WO2010134942A1

WO2010134942A1 - Electrostatically charged multi-acting nasal application, product and method

Info

Publication number: WO2010134942A1
Application number: PCT/US2009/069689
Authority: WO
Inventors: Ashok L. Wahi
Original assignee: Trutek Corp.
Priority date: 2009-05-16
Filing date: 2009-12-29
Publication date: 2010-11-25
Also published as: JP2012526857A; CN102438601A

Abstract

A product to reduce and method of reducing the risk of inhalation of harmful substances by applying a formulation composition to a substrate or the skin in close proximity of one or more nostrils. This formulation, when applied creates an electrostatic field having a charge. The electrostatic field attracts airborne particulates of opposite charge to the substrate that are in close proximity to the substrate close to the skin and a biocidic agent renders microorganisms coming in contact the substrate or skin less harmful.

Description

TITLE OF INVENTION

ELECTROSTATICALLY CHARGED MULTI-ACTING NASAL APPLICATION,

PRODUCT AND METHOD

CROSS REFERENCE TO RELATED APPLICATIONS a) The Present Application claims the benefit of and priority to my pending US Non-Provisional Patent Application Serial No. 12/467,271 filed on May 16, 2009 which is incorporated by reference in its entirety herein. b) The Present Application claims the benefit of and priority to my pending International Application No. PCT/US09/44755 filed on May 20, 2009 which is incorporated by reference in its entirety herein. FIELD OF THE INVENTION

The Present Invention relates to the field of protective compositions against assault by various irritants and noxious substances as well as against assault by assorted microorganisms that typically gain entry into the body through the airway and/or nasal mucosa. The Present Invention also relates to anti-viral, anti-bacterial, and anti-microbal products and methods that involve the use of products heretofore developed for restricting the flow of airborne contaminants into the nasal passages by creating an electrostatic field in an area near about the nasal passages. This reduced the inflow of airborne contaminants to the nasal passages by capturing the contaminants and keeping them from entering the body. In the present invention, these electrostatically charged nasal application products capture and hold the contaminants including viruses, bacteria, and other harmful microorganisms or toxic particulates, inactivate them dermally outside the body and render them harmless . BACKGROUND OF THE INVENTION

The nasal passages and nasal mucosa serve as body entry points for a wide variety of noxious and toxic substances . The body's immune system responds with certain relatively harmless irritants to the nasal passages and airways with reflex responses such as coughing and sneezing. This merely reintroduces the irritants into the environment. However, when the irritant comprises microorganisms, especially those that reproduce within the body and that are transmitted by coughing and sneezing, others may become infected. When a person feels a cough or a sneeze coming on, he merely covers his nose and mouth. However, if that person is contagious, this action does little to prevent others from also becoming infected. Furthermore, the use of a tissue or handkerchief for this purpose is extremely inefficient. This limits the protection of an individual from becoming infected or infecting others.

Other means of dealing with preventing inhalation of harmful or irritating substances or of infections agents include wearing facemasks to filter out these irritants. An example of this is the simple dust mask, typically found in the hardware store or medical supply store. However, even these are inadequate and inefficient. In many localities, during flu season, one can see a large number of people wearing these dust masks in public places. The dust masks are now known to be ineffective. Another example of this preventative method is the gas mask, which is more efficient than the dust mask. Yet, even gas masks are not highly efficient with respect to microscopic and sub-microscopic microorganisms. Furthermore, they are extremely cumbersome and cannot generally be used during normal day-to-day activities . Patents such as US 6,844,005 describe electrostatically charged compositions that may be applied externally in the vicinity of the nostril and attract oppositely charged materials that would otherwise be inhaled. However those compositions simply create an electrostatic field that helps to filter out oppositely charged materials. While this action may offer suitable protection against particles that are inhaled passively, they suffer from the fact that they cannot completely deal with particulates that have their own internal means of overcoming the electrostatic forces, such as microorganisms that are motile within the air stream. Furthermore, actions by the person having those electrostatic compositions in the vicinity of the nostrils can sufficiently displace the offending particles or organisms, especially in such instances as blowing or wiping the nose, so that particles that were held captive by the former compositions could become dislodged, again set free, and be inhaled. OBJECTS OF THE INVENTION

It is therefore an object of the invention to provide a composition that can be readily applied to the exterior region around the nostril and/or slightly inside the edge of the nostril or near the vicinity of the source of release with method and compositions capable of capturing particulates and microorganisms . It is another object of the invention to have the capability to hold it for a duration from being dislodged into the air stream again.

