# Patent

## Title
Antimicrobial and antiviral composition

## Abstract

A method of reducing the number of microorganisms entering the nose and proliferating in the nasal cavity including application of a solution of an antimicrobial, antiviral and antifungal composition to the anterior vestibular region of the nares. The antimicrobial, antiviral and antifungal solution includes ethyl alcohol as an active ingredient. Various embodiments may also include one or more of the following additional ingredients: orange oil, coconut oil; soy oil; emu oil; grapefruit seed extract; glycine soja; simmondsia chinensis (Jojoba); lauric acid; aloe vera; and a preservative, such as benzalkonium chloride and vitamin E.

## Background
This patent application is a Continuation-In-Part (CIP) of patent application Ser. No. 14/318,972 filed on Jun. 30, 2014, which is a Continuation-In-Part (CIP) of patent application Ser. No. 13/447,912 filed on Apr. 16, 2012, which is a continuation patent application of patent application Ser. No. 12/658,116 filed on Feb. 1, 2010, which is a divisional of patent application Ser. No. 11/906,640 filed on Oct. 3, 2007, now abandoned, which is a Continuation-In-Part (CIP) patent application of patent application Ser. No. 11/189,242 filed on Jul. 26, 2005, now abandoned.


BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to antiseptic compositions and, more particularly, to a nasal antiseptic barrier composition having antimicrobial, antiviral, and antifungal properties.
2. Discussion of the Related Art
In recent years, outbreaks of new and potentially deadly diseases such as Middle East Respiratory Syndrome (MERS) and the Avian and Swine Influenzas have captured worldwide attention and concern. New and unusual strains of the flu virus have also emerged in the last few years and have spread throughout the world population at epidemic levels. It is believed that increases in world population, rapid travel between distance regions and high concentration of individuals in confined areas where there is poor air filtration (e.g. aircraft, trains, buses and tourist sites) have resulted in the increase in the number of, as well as mutation of, pathogenic organisms.
The onset of respiratory disease is primarily a result of inhalation of airborne pathogens through the nose and mouth. However, the oral cavity is better equipped to kill airborne pathogens before they can enter and infect the body. Specifically, saliva in the mouth captures many airborne pathogens before they are inhaled into the lungs. Once the saliva containing the pathogens is swallowed, stomach acids are highly effective in killing these pathogens before they can infect the body. The nasal passages, on the other hand, are less effective in trapping and killing microorganisms. Airborne pathogens inhaled through the nose usually enter the lungs where there can cause respiratory infection or other types of infection once these pathogens enter the blood stream.
Worldwide concern of epidemic outbreaks has lead to more drastic preventative measures including emergency mass production of new vaccines. Individuals have adopted preventive practices such as frequent hand washing and use of antiseptic hand lotions and wipes. While these are good practices to help reduce the possibility of infection, they are not long lasting and are usually only effective to kill germs that were on the hands or other areas of the body prior to cleansing. With little to no residual effect, the hands can become contaminated with pathogens shortly after washing.
Some societies have begun to use face masks as a means of protection against respiratory infections. Face masks are effective to prevent entry of pathogens into the respiratory system. However, the use of face masks is generally impractical, inefficient and socially unappealing.
Besides the concern for the health and well beings of individuals there are economic interests in preventing the spread on communicable diseases. For instance, over the course of just one year Americans suffer approximately 1 billion colds. The economic impact of the common cold is enormous. The National Center for Health Statistics (NCHS) estimates that over 70 million cases of the common cold in the United States required medical attention or resulted in restricted activities. Colds cause more than 50 million days of restricted activity and 25 million days lost from school and the work place. Overall, the estimated cost to the U.S. economy of the common cold and other related illnesses is approximately $150 billion per year.
Accordingly, there is an immediate need for more effective protection measures to decrease the spread of disease, and particularly respiratory infections that result from exposure to airborne pathogens.
SUMMARY OF THE INVENTION
