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Title:
USE OF NON-TOXIC ANTIMICROBIAL, OXYCHLORINE, HYPOCHLOROUS ACID AND SUPEROXIDIZED WATER PRODUCTS
Document Type and Number:
WIPO Patent Application WO/2010/025305
Kind Code:
A1
Abstract:
This invention describes systems and methods for prophylactic and therapeutic treatment for exposure to pathogenic microorganisms and other conditions. Particularly, hyper-lethal microorganisms can be eradicated by the systems and methods of using the compositions described herein.

Inventors:
IVERS, Joel, Ira (10584 Tanager Hills Drive, Cincinnati, Ohio, 45249, US)
GRIGGS, Jacob (10549 Big Bone Road, Union, Kentucky, 41091, US)
GONZALES, Gilbert (114 East 7th Street, Apt. 6-ENew York, New York, 10021, US)
GRIGGS, Roger, D. (10650 Big Bone Church Road, Union, Kentucky, 41091, US)
SCHAEFFER, Andrew, J. (5000 Idlewild Road, Burlington, Kentucky, 41005, US)
Application Number:
US2009/055258
Publication Date:
March 04, 2010
Filing Date:
August 27, 2009
Export Citation:
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Assignee:
DRUG ENHANCEMENT COMPANY OF AMERICA, LLC (P. O. Box 276, Union, Kentucky, 41091, US)
IVERS, Joel, Ira (10584 Tanager Hills Drive, Cincinnati, Ohio, 45249, US)
GRIGGS, Jacob (10549 Big Bone Road, Union, Kentucky, 41091, US)
GONZALES, Gilbert (114 East 7th Street, Apt. 6-ENew York, New York, 10021, US)
GRIGGS, Roger, D. (10650 Big Bone Church Road, Union, Kentucky, 41091, US)
SCHAEFFER, Andrew, J. (5000 Idlewild Road, Burlington, Kentucky, 41005, US)
International Classes:
A61L2/00; A61L2/18; A61L9/00
Attorney, Agent or Firm:
TRUONG, Linda, B. et al. (Davis Wright Tremaine LLP, 865 South Figueroa StreetSuite 240, Los Angeles California, 90017, US)
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Claims:
WHAT IS CLAIMED IS:

1. A system to prevent, treat, and/or reduce the chance of experiencing a harmful effect from an actual or perceived exposure to a pathogenic microorganism in a mammal in need thereof, comprising: an agent to prevent, treat and/or reduce the chance of experiencing the harmful effect; and a vehicle to dispense the agent to the mammal to prevent, treat and/or reduce the chance experiencing the harmful effect.

2. The system of claim 1 , wherein the agent comprises oxychlorine compounds.

3. The system of claim 1 , wherein the agent comprises about 99.99% oxidized water, sodium hypochlorite (NaOCl)1 hypochlorous acid (HOCI) and sodium chloride (NaCI).

4. The system of claim 1 , wherein the pathogenic microorganism is selected from the group consisting of fungus, archaea, protest, protozoa, bacterium, bacterial spore, bacterial endospore, virus, viral vector, prion and combinations thereof.

5. The system of claim 1 , wherein the pathogenic microorganism is a hyper- lethal pathogenic microorganism.

6. The system of claim 5, wherein the hyper-lethal pathogenic microorganism is selected from the group consisting of Naegleήa fowleri, Coccidioides immitis, Bacillus anthracis, Haemophilus influenzae, Listeria monocytogenes, Neisseria meningitides, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus agalactiae, Pseudomonas aeruginosa, Yersinia pestis, Clostridium botulinum, Francisella tularensis, variola major, Nipah virus, Hanta virus, Pichinde virus, Crimean-Congo hemorrhagic fever virus, Ebola virus, Marburg virus, Lassa virus, Junin virus, human immunodeficiency virus ("HIV"), SARS-associated coronavirus ("SARS-CoV"), prion that causes Creutzfeldt-Jakob Disease (CJD), prion that causes Variant Creutzfeldt-Jakob Disease (vCJD), prion that causes Gerstmann-Straussler-Scheinker Syndrome, prion that causes fatal familial insomnia, prion that causes bovine spongiform encephalopathy (BSE), prion that causes chronic wasting disease (CWD), prion that causes scrapie, prion that causes transmissible mink encephalopathy, prion that causes feline spongiform encephalopathy, and prion that causes ungulate spongiform encephalopathy.

7. A method to prevent, treat, and/or reduce the chance of experiencing a harmful effect from an actual or perceived exposure to a pathogenic microorganism in a mammal in need thereof, comprising: providing an agent to prevent, treat and/or reduce the chance of experiencing the harmful effect; and administering the agent to the mammal to prevent, treat and/or reduce the chance of the experiencing the harmful effect.

8. The method of claim 5, wherein the method further comprises providing the agent in a vehicle to dispense the agent,

9. The method of claim 5, wherein the agent comprises oxychlorine compounds,

10. The method of claim 5, wherein the agent comprises about 99.99% oxidized water, sodium hypochlorite (NaOCI), hypochlorous acid (HOCI) and sodium chloride (NaCI).

11. The method of claim 7, wherein the pathogenic microorganism is selected from the group consisting of fungus, archaea, protest, protozoa, bacterium, bacterial spore, bacterial endospore, virus, viral vector, prion and combinations thereof.

12. The method of claim 7, wherein the pathogenic microorganism is a hyper- lethal pathogenic microorganism.

13. The method of claim 12, wherein the hyper-lethal pathogenic microorganism is selected from the group consisting of Naegleria fowlers, Coccidioides immitis, Bacillus anthracis, Haemophilus influenzae, Listeria monocytogenes, Neisseria meningitides, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus agalactiaβ, Pseudomonas aeruginosa, Yersinia pestis, Clostridium botulinum, Francisella tularensis, variola major, Nipah virus, Hanta virus, Pichinde virus, Crimean-Congo hemorrhagic fever virus, Ebola virus, Marburg virus, Lassa virus, Junin virus, human immunodeficiency virus ("HIV)1 SARS-associated coronavirus ("SARS-CoV"), prion that causes CreutzfeldKJakob Disease (CJD), prion that causes Variant Creutzfeldt-Jakob Disease (vCJD), prion that causes Gerstmann-Straussler-Scheinker Syndrome, prion that causes fatal familial insomnia, prion that causes bovine spongiform encephalopathy (BSE), prion that causes chronic wasting disease (CWD), prion that causes scrapie, prion that causes transmissible mink encephalopathy, prion that causes feline spongiform encephalopathy, and prion that causes ungulate spongiform encephalopathy.

14. The method of claim 7, wherein administering the agent comprises administering via an aerosol, topical, ocular, nasal, oral, auricular, anal, vaginal, urethral, transmucosal, transdermal, enteral, or parental route.

15. The method of claim 7, wherein administering the agent comprises spraying the agent onto an affected surface of the mammal.

16. A method to prevent and/or reduce the chances of transmission of a pathogenic microorganism to a subject, comprising; providing an agent to prevent, treat and/or reduce a chance of experiencing a pathogenic microorganism's harmful effect; and applying the agent to a fomite to prevent or reduce the chances of transmission of the pathogenic microorganism to the subject,

17. The method of claim 16, the agent comprises oxychlorine compounds.

18. The method of claim 16, wherein the agent comprises oxidized water, sodium hypochlorite (NaOCI), hypochlorous acid (HOCI) and sodium chloride (NaCI).

19. The method of claim 16, wherein applying the agent comprises spraying the agent onto the fomite.

20. A method to treat a condition caused by an infection by a pathogenic microorganism in a mammal in need thereof, comprising; providing a non-toxic or substantially non-toxic agent capable treating the condition; and administering the agent to the mammal to treat the condition.

21. The method of claim 20, wherein the agent comprises oxychlorine compounds.

22. The method of claim 20, wherein the agent comprises oxidized water, sodium hypochlorite (NaOCI), hypochlorous acid (HOC!) and sodium chloride (NaCI).

23. The method of claim 20, wherein the pathogenic microorganism is selected from the group consisting of fungus, archaea, protest, protozoa, bacterium, bacterial spore, bacterial endospore, virus, viral vector, prion and combinations thereof.

24, The method of claim 20, wherein the condition is selected from the group consisting of ulcer, gastroenteritis, diarrhea, vomiting, gastroparesis, halitosis, body odor, foot odor, respiratory disorder, gastrointestinal disorder, giardiasis, and ear infection.

25. The method of claim 20, wherein administering the non-toxic or substantially non-toxic agent comprises administering via an aerosol, topical, ocular, nasal, oral, auricular, anal, vaginal, urethral, transmucosal, transdermal, enteral, or parental route.

