Methods and Uses of Producing Compositions Stably Comprising Free Available Chlorine Species and Peroxides

The present specification discloses a method of making a composition stably comprising one or more peroxides and one or more free available chlorine species, one or more peroxide for use in the manufacture of a composition stably comprising one or more peroxides and one or more free available chlorine species, as well as formulated compositions using a composition manufactured according to a method or use disclosed herein.

Hydrogen peroxide and hypochlorous acid may be used separately for the sterilization of various surfaces, including surgical tools, and may be deployed as a vapor (VHP) for room sterilization and may be used to treat topical infections as well as those infections developed within body cavities. Both compounds demonstrate broad-spectrum efficacy against viruses, bacteria, yeasts and fungi, and bacterial spores. However, since hydrogen peroxide is a strong oxidizer, free available chlorine, which may include hypochlorous acid amongst other forms of chlorine, remains highly unstable in the presence of hydrogen peroxide. Attempts to mix hydrogen peroxide and hypochlorous acid to date have failed to demonstrate a stable aqueous solution containing both compounds. Certain methods of production of hypochlorous acid, such as electrolysis, have cited the potential presence of theoretical peroxide in solution in insignificant and unstable amounts. The present specification disclosed herein pertains to a novel production of hydrogen peroxide which may include other reactive oxygen species in substantial amounts and the benefits of such discovery for producing a solution also comprising HOCl and/or one or more stable chlorine reactive species. As such, making a composition comprising both stable hydrogen peroxide, or other reactive oxygen species, and free available chlorine in the same solution has not been previously documented.

The present specification discloses compositions comprising a stable free available chlorine that can coexist in the presence of hydrogen peroxide, molecular oxygen, or another reactive oxygen species (ROS), now making it possible to combined free available chlorine with hydrogen peroxide. As shown herein, a composition comprising hydrogen peroxide and a stable free available chlorine exhibits significantly improved the cleaning, disinfecting, sanitizing, and/or sterilizing properties, physical properties, and product stability.

SUMMARY

Aspects of the present specification disclose a composition comprising hydrogen peroxide and a stable free available chlorine. A composition disclosed herein can further comprise and one or more metallic particles, one or more metal salts and/or a phosphate buffer like calcium phosphate or sodium phosphate. Stable free available chlorine disclosed herein may include compositions of hypochlorous acid, hypochlorite (OCl−), chlorine gas (Cl2), superchloride (Cl2−), chlorine oxide radical (ClO), peroxyhypochlorous acid (HOOCl), another reactive chlorine species (RCS), or a combination thereof.

Other aspects of the present specification disclose a composition comprising hydrogen peroxide, a stable free available chlorine, and one or more metallic particles. A composition disclosed herein can further comprise one or more metal salts and/or a phosphate buffer like calcium phosphate or sodium phosphate. Stable free available chlorine disclosed herein may include compositions of hypochlorous acid, hypochlorite (OCl−), chlorine gas (Cl2), superchloride (Cl2−), chlorine oxide radical (ClO), peroxyhypochlorous acid (HOOCl), another reactive chlorine species (RCS), or a combination thereof.

Other aspects of the present specification disclose a composition comprising hydrogen peroxide, a stable free available chlorine, and one or more metal salts. A composition disclosed herein can further comprise one or more metallic particles and/or a phosphate buffer like calcium phosphate or sodium phosphate. Stable free available chlorine disclosed herein may include compositions of hypochlorous acid, hypochlorite (OCl−), chlorine gas (Cl2), superchloride (CIA chlorine oxide radical (ClO), peroxyhypochlorous acid (HOOCl), another reactive chlorine species (RCS), or a combination thereof.

Other aspects of the present specification disclose a method of making a composition comprising one or more peroxides and a stable free available chlorine. A disclosed method uses a peroxide as a reagent in the manufacture of a stable free available chlorine. One or more peroxides disclosed herein include hydrogen peroxide, sodium peroxide, calcium peroxide, lithium peroxide, potassium peroxide, other alkali metal peroxides, other alkali earth metal peroxides, or a combination thereof. Presence free available chlorine disclosed herein may include compositions of hypochlorous acid, hypochlorite (OCl−), chlorine gas (Cl2), superchloride (Cl2−), chlorine oxide radical (ClO), peroxyhypochlorous acid (HOOCl), another reactive chlorine species (RCS), or a combination thereof. Additionally, the disclosed method produces a composition further comprising one or more reactive oxygen species, including, without limitation, oxygen gas (O2), superoxide (O2−), singlet oxygen (1O2), α-oxygen (α-O), protonated oxygen (HO2+), hydroperoxyl radical (HO2), hydroxyl radical (OH), peroxide (O2−2), ozone (O3), ozonide (O3−), another reactive oxygen species (ROS), or a combination thereof.

Other aspects of the present specification disclose a method of making a composition comprising hydrogen peroxide and a stable free available chlorine. A disclosed method uses a peroxide disclosed herein as a reagent in the manufacture of a stable free available chlorine. Stable free available chlorine disclosed herein may include compositions of hypochlorous acid, hypochlorite (OCl−), chlorine gas (Cl2), superchloride (Cl2), chlorine oxide radical (ClO), peroxyhypochlorous acid (HOOCl), another reactive chlorine species (RCS), or a combination thereof.

Other aspects of the present specification disclose a kit comprising one or more containers including a composition disclosed herein and/or one or more containers including components of a composition disclosed herein. A disclosed kit further comprises one or more delivery or application systems, and/or instructions, and/or a container.

