PRODUCT AND PROCESS FOR DECONTAMINATION OF HARMFUL SUBSTANCES FROM THE SKIN
20230089419 · 2023-03-23
Assignee
Inventors
Cpc classification
A61K8/97
HUMAN NECESSITIES
International classification
Abstract
The present invention relates to the field of skin decontamination from harmful substances. In particular, the invention provides composition for decontamination of skin from hazardous agents, such as nanoparticles, microplastic particles and viruses, wherein said composition comprises ⋅1 to 40% by weight of at least one water-soluble polymer, ⋅1 to 40% by weight of at least one phyllosilicate, ⋅1 to 30% by weight charcoal and/or graphite, and ⋅Water; and wherein said composition for decontamination of skin does not comprise penetration enhancers. In further embodiment, the invention provides a “ready to use” kit comprising said composition, which enables more than 99% decontamination of affected skin areas within the very important first minutes. The kit allows the use with one hand, thus significantly reducing the risk of secondary contamination of other skin areas. In further embodiment, the invention also relates to a process for skin decontamination from hazardous agents, such as nanoparticles, microplastic particles and viruses comprising the composition and/or kit of the invention.
Claims
1. A composition for decontamination of skin from hazardous agents, such as particle-like and hydrophobic hazardous agents, wherein said composition comprises 1 to 40 wt % of at least one polymer selected from the group consisting of a water-soluble polymer and a block-copolymer, 1 to 40 wt % of at least one phyllosilicate, 1 to 30 wt % of a carbon based powder, and water; and wherein said composition for decontamination of skin is free from penetration enhancers.
2. The composition of claim 1, wherein said at least one water-soluble polymer or block-copolymer is selected from polyethylene glycol, polypropylene glycol, poloxamers, poloxamines, poly(N-isopropylacrylamide), polyvinyl alcohol, polyacrylic acid, chitosan, dextran, guar gum, bovine serum albumin (BSA), polygelin, polyacryl amide, polyphosphate (sodium polyphosphate), polyphosphazene, pectin and carrageenan.
3. The composition of claim 1, wherein said at least one polymer is selected from the group consisting of polyethylene glycol and Of polypropylene glycol.
4. The composition claim 1, wherein said at least one phyllosilicate is selected from ajoite, allophane, annite, apophyllite, apophyllite-(kf), bentonite, biotite, bowenite, brammallite, carletonite, caryopilite, cavansite, chamosite, chapmanite, chrysocolla, clay, clay mineral, clintonite, cymrite, delessite, dickite, ekanite, ephesite, expanded clay aggregate, fraipontite, franklinphilite, fuchsite, greenalite, gyrolite, halloysite, hisingerite, imogolite, kampfite, kaolinite, kegelite, kerolite, lepidolite, macaulayite, macdonaldite, magadiite, medicinal clay, meerschaum pipe, metal clay, mica, minnesotaite, nelenite, neptunite, okenite, organoclay, pentagonite, petalite, phlogopite, pimelite, pyrophyllite, sanbornite, searlesite, sepiolite, seraphinite, sericite, sericitic alteration, siderophyllite, soapstone, stilpnomelane, talc, thuringite, tumchaite, tuperssuatsiaite, ussingite, zakharovite, and zussmanite.
5. The composition according to claim 1, wherein said at least one phyllosilicate is selected from the group consisting of bentonite and kaolin.
6. The composition according to claim 1, wherein said charcoal is activated carbon, wherein said activated carbon is made from hard coal, bituminated coal, coconut or peat and wherein said other carbon based powder is selected from fruit shell or stone powder such as Olea Europaea Seed Powder, Prunus Amygdalus Dulcis (Sweet Almond) Shell Powder, Prunus Persica (Peach) Seed Powder, Pistacia Vera (Pistachio) Shell Powder, Persea Gratissima (Avocado) Extract, Prunus Armeniaca Seed Powder, Argania Spinosa Kernel Extract, Juglans Regia Shell Powder.
