Classifications

• • 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
• • 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
  • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
  • A61K8/36—Carboxylic acids; Salts or anhydrides thereof
  • A61K8/361—Carboxylic acids having more than seven carbon atoms in an unbroken chain; Salts or anhydrides thereof
• • 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
  • A61K8/92—Oils, fats or waxes; Derivatives thereof, e.g. hydrogenation products thereof
  • A61K8/922—Oils, fats or waxes; Derivatives thereof, e.g. hydrogenation products thereof of vegetable origin
• • 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
  • A61K8/92—Oils, fats or waxes; Derivatives thereof, e.g. hydrogenation products thereof
  • A61K8/925—Oils, fats or waxes; Derivatives thereof, e.g. hydrogenation products thereof of animal origin
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
  • A61Q19/00—Preparations for care of the skin
  • A61Q19/10—Washing or bathing preparations
• • C—CHEMISTRY; METALLURGY
  • C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
  • C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
  • C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
  • C11D3/48—Medical, disinfecting agents, disinfecting, antibacterial, germicidal or antimicrobial compositions
  • C11D3/485—Halophors, e.g. iodophors
• • C—CHEMISTRY; METALLURGY
  • C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
  • C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
  • C11D9/00—Compositions of detergents based essentially on soap
  • C11D9/04—Compositions of detergents based essentially on soap containing compounding ingredients other than soaps
  • C11D9/48—Superfatting agents

Definitions

• the present invention relates to a cleaning agent particularly adapted for washing the hands, methods of making such a cleaning agent and a method for washing the hands using such a cleaning agent.
• the present inventor has postulated that the principal mode of transmission of bacteria and viruses among humans is by auto-inoculation, that is that bacteria, viruses and other disease causing vectors are picked up on the fingers or other parts of the hand and then introduced into the body through touching the eyes, mouth, nose, ears or other bodily orifices and by superficial scratching of the skin. Studies carried out by the present inventor and others indicates that the incidence of infection through airborne vectors is relatively low. It has been realised by the present inventor that the fingertips, and particularly the area under the fingertips, i.e.
• the subungual area is an ideal environment for the survival of pathogenic vectors. These areas show the conditions of warmth, moisture, blood flow, pulse resonance, and contact with saliva and mucous which are conducive to the survival of microorganisms.
• substrates such as keratin to which many bacteria and viruses can bind electrostatically or otherwise are also present at the fingertips which allows the microorganisms to resist removal by superficial washing.
• the present inventor has noted that in both human adults and children there is a strong tendency to touch the eyes, nasal area, mouth and ears as well as coming into contact with the genitalia and possibly the anus.
• the fingernails also cause and come into contact with minor and major skin breaks.
• pathagenic organisms and materials lodged in the fingertip area of a host have ample opportunity to be transmitted into the body of that host. If, as is postulated, infectious organisms lodged under the fingernails have predisposed themselves to infection of the host it will be appreciated that the rate of self infection, i.e. auto-inoculation will be high.
• the fingertips will also represent a source of re-infection such that after being treated with antibiotics a host may be reinfected from the fingertips where the pathogenic organism has survived the hosts antibiotic treatment.
• This cycle of infection and re-infection from the fingertips can only be broken by cleaning the fingertip area sufficiently to reduce the population of bacteria, viruses and other pathogens resident there and/or by changing the physical and chemical environment in that area such that it represents a less desirable niche for development of pathogenic organisms and the collection of pathogenic materials.
• Conventional hand washing concentrates the cleaning action on the palms of the hands leaving the fingertip area largely untouched unless the fingernails are specifically scrubbed. Even with regular fingernail scrubbing with conventional soaps little long term reduction of pathogen populations has been observed.
• the fingertip area may be readily cleaned by pushing the fingertips, which term is taken to include the tip of the thumbs downwardly, to a position beyond the fingernails, into a cleaning agent which is solid but is of such a penetrability that the fingertips may be readily pushed into it and it will enter the subungual area of the fingers.
• the cleaning agent clinging to the fingers may then be used to wash the hands.
• the present invention consists in a water soluble or dispersible cleaning agent which is solid at room temperature, has a penetrability (as hereinafter defined) of from 50 to 250 mm, a speed of solubility (as hereinafter defined) of less than 2 minutes, and is of such a consistency that when the fingers of a human hand are pushed into the cleaning preparation 30 mm and withdrawn sufficient cleaning preparation will adhere thereto to enable the hand of the user to be washed with the cleaning preparation adhered to the fingertips.