Other aspects of the present specification disclose a method to clean, disinfect, sanitize, and/or sterilize a device. The disclosed method comprising applying a composition disclosed herein to a device, wherein application of the composition cleans, disinfects, sanitizes, and/or sterilizes the device. The disclosed method may further comprise rinsing a cleaned, disinfected, sanitized, and/or sterilized device with a rinse solution disclosed herein. In other aspects of the present specification disclose a composition disclosed herein for use in cleaning, disinfecting, sanitizing, and/or sterilizing a device. In other aspects of the present specification disclose a use of a disclosed composition clean, disinfect, sanitize, and/or sterilize a device.

Other aspects of the present specification disclose a method to clean, disinfect, sanitize, and/or sterilize a surface area. The disclosed method comprising applying a composition disclosed herein to a surface area, wherein application of the composition cleans, disinfects, sanitizes, and/or sterilizes the surface area. The disclosed method may further comprise rinsing a cleaned, disinfected, sanitized, and/or sterilized surface area with a rinse solution disclosed herein. In other aspects of the present specification disclose a composition disclosed herein for use in cleaning, disinfecting, sanitizing, and/or sterilizing a surface area. In other aspects of the present specification disclose a use of a disclosed composition clean, disinfect, sanitize, and/or sterilize a surface area.

Other aspects of the present specification disclose a method to clean, disinfect, sanitize, treat, and/or sterilize a wound in an individual. The disclosed method comprising applying a composition disclosed herein to an individual, wherein application of the composition cleans, disinfects, sanitizes, treat, and/or sterilizes a wound. In other aspects of the present specification disclose a composition disclosed herein for use in cleaning, disinfecting, sanitizing, and/or sterilizing of a wound in an individual. In other aspects of the present specification disclose a use of a disclosed composition clean, disinfect, sanitize, treat, and/or sterilize of a wound in an individual. In other aspects of the present specification disclose a use of a disclosed composition in the manufacture of a medicament to clean, disinfect, sanitize, treat, and/or sterilize of a wound in an individual.

Other aspects of the present specification disclose a method to clean, disinfect, sanitize, treat, and/or sterilize a body tissue or body cavity in an individual. The disclosed method comprising applying a composition disclosed herein to an individual, wherein application of the composition cleans, disinfects, sanitizes, treat, and/or sterilizes a body tissue or body cavity. In other aspects of the present specification disclose a composition disclosed herein for use in cleaning, disinfecting, sanitizing, treat, and/or sterilizing of a body tissue or body cavity in an individual. In other aspects of the present specification disclose a use of a disclosed composition clean, disinfect, sanitize, treat, and/or sterilize of a body tissue or body cavity in an individual. In other aspects of the present specification disclose a use of a disclosed composition in the manufacture of a medicament to clean, disinfect, sanitize, treat, and/or sterilize of a body tissue or body cavity in an individual. A body cavity can be a space, compartment, or lumen, or potential space, compartment or lumen in the body. A body cavity may include any space, compartment or lumen that contains organs, limbs, tissues, and surfaces within the body, or any space, compartment or lumen within organs, limbs, or tissues. A body cavity may include areas with the organs, for example an airway within the lungs, a nasal cavity, an oral cavity, a lumen of the gastrointestinal or excretory system including urethra and ureter, and spaces within the reproductive organs. A body cavity may be exposed to the outside of the body or may not be exposed to the outside space of the body. A body cavity any space created in the body. A body cavity may also include a space created in the body from injury or surgery or other artificial means.

Other aspects of the present specification disclose a method to clean, disinfect, sanitize, treat, and/or prevent an infection in an individual. The disclosed method comprising applying a composition disclosed herein to an individual, wherein application of the composition cleans, disinfects, sanitizes, treat, and/or prevent an infection. In other aspects of the present specification disclose a composition disclosed herein for use in cleaning, disinfecting, sanitizing, treat, and/or prevent of an infection in an individual. In other aspects of the present specification disclose a use of a disclosed composition clean, disinfect, sanitize, treat, and/or prevent an infection in an individual. In other aspects of the present specification disclose a use of a disclosed composition in the manufacture of a medicament to clean, disinfect, sanitize, treat, and/or prevent an infection in an individual. An infection can be a microbial infection.

Other aspect of the present specification disclose a method to treat or prevent a respiratory infection in an individual. The disclosed method comprising applying a composition disclosed herein to an individual, wherein application of the composition cleans, disinfects, sanitizes, treats, and/or prevents a respiratory infection. In other aspects of the present specification disclose a composition disclosed herein for use in cleaning, disinfecting, sanitizing, treating, and/or preventing a respiratory infection in an individual. In other aspects of the present specification disclose a use of a disclosed composition to clean, disinfect, sanitize, treat, and/or prevent a respiratory infection in an individual. In other aspects of the present specification disclose a use of a disclosed composition in the manufacture of a medicament to clean, disinfect, sanitize, treat, and/or prevent a respiratory infection in an individual. An infection can be a viral, bacterial, or fungal infection. A viral infection can be an infection from a coronoavirus (including SARS-CoV-2, MERS, SARS), influenza, Respiratory syncytial virus (RSV), enterovirus, and other viruses.