7. The composition according to claim 1, comprising 1 to 40 wt % of at least one water-soluble polymer, 2 to 30 wt % of at least one phyllosilicate, ≥10 wt % carbon based powder, and water.
8. The composition according to claim 1, further comprising up to 10 wt % preservatives; and 1 to 10 wt % of a gelation agent.
9. The composition according to claim 8, wherein said preservatives are paraben-free and are selected from phenethyl alcohol, phenoxyethanol, a sorbate, potassium sorbate, sodium sorbate, sorbic acid, sodium benzoate, benzoic acid, oleuropein, cranberry extract, Lactobacillus ferment, Usnea barbata extract, pomegranate extract, Populus tremuloides bark extract, resveratrol, anisic acid, sodium anisate, phenyl propanol, undecylenic acid and sorbitan caprylate, and a combination thereof.
10. The composition according to claim 8, wherein said gelation agent is selected from cellulose ether (e.g., methyl cellulose, carboxymethyl cellulose, hypromellose, ethylcellulose, ethyl methyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxyethyl methyl cellulose, ethyl hydroxyethyl cellulose, or a combination thereof), xanthan, carrageenan, carbomer, polyoxazoline, and combinations thereof.
11. The composition according to claim 1, comprising 1 to 40% by weight of at least one said water-soluble polymer, 1 to 40% by weight of at least one said phyllosilicate, 1 to 30%, of a carbon based powder, up to 10% by weight preservatives; 1 to 10% by weight of a gelation agent; and water.
12. The composition according to claim 1, comprising 30 to 35% by weight of at least one said water-soluble polymer; 16 to 25% by weight of at least one said phyllosilicate; ≥10% of said carbon based powder; up to 10% by weight preservatives; 1 to 10% by weight of a gelation agent; and water.
13. The composition according claim 1, comprising 30 to 35% by weight of a polyethylene glycol; 16 to 25% by weight of said phyllosilicate selected from bentonite and kaolin; ≥10% by weight of said carbon based powder; up to 10% by weight preservatives; 1 to 10% by weight of a gelatin agent selected from carboxymethyl cellulose and xanthan carrageenan; and water.
14. The composition according to claim 1, further comprising an anti-inflammatory agent and an agent beneficial fora skin barrier function.
15. The composition according to claim 14, wherein said anti-inflammatory agent and said agent beneficial for a skin barrier function are selected from schizophyllan, glucomannan, polycitronellol, polycitronellol acetate, and a combination thereof.
16. The composition according to claim 1, further comprising a buffering agent to adjust pH value of the composition.
17. The composition according to claim 16, wherein said buffering agent is selected from hydrochloric acid, phosphoric acid, sodium hydroxide, sodium carbonate, sodium hydrogencarbonate, sulfuric acid, nitric acid, and a combination thereof.
18. The composition according to claim 1, wherein said composition does not contain surfactants.
19. The composition according to claim 1, wherein said composition does not contain polyvinyl pyrrolidone, carboxymethyl cellulose, hyaluronic acid, polyethylene imine, polyvinyl polypyrrolidon (PVPP), DMSO, xanthan, glycerin, caprylyl glycol, acemannan, carvacrol, gluconolactone, green tea extract, Helianthus annuus seed oil, polyaminopropyl biguanide, polyglyceryl-3 palmitate, polyglyceryl-6 caprylate, Rosmarinus oificinalis leaf extract, benzyl alcohol, carrageenan, Poloxamer 188 and Poloxamer 401.
20. The composition according to claim 1, wherein said composition does not affect the barrier function of the skin.
21. The composition according to claim 1, wherein said hydrophobic hazardous agents are selected from polylcyclic aromatic hydrocarbons (PAH), sulfur, mustard, tabun/GA, sarin, soman, O-Ethyl-S-2-diisopropylaminoethylmethylphosphonothiolate (VX), ethidiumbromide, nanoparticles, microplastic particles and viruses.
22. The composition according to claim 21, wherein said hydrophobic hazardous agents are selected from metallic nanoparticles, inorganic nanoparticles, organic nanoparticles and semiconductive nanoparticles.
