WO2009101409A1 - Sanitiser composition - Google Patents
Sanitiser composition Download PDFInfo
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- WO2009101409A1 WO2009101409A1 PCT/GB2009/000392 GB2009000392W WO2009101409A1 WO 2009101409 A1 WO2009101409 A1 WO 2009101409A1 GB 2009000392 W GB2009000392 W GB 2009000392W WO 2009101409 A1 WO2009101409 A1 WO 2009101409A1
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- composition according
- quaternary ammonium
- ammonium compound
- composition
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
- A61K8/0208—Tissues; Wipes; Patches
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
- A61K8/40—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing nitrogen
- A61K8/41—Amines
- A61K8/416—Quaternary ammonium compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
- A61K8/40—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing nitrogen
- A61K8/42—Amides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
- A61K8/49—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- A61Q17/00—Barrier preparations; Preparations brought into direct contact with the skin for affording protection against external influences, e.g. sunlight, X-rays or other harmful rays, corrosive materials, bacteria or insect stings
- A61Q17/005—Antimicrobial preparations
Abstract
A rinseless sanitiser composition suitable for use on human skin is provided. The rinseless sanitiser composition comprises a quaternary ammonium compound and an alcohol free carrier. A non-pressurised pump comprising the sanitiser composition is provided for dispensing the composition as a foam. A wipe comprising the sanitiser composition is provided for convenient application of the sanitiser composition.
Description
SANITISER COMPOSITION
The present invention relates to a sanitiser composition, and in particular to a sanitiser composition suitable for use on human skin.
Microorganisms are well known to present health hazards, for example bacteria such as E. CoIi and Salmonella, and more recently so-called "superbugs" such as MRSA and Clostridium Difficile have been responsible for -many deaths. Additional health threats are posed by Avian Flu and SARS. Antimicrobial compositions are commonly used to counter these health threats .
Herein the terms "microbe" and "microorganism" are used as generic terms encompassing bacteria, microbacteria, spores, yeasts, molds, algea, viruses and the like.
Antimicrobial compositions are well known in the art, and are widely commercially available. For example, bacteriocidal, fungicidal, algicidal, yeasticidal and moldicidal agents are known. Antimicrobial agents are used to destroy microorganisms in a wide range of environments, including medical, industrial and domestic.
Microorganisms can often remain active for hours outside the human or animal body. Transmittal of microorganisms by touch therefore poses a significant health hazard, particularly in health care industries, such as hospitals, or in industrial or domestic food preparation. Personal hygiene and in particular the sanitisation of hands is widely accepted as a particularly effective means to hinder or prevent the transmittal of microorganisms by touch.
Antimicrobial agents act through a variety of mechanisms.
Thus, some antimicrobial agents are poisonous to microorganisms and destroy them on contact, for example bleaches, phenol and phenolic compounds, and arsenic and its salts. Other antimicrobial agents use organic and inorganic salts of metals such as copper, silver and tin. Another type of antimicrobial agents are disinfectants, such as household bleach. However, such agents are often also poisonous or corrosive, and thus cannot be used for contact with the human skin.
Other antimicrobial agents use antibiotic compounds, which disrupt microorganism biochemistry. However, antibiotics can lead to tolerance by microorganisms, and the development of so-called "superbugs" referred to above. They are also typically too expensive for regular use as a hand wash.
Thus only a limited range of antimicrobial compositions are suitable for use on human skin. Such antimicrobial agents may include for example alcohols, trichlorohydroxy diphenyl ether (Tri-closan) , and parachlorometaxylenol (PCMX) .
The sanitisation of hands is particularly important in' medical health care practises such as hospitals and as such higher standards of sanitisation are often required. Typically alcohol based mixtures have been the sanitisers of choice in hospitals because they achieve a high standard of sanitisation. Alcohol based sanitisers also evaporate quickly from hands without leaving a sticky residue and do not need to be removed by a water rinse (i.e. "rinseless") .
Alcohol may be present in a sanitiser composition for various purposes, for example as an antimicrobial agent, a solvent or a dry time enhancer. In this context, the term "alcohol" refers to volatile, low molecular weight alcohols, some non- limiting examples of which are methanol, ethanol, propanol,
butanol and mixtures thereof.
However, alcohol based sanitisers • suffer from various disadvantages. Alcohol based sanitisers typically contain 60 to 90 weight percent alcohol, which high percentage of alcohol can remove the protective sebum layer on the skin and dry the user's hands leading to irritation. Consequently a user may be unwilling to sanitise their hands as often as is necessary to prevent health risk. Additionally, typical alcohol based sanitisers do not kill many microorganisms including Clostridium Difficle and spores.