Description:
USE OF NON-TQXtC ANTIMICROBIAL, OXYCHLORINE, HYPOCHLOROUS ACID AND SUPEROXIDIZED WATER PRODUCTS

FIELD OF INVENTION This invention relates to prophylactic and therapeutic treatment for exposure to pathogenic microorganisms and other conditions

BACKGROUND

All publications herein are incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference The following description includes information that may be useful in understanding the present invention It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art

Various conditions and disease conditions are caused by infection by a pathogen For example, body odor (e gr , foot odor) is the scent of bacteria growing on the body These bacteria proliferate in the presence of sweat and, a non-pleasant odor is released Halitosis is another condition caused by bacteria One cause of halitosis is through proteins trapped in the mouth that are processed by oral bacteria Over 600 types of bacteria are typically found in the mouth and a portion of these bacteria can produce high levels of foul odors

Additional conditions caused by pathogenic infection include gastrointestinal disorders such as ulcers (e g , caused by Helicobacter pylon (H pylori)), gastroenteritis (e g , caused by viruses, bacteria or their toxins, or parasites), giardiasis (e g , caused by the protozoan Giardia lambha), diarrhea, vomiting, and gastroparesis (e g , caused by viral infections)

Generally, treatment for conditions caused by pathogenic infections exists in the art However, adverse effects to humans may occur as therapeutics may have some degree of toxicity to humans Thus, there is a need in the art for additional therapeutic treatments that may be non-toxic or have a lower level of toxicity to humans, and that may be more conveniently manufactured, easily administered and/or better tolerated i In many instances, upon exposure to a pathogenic microorganism, the response time is crucial to lower the subject's chances of becoming infected and thereby causing a harmful effect on the subject. While many infections are treatable, there are those that can become life-threatening. It would be especially helpful to prevent, treat and/or reduce the chances of experiencing the pathogenic microorganism's harmful effect on the subject. Even with treatable infections, it is still helpful to prevent, treat and/or reduce the chances of experiencing the pathogenic microorganism's harmful effect for non life-threatening diseases caused by them. Pathogenic microorganisms include but are not limited bacteria, viruses, prions, fungus, archaea, protist, protozoa, and their spores and/or endospores, and it is beneficial to prevent, treat and/or reduce the likelihood of experiencing their harmful effect. For example, Plasmodium (e.g., Plasmodium falciparum, Plasmodium vivax, Plasmodium ovale, and Plasmodium malariae) can infect humans and cause malaria. Thus, there is a need in the art to prevent, treat and/or reduce the likelihood of experiencing the pathogenic microorganism's harmful effect. The Centers for Disease Control and Prevention {"CDC") lists three categories of bioterrorism agents and diseases. While these agents and diseases are under the category of bioterrorism, outbreaks and transmission of these diseases do not necessarily need to occur as a result of a terrorist event. Category A includes organisms that can be easily transmitted from person to person, result in high mortality rates and have the potential for major public health impact. Diseases or disease conditions caused by bacteria included in Category A are anthrax (Bacillus anthracis), botulism (Clostridium botulinum toxin), plague (Yersinia pestis), and tularemia (Francisella tularensis). Category A, as it pertains to viruses, includes smallpox (variola major) and viral hemorrhagic fevers. Category B includes organisms that result in moderate morbidity rates and low mortality rates. Category B, as it pertains to bacteria, includes brucellosis (Brucella species), epsilon toxin of Clostridium perfringens, food safety threats (e.g., Salmonella species, Escherichia coli, Shigella), glanders (Burkholderia mallei), melioidosis (Burkholderia pseudomallei), psittacosis (Chlamydia psittaci), Q Fever (Coxiella burnetii), Staphylococcal enterotoxin B, typhus fever (Rickettsia prowazekii), and water safety threats (e.g., Vibrio cholerae, Cryptosporidium parvum). Category B, as it pertains to viruses, includes viral encephalitis (alphaviruses). Category C includes emerging organisms that can be engineered for mass dissemination because of their potential for high morbidity and mortality rates and major health impact; for example, Nipah virus and hantavirus. Pneumonia, which can be caused by bacteria, is one of the most common acute respiratory infections and it is responsible for numerous deaths worldwide, especially in children and the elderly. Children with low birth weight or compromised immune systems are more susceptible to the disease. The disease progresses rapidly if left untreated and it is spread via contact with the bodily fluids of infected individuals, especially via airborne inhalation of infected droplets containing the bacteria.

Necrotizing Fasciitis, commonly known as "flesh-eating disease" or "flesh- eating bacteria," is an infection of the deeper layers of skin and subcutaneous tissues, easily spreading across the fascial plane within the subcutaneous tissue. Many types of bacteria can cause necrotizing fasciitis (e.g., Group A streptococcus, Vibrio vulnificus, Clostridium perfringens, Bacteroides fragilis), of which Group A streptococcus (also known as Streptococcus pyogenes) is the most common cause. The infection begins locally, at a site of trauma, which may be severe (such as the result of surgery), minor, or even non-apparent. The affected skin is classically, at first, very painful without any grossly visible change. With progression of the disease, tissue becomes swollen, often within hours. Diarrhea and vomiting are common symptoms as well. Inflammation does not show signs right away if the bacteria are deep within the tissue. If they are not deep, signs of inflammation such as redness and swollen or hot skin show very quickly. Skin color may progress to violet and blisters may form, with subsequent necrosis of the subcutaneous tissues. Patients with necrotizing fasciitis typically have a fever and appear very ill. Mortality rates have been noted as high as 73%.

Tuberculosis ( 1 TB") is a common and often deadly infectious disease caused by mycobacteria, mainly Mycobacterium tuberculosis. Although TB has been largely eradicated in many parts of the world through the use of vaccines, it is still a deadly killer in some regions. Moreover, some strains of TB are antibiotic resistant. TB is highly contagious, and only a small amount of the bacteria is needed to infect another person. Viral hemorrhagic fevers (VHFs), which refer to a group of illnesses that are caused by several distinct families of viruses, have severe multisystem syndrome effects. Typically, the overall vascular system is damaged, and the body's ability to regulate itself is impaired. These symptoms are often accompanied by hemorrhage and many of the viruses can cause severe, life-threatening disease. VHFs are caused by viruses of four distinct families: arenaviruses, filoviruses, bunyaviruses, and flaviviruses. With a few exceptions, there is no cure or established drug treatment for VHFs.

Viruses causing hemorrhagic fever (e.g., Ebola, Marburg, Lassa and Crimean-Congo hemorrhagic fever viruses) can be transmitted directly, through close contact with infected people or their body fluids, or indirectly, through contact with objects contaminated with infected body fluids (e.g., contaminated syringes and needles). Signs and symptoms of VHF include, marked fever, fatigue, dizziness, muscle aches, loss of strength, and exhaustion and in severe cases, bleeding under the skin, in internal organs, or from body orifices such as the mouth, eyes, or ears. Patients receive supportive therapy, but generally speaking, there is no other treatment or established cure for VHFs.

Ebola Hemorrhagic Fever is incredibly deadly, with a 90% fatality rate. It is transmitted via blood and bodily fluids from person to person. Ebola causes microscopic holes in capillary walls, leading to internal bleeding that contributes to the cause of death. It is mainly limited to areas in Africa, but little is known about the disease. Lassa Fever is an acute viral infection that occurs in some regions in Africa and causes approximately 5,000 deaths per year. While the disease is spread mainly via contact with rodent excrement, it, however, can also be spread via human contact with infected bodily fluids. The disease causes fever, sore throat, tremors, vomiting, diarrhea, and facial swelling. Marburg Hemorrhagic Fever is related to Ebola and originated in Africa. It is found in fruit bats, humans, and primates. The disease is also spread via exposure to bodily fluids. The symptoms include fever, rash, headache, jaundice, and delirium. It can also cause renal failure. With the exception of yellow fever and Argentine hemorrhagic fever, for which vaccines have been developed, no vaccines exist that can protect against these diseases. Therefore, prevention efforts must concentrate on avoiding contact with host species. Viruses that cause VHFs are only examples of potential viruses in which the prevention, treatment, and/or reduction in the chance of experiencing the virus' harmful effect is desired.

Another virus wherein prevention, treatment, or reduction in the chance of experiencing the virus' harmful effect would be beneficial is the human immunodeficiency virus ("HIV"), which leads to acquired immunodeficiency syndrome ("AIDS"). HIV/AIDS is one of the deadliest diseases known to man, as it has no known cure. HIV is transmitted through direct contact of a person's mucous membrane or bloodstream with infected bodily fluids. AIDS is considered a pandemic worldwide, as it kills approximately 2.1 million people per year. Although the disease is prevalent all over the world, the majority of deaths occur in Sub- Saharan Africa.

Severe Acute Respiratory Syndrome ("SARS") caused by a coronavirus known as the SARS-associated coronavirus ("SARS-CoV") is yet another virus. SARS is a respiratory disease that is fairly deadly in the elderly (50% mortality in those aged 65 and older). It caused a global alert in 2003 because the disease is easily spread from person to person via casual contact or direct contact with the bodily fluids of an infected individual.

Pneumonia, which can be caused by viruses, is one of the most common acute respiratory infections and it is responsible for numerous deaths worldwide, especially in children and the elderly. Children with low birth weight or compromised immune systems are more susceptible to the disease. The disease progresses rapidly if left untreated and it is spread via contact with the bodily fluids of infected individuals, especially via airborne inhalation of infected droplets containing the viruses. Pneumonia can also develop from exposure to the influenza virus. Influenza causes numerous deaths each year, and is responsible for 10,000-

40,000 deaths in the United States alone. The avian influenza strain (H5N1) is of great concern to scientists because of the possibility of mutation to become transmissible from human to human contact. Since the virus does not commonly infect humans, if the mutation does occur, it could be quite deadly and spread rapidly, causing a pandemic. The mortality rate for people infected with the disease is over 50%.