• the term "penetrability” means the distance in millimetres that a 30 mm cone and a 50 g weight in a Stanhope - Seta (obtainable from Stanhope - Seta Ltd., Surry, U.K.) penetrometer will penetrate into the cleaning agent after the cone has been aligned with the surface thereof and released.
• speed of solubility means the time taken for 10 grams of the cleaning agent to be dissolved or dispersed when placed in 100 g of water at 55°C and stirred briskly with a hand held spatula.
• the cleaning agent according to the present invention should be distinguished from conventional hard soaps which have a penetrability of 5 mm or less and into which the fingers cannot be pushed.
• liquid soaps which have an infinite penetrability and into which the fingers may be freely immersed without resistance.
• the liquid soaps do not have sufficient resistance to penetration to ensure that the cleaning agent is forced into the subungual area and other crevices surrounding the fingertip in which bacteria, viruses and other pathogens can be harboured.
• the cleaning agent according to this invention is further distinguished by its rapid rate of dissolution or dispersion of the cleaning agent in water. This ensures that the cleaning agent forced into the subungual and other areas will not remain there after the washing of the hands. If the cleaning agent were to remain under the fingernails after washing of the hands there would be a tendency for dried particles of cleaning agent to be introduced into the mouth, nose or eyes of the user.
• Conventional hand soaps have been found to have speeds of solubility of substantially greater than 2 minutes and typically greater than 5 minutes and after in excess of one hour.
• the cleaning agent according to the present invention preferably has a consistency such that from 0.5 g to 1 g of cleaning agent is left clinging to the fingers of one hand of a typical adult male human when pushed into the cleaning agent a distance of 30 mm and withdrawn. This amount of cleaning agent is typically enough to wash that hand. If the cleaning agent did not to some extent cling to the hand of a user there would be less cleaning action in the subungual axea of the fingers.
• the cleaning agent according to this invention is such that the pH of the surface of the washed skin is from 7.5 to 8.5. It is believed that at these mildly alkaline conditions the keratin of the skin is substantially isoelectric and the ability of pathogenic microorganisms to cling to the skin by electrostatic forces is reduced. For this reason the cleaning agent preferably has a pH from 7.5 to 9.5. Typically conventional hand soaps will have a pH higher than 9.5.
• the pH of the cleaning agent is linked to another preferred characteristic of cleaning agents according to this invention when the main active ingredient is a soap i.e., a salt of a long chain fatty acid.
• the soaps are normally made by reacting caustic soda with long chain fatty acids.
• cleaning agents according to this invention the fats and oils from which the fatty acids are derived are present in a substantial stochiometric excess over the caustic soda.
• Such cleaning agents are known as "superfatted" soaps. The superfatting has two desirable qualities.
• the pH will be generally lower in a superfatted soap and in the second place the excess fats and oils in the soap prevent "drying" of the hands of a user and leave on the hands of a user a film which can carry antimicrobial agents as well as imparting a pleasant "feel” to the hands .
• Such soaps will as a result of the stochiometric deficiency of the caustic soda have a very low free alkalinity.
• the preferred cleaning agents according to this invention have less than 0.02% free alkalinity when measured by Australian Standard AS1877-1976. This is to be contrasted with typical hand soaps which have a free alkalinity of about 0.1%.
• the cleaning agents according to the present invention will normally be soap based it is possible to formulate cleaning agents according to the present invention from synthetic detergents. In this case, however, care must be taken in the total formulation if a high fat content is to be obtained. It is strongly preferred that the soap on which the cleaning agent is based contains fatty acids from at least four sources.
• the fatty acids preferably comprise those derived from at least four of the fats selected from the group comprising: Lard;
• the weight of the fats to the caustic soda used in the production of the soap base preferably is from 7.3 to 8.5 parts by weight of fat per part by weight of caustic soda.
• non-drying fats and oils in the cleaning agent according to this invention as these fats and oils do not tend to cross-link with storage as happens with the drying oils.
• the selection of palm oil with its high content of palmitic acid and the use of cholesterol containing fats is believed to assist in giving the cleaning agent viricidal properties. It is believed that these materials dissolve the lipid coatings of viruses and denature the pirus. It is believed however that the presence of the dissolved viral materials on the fingertips contributes to a "self-vaccination" of the user with those viral antigens. This self-vaccination helps the body resist infection from that virus in the future.