Furthermore, alcohol based sanitisers pose a significant fire hazard. Large medical care or food preparation installations may required significant quantities of hand sanitiser for their employees' use. This must be stored under additional fire safety precautions which leads to a heightened cost of storage .
Typically, non-alcoholic based sanitisers have been unable to replace rival alcoholic sanitisers in the medical care and food preparation markets because they are not as effective against a. range of microorganisms. Additionally non-alcoholic rinseless sanitisers may leave an unpleasant residue on the hands of a user.
Therefore there exists a need for a rinseless alcohol free sanitiser suitable for use on human skin which is both effective and fast acting against a wide range of microorganisms, including Clostridium Difficle, E. CoIi, Enteroccus Hirae, Staph Aureus (MRSA) and P. Aeruginosa, and evaporates from and/or is absorbed into the skin without the need for a water rinse.
As used herein, the term "rinseless" refers to a composition
which either evaporates from and/or is absorbed into the skin without leaving a substantial residue.
According to the present invention there is thus provided a rinseless sanitiser composition suitable for use on human skin comprising a quaternary ammonium compound and an alcohol free carrier. Preferably, the composition is substantially alcohol free.
The compositions of the present invention are effective and fast acting against a wide range of microorganisms including Clostridium Difficile, E. CoIi, Enteroccus Hirae, MRSA and P. Aeruginosa.
The sanitiser composition of the present invention comprises a quaternary ammonium compound. Preferred quaternary ammonium compounds have the formula NR4 1X" wherein each group R is independently selected from a substituted or unsubstituted alkyl, aryl, alkaryl, aralkyl, ether, or polyoxyalkyl group, for example a polyoxyethyl group, or two R groups may combine to form a heterocyclic compound, such as a pyridinium compound, and X is an anion, preferably a halide ion, more preferably chloride.
Preferred quaternary ammonium compounds include tetraalkyl ammonium salts, in particular dialkyldimethyl ammonium halides, wherein the alkyl group preferably has from 10 to 16 carbon atoms, for example a decyl, dodecyl or cetyl group, and the halide is preferably chloride. A particularly preferred quaternary ammonium salt for use in the present invention is N,N-Didecyl-N,N-dimethyl ammonium chloride.
Other preferred quaternary ammonium compounds for use in the present invention include monoalkyltrimethyl quaternary ammonium salts. Particularly preferred monoalkyltrimethyl
quaternary ammonium salts include myristyltrimethyl ammonium salts .
Other preferred quaternary ammonium salts include monoalkyldimethylbenzyl ammonium salts wherein the alkyl group has from 8 to 18 carbon atoms, more preferably 10 to
16 carbon atoms, for example a decyl, dodecyl or cetyl group.
For example, the quaternary ammonium compound may be a benzalkonium halide, wherein the halide is chloride or bromide.
Other quaternary ammonium compounds which may be used in the present invention include ether substituted quaternary ammonium compounds, for example quaternary ammonium compounds substituted by one or more polyether groups, ■ such as a polyoxyethyl and/or polyoxypropyl group. An example of such a quaternary ammonium compound is N, N-didecyl-N-methyl- poly (oxyethyl) ammonium propionate.
Preferred quaternary ammonium compounds are salts having a water solubility of at least 0.5 wt%.
One or more quaternary ammonium salts may be used in the composition of the present invention.
The amount of quaternary ammonium compound used in the present invention is preferably in the range of 0.2 to 5.0 wt%, more preferably in the range of 0.5 to 3.0 wt%. Whilst the amount of quaternary ammonium compound used in the composition of the present invention must be sufficient to provide sanitisation, amounts of less than 5 wt% have been found to be less likely to irritate skin under normal usage conditions .
The sanitiser composition of the present invention also
comprises an alcohol free carrier. Any suitable alcohol free carrier may be used, for example water.
The sanitiser composition of the present invention preferably comprises a non alcoholic dry time enhancer, i.e. an additive which promotes evaporation and/or absorption of the composition from/into the skin. A preferred dry time enhancer is methyl diisopropyl propionamide. Furthermore, use of a dry time' enhancer, such as methyl diisopropyl propionamide, can bring comfort and freshness to the skin of a user through a cooling sensation without the need for an alcohol solvent, and simulates the effect given by the alcohol evaporation of conventional alcohol based sanitisers.
The dry time enhancer may be preferably used in the present invention in a range of 0.05 to 1.0 wt%, more preferably 0.15 to 0.8 wt%.