It is a further object of the invention to provide a composition that can be applied near the vicinity of the source of release or to the area around the exterior of and/or slightly inside the edge of the nostril that will inactivate, kill, or render harmless a microorganism, which has been captured and held by the composition.

It is yet another object of the invention to provide a composition that can be applied to a filter substrate for improving the substrates ability to trap and hold particulates and microorganisms and to simultaneously inactivate, kill, or render harmless the microorganisms so trapped. Such filter substrate could be placed in the close proximity of the skin near the path of inhalation, near the source of release of such particulates while the inhaler is at a distance or both.

It is still another object of the invention to provide a method of prophylactically preventing or of substantially reducing the risk of infection by an infectious agent without the utilization of ingested antiviral and/or antibacterial agents .

Yet other objects of the invention will be apparent to those of ordinary skill once having benefit of the instant disclosure. In all of the foregoing objects, the deficiencies of the previously mentioned prior art are overcome by the teachings of this invention. SUMMARY OF THE INVENTION

These and other objects of the invention are unexpectedly achieved by an electrostatically charged composition having at least one polymeric quaternary compound in an aqueous or nonaqueous based formulation, which when applied to a surface, creates an electrostatic field such that oppositely charged airborne particulates (including microorganisms) in the vicinity of the surface are electrostatically trapped, held thereto and one or more of the microorganisms so captured is neutralized, killed, inactivated, and rendered harmless. DETAILED DESCRIPTION OF THE INVENTION

The present invention relates to anti-microorganism, anti-viral/antibacterial products and methods that involve the use of products that restrict the flow of airborne contaminants into the nasal passages by creating an electrostatic field in an area near about the nasal passages. Additionally, in the present invention, these electrostatically charged nasal application products are used to hold the contaminants including microorganisms, viruses, bacteria, and other harmful or toxic particulate outside the body and render them harmless .

Emergences of Anthrax lead to the concept of avoidance of inhaling airborne microscopic and sub-microscopic contaminants. It is the intention of the Present Invention to filter and render harmless materials such as anthrax spores, human corona virus, smallpox virus, influenza virus, avian influenza virus, swine influenza virus, rhino virus, and other biological or chemical elements/toxins/irritants, and the like, prior to their entering the nasal passages. Airborne microorganisms are a major cause of respiratory ailments in humans, causing allergies, asthma, and pathogenic infections of the respiratory tract. Airborne fungal spores are also important agents that spread diseases. Respiratory diseases cause many fatalities and are a cause of great concern. During a sneeze, millions of tiny droplets of water and mucus are expelled at a high velocity. The droplets contain viral particles and/or bacteria. This is a means of transmission of several diseases by inhaled airborne particles as follows:

Diseases caused by environmental particulates include, but are not limited to the following:

ENVIRONMENTAL PARTICULATE DISEASES SOURCE

Psittacosis (Chlamydia psittaci) Dried, powdery droppings from infected birds (parrots, pigeons, etc.)

Legionnaire's disease (Legionella Droplets from air-conditioning pneumophila) systems, water storage tanks, etc., where the bacterium grows.

Acute allergic alveolitis (various Fungal or actinomycete spores from fungal and actinomycete spores) decomposing organic matter (composts, grain stores, hay, etc.)

Aspergillosis (Aspergillus fumigatus, Fungal spores inhaled from A. flavus, A nigeή decomposing organic matter.

Histoplasmosis (Histoplasma Spores of the fungus, in old, capsulatum) weathered bat or bird droppings.

Coccidioidomycosis (Coccidioides Spores in air-blown dust in desert immitis) regions (Central, South and North America) where the fungus grows in the soil. To accomplish the present invention, a formulation having at least one polyquaternary ammonium compound is prepared, such compounds, alone or together capable of creating an electrostatic field on and around a surface to which it is applied, including surfaces such as skin, textile (woven and non- woven) , and hard surfaces, such as floors, walls, wood, metal, plastic, glass, etc.