Other aspects of the present specification disclose a method to treat a wound in an individual. The disclosed method comprising applying a composition disclosed herein to an individual, wherein application of the composition promotes healing of a wound. In other aspects of the present specification disclose a composition disclosed herein for use in treating a wound in an individual. In other aspects of the present specification disclose a use of a disclosed composition to treat a wound in an individual. In other aspects of the present specification disclose a use of a disclosed composition in the manufacture of a medicament to treat a wound in an individual.

Other aspect of the present specification disclose a method to clean, disinfect, sanitize, treat, prevent and/or provide relief an inflammatory response in the respiratory system, including the lung, of an individual. In aspects a disclosed method comprising applying a composition disclosed herein to an individual, wherein application of the composition promotes healing of a respiratory inflammation. In other aspects of the present specification disclose a composition disclosed herein for use in cleaning, disinfecting, sanitizing, treating, preventing and/or providing relief of a respiratory inflammation in an individual. In yet other aspects of the present specification disclose a use of a disclosed composition to treat and/or provide relief from a respiratory inflammation in an individual. In still other aspects of the present specification disclose a use of a disclosed composition in the manufacture of a medicament to clean, disinfect, sanitize, treat, prevent and/or provide relief from a respiratory inflammation in an individual.

DETAILED DESCRIPTION

Aspects of the present specification disclose a method of combining stable free available chlorine with one or more peroxides in an aqueous solution. Stable free available chlorine disclosed herein may include compositions of hypochlorous acid, hypochlorite (OCl−), chlorine gas (Cl2), superchloride (Cl2), chlorine oxide radical (ClO), peroxyhypochlorous acid (HOOCl), another reactive chlorine species (RCS), or a combination thereof. One or more peroxides disclosed herein include hydrogen peroxide, sodium peroxide, calcium peroxide, lithium peroxide, potassium peroxide, other alkali metal peroxides, other alkali earth metal peroxides, or a combination thereof. Additionally, the disclosed method produces a composition further comprising one or more reactive oxygen species, including, without limitation, oxygen gas (O2), superoxide (O2−), singlet oxygen (1O2), α-oxygen (α-O), protonated oxygen (HO2+), hydroperoxyl radical (HO2), hydroxyl radical (OH), peroxide (O2−2), ozone (O3), ozonide (O3−), another reactive oxygen species (ROS), or a combination thereof.

Standard understanding of chlorine chemistry has shown combinations of HOCl or FAC with hydrogen peroxide are unstable formulations. An example of such reaction is as follows:

In this example, the HOCl and peroxide interact to generate oxygen gas (O2) and an acidic solution. This redox reaction moves rapidly in a unidirectional manner to eliminate the peroxide and HOCl in an aqueous solution to produce water, hydrochloric acid and oxygen gas.

The disclosed methods involve a novel chemistry that establishes a solution in equilibrium with the addition of sodium peroxide (NA2O2) and chlorine gas (Cl2) in an aqueous solution. Without wishing to be limited to any theory, the proposed chemical equations are believed to be as follows:

The importance of the new chemistry involves the equilibrium achieved with the combination of sodium peroxide and free chlorine. An aspect of the present specification discloses a chemistry that balances this chemical equilibrium to allow for the simultaneous presence of hydrogen peroxide and hypochlorous acid. Notably, as the solution achieves saturation of dissolved chlorine to achieve balance with the dissolved peroxide, the solution exhibits a color change to become greyer in appearance and the formation and release of excess oxygen gas (O2) occurs during the manufacturing process while significantly reducing the release of chlorine gas (odor) from the manufactured solution. Additionally, there is a dynamic interplay of various reactive ionic species of chlorine and oxygen, that is at least partially pH dependent for a subset of these species. Besides hypochlorous acid, hypochlorite (OCl−), chlorine gas (Cl2), other stable free available chlorine species include, without limitation, superchloride (Cl2−), chlorine oxide radical (ClO), peroxyhypochlorous acid (HOOCl), another reactive chlorine species (RCS), or a combination thereof. Reactive oxygen species produced by this dynamic equilibrium shift can include, without limitation, superoxide (O2−), singlet oxygen (1O2), α-oxygen (α-O), protonated oxygen (HO2+), hydroperoxyl radical (HO2), hydroxyl radical (OH), peroxide (O2−2), ozone (O3), ozonide (O3−), another reactive oxygen species (ROS), or a combination thereof.

In some embodiments, method of producing a solution comprising one or more stable free available chlorine species and one or more peroxides comprises first preparing a first solution comprising purified water and an appropriate trace amount of one or more peroxides. Chlorine gas is then introduced to the first solution for a first period of time to produce a first reaction solution. Without wishing to be bound by any theory, it is believed that this first reaction solution comprises approximately equimolar amounts of one or more free available chlorine species and one or more peroxide species and has a pH below 4. Once this first reaction step is completed, an appropriate trace amount of one or more peroxides is added to the first reaction solution. This peroxide addition has the effect of increasing the pH to above 9 and eliminating the detection of the one or more free available chlorine species previously produced. Chlorine gas is then again introduced to the first reaction solution for a second period of time to produce a second reaction solution. Without wishing to be bound by any theory, it is believed that this second reaction solution comprises approximately equimolar amounts of one or more free available chlorine species and one or more peroxide species and has a pH below 4. Surprisingly, repeating of the peroxide addition and chlorine gassing steps a second time resulted in significantly higher levels of one or more free available chlorine species and one or more peroxides in the resulting second reaction solution as compared to the first reaction solution, even though no free available chlorine species is detected after the second addition of the one or more peroxides. Subsequent repeats of the peroxide addition and chlorine gassing steps for a third time or more resulted in further increased levels of one or more free available chlorine species and one or more peroxides in the resulting solution. In some embodiments, the periods of time a solution is introduced with chlorine gas is successively shorter in duration. For example, in a method disclosed herein comprising two rounds of peroxide addition and chlorine gassing steps, the first period of time will be longer in duration than the second period of time. Similarly, in a method disclosed herein comprising three rounds of peroxide addition and chlorine gassing steps, the first period of time will be longer in duration than the second period of time and the second period of time will be longer in duration than the third period of time depending on the increased amount of sodium peroxide added and final desired free available chlorine in the final solution.