The sanitiser composition of the present invention may also include other ingredients to improve the effectiveness of the composition, including preservatives, thickeners, foaming agents, pH adjusters, skin conditioners, dyes, fragrances, and the like.
For example, a preferred non alcoholic preservative which may be used in the composition is 2-methyl-4-isothiazolin-3-one . Preferred foaming agents which may be used in the composition include Cocamidopropyl Betaine (Dehyton K cos) and Cocamine Oxide (Aromox MCD-W) . A preferred thickener which may be used in the composition is Hydroxypropyl Guar (Jaguar HP105) .
The sanitiser composition of the present invention may be provided for use by a user in any convenient form. For example, the composition may be provided as a solid or liquid soap, gel, wipe, or foam. A preferred method of application
of the composition is when dispensed as a foam from a non- pressurised pump. A foam will not run off a users hands as quickly as a liquid, and can thus be easily spread over the skin, for example between fingers.
Embodiments of the present invention will now be described in detail by way of examples.
Example 1 An embodiment of the sanitiser composition of the present invention has the following composition:
N. B. BARDAC 22-40 is a 40% aqueous N, N-Didecyl-N, N-dimethyl ammonium chloride solution, i.e. 6.10 wt% BARDAC 22-40 provides 2.4 wt% of N, N-Didecyl-N, N-dimethyl ammonium chloride.
Example 2
The embodiment of the present invention described in Example
1 was made as follows:
Equipment: A closed tank, with agitation system.
Process: Demineralized water was added to the tank and strongly agitated, and WS 23 was sprinkled into the demineralized water. When the solution was clear, BARDAC 22-40 was added under agitation, followed by NEOLONE 950, followed by Perfume
(Soft Skin) , at which point the solution became opalescent. Agitation was maintained until the solution became clear.
Example 3
The embodiment of the present invention described in Example 1 underwent user trials as follows:
Test performed: BS EN 1500 (1997) Hygienic Handrub Test
Method
The principle of the test is to assess the number of test organisms released from the fingertips of artificially contaminated hands before and after applying the sanitiser composition. The ratio of the two resulting values is called the reduction factor, and represents a " measure of antimicrobial activity of the sanitiser composition. In order to achieve the necessary precision a large number of subjects has to be used because of the possible variation in bacterial flora found on human skin. In this case a total of twelve (12) healthy adults were chosen each one carrying out the test procedure in precisely the same way as the others. To compensate for extraneous influences "the test sample reduction factor (P) is compared with the reduction factor obtained with a parallel reference procedure (R) which is performed with the same subjects, on the same day and under comparable environmental conditions using a 60% solution of propan-2-ol .
Experimental procedure:
1) Application of the contamination fluid.
Each of the 12 subjects was asked to wash their hands for 1 minute in soft soap to remove natural commensal organisms and dried thoroughly on a paper towel. The hands were then contaminated with very large numbers of bacteria well in excess of that experienced in normal everyday occurrence. The hands were immersed in the contamination fluid (containing an overnight culture of the test organism, in this instance Escherichia coli at a concentration of approximately 108 cfu per ml) in a suitably sized container for 5 seconds. The hands were removed from the contamination fluid and surplus liquid allowed to drain back into the container. The hands were then allowed to air dry for approximately 3 minutes holding them horizontally with fingers spread out and rotating them to and fro to avoid the formation of droplets.
2) Prevalues:
Immediately after drying, each of the 12 subjects was asked to rub their fingertips, including the thumbs for 1 minute on the base of a petri dish, using a separate petri dish for each hand, containing 10ml of maximum recovery diluent (MRD) without neutraliser, in order to assess the release of test organisms before treatment of the hands. Dilutions of these sample fluids were prepared to 10"3 and 10"4. A ImI aliquot of each dilution for each hand was placed in a separate petri dish, 10 - 15ml of Tryptone Soy Agar sterilised and cooled to 450C was added and mixed thoroughly. Plates were allowed to set and incubated at 370C for 24 hours. Each plate was then examined for growth of the test organism.
3) Reference procedure (R) :
Each of the 12 subjects was asked to pour 3ml of propan-2-ol
(60%) into cupped dry hands and rub vigorously for 30 seconds in accordance with the standard handrub procedure. This comprises five strokes backwards and forwards palm to palm, right palm over left dorsum and left palm over right dorsum, palm to palm with fingers interlaced, back of fingers to opposing palms with fingers interlocked, rotational rubbing of right thumb clasped in left palm and left thumb clasped in right palm, rotational rubbing with clasped fingers of right hand in palm of left hand and clasped fingers of left hand in right palm. This was repeated with a further 3ml propan-2-ol to give a total rubbing time of 60 seconds. The reference procedure is completed by a 5 second rinse of the fingers under running tap water; excess water is shaken off.