23. The composition according to claim 1, wherein said composition has a consistency selected from a cream, a paste, a lotion and a gel.
24. (canceled)
25. (canceled)
26. A method of treating skin that is contaminated with hazardous agents, such as particle-like and hydrophobic hazardous agents, selected from polylcyclic aromatic hydrocarbons (PAH), chemical warfare agents, chemical warfare agents), ethidiumbromide, nanoparticles, microplastic particles and viruses, said method comprising the steps of administering the composition according to claim 1 on said contaminated skin of a subject in need thereof and decontaminating said skin from the hazardous agents, such as particle-like and hydrophobic hazardous agents, selected from polylcyclic aromatic hydrocarbons (PAH), chemical warfare agents, ethidiumbromide, nanoparticles, microplastic particles and viruses.
27. (canceled)
28. The method according to claim 26, further comprising the step of performing a quality control to ensure that the hazardous agents, such as particle-like and hydrophobic hazardous agents, selected from polylcyclic aromatic hydrocarbons (PAH), chemical warfare agents, ethidiumbromide, nanoparticles, microplastic particles and viruses were washed off completely by investigating with the naked eye, whether the charcoal or graphite contained in the decontamination composition was washed off from the skin completely.
29. Application device comprising a composition according to claim 1.
30. The application device according to claim 29, wherein said application device is selected from a sponge, cloth, shoe cleaning tube, spray can or spray device.
31. The application device according to claim 30, wherein said application device is a sponge, and wherein said composition is in the form of a gel.
32. The application device according to claim 31, further comprising an indicator showing whether an affected area of the skin has been cleaned sufficiently and effectively.
33. The composition according to claim 1, wherein said carbon based powder is selected from charcoal, graphite, and a mixture thereof.
Description
BRIEF DESCRIPTION OF THE FIGURES
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[0161]
EXAMPLES OF THE INVENTION
Example 1
General Manufacturing Process of the Decontamination Composition
[0162] In a first step, at least one water-soluble polymer and optionally a gelation agent are mixed with purified water. Then, the at least one activated phyllosilicate and the activated carbon are homogenized and after homogenization added to the wet mixture of the at least one water-soluble polymer and optionally the gelation agent in water. The so completed mixture is thoroughly stirred until homogenization.
[0163] Further described is the representative manufacture of 100 g of a gel:
[0164] 24 g of PEG and 6 g carboxymethyl cellulose is mixed with 31 g of purified water (18.2 Me). Then, 13 g of Bentonite, 13 g of Kaolin, and 13 g of activated carbon are homogenized before adding to the wet mixture. The completed mixture is thoroughly stirred until homogenization.
Example 2
General Design of the Decontamination Experiments
[0165] Decontamination experiments were performed with porcine skin.
Preparation of Porcine Skin
[0166] Porcine skin was prepared as follows:
[0167] Pigs of the German Landrace are used, aged between 5 and 8 months. The age, sex and weight of each donor animal were documented in the test protocol.
[0168] Pieces of skin of approximately 10 cm×10 cm were removed from the area of the lateral abdominal wall with the help of a scalpel. A distance of at least 5 cm from the spinal column, ribs and the middle of the abdomen were maintained. The pieces of skin are wrapped in surgical drapes to avoid contamination with subcutaneous fatty tissue. The transport to the laboratory is carried out in freezer bags in a cool box at approx. 4-8° C. on cooling batteries or ice.