A method of producing a solution comprising one or more stable free available chlorine species and one or more peroxides comprises preparing a first solution comprising an appropriate amount of one or more peroxides. In some embodiments, an appropriate amount of one or more peroxides in a first solution can be, e.g., about 0.01% to about 0.15%, about 0.02% to about 0.12%, about 0.03% to about 0.11%, about 0.04% to about 0.10%, about 0.05% to about 0.09%, or about 0.06% to about 0.08% by weight of the first solution.

A method of producing a solution comprising one or more stable free available chlorine species and one or more peroxides comprises introducing a chlorine gas to a first solution for a first period of time. In some embodiments, a first period of time can be, e.g., about 30 minutes to about 40 minutes, about 30 minutes to about 45 minutes, about 30 minutes to about 50 minutes, about 30 minutes to about 55 minutes, or about 30 minutes to about 60 minutes.

A method of producing a solution comprising one or more stable free available chlorine species and one or more peroxides comprises preparing a first reaction solution comprising an appropriate amount of one or more peroxides. In some embodiments, an appropriate amount of one or more peroxides in a first reaction solution can be, e.g., about 0.001% to about 0.01%, about 0.001% to about 0.0125%, about 0.001% to about 0.015%, about 0.001% to about 0.0175%, about 0.001% to about 0.02%, about 0.001% to about 0.03%, about 0.001% to about 0.04%, about 0.0025% to about 0.01%, about 0.0025% to about 0.0125%, about 0.0025% to about 0.015%, about 0.0025% to about 0.0175%, about 0.0025% to about 0.02%, about 0.0025% to about 0.03%, about 0.0025% to about 0.04%, about 0.005% to about 0.01%, about 0.005% to about 0.0125%, about 0.005% to about 0.015%, about 0.005% to about 0.0175%, about 0.005% to about 0.02%, about 0.005% to about 0.03%, about 0.005% to about 0.04%, about 0.0075% to about 0.01%, about 0.0075% to about 0.0125%, about 0.0075% to about 0.015%, about 0.0075% to about 0.0175%, about 0.0075% to about 0.02%, about 0.0075% to about 0.03%, about 0.0075% to about 0.04%, about 0.01% to about 0.0125%, about 0.01% to about 0.015%, about 0.01% to about 0.0175%, about 0.01% to about 0.02%, about 0.01% to about 0.03%, or about 0.01% to about 0.04% by weight of the first reaction solution.

A method of producing a solution comprising one or more stable free available chlorine species and one or more peroxides comprises introducing a chlorine gas to a first reaction solution for a second period of time. In some embodiments, the second period of time of introducing a chlorine gas to a first reaction solution is of shorter duration than the first period of time of introducing a chlorine gas to a first solution. In some embodiments, a second period of time can be, e.g., about 5 minutes to about 10 minutes, about 5 minutes to about 15 minutes, about 5 minutes to about 20 minutes, about 5 minutes to about 30 minutes, about 10 minutes to about 15 minutes, about 10 minutes to about 20 minutes, about 10 minutes to about 30 minutes, about 15 minutes to about 20 minutes, about 15 minutes to about 30 minutes, or about 20 minutes to about 30 minutes.

A method of producing a solution comprising one or more stable free available chlorine species and one or more peroxides comprises preparing a second reaction solution comprising an appropriate amount of one or more peroxides. In some embodiments, an appropriate amount of one or more peroxides in a second reaction solution can be, e.g., about 0.001c/o to about 0.01c/o, about 0.001% to about 0.0125%, about 0.001% to about 0.015%, about 0.001% to about 0.0175%, about 0.001% to about 0.02%, about 0.001% to about 0.03%, about 0.001% to about 0.04%, about 0.0025% to about 0.01%, about 0.0025% to about 0.0125%, about 0.0025% to about 0.015%, about 0.0025% to about 0.0175%, about 0.0025% to about 0.02%, about 0.0025% to about 0.03%, about 0.0025% to about 0.04%, about 0.005% to about 0.01%, about 0.005% to about 0.0125%, about 0.005% to about 0.015%, about 0.005% to about 0.0175%, about 0.005% to about 0.02%, about 0.005% to about 0.03%, about 0.005% to about 0.04%, about 0.0075% to about 0.01%, about 0.0075% to about 0.0125%, about 0.0075% to about 0.015%, about 0.0075% to about 0.0175%, about 0.0075% to about 0.02%, about 0.0075% to about 0.03%, about 0.0075% to about 0.04%, about 0.01% to about 0.0125%, about 0.01% to about 0.015%, about 0.01% to about 0.0175%, about 0.01% to about 0.02%, about 0.01% to about 0.03%, or about 0.01% to about 0.04% by weight of the first reaction solution.