4) Handwash procedure with sanitiser composition (P):
Approximately 3ml of sanitiser composition was applied as a foam from a foam tub and rubbed thoroughly onto the hands using the technique described above, and then rinsed off with running water. The total rubbing time is limited to 60 seconds. To avoid recontamination of the sample area (i.e. the fingertips) subjects are requested to hold their hands such that the fingertips are pointing upwards. Wrists and forearms are wiped dry by another person.
5) Postvalues:
Immediately after drying the wrists the 12 subjects were asked to rub the fingertips on the base of a petri dish containing 10ml of MRD with neutraliser for 1 minute using a separate petri dish for each hand. Then ImI of each of the undiluted sample fluids was placed in a petri dish and covered with 15ml of TSA mixed thoroughly and allowed to set. Plates were then incubated overnight at 370C and examined for growth of the test organism.
6) Calculation:
The number of colony forming units (CFU) per plate for each dilution was recorded and the number of cfus per ml of sample fluid calculated. For both reference and test procedure the log counts from right and left hands of each subject were averaged separately for prevalues and postvalues .
From the difference between this individual combined log prevalue and the log postvalue a log reduction factor is established for each subject. Then the two arithmetic means of all individual log reduction factors are calculated for both the reference and the test procedure. For the sanitiser composition of the present invention to pass the criteria of EN 1500 the mean log reduction factor obtained must not be significantly smaller than that obtained by a reference handrub with propan-2-ol 60% v/v. Test of significance of log reduction factors of P against R is carried out using the Wilcoxon matched pairs signed ranks test and the 'results are shown below.
Reference Handrub Procedure (R) Handrub with Foam Tub sanitiser (P)
Where Log x = log prevalue.
Log y = log post value
Log z = log reduction factor
X = overall mean value of log x, log y and log z.
N = number of subjects in each column.
Log RF derived from Difference Rank of difference
Comparison of matched pairs with Wilcoxon signed - rank test values shows that there is a significant difference in values at the 1% level (p = 0 . 01 level ) and Medihex 4 , when used
neat as received, is equal to that of propan-2-ol. The sanitiser composition of the present invention gives a 250,000 fold reduction in the number of contaminating organisms in the time taken to wash the hands.
Example 4
The effectiveness of the sanitiser composition described in Example 1 against Clostridium difficile was tested as follows :
Analysis Required: BS EN 13704 Quantitative suspension test for evaluation of sporicidal activity of chemical disinfectants .
Sanitiser composition stored at room temperature in the dark.
Experimental conditions:
Contact time: 5 mins . Test Temperature: 200C ± 0.50C
Neutralising solution: 3% Tween 80, 3% Saponin,
0.1% Histidine, 0.1%
Cysteine
Temperature of incubation: 370C ± 1 0C Identification of bacterial strains used: Clostridium difficile NCTC 11209
Test Results
Vc = Viable Count.
N = Number of cfu/ml of the bacterial test suspension.
Nv = Number of cfu in bacterial suspension.
R- = Reduction in viability.
Na = Number of cfu/ml in the test mixture
Conclusion: According to BS EN13704 the sanitiser composition of the present invention possesses satisfactory sporicidal activity in 5 minutes at 200C for the reference strain detailed.
Example 5
The effectiveness of the sanitiser composition described in Example 1 against the microorganisms described below was tested as follows:
Analysis Required: BS EN 12054 Quantitative suspension test
•for evaluation of bactericidal activity of products for hygienic and surgical handrub and handwash.
Product stored at room temperature in the dark.
Experimental conditions:
Contact time: 1 mins
Test Temperature: 200C ± 0.50C Neutralising solution: 3% Tween 80, 3% Saponin, 0.1%
Histidine, 0.1% Cysteine
Temperature of incubation: 370C ± 1 °c Identification of bacterial strains used: P s.eudomona s a e rugino s a ATCC
15442
Escherichia coli NCTC 10418
Staphylococcus aureus NCTC
10788
Enterococcus hirae A TCC 8043
Na = Number of cfu/ml in the test mixture
Conclusion : According to BS EN12054 the sanitiser composition of the present invention possesses satisfactory bactericidal activity in 1 minute at 200C for the reference strains detailed.