The formulation is generally aqueous based, but may include non-aqueous solvents used which are compatible with the other formulation components and the application surface to which it is applied. Preferably, the formulation is an aqueous formulation. In addition to the polyquaternary ammonium compound (hereinafter to be also referred to as a quaternary thickener or a polymeric quaternary ammonium compound), the composition includes at least a biocidic agent. Furthermore, the composition may contain, but is not required to contain various thickeners, gellants, fragrances, colorants, emollients, humectants, and generally other suitable components that are compatible with the end use application and the other components of the formulations. Thus, a composition of the invention that is intended to be applied to a filter substrate that is perhaps used as a mask with an additional liner between a user and the filter substrate may utilize materials that would not be compatible with direct contact with skin, although it is preferable that all of the components are compatible with direct application to the skin as a means of limiting reaction due to inadvertent contact between the composition and the skin.

A formulation of the invention comprises : • water,

• at least one quaternary thickener,

• a preservative,

• a conditioner,

• an emulsifier, • a biocidic agent, and • a neutralizing agent (hereinafter to be also referred to as a pH adjuster.) added to adjust and achieve a pH in the range of 5.0 to 6.8.

It may further comprise without limitation a combination of the following:

• a surfactant,

• a thickener,

• an emollient,

• a humectant, and * SL binder.

In an exemplary embodiment of such a formulation, a guaternary thickener may comprise without limitation, at least one of the following:

• Polyquaternium-10 • Polyquaternium-22

• Polyquaternium-67

• Polyquaternium-70

• Polyquaternium-72

• Polyquaternium-88 • Cocodimonium Hydroxypropyl Hydrolyzed Keratin

• Hydroxypropyltrimonium Wheat Protein

The amount of the quaternary thickener is preferably 0.5 - 30 wt%, more preferably 7 - 20 wt%.

Benzalkonium Chloride may also serve the same function, but it is also a cationic agent as well as a biocide. Other biocides that may be used are Lysine HCL and hydrogen peroxide.

The total amount of the biocidic agent in the composition is preferably 0.25 - 10 wt%, more preferably 0.25 - 6 wt%, most preferably 1 - 5 wt%. In an exemplary embodiment of such a formulation, an emulsifier may comprise without limitation, at least one of the following:

• Cetyl Alcohol (which can also serve as a thickener)

• Cetearyl Alcohol • Glyceryl Stearate • Ceteareth-20

• PEG-40 Stearate

• Dicetyl Phosphate

• Ceteth-10 Phosphate The amount of the emulsifier is preferably 0.3 - 5 wt%, more preferably 0.5 - 4 wt%. Within this range, good aqueous gel for use can be obtained.

In an exemplary embodiment of such a formulation, the emollient may be Isocetyl Behenate without limitation. The thickener may be Cetyl Alcohol or Stearyl Alcohol without limitation.

In an exemplary embodiment of such a formulation, a preservative may comprise without limitation, at least one of the following: • Phenoxyethanol;

• Methylparaben;

• Butylparaben;

• Ethylparaben;

• Propylparaben; • Isobutylparaben.

In the composition of the present invention, water is a solvent and has a function as a moisturizer. The amount of water in the composition is preferably 30 - 90 wt%, more preferably 35 - 75 wt%. Examples of typical formulations found to be effective appear in the tables that follow. Percentages are given by weight .

TABLE 1

TABLE 2

TABLE 3

TABLE 4

TABLE 5

TABLE 6

TABLE 7

TABLE 8

TABLE 9

TABLE 10

TABLE 11

For example, the formulation of Table 11 includes 8 kinds of cationic polymers in predetermined amounts. However, any one or more of the 8 kinds only need to be contained, and addition of all the 8 kinds is not always essential.

All of the formulations described in Table 1-11 representing various embodiments of the Present Invention operate in the manner that was disclosed herein. The same results may be achieved by varying the percentages for the active and inactive ingredients . Varying the percentages for the active ingredients affects the potency of the formulation. Varying the percentages for the inactive ingredients affects the consistency of the formulation. The desired results may be achieved by varying the ingredients and their amounts by those skilled in the art without undue experimentation. [Method of using antiviral preparation]