Additionally, prion diseases or transmissible spongiform encephalopathies (TSEs) are a family of rare progressive neurodegenerative disorders that affect both humans and animals. They are distinguished by long incubation periods, characteristic spongiform changes associated with neuronal loss, and a failure to induce inflammatory response. The causative agent of TSEs is believed to be a prion. A prion is an abnormal, transmissible agent that is able to induce abnormal folding of normal cellular prion proteins in the brain, leading to brain damage and the characteristics signs and symptoms of the disease. Prion diseases are usually rapidly progressive and always fatal.

Thus, there is a need in the art to prevent, treat and/or reduce the likelihood of experiencing the pathogenic microorganism's harmful effect.

Additionally, an outbreak of diseases caused by these pathogenic microorganisms may also incite fear and panic, which may compel healthcare providers to abandon those infected for fear of becoming inadvertently exposed and/or infected. For example, during an outbreak of the Ebola virus in Kinshasa, Uganda in 2000, many healthcare individuals refused to report to the hospital and demanded that the hospital be closed. Accordingly, having an agent that reduces pathogenic microorganism exposure burden to areas of the body that are not always protected or treated (e.g., mucous membrane exposure to eyes, nose and mouth), can prevent or reduce fear and panic. A reduction or the prevention of fear and panic associated with an outbreak will be beneficial and it would enable those in need of treatment to receive the necessary health care.

In cases of exposure, a person needs a product that works effectively and is safe to use anywhere by individuals such as consumers, patients, physicians, heath care workers, paramedics, first responders, military personnel and emergency workers.

Consequently, there is also a need in the art for a storage and delivery system to enable the use of such product anywhere. Selection of a storage system for a particular agent may be based on a variety of factors, such as the durability, cost, ease of manufacturing, or functionality of the storage system. However, the chemical properties of the agent and the relationship of those properties to the storage system must also be considered. So, too, must one consider the setting in which the storage system will be utilized. There are agents that might become altered, seep out of, interact with or otherwise be affected by the storage system material in such a manner that the agents lose their medicinal efficacy or the like. Thus, particularly in connection with pharmaceutical and medicinal agents, care must be exercised in selecting an appropriate storage system and materials to construct the same. Regarding the setting in which a storage system may be used, it might not be desirable to use, for example, a storage system constructed of a material that is easily breakable when the system is to be carried by an emergency worker in the field. There, the performance of even routine tasks may compromise the integrity of the storage system. It might become inoperative or shatter and spill its contents. Storage and delivery systems currently available in the art that enable individuals to conveniently transport small quantities of pharmaceuticals, medicants and other agents are frequently constructed from plastic, rubber and/or similar materials. However, as described above, many agents cannot be stored in such containers without losing efficacy or experiencing other undesirable effects. Moreover, the environment in which such storage and delivery systems may be used necessitates, in some cases, the use of a system that can withstand the exertion of anything from minor jostling to severe blunt force.

There is therefore a need in the art for a storage and delivery system that overcomes the aforementioned challenges to dispense the product to prevent, treat, and/or reduce the chance of experiencing the pathogenic microorganism's harmful effect.

SUMMARY OF THE INVENTION

Embodiments of the invention provide for a system to prevent, treat, and/or reduce the chance of experiencing a harmful effect from an actual or perceived exposure to a pathogenic microorganism in a mammal in need thereof, comprising an agent to prevent, treat and/or reduce the chance of experiencing the harmful effect; and a vehicle to dispense the agent to the mammal to prevent, treat and/or reduce the chance experiencing the harmful effect. In various embodiments, the agent may comprise oxychlorine compounds. In a particular embodiment, the agent may comprise about 99.99% oxidized water, sodium hypochlorite (NaOCl), hypochlorous acid (HOCI) and sodium chloride (NaCI). In various embodiments, the pathogenic microorganism may be selected from the group consisting of fungus, archaea, protest, protozoa, bacterium, bacterial spore, bacterial endospore, virus, viral vector, prion and combinations thereof.

In other embodiments, the pathogenic microorganism may be a hyper-lethal pathogenic microorganism. In certain embodiments, the hyper-lethal pathogenic microorganism may be selected from the group consisting of Naegleria fowleri, Coccidioides immitis, Bacillus anthracis, Haemophilus influenzae, Listeria monocytogenes, Neisseria meningitides, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus agalactiae, Pseudomonas aeruginosa, Yersinia pestis, Clostridium botulinum, Francisella tularensis, variola major, Nipah virus, Hanta virus, Pichinde virus, Crimean-Congo hemorrhagic fever virus, Ebola virus, Marburg virus, Lassa virus, Junfn virus, human immunodeficiency virus ("HIV"), SARS-associated coronavirus ("SARS-CoV"), prion that causes Creutzfeldt-Jakob Disease (CJD), prion that causes Variant Creutzfeldt-Jakob Disease (vCJD), prion that causes Gerstmann-Straussler-Scheinker Syndrome, prion that causes fatal familial insomnia, prion that causes bovine spongiform encephalopathy (BSE), prion that causes chronic wasting disease (CWD), prion that causes scrapie, prion that causes transmissible mink encephalopathy, prion that causes feline spongiform encephalopathy, and prion that causes ungulate spongiform encephalopathy. Embodiments of the present invention also provide for a method to prevent, treat, and/or reduce the chance of experiencing a harmful effect from an actual or perceived exposure to a pathogenic microorganism in a mammal in need thereof, comprising: providing an agent to prevent, treat and/or reduce the chance of experiencing the harmful effect; and administering the agent to the mammal to prevent, treat and/or reduce the chance of the experiencing the harmful effect. In certain embodiments, the method may further comprise providing the agent in a vehicle to dispense the agent.

In various embodiments, the agent may comprise oxychlorine compounds. In a particular embodiment, the agent may comprise about 99.99% oxidized water, sodium hypochlorite (NaOCI), hypochlorous acid (HOCI) and sodium chloride (NaCI). In various embodiments, the pathogenic microorganism may be selected from the group consisting of fungus, archaea, protest, protozoa, bacterium, bacterial spore, bacterial endospore, virus, viral vector, prion and combinations thereof. In other embodiments, the pathogenic microorganism may be a hyper-lethal pathogenic microorganism. In certain embodiments, the hyper-lethal pathogenic microorganism may be selected from the group consisting of Naegleria fowleri, Coccidioides immitis, Bacillus anthracis, Haemophilus influenzae, Listeria monocytogenes, Neisseria meningitides, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus agalactiae, Pseudomonas aeruginosa, Yersinia pestis, Clostridium botulinum, Francisella tularensis, variola major, Nipah virus, Hanta virus, Pichinde virus, Crimean-Congo hemorrhagic fever virus, Ebola virus, Marburg virus, Lassa virus, Junin virus, human immunodeficiency virus ("HlV"), SARS-associated coronavirus ("SARS-CoV"), prion that causes Creutzfeldt-Jakob Disease (CJD), prion that causes Variant Creutzfeldt-Jakob Disease (vCJD), prion that causes Gerstmann-Straussler-Scheinker Syndrome, prion that causes fatal familial insomnia, prion that causes bovine spongiform encephalopathy (BSE), prion that causes chronic wasting disease (CWD), prion that causes scrapie, prion that causes transmissible mink encephalopathy, prion that causes feline spongiform encephalopathy, and prion that causes ungulate spongiform encephalopathy.

In various embodiments, administering the agent may comprise administering via an aerosol, topical, ocular, nasal, oral, auricular, anal, vaginal, urethral, transmucosal, transdermal, enteral, or parental route. In a particular embodiment, administering the agent may comprise spraying the agent onto an affected surface of the mammal.

Embodiments of the present invention also provide for a method to prevent and/or reduce the chances of transmission of a pathogenic microorganism to a subject, comprising: providing an agent to prevent, treat and/or reduce a chance of experiencing a pathogenic microorganism's harmful effect; and applying the agent to a fomite to prevent or reduce the chances of transmission of the pathogenic microorganism to the subject.

In one embodiment, the agent may comprise oxychlorine compounds. In another embodiment, the agent may comprise oxidized water, sodium hypochlorite (NaOCI), hypochlorous acid (HOCI) and sodium chloride (NaCI).

In a certain embodiment, applying the agent may comprise spraying the agent onto the fomite. Embodiments of the present invention also provide for a method to treat a condition caused by an infection by a pathogenic microorganism in a mammal in need thereof, comprising: providing a non-toxic or substantially non-toxic agent capable treating the condition; and administering the agent to the mammal to treat the condition.

In one embodiment, the agent may comprise oxychlorine compounds. In a particular embodiment, the agent may comprise oxidized water, sodium hypochlorite (NaOCI), hypochlorous acid (HOCI) and sodium chloride (NaCI).

In various embodiments, the pathogenic microorganism may be selected from the group consisting of fungus, archaea, protest, protozoa, bacterium, bacterial spore, bacterial endospore, virus, viral vector, prion and combinations thereof. In various embodiments, the condition may be selected from the group consisting of ulcer, gastroenteritis, diarrhea, vomiting, gastroparesis, halitosis, body odor, foot odor, respiratory disorder, gastrointestinal disorder, giardiasis, and ear infection.

In certain embodiments, administering the non-toxic or substantially non-toxic agent may comprise administering via an aerosol, topical, ocular, nasal, oral, auricular, anal, vaginal, urethral, transmucosal, transdermal, enteral, or parental route.

BRIEF DESCRIPTION OF THE FIGURES

Exemplary embodiments are illustrated in referenced figures. It is intended that the embodiments and figures disclosed herein are to be considered illustrative rather than restrictive. Figure 1 depicts a perspective view of a vial and dispenser assembly in accordance with an embodiment of the present invention.