The present invention is directed to an antimicrobial and antifungal barrier composition for topical application to the proximal anterior nares (rim surrounding the nostrils). The composition includes an antiseptic solution in combination with cocos nucifera (coconut oil) and one or more citrus oils such as, for example, citrus sinensis (orange oil). Examples of an antiseptic solution include one or more alcohols, such as ethyl alcohol, or hydrogen peroxide. The composition may include one or more additional ingredients, including: lauric acid; simmondsia chinensis (Jojoba); d-limonene; soy oil; emu oil; grapefruit seed extract; glycine soja; aloe vera and a preservative, such as sodium benzoate, benzalkonium chloride, BHT and vitamin E.
When properly applied to the skin surrounding the nostril openings, the composition has been proven effective in killing 99.99999% (7 log) or greater germs. This extremely efficient antimicrobial efficiency persists for at least 8 hours. Results from laboratory studies have shown efficacy in killing streptococcus (pneumoniae and pyogenes), staphylococcus aureus, mycobacterium smegmatis, and haemophilus influenza bacterias. The antimicrobial and antiviral composition of the present invention was further shown to be effective in eradicating the rhinovirus and influenza A virus (avian flu), as well as the corona virus. The corona virus is known to be the cause of SARS.
In addition to the anti-pathogen properties, the composition of the present invention has also been proven to help alleviate the body's immuno-response to many allergens including, but not limited to, dust mites, pollen, hay fever, animal dander, dust, particulate pollution, ozone, sulfur dioxide, and nitrogen oxide. The composition is effective in trapping these allergens and alleviating the body's response to their presence. In the case of ozone, SO2 and NO, the composition acts as a barrier in the nose and lessens the IGA response in the body. It is also believed that the composition works to lessen the Interleukin expression in the nose, especially ILB, commonly perspective for the inflammation response in the nasal cavity. A particularly effective formulation includes one or more of the following ingredients in combination with citrus oils, cocos nucifera and glycine soja: beeswax; bees milk; and fruit wax.
OBJECTS AND ADVANTAGES OF THE INVENTION
Considering the forgoing, it is a primary object of the present invention to provide an antimicrobial and antiviral composition for topical application to the anterior nostril openings for protecting against harmful exposure to airborne pathogens.
It is a further object of the present invention to provide a safe and highly effective antimicrobial and antiviral composition for topical application to the rim of each nostril to provide protection against a broad spectrum of harmful pathogens for at least 8 hours.
It is still a further object of the present invention to provide an antimicrobial and antiviral composition for topical application to the rim of each nostril to enhance the natural filtration properties of the nose.
It is yet a further object of the present invention to provide an antimicrobial and antiviral composition for topical application to the rim of the nostrils for trapping and killing airborne pathogens before these pathogens can replicate within the nasal cavity.
It is still a further object of the present invention to provide an antimicrobial and antiviral composition that significantly reduces the number of harmful pathogens that proliferate freely within the nasal cavity, thereby minimizing the degree and severity of potential respiratory infection.
It is still a further object of the present invention to provide an antimicrobial and antiviral composition of topical application to the rim of the nostrils, and wherein the composition has a pleasant scent and contributes to the lubrication and filtration of the nasal passages.
It is yet a further object of the present invention to provide an antimicrobial and antiviral composition for topical application to the rim of the nostrils, wherein the composition is effective in trapping allergens and alleviating the body's response to their presence.
These and other objects of the present invention are more readily apparent with reference to the detailed description which follows.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a side elevational view showing an applicator device in the prior art that has a glass ampoule contained within a flexible tube with a porous polyethylene applicator tip;
FIG. 2 is an elevational view of another applicator device in the prior art that includes a lower reservoir, a plunger on the end of a hollow tube and an applicator tip at the opposite end of the hollow tube;
FIG. 3 is an elevational view of yet another type of applicator in the prior art having a hollow stem that is divided into two chambers by an internal breakable membrane and a cotton applicator tip at one end of the stem; and
FIG. 4 is an elevational view of yet another type of applicator in the prior art directed to a flocked swab having a polystyrene handle with a flock applicator tip.



DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
The present invention is directed to a long lasting antimicrobial and antiviral barrier composition for topical application to the proximal anterior nares (skin surface surrounding the opening of the nostrils). The antimicrobial and antiviral composition of the present invention incorporates the use of one or more antiseptic solutions in combination with cocos nucifera (coconut oil), citrus sinensis (orange oil), and simmondsia chinensis (Jojoba). In one preferred embodiment, the antiseptic solution is USP ethyl alcohol. In another preferred embodiment, the antiseptic solution is hydrogen peroxide. Other alcohols and antiseptic agents are contemplated for use in the composition as the antiseptic solution, either alone or as a combination.
The essential ingredients of the composition are present according to the following percentages by weight of the composition:















Amount



Essential Ingredients
(% by Weight of the Composition)









Antiseptic solution
between 50% and 75%










The antimicrobial and antiviral composition of the present invention may further include the following additional ingredients, alone or in combination: lauric acid; simmondsia chinensis; d-limonene; soy oil; emu oil; grapefruit seed extract; glycine soja; and a preservative such as sodium benzoate, benzalkonium chloride, BHT, vitamin E. These additional ingredients of the composition may be present according to the following percentages by weight of the composition:















Amount



Additional Ingredients
(% by Weight of the Composition)









Lauric acid
between 0.05% and 49.90%



Citrus Sinensis
between 0.05% and 49.90%



Simmondsia Chinensis
between 0.1% and 75%



D-limonene
between 0.01% and 5%



Glycine Soja (soy oil)
between 0.1% and 80%



Emu oil
between 0.1% and 10%



Grapefruit Seed extract
between 0.1% and 8%



Aloe Vera
between 0.1% and 30%



Benzalkonium Chloride
between 0.05% and 0.15%



Vitamin E
between 0.1% and 4%



Cocos Nucifera
between 0.025% and 70%










A further embodiment of the composition has been proven to help alleviate the body's immune-response to many allergens and pollutants. The following ingredients have been found to be effective in the composition when present according to the following percentages by weight of the composition:















Amount



Ingredients
(% by Weight of the Composition)









Beeswax
between 0.01% and 30%



Bees Milk
between 0.01% and 30%



Fruit Wax
between 0.1% and 5%










Antiseptic solutions such as ethyl alcohol and hydrogen peroxide typically evaporate at a rapid rate. For this reason, when antiseptic solutions are used alone, they usually have little to no residual effect. The base oils of the composition, namely citrus sinensis, cocos nucifera, and simmondsia chinensis, are effective to trap the antiseptic solution in a pseudo-emulsion antiseptic that remains active for an extended period of time. This allows the composition to have a long lasting antimicrobial and antiviral protection. The base oils also provide antimicrobial, antiviral and antifungal properties.
When the base oils are combined with the antiseptic solution, a synergistic effect is observed. For instance, the efficacy of any one of the base oils or the antiseptic solution, alone, does not exceed 99.99% (4 log). However, when all ingredients are combined in suitable ratios an unexpected removal efficiency rating (efficacy) of 99.99999% (7 log) or greater is achieved. This synergism is a key to the novelty of the composition, providing antimicrobial and antiviral kill levels that are significantly greater than those observed in connection with any of the ingredients individually or other known antimicrobials and antivirals.
The following examples demonstrate various combinations of ingredients, which have been observed to yield antimicrobial and antiviral kill rates of 7 log or greater.












