claim 1  further comprising an ethoxylated and/or propoxylated alcohol and esters and derivatives thereof.  
     
     
         8 . The composition of  claim 7  wherein the ethoxylated and/or propoxylated alcohol and esters and derivatives thereof is a polyethoxylated alcohol.  
     
     
         9 . The composition of  claim 1  further comprising an antimicrobial agent distinct from the lower alcohol.  
     
     
         10 . The composition of  claim 1  wherein the lower alcohol and water are in a weight ratio in excess of a 64:36.  
     
     
         11 . The composition of  claim 1  further comprising at least one emulsifier comprising: 
 (i) at least one hydrophobic group selected from the group consisting of: 
 (A) an alkyl group of at least 22 carbon atoms;  
 (B) an alkenyl group of at least 22 carbon atoms; and  
 (C) an aralkyl or an aralkenyl group of at least 22 carbon atoms;  
 
 (ii) at least one hydrophilic group selected from the group consisting of: 
 (A) an ethylene oxide- and/or propylene oxide-containing group, which is bonded to the hydrophobic group through an ether or ester bond and optionally terminated with a (C1-C36)alkyl ester, (C2-C36)alkenyl ester, or (C6-C36)alkaryl ester;  
 (B) an alcohol group;  
 (C) a polyhydric alcohol group;  
 (D) an ester or ether group of a polyhydric alcohol or polyalkoxylated derivative thereof;  
 (E) an ester or ether group of sorbitan or polyalkoxylated derivative thereof; and  
 (F) combinations of these groups.  
 
 
     
     
         12 . The composition of  claim 1  further comprising at least one emollient.  
     
     
         13 . The composition of  claim 12  wherein the emollient and emulsifiers are in wax form and liquid form and the ratio of wax emollients and wax emulsifiers to liquid emollients and liquid emulsifiers is between about 5:1 and 1:5.  
     
     
         14 . The composition of  claim 1  wherein each emulsifier is present in an amount of at least about 0.5% by weight.  
     
     
         15 . The composition of  claim 1  wherein at least one emulsifier is selected from the group consisting of an alkyl polyglucoside, an alkenyl polyglucoside, a C 1 -C 4  alkyl or alkenyl ester of a long chain alkyl or alkenyl alcohol, a C 1 -C 4  ester of a long chain acid, a polyglycerol ester, a tertiary amine and protonated salts thereof, an amine oxide, a zwitterionic compound, an alkyl amide, an alkenyl amide, an anionic compound, and mixtures thereof.  
     
     
         16 . The composition of  claim 1  wherein the composition comprises one or more emulsifiers capable of forming an alcoholic composition having a viscosity of at least about 4,000 centipoise at 23 ? C in the absence of an auxiliary thickener.  
     
     
         17 . The composition of  claim 1  which is in the form of a lotion or a foam.  
     
     
         18 . A hydroalcoholic skin disinfection composition comprising: 
 a) a lower alcohol and water in a weight ratio of about 35:65 to about 95:5; and    b) at least two emulsifiers, wherein at least one of the emulsifiers is solid at ambient temperature and each is present in an amount of at least about 0.05% by weight, based on the total weight of the composition; wherein at least one emulsifier comprises: 
 (i) at least one hydrophobic group selected from the group consisting of: 
 (A) an alkyl group of at least 18 carbon atoms:  
 (B) an alkenyl group of at least 18 carbon atoms; and  
 (C) an aralkyl or an aralkenyl group of at least 18 carbon atoms; and  
 
 (ii) at least one hydrophilic group selected from the group consisting of: 
 (A) a short chain ester of a long chain alcohol or acid;  
 (B) a polyglucoside group having 1-10 glucose units;  
 (C) a polyglycerol ester group having 1-15 glycerol units;  
 (D) a secondary amine group;  
 (E) an amine oxide group;  
 (F) a zwitterionic group;  
 (G) a polyhydric alcohol group;  
 (H) an ester or ether group of a polyhydric alcohol or polyalkoxylated derivative thereof having 2-150 moles of alkylene oxide per mole of hydrophobic group; and  
 (I) combinations of these groups.  
 
   
     
     
         19 . The composition of  claim 19  further comprising at least one emulsifier comprising a quaternary amine group and having a hydrophobic group comprised of an alkyl chain of at least 20 carbon atoms.  
     
     
         20 . The composition of  claim 19  wherein at least one emulsifier has at least one hydrophobic group selected from the group consisting of: 
 (A) an alkyl group of at least 20 carbon atoms:  
 (B) an alkenyl group of at least 20 carbon atoms; and  
 (C) an aralkyl or an aralkenyl group of at least 20 carbon atoms  
 
     
     
         21 . The composition of  claim 21  further comprising an antimicrobial agent distinct from the lower alcohol.  
     
     
         22 . The composition of  claim 19  further comprising an antimicrobial agent distinct from the lower alcohol.  
     
     
         23 . The composition of  claim 23  wherein the antimicrobial agent is selected from chlorhexidine, surfactants comprising a C12-C22 hydrophobe and a quaternary amine group, and triclosan.  
     
     
         24 . The composition of  claim 19  wherein the lower alcohol and water are in a weight ratio in excess of a 64:36.  
     
     
         25 . The composition of  claim 19  further comprising at least one emollient.  
     
     
         26 . The composition of  claim 25  wherein the emollient and emulsifiers are in wax form and liquid form and the ratio of wax emollients and wax emulsifiers to liquid emollients and liquid emulsifiers is between about 5:1 and 1:5.  
     
     
         27 . The composition of  claim 19  wherein each emulsifier is present in an amount of at least about 0.5% by weight.  
     
