GB2518607A - Disinfectant composition - Google Patents
Disinfectant composition Download PDFInfo
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- GB2518607A GB2518607A GB1316982.6A GB201316982A GB2518607A GB 2518607 A GB2518607 A GB 2518607A GB 201316982 A GB201316982 A GB 201316982A GB 2518607 A GB2518607 A GB 2518607A
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- disinfectant composition
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- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N43/00—Biocides, pest repellants or attractants, or plant growth regulators containing heterocyclic compounds
- A01N43/48—Biocides, pest repellants or attractants, or plant growth regulators containing heterocyclic compounds having rings with two nitrogen atoms as the only ring hetero atoms
- A01N43/50—1,3-Diazoles; Hydrogenated 1,3-diazoles
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- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N29/00—Biocides, pest repellants or attractants, or plant growth regulators containing halogenated hydrocarbons
- A01N29/04—Halogen directly attached to a carbocyclic ring system
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N33/00—Biocides, pest repellants or attractants, or plant growth regulators containing organic nitrogen compounds
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N33/00—Biocides, pest repellants or attractants, or plant growth regulators containing organic nitrogen compounds
- A01N33/02—Amines; Quaternary ammonium compounds
- A01N33/04—Nitrogen directly attached to aliphatic or cycloaliphatic carbon atoms
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- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N33/00—Biocides, pest repellants or attractants, or plant growth regulators containing organic nitrogen compounds
- A01N33/02—Amines; Quaternary ammonium compounds
- A01N33/08—Amines; Quaternary ammonium compounds containing oxygen or sulfur
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- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N33/00—Biocides, pest repellants or attractants, or plant growth regulators containing organic nitrogen compounds
- A01N33/02—Amines; Quaternary ammonium compounds
- A01N33/12—Quaternary ammonium compounds
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N35/00—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having two bonds to hetero atoms with at the most one bond to halogen, e.g. aldehyde radical
- A01N35/02—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having two bonds to hetero atoms with at the most one bond to halogen, e.g. aldehyde radical containing aliphatically bound aldehyde or keto groups, or thio analogues thereof; Derivatives thereof, e.g. acetals
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- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N37/00—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids
- A01N37/44—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids containing at least one carboxylic group or a thio analogue, or a derivative thereof, and a nitrogen atom attached to the same carbon skeleton by a single or double bond, this nitrogen atom not being a member of a derivative or of a thio analogue of a carboxylic group, e.g. amino-carboxylic acids
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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
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
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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
- A61K8/18—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
- A61K8/34—Alcohols
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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
- A61K8/18—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
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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
- A61K8/18—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
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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
- A61K8/18—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
- A61K8/43—Guanidines
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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
- A61K8/18—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
- A61K8/494—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds with more than one nitrogen as the only hetero atom
- A61K8/4946—Imidazoles or their condensed derivatives, e.g. benzimidazoles
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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
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- 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
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- Dentistry (AREA)
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- Chemical Kinetics & Catalysis (AREA)
- Oil, Petroleum & Natural Gas (AREA)
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Abstract
A disinfectant composition comprises DMDM hydantoin, chlorhexidine digluconate and benzalkonium chloride. The composition may further comprise lauramine oxide, isopropyl alcohol, glycerol and/or hydroxyethyl cellulose as well as water. Also claimed is a method of disinfecting human or animal skin with the composition, and a method of preparing the disinfectant composition by mixing the ingredients in a mixer.
Description
Title: Disinfectant composition
Description of Invention
The present invention relates to a disinfectant composition. More particularly, the present invention relates to a disinfectant composition, for example an antiseptic composition, for cleaning human or animal skin. The present invention also relates to a method of forming a disinfectant composition for cleaning human or animal skin.
Disinfectants are regularly used to clean human or animal skin, for example before, during or after surgery. Human or animal skin provides an environment for, and provides a breeding ground for, potentially harmful pathogens. A potentially harmful pathogen is any organism which can cause disease. Non-limiting examples of potentially harmful pathogens include bacteria, fungi, viruses, moulds and yeasts.
Among other functions, human or animal skin acts as a barrier between the internal human or animal body and the atmosphere. When human or animal skin is perforated, for example by an accidental or non-accidental (for example surgical) cut, it is possible for pathogens on the surface of the skin to enter the bloodstream and potentially cause an ailment and/or a disease.
Furthermore, pathogens on the surface of the skin of a human or animal can multiply and enter the body of the host through a bodily orifice, for example the mouth, nose or ears.