A method of producing a solution comprising one or more stable free available chlorine species and one or more peroxides comprises introducing a chlorine gas to a second reaction solution for a third period of time. In some embodiments, the third period of time of introducing a chlorine gas to a second reaction solution is of shorter duration than the second period of time of introducing a chlorine gas to a first reaction solution. In some embodiments, a first period of time can be, e.g., about 1 minute to about 3 minutes, about 1 minute to about 5 minutes, about 1 minute to about 7 minutes, about 1 minute to about 10 minutes, about 3 minutes to about 5 minutes, about 3 minutes to about 7 minutes, about 3 minutes to about 10 minutes, about 5 minutes to about 10 minutes, or about 7 minutes to about 10 minutes.

A method of producing a solution comprising one or more stable free available chlorine species and one or more peroxides comprising further peroxide addition and chlorine gassing steps, i.e., a fourth repeat, fifth repeat, sixth repeat, etc. will employ conditions similar to the third repeated cycle.

In some embodiments, a method disclosed herein uses a peroxide disclosed herein to stabilize free available chlorine. In some embodiments, the method includes adding a peroxide disclosed herein at the time of producing free available chlorine. In aspects of these embodiments, free available chlorine is produced using a hydrolysis method or an electrolysis method. A peroxide disclosed herein may be added as a starting ingredient to facilitate simultaneous produce free available chlorine and a peroxide disclosed herein in situ.

In some embodiments, a method disclosed herein uses sodium peroxide to stabilize free available chlorine. In some embodiments, the method includes adding sodium peroxide at the time of producing free available chlorine. In aspects of these embodiments, free available chlorine is produced using a hydrolysis method or an electrolysis method. Sodium peroxide may be added as a starting ingredient to facilitate simultaneous produce free available chlorine and hydrogen peroxide in situ.

Aspects of the present specification disclose a method of producing a composition comprising stable free available chlorine and one or more peroxides in an aqueous solution. An alternative method to achieve the above stable chemistry in equilibrium may be achieve by the combination of oxygen gas (O2) with chlorine gas (Cl2) in an aqueous solution with dissolved NaCl. Although not as efficient as the sodium peroxide method, the chemistry may be reproduced to equilibrium with such methods.

Aspects of the present specification disclose a method of combining stable free available chlorine with hydrogen peroxide in an aqueous solution. Stable free available chlorine disclosed herein may include compositions of hypochlorous acid, hypochlorite (OCl−), chlorine gas (Cl2), superchloride (Cl2), chlorine oxide radical (ClO), peroxyhypochlorous acid (HOOCl), another reactive chlorine species (RCS), or a combination thereof. In some embodiments, a method disclosed herein uses sodium peroxide to stabilize free available chlorine. In some embodiments, the method includes adding sodium peroxide at the time of producing free available chlorine. In aspects of these embodiments, free available chlorine is produced using a hydrolysis method or an electrolysis method. Sodium peroxide may be added as a starting ingredient to facilitate simultaneous produce free available chlorine and hydrogen peroxide in situ.

Aspects of the present specification disclose a method of producing a composition comprising stable free available chlorine and one or more peroxides in an aqueous solution. Stable free available chlorine disclosed herein may include compositions of hypochlorous acid, hypochlorite (OCl−), chlorine gas (Cl2), superchloride (Cl2−), chlorine oxide radical (ClO), peroxyhypochlorous acid (HOOCl), another reactive chlorine species (RCS), or a combination thereof. A peroxide is a compound with the structure R—O—O—R. The O—O group in a peroxide is called the peroxide group or peroxo group. In contrast to oxide ions, the oxygen atoms in the peroxide ion have an oxidation state of −1. A peroxide includes metal peroxides where R is a metal atom. Metal peroxides may include alkali metal and alkaline earth metal atoms which form ion peroxides, zinc, cadmium, mercury atoms which form covalent peroxides; and magnesium atoms which form ion-covalent hybrid peroxides. One or more peroxides disclosed herein include hydrogen peroxide, sodium peroxide, calcium peroxide, lithium peroxide, potassium peroxide, other alkali metal peroxides, other alkali earth metal peroxides, or a combination thereof. In some embodiments, a method disclosed herein uses sodium peroxide to stabilize free available chlorine. In some embodiments, the method includes adding sodium peroxide at the time of producing free available chlorine. In aspects of these embodiments, free available chlorine is produced using a hydrolysis method or an electrolysis method. Sodium peroxide may be added as a starting ingredient to facilitate simultaneous produce free available chlorine and hydrogen peroxide in situ. Additionally, the disclosed method produces a composition further comprising one or more reactive oxygen species, including, without limitation, oxygen gas (O2), superoxide (O2−), singlet oxygen (1O2), α-oxygen (α-O), protonated oxygen (HO2+), hydroperoxyl radical (HO2), hydroxyl radical (OH), peroxide (O2−2), ozone (O3), ozonide (O3−), another reactive oxygen species (ROS), or a combination thereof.

Aspects of the present specification disclose a method of producing a composition comprising stable free available chlorine and hydrogen peroxide in an aqueous solution. Stable free available chlorine disclosed herein may include compositions of hypochlorous acid, hypochlorite (OCl−), chlorine gas (Cl2), superchloride (Cl2−), chlorine oxide radical (ClO), peroxyhypochlorous acid (HOOCl), another reactive chlorine species (RCS), or a combination thereof. In some embodiments, a method disclosed herein uses sodium peroxide to stabilize free available chlorine. In some embodiments, the method includes adding sodium peroxide at the time of producing free available chlorine. In aspects of these embodiments, free available chlorine is produced using a hydrolysis method or an electrolysis method. Sodium peroxide may be added as a starting ingredient to facilitate simultaneous produce free available chlorine and hydrogen peroxide in situ.