Example 6
The effectiveness of the sanitiser composition described in Example 1 against the . microorganisms described below was tested as follows:
Analysis Required: BS EN 13727 Quantitative Suspension Test for the Evaluation of Bactericidal activity of chemical disinfectants used in the medical area.
Product stored at room temperature in the dark.
Experimental conditions:
Interfering substance; 3 . 0g/l Bovine albumin
3ml /1 Sheep erythrocytes
Contact time: 1 mins Test Temperature: 200C ± O . 5°C Neutralising solution: 3% Tween 80 , 3% Saponin, 0 . 1%
Histidine , 0 . 1% Cysteine
Temperature of incubation: 370C ± 1 °c Identification of bacterial strains used: Salmonella typhimurium ATCC
14028
Listeria monocytogenes NCTC
11994
Test Results
Vc = Viable Count.
N = Number of cfu/inl of the bacterial test suspension.
Nv = Number of cfu in bacterial suspension.
R = Reduction in viability.
Na = Number of cfu/ml in the test mixture
Conclusion: According to BS EN13727 the sanitiser composition of the present invention possesses satisfactory bactericidal activity in 1 minute at 200C for the reference strains detailed.
Example 7
The effectiveness of the sanitiser composition described in Example 1 against the microorganism described below was tested as follows:
Analysis Required: BS EN 13727 Quantitative Suspension Test for the Evaluation of Bactericidal activity of chemical disinfectants used in the medical area. '
Product stored at room temperature in the dark.
Experimental conditions
Interfering substance: 3.0g/l Bovine albumin
3ml/1 Sheep erythrocytes
Contact time: 1 mins Test Temperature: 200C ± O.5°C Neutralising solution: 3% Tween 80, 3% Saponin, 0.1%
Histidine, 0.1% Cysteine
Temperature of incubation: 370C + 1 0C Identification of bacterial strains used: Methycillin Resistant Staphylococcus Aureus ATCC 33591
Test Results
Vc = Viable Count.
N = Number of cfu/ml of the bacterial test suspension.
Nv = Number of cfu in bacterial suspension.
R = Reduction in viability.
Na = Number of cfu/ml in the test mixture
Conclusion: According to BS EN13727 the sanitiser composition of the present invention possesses satisfactory bactericidal activity in 1 minute at 200C for the reference strains detailed.
Example 8
The residual activity of the sanitiser composition of the present invention was tested as follows:
Product stored at room temperature in the dark.
Experimental conditions:
Three agar plates were inoculated with 0. ImI of an overnight broth culture of Staphylococcus aureus. The culture was spread evenly over the surface of the agar and allowed to dry in a cool environment. Hands were washed thoroughly with hot soapy water and rinsed with clean cold water and dried with a paper towel. One dose of the sanitiser composition was applied as a foam by placing on each hand and working into all parts of the hand, especially the finger tips, until the hands appeared dry. Immediately, one finger from each hand was placed on the surface of a seeded agar plate and held firmly for 30 seconds then removed from the surface. After one hour of 'normal' activity another finger from each hand was placed on the surface of a second seeded plate and held there for 30 seconds and removed. After three hours the exercise was repeated using a further two "unused" fingers from each hand. Each of the three agar plates were incubated at 370C for 24 hours and then examined for evidence of inhibition of bacterial growth. The results obtained are recorded below.
Time 0 Full inhibition, no evidence of bacterial growth in the region of the finger placement
1 hour Significant inhibition, only a few single colonies visible in the region of finger placement
3 hours Some inhibition several single colonies growing in the area of the finger placement but no confluent growth.
Conclusion: the sanitiser composition of the present invention shows substantial residual activity on treated fingers for up to one hour after application. There is still some residual activity after 3 hours.
Example 9
Another embodiment of the sanitiser composition of the present invention has the following composition:
N. B. BARDAC 22-40 is a 40% aqueous N, N-Didecyl-N, N-dimethyl ammonium chloride solution, i.e. 6.10 wt% BARDAC 22-40 provides 2.4 wt% of N, N-Didecyl-N, N-dimethyl ammonium chloride.
Example 10 The embodiment of the present invention described in Example 9 was made as follows:
Equipment : A closed vessel number 1, equipped with a stirring system.
A closed vessel number 2, equipped with a stirring system.
Process: The manufacturing, storage and packaging equipment must be perfectly clean and dry.
On the day before, in vessel number, 1 mix 10% JAGUAR HP 105 with demineralized water according to the following procedure: first introduce the demineralized water, create a vortex and sprinkle the JAGUAR HP 105. Stir until a lump- free solution is obtained.