Many pathogens exist on the surface of the skin of humans without causing infection. Surgery can permit such pathogens to enter the human blood stream and cause infection. An example of a pathogen which it is often desired to kill, in a surgical environment, is Candida albicans. Candida albicans is a fungus which is a causal agent of infections in humans, particularly in immunocompromised individuals. Another example of a pathogen which it is often desired to kill, in a surgical environment, is Staphylococcus aureus. Staphylococcus aureus is a bacteria. Both Gandida albicans and Staphylococcus aureus are common causes of hospital acquired infections, for example after surgery.
It is common to clean human or animal skin with agents which act to mitigate and/or destroy potentially harmful pathogens. The cleaning of human or animal skin in this way is beneficial to human or animal health, so as to prevent the spread of disease and mitigate the chances of a subject or subjects contracting a disease by mitigating and/or destroying potentially harmful pathogens on the skin of a human or animal.
It is particularly beneficial to mitigate and/or destroy potentially harmful pathogens on the skin of a subject before, during and/or after surgery. During surgery it is common to pierce the skin of a subject with a scalpel or scissors, for example. Before piercing the skin of a subject, it is desirable to minimise the number of potentially harmful bacteria on the skin. Furthermore, before piercing the skin of a subject, it is desirable to minimise the number of potentially harmful bacteria on the skin of a surgeon, or other medical professional who may come into contact with the subject during surgery.
At the present time, there are often reports of persons contracting potentially harmful diseases in hospitals when they have gone to hospital for routine operations and/or procedures. There has been particularly visible media coverage, in the UK at least, of persons contracting, inter alia, Clostridium difficile and Methicillin Resistant Staphylococcus Aureus (MRSA) whilst in hospital.
There are a number of products on the market which provide disinfectant actions when applied to skin. One example of a scrub used in a surgical environment is HiBiSCRUBTM, sold by Regent Medical Ltd in the UK. Another example of a scrub used in a surgical environment is OCTENSIANTM, sold by Schulke & Mayr UK Ltd in the UK.
In substantially disinfecting the skin of a human or animal, optionally before, during or after a surgical procedure, it is preferable for the disinfectant to be active on the surface of the skin for a period of time, for example, up to 1, 2, 3, 4, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50 or 55 minutes, 1, 2, 3, 4, 5, 6, 7, 8, 9 or hours, and all other times in between. It is particularly preferable for the anti-pathogen agent to be active for at least 6 hours in a surgical environment so that a surgical operative has sufficient time to complete surgical procedures without fear of contamination of an area undergoing surgery.
There is a need for a new disinfectant which can be applied to the skin of a human or animal and which provides a relatively long anti-pathogen activity (at least 6 hours) and anti-pathogen activity against a range of pathogens, along with no harmful side affects on humans and animals.
According to the present invention, there is provided a disinfectant composition, comprising: DMDM hydantoin; chlorhexidine digluconate; and, benzalkonium chloride.
Preferably, comprising 2.00-8.00 % w/w chlorhexidine digluconate.
Further preferably, comprising 2.00-6.00 % w!w, or 2.50-5.00 % wlw, or 3.00- 4.50 % w/w chlorhexidine digluconate.
Advantageously, comprising 0.10-1.00 %W/W DMDM hydantoin; Preferably, comprising 0.10-0.50 % w/w, or 0.10-0.40 % w/w, or 0.10-0.30 % w/w DMDM hydantoin.
Further preferably, comprising 0.20-1.0 % w/w benzalkonium chloride.
Advantageously, comprising 0.30-0.80 % w/w, or 0.40-0.70 % w/w benzalkonium chloride.
Preferably, further comprising lauramine oxide.
Further preferably, comprising 5.00-1 0.00 % w/w lauramine oxide.
Advantageously, further comprising isopropyl alcohol.
Preferably, comprising 5.00-20.00 % w/w isopropyl alcohol.
Further preferably, further comprising glycerol.
Advantageously, comprising 2.00-1 0.00 % w/w glycerol.
Preferably, further comprising hydroxyethyl cellulose.
Further preferably, comprising 0.20-1.0 % w/w hydroxyethyl cellulose.
Advantageously, comprising or consisting of: deionised water; hydroxyethyl cellulose; glycerol; isopropyl alcohol; DMDM hydantoin; chlorhexidine digluconate; benzalkonium chloride; and, lauramine oxide.
Preferably, comprising or consisting of, in % w/w: 0.20-1.0 hydroxyethyl cellulose; 2.00-10.00 glycerol; 5.00-20.00 isopropyl alcohol; 0.10-1.00 DMDM hydantoin; 2.00-8.00 chlorhexidine digluconate; 0.20-1.00 benzalkonium chloride; and, 5.00-10.00 lauramine oxide; the balance being deionised water.