Amount


Ingredient
(% by Weight of the Composition)















Example 1








USP Ethyl Alcohol (190 proof)
 62%


Cocos Nucifera
 1%


Citrus Sinensis
 8%


Simmondsia Chinensis
 28%


Lauric Acid
0.9%


Benzalkonium Chloride
0.1%







Example 2








USP Ethyl Alcohol (190 proof)
54.8% 


Cocos Nucifera
 3%


Citrus Sinensis
 2%


Aloe Vera
 3%


Lauric Acid
0.1%


Glycine Soja
 37%


Sodium Benzoate (preservative)
0.1%







Example 3








USP Ethyl Alcohol (190 proof)
54.8% 


Cocos Nucifera
 10%


Citrus Sinensis
 5%


Aloe Vera
 30%


Lauric Acid
0.1%


Glycine Soja
0.1%







Example 4








USP Ethyl Alcohol (190 proof)
54.9% 


Cocos Nucifera
 8%


Citrus Sinensis
 8%


Aloe Vera
14.45% 


Lauric Acid
0.2%


Glycine Soja
14.45% 







Example 5








USP Ethyl Alcohol (190 proof)
54.9% 


Emu Oil
 3%


Citrus Sinensis
 2%


Glycine Soja
 40%


Sodium Benzoate (preservative)
0.1%







Example 6








USP Ethyl Alcohol (190 proof)
 50%


Cocos Nucifera
 3%


Citrus Sinensis
 2%


Simmondsia chinensis
 35%


Glycine Soja
9.5%


Sodium Benzoate (preservative)
0.1%


Benzalkonium chloride
0.1%


Vitamin E
0.3%







Example 7








USP Ethyl Alcohol (190 proof)
 65%


Cocos Nucifera
 3%


Citrus Sinensis
 2%


Simmondsia chinensis
 25%


Glycine Soja
4.6%


Benzalkonium chloride
0.1%


Vitamin E
0.3%







Example 8








USP Ethyl Alcohol (190 proof)
 75%


Cocos Nucifera
 2%


Citrus Sinensis
 3%


Simmondsia chinensis
 17%


Glycine Soja
2.5%


Benzalkonium chloride
0.1%


Vitamin E
0.4%









In use, the antimicrobial and antiviral composition is applied to the skin surface surrounding the opening of the nostrils according to the following instructions:
1) Shake the bottle, container, applicator device or other vessel containing the composition well to insure complete mixture of the ingredients.
2) Apply between approximately 2-6 drops of the composition to the applicator member of the device being used for application.
3) Prepare to apply the composition to the rim of each nostril just past the nasal opening. Caution: Do not extend the applicator member into the nasal canal any further than 1.25 cm.
4) Carefully place only the applicator member just inside of the nostril opening. Using a gentle motion, make 3 or 4 circles to fully apply the composition to the rim of the nostril. Repeat this step for the other nostril.
5) Discard the applicator device if appropriate. Gently squeeze the nostrils together to ensure even distribution of the solution about the rim surrounding each nostril opening.
It is noted that the applicator used for applying the antimicrobial and antiviral composition of the present invention can be any suitable applicator including, but not limited to those applicators shown in FIGS. 1-4 of the drawings or even the tip of a person's finger.
In order to evaluate the antimicrobial efficacy of one sample of the composition when applied to the proximal external nares of human volunteers, the test study was conducted at Bioscience Laboratory, Inc. in Bozeman, Mont. The results of the study are set forth below.
Purpose of Study:
This study was designed to evaluate the persistent antimicrobial efficacy of one (1) test product intended for prevention of airborne illness when applied within the proximal nares (the first 0.25′′ of a naris) and one (1) control material.
Scope of Study:
Thirty (30) human subjects were evaluated in this study. Twenty-five (25) human subjects were used to evaluate the test product, and five (5) human subjects were used to evaluate the control material (sterile deionized water). Samples were taken from the proximal nares (the first 0.25′′ of the nostrilar canal). Baseline samples were collected a minimum of twenty-four (24) hours apart to allow recolonization of the normal flora. On the test day, the product was applied to each naris. Each naris was apportioned on a sagittal plane into two (2) sample sites, medial and lateral. Ten (10) samples each were taken for the two (2) hour±fifteen (15) minutes and four (4) hour±fifteen (15) minutes post-product exposures to the test product, and for the immediate (within one [1] minute of application) and four (4) hour±fifteen (15) minutes post-product exposures to the control material. Twenty (20) samples each were taken for the immediate (within one [1] minute of application), six (6) hour±fifteen (15) minutes, eight (8) hour±fifteen (15) minutes, and twelve (12) hour±fifteen (15) minutes post-product exposures to the test product.
Validation of the Neutralizer System:
A neutralization study was performed to assure the effectiveness of the neutralizers used in the diluting medium. The neutralization followed guidelines set forth in ASTM E 1054-02, Standard Test Methods for Evaluation of Inactivators of Antimicrobial Agents, except that the microorganism was added to the neutralizers prior to the addition of the test or comparison antiseptic. Staphylococcus aureus (ATCC #6538) was used as the challenge species in the neutralizer validation study. The neutralization study demonstrated that the antimicrobial activities of the test and reference products were effectively eliminated.
Adverse Events:
No Adverse Events were observed during or following completion of this study.
Results:
Table I presents the statistical summary of the log 10 recovery values with relation to use of the Test Product.