[0169] First, the skin surface is cleaned with lukewarm water. Then the preparation base is covered with a layer of aluminium foil and above that a layer of absorbent material (e.g. Zemuko universal compress). A piece of skin is placed on top of this with the stratum corneum side down. Artery clamps are attached to the four corners of the skin, and the skin is stretched by means of the rubber bands. Alternatively, the skin can be fixed with four needles which are inserted through the skin corners into a polystyrene pad. The subcutaneous fatty tissue is grasped with surgical tweezers and separated directly below the dermis with a scalpel. Care must be taken that no contact of the surface with subcutaneous fat occurs. Due to the risk of contamination, the outermost 5 mm in the marginal area must be discarded after the subcutaneous fat tissue has been dissected. The prepared skin is then placed on the aluminium foil with anatomical tweezers, smoothed if necessary, and wrapped in aluminium foil and placed in a freezer bag. The freezer bag is sealed as airtight as possible. The skin is frozen at −20° C. to −30° C. in the freezer on a flat surface. For further use, the samples shall be stored in the freezer for at least 24 hours. The maximum storage period is 6 months. A documentation of the storage period must be provided.
[0170] Before use in the experiments, the skin pieces must be hydrated. For hydration, a beaker with acceptor medium is tempered to 32° C. The skin pieces are then placed in the beaker and completely covered by the acceptor medium.
Decontamination Experiments
[0171] Skin samples were contaminated with 2 to 6 nm CdSe quantum dot particles, which are particularly difficult to remove due to their small size and are therefore representative for a good decontamination efficacy also for nanoparticles of larger size. Due to their fluorescence the quantum dot particles are quantitatively well detectable. After an exposure time of 30 seconds after contamination appropriate countermeasures were taken. These were thorough rubbing with the composition of the invention and subsequent washing with cold water. All pieces of skin were examined in a fluorescence spectrometer.
Example 3
Screening of Effective Amounts of the Composition Ingredients
[0172] Porcine skin pieces were contaminated with nanoparticles and treated different decontamination compositions as described in example 2. The results are shown in table 1.
TABLE-US-00001 TABLE 1 Efficiency of different decontamination compositions Decontamination Efficiency, % Ingredient 1 wt % Ingredient 2 wt % 69.0 PEG 100 None 75.4 PEG 43 Water 57 37.8 Polypropylene 100 None glycol 96.8 Water 65 Activated carbon 35 78.9 Water 60 Pumice stone flour 40 81.5 Water 83 Kaolin 17 27.1 Water 78 Bentonite 22 33.2 Water 90 Hyaluronic acid 10 36.6 Water 50 Polyethylene imine 50 61.7 Water 94 Polyvinyl alcohol 6 54.2 Water 50 Polyvinyl 50 pyrrolidone 82.5 Water 50 Polyacrylic acid 50 4.3 PEG 99 Activated carbon 1 14.2 PEG 95 Activated carbon 5 68.6 PEG 90 Activated carbon 10 97.3 PEG 80 Activated carbon 20 97.7 PEG 70 Activated carbon 30 72.5 PEG 99 Bentonite 1 81.7 PEG 90 Bentonite 10 89.0 PEG 80 Bentonite 20 90.6 PEG 70 Bentonite 30 78.7 PEG 60 Bentonite 40 blank PEG 50 Bentonite 50 80.3 PEG 99 Kaolin 1 79.1 PEG 90 Kaolin 10 84.5 PEG 80 Kaolin 20 60.2 PEG 70 Kaolin 30 40.1 Water 70 Talc 30 47.1 Water 70 Montmorillonite 30 41.5 Water 70 Illite 30
[0173] The results in table 1 show that mixtures of PEG, a water-soluble polymer, with phyllosilicates, such as bentonite or kaolin, and activated carbon are generally more efficient in the decontamination of nanoparticles from skin.
Example 4
Optimization of the Decontamination Composition
[0174] Based on the results achieved in example 3, the decontamination compositions were further optimized in regard to the specific ingredients and their amounts contained in the compositions. Efficacy tests were performed in triplicates as described in example 2. Compositions were prepared as described in example 1. The results are shown in table 2.