Further preferably, consisting of, in % w/w: 72.30 deionised water 0.50 hydroxyethyl cellulose; 5.00 glycerol; 10.0 isopropyl alcohol; 0.20 DMDM hydantoin; 4.00 chlorhexidine digluconate; 0.50 benzalkonium chloride; and, 7.50 lauramine oxide.
According to a further aspect of the present invention, there is provided an aqueous mixture comprising: water and a disinfectant composition according to any one of the above.
Preferably, wherein the water is tap water, potable water and/or deionised water.
Further preferably, wherein the aqueous mixture has a ratio of water to disinfectant composition of from 99% water to 1% disinfectant composition to 1% water to 99% disinfectant composition.
Advantageously, wherein the composition has a ratio of water to disinfectant composition of 99%, 95%, 90%, 85%, 80%, 75%, 70%, 65%, 60%, 55%, 50%, 45%, 40%, 35%, 30%, 25%, 20%, 15%, 10%, 5%, 4%, 3%, 2%, 1.5%, 1%, 0.9%, 0.8%, 0.7%, 0.6%, 0.5%, 0.4%, 0.3%, 0.2%, 0.1% or 0.05% water to disinfectant composition.
According to a further aspect of the present invention, there is provided a method of disinfecting human or animal skin, comprising: providing a disinfectant composition or an aqueous mixture according to any one of the above; and, applying the composition or mixture to human or animal skin.
According to a further aspect of the present invention, there is provided a method of preparing a disinfectant according to any one of the above, comprising: providing the ingredients according to any one of the above; and, mixing the ingredients in a mixer.
Some of the components of the disinfectant compositions of the present invention, together with their sources, are set out below.
DMDM Hydantoin DMDM Hydantoin is an antimicrobial agent with the following chemical structure:
N
DMDM acts to mitigate and/or destroy pathogens by releasing formaldehyde.
Chlorhexidine Digluconate Chlorhexidine Digluconate is an antimicrobial agent with the following chemical structure: _Jf J# "f" CH2(CH2)4CH2'11 N%1... IIIIITJL..
OH OH
Chlorhexidine is effective against both Gram-positive and Gram-negative bacteria.
Benzalkonium Chloride Benzalkonium chloride is an antimicrobial agent with the following chemical structure: =8,10,12,14, Benzalkonium chloride is a quaternary ammonium compound. Benzalkonium chloride acts as to mitigate and/or kill bacteria, moulds and yeasts.
Without wishing to be bound by theory, it is believed that the combination of DMDM Hydantoin, Chlorhexidine Digluconate and Benzalkonium Chloride, provides a disinfectant composition with beneficial properties. In particular, it is believed that this combination provides a synergistic effect.
Composition A Composition A (sometimes referred to as composition NPP49O by the applicant), shown in Table 1, is a non-limiting example of a composition according to the present invention:
Table 1
Composition A Component CAS number Amount (% w/w) Action(s) Deionised water 7732-18-5 72.30 Solvent Hydroxyethyl 9004-62-0 0.50 Gelling agent cellulose Glycerol EC No. 200-289-5 5.00 Humectant and moisturiser Isopropyl alcohol 67-63-0 10.0 Solvent DMDM Hydantoin 6440-58-0 0.20 Antimicrobial Chlorhexidine 18472-51-0 4.00 Antiseptic digluconate Benzalkonium 63449-41-2 0.50 Biocide and chloride surfactant Lauramine oxide 68155-0909 7.50 Amine oxide surfactant Total 100 Composition A is a disinfectant composition according to a preferred embodiment of the present invention. The names of the components of the composition, along with the GAS (Chemical Abstract Service) number, are given. The GAS number has been given in each case because the GAS registry is a standard reference for persons looking to classify chemical compounds which are known in the scientific literature. In the case of glycerol, the EC number (European Chemical number, from the EC registry) is given instead of the CAS number. In Table 1, the amount of each component of the composition is provided in weight % (also referred to in this specification as wt %or%w/w).
Composition A has a clear and colourless appearance. Composition A is a viscous liquid and has a pH of between 6.0 and 7.5.
The action of composition A against certain pathogens has been tested and is discussed below.
Ranges for each of the ingredients in composition A are provided in Table 2, below. All disinfectant compositions falling within these boundaries are expected to have the same effects. The ranges are provided to show the ranges which have been tested for disinfectant activity. The ranges include each intermediate value, for example 5-20 include 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20, and each further intermediate value.
