This application is a continuation of U.S. patent application Ser. No. 11/102,017, filed Apr. 9, 2005, to J. Steven Brown, now pending, which is a continuation of Great Britain Patent Application Serial No. 04 12329.5, filed on Jun. 3, 2004, now Great Britain Patent No. GB2414666, issued Jan. 7, 2009, which has as a divisional application Great Britain Patent Application Serial No. 08 21820.8, filed Nov. 28, 2008, now pending.
FIELD OF THE INVENTION
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This invention relates to a sanitizing composition and its method of preparation. More particularly, but not exclusively, the invention relates to an alcohol hand sanitizer for use in a health care environment.
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OF THE INVENTION
Currently, hospital acquired infections affect about 100,000 Britons each year and generate costs of £lbn. An increasing percentage of these infections are resistant to antibiotics. The hospital “superbug”, methicillin resistant Staphylococcus aureus (MRSA), kills between 5,000 and 20,000 Britons each year. Other multiple-resistant pathogens such as vancomycin resistant Enterococci (VRE), vancomycin intermediate Staphylococcus aureus (VISA) have been observed in the UK. As pervasive use of antibiotics continues, more multiple-resistant pathogens are expected to appear in the future. This trend has increased over the past 10 years.
Health care environments are the prime breeding grounds for multiple-resistant pathogens due to the high ambient levels of antibiotics, the density of human hosts with weakened immune systems, and the ready means of cross-inoculation afforded by health care workers tending to many different patients. The single most significant inoculation vector is the health care worker's hand.
Hand hygiene is of primary importance in controlling infection in a health care environment. There exist specific standards to specify when, where and how health care workers (HCW) should clean their hands. In the U.K., the National Health Service (NHS) is challenged to enforce these standards to the point at which infection rates decrease. Enforcing these, or any future updated standards of hygiene will be crucial in controlling hospital infection. Unfortunately, many HCW fail to clean their hands properly thereby aiding the cross-inoculation of germs to many different patients. HCW line management cannot rely on conventional shaming methods to overcome HCW baseline reluctance to wash their hands.
Many of the problems associated with the failure to prevent cross-inoculation can be linked with HCW negative feelings towards hand washing using conventional methods. The traditional form of hand washing using soap and water is considered by many HCW as time consuming. HCW are becoming increasingly busy, and may not find enough time to carry out the important process of washing often enough. Sinks are not always located in the most convenient places; HCW may have to go to great lengths to find a sink to wash their hands, and may not do so if it is too inconvenient. Constant washing with soap can also cause skin irritation and dryness. All these factors contribute to the need to make handwashing more attractive and convenient to the HCW in order to improve health hygiene standards.
Alcohol hand sanitizers (AHS) have been introduced into health care environments to provide a solution to this problem. Currently, the use of alcohol solutions, gels and foams are established hospital practise. They are considered more effective than soap in reducing the number germs on hands. The proportion of alcohol contained within the alcohol gel formulations can vary between 60 and 95%. They are used extensively to sanitize hands because of their ability to denature proteins. Alcohol has an excellent initial antimicrobial log reduction activity of gram-positive and gram-negative bacteria, fungi and multi-drug resistant pathogens such as Vancomycin-resistant Enterococcus (VRE) and methicillin-resistant Staphylococcus aureus (MRSA).
AHS exhibit many advantages over soap and water. AHS can be used at any time and anywhere without water or towels. Hand washing using AHS is achievable if soap and water are not readily available. AHS can be provided in different types and sizes of bottles, bowls by the patient's bed or in already existing dispensers, unlike traditional methods where the HCW needs to locate a sink nearby. AHS are more accessible and convenient than the traditional soap and water method. Another advantage is that AHS take less time to use and the high volatility of alcohol means that they dry on the hands quickly.
Extra antimicrobial agents have been dissolved into the alcohol of known AHS formulations to give greater efficacy against bacterial, viral and fungal pathogens than simple AHS formulations. This is taught by U.S. Pat. No. 6,248,343 to Jampani et al, and U.S. Pat. No. 6,022,551, also to Jampani et al.
Conventional AHS, even those that include extra antimicrobial agents, do not have the residual ability to inhibit microorganisms over the whole day. When the alcohol has evaporated to leave the hands dry, there is very little antimicrobial agent and even less residual alcohol for the AHS to have a continuing disinfecting effect on the hands. Therefore it is necessary for the HCWs to wash their hands regularly, before and after each patient.