Figure 2 depicts an exploded, perspective view of the vial and dispenser assembly shown in Figure 1 , in accordance with an embodiment of the present invention. Figure 3 depicts a cross-sectional view of the vial and dispenser assembly shown in Figure 1 , in accordance with an embodiment of the present invention.

io Figure 4 depicts a perspective view of the vial and dispenser assembly shown in Figure 1 in combination with a barrel and cap (the cap is in the open position), in accordance with an embodiment of the present invention.

Figure 5 depicts an exploded, perspective view of the vial and dispenser assembly with the barrel and cap shown in Figure 4, in accordance with an embodiment of the present invention.

Figure 6 depicts a cross-sectional view of the vial and dispenser assembly with the barrel and cap (the cap is in the closed position) shown in Figure 4, in accordance with an embodiment of the present invention. Figure 7 depicts a top perspective view of a barrel, in accordance with an embodiment of the present invention.

Figure 8 depicts a bottom perspective view of a cap, in accordance with an embodiment of the present invention.

DESCRIPTION OF THE INVENTION

All references cited herein are incorporated by reference in their entirety as though fully set forth. Unless defined otherwise, technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Singleton et a/. , Dictionary of Microbiology and Molecular Biology 3"* ed., J. Wiley & Sons (New York, NY 2001 ) and March, Advanced Organic Chemistry Reactions, Mechanisms and Structure 5 th ed., J. Wiley & Sons (New York, NY 2001) provide one skilled in the art with a general guide to many of the terms used in the present application.

One skilled in the art will recognize many methods and materials similar or equivalent to those described herein, which could be used in the practice of the present invention. Indeed, the present invention is in no way limited to the methods and materials described. For purposes of the present invention, the following terms are defined below.

"Beneficial effects" may include, but are in no way limited to, lessening or alleviating the severity of a disease, a condition or a symptom thereof; preventing or lowering the chances of having the disease, the condition or the symptom thereof from worsening; curing the disease or the condition; and prolonging a subject's life or life expectancy.

I l "Conditions" and "disease conditions," as used herein may include, but are in no way limited to those caused by pathogenic microorganisms. Examples include, but are not limited to, halitosis, body odor, foot odor, respiratory disorders (e.g., sinusitis, tonsillitis, bronchitis, pharyngitis, laryngitis, pneumonia, and tuberculosis), gastrointestinal disorders (e.g., ulcers and other pathologies resulting from

Helicobacter pylori (H. pylori) infection, gastroenteritis [caused by viruses, bacteria or their toxins, or parasites], giardiasis [cause by the protozoan Giardia lamblia], diarrhea, vomiting, gastroparesis [caused by viral infections]), and ear infections. Additionally examples of conditions and disease conditions are described throughout the specification.

"Mammal" as used herein refers to any member of the class Mammalia, including, without limitation, humans and nonhuman primates such as chimpanzees, and other apes and monkey species; farm animals such as cattle, sheep, pigs, goats and horses; domestic mammals such as dogs and cats; laboratory animals including rodents such as mice, rats and guinea pigs, and the like. The term does not denote a particular age or sex. Thus, adult and newborn subjects, as well as fetuses, whether male or female, are intended to be included within the scope of this term.

"Pathogenic microorganism" as used herein refers to a microorganism or infectious agent that causes a harmful effect on a mammal. These microorganism or infectious agent include, but are not limited to, bacteria, viruses, viral vectors, prions, fungi, archaea, protists [Cryptosporidium parvum), protozoas (e.g., Kinetoplastids, Apicomplexa, Plasmodium [e.g., Plasmodium falciparum, Plasmodium vivax, Plasmodium ovale, and Plasmodium malariae]) and their spores or endospores.

Examples of fungi include, but are not limited to, Candida albicans, Malassezia (also known as Pityrosporum, and causes dandruff), Microsporum (e.g., M. audouinii, M. canis, M. canis van distortum, M. cookei, M. equinum, M. ferrυgineum, M. fulvum, M. gallinae, M. gypseum, M. nan urn, M. persicofoή, Trichophyton (e.g., T. ajelloi, T. concentricum, T. equinum, T. flavescens, T, gloriae, T. megnini, T. mentagrophytes var. erinacei, T. mentagrophytes var. interdigitale, T. phaseoliforme, T. rubrum, T. rubrum downy strain, T. rubrum granular strain, T. schoenleinii, T. simii, T. soudanense, T, terrestre, T. tonsurans, T. vanbreuseghemii, T. verrucosum, T. violaceum, T. yaoundei) and Epidermophyton (e.g., E. floccosum, a cause of tinea corporis (ringworm), tinea cruris, tinea pedis (athlete's foot), and tinea unguium, (a fungal infection of the nail bed), Candida species (e.g., Candida albicans), Cryptococcus neoformans, Aspergillus, Naegleria fowleri (brain eating amoeba), and Coccidioides immitis (causing coccidioidomycosis, a.k.a., Valley Fever meningitis). "Pathology" of the condition or disease condition includes all phenomena that compromise the well-being of the patient.

"Bacteria" as used herein include to bacteria, bacterial spores, and bacterial endospores that cause a harmful effect on a mammal. Examples of bacteria include, but are not limited to, Acinetobacter (e.g., A. baumannii), Bacillus (e.g., B. anthracis), Bacteroides (e.g., B. fragilis), Bordetella (e.g., pertussis), Brucella (e.g., B. melitensis), Burkholdeήa (e.g., B. mallei, B. pseudomallei), Chlamydia (e.g., C. psittacf), Clostridium (e.g., C. difficile, C. botulinum, C. perfringens), Coxiella (e.g., C. burnetii), Enterobacter(e.g., E. aerogenes), Enterococcus (e.g., E. faecalis), Enterococcus (e.g., E. faecium), Escherichia (e.g., E. coli), Francisella (e.g., F. tuiarensis), Haemophilus (e.g., H. influenzae), Listeria (e.g., L monocytogenes), Klebsiella (e.g., K. oxytoca, K. pneumoniae), Micrococcus (e.g., M. luteus), Mycobacterium (e.g., M. tuberculosis), Neisseria (e.g., N. gonorrhoreae, N. meningitidis), Proteus (e.g., P. mirabilis), Pseudomonas (e.g., P aeruginosa), Rickettsia (e.g., R prowazekii), Salmonella (e.g., S. bongori, S. enterica), Serratia (e.g., S. marcescens), Shigella (e.g., S. boydii, S. dysenteriae, S. flexneri, S. sonnei), Staphylococcus (e.g., S. aureus [including Methicillin-resistant Staphylococcus aureus ("MRSA")], S. epidermidis, S. haemolyticus, S. hominis, S. saprophytics), Streptococcus (e.g., S. pneumoniae, S. pyogenes), Vibrio (e.g., V. cholerae, V. vulnificus), and Yersinia (e.g., Y. pestis). "Virus" as used herein includes viruses and viral vectors that cause a harmful effect on a mammal. Examples of viruses include, but are not limited to, Picomavirus (e.g., Hepatovirus genus, hepatitis A virus species), Hepadnaviridae family (e.g., Orthohepadnavirus genus [e.g., Hepatitis B virus species]), Flaviviridae family (e.g., Hepacivirus genus [e.g., Hepatitis C virus species], Flavivirus genus [e.g., Yellow fever virus species), cold virus, Orthomyxoviridae family (e.g., human influenza viruses, avian influenza viruses [e.g., H5N1]), Herpesviridae family (e.g., Alphaherpesvirinae Subfamily, Simplexvirus Genus [e.g., herpes simplex virus type 1 (HSV-1) species, herpes simplex virus type 2 (HSV-2) species]), variola major

I3 species, Henipavirus genus {e.g., Nipah virus species), Bunyaviridae family (e.g, hantavirus genus, Nairovirus genus [e.g., Crimean-Congo hemorrhagic fever virus]), Filoviridae family {e.g., Ebolavirus genus [e.g., Ebola virus species], Marburgvirus genus, [e.g., Marburg virus species]), Arenaviridae family (e.g., Arenavirus genus [e.g., Lassa virus species, Junin virus species (causing Argentine hemorrhagic fever)]), Retroviridae family (e.g., Lentivirus genus [e.g., human immunodeficiency virus ("HIV") species], Coronavirus genus (e.g., SARS-associated coronavirus ("SARS-CoV") species), viruses that cause pneumonia, Paramyxoviridae family (e.g., Morbillivirus species (causing measles)), Togaviridae family (e.g., Rubivirus genus [e.g. Rubella virus species (causing German measles)]), and Pichinde virus (e.g., strain CoAn4763).

"Harmful effect" as used herein includes, but is in no way limited to, any detrimental effect to a mammal's health. Examples of harmful effects include, but are not limited to, infection by a pathogenic microorganism (acute or chronic), a disease caused by the pathogenic microorganism, a disease condition caused by the pathogenic microorganism, becoming a carrier of the pathogenic microorganism (and thereby potentially imparting a harmful effect to another mammal), alteration of the microbial flora in or on a physiological structure of the mammal (e.g., organs such as heart, lungs, brain, eyes, stomach, spleen, bones, pancreas, kidneys, liver, intestines (small and large), skin, bladder, uterus and testicles; systems such as digestive, respiratory, nervous, circulatory, endocrine, lymphatic, reproductive, urinary, skeletal and muscular; and membranes such as mucus, basement and serous), pain, discomfort, swelling, inflammation, discomfort, psychological effects, fear, panic, and death.

