Gentle-acting skin-disinfectants and hydroalcoholic gel formulations

Antimicrobial compositions having synergistic combinations of octoxyglycerin and one other antimicrobial agent in formulations which are more powerful than prior art compositions without inducing increased irritation to the skin of the average user. In certain embodiments, skin irritation might be lessened by low concentrations of antimicrobials and/or the presence of soothing compounds such as zinc. Preferred embodiments include combinations of octoxyglycerin, a quaternary compound, and at least one other antimicrobial agent. Without being bound to any specific theory, it is hypothesized that the unexpected antimicrobial potency of combinations of octoxyglycerin may come from an improvement of the permeability of microbes to antimicrobials brought on by octoxyglycerin. Hydroalcoholic gel makeup containing alcohol, water, hydrogel, and emollient or emulsifier, whereas the composition has a viscosity of below 2000 centipoises in between 20 and 40. degree. C. This consists of hydroalcoholic gel makeup, which is further combined with silicone polymer, emollient solvent, thickening agent and antimicrobial agent, enhances long-term and rapid antimicrobial efficacy.

 

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BACKGROUND

 

 
“Skin disinfectants” are routinely used in professional and non-professional contexts to kill microbes. A doctor has a necessity to disinfect his or her skin both prior to and after analyzing a patient. Before the operation of aninvasive medical process, the skin of this subject must be properly washed to avoid post-procedure infections. In non-professional contexts, a commuter, riding public transportation, might want to disinfect her hands before handling food; a child,playing at a park, might want to clean his hands but not have the ease of water and soap nearby. Every one of those situations require, optimally, a skin disinfectant that’s effective, easy to use, and non-irritating so as to permit repeated use.
 

 
Numerous skin disinfectants have been developed that use alcohol as the main antimicrobial agent. There are two general issues associated with alcohol-based disinfectants. First, the effective concentration of alcohol, generallyregarded to be higher than approximately 60 percent fat (hereafter, all percentages should be contemplated weight/volume percentages, unless defined otherwise) of ethanol, or its equivalent, is irritating to the skin, leading to tingling and consequent peelingand cracking. Because chapped skin will be vulnerable to microbial contamination, repeated use of alcohol disinfectants can exacerbate the very problem they are intended to solve. Secondly, whereas alcohol can be an effective disinfectant, onceit hastens its antimicrobial action is missing.
 

 
Alcohol-based skin disinfectants which are known in the art, some of which address the two problems mentioned previously, include the following.
 

 

U.S. Pat.

No. 6,107,261 by Taylor et al., issued Aug.. 22, 2000, and its own continuations-in-part, U.S. Pat. No. 6,204,230 by Taylor et al., issued Mar.. 20, 2001 and U.S. Pat. No. 6,136,771 by Taylor et al., issued Oct.. 24, 2000, discloseantibacterial compositions that have an antibacterial agent in a percent saturation of 50 percent. The compositions further comprise, as solubility promoters, a surfactant and a hydric solvent, which might be an alcoholic.
 

 

U.S. Pat.

No. 5,776,430 by Osborne et al., issued Jul.. 7, 1998, reveals a topical antimicrobial cleaner containing roughly 0.65-0.85 percent chlorhexidine and about 50-60 percent denatured alcohol, that can be scrubbed onto then rinsed offthe skin.
 

 
European Patent Application 0604 848 discloses a gel containing an antifungal agent, 40-90 percent by means of an alcoholic, and a polymer and thickening agent.
 

 

U.S. Pat.

No. 4,956,170 from Lee, issued Sep. 11, 1990 relates to a high alcohol content antimicrobial gel composition which includes various emollients and a humectant to guard the skin against the drying effects of alcohol. In alcoholformulations, higher amounts of alcohol are essential to provide immediate kill against sensitive as well as resistant strains of bacteria.
 

 
Certain formulations almost include alcohol as a principal antimicrobial agent, including, as an instance, the skin sanitizing compositions revealed in U.S. Pat. No. 6,187,327 by Stack, issued Feb.. 13, 2001, which comprises triclosan(2,4,4′-trichloro-2′-hydroxydiphenyl ether; concentration 0.1-0.35 weight percentage ) in a topical cream included of a surfactant phase along with a wax phase, which supposedly provides antimicrobial defense for 3-4 hours following application. The compositionprepared Based on the claims of U.S. Pat. No. 6,187,327 further comprises chlorhexidine digluconate.
 