Aspects of the present specification disclose a peroxide for use in making a composition comprising one or more peroxides and stable free available chlorine. In other aspects, the present specification disclose use of a peroxide in making a composition comprising one or more peroxides and stable free available chlorine. In yet other aspects, the present specification disclose use of a peroxide in the manufacture of a composition comprising one or more peroxides and stable free available chlorine. Stable free available chlorine disclosed herein may include compositions of hypochlorous acid, hypochlorite (OCl−), chlorine gas (Cl2), superchloride (CIA chlorine oxide radical (ClO), peroxyhypochlorous acid (HOOCl), another reactive chlorine species (RCS), or a combination thereof. One or more peroxides disclosed herein include hydrogen peroxide, sodium peroxide, calcium peroxide, lithium peroxide, potassium peroxide, other alkali metal peroxides, other alkali earth metal peroxides, or a combination thereof.

Aspects of the present specification disclose a peroxide for use in making a composition comprising hydrogen peroxide and stable free available chlorine. In other aspects, the present specification disclose use of a peroxide in making a composition comprising hydrogen peroxide and stable free available chlorine. In yet other aspects, the present specification disclose use of a peroxide in the manufacture of a composition comprising hydrogen peroxide and stable free available chlorine.

Aspects of the present specification disclose a sodium peroxide for use in making a composition comprising hydrogen peroxide and stable free available chlorine. In other aspects, the present specification disclose use of a sodium peroxide in making a composition comprising hydrogen peroxide and stable free available chlorine. In yet other aspects, the present specification disclose use of a sodium peroxide in the manufacture of a composition comprising hydrogen peroxide and stable free available chlorine.

Aspects of the present specification disclose a peroxide for use in making a composition comprising one or more peroxides and stable hypochlorous acid. In other aspects, the present specification disclose use of a peroxide in making a composition comprising one or more peroxides and stable hypochlorous acid. In yet other aspects, the present specification disclose use of a peroxide in the manufacture of a composition comprising one or more peroxides and stable hypochlorous acid. Stable free available chlorine disclosed herein may include compositions of hypochlorous acid, hypochlorite (OCl−), chlorine gas (Cl2), superchloride (Cl2−), chlorine oxide radical (ClO), another reactive chlorine species (RCS), or a combination thereof. One or more peroxides disclosed herein include hydrogen peroxide, sodium peroxide, calcium peroxide, lithium peroxide, potassium peroxide, other alkali metal peroxides, other alkali earth metal peroxides, or a combination thereof.

Aspects of the present specification disclose a peroxide for use in making a composition comprising hydrogen peroxide and stable hypochlorous acid. In other aspects, the present specification disclose use of a peroxide in making a composition comprising hydrogen peroxide and stable hypochlorous acid. In yet other aspects, the present specification disclose use of a peroxide in the manufacture of a composition comprising hydrogen peroxide and stable hypochlorous acid.

Aspects of the present specification disclose a sodium peroxide for use in making a composition comprising hydrogen peroxide and stable hypochlorous acid. In other aspects, the present specification disclose use of a sodium peroxide in making a composition comprising hydrogen peroxide and stable hypochlorous acid. In yet other aspects, the present specification disclose use of a sodium peroxide in the manufacture of a composition comprising hydrogen peroxide and stable hypochlorous acid.

The amount of a peroxide disclosed herein used in a method or use disclosed herein is an amount sufficient to stabilize free available chlorine or a component thereof. In aspects of these embodiments, the amount of a peroxide disclosed herein added to a method or use disclosed herein is to a final concentration of, e.g., about 0.001%, about 0.0025%, about 0.005%, about 0.0075%, 0.01%, about 0.02%, about 0.03%, about 0.04%, about 0.05%, or about 0.1%. In other aspects of these embodiments, the amount of a peroxide disclosed herein added to a method or use disclosed herein is to a final concentration of, e.g., at least 0.001%, at least 0.0025%, at least 0.005%, at least 0.0075%, at least 0.01%, at least 0.02%, at least 0.03%, at least 0.04%, at least 0.05%, or at least 0.1%. In yet other aspects of these embodiments, the amount of sodium peroxide added to a method or use disclosed herein is to a final concentration of, e.g., at most 0.001%, at most 0.0025%, at most 0.005%, at most 0.7%, at most 0.01%, at most 0.02%, at most 0.03%, at most 0.04%, at most 0.05%, or as most 0.1%. In still other aspects of these embodiments, the amount of a peroxide disclosed herein added to a method or use disclosed herein is to a final concentration of, e.g., about 0.001% to about 0.002%, about 0.001% to about 0.005%, about 0.005% to about 0.01%, about 0.01% to about 0.02%, about 0.01% to about 0.03%, about 0.01% to about 0.04%, about 0.01% to about 0.05%, about 0.02% to about 0.03%, about 0.02% to about 0.04%, about 0.02% to about 0.05%, about 0.03% to about 0.04%, about 0.03% to about 0.05%, about 0.03% to about 0.05%, or about 0.05% to 0.1%.