"Hyper-lethal microorganisms" as used herein refers to pathogenic microorganisms that when actively infect a mammalian subject (e.g., human) results in the death of the mammalian subject in an unusually high rate. "Hyper-lethal microorganisms" include but are not limited to hyper-lethal bacteria, hyper-lethal viruses, hyper-lethal prions, as well the following microorganisms: Naegleria fowleri (brain eating amoeba) and Coccidioides immitis (causing coccidioidomycosis, a.k.a., Valley Fever meningitis). "Hyper-lethal bacteria" as used herein refer to bacteria, bacterial spores and bacterial endospores that when actively infect a mammalian subject (e.g., human) results in the death of the mammalian subject in an unusually high rate. "Hyper- lethal bacteria" include but are not limited to the following bacteria: Bacillus anthracis; Haemophilus influenzae, Usteria monocytogenes, Neisseria meningitides, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus agalactiae, and Pseudomonas aeruginosa (causing bacterial meningitis); Yersinia pestis (causing the Bubonic Plague); Clostridium botulinum (causing botulism); and Francisella tularensis (causing tularemia). "Hyper-lethal viruses" as used herein refer to viruses that when actively infect a mammalian subject (e.g., human) results in the death of the mammalian subject in an unusually high rate. "Hyper-lethal viruses" includes but are not limited to the following viruses: variola major, Nipah virus, Hanta virus, Pichinde virus, particularly, strain CoAn4763, Crimean-Congo hemorrhagic fever virus, Ebola virus, Marburg virus, Lassa virus, Junin virus, human immunodeficiency virus ("HIV"), and SARS- associated coronavirus ("SARS-CoV").

"Hyper-lethal prions" as used herein refers to prions that when actively infect a mammalian subject (e.g., human) results in the death of the mammalian subject in an unusually high rate. "Hyper-lethal prions" include but are not limited to prions that cause Creutzfeldt-Jakob Disease (CJD), Variant Creutzfeldt-Jakob Disease (vCJD), Gerstmann-Straussler-Scheinker Syndrome, fatal familial insomnia, Kuru, bovine spongiform encephalopathy (BSE), chronic wasting disease (CWD), scrapie, transmissible mink encephalopathy, feline spongiform encephalopathy, and ungulate spongiform encephalopathy. "Treatment" and "treating," as used herein refer to both therapeutic treatment and prophylactic or preventative measures, wherein the object is to prevent or slow down (lessen) the targeted pathologic condition or disorder even if the treatment is ultimately unsuccessful. Those in need of treatment include those already with the disorder as well as those prone to have the disorder or those in whom the disorder is to be prevented.

Various embodiments of the present invention describe the use of non-toxic antimicrobial, oxychlorine, hypochlorous acid or superoxidized water products to treat a condition.

One embodiment of the present invention provides for a method to treat a condition in a mammal in need thereof, comprising: providing a non-toxic antimicrobial agent; and administering the agent to the mammal to treat the condition. The condition treated by the method of the present invention is any condition that is caused by an infection by a pathogen. The pathogen may be any pathogen as noted above. One of skill in the art will readily appreciate that the lists of pathogens above are not exhaustive and conditions caused by other pathogens may be treated by the present invention. Furthermore, one of skill in the art will readily appreciate that the various species noted above are representative of their genus; thus, the various embodiments of the present invention can be readily used on other species within the genus. Similarly, the genera noted above are representative of their families; thus, the various embodiments of the present invention can be used on other genera within the families. Administering the agent may be through any route of administration as noted below.

One embodiment of the present invention provides for a system for the prevention, treatment, and/or reduction of the chance of experiencing a harmful effect from exposure to a pathogenic microorganism, comprising an agent to prevent, treat and/or reduce the chance of a subject experiencing the harmful effect from exposure to the pathogenic microorganism. The system may further comprise a vehicle to dispense the agent.

Pathogenic microorganisms for which harmful effects may be prevented and/or treated, and/or for which the chance of experiencing a harmful effect may be reduced by the present inventive system include any of pathogenic microorganisms discussed above. However, the aforementioned list is not an exhaustive list of pathogenic microorganisms that may be prevented, treated and/or for which the chance of experiencing a harmful effect may be reduced by the present invention, as will readily be appreciated by those of skill in the art. Furthermore, one of skill in the art will readily appreciate that the various species noted above are representative of their genus; thus, the various embodiments of the present invention can be used on other species within the genus. Similarly, the various genera noted above are representative of their families; thus, the various embodiments of the present invention can be used on other genera within the families. In an embodiment of the present invention, the agent used to prevent, treat, and/or reduce the chance of experiencing a harmful effect by the present inventive system contains a pharmaceutically active ingredient in a carrier. The agent can be in any state; for example, liquid, solid, semi-solid, gel, gaseous. In another embodiment, the agent is antimicrobial, antiviral, antimycobacterial, antifungal and/or sporicidal. In another embodiment, the agent is substantially non-irritating to the eyes, ears, mouth, nose, wounds, mucous membranes and/or non-mucous membranes of a mammalian subject; particularly of a human subject. In another embodiment, the agent is substantially alcohol-free. In another embodiment, the agent contains a solution of oxychlorine compounds. In another embodiment, the agent comprises hypochlorous acid (HOCI) and hypochlorite ions (OCI ). In another embodiment, the agent comprises oxidized water, sodium hypochlorite (NaOCI), hypochlorous acid (HOCI) and sodium chloride (NaCI). In another embodiment, the agent contains about 99.99% oxidized water, sodium hypochlorite (NaOCI), hypochlorous acid (HOCI) and sodium chloride (NaCI).

In another embodiment, the agent is Microcyn® OTC Wound Care (available from Oculus Innovative Sciences, Inc.). In another embodiment, the agent is among the products described in U.S. Patent No. 7,090,753, or U.S. Patent Application Publication Nos. 2005/0142157, 2005/0139808, 2005/0196462, 2006/0235350, 2006/0241546, 2006/0253060, 2006/0272954, 2007/0173460, 2007/0173755,

2007/0196357, or 2007/0196434, each of which is incorporated by reference herein in its entirety as if fully set forth.

In another embodiment, the agent is a Sterilox™ solution (available from PuriCore pic). In another embodiment, the agent is among the products described in U.S. Patent Nos. 5,427,667, 5,540,819, 5,628,888, 5,635,040, 5,783,052, 5,871 ,623, 5,985,110, 6,004,439, 6,843,895, 6,632,347, 7,276,255, 6,528,214, 6,296,744, 6,752,757, 7,303,660 and U.S. patent application publication Nos. 2004/0060815, 2006/0124453, 2006/0249375, 2006/0278585, 2007/0017820, 2007/0051640, 2007/0108064, 2008/0075832, 2008/0156674, 2008/0160612, 2008/0156674, and 2008/0075832, each of which is incorporated by reference herein in its entirety as if fully set forth.

The agents described above generally impart the therapeutic effect by the oxychlorine compounds' ability to deactivate the microorganism's essential enzymes

I7 and structures, rendering them non-viable. (See, e.g., Landa-Solis et al., Microcyn ® : a novel super-oxidized water with neutral pH and disinfectant activity. J. H OSP INFECT. 2005;61(4):291-299; Tanaka et al., Antimicrobial activity of super-oxidized water. J HOSP INFECT. 1996;34(1):43-49; DaIIa Paola et al., Use ofDermacyn ® , a new antiseptic for the local treatment of diabetic foot ulcers. J WOUND HEALING.

2005;2:201; Altamirano, A-, Reducing Bacterial Infectious Complications from Burn Wounds. A look at the use of Oculus Microcyn ® to treat wounds in Mexico. WOUNDS. 2006, Supp:17-19; Gutierrez, A., Super-Oxidized Water Kills Bacteria; Demonstrates Potential for Healing, DERMATOLOGY TIMES. 26{6), June 2005; Nakae e. a/., Effectiveness of electrolyzed oxidized water irrigation in a burn-wound infection model. J. TRAUMA. 2000;49{3):511-514; Ie Due et al., A Cytotoxic Analysis of Antiseptic Medication on Skin Substitutes and Autograft. BRITISH JOURNAL OF DERMATOLOGY. March 2007; Davis etal., An In Vitro Comparison of the Antimicrobial Effects of Various Endodontic Medicaments on Enterococcus faecalis. JOURNAL OF ENDODONTICS. 33(5), May 2007; Zahumensky, E., Infections and diabetic foot syndrome in field practice. VNITR LEK. 2006;52:411-416; and Veverkova et al., Methicilin-resistent Staphylococcus aureus - problem in health care. J WOUND HEALING. 2005, 2:201-202.)

The agents can generally be produced by the electrolysis of water and salt, resulting in the following chemical reaction to generate the active agents:

NaCl + H 2 O = NaOCI + HOCI = Na + + H + + OCI "

Hypochlorous acid (HOCI) and hypochlorite ions (OCI " ) react with a wide range of biological molecules. Notably, hypochlorous acid (HOCI) is produced by neutrophils in the human body in its defense against microorganisms and thus, is a suitable agent to use in the prevention, treatment and/or reduction of the chance of experiencing a harmful effect by a pathogenic microorganism in accordance with various embodiments of the present invention. Additionally, it is a suitable agent to use in the treatment of a condition caused by a pathogenic microorganism infection. Furthermore, in one embodiment, the pH of the agent can be neutral because both acids and bases are present creating a buffered solution.