The antiviral preparation of the present invention (hereinafter to be also referred to as antiviral composition) can be used for various embodiments as exemplified below. For example, it can be used in the form of ointment, cream, gel, paste-like agent, powder agent, lotion, spray, embrocation, adhesive skin patch, patch preparation, aerosol agent, foundation, liquid, emulsion or suspension. Specifically, it is (1) directly applied to the skin near the nostril with a finger, swab and the like (2) used in the form of a mask containing a filter substrate applied with the preparation or (3) applied to the room wall, floor, ceiling and the like. The formulation of the antiviral composition can be appropriately adjusted according to the object of use. For direct application to the skin, for example, the water concentration of the composition is set higher, and the concentration of a biocidic agent and the like is set lower, in consideration of the skin irritation and the like. On the other hand, for use as a mask and the like, since a direct contact with the skin is less often, the biocidic agent concentration is preferably set rather high and the water concentration after treatment is preferably set low, so that the air can permeate through the filter substrate applied with the composition. When contact with human is absent such as room wall and the like, the viscosity of the coating composition may be controlled and the amount of the efficacy component such as a biocidic agent and the like in the applied composition may be set high, so that an efficient coating can be performed using a spray and the like. Examples

The present invention is explained in detail in the following by referring to Examples 1 - 3 as specific examples of the formulation of Table 11, which are not to be construed as limitative. [Production Example] The composition of the Production Example of the present invention can be produced by a conventional method including sequential and in-sequential heating and cooling processes, between 35°C - 85°C, successively adding each component to water, and dissolving and dispersing the component. The prepared aqueous gel composition has pH 5.0 -

6.8 at 30⁰C and then appropriately cooling it down to room temperature to be stored in suitable containers .

Table 12 shows ingredient composition of the antivirus agents of Example 1 (composition Sl) , Example 2 (composition S2) and Example 3 (composition S3) .

TABLE 12

*1 . Total amount of water in aqueous hydrogen peroxide and water *²: Total amount of Polyquaterniums, Cocodimonium Hydroxypropyl Hydrolyzed Keratin and Hydroxypropyltrimonium Wheat Protein *³: Total of lysine HCL, benzalkonium chloride and hydrogen peroxide

^*4: Explanation of ingredients Phenonip® (trade name, manufactured by Clariant UK Ltd., blend of paraben esters in phenoxyethanol, contains methylparaben, ethylparaben, butylparaben, propylparaben, isobutylparaben as paraben esters) ; (glyceryl acetate/acrylic acid) copolymer (LUBRAJEL PF (trade name), manufactured by United Guardian Inc.); Polyquaternium-10 (UCARE Polymer JR 400 (trade name) , manufactured by Amerchol Corporation) ; Polyquaternium-67 (SoftCat Polymer SX1300H (trade name) , manufactured by Amerchol Corporation) ; Polyquaternium-72 (MIRUSTYLE CP (trade name), manufactured by Croda Inc.); Cocodimonium Hydroxypropyl Hydrolyzed Keratin (Croquat WKP (trade name) , manufactured by Croda Inc.); Cetrimonium Chloride (MicroCare Quat CTC 30 (trade name), manufactured by Thor Sari Inc.); Polyquaternium- 88 (Colaquat PDQ (trade name) , manufactured by Colonial

Chemical Inc.); Polyquaternium-22 (Merquat 280 (trade name), manufactured by Nalco Company) ; emulsifier (Lipomulse Luxe (trade name), manufactured by Lipo Chemicals Inc., Lipomulse Luxe is a blend of Cetearyl Alcohol, Glyceryl Stearate, PEG-40 Stearate and Ceteareth-20) ; polybutene (INDOPOL H 100 (trade name), INDOPOL H 1500 (trade name), manufactured by INEOS Oligomers) . [Evaluation of antivirus property]

The compositions of the Examples of the present invention mentioned above were evaluated for the antivirus property. Test I. Evaluation of antivirus effect of compositions of Examples 1 - 3 against influenza virus

(a) Test Virus

Swine influenza virus (A/Osaka) and influenza virus (A/New Caledonia) having HlNl chain were used.

MDCK cells were infected with the virus and cultured in Dulbecco's modified Eagle medium (DMEM, NISSUI PHARMACEUTICAL CO., LTD.) supplemented with 2.5 μg/mL purified trypsin for 3 days at 34°C. The culture medium was centrifuged at 1500 g for 10 min. The cells were recovered and stored at -80⁰C. The titer of the virus was measured by the indirect immunofluorescent technique using MDCK cells and shown in cell-infecting unit (CIU) /mL.

(b) Test Samples Composition (Sl) of Example 1, Composition (S3) of Example 3, and control (Cl)

(control: α2, 6-sialyllactosamine polymer (6'-SLN) 20 mg/mL)

(c) Test Methods

(1) MDCK cells were spread on a 96 well plate, and cultured overnight to form one layer of cells on the bottom of the well.