In aspects of these embodiments, the amount of sodium peroxide added to a method or use disclosed herein is to a final concentration of, e.g., about 0.001%, about 0.0025%, about 0.005%, about 0.0075%, 0.01%, about 0.02%, about 0.03%, about 0.04%, about 0.05%, or about 0.1%. In other aspects of these embodiments, the amount of sodium peroxide added to a method or use disclosed herein is to a final concentration of, e.g., at least 0.001%, at least 0.0025%, at least 0.005%, at least 0.0075%, at least 0.01%, at least 0.02%, at least 0.03%, at least 0.04%, at least 0.05%, or at least 0.1%. In yet other aspects of these embodiments, the amount of sodium peroxide added to a method or use disclosed herein is to a final concentration of, e.g., at most 0.001%, at most 0.0025%, at most 0.005%, at most 0.7%, at most 0.01%, at most 0.02%, at most 0.03%, at most 0.04%, at most 0.05%, or as most 0.1%. In still other aspects of these embodiments, the amount of sodium peroxide added to a method or use disclosed herein is to a final concentration of, e.g., about 0.001% to about 0.002%, about 0.001% to about 0.005%, about 0.005% to about 0.01%, about 0.01% to about 0.02%, about 0.01% to about 0.03%, about 0.01% to about 0.04%, about 0.01% to about 0.05%, about 0.02% to about 0.03%, about 0.02% to about 0.04%, about 0.02% to about 0.05%, about 0.03% to about 0.04%, about 0.03% to about 0.05%, about 0.03% to about 0.05%, or about 0.05% to 0.1%.

A method of manufacture disclosed herein produces a composition comprising one or more peroxides and a stable free available chlorine. One or more peroxides disclosed herein include hydrogen peroxide, sodium peroxide, calcium peroxide, lithium peroxide, potassium peroxide, other alkali metal peroxides, other alkali earth metal peroxides, or a combination thereof. Stable free available chlorine disclosed herein may include compositions of hypochlorous acid, hypochlorite (OCl−), chlorine gas (Cl2), superchloride (Cl2−) chlorine oxide radical (ClO), peroxyhypochlorous acid (HOOCl), another reactive chlorine species (RCS), or a combination thereof. Additionally, the disclosed method produces a composition further comprising one or more reactive oxygen species, including, without limitation, oxygen gas (O2), superoxide (O2−), singlet oxygen (1O2), α-oxygen (α-O), protonated oxygen (HO2+), hydroperoxyl radical (HO2), hydroxyl radical (OH), peroxide (O2−2), ozone (O3), ozonide (O3−), another reactive oxygen species (ROS), or a combination thereof.

A composition manufactured according to a method or use disclosed herein may comprise one or more peroxides disclosed herein. In some embodiments, a composition manufactured according to a method or use disclosed herein comprises an amount of one or more peroxides that provides a desired beneficial effect to a composition manufactured according to a method or use disclosed herein. In some embodiments, when a composition manufactured according to a method or use disclosed herein comprising one or more peroxides is formulated to be used in an undiluted state, the amount of peroxide used is an amount effective to clean, disinfect, sanitize, and/or sterilize. In some embodiments, when a composition manufactured according to a method or use disclosed herein comprising one or more peroxides is formulated to be used in an undiluted state, the amount of peroxide used is a microbiostatic effective amount. A microbiostatic effective amount of one or more peroxides is an amount that restrains, prohibits, or otherwise prevents microbial population growth without eradicating the microbes. In an aspect of this embodiment, a microbiostatic effective amount of one or more peroxides is an amount that restrains, prohibits, or otherwise prevents microbial population growth without eradicating the microbes to a degree that achieves disinfection, sanitization, or sterilization. Alternatively, when a composition manufactured according to a method or use disclosed herein comprising one or more peroxides will be diluted, the amount of peroxide used in such concentrated formulations can be any amount that does not cause precipitation of components in the composition disclosed herein or otherwise create unwanted effects that make the composition inoperable.

A composition manufactured according to a method or use disclosed herein may comprise a hydrogen peroxide. The simplest peroxide, hydrogen peroxide has the chemical formula H2O2, while its molecular formula is written as HOOH. As shown in Formula I, hydrogen peroxide is a simple, nonplanar molecule with a twisted C2 symmetry and has molar mass is 34.01 g/mol. Although the O—O bond is a single bond, the molecule has a relatively high rotational barrier of 2460 cm−1(29.45 kJ/mol).

Hydrogen peroxide is a very pale blue liquid in its pure form, slightly more viscous than water. Hydrogen peroxide is manufactured almost exclusively by the anthraquinone process. It begins with the reduction of an anthraquinone (such as 2-ethylanthraquinone or the 2-amyl derivative) to the corresponding anthrahydroquinone, typically by hydrogenation on a palladium catalyst. In the presence of oxygen, the anthrahydroquinone then undergoes autoxidation: the labile hydrogen atoms of the hydroxy groups transfer to the oxygen molecule, to give hydrogen peroxide and regenerating the anthraquinone. Most commercial processes achieve oxidation by bubbling compressed air through a solution of the anthrahydroquinone, with the hydrogen peroxide then extracted from the solution and the anthraquinone recycled back for successive cycles of hydrogenation and oxidation. As an alternative, sodium peroxide (Na2O2) can undergo hydrolysis in the presence of water to yield hydrogen peroxide and sodium hydroxide (NaOH).