On the next day, in vessel number 2, add in the following order while maintaining stirring: Demineralized water (-9%), BARDAC 22-40, DEHYTON K cos, AROMOX MCD-W, NEOLONE 950 and PARFUM SOFT SKIN. When the mixture is homogeneous, add while stirring 10% of the re-homogenized JAGUAR HP 105 per-gel made the day before (so that you have in the end 1% JAGUAR HP 105) . In the vessel maintain sufficient stirring until a clear solution is obtained. Keep in a closed vessel until packaging.
Example 11
The irritation potential of the sanitiser composition of Example 9 was tested as follows:
Α single application of 0.02 ml of the sanitiser composition of Example 9, diluted at 5%, was applied to the external face of the arms of 12 volunteers, of male of female sex between the ages of 18 and 65 with a normal skin without any dermatological lesion on the experiment area, and maintained in contact with the skin for 48 hours with the help of a semi-occlusive patch. The clinical quotation was made 30 minutes after the patch was removed and took into account any erythema, papules, vesicles and blisters. Of the 12 volunteers, none were observed to show any irritation. The sanitiser composition of Example 9, diluted at 5%, can therefore be considered a non-irritant.
Example 12
The embodiment of the present invention described in Example
9 underwent user trials as follows:
Test performed: BS EN 12791 (2005) Hand disinfection - test method
The test was performed as described in Example 3, with the exception that the total rubbing time with the sanitiser composition was limited to 5 minutes.
Post values (immediate) :
After treatment and drying, a similar sampling procedure is used on one hand as described above for the prevalues but volumes of ImI and 0.1ml of undiluted sampling fluid were plated out for quantitative culture. Meanwhile the other hand
was dried using a sterile towel taking care to avoid contamination.
Post values (3-hour) :
After treatment and drying the other hand is protected from extraneous contamination by wearing a surgical glove for three hours, the glove is then removed and a similar sampling procedure is used on this hand as described from the postvalue (immediate) .
Calculation:
The number of colony forming units (CFU) per plate for each dilution was recorded and the number of cfus per ml of sample fluid calculated. For both reference and test procedure the log counts from right and left hands of each subject were averaged separately for prevalues and postvalues .
From the difference between this individual combined log prevalue and the log postvalue a log reduction factor is established for each subject. Then the two arithmetic means of all individual log reduction factors are calculated for both the reference and the test procedure. For the sanitiser composition to pass the criteria of EN 12791 the mean log reduction factor obtained must not be significantly smaller than that obtained for the reference handrub with propan-1-ol 60%v/v. Test of significance of log reduction factors of P against R is carried out using the Wilcoxon matched pairs signed ranks test and the results are shown below.
Reference : Propan-1-ol
Where Log x = log prevalue.
Log y = log post value
Log z = log reduction factor
X = overall mean value of log x, log y and log z.
N = number of subjects in each column.
Where Log x = log prevalue. Log y = log post value Log z = log reduction factor X = overall mean value of log x, log y and log z. N = number of subjects in each column.
Sanitiser composition
Where Log x = log prevalue.
Log y = log post value
Log z = log reduction factor
X = overall mean value of log x, log y and log z.
N = number of subjects in each column.
Log RF derived from Difference Rank of difference Immediate effect
Comparison of matched pairs with Wilcoxon signed-rank test values shows that there is a significant difference in values at the 1% level (p = 0.01 level) and that the sanitiser composition of the present invention gives a 24,000 fold reduction in numbers of contaminating organisms in the time taken to wash the hands immediately, and gives a 32,000 fold reduction after three hours.
It will be understood that the embodiments illustrated describe the invention only for the purposes of illustration. In practise, the invention may be applied to many different configurations, the detailed embodiments being straightforward for those skilled in the art to implement.
Claims
1. A rinseless sanitiser composition suitable for use on human skin comprising a quaternary ammonium compound and an alcohol free carrier.
2. A composition according to claim 1 which is effective against Clostridium Difficile, E. CoIi, Enteroccus Hirae, MRSA and P. Aeruginosa.
3. A composition according to claim 1 or 2 wherein the quaternary ammonium compound has the formula NR4 +X" wherein each group R is independently selected from a substituted or unsubstituted alkyl, aryl, alkaryl, aralkyl, ether, or polyoxyalkyl group, or two R groups may combine to form a heterocyclic compound, and X is an anion
4. A composition according to claim 3 wherein X is a halide ion.
5. A composition according to claim 4 wherein X is chloride.
6. A composition according to claim 3, 4 or 5 wherein the quaternary ammonium compound is a tetraalkyl ammonium salt.
7. A composition according to claim 6 wherein the tetraalkyl ammonium salt is a dialkyldimethyl ammonium halide wherein the alkyl group has from 10 to 16 carbon atoms.