(2) The above-mentioned Test samples (Sl, S3, Cl) were dissolved in phosphate-buffered saline (PBS) solution at a concentration of 1 mg/mL.

(3) Two kinds of virus solutions of swine influenza virus (A/Osaka) and influenza virus (A/New Caledonia) were prepared to 4.OxIO⁵ CIU/mL, 50 μL each thereof was mixed with test samples, and reacted at 25°C for 0.5 hr.

(4) Cell culture medium was removed from each well by suction, each reaction mixture of the test sample and the virus was added onto the cell layer of two wells by 50 μL, and allowed to adsorb thereonto at 37°C for 0.5 hr in a 5% CO₂ incubator.

(5) DMEM culture medium (150 μL) was added to each well, and the mixture was further cultured for 12 hr in a 5% CO₂ incubator at 37°C. (6) The culture medium was removed from each well by suction, and the cells were fixed with 1% para-formaldehyde PBS solution for 1 hr.

(7) The cells were further treated with 1% Triton X-100 for 15 min and washed with PBS solution. (8) The infected cells were stained by the immunofluorescence antibody method, and positive cells were counted with a fluorescence microscope. The antibody used for staining each cell infected with the virus was the same as the one used for the virus titer measurement. (d) Test results

Example 1 (composition Sl), Example 3 (composition S3), and control (Cl) were tested to determine the range of dilution rate at which a virus inhibitory effect is observed.

The results are shown in Table 13. Control (Cl) did not show a virus inhibitory effect. TABLE 13

Dilution rate showing virus inhibitory effect of nearly 100%

(Numerical values in Table 13 are dilution rate 1/n where greater n shows higher virus inhibitory effect.) (e) Test I summary

Table 13 reveals that composition Sl of Example 1 and composition S3 of Example 3 of the present invention have a superior antivirus property against swine influenza virus (A/Osaka) and Influenza virus (A/New Caledonia) . Test II. Evaluation of virucidal efficacy against human rhinovirus on artificial skin

Examples 1 - 3 (compositions Sl, S2, S3) were evaluated for the virucidal efficacy against human rhinovirus on artificial skin. (a) Test Virus

Human rhinovirus was used. The virus was grown and titrated in MRC-5 cells. Stock viruses were stored in 1 inL aliquots at -80⁰C. On the day of use, an aliquot was removed, thawed, and placed on ice until used in the experiment. (b) Cell cultures

MRC-5 cell line, which exhibits cytopathic effect (CPE) upon infection with human rhinovirus, was used as the indicator cell line in infectivity assays. The cells were maintained and used as monolayers in disposable tissue culture flasks and 96-well micro titer plates as needed. On the day of testing the cells were observed to have proper cell integrity and were suitable for virus titrations . The cells were grown at 37°C.

(c) Cell culture medium The cells were grown in Eagle's minimum essential medium containing penicillin 150 IU/mL, streptomycin 150 μg/mL, neomycin 50 μg/mL, ciprofloxacin 10 μg/mL and fungizone 1.5 μg/mL.

(d) Test Methods

(dl) Preparation of test substance The test compositions Sl, S2 and S3 had a gel-like consistency on visual examination and were used without dilution. (d2) Preparation of skin substrate

The VITRO-SKIN™ was hydrated prior to use by aseptically placing it in a humidified atmosphere of 87% relative humidity for 16-18 hours. On the day of use, several pieces of approximately 1 cm² were aseptically cut from the VITRO-SKIN™ sheet and six pieces of skin were placed in a sterile 6-well plate using one piece per well. (d3) Procedure

The re-hydrated pieces of skin were transferred to a 6- well plate using one piece per well. To each of the first 5 pieces (numbered 1 to 5) , 20 μL of the composition was applied on the coarse surface. The composition was smeared on skin piece evenly with fingertip. The 6^th skin piece (No. 6) was used as a positive control (virus only; no composition) . 20 μL of rhinovirus was applied to each of the 6 pieces. The applied virus was spread with the help of a bacteriological loop. After various time intervals (Table 14), the virus was eluted from skin pieces using 3% Beef extract-0.05M Glycine buffer, pH 7.2 (using 0.9 mL of buffer per piece). Serial 10-fold dilutions of the eluate were made immediately and inoculated in cell monolayers established in 96-well micro titer plates