Table 2
Composition A ranges Component CAS number Amount (% w/w) Ranges (% wtw) Deionised water 7732-18-5 72.30 49.00-85.50 Hydroxyethyl 9004-62-0 0.50 0.20-1.0 cellulose Glycerol EC No. 200-289-5 5.00 2.00-10.00 Isopropyl alcohol 67-63-0 10.0 5.00-20.00 DMDM Hydantoin 6440-58-0 0.20 0.10-1.0 Chlorhexidine 18472-51-0 4.00 2.00-8.00 digluconate Benzalkonium 63449-41-2 0.50 0.20-1.0 chloride Lauramine oxide 681 55-0909 7.50 5.00-10.00 Total 100 Composition A, according to the present invention, is in compliance with Regulation (EC) 1223/2009 (on cosmetic products), the Biocidal Products Directive 98/8/EC and the UK Biocidal Products (Amendment) Regulations 2007. In other words, the ingredients comply with the relevant European law on the safety of cosmetic products.
Manufacturing protocol for composition A The following is a protocol for forming a cleaning liquid according to composition A, shown in Table 1. The amounts of each component used at each step are shown above, i.e. they are not specified in the method below.
In one exemplary embodiment, all of the components of composition A are mixed in any order, in the amounts specified in Table 1, to result in a composition according to the present invention.
In another exemplary embodiment, the compositions of the present invention are prepared as follows: Select a clean manufacturing vessel, for example a stainless steel mixing vessel with a propeller shaft.
ii. Introduce the deionised water into the pre-cleaned mixing vessel.
Di. Introduce the hydroxyethyl cellulose into the mixing vessel, stir and permit hydration.
iv. Introduce the DMDM hydantoin into the mixing vessel and continue stirring.
v. Introduce the glycerol into the mixing vessel and continue stirring.
vi. Introduce the isopropyl alcohol into the mixing vessel and continue stirring.
vU. Introduce the chlorhexidine digluconate into the mixing vessel and continue stirring until the solution turns clear.
vUi. Introduce the benzalkonium chloride into the mixing vessel and continue stirring.
ix. Gradually (over ten minutes) reduce the speed of mixing to mitigate the build up of any foam.
x. Introduce the lauramine oxide into the mixing vessel and continue stirring for 10 to 30 minutes.
After step x., the composition can be portioned into plastic container vessels and stored, ready for use.
In use, the compositions of the present invention may be mixed with water.
Preferable mixing ratios with water for composition A are, in percentage terms (where 1 % means 99 parts water to 1 part exemplary composition) 100%, flIZ0/ flAb! QIZO/ QflO/ 71Z0/ 7fl0/ O/ flO/ IZIZO! fl0/ AO/ ,lflO/ DiZO/ JU /0, QJ /0, UU /0, OL) /0, I U /0, I LI /0, UU /0, ULI /0, UU /0, ULI /0, tU o, -w o, UU /0, OflO/ 0gb! OflO! 1 gO! i no! goi AOl 00/ 00/ 1 R0l 10/ A no! n 00/ 0 70/ UU/O,CU/O,CIJ/0, lU/b, IU/0,U/0,'t/0,O/0,C/0, lU/b, I /0,U./0,LI.U/0, LII /0, 0.6%, 0.5%, 0.4%, 0.3%, 0.2%, O.1%ando.05%.
In use, the disinfectant compositions of the present invention may be applied to the skin of a user, optionally prior to surgery. The compositions may be applied to the skin of a user by application on a sponge, a flannel, a wipe or a towel.
A preferred application regime, in a hospital environment, for compositions of the present invention is as follows: Wet the body of a subject, for example in a shower.
ii. Turn off water supply.
iU. Wash hair with composition A. iv. Place some of composition A on a hand or wet sponge and wash the body of the subject, paying particular attention to the mouth, nose, armpits, navel, groin and genitals of the subject.
v. Optionally, leave the foamed composition on the surface of the skin for 1-2 minutes.
vi. Turn on the water supply.
vii. Rinse off composition A. vDi. Repeat steps ii. to vU. so the subject is washed twice.
ix. Dry subject with a clean towel.
Trials Tests were carried out on the effectiveness of composition A of the present invention, namely that detailed in Table 1.
a. Minimum inhibitory concentration test comparisons Fanspermia Microbiology Laboratories Ltd ("Fanspermia"), Burnham-on-Crouch, Essex, UK, carried out minimum inhibitory concentration tests on composition A (from Table 1) and a number of other comparison compositions.
These tests were carried out under a non-disclosure agreement.