In another embodiment, the agent is a SteriFx ® composition and/or solution (available from SteriFx ® , Inc.); for example, FreshFx ® Antimicrobial Solution, VetFx ® Wound Care Spray, CleanseFx ® Antimicrobial Skin Cleanser, DeconFx™ is Decontamination Solution, Fx HSD Disinfectant and the compositions and/or solutions contained in the Personal Decontamination Kits available from SteriFx ® . In another embodiment, the agent is among the products described in U.S. Patent No. 6,375,976, which is incorporated by reference herein in its entirety as if fully set forth. In another embodiment, the agent is among the products described in U.S. Patent Publication Nos. 2004/0211935 and 2002/0182264, each of which is incorporated by reference herein in its entirety as if fully set forth.

In another embodiment, the agent is among the products described in U.S. Patent No. 7,374,645. In another embodiment, the agent is an organosilane compound. In another embodiment, the agent is among the products described in U.S. Patent Nos. 5,959,014, 6,632,805, 6,221 ,944, 5,954,869, 6,113,815, 6,120,587, 6,469,120, or 6,762,172, each of which is incorporated by reference herein in its entirety as if fully set forth. The agent according to the present invention can also contain any pharmaceutically acceptable carrier. "Pharmaceutically acceptable carrier" as used herein refers to a pharmaceutically acceptable material, composition, or vehicle that is involved in carrying or transporting a compound of interest from one tissue, organ, or portion of the body to another tissue, organ, or portion of the body. For example, the carrier may be a liquid or solid filler, diluent, excipient, solvent, or encapsulating material, or a combination thereof. Each component of the carrier must be "pharmaceutically acceptable" in that it must be compatible with the other ingredients of the formulation. It must also be suitable for use in contact with any tissues or organs with which it may come in contact, meaning that it must not carry a risk of toxicity, irritation, allergic response, immunogenicity, or any other complication that excessively outweighs its therapeutic benefits.

The pharmaceutical compositions according to the invention can also be in the form of tablets, gel capsules, sugar-coated tablets, syrups, suspensions, solutions, emulsions, powders, granules, emulsions, microspheres or nanospheres or lipid vesicles or polymer vesicles allowing controlled release encapsulated for oral route of administration. Pharmaceutically acceptable solid or liquid carriers may be added to enhance or stabilize the composition, or to facilitate preparation of the composition. Liquid carriers include syrup, peanut oil, olive oil, glycerin, saline, alcohols and water. Solid carriers include starch, lactose, calcium sulfate, dihydrate, terra alba, magnesium stearate or stearic acid, talc, pectin, acacia, agar or gelatin. The carrier may also include a sustained release material such as glyceryl monostearate or glyceryl distearate, alone or with a wax. The pharmaceutical preparations are made following the conventional techniques of pharmacy involving milling, mixing, granulation, and compressing, when necessary, for tablet forms; or milling, mixing and filling for hard gelatin capsule forms. When a liquid carrier is used, the preparation may be in the form of a solution, syrup, elixir, emulsion or an aqueous or non-aqueous suspension. Such a liquid formulation may be administered directly p.o. or filled into a soft gelatin capsule.

The pharmaceutical compositions according to the invention may be delivered in a therapeutically effective amount. The precise therapeutically effective amount is that amount of the composition that will yield the most effective results in terms of efficacy of treatment in a given subject. This amount will vary depending upon a variety of factors, including but not limited to the characteristics of the therapeutic compound (including activity, pharmacokinetics, pharmacodynamics, and bioavailability), the physiological condition of the subject {including age, sex, disease type and stage, general physical condition, responsiveness to a given dosage, and type of medication), the nature of the pharmaceutically acceptable carrier or carriers in the formulation, and the route of administration. One skilled in the clinical and pharmacological arts will be able to determine a therapeutically effective amount through routine experimentation, for instance, by monitoring a subject's response to administration of a compound and adjusting the dosage accordingly. For additional guidance, see Remington: The Science and Practice of Pharmacy (Gennaro ed. 20th edition, Williams & Wtlkins PA, USA) (2000).

Typical dosages of an effective amount of the agent can be as indicated to the skilled artisan by the in vitro responses or responses in animal models. Such dosages typically can be reduced by up to about one order of magnitude in concentration or amount without losing the relevant biological activity. Thus, the actual dosage can depend upon the judgment of the physician, the condition of the patient, and the effectiveness of the therapeutic method based, for example, on the in vitro responsiveness of the relevant primary cultured cells or histocultured tissue sample, or the responses observed in the appropriate animal models.

In various embodiments, the carrier is a pharmaceutically acceptable excipient. "Pharmaceutically acceptable excipient" means an excipient that is useful in preparing a pharmaceutical composition that is generally safe, non-toxic, and desirable, and includes excipients that are acceptable for veterinary use as well as for human pharmaceutical use. Such excipients may be solid, liquid, semisolid, gel or, in the case of an aerosol composition, gaseous.

In various embodiments, the agent according to the present invention may be formulated for delivery via any route of administration. "Route of administration" may refer to any administration pathway known in the art, including but not limited to aerosol, topical, ocular, nasal, oral, auricular, anal, vaginal, urethral, transmucosal, transdermal, enteral, or parenteral. "Parenteral" refers to a route of administration that is generally associated with injection, including intraorbital, infusion, intraarterial, intracapsular, intracardiac, intradermal, intramuscular, intraperitoneal, intrapulmonary, intraspinal, intrasternal, intrathecal, intrauterine, intravenous, subarachnoid, subcapsular, subcutaneous, transmucosal, or transtracheal. Via the parenteral route (or any other route where it would be appropriate), the compositions may be in the form of solutions or suspensions for infusion or for injection, or as lyophilized powders. Via the topical route, the pharmaceutical compositions based on agents according to the invention may be formulated for treating the skin and mucous membranes and are in the form of ointments, creams, milks, salves, powders, impregnated pads, solutions, gels, sprays, lotions or suspensions. They can also be in the form of microspheres or nanospheres or lipid vesicles or polymer vesicles or polymer patches and hydrogels allowing controlled release. These topical-route compositions can be either in anhydrous form or in aqueous form depending on the clinical indication. Furthermore, administration may be via jet spray. Jet spray applicators are known in the art. For example, Medi-Jector VISION® (available from Antares Pharma) uses pressure to create a micro-thin stream of insulin that penetrates the skin in a fraction of a second and is dispersed into subcutaneous tissue; SteriJect; and PenJet, a small, needle-less, disposable jet injector that delivers a single dose of medication, powered by self-contained compressed inert gas. These jet spray applicators may be used for dermal crevices, dermal surfaces, and subdermal surfaces (but not necessarily subcutaneously into blood vessels). Via the aerosol route, the agent may be formulated, for example, for use in a nebulizer, which may be useful to treat a respiratory condition caused by airborne pathogenic microorganisms, and their spores and/or endospores that may bring about a harmful respiratory effect. Via the enteral route, the pharmaceutical compositions can be in the form of tablets, gel capsules, sugar-coated tablets, syrups, suspensions, solutions, powders, granules, emulsions, microspheres or nanospheres or lipid vesicles or polymer vesicles allowing controlled release. Via the ocular route, they may be in the form of eye drops. In various particular embodiments, the agent is formulated as a mouthwash or toothpaste, or onto dental floss. Accordingly, these may be useful for treating conditions caused by pathogenic infections in the oral cavity; for example, halitosis.

In further embodiments, the agent may be provided in a cosmetic product (e.g., liquid or cream foundation, liquid, cream, or gel blush, lip gloss, lip balm, lipstick, liquid, gel or cream eye liner, mascara, nail polish). In still further embodiments, the agent may be provided in a cream, paste, gel, lotion, sunblock lotion, suntan lotion, contact lens solution, eye drop, ear drop, shampoo, conditioner, hair product {e.g., gel, hairspray, mousse), mouthwash, or toothpaste. The system may be used to on mammalian subjects and fomites. The fomites can be any inanimate object that may be contaminated with the pathogenic microorganisms and serve in their transmission. Examples of fomites include but are not limited to utensils, dishes, cups, toothbrushes, combs, microscopes, books, doorknobs, keys, clothing, goggles, gloves, bedding, light switches, and faucets. The vehicle to dispense the agent may be any vehicle that is suitable for delivery of the agent to a subject who has been exposed to or suspected to have been exposed to the pathogenic microorganism. Selection of an appropriate vehicle may depend on the route of administration and/or the location to which the agent is administered. It may be particularly useful to enable the agents to be used directly (e.g., sprayed) onto a subject's face or other body surface and into a subject's eyes, ears, mouth, nose, and open wounds.

Thus, in one embodiment, wherein the agent is sprayed onto or into the subject, or a body part of the subject, the vehicle may be a spray bottle. In a particular embodiment, the vehicle is an inert container and dispenser as set forth in Example 1 below.