8. A composition according to claim 7 wherein the alkyl group is a decyl, dodecyl or cetyl group.
9. A composition according to any preceding claim wherein the quaternary ammonium compound is N, N-Didecyl-N,N-dimethyl ammonium chloride.
10. A composition according to any one of claims 1 to 6 wherein the quaternary ammonium compound is a
5 monoalkyltrimethyl quaternary ammonium salt.
11. A composition according to claim 10 wherein the monoalkyltrimethyl quaternary ammonium salt is a myristyl trimethyl ammonium salt.
10
12. A composition according to any one of claims 1 to 5 wherein the quaternary ammonium compound is a monoalkyldimethylbenzyl ammonium salt.
15 13. A composition according to claim 12 wherein alkyl group has from 10 to 16 carbon atoms.
14. A composition according to claim 13 wherein the alkyl group is a decyl, dodecyl or cetyl group.
20
15. A composition according to any one of claims 12 to 14 wherein the quaternary ammonium compound is a benzalkonium halide .
25 16. A composition according to any one of. claims 1 .to 5 wherein the quaternary ammonium compound is an ether substituted quaternary ammonium compound.
17. A composition according to claim 16 wherein the 30 quaternary ammonium compound is substituted by one or more polyether groups .
18. A composition according to claim 17 wherein the polyether groups comprises a polyoxyethyl and/or polyoxypropyl group.
35
19. A composition according to any one of claims 16 to 18 wherein the quaternary ammonium compound is N,N-didecyl-N- methyl-poly (oxyethyl) ammonium propionate.
5 20. A -composition according to any preceding claim wherein the quaternary ammonium compound is a salt having a water solubility of at least 0.5 wt%.
21. A composition according to any preceding claim which 10 comprises one or more quaternary ammonium salts.
22. A composition according to any preceding claim which comprises 0.2 to 5.0 wt% quaternary ammonium compound.
15 23. A composition according to claim 22 which comprises 0.5 to 3.0 wt% quaternary ammonium compound.
24. A composition according to any preceding claim wherein the alcohol free carrier is water.
20
25. A composition according to any preceding claim which further comprises a non alcoholic dry time enhancer.
26. A composition according to claim 25 wherein the dry time 25 enhancer is methyl diisopropyl propionamide .
27. A composition according to claim 25 or 26 wherein the dry time enhancer is present in a range of 0.05 to 1.0 wt%.
30 28. A composition according to claim 27 wherein the dry time enhancer is present in a range of 0.15 to 0.8 wt%.
29. A composition according to any preceding claim which further comprises a preservative. 35
30. A composition according to claim 29 wherein the preservative comprises 2-methyl-4-isothiazolin-3-one.
31. A composition according to claim 30 wherein the 5 composition is dispensed as a foam from a non-pressurised pump.
32. A composition according to any preceding claim which is alcohol free.
10
33. A non-pressurised pump comprising a composition according to any preceding claim for dispensing the composition as a foam.
15 34. A wipe comprising a composition according to any preceding claim.