 

U.S. Pat.

No. 5,965,610 by Modak et al., issued Oct.. 12, 1999, teaches skin cleaning compositions comprising antifungal agents and zinc salts, where zinc salts have a calming influence on the skin. The claimed subject matter includesformulations containing a gel formed between zinc gluconate, chlorhexidine gluconate and a solvent, to which various thickening agents, emulsifying agents and/or emollients might be added.
 

 

U.S. Pat.

No. 5,985,918 by Modak et al., issued Nov.. 16, 1999, relates to “Zinc-Based Anti-Irritant Creams”.
 

 

U.S. Pat.

No. 5,705,532 by Modak et al., issued Jan.. 6, 1998, relates to”Triple Antimicrobial Compositions” containing less than or equal to 2 per cent of a chlorhexidine chemical, less than or equal to 0.1 per cent of a quaternary ammoniumcompound, and less than or equal to two per cent parachlorometaxylenol.
 

 
Octoxyglycerin, sold under the trade name Sensiva.RTM. SC50 (Schulke & Mayr), is a glycerol alkyl ether known to be gentle to the skin. Octoxyglycerin exhibits antimicrobial activity against many different Gram-positive bacteria related withperspiration odor, including Micrococcus luteus, Corynebacterium aquaticum, Corynebacterium flavescens, Corynebacterium callunae, and Corynebacterium nephredi, also is utilized in various skin deodorant preparations in concentrations between about 0.2 and 3percent (Sensiva.RTM. Product literature, Schulke & Mayr).
 

 

For example, U.S. Pat.

No. 5,885,562 by Lowry et al., issued Mar.. 23, 1999, relates to deodorant compositions comprising an antimicrobial agent, namely polyhexamethylene biguanide (in a concentration of between 0.01 and 0.5 percent), togetherwith a polarity modifier such as Sensiva.RTM.SC50, at amounts of typically 1-15 percent. Compositions disclosed in U.S. Pat. No. 5,885,562 may further include a brief string monohydric alcohol such as ethanol at a level of between 20 and 80 percent.Formulations used as deodorants, nevertheless, would differ from the ones utilized as skin sanitizers in that epidermis sanitizers would optimally display rapid broad spectrum activity against bacteria, fungi, and viruses, and not merely gram positive odor causingbacteria.
 

 

U.S. Pat.

No. 5,516,510 by Beilfuss et al., issued May 14, 1996, discloses deodorant compositions which include glycerin monoalkyl ethers like octoxyglycerin (referred to therein as 2-ethyl hexyl glycerin ether, also as being the mostpreferred among these compounds). The deodorant compositions of all U.S. Pat. No. 5,516,510 may be formulated in aqueous and/or alcoholic solutions and may further comprise additional antimicrobial compounds, such as triclosan, chlorhexidine salts,alexidine salts, and phenoxyethanol, among others. Specific concentration ranges for triclosan and the biguanides aren’t provided.
 

 

U.S. Pat.

No. 5,951,993 by Scholz et al., issued on Sep. 14, 1999, and U.S. Pat. No. 6,352,701 by Scholz et al., issued Mar.. 5, 2002, that is a continuation application , each relate to hydroalcoholic compositions having a loweralcohol and water in a weight ratio of approximately 35:65 to 100:0, between at least 0.5% and 8.0% by weight thickener method of two emulsifiers, wherein each emulsifier is present in at least 0.05% by weight, wherein the composition free of auxiliarythickeners has a viscosity of at least 4000 centipoise in 23. degree. C., and wherein each emulsifier is comprised of at least one hydrophilic group.
 

 

U.S. Pat.

No. 6,022,551 by Jampani et al., issued Feb.. 8, 2000, describes an antimicrobial alcohol-containing composition comprising specified antimicrobial compositions in solution with greater than 30% by volume of alcohol along with a carbomerpolymer thickener with a viscosity of greater than 9000 centipoise. Optional ingredients further include essential oils, tack modifiers, fragrances, emollients, pH adjusters, viscosity modifiers, transdermal enhancers, sarfactants, dyes, colors andwater.
 