In other embodiments, the vehicle may be: bandaging materials (e.g., wherein the agent is applied onto the subject via a wound dressing; for example, a wound dressing may be soaked with the agent and then applied and/or wrapped around the subject or a body part of the subject, or a wound dressing may be presoaked with the agent for convenience and quick application of the bandaging materials); a nasal spray device (e.g., wherein the agent is applied into the subject's nasal passageway); a eye drop or eye wash bottle, {e.g., wherein the agent is administered into the subject eyes); a bottle (e.g., to refill other delivery vehicles, to allow the subject to use it as a mouth wash, to pour the agent onto the subject, etc.); a tube {e.g., to store a gel, paste or lotion form of the agent); and pre-moistened wipes (e.g., packaged towels or blankets that can be conveniently opened and used to wipe a surface of the body).

Another embodiment of present invention provides for a method of preventing, treating and/or reducing the chance of experiencing a harmful effect from exposure to a pathogenic microorganism in a subject in need thereof, comprising providing an agent to prevent, treat and/or reduce the chance of experiencing a harmful effect from the pathogenic microorganism, providing a vehicle to dispense the agent, and administering the agent to the subject. In an alternative embodiment, the agent is provided in the vehicle. In various embodiments, the agent is administered directly onto a subject's face or other body surface and/or into a subject's eyes, ears, mouth, nose, and/or open wounds. In various embodiments, administering the agent may comprise administering the agent to the subject after the subject has actually or potentially been exposed to the pathogenic microorganism, and/or administering the agent after the subject has been in close proximity to or in contact with subjects or bodily fluids of subjects that are known to be or are suspected of being infected with or hosts of the pathogenic microorganism.

In various embodiments, the agents used to prevent, treat and/or reduce the chance of experiencing a harmful effect from the pathogenic microorganism are as described above. Similarly, the vehicles used to dispense the agent are as described above. Furthermore, administration can be by any route of administration as described above.

In another embodiment, the present invention provides for a method of preventing and/or reducing the transmission of a pathogenic microorganism to a subject, comprising providing an agent to prevent and/or reduce the chance of experiencing a harmful effect from the pathogenic microorganism, providing a vehicle to dispense the agent, and applying the agent to a fomite so that the transmission of the pathogenic microorganism to a subject is prevented and/or reduced. Similar to the method discussed above, the agent can alternatively be provided in the vehicle. The fomites can be any inanimate object that may be contaminated with the pathogenic microorganism and serve in their transmission as discussed supra.

The present invention is also directed to a kit to prevent, treat and/or reduce the chance of experiencing a harmful effect from exposure to a pathogenic microorganism. The kits may also be useful for treating a condition caused by pathogenic infection. The kit is an assemblage of materials or components, including at least one of the agents to prevent, treat and/or reduce the chance of experiencing a harmful effect from an exposure to a pathogenic microorganism as described above. Thus, in some embodiments, the kit contains a composition including an agent, as described above.

The exact nature of the components configured in the inventive kit depends on its intended purpose. For example, some embodiments are configured for the purpose of treating a first responder at or near the site of a trauma or for treating an aid worker or military personnel in an unsanitary, or pathogenic microorganism- ridden environment. Some embodiments are configured for the purposes of treating oral conditions, respiratory conditions, or gastrointestinal conditions caused by pathogenic infection. In one embodiment, the kit is configured particularly for the purpose of treating mammalian subjects. Some embodiments are configured for the purposes of treating oral conditions, respiratory conditions, or gastrointestinal conditions caused by pathogenic infection, in another embodiment, the kit is configured particularly for the purpose of treating human subjects. In further embodiments, the kit is configured for veterinary applications, treating subjects such as, but not limited to, farm animals, domestic animals, and laboratory animals.

Instructions for use may be included in the kit. "Instructions for use" typically include a tangible expression describing the technique to be employed in using the components of the kit to effect a desired outcome, such as to prevent, treat and/or reduce the chance of experiencing a harmful effect from an exposure to a pathogenic microorganism; or to treat a condition caused by pathogenic infection, such as oral conditions, respiratory conditions, or gastrointestinal conditions. Optionally, the kit also contains other useful components, such as, diluents, buffers, pharmaceutically acceptable carriers, syringes, catheters, applicators, pipetting or measuring tools, bandaging materials, spray bottles, cleansing wipes or other useful paraphernalia as will be readily recognized by those of skill in the art.

The materials or components assembled in the kit can be provided to the practitioner stored in any convenient and suitable ways that preserve their operability and utility. For example the components can be in dissolved, dehydrated, or lyophilized form; they can be provided at room, refrigerated or frozen temperatures. The components are typically contained in suitable packaging material(s). As employed herein, the phrase "packaging material" refers to one or more physical structures used to house the contents of the kit, such as inventive compositions and the like. The packaging material is constructed by well known methods, preferably to provide a sterile, contaminant-free environment. In one embodiment, the packaging materials employed in the kit are those customarily utilized in first aid kits. As used herein, the term "package" refers to a suitable solid matrix or material such as glass, plastic, paper, foil, and the like, capable of holding the individual kit components. Thus, for example, a package can be an inert container and dispenser or a bottle used to contain suitable quantities of the agent. The packaging material generally has an external label which indicates the contents and/or purpose of the kit and/or its components.

EXAMPLES

The following examples are provided to better illustrate the claimed invention and are not to be interpreted as limiting the scope of the invention. To the extent that specific materials are mentioned, it is merely for purposes of illustration and is not intended to limit the invention. One skilled in the art may develop equivalent means or reactants without the exercise of inventive capacity and without departing from the scope of the invention.

Example 1 Inert container and dispenser

As illustrated in Figures 1-3, in one embodiment, the device includes a vial 101 with a dispenser assembly 102. An agent 103 may be stored in the vial 101 and delivered by operation of the dispenser assembly 102.

The vial 101 illustratively depicted in Figures 1-3 is generally cylindrical along its axis, with a closed base 104 and an open top 105. External screw threading 106 surrounds the open top 105, to enable the mechanical interaction of the vial 101 with corresponding internal screw threading 107 on the dispenser assembly 102. The mechanical interaction of the external screw threading 106 on the vial 101 with the internal screw threading 107 on the dispenser assembly 102 may create a substantially fluid-tight seal between these elements. A washer 108 may be included between the open top 105 and the dispenser assembly 102 to provide an additional (and in some cases less permeable) fluid seal. The washer may be constructed from any suitable material, as will be readily appreciated by those of skill in the art, such as, alone or in combination, an elastomeric material, rubber, silicone, plastic, polytetrafluoroethylene ("PTFE;" available under the trade name Teflon® from DuPont Corporation), the fluoropolymer PFA (e.g., perfluoroalkoxy polymer resin; also available under the trade name Teflon® from DuPont Corporation), the Dyneon™ TFM™ range of chemically-modified PTFE (available from 3M), aluminum, polyetheretherketone (PEEK), fluorinated ethylene propylene (FEP), fluoro-treated high-density polyethylene (HDPE), and any number of other materials that are substantially inert or non-reactive with regard to the agent 103. In alternate embodiments of the present invention, different mechanisms may be used to affix the dispenser assembly 102 to the vial 101; for example, but in no way limited to, a snap fitting, a pressure fitting, a heat seal, a chemical adhesive or any number of other mechanical or chemical mechanisms readily known to those of skill in the art.

In alternate embodiments of the present invention, the vial 101 may be selected from any of a variety of shapes, such as, alone or in combination, cylindrical, rectangular, spheroid or any other desirable geometric configuration. In alternate embodiments, the via) 101 may have a shape that remains consistent or changes in cross-section along its axis, such as circular, elliptical, square, rectangular, rhomboid, trapezoidal, triangular, pentagonal, hexagonal, octagonal, and so on. As noted above, as illustratively depicted in Figures 1-3, the vial 101 is generally cylindrical and thus retains a generally circular shape along the entirety of its axis.

The vial 101 may be constructed from any suitable material. The material may be selected based upon, among other things, the chemical properties of the agent 103 that is to be contained in the vial 101. Specifically, it may be desirable to select a material that does not have a deleterious impact on the chemical composition, medicinal efficacy, stability or other properties of the agent 103; particularly insofar as the agent 103 is to be stored in the vial 101 for any appreciable amount of time, as may be necessitated by the intended use of the present invention. By way of example, in some embodiments the vial 101 may be constructed from various types of plastic, metal, stainless steel, glass (e.g., borosilicate glass), PTFE, the fluoropolymer PFA (e.g., perfluoroalkoxy polymer resin), the Dyneon™ TFM™ range of chemically-modified PTFE, aluminum, polyetheretherketone (PEEK), fluorinated ethylene propylene (FEP), fluoro-treated high-density polyethylene (HDPE), and any number of other materials that are substantially inert or non-reactive with regard to the agent 103. As will be readily appreciated by those of skill in the art, a variety of different materials may be used to construct the vial 101 and may be desirable based on the selection of various agents 103, and such materials are all contemplated as being within the scope of the present invention and can be readily used in alternate embodiments thereof without undue experimentation.

The dispenser assembly 102 may be selected from any apparatus useful to dispense the agent 103 from the vial 101. Those of skill in the art will recognize numerous such apparatuses, which may include, but are no way limited to, pump sprayers, squeeze tops (e.g., those akin to the end of a conventional tube of toothpaste), aerosol sprayers, eye-droppers and applicator pads. As illustratively depicted in Figure 1 , in one embodiment of the present invention, the dispenser assembly 102 is a pump sprayer, and is configured with conventional components, including a spray head 102a, a plunger 102b, a spring 102c, a ball 102d and a hole 102e. The components may be constructed from any desirable materials, which, in some embodiments, are inert with respect to the agent 103. The ball 102d may be constructed from any desirable material, which, in one embodiment, is stainless steel. Because certain components of the dispenser assembly 102 only come into contact with the agent 103 upon actuation {i.e., when a user dispenses the agent 103 from the vial 101), such components may need not be constructed of materials that are inert with respect to the agent. In those embodiments of the invention where the dispenser assembly 102 is a pump sprayer, the components that do not come into contact with the agent 103 until actuation may include the spray head 102a, plunger 102b, spring 102c and/or ball 102d.