• the cleaning agent according to the present invention preferably contains an antimicrobial agent.
• an antimicrobial agent refers to an agent which will either inhibit the growth of bacteria or other microorganisms or will actually kill such microorganisms.
• the term includes fungicides, fungistat, bactericides and bacteriostatic agents.
• the antimicrobial agent is preferably both fungicidal and bactericidal. In practice it has been found desirable to include in the cleaning agent a plurality of antimicrobial agents.
• the antimicrobial agent should not kill all pathogenic organisms on the fingertips. It is preferred that a small population be allowed to remain so that self-vaccination of the person using the cleaning agent will occur.
• the present invention postulates that if a small, non-viable population of weakened organisms is left in the region of the fingertips these organisms will be introduced into the body of the user through the nose, mouth, eyes etc. where they will induce an antibody reaction.
• the bodies antibody response mechanism will thus become attuned to the microorganisms with which the body is coming into contact.
• the bodies immune system will thus be better able to deal with any substantial invasion of the body by such organisms.
• a superfatted cleaning agent when used in the method according to this invention, introduces a thin fat film onto the finger tips and under the finger nails. This film is non-conductive and interferes with the bio-electric currents in the finger tip region which show up in Kirlian high voltage photography of the fingers. It is postulated by the present inventor that the insulation of microorganisms in the subungual area from the bio-electricity in that region will inhibit the growth and infectivity of the organisms.
• the antimicrobial agents include that marketed under the trade mark "IRGASAN” such as Irgasan DP300, the active ingredient of which is 2,4,4' - trichloro-2'-hydroxy diphenyl-ether in amounts by weight of from 0.1% to 5%, most preferably about 1%. It is also preferred that the cleaning agent includes iodine, potassium iodide or a mixture thereof as a further antimicrobial agent. Other antimicrobial agents such as formalin and zinc oxide may be included in addition to or instead of the foregoing preferred antimicrobial agents.
• iodine based antimicrobial agent the inventor has found that the best antimicrobial activity is obtained when iodine and an iodide are used together in a weight ratio of from 1 to 20 to 1 to 60, most preferably 1 to 50.
• the cleaning agent according to this invention will have a water content of from 30 to 85% by weight. The higher the water content the lower is the price of the product however the cleaning and antimicrobial activity is also likely to be lower with a greater water content.
• the fat and soap content preferably comprises from 10 to 50% by weight of the cleaning agent.
• the cleaning agent may include incidental ingredients for a variety of purposes.
• Honey is preferably included as it is hygroscopic. It is believed that the presence of- small amounts of honey in the film left on the hands will tend to dry out the skin in the subungual region of the fingertips rendering the area less suitable for the lodgement and growth of pathogenic microorganisms.
• the cleaning preparation is preferably of a colour which will not contrast greatly with the skin thus pinks, beiges, pale browns and other flesh tones are. preferred. Suitable colourants may be added if desired so that any slight film left on the skin or under the nails will not be visibly obvious.
• the present invention consists in a method for washing the hands comprising pushing the dry fingers, including the thumb, substantially vertically downwardly into a cleaning agent according to this invention to a depth sufficient to at least cover the fingernails, but without inserting the whole fingers into the cleaning agent, withdrawing the fingers from the cleaning agent, wetting the hands with water and lathering the hands with the cleaning agent adhered to the fingers.
• the cleaning preparation according to this invention is particularly applicable to the cleaning of the hands, particularly the fingertips, it should be recognised that this cleaning preparation is also efficacious in cleaning the remainder of the body of humans and for other cleaning purposes. It may be applied with the fingers, with a sponge or in any other suitable manner.
• the cleaning agent is however particularly preferred for use as a hand cleaning agent due to its ability to penetrate into the subungual areas and other crevices surrounding the fingertips and to removed dirt and debris therefrom in addition to assisting in the physical removal of pathogenic organisms. As has been outlined above the cleaning agent may so alter the physical and chemical environment of the fingertips that they no longer offer the supportive niche normally found there by pathogenic organisms.
• the soap according to the present invention may be made in one of two preferred methods hereinafter called the cold method and the hot method respectively.