Panspermia's minimum inhibitory concentration test method: * Make up a working solution of the anti-microbial composition to be tested in a nutrient broth. The solution is 50% w/w of the neat anti-microbial agent and 50% wlw nutrient broth.
* Sterilise and label 12 test tubes containing 5m1 of nutrient broth (not including the anti-microbial agent).
* Aseptically add 5m1 of the working solution to the first tube using a sterile pipette.
* Vibrationally mix the tube to homogenise the broth.
* Serially dilute the sample by taking 5m1 from the first tube into a second tube, vibrationally mixing, and then taking 5m1 of the resulting mixture into a third tube, and so on, until all tubes containing 5m1 of liquid, each tube being half the concentration of the previous tube.
* Inoculate each tube with 1 drop from a pipette of an overnight culture of the test organism. Vibrationally mix each tube after addition of inoculums.
* Incubate the tubes at 3OC for 12 hours.
* After incubation, vibrationally mix the tubes to ensure even mixing.
* Take a sub-culture (using a sterile plastic loop) from each tube and place each sub-culture onto separate agar plates suitable for the microorganism (for example: bacteria = tryptone soy agar; yeasts = Sabouraud dextrose agar).
* Incubate each agar plate for the same amount of time (12 hours) and assign each plate with a reading of growth: = no growth; "+" = sparse growth; "++" or "+++" = growth; "++++" = profuse growth.
Table 3 shows the results of Panspern-iia's trials. In summary, the minimum inhibitory concentrations of different compositions were tested against Staphylococcus aureus ATCC 6538 and Candida albicans ATCC 10231. (The ATCC numbers refer to the numbers applied to these microorganisms by the American Type Culture Collection).
Referring to Table 3, the compositions tested by Panspermia were: Tester 1: Same as composition A (from Table 1), without any DMDM Hydantoin.
Tester 2: Same as composition A (from Table 1), without any Chlorhexidine digluconate.
Tester 3: Same as composition A (from Table 1), without any Benzalkonium chloride.
Tester 4: HiBiSCRUBIM, as sold Regent Medical Ltd in the UK.
Tester 5: Composition A (from Table 1).
Tester 6: Placebo (isopropyl alcohol 10% w/w in deionised water).
The concentrations of each of testers 1-6 in deionised water were changed, as shown along Table 3 (from 25% to 0.01 %). A "-" mark for a particular tester at a particular concentration shows the tester is effective in killing the microorganism at that concentration. A 4" mark shows sparse growth of the microorganism. A "++" or "+++" mark shows some growth. A ++++" mark shows profuse growth.
All of tester compositions 1-5 showed a greater effect than the placebo against Staphylococcus aureus.
Composition A (Tester 5) showed by far the greatest kill effect against Candida albicans at low concentrations out of all of the testers. Without wishing to be bound by theory, this indicates that the combination of DMDM Hydantoin, Chlorhexidine Digluconate and Benzalkonium Chloride provides a synergistic effect.
b. Hospital tests The effectiveness of composition A was tested in a hospital environment at the Hospital Infection Research Laboratory, Queen Elizabeth Hospital, Birmingham, UK. The tests were carried out under a non-disclosure agreement.
Test products: i. HiBiSCRUBIM (Tester 7) U. Composition A (from Table 1) (Tester 8) Concentrations: Both products were tested at in-use compositions, i.e. not diluted.
Test organisms: Staphylococcus aureus NCTC 10788 Methicilin-resistant Staphylococcus aureus NCTC 12493 Candida albicans ATCC 10231 NCTC refers to the reference number given to the microorganism provided by the National Collection of Type Cultures.
Test temperature: 20C Test method: As set out in EN 13727: (2003) Chemical disinfectants and antiseptics -Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants for instruments in the medical area. EN 13727 is a European standard test, as set out by the European Standardisation Organisation. A copy of EN 13727 is available from BSI, 389 Chiswick High Road, London, W4 4AL. EN 13727 was modified to test different microorganisms from those tested in the published European standard. Also, the maximum time tested was 5 minutes.
The test method involved mixing 1 ml of the test organisms with 1 ml of interfering substance (0.3% w/v Bovine albumin), and then adding 8 ml of the test product. After the required contact time, 0.1 ml was removed to 9.9 ml of recovery broth (8.9 ml neutraliser and 1 ml water) for 5 minutes after which is was placed onto Tryptone Soya Agar to detect surviving test bacteria, and Sabouraud Dextrose Agar to detect surviving test organism.