Certain components of the dispenser assembly 102 may remain in fluid communication with the agent 103, irrespective of device actuation (e.g., during such time as the agent 103 is stored in the vial 101). For instance, in those embodiments of the present invention when the dispenser assembly 102 is a pump sprayer (as depicted in Figures 1-3 and 5), an insert portion 109 thereof may extend axially from the portion of the pump sprayer that remains external to the vial 101, into the interior of the vial 101 where the agent 103 is contained. In certain embodiments of the present invention it may be desirable for the insert portion 109 to be constructed of a material that does not have a deleterious impact on the chemical composition, medicinal efficacy or other properties of the agent 103. Therefore, in particular embodiments of the present invention, the insert portion 109 may be constructed from various types of glass (e.g., borosilicate glass), PTFE, the fluoropolymer PFA (e.g., perfluoroalkoxy polymer resin), the Dyneon™ TFM ™ range of chemically- modified PTFE, aluminum, polyetheretherketone (PEEK), fluorinated ethylene propylene (FEP), fluoro-treated high-density polyethylene (HDPE), and any number of other materials that are substantially inert or non-reactive with regard to the agent 103. The insert portion 109 may be substantially rigid and configured to reach a region of the vial 101 near its closed base 104, such that most, if not substantially all of the agent 103 contained in the vial 101 may be dispensed through operation of the dispenser assembly 102. In various embodiments of the present invention, the radial dimensions of the insert portion 109 may vary along its length, or, alternatively, remain substantially constant. In the embodiment illustratively pictured in Figures 1- 3 and 5, the insert portion 109 includes exterior radii of different dimensions along its length, as well as interior radii of increasingly narrow dimension from the end of the insert portion 109 nearest the open top 105 of the vial 101 to its closed base 104. Among other things, such a configuration may serve to accommodate the various components of the dispenser assembly 102 and/or minimize the amount of materia! needed to manufacture the insert portion 109. In an embodiment, the insert portion 109 is a unitary item, rather than several segments that are manufactured separately and adhered or otherwise affixed to one another; although both alternatives are envisioned as being within the scope of the instant invention.

In another embodiment of the present invention, as depicted in Figures 4-7, the vial 101 and dispenser assembly 102 may be fitted within a barrel 110 and cap 111. The vial 101 may be stabilized within the barrel by a series of support elements 112 in mechanical contact with the closed base 104 on one end, and a series of flanges 113 that grasp the vial about its open top 105 beneath the external screw threading 106. The series of flanges 113 may be configured to separate in a radial direction from one another to allow the vial 101 to be inserted into the barrel 110. Once inserted, the flanges 113 may provide the aforementioned grasping force to retain the vial 101 within the barrel 110, such that it cannot be easily removed therefrom or slide out of the barrel 110 during normal operation. In an alternate embodiment, the flanges 113 exert substantially minimal force on said vial 101, but instead retain the vial 101 within the barrel 110 by virtue of having a circumference generally smaller than that of the outer surface of the vial 101 ; such that the vial 101 cannot slide through the flanges 113 without substantial force.

The flanges 113 may have locking elements 114 on their exterior surface configured to mechanically interact with receiving elements 115 on the interior surface of the cap 111 (Figure 8). The mechanical interaction of the locking elements 114 with the receiving elements 115 may keep the cap 111 and barrel 110 affixed to one another until such time as the cap 111 is intentionally removed from the barrel 110 by a user. As illustrated in Figure 6, when the cap 111 and barrel 110 are locked together, the dispenser assembly 102 is protected from inadvertent use. In another embodiment, the cap 111 may include a tab 116, configured to allow a user to easily remove the cap 111 from the barrel 110 by dislodging the locking elements 114 from the receiving elements 115. As illustrated in Figure 6, in one embodiment, the tab 116 includes a forward portion 117 affixed to one side of the cap 111, a rear portion 118 configured to receive a mechanical force from a user to separate the cap 111 from the barrel 110, and an intermediate portion 119 therebetween. The angle between the forward portion 117 and the axis of the cap 111 may be from about 0°to about 10°; the angle between the intermediate portion 119 and the axis of the cap 111 may be from about 45° to about 55°, and in one embodiment, about 50°; and the angle between the rear portion 118 and the axis of the cap 111 may be from about 0° to about 8°. The rear portion 118 may include a surface 120 configured to receive the finger of a user, the generally radial force (i.e., including, at most, a minimal longitudinal component) of which upon the surface 120 may dislodge the cap 111 from the barrel 110.

In an alternative embodiment, the vial and barrel exists as a unitary barrel, rather than separate components that are manufactured separately and affixed to one another. In one embodiment, the dispenser assembly 102 is fitted directly onto the unitary barrel. For instance, the unitary barrel may have an external screw threading surrounding the open top (not shown) similar to the external screw threading 106 that is on the vial 101 described above, to enable the mechanical interaction of the barrel with the corresponding internal screw threading 107 on the dispenser assembly 102. The mechanical interaction of the external screw threading on the unitary barrel with the internal screw threading 107 on the dispense assembly 102 may create a substantially fluid-tight seal between these elements. A washer 108 may be included between the open top and the dispenser assembly 102 to provide an additional (in some cases less permeable) fluid seal. The unitary barrel may be constructed from any suitable material. The material may be selected based upon, among other things, the chemical properties of the agent 103 that is to be contained in the unitary barrel. Specifically, it may be desirable to select a material that does not have a deleterious impact on the chemical composition, medicinal efficacy, stability or other properties of the agent 103; particularly insofar as the agent 103 is to be stored in the unitary barrel for any appreciable amount of time, as may be necessitated by the intended use of the present invention. By way of example, in some embodiments the unitary barrel may be constructed from various types of plastic, metal, stainless steel, glass (e.g., borosilicate glass), PTFE, the fluoropolymer PFA (e.g., perfluoroalkoxy polymer resin), the Dyneon™ TFM™ range of chemically-modified PTFE, aluminum, polyetheretherketone (PEEK), fluorinated ethylene propylene (FEP) 1 fluoro-treatecl high-density polyethylene (HDPE), and any number of other materials that are substantially inert or non-reactive with regard to the agent 103. As will be readily appreciated by those of skill in the art, a variety of different materials may be used to construct the unitary barrel and may be desirable based on the selection of various agents 103, and such materials are all contemplated as being within the scope of the present invention and can be readily used in alternate embodiments thereof without undue experimentation.

Example 2 Elimination of Microorganisms, Reduction of Pathogenic Microorganism Titers,

Germ-Killing, Antimicrobial/Anti-Viral/Anti-Fungal Activity, and/or Sporicidal Activity on a Surface Area of a Human Subject

A device as described herein is provided, including a glass vial with a pump sprayer, wherein the elements of the pump sprayer that are in direct contact with the agent contained in the device irrespective of device actuation are made from an inert material with respect to the agent. The glass vial includes a volume of an agent containing about 99.99% oxidized water, sodium hypochlorite (NaOCt) 1 hypochlorous acid (HOCI) and sodium chloride (NaCI). The glass vial and pump sprayer are fitted within a plastic barrel and cap assembly; the cap includes a tab with a surface configured to receive a user's finger.

A user exerts a generally radial force on the tab surface; thereby releasing the cap from the barrel. The user then sprays a quantity of the agent onto a wound, into his eyes, into his ears, into his mouth and/or onto any additional surfaces of his body after being contacted by a substance believed to contain pathogens. The agent prevents, treats and/or reduces the chance of an experiencing a harmful effect on the surfaces to which it is applied.

Various embodiments of the invention are described above in the Detailed Description. While these descriptions directly describe the above embodiments, it is understood that those skilled in the art may conceive modifications and/or variations to the specific embodiments shown and described herein. Any such modifications or variations that fall within the purview of this description are intended to be included therein as well. Unless specifically noted, it is the intention of the inventors that the words and phrases in the specification and claims be given the ordinary and accustomed meanings to those of ordinary skill in the applicable art(s).

The foregoing description of various embodiments of the invention known to the applicant at this time of filing the application has been presented and is intended for the purposes of illustration and description. The present description is not intended to be exhaustive nor limit the invention to the precise form disclosed and many modifications and variations are possible in the light of the above teachings. The embodiments described serve to explain the principles of the invention and its practical application and to enable others skilled in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. Therefore, it is intended that the invention not be limited to the particular embodiments disclosed for carrying out the invention.

While particular embodiments of the present invention have been shown and described, it will be obvious to those skilled in the art that, based upon the teachings herein, changes and modifications may be made without departing from this invention and its broader aspects and, therefore, the appended claims are to encompass within their scope all such changes and modifications as are within the true spirit and scope of this invention. It will be understood by those within the art that, in general, terms used herein are generally intended as "open" terms (e.g., the term "including" should be interpreted as "including but not limited to," the term "having" should be interpreted as "having at least," the term "includes" should be interpreted as "includes but is not limited to," etc.).