TABLE I







Statistical Summary of the log 10 Recovery


Values for the Test Product
















95%




Sample

Standard
Confidence
Log10


Sample
Size
Mean
Deviation
Interval
Reduction















Baseline
25
4.51
0.39
4.35 to 4.67
N/A


Pooled


Immediate Post-
21
3.38
1.28
2.79 to 3.96
1.13


Product Exposure


2 Hours Post-
11
3.61
1.14
2.85 to 4.38
0.90


product Exposure


4 Hours Post-
9
3.58
0.56
3.15 to 4.02
0.93


Product Exposure


6 Hours Post-
18
3.59
0.52
3.34 to 3.85
0.92


Product Exposure


8 Hours Post-
21
3.88
0.65
3.58 to 4.71
0.63


Product Exposure


12 Hours Post-
19
4.28
0.67
3.96 to 4.60
0.23


Product Exposure









Table II presents the Statistical Summary of the log 10 recovery values with relation to use of the Control Material (Sterile Deionized Water)







TABLE II







Statistical Summary of the log 10 Recovery Values


for the Control Material Sterile Deionized Water
















95%




Sample

Standard
Confidence
Log10


Sample
Size
Mean
Deviation
Interval
Reduction















Baseline
5
4.31
0.49
3.70 to 4.92
N/A


Pooled


Immediate Post-
10
4.66
0.59
4.24 to 5.08
0.00


Product Exposure


4 Hours Post-
10
4.23
0.63
3.78 to 4.68
0.08


Product Exposure









While the composition of the present invention has been described and exemplified according to several preferred embodiments thereof, it is recognized that departures from the instant disclosure are fully contemplated within the spirit and scope of the invention which is not to be limited except as defined in the following claims as interpreted under the Doctrine of Equivalents.

## Claims

1. A method of reducing the number of microorganisms entering the nose and proliferating in the nasal cavity of a human in need thereof consisting essentially of administering to said human's nose an applicator with a composition consisting essentially of ethanol and a component selected from the group consisting of orange oil, jojoba oil, vitamin E, coconut oil, benzalkonium chloride and lauric acid, wherein said number of microorganisms are reduced from entering the nose of the human.

2. The method of claim 1, wherein the applicator is a porous tip for delivering the composition to the human's nose.

3. The method of claim 1, wherein the applicator is a porous tip and a breakable glass ampoule.

4. The method of claim 1, wherein the applicator is a flocked swab.

5. The method of claim 1, wherein the applicator is a cotton swab.

6. The method of claim 1, wherein the applicator is a human finger.

7. The method of claim 1, wherein the applicator is a device structured to hold the composition and apply the composition to the inner surface of the nostril openings of the human's nose.