The neutralisers used were: * TweenTM 80 (30g/l), lecithin (3g11), saponin (30g11), histidine (1 gIl), sodium thiosulphate (5g11), sodium chloride (8.5g11) and tryptone (1 gIl) -for Gandida albicans.
* TweenlM 80 (30g11), lecithin (3g11), sodium lauryl sulphate (4g1l), sodium chloride (8.5g1l) and tryptone (1 gIl) -for Staphylococcus aureus.
Referring to Tables 4 and 5, the compositions tested at the Hospital Infection Research Laboratory were: Tester 7: HiBiSCRUBTM, as sold Regent Medical Ltd in the UK.
Tester 8: Composition A (from Table 1).
Validation of test method: V = Viable count Nvo = cfulml of test organism suspension The methodology is valid if, A and B are equal to or greater than 0.5 x Nvo, and C is equal to or greater than 0.5 x B.
Table 4
1)ilutio,oi,trajizitiou ontrol EXpeI'IJTIen(2J -. C1eu ()i'gamsrn -Neutratzer Test organism eoni1itons toxicity entro (C) Clean l'ester Tester S c:;IT Yc: 57, 158 StapJ,ytoroccs aureus(NCTC Nv0: 683 A: 824 B: 438 C: 395 2 315
-----------
MRSA (NCTC Ve: 506, 428 Vo: 532,483 Vc: 339, 322 Vc: 29h 245 Ye: 271.254 12493) N0: 934 A: 015 8: 661 C: 535 C: 525 ____--1--____ (andith,a?hica,ø Ye: 4, $ V: 17, 15 Ye: 8,8 Ve: 5,5 Yc 9,11 (ATCC 10231) Nv:22 A:32 8: 6 C: 10 C: 20
_______I
Table 4 shows that the results of this trial are validated.
Table 5 shows the microbicidal activity of Tester 7 and Tester 8, using the modified EN 13727 test set out above. The tests were carried out in duplicate.
Table 5
Mean reduction -, contact Tester 7 TesterS lest orgarnsm. untial -_____ -time Ff 1 Test 2 Mean Tt 1 Test 2 Mean sec 4.04 4.29 4.17 >5.85 5.85 >5.85 Sttnthyloc'occus 1 ------------------______ i mm >sss 5 c >585.585 >585 >585 aureu.v..... 7.85 -_____.---_--------.,------..---.------ 2mm AS >85 >585 SS5 >585 >585 (NCTCIO7SS) -miii >5.85 >5.85 >5.85 >5.85 >5.85 >5.85 iOsec 491 --.>599 >545 >599 >59Q >599 MRSA miri F >599 >599 F_____ 7.99 -------------------4 1\C1C 12491) 2mm >599 >599 >599 > 99 >599 5 99 >599 >599 >599 >590 >5,99 ->5.99 --30 sec 0.12 0.17 (hiS >4.40 4.40 >4.40 thndida --------1 H-------_____ ____-___ -I mm -022 0.70 0.46 >4.40 >4.49 >4.40 tdbkins._._-___---6.40 r----------i--------F 2 miii 0,50 0,55 0.53 >4.40 >4.40 >4.40 (ATCCJO231) ----------1 -----4---miii (350 0.70 0.60 >4.40 { >4.40 >4,49 Table 5 shows that Tester 7 possesses antibacterial activity, achieving >5 log10 reduction against Staphylococcus aureus and MRSA within one minute.
However, Tester 7 displayed negligible activity against Candida albicans during the five minute test period.
Tester 8 (Composition A, as set out in Table 1, above) showed effective antimicrobial activity against every tested microorganism within 30 seconds.
c. Comparison with HiBiSCRUBTM Composition A of the present invention contains less % w/w chlorhexidine digluconate, and less overall % w/w active components, than HiBiSCRUBTM, but has a stronger effect against certain pathogens. Minimising the % w/w of active ingredients is desirable because, although the necessary amounts of active ingredients to mitigate and/or kill pathogens is essential, it is also desirable to keep the amounts of active chemicals to a minimum. This saves resources and reduces the chance of adverse reactions in users. Qualitative results from use of Composition A on different individuals shows reduced skin irritation, compared with the use of HiBiSCRUBTM.
The amounts of chlorhexidine digluconate, DMDM hydantoin and chlorhexidine present in composition A, according to the present invention, are well within the limits set by EC regulations for human use.
d. Contact time tests Panspermia, under a non-disclosure agreement, tested the contact time of Composition A (as set out in Table 1) at different times to calculate percentage kills after differing amounts of time.