35. A hand soap comprising a composition according to any preceding claim.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GB0802717A GB0802717D0 (en) | 2008-02-13 | 2008-02-13 | Sanitiser composition |
| GB0802717.9 | 2008-02-13 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2009101409A1 true WO2009101409A1 (en) | 2009-08-20 |
Family
ID=39247636
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/GB2009/000392 WO2009101409A1 (en) | 2008-02-13 | 2009-02-13 | Sanitiser composition |
Country Status (2)
| Country | Link |
|---|---|
| GB (1) | GB0802717D0 (en) |
| WO (1) | WO2009101409A1 (en) |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2014191096A1 (en) * | 2013-05-28 | 2014-12-04 | Thor Gmbh | Microbicidal composition comprising 2-methyl-4-isothiazolin-3-one and an amineoxide |
| WO2014191097A3 (en) * | 2013-05-28 | 2015-01-29 | Thor Specialities (Uk) Limited | Microbicidal composition comprising an isothiazolone and an amineoxide |
| US20150045443A1 (en) * | 2012-08-13 | 2015-02-12 | Aphex Biocleanse Systems, Inc | Using an unsubstituted quatenary ammonium salt composition with other ingredients as a skin sanitizing solution and natural skin conditioner |
| US9357771B2 (en) | 2012-12-17 | 2016-06-07 | Kimberly-Clark Worldwide, Inc. | Foaming sanitizing formulations and products including a quaternary ammonium compound |
| RU2611140C1 (en) * | 2015-10-08 | 2017-02-21 | Наталья Александровна Коляго | Method for alcohol-free perfumes production |
| US11116220B2 (en) | 2017-12-22 | 2021-09-14 | Ecolab Usa Inc. | Antimicrobial compositions with enhanced efficacy |
Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0853941A2 (en) * | 1996-12-20 | 1998-07-22 | Kao Corporation | Detergent composition |
| WO2000030600A1 (en) * | 1998-11-23 | 2000-06-02 | The Procter & Gamble Company | Skin deodorizing compositions |
| WO2001021138A1 (en) * | 1999-09-22 | 2001-03-29 | First Scientific, Inc. | Antimicrobial topical composition and methods |
| US20030008791A1 (en) * | 2001-06-06 | 2003-01-09 | Lonza Inc. | Non-alcoholic hand sanitizer |
| CA2468543A1 (en) * | 2004-05-31 | 2005-11-30 | Fadi Dagher | Anti-microbe foaming hand sanitizer |
| US20070248691A1 (en) * | 1999-11-08 | 2007-10-25 | Water Journey Ltd. | Antibacterial compositions and method of using same |
| EP1955591A1 (en) * | 2007-01-09 | 2008-08-13 | Painless Tech GbR | Agent for cleaning and antimicrobial treatment of skin |
-
2008
- 2008-02-13 GB GB0802717A patent/GB0802717D0/en not_active Ceased
-
2009
- 2009-02-13 WO PCT/GB2009/000392 patent/WO2009101409A1/en active Application Filing
Patent Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0853941A2 (en) * | 1996-12-20 | 1998-07-22 | Kao Corporation | Detergent composition |
| WO2000030600A1 (en) * | 1998-11-23 | 2000-06-02 | The Procter & Gamble Company | Skin deodorizing compositions |
| WO2001021138A1 (en) * | 1999-09-22 | 2001-03-29 | First Scientific, Inc. | Antimicrobial topical composition and methods |
| US20070248691A1 (en) * | 1999-11-08 | 2007-10-25 | Water Journey Ltd. | Antibacterial compositions and method of using same |
| US20030008791A1 (en) * | 2001-06-06 | 2003-01-09 | Lonza Inc. | Non-alcoholic hand sanitizer |
| CA2468543A1 (en) * | 2004-05-31 | 2005-11-30 | Fadi Dagher | Anti-microbe foaming hand sanitizer |
| EP1955591A1 (en) * | 2007-01-09 | 2008-08-13 | Painless Tech GbR | Agent for cleaning and antimicrobial treatment of skin |
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20150045443A1 (en) * | 2012-08-13 | 2015-02-12 | Aphex Biocleanse Systems, Inc | Using an unsubstituted quatenary ammonium salt composition with other ingredients as a skin sanitizing solution and natural skin conditioner |
| US9204633B2 (en) * | 2012-08-13 | 2015-12-08 | Aphex Biocleanse Systems, Inc. | Using an unsubstituted quatenary ammonium salt composition with other ingredients as a skin sanitizing solution and natural skin conditioner |
| US9357771B2 (en) | 2012-12-17 | 2016-06-07 | Kimberly-Clark Worldwide, Inc. | Foaming sanitizing formulations and products including a quaternary ammonium compound |
| WO2014191096A1 (en) * | 2013-05-28 | 2014-12-04 | Thor Gmbh | Microbicidal composition comprising 2-methyl-4-isothiazolin-3-one and an amineoxide |
| WO2014191097A3 (en) * | 2013-05-28 | 2015-01-29 | Thor Specialities (Uk) Limited | Microbicidal composition comprising an isothiazolone and an amineoxide |
| RU2611140C1 (en) * | 2015-10-08 | 2017-02-21 | Наталья Александровна Коляго | Method for alcohol-free perfumes production |
| US11116220B2 (en) | 2017-12-22 | 2021-09-14 | Ecolab Usa Inc. | Antimicrobial compositions with enhanced efficacy |
| US11930819B2 (en) | 2017-12-22 | 2024-03-19 | Ecolab Usa Inc. | Antimicrobial compositions with enhanced efficacy |
Also Published As
| Publication number | Publication date |
|---|---|
| GB0802717D0 (en) | 2008-03-19 |
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