Constant use of AHS can cause unpleasant irritation and dryness of the skin. Some AHS have added emollients and moisturisers to the formulation to combat the dehydrating effect that alcohol has on skin. An emollient is a product that makes dry or sore skin softer or less painful and a moisturiser is a product for application to skin to stop it from becoming dry. Many products provide both emollient and moisturizing properties.
U.S. Pat. No. 4,956,175 to Lee teaches the use of high alcohol content antimicrobial gel compositions for disinfecting hands possessing moisturising and conditioning agents, and U.S. Pat. No. 6,617,294 to Narula et al. describes a waterless sanitizing hand cleanser comprising an effective amount of alcohol to produce a reduction in micro organisms on the surface of the skin, and emollients or oils for skin moisturising. In the above patents, the moisturiser is simply added to the alcoholic base formulation to tackle it's dehydrating effects.
As well as emollients and moisturisers, other AHS formulations add extra ingredients such as fragrance and colourings to make them more attractive and aesthetically pleasing. The use of fragrance and colour in the AHS formulation is a matter of personal preference and does not necessarily make it more attractive to the HCW. Some HCW have complained about the AHS leaving a coloured residue on their hands and clothing. The added ingredients may also cause allergic reactions.
The adverse side effects mentioned above lead to a lack of acceptance of the AHS and may result in HCW not washing their hands often enough nor for long enough. If this is the case, the AHS will not work to its maximum ability and prevent the spread of infections. There is a need for a better, more effective method of enforcement of hand hygiene standards.
In one embodiment, the present invention provides a novel antimicrobial AHS that facilitates the enforcement of proper hand hygiene standards by incorporating particles in the alcohol formulation. The suspended particles are sufficiently hard have a gritty feeling and disappear only after a standard and controllable amount of rubbing energy has been expended. For this reason, a HCW is compelled to give the alcohol gel a more thorough and complete application than a conventional AHS.
By appropriate choice of particle, the antimicrobial AHS can be designed to be compatible with HCW skin and can take into account the personal preferences of the HCW. For example, the particles may contain an emollient and/or moisturiser. These changes to the AHS will make it more attractive to the HCW and should result in the formulation being used more regularly. All the active ingredients can be provided in the AHS contained in hard, suspended particles. The AHS particles can be modified to combat bacteria, bacterial spores, viruses\', and fungus/yeast, specific to the requirements of the health care environment at the time. If desired, the suspended particles can be seen and distinguished visually; therefore it is possible to identify the ingredients and check the compatibility of the AHS with the HCW and the health care environment. A fragrance or UV-activated particles may also be incorporated within the AHS. This would allow the HCW supervisor to check whether the HCW is adhering to the hand sanitation regulations by smell or by shining UV light onto hands. The flexibility and visuality of the formulation will increase its acceptance by HCW.
It is known to incorporate emollients in their “dry form” as soft suspended particles or beads in cosmetic, personal care and pharmaceutical products as illustrated in U.S. Pat. No. RE38,141E to Brown and U.S. Pat. No. 5,968,530 to Arquette. U.S. Pat. No. 6,432,421 to Brown et al. provides details regarding emollient compositions with polyethylene beads. These products are alcohol-free or contain low amounts of alcohol. In contrast, the composition of the invention contains a high amount of alcohol. Further, the prior art provides no guidance to solve the problem of enforcing hand hygiene standards.
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OF THE INVENTION
The present invention seeks to provide a sanitizing composition for the enforcement of hand hygiene standards, so as to overcome, or at least reduce the above-mentioned problems of the prior art.
Accordingly, in a first aspect the invention provides a sanitizing composition in the form of a viscous liquid or gel suitable for use as a handwash composition comprising alcohol, water and a thickener wherein the viscous liquid or gel has particles suspended therein wherein said particles provide the composition with a granular texture and are capable of being worn away when rubbed.
In another aspect the invention provides a method of preparing a sanitizing composition suitable for use as a handwash composition said method comprising the steps of:
mixing together an alcohol, water and a thickener to form a viscous liquid or gel;
adding particles to the viscous liquid or gel to provide the composition with a granular texture, said particles being capable of being worn away when rubbed; and,
mixing the particles and the viscous liquid or gel to suspend the particles substantially uniformly in the viscous liquid or gel.
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OF THE INVENTION
The major component of the proposed sanitizing composition is alcohol. It is useful as an agent for the immediate disinfection of topical surfaces e.g. the hands of HCW. Alcohol is well known to dehydrate the skin and the larger the proportion of alcohol, the greater the dehydrating effects. A solution made of pure alcohol would be very dehydrating and damaging to the skin if used regularly to wash hands. The quantity of alcohol contained within the composition may vary from 30 to 95% by weight. More preferably the quantity of alcohol is from 45 to 90% by weight, and most preferably within the range of 55 to 80% by weight, e.g. 62% by weight.