Method: To 20m1 of a sample was added 1 ml of an overnight culture of the test organism (either Staphylococcus aureus ATCC 6358 or Candida a/b/cans ATCC 10231). At each contact time (1 minute or 6 hours), 1 ml of each sample was removed, neutralised and the microorganism present was enumerated.
Log reductions of greater than 6.54 for Staphylococcus aureus, and greater than 4.92 for Candida albicans, were seen at both 1 minute and 6 hours. This data shows that composition A of the present invention swiftly kills these microorganisms and there is no subsequent regrowth 6 hours after the initial contact. This 6 hour time is particularly beneficial in a surgical and/or hospital environment.
e. Stability Composition A, when packed in a sealed plastic container and kept at 202C, was found to be stable for at least 2 years. There was no measurable loss of activity after 2 years.
Samples of composition A, when packed in a sealed plastic container, were placed in ovens at 62C, 202C, 302C and 402C, and left for 6 months. The disinfectant effects of each sample remained the same after leaving each sample at the allotted temperature for 6 months.
As can be seen from the above results, disinfectant compositions according to the present invention have beneficial properties.
When used in this specification and claims, the terms "comprises" and "comprising" and variations thereof mean that the specified features, steps or integers are included. The terms are not to be interpreted to exclude the presence of other features, steps or components.
The features disclosed in the foregoing description, or the following claims, or the accompanying drawings, expressed in their specific forms or in terms of a means for performing the disclosed function, or a method or process for attaining the disclosed result, as appropriate, may, separately, or in any combination of such features, be utilised for realising the invention in diverse forms thereof.
Claims (26)
- Claims 1. A disinfectant composition, comprising: DMDM hydantoin; chlorhexidine digluconate; and, benzalkonium chloride.
- 2. The disinfectant composition according to claim 1, comprising 2.00-8.00 % w/w chlorhexidine digluconate.
- 3. The disinfectant composition according to claim 1 or claim 2, comprising 2.00-6.00 % w/w, or 2.50-5.00 % w/w, or 3.00-4.50 % w/w chlorhexidine digluconate.
- 4. The disinfectant composition according to any one of claims 1-3, comprising 0.10-1.00 %w/w DMDM hydantoin.
- 5. The disinfectant composition according to any one of claims 1-4, comprising 0.10-0.50 % w/w, or 0.10-0.40 % w/w, or 0.10-0.30 % w/w DMDM hydantoin.
- 6. The disinfectant composition according to any one of claims 1-5, comprising 0.20-1.0 % wiw benzalkonium chloride.
- 7. The disinfectant composition according to any one of claims 1-6, comprising 0.30-0.80 % wiw, or 0.40-0.70 % w/w benzalkonium chloride.
- 8. The disinfectant composition according to any one of claims 1-7, further comprising lauramine oxide.
- 9. The disinfectant composition according to claim 8, comprising 5.00- 10.00 % w/w lauramine oxide.
- 10. The disinfectant composition according to any one of claims 1-9, further comprising isopropyl alcohol.
- 11. The disinfectant composition according to claim 10, comprising 5.00- 20.00 % w/w isopropyl alcohol.
- 12. The disinfectant composition according to any one of claims 1-11, further comprising glycerol.
- 13. The disinfectant composition according to claim 12, comprising 2.00- 10.00 % w/w glycerol.
- 14. The disinfectant composition according to any one of claims 1-13, further comprising hydroxyethyl cellulose.
- 15. The disinfectant composition according to claim 14, comprising 0.20-1.0 % w/w hydroxyethyl cellulose.
- 16. The disinfectant composition according to any one of claims 1-15, comprising or consisting of: deionised water; hydroxyethyl cellulose; glycerol; isopropyl alcohol; DMDM hydantoin; chlorhexidine digluconate; benzalkonium chloride; and, lauramine oxide.
- 17. The disinfectant composition according to any one of claims 1-16, comprising or consisting of, in % w/w: 0.20-1.0 hydroxyethyl cellulose; 2.00-10.00 glycerol; 5.00-20.00 isopropyl alcohol; 0.10-1.00 DMDM hydantoin; 2.00-8.00 chlorhexidine digluconate; 0.20-1.00 benzalkonium chloride; and, 5.00-10.00 lauramine oxide; the balance being deionised water.
- 18. The disinfectant composition according to any one of claims 1-17, consisting of, in % w/w: 72.30 deionised water 0.50 hydroxyethyl cellulose; 5.00 glycerol; 10.0 isopropyl alcohol; 0.20 DMDM hydantoin; 4.00 chlorhexidine digluconate; 0.50 benzalkonium chloride; and, 7.50 lauramine oxide.