TABLE-US-00002 TABLE 2 Efficiency of the optimized decontamination compositions Decontamination Efficiency, % Ingredient 1 wt % Ingredient 2 wt % Ingredient 3 wt % Ingredient 4 wt % Ingredient 5 wt % 95.5 PEG 31 Water 42 Activated 9 Kaolin 9 Bentonite 9 carbon 98.5 PEG 31 Water 42 Activated 9 Kaolin 9 Bentonite 9 carbon 97.2 PEG 31 Water 42 Activated 9 Kaolin 9 Bentonite 9 carbon 97.9 PEG 31 Water 42 Graphite .sup.1 9 Kaolin 9 Bentonite 9 96.5 PEG 31 Water 42 Graphite .sup.1 9 Kaolin 9 Bentonite 9 98.1 PEG 31 Water 42 Graphite .sup.1 9 Kaolin 9 Bentonite 9 98.3 PEG 31 Water 42 Graphite .sup.2 9 Kaolin 9 Bentonite 9 92.3 PEG 31 Water 42 Graphite .sup.2 9 Kaolin 9 Bentonite 9 88.4 PEG 31 Water 42 Graphite .sup.2 9 Kaolin 9 Bentonite 9 100 PEG 31 Water 42 Activated 9 Kaolin 9 Bentonite 9 carbon .sup.3 98.8 PEG 31 Water 42 Activated 9 Kaolin 9 Bentonite 9 carbon .sup.3 100 PEG 31 Water 42 Activated 9 Kaolin 9 Bentonite 9 carbon .sup.3 99.9 PEG 31 Water 42 Activated 9 Kaolin 9 Bentonite 9 carbon .sup.4 100 PEG 31 Water 42 Activated 9 Kaolin 9 Bentonite 9 carbon .sup.4 100 PEG 31 Water 42 Activated 9 Kaolin 9 Bentonite 9 carbon .sup.4 98.5 PEG 31 Water 42 Activated 9 Kaolin 9 Bentonite 9 carbon .sup.3 99.7 PEG 31 Water 42 Activated 9 Kaolin 9 Bentonite 9 carbon .sup.3 98.9 PEG 31 Water 42 Activated 9 Kaolin 9 Bentonite 9 carbon .sup.3 98.3 PEG 31 Water 42 Activated 9 Kaolin 9 Bentonite 9 carbon .sup.3 96.6 PEG 31 Water 42 Activated 9 Kaolin 9 Bentonite 9 carbon .sup.3 95.7 PEG 31 Water 42 Activated 9 Kaolin 9 Bentonite 9 carbon .sup.3 99.1 PEG 44.6 Water 17.8 Activated 12.5 Kaolin 12.5 Bentonite 12.5 carbon 87.3 Dextran 31 Water 42 Activated 9 Kaolin 9 Bentonite 9 carbon .sup.1 Graphite Aldrich <20 μm, .sup.2 Graphite Alfa Aesar 200 mesh, .sup.3 Activated carbon Norit SX Super E153 8033.8; .sup.4 Norit SX Super E153 8017.7
[0175] The results in table 2 show that compositions comprising 31% per weight PEG, 42% per weight water, 9% per weight activated carbon or graphite, 9% per weight kaolin and 9% per weight bentonite are highly effective showing decontamination rates of 88.4% up to 100%.
Example 5
Decontamination of Skin from Microplastic Particles
[0176] The invention was also tested for the decontamination of microplastic particles. For this, polystyrene microplastic particles with a diameter of 3 μm or 20 μm (purchased from polysciences.com) were labelled with nile red to enable the detection via fluorescence. (Erni-Cassola, G. et al., Lost, but found with Nile red; a novel method to detect and quantify small microplastics (20 μm-1 mm) in environmental samples. Environ. Sci. Technol., Publication Date (Web): 7 Nov. 2017, 27 pages, doi:10.1021/acs.est.7b04512) The decontamination experiments were conducted as described in example 2. The decontamination efficiency by the invention was 100%.
Example 5
Decontamination of Skin from Hazardous Hydrophobic Agents
[0177] Porcine skin was prepared as described in example 2.
[0178] The PAHs Fluorene and Benz[a]Pyren were tested as representative compounds of this class of chemicals. Stock solutions were prepared as follows:
[0179] Fluoren: 2.2 mg/mL in chloroform
[0180] Benz[a]Pyren 3.3mg/mL in chloroform
[0181] 10 μL of each solution were applied on the skin. Decontamination measures started 30 s after exposure. Results are shown in Table 3.