(0.1 mL per well) using four wells per dilution. Uninfected cell controls were inoculated with test medium alone. The inoculated cells were incubated at 32°C in a humid atmosphere containing 5% CO₂. The cells were examined daily under a light microscope for the appearance of CPE. After six days of incubation, final CPE readings were taken and virus titers calculated by the Karber method. The results are shown in Table 14. (d4) Virus Control

Piece number 6 served as virus control in which virus was applied but no composition. This was used to determine the input titer of the virus . (e) Results

TABLE 14

Effect of test compositions Sl, S2 and S3 against human rhinovirus

The results are an average of 3 experiments

1. After a contact (exposure) time of 15 minutes, the compositions S2 and S3 demonstrated a virucidal efficacy against human rhinovirus over 98%.

2. After a contact (exposure) time of 30 minutes, the compositions S2 and S3 demonstrated a virucidal efficacy against human rhinovirus over 99%.

Test III. Evaluation of virucidal efficacy against swine influenza virus (SIV) and avian influenza virus (AIV) on artificial skin

Example 2 (composition S2) and Example 3 (composition S3) were evaluated for the virucidal efficacy against swine influenza virus (SIV) and avian influenza virus (AIV) ) on the artificial skin, (a) Test Virus

HlNl subtype of swine influenza virus (SIV) and H7N2 subtype of avian influenza virus (AIV) were used. The virus was grown and titrated in MDCK cells. Stock viruses were stored in 1 iαL aliquots at -80 ⁰C. On the day of use, an aliquot was removed, thawed, and placed on ice until used in the experiment . (b) Cell cultures

MDCK (Madin-Darby canine kidney) cell line, which exhibits cytopathic effects (CPE) upon infection with SIV and AIV, was used as the indicator cell line in infectivity assays . The cells were maintained and used as monolayers in disposable tissue culture flasks and 9β-well micro titer plates as needed. On the day of testing the cells were observed to have proper cell integrity and were suitable for virus titrations.

(c) Cell culture medium The cells were grown in Eagle's minimum essential medium containing penicillin 150 IU/mL streptomycin 150 μg/mL, neomycin 50μg/mL, ciprofloxacin lOμg/mL and fungizone 1.5 μg/mL.

(d) Test Methods (dl) Preparation of test substance

The test compositions S2 and S3 had a gel-like consistency on visual examination and were used without dilution. (d2) Preparation of skin substrate The VITRO-SKIN™ was hydrated prior to use by aseptically placing it in a humidified atmosphere of 87% relative humidity for 16-18 hours. On the day of use, several pieces of approximately 1 cm² were aseptically cut from the VITRO-SKIN™ sheet and six pieces of skin were placed in a sterile 6-well plate using one piece per well. (d3) Procedure

The re-hydrated pieces of skin were transferred to a 6- well plate using one piece per well. To each of the first 5 pieces (numbered 1 to 5) , 20 μL of composition was applied on the coarse surface. The composition was smeared on skin piece evenly with fingertip. The 6^th skin piece (No. 6) was used as a positive control (virus only; no composition) . 20 μL of SIV or AIV was applied to each of the 6 pieces . The applied virus was spread with the help of a bacteriological loop. After various time intervals (Table 15) , the virus was eluted from skin pieces using 3% Beef extract-0.05M Glycine buffer, pH 7.2 (using 0.9 mL of buffer per piece). Serial 10-fold dilutions of the eluate were made immediately and inoculated in cell monolayers established in 96-well micro titer plates (0.1 mL per well) using four wells per dilution. Uninfected cell controls were inoculated with test medium alone. The inoculated cells were incubated at 35-37°C in a humid atmosphere containing 5% CO₂. The cells were examined daily under a light microscope for the appearance of CPE. After 96 hours of incubation, final CPE readings were taken and virus titers calculated by the Karber method. The results are shown in Table 15. (d4) Virus Control

Piece number 6 served as virus control in which virus was applied but no composition. This was used to determine the input titer of the virus . (e) Result

TABLE 15 Effects of the test compositions S2 and S3 against AIV and SIV

The results are an average of 3 experiments (f) Test III Conclusion

1. After a contact (exposure) time of 15 minutes the compositions S2 and S3 of the examples of the present invention demonstrated a virucidal efficacy against HlNl swine influenza (SIV) and H7N2 avian influenza (AIV) viruses over 98%.