- 19. An aqueous mixture comprising: water and a disinfectant composition according to any one of claims 1-18.
- 20. The aqueous mixture of claim 19, wherein the water is tap water, potable water and/or deionised water.
- 21. The aqueous mixture of one of claims 19 or 20, wherein the aqueous mixture has a ratio of water to disinfectant composition of from 99% water to 1% disinfectant composition to 1% water to 99% disinfectant composition.
- 22. The aqueous mixture of claim 21, wherein the composition has a ratio of water to disinfectant composition of 99%, 95%, 90%, 85%, 80%, 75%, 70%, O/ flO/ Ol gno! A go! AflO1)ol)flo! Ogo! nnoi i go, i no, go, Aol UUIO, UU/O, JU/O, QU/o, tQ/o, "J/0, QU/O, QLI/O, £Q/0, tU/0, 1Q10, Wl0, Q/0, t/0, 001 001 1 gO! ioi (1(10! (1001 (170! (10! flgO! (lAO! (100! (100! (110! 3/0, C /0, I.Q /0, I /0, U.J /0, U.U /0, U.! /0, U.U /0, J.Q /0, U.'t /0, U.Q /0, U.C /0, U. I /0 or O.O5% water to disinfectant composition.
- 23. A method of disinfecting human or animal skin, comprising: providing a disinfectant composition or an aqueous mixture according to any one of claims 1 to 22; and, applying the composition or mixture to human or animal skin.
- 24. A method of preparing a disinfectant according to any one of claims 1- 18, comprising: providing the ingredients according to any one of claims 1 to 18; and, mixing the ingredients in a mixer.
- 25. A disinfectant composition as hereinbefore described, with reference to Table 1 and/or Table 2.
- 26. Any novel feature or combination of features disclosed herein.
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GB1316982.6A GB2518607A (en) | 2013-09-25 | 2013-09-25 | Disinfectant composition |
GB1414619.5A GB2518967A (en) | 2013-09-25 | 2014-08-18 | Disinfectant composition |
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
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WO2018033718A1 (en) * | 2016-08-17 | 2018-02-22 | Byotrol Plc | Anti-microbial composition |
EP3694439A4 (en) * | 2017-10-12 | 2021-12-15 | Medline Industries, Inc. | Antiseptic wipes |
Families Citing this family (1)
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CN109221117A (en) * | 2018-09-19 | 2019-01-18 | 青岛安特斯生物制药有限公司 | A kind of pet deodorization bacteria-removing liquid and its preparation and application |
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WO1997035627A1 (en) * | 1996-03-26 | 1997-10-02 | Virotex Corporation | Method and composition for cleansing wounds with minimal cytotoxicity for minimal scarring |
WO2004014416A1 (en) * | 2002-08-12 | 2004-02-19 | Lonza Inc. | Antimicrobial compositions |
US20050048139A1 (en) * | 2002-02-07 | 2005-03-03 | Modak Shanta M. | Zinc salt compositions for the prevention of dermal and mucosal irritation |
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- 2013-09-25 GB GB1316982.6A patent/GB2518607A/en not_active Withdrawn
-
2014
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WO1997035627A1 (en) * | 1996-03-26 | 1997-10-02 | Virotex Corporation | Method and composition for cleansing wounds with minimal cytotoxicity for minimal scarring |
US20050048139A1 (en) * | 2002-02-07 | 2005-03-03 | Modak Shanta M. | Zinc salt compositions for the prevention of dermal and mucosal irritation |
WO2004014416A1 (en) * | 2002-08-12 | 2004-02-19 | Lonza Inc. | Antimicrobial compositions |
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Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2018033718A1 (en) * | 2016-08-17 | 2018-02-22 | Byotrol Plc | Anti-microbial composition |
CN109561694A (en) * | 2016-08-17 | 2019-04-02 | 拜奥特罗尔有限公司 | Antimicrobial compositions |
CN109561694B (en) * | 2016-08-17 | 2022-09-27 | 拜奥特罗尔有限公司 | Antimicrobial compositions |
EP3694439A4 (en) * | 2017-10-12 | 2021-12-15 | Medline Industries, Inc. | Antiseptic wipes |
US11369549B2 (en) | 2017-10-12 | 2022-06-28 | Medline Industries, Lp | Antiseptic wipes |
AU2018348194B2 (en) * | 2017-10-12 | 2024-04-18 | Medline Industries, Inc. | Antiseptic wipes |
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GB201316982D0 (en) | 2013-11-06 |
GB201414619D0 (en) | 2014-10-01 |
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