 

U.S. Pat.

No. 5,403,864 by Bruch et al., issued Apr.. 4, 1995, describes alcohol-based alternative containing 40-70percent by weight of an alcohol or alcohol mixture, antimicrobial compounds such as triclosan and chloroxylenol (PCMX), and optionallyincludes emollients, surfactants, perfuming agents and chelating agents.
 

 

U.S. Pat.

No. 4,478,853 by Chausse, issued Oct.. 23, 1984, relates to a skin purifier comprising a hydroalcohol gel having from about 35 to 50 percent by means of a lower alkanol, from approximately 0.1 to 1 percent by means of a neutralizegelling agent, wherein the gelling agent is a polyacrylic acid cross-linked using a polyether of an oligosaccharide, and from about 1 to 15 percentage by weight of a foundation composition made from a panthenol moisturizer plus an emollient such as a polyhydricalcohol humectant and polyether derivative. The viscosity of these compositions are revealed to range generally from 2,000 to 20,000 cps.
 

 

U.S. Pat.

No. 3,485,915 by Gerstein et al., issued Dec.. 23, 1969, relates to aqueous and/or alcoholic compositions suitable for topical application to the skin containing, as thickening agents, about 0.1 to about 5 percent by weight of aneutralized carboxy polymer and about 0.1 to about 2 per cent by weight of hydroxypropyl cellulose.
 

 
A product called Avagard, made by 3M, is commercially available having a combination of emulsifiers, namely Beheneth-10, behenyl alcohol, cetylpalmitate, and diisopropyl dimer dilinoleate using 1% chlorhexidine gluconate solution and 61 percent ethylalcohol (w/w).
 

 
A product named Prevacare, produced by Johnson & Johnson, is available with petrolatum as its active ingredient; water as a car; liposome-building blocks including glycerol distearate, stearate-10, cholesterol, along with polysorbate80; sodium laureth sulfate as a sarfactant; propylene glycol as a moisterizer; and additives including diazolidinyl urea, methylparaben, and propylparaben. Prevacare-D is a commercially available item having white petrolatum and dimethicone asactive components, plus also contains cyclomethicone as an emollient; polyethylene and silica as viscosity contractors; mineral oil as a moisturizer/emollient, propylparaben as a preservative and odor.
 

 
A product called Hibiclens, made by Zeneca Pharmaceuticals, is commercially available having 4 percent chlorhexidine gluconate as its active ingredient. Inactive ingredients include odor, isopropyl alcohol, purified water, red #40 andother ingredients not defined in its own form.
 

 
A product named Purell, made by GOJO Industries Inc., is commercially available in four formulations. According to the product literature, the active ingredient in every formula of Purell is 62 percent ethyl alcohol. Inactive ingredientsfor Purell 2 in 1 are water, Stearyl Alcohol, Cyclomethicone, C12-15 Alkyl Benzoate, Cetyl Lactate, Cocamidopropyl PG-Dimonium Chloride Phosphate, Glycerin, PEG-4, Propylene Glycol, Tocopheryl Acetate, Aminomethyl Propanol, Carbomer, Styrene/AcrylatesCopolymer, Fragrance (Parfum), Diazolidinyl Urea, Iodopropynyl Butylcarbamate, Methylparaben, along with Propylparaben; such as Purell Original are water, Glycerin, Isopropyl Myristate, Propylene Glycol, Tocopheryl Acetate, Aminomethyl Propanol, Carbomer, andFragrance (Parfum); for Purell with Aloe are: water, Aloe Barbadensis Leaf Juice, Glycerin, Isopropyl Myristate, Propylene Glycol, Tocopheryl Acetate, Aminomethyl Propanol, Carbomer, Fragrance (Parfum), Blue 1 (CI-42090), Yellow 5 (CI 19140); and forPurell Kid’s Own are water, Isopropyl Myristate, Propylene Glycol, Aminomethyl Propanol, Carbomer, Fragrance (Parfum), along with Red 33.
 

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