2. After a contact (exposure) time of 30 minutes the compositions S2 and S3 demonstrated a virucidal efficacy against HlNl swine influenza (SIV) and H7N2 avian influenza (AIV) viruses over 99%.

As explained in Test I, the antiviral composition of the present invention shows an antivirus property even when diluted 128- to 512-fold, and clearly has extremely effective antivirus property. As explained in Test II and Test III, moreover, when a composition of the antivirus agent of the present invention is applied to the skin, a virus that came into contact with the applied surface can be inactivated and rendered harmless in a short time.

By combining a biocidic agent and a polymeric quaternary compound, the present invention has realized a virucidal effect difficult to achieve by a biocidic agent alone. In other words, the antiviral composition of the present invention provides a remarkable effect by the co-presence of a polymeric quaternary compound and a biocidic agent, in that it can exhibit not only a bacteriocidal function but also an extremely effective virucidal function. INDUSTRIAL APPLICABILITY

The composition of the present invention can be used not only for antibacterial or antivirus use by directly applying to the skin, particularly the skin near nostrils, but also for antibacterial or antivirus use by applying to fiber products and the like, and using the coated fiber products as mask, sanitary goods, diapers, clothes, towels, stockings, gloves, various filters, Airborne Infection Isolation Tent and the like. In addition, the composition can be used by directly coating the walls and floor of a sterile room or sterile box, and further, wall, floor, ceiling, door knob, furniture, appliance and the like for domestic use with the composition.

Claims

CIAIMS

1. A method for electrostatically preventing harmful particulate matter from infecting an individual through nasal inhalation wherein a formulation is applied to skin or tissue of nasal passages of the individual in a thin film, said method comprising: a) electrostatically attracting the particulate matter to the thin film; b) holding the particulate matter in place by adjusting the adhesion of the thin film to permit said thin film to stick to the skin or tissue and by adjusting the cohesion of the formulation to provide adequate impermeability to the thin film; and, c) inactivating the particulate matter by adding at least one ingredient that would render said particulate matter harmless.

2. A method of reducing the risk of inspiration of a harmful particulate substances comprising applying composition to a substrate or skin, wherein said substrate is applied: a) in close proximity, in a range from 0 to 150 mm to a release source of the particulate substances; b) to one or more nostrils; and wherein : c) said skin is in the region of, or in at least one nostril; d) said composition, when applied creates in and around said substrate or said skin an electrostatic field having a charge, such that the electrostatic field attracts jthe particulate substances having an opposite charge to said substrate from air being passed in close proximity to said substrate or through said substrate or close to said skin; and e) said particulate substances are held in place for a duration long enough to render microorganisms contained therein and coming in contact with said skin or said substrate less harmful than microorganisms that are not contained therein.

3. A formulation for electrostatically preventing harmful particulate matter from infecting an individual through nasal s inhalation wherein the formulation is applied to skin or tissue of nasal passages of the individual in a thin film, said formulation comprising: a) a means for holding the particulate matter in place by adjusting the adhesion of the thin film to permit said thino film to stick to the skin or tissue and by adjusting the cohesion of the formulation to provide adequate impermeability to the thin film; and, b) a means for inactivating the particulate matter by adding at least one ingredient that would render said particulates matter harmless.

4. A formulation for electrostatically preventing harmful particulate matter from infecting an individual through nasal inhalation wherein the formulation is applied to skin or0 tissue of nasal passages of the individual in a thin film, said formulation comprising at least one cationic agent and at least one biocidic agent, and wherein said formulation, once applied: a) electrostatically attracts the particulate matter to the5 thin film; b) holds the particulate matter in place by adjusting the adhesion of the thin film to permit said thin film to stick to the skin or tissue and by adjusting the cohesion of the formulation to provide adequate impermeability to the thin0 film; and, c) inactivates the particulate matter and renders said particulate matter harmless .

5. The formulation of claim 4 wherein the at least one 5 cationic agent is a polymeric quaternary ammonium compound.

6. The formulation of claim 5 wherein the at least one polymeric quaternary ammonium compound is taken from the group consisting of:

^• Polyquaternium-10,

• Polyquaternium-22,

^• Polyquaternium-67,

• Polyquaternium-70, • Polyquaternium-72, and

^• Polyquaternium-88.

7. The formulation of claim 4 wherein the at least one cationic agent is Cocodimonium Hydroxypropyl Hydrolyzed Keratin or Hydroxypropyltrimonium Wheat Protein.