Preferably, the alcohol is selected from the group comprising ethanol, isopropanol, n-propanol, n-butanol, 2-butanol, isobutanol, 2-isobutanol, benzyl-alcohol or a mixture thereof. Ethanol or isopropanol is most preferred.
The composition of the invention contains water as water boosts the efficacy of the alcohol as a disinfectant. However, a solution created from solely water and alcohol has such a low viscosity that a HCW would find it troublesome to wash their hands. The fluid would pour very quickly out of a dispenser for the fluid onto the hands to be cleaned and would easily run off the hands onto the surrounding surfaces. As it is quite difficult to control the flow of a very thin fluid, it is likely that more fluid than needed would be used. A fluid having a thicker consistency would be easier to dispense, manipulate and rub into hands. For this reason, the composition of the invention contains a thickener for increasing the viscosity of the alcohol/water solution.
The quantity of thickener may vary from 0.05 to 10% by weight depending on the specific ingredient chosen. However, the concentration of thickener is best described in terms of the achieved viscosity at 25° C.
The thickener may be employed in an amount such that the composition has a viscosity from 100 to 100,000 cP at 25° C., preferably from 5,000 to 50,000 cP at 25° C. and most preferably from 10,000 to 20,000 cP at 25° C.
Examples of suitable thickeners include Acrylates/C1O-C30 alkyl acrylate crosspolymer, Acrylates/ceteth-20 itaconate copolymer, Acrylates/ceteth-20 methacrylates copolymer, Acrylates/palmeth-25 acrylate copolymer, Acrylates/steareth-20 itaconate copolymer, Acrylates/steareth-20 methacrylate copolymer, Acrylates/steareth-50 acrylate copolymer, Acrylates NA crosspolymer, Acrylates/vinyl isodecanoate crosspolymer, Acrylic acid/acrylonitrogens copolymer, Algin, Aluminum/magnesium hydroxide stearate, Ammonium acrylates/acrylonitrogens copolymer, Ammonium alginate, Ammonium polyacryl dimethyl tauramide NA, Arachidyl alcohol, Attapulgite, Behenic acid, Behenyl alcohol, Behenyl behenate, Bentonite, CI-5 alkyl galactomannan CIS-36 acid, CIS-36 acid glycol ester, CIS-36 acid triglyceride, Calcium alginate, Calcium carrageenan, C 12-15 alcohols, C12-16 alcohols, Caprylic alcohol, Carbomer, Carboxymethyl hydroxyethylcellulose, Carrageenan (Chondrus crispus), Cellulose, Cellulose gum, Ceteareth-3, Ceteareth-60 myristyl glycol, Cetearyl alcohol, Cetearyl behenate, Cetearyl octanoate, Cetearyl stearate, Cetostearyl stearate, Cetyl alcohol, Cetyl betaine, Cetyl esters, Cetyl hydroxyethylcellulose, Cetyl myristate, Cetyl palmitate, Cocamide, Cocamide DEA, Cocamide MEA, Cocamide MIPA, Cocamidopropylamine oxide, Cocamidopropyl betaine, Coco-betaine, Coco/oleamidopropyl betaine, Coco-rapeseedate, Cocoyl amido hydroxy sulfobetaine, Cocoyl monoethanolamide ethoxylate, Colloidal silica sols, DEA-hydrolyzed lecithin DEA-linoleate, DEA-oleth-3 phosphate, DEA oleth-10 phosphate, Decyl alcohol, Dextran, Dextrin, Dihydroxyethyl Tallowamime, Dioleate, Dilaureth-10 phosphate, Dilinoleamidopropyl dimethyl amine, Dioleth-S phosphate, DMHF, Ethoxylated fatty alcohol, Ethylcellulose, Gellan gum, Glucouis, Glyceryl behenate, Glyceryl poly methacrylate, Glyceryl stearate, Glyceryl stearate SE, Guar (Cyanopsis tetragonoloba) gum, Guar hydroxypropyltrimonium chloride, Hectorite, Hexyl alcohol, Hydrated silica, Hydrogenated rapeseed oil, Hydrogenated starch hydrolysate, Hydrogenated vegetable glycerides, Hydrolyzed