• the fats and oils, antimicrobial agents and the like are heated and mixed together and allowed to cool. Simultaneously the water and caustic soda are mixed and allowed to cool. The two cooled mixtures are then mixed intimately together to form an emulsion and the emulsion is poured into a small container in which the finished cleaning agent is to be sold.
• the soap base is made in the final container in which it is to be sold by the reaction between fatty acids of the fats and oils and the caustic soda.
• preformed soap is boiled with water, superfatting ingredients and antimicrobial agents are added and dispersed as the soap solution cools, the soap being present in sufficient quantities to cause the solution to gel or set to a solid consistency on cooling.
• Example 1 The cleaning agent according to this invention, its method of manufacture and its use for the cleaning of hands will be hereinafter described in greater detail with reference to the following examples.
• Example 1 The cleaning agent according to this invention, its method of manufacture and its use for the cleaning of hands will be hereinafter described in greater detail with reference to the following examples.
• This example describes the manufacture of a cleaning agent according to this invention by the cold method.
• the cooled mixtures were blended together and poured into containers each containing 100g.
• the containers were set aside for a few days to allow time for the caustic soda to react with the fatty acids in the fats and oils contained in the first mixture.
• the resulting product was found to perform excellently as a cleaning agent for the hands having a penetrability of about 90mm and a speed of solubility of about 1-2 minutes. It was found that the fingers of the hand could be readily inserted into the cleaning agent though there was sufficient resistance to force the cleaning agent under the fingernails.
• This example describes the preparation of a cleaning agent by the hot method. 1000g of soap flakes were dissolved in water and boiled and allowed to cool. When the soap solution was approx. 40 C the following were added and dissolved or dispersed in the soap solution:-
• This final soap mixture was cooled to 25°C and poured into small containers in which it set to a solid. This soap also performed well as a cleaning agent for the hands.
• Example 1 was tested and the results thereof are set out hereunder.
• Two trained microbiologists were swabbed under the fingernails and the bacterial flora thereunder was enumerated using PCA/30°/72hr : Pour plate technique.
• normal hand washing techniques were used i.e. iodine/surfactant solution after laboratory work and household soap after ablutions, meals etc.
• the subjects replaced the iodine handwash with the soap according to Example 1 which soap was used by the process according to this invention.
• the cleaning agent according to Example 1 was subjected to a Primary Skin Irritation Test according to the method as outlined by J.H.Draize, 1959 - Dermal Toxicity Inst., Association of Food and Drug Officials of the U.S., Austin, Texas “Appraisal of Safety of Chemicals in Foods, Drugs and Cosmetics", pages 46-59.
• the sample was diluted 1:2 with sterile distilled water and mixed to form a paste.
• Each of the rabbits received 0.2ml of the paste absorbed into a 5cm x 5cm piece of double gauze, on the intact and abraided skin areas. These were held in place with adhesive tape and the whole of the trunk was covered with an impervious rubber sleeve. After twenty-four hours the rubber and the material were removed and the reactions graded.
• Example 5 This experiment was conducted to determine the effect of the cleaning agent of Example 1 on the bacterial density of the under fingernail region. Tests were carried out to determine the change if any of the population of mesophilic aerobic bacteria as well as any change in the presence of coagulase positive Staphylococcus spp. and any change in the presence of coagulase positive Staphylococcus spp. Materials and Methods
• Liaison was carried out with the committee of the N.S.W. Car Club and it was agree that they would use the product over a period of time and allow microbiological samples to be taken.
• Samples were taken using sterile Aimes Transport medium swabs and were stored for a maximum of 18 hours under refrigeration prior to testing.
• Total mesophilic aerobic bacterial counts were carried out as per A.S.A. 1766 with the substitution of Letheen agar for the more usual Plate Count agar. This was done to denature any soap residue carried over in the sample.
• Staphylococcus spp was carried out by pre-enrichment in Tryptone Soya Broth with 10% NaCl, followed by plating onto Baird-Parker Medium (Oxoid CM275) suspect colonies were confirmed by the slide coagulase test.

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• 1985
  • 1985-03-15 WO PCT/AU1985/000051 patent/WO1985004184A1/fr not_active Application Discontinuation
  • 1985-03-15 EP EP19850901310 patent/EP0176523A4/fr not_active Ceased
  • 1985-11-13 FI FI854464A patent/FI854464A/fi not_active Application Discontinuation
  • 1985-11-13 DK DK522385A patent/DK522385D0/da not_active Application Discontinuation

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