8. The formulation of claim 4 wherein the at least one cationic agent is Benzalkonium Chloride.

9. The formulation of claim 4 wherein the at least one biocidic agent is Benzalkonium Chloride or Lysine HCL.

10. A formulation for electrostatically preventing harmful particulate matter from infecting an individual through nasal inhalation wherein the formulation is applied to skin or tissue of nasal passages of the individual in a thin film, said formulation comprising: a) at least one biocidic agent, and b) at least one quaternary thickener.

11. The formulation of claim 10 wherein the at least one biocidic agent is Benzalkonium Chloride or Lysine HCL.

12. The formulation of claim 10 wherein the at least one quaternary thickener is taken from the group consisting of: • Polyquaternium-10,

• Polyquaterniuin-22,

• Polyquaternium-67,

• Polyquaternium-70,

5 • Polyquaternium-72, and

• Polyquaternium-88.

13. The formulation of claim 10 wherein the at least one quaternary thickener is Cocodimonium Hydroxypropyl Hydrolyzed 0 Keratin or Hydroxypropyltrimonium Wheat Protein.

14. The formulation of claim 10 wherein the at least one quaternary thickener is Benzalkonium Chloride. 5

15. The formulation of claim 10 further comprising: a) water, b) a preservative, c) a conditioner, and d) an emulsifier. 0

16. The formulation of claim 15 further comprising a neutralizing agent added to adjust a pH in the range of 5.0 to 6.8. 5

17. The formulation of claim 15 further comprising a surfactant .

18. The formulation of claim 15 further comprising a thickener.

30 19. The formulation of claim 15 further comprising an emollient .

20. The formulation of claim 15 further comprising a humectant,

35 21. The formulation of claim 15 further comprising a binder.

22. The formulation of claim 15 wherein the preservative is taken from the group consisting of:

• Phenoxyethanol, • Methylparaben,

• Butylparaben,

• Ethylparaben, and

• Isobutylparaben.

23. The formulation of claim 15 wherein the emulsifier is taken from the group consisting of:

• Cetyl Alcohol,

• Cetearyl Alcohol,

• Glyceryl Stearate, • Ceteareth-20,

• PEG-40 Stearate,

• Dicetyl Phosphate,

• Ceteth-10 Phosphate.

24. The formulation of claim 18 wherein the thickener is Cetyl Alcohol or Stearyl Alcohol.

25. The formulation of claim 15 wherein: a) the amount of water ranges from 54% to 90% by weight b) the amount of the quaternary thickener ranges from 0.5% to 5.0% by weight. c) the amount of biocidic agent ranges from 0.25% to 2% by weight . d) the amount of emulsifier ranges from 0.5% to 4% by weight.

26. An antivirus agent composition comprising a cationic agent, a biocidic agent and water.

27. The composition of claim 26, wherein the cationic agent is a polymeric quaternary ammonium compound.

28. The composition of claim 27, wherein the polymeric quaternary ammonium compound is selected from the group consisting of Polyquaternium-10, Polyquaternium-22, 5 Polyquaternium-67, Polyquaternium-70, Polyquaternium-72, Polyquaternium-88, Cocodimonium Hydroxypropyl Hydrolyzed Keratin, Hydroxypropyltrimonium Wheat Protein, and a combination thereof.

io 29. The composition of any one of claims 26 - 28, wherein the biocidic agent is selected from the group consisting of benzalkonium chloride, lysine hydrochloride, hydrogen peroxide, and a combination thereof.

15 30. The composition of any one of claims 26 - 29, further comprising at least 1 kind selected from the group consisting of preservative, neutralizer, skin softener, moisturizing agent, binder, conditioner, and thickener.

20 31. The composition of claim 30, further comprising an emulsifier and in the form of an aqueous gel.

32. The composition of claim 26, wherein a) the amount of water is 30 - 90 wt%,

25 b) the amount of the cationic agent is 0.5 - 30 wt%, and c) the amount of the biocidic agent is 0.25 - 10 wt%.

33. The composition of any one of claims 26 - 32, which is in the form of ointment, cream, gel, paste-like agent, powder

30 agent, lotion, spray, embrocation, adhesive skin patch, patch preparation, aerosol agent, foundation, liquid, emulsion or suspension.

34. The composition of claim 33 for application to the nostril, 35 skin near the nostril or nasal mucous.