oat flour, Hydrolyzed transgenic collagen, Hydroxyethylcellulose, Hydroxypropylcellulose, Hydroxypropyl chitosan, Hydroxypropyl guar, Hydroxypropyl methylcellulose, Isoceteth-10, Isostearamide DEA, Isostearamidopropylamine oxide, Jojoba wax, Karaya (Stericulia urens) gum, Lauramide DEA, Lauramidopropyl betaine, Laureth-3, Laureth-10, Lauric acid, Lauric-linoleic DEA, Lauroyl-linoleoyl diethanolamide, Lauroyl-myristoyl diethanolamide, Lauryl alcohol, Lauryl betaine, Linoleamide DEA, Linoleic acid, Linolenic acid, Lithium magnesium sodium silicate, Locust bean (Ceratonia siliqua) gum, Mannan gum, Magnesium aluminum silicate, MDM hydantoin, Methylcellulose, Montmorillonite, Myristamide DEA, Myristamide MEA, Myristamine oxide, Myristic acid, Myristyl alcohol, Octacosanyl stearate, Oleamide, Oleamide DEA, Palmitamide MEA, Paraffin, Pectin, PEG-8, PEG-80 Glyceryl tallowate, PEG-8 PPG-3 Diisostearate, PEG-200 Hydrogenated glyceryl palmate, PEG-5M, PEG-9M, PEG-23M, PEG-45M, PEG-90M, PEG-160M, PEG-6 beeswax, PEG-S beeswax, PEG-12 beeswax, PEG-150/decyl/SMDI copolymer, PEG-4 diisostearate, PEG-8 dioleate, PEG-3 distearate, PEG-4 distearate, PEG-8 distearate, PEG-150 distearate, PEG-18 glyceryl oleatelcocoate, PEG-200 glyceryl stearate, PEG-28 glyceryl tallowate, PEG-200 glyceryl tallowate, PEG-7 hydrogenated castor oil, PEG-40 jojoba oil, PEG-3 lauramide, PEG-3 lauramine oxide, PEG-2 laurate, PEG-120 methyl glucose dioleate, PEG-4 oleamide, PEG-ISO pentaerythrityl tetrastearate, PEG-55 propylene glycol oleate, PEG-4 rapeseedamine, PEG-160 sorbitan triisostearate, PEG-S stearate, PEG-75 stearate, PEG-100 stearate, PEG-150/stearyl/SMDI copolymer, PEG-50 tallow amide, Pentaerythrityl tetrabehenate, Pentaerythrityl tetrastearate, Poloxamer 105, Poloxamer 124, Poloxamer 185, Poloxamer 237, Poloxamer 238, Poloxamer 338, Poloxamer 407, Polyacrylic acid, Polyquarternium-37, Polysorbate 20, Potassium alginate, Potassium chloride, Potassium oleate, Potassium stearate, PPG-5-ceteth-10 phosphate, PPG-14 laureth-60 alkyl dicarbamate, PPG-14 palmeth-60 alkyl dicarbamate, Propylene glycol stearate, Propylene glycol stearate SE, PVMIMA decadiene crosspolymer, PVP, Quaternium-90, Bentonite, Quaternium-18 bentonite, Quaternium-18 hectorite, Rapeseed oil, ethoxylated high erucic acid, Ricinoleamide MEA, Sclerotium gum, Sesamide, DEA, Silica, Sodium acrylates/vinyl isodecanoate crosspolymer, Sodium carbomer, Sodium carrageenan, Sodium ceteth-13-carboxylate, Sodium chloride, Sodium hyaluronate, Sodium hydroxypropyl starch phosphate, Sodium isostearoamphopropionate, Sodium lauryl sulfoacetate, Sodium magnesium silicate, Sodium stearate, Sorbitan sesquiisostearate, Sorbitan tristearate, Soy amide DEA, Soyamidopropyl betaine, Starch polyacrylonitrile copolymer-potassium salt, Starch polyacrylonitrile copolymer-sodium salt, Stearalkonium bentonite, Stearalkonium hectorite, Stearamide, Stearamide, DEA, Stearamide MEA, Stearamide MEA-stearate, Stearamidopropyl dimethyl amine lactate, Stearamine oxide, Steareth-10 alkyl ether/acrylates copolymer, Stearic acid, Stearyl alcohol, Synthetic beeswax, Tallowamide MEA, TEA-acrylates/acrylonitrogens copolymer, Tragacanth (Astragalus gummifer) gum, Tribehenin, Trideceth-2 carboxamide MEA, Trihydroxystearin, Tromethamine magnesium aluminum silicate, Wheat germamide DEA, Wheat germamidopropyl betaine, Xanthan gum, and mixtures thereof.
As understood in the art, some thickeners need to be mixed with an activating agent to induce the thickener to form a viscous gel.