     
         28 . A hydroalcoholic skin disinfection composition comprising: 
 a) a lower alcohol and water in a weight ratio of about 35:65 to about 95:5; and    b) at least two emulsifiers, wherein at least one of the emulsifiers is solid at ambient temperature and each is present in an amount of at least about 0.05% by weight, based on the total weight of the composition; wherein at least one emulsifier comprises a quaternary amine group and has a hydrophobic group comprised of an alkyl chain of at least 20 carbon atoms, and wherein at least one emulsifier comprises an alcohol group and at least one hydrophobic group selected from the group consisting of: 
 (A) an alkyl group of at least 18 carbon atoms:  
 (B) an alkenyl group of at least 18 carbon atoms; and  
 (C) an aralkyl or an aralkenyl group of at least 18 carbon atoms.  
   
     
     
         29 . The composition of  claim 29  further comprising an antimicrobial agent distinct from the lower alcohol.  
     
     
         30 . The composition of  claim 29  wherein the antimicrobial agent is selected from chlorhexidine, surfactants comprising a C12-C22 hydrophobe and a quaternary amine group, and triclosan.  
     
     
         31 . A hydroalcoholic skin disinfection composition comprising: 
 a) a lower alcohol and water in a weight ratio of about 35:65 to about 95:5; and    b) at least two emulsifiers, wherein at least one of the emulsifiers is solid at ambient temperature and each is present in an amount of at least about 0.05% by weight, based on the total weight of the composition; wherein at least one emulsifier comprises a quaternary amine group and has a hydrophobic group comprised of an alkyl chain of at least 20 carbon atoms, and wherein at least one emulsifier comprises a polyhydric alcohol group and at least one hydrophobic group selected from the group consisting of:    (A) an alkyl group of at least 18 carbon atoms:    (B) an alkenyl group of at least 18 carbon atoms; and    (C) an aralkyl or an aralkenyl group of at least 18 carbon atoms.    
     
     
         32 . A hydroalcoholic skin disinfection composition comprising: 
 a). a lower alcohol and water in a weight ratio of about 35:65 to about 95:5;    b) at least two emulsifiers, wherein at least one of the emulsifiers is solid at ambient temperature and each is present in an amount of at least about 0.05% by weight, based on the total weight of the composition; wherein at least one emulsifier comprises a quaternary amine group and has a hydrophobic group comprised of an alkyl chain of at least 20 carbon atoms; and    c) chlorhexidine.    
     
     
         33 . A hydroalcoholic skin disinfection composition comprising: 
 a) a lower alcohol and water in a weight ratio of about 35:65 to about 95:5; and    b) at least two emulsifiers, wherein at least one of the emulsifiers is solid at ambient temperature and each is present in an amount of at least about 0.05% by weight, based on the total weight of the composition; wherein at least one emulsifier comprises a quaternary amine group and has a hydrophobic group comprised of an alkyl chain of at least 20 carbon atoms, and wherein at least one emulsifier comprises a compound of the formula:                          wherein:    R 6  is a straight or branched chain alkyl or alkenyl hydrocarbon chain of at least 16 carbon atoms optionally substituted in available positions by N, O, or S atoms; or an aralkyl or aralkenyl group of at least 22 carbon atoms optionally substituted in available positions by N, O, and S atoms;    m=0-200;    p=0 or 1;    R 8 ═H or —C(O)—R 12 , where R 12  is an alkyl or alkenyl group of 1-36 carbon atoms optionally substituted by N, O or S, or an aralkyl group of 6 to 36 carbon atoms; and    r=0-50.    
     
     
         34 . A hydroalcoholic skin disinfection composition comprising: 
 a) a lower alcohol and water in a weight ratio of about 35:65 to about 95:5; and    b) at least two emulsifiers, wherein at least one of the emulsifiers is solid at ambient temperature and each is present in an amount of at least about 0.05% by weight, based on the total weight of the composition; wherein at least one emulsifier comprises a quaternary amine group and has a hydrophobic group comprised of an alkyl chain of at least 20 carbon atoms, and wherein at least one emulsifier comprises a compound of the formula:                          wherein:    t=0-4;    s=0 or 1;    each R 9  is independently chosen from H, —CH 2 OR 10 , —OH, or a hydrocarbon chain of 1 to 4 carbon atoms; wherein R 10 =H or R 12  wherein R 12  is an alkyl or alkenyl group of 1-36 carbon atoms optionally substituted by N, O or S, or an aralkyl group of 6 to 36 carbon atoms.    
     
     
         35 . A hydroalcoholic skin disinfection composition comprising: 
 a) a lower alcohol and water in a weight ratio of about 35:65 to about 95:5; and    b) at least two emulsifiers, wherein at least one of the emulsifiers is solid at ambient temperature and each is present in an amount of at least about 0.05% by weight, based on the total weight of the composition; wherein at least one emulsifier comprises a quaternary amine group and has a hydrophobic group comprised of an alkyl chain of at least 20 carbon atoms, and wherein at least one emulsifier comprises a compound of the formula:    (R) a (L) b      wherein:    R represents a hydrophobic group selected from the group consisting of: 
 (A) an alkyl group of at least 16 carbon atoms:  
 (B) an alkenyl group of at least 16 carbon atoms; and  
 (C) an aralkyl or an aralkenyl group of at least 20 carbon atoms;  
   L represents an ethylene oxide- and/or propylene oxide-containing group, which    is bonded to the hydrophobic group through an ether or ester bond and optionally terminated with a (C1-C36)alkyl ester, (C2-C36)alkenyl ester, or (C6-C36)alkaryl ester; and    a and b are independently 1 to 4.