[0182] Decontamination efficiency was measured by immersing the samples into ethanol and subsequent analysis with a gas chromatograph. Chem. Warfare agents: for safety of the tests, harmless simulant agents were used which closely match physicochemical properties. Criteria for similarity are vapor pressure since it influences ad/desorption as well as diffusion. For decontamination another relevant parameter is the Octanol/Water and Octanol air partition coefficient K.sub.OW and K.sub.OA (see Bartelt-Hunt, S. L. et al., A Review of Chemical Warfare Agent Simulants for the Study of Environmental Behavior. Critical Reviews in Environmental Science and Technology, 38:2, 112-136)
[0183] Stock solutions of the simulant agents in ethanol comprising 10 mg/mL of a compound selected from malathion, methyl salicylate, triethylphosphate, dimethyl methylphosphonate and diethyl methylphosphonate were prepared. 10 μL were placed on the pig skin model. After 30s the respective decontamination measure was started. Results are shown in Table 3.
TABLE-US-00003 TABLE 3 Efficiency of the cleaning of PAH and chemical warfare agents Tested chemical Cleaning efficiency Benz[a]Pyrene 98.5% Fluorene 96.1% Malathion >99.9% Dimethyl methylphosphonate 99.9% Diethyl methylphosphonate 99.7% Triethylphosphate 99.6% Methyl Salicylate 99.7%
Example 7
Comparison of Decontamination Efficiency with Commercial Products
[0184] Porcine skin was prepared as described in example 2. A composition of the invention comprising 31% per weight PEG, 42% per weight water, 9% per weight activated carbon or graphite, 9% per weight kaolin and 9% per weight bentonite was prepared as described in example 1. Decontamination experiments were performed as described in example 2.
[0185] The measurements show that washing with water removes only 5.2% of the particles from the skin, treatment with water and soap removes 75% of the particles. The composition of the invention was able to remove 99.1% of the particles from the skin, and thus, was more efficient than soap and water, but was also more efficient than other special products used for decontamination of the skin (Decontafix and MediDecon), which were able to remove 72.5% and 87.2% of the particles from the skin. These results are shown in
[0186] Conventional cleansing products such as soap and water, cause the skin pores to dilate and are thus unsuitable. After a large series of tests with various water-soluble plastics, polyethylene glycol showed the best decontamination ability. Since the decontamination capability alone was not sufficient, other ingredients were tested that further improved the decontamination performance. An important criterion was the compatibility of the components with each other in order to produce the composition of the invention in a functional way. Kaolin and bentonite (phyllosilicates or clay minerals), which primarily bind and immobilize charged nanoparticles in order to prevent them from skin penetration, were well suited for this purpose. In addition, the composition contains activated carbon, which has a very large surface area for non-specific binding of nanoparticles.
[0187] In addition, time-dependent decontamination tests after 30 s, 1 min, 2 min and 10 min were performed with the decontamination composition of the invention vs. a detergent (dish soap).
[0188] The results show that the detergent is less suitable for decontamination and decreases sharply in efficiency from 2 minutes, while the composition of the invention constantly remains high decontamination efficiency (
Example 8
Indicator Function of the Decontamination Composition
[0189] Activated carbon or graphite gives the composition a black color, which is an indicator of whether there is still composition with removed nanoparticles on the skin (see
[0190] After the skin has come into contact with nanoparticles, a sponge comprising the decontamination composition of the invention was used and the contaminated area of the skin was rubbed therewith, as shown in
Example 9
Decontamination Kit
[0191] An example of a decontamination kit of the invention comprises a sponge-like applicator impregnated with a decontamination composition of the invention in the form of a gel (see
[0192] A further example of a decontamination kit of the invention comprises a tube applicator comprising a spongue for application of the decontamination composition of the invention in the form of a paste (see