In some embodiments, a composition manufactured according to a method or use disclosed herein comprises an amount of hydrogen peroxide that provides a desired beneficial effect to a composition manufactured according to a method or use disclosed herein. In some embodiments, when a composition manufactured according to a method or use disclosed herein comprising hydrogen peroxide is formulated to be used in an undiluted state, the amount of hydrogen peroxide used is an amount effective to clean, disinfect, sanitize, and/or sterilize. In some embodiments, when a composition manufactured according to a method or use disclosed herein comprising hydrogen peroxide is formulated to be used in an undiluted state, the amount of hydrogen peroxide used is a microbiostatic effective amount. A microbiostatic effective amount of hydrogen peroxide is an amount that restrains, prohibits, or otherwise prevents microbial population growth without eradicating the microbes. In an aspect of this embodiment, a microbiostatic effective amount of hydrogen peroxide is an amount that restrains, prohibits, or otherwise prevents microbial population growth without eradicating the microbes to a degree that achieves disinfection, sanitization, or sterilization. Alternatively, when a composition manufactured according to a method or use disclosed herein comprising hydrogen peroxide will be diluted, the amount of hydrogen peroxide used in such concentrated formulations can be any amount that does not cause precipitation of components in the composition disclosed herein or otherwise create unwanted effects that make the composition inoperable.

A composition manufactured according to a method or use disclosed herein may comprise a sodium peroxide. In some embodiments, a composition manufactured according to a method or use disclosed herein comprises an amount of sodium peroxide that provides a desired beneficial effect to a composition manufactured according to a method or use disclosed herein. In some embodiments, when a composition manufactured according to a method or use disclosed herein comprising sodium peroxide is formulated to be used in an undiluted state, the amount of sodium peroxide used is an amount effective to clean, disinfect, sanitize, and/or sterilize. In some embodiments, when a composition manufactured according to a method or use disclosed herein comprising sodium peroxide is formulated to be used in an undiluted state, the amount of sodium peroxide used is a microbiostatic effective amount. A microbiostatic effective amount of sodium peroxide is an amount that restrains, prohibits, or otherwise prevents microbial population growth without eradicating the microbes. In an aspect of this embodiment, a microbiostatic effective amount of sodium peroxide is an amount that restrains, prohibits, or otherwise prevents microbial population growth without eradicating the microbes to a degree that achieves disinfection, sanitization, or sterilization. Alternatively, when a composition manufactured according to a method or use disclosed herein comprising sodium peroxide will be diluted, the amount of sodium peroxide used in such concentrated formulations can be any amount that does not cause precipitation of components in the composition disclosed herein or otherwise create unwanted effects that make the composition inoperable.

A composition manufactured according to a method or use disclosed herein may comprise a stable free available chlorine. Stable free available chlorine can be produced using hydrolysis and electrolysis methods disclosed herein. Hydrolysis involved the dissolution of chlorine gas into an aqueous solution yielding H+, Cl−, and HOCl. Electrolysis involves exposure of a saline solution (H2O and NaCl) to anode and cathode powered electrodes and results in a release of H2gas at the cathode, Cl2gas at the anode and production of aqueous NaOH. Cl2gas is free to hydrolyze to produce HOCl. Thus, stable free available chlorine disclosed herein may include compositions of hypochlorous acid, hypochlorite (OCl−), chlorine gas (Cl2), superchloride (Cl2−), chlorine oxide radical (ClO), peroxyhypochlorous acid (HOOCl), another reactive chlorine species (RCS), or a combination thereof.

The chlorine amount may be measured by methods known in the art, such as a DPD colorimeter method (Lamotte Company, Chestertown, Md.), a UV spectrophotometry method, or other known methods established by the Environmental Protection Agency. In the DPD colorimeter method, a yellow color is formed by the reaction of free chlorine With N,N-diethyl-p-phenylenediamine (DPD) and the intensity is measured With a calibrated calorimeter that provides the output in parts per million. Further addition of potassium iodide turns the solution a pink color to provide the total chlorine value.

In some embodiments, a composition manufactured according to a method or use disclosed herein comprises an amount of stable free available chlorine that provides a desired beneficial effect to a composition disclosed herein. In some embodiments, when a composition manufactured according to a method or use disclosed herein comprising stable free available chlorine is formulated to be used in an undiluted state, the amount of stable free available chlorine used is an amount effective to clean, disinfect, sanitize, and/or sterilize. In some embodiments, when a composition manufactured according to a method or use disclosed herein comprising stable free available chlorine is formulated to be used in an undiluted state, the amount of stable free available chlorine used is a microbiostatic effective amount. A microbiostatic effective amount of stable free available chlorine is an amount that restrains, prohibits, or otherwise prevents microbial population growth without eradicating the microbes. In an aspect of this embodiment, a microbiostatic effective amount of stable free available chlorine is an amount that restrains, prohibits, or otherwise prevents microbial population growth without eradicating the microbes to a degree that achieves disinfection, sanitization, or sterilization. Alternatively, when a composition manufactured according to a method or use disclosed herein comprising stable free available chlorine will be diluted, the amount of stable free available chlorine used in such concentrated formulations can be any amount that does not cause precipitation of components in the composition disclosed herein or otherwise create unwanted effects that make the composition inoperable.

In aspects of this embodiment, a composition manufactured according to a method or use disclosed herein comprises stable free available chlorine in an amount of, e.g., about 0.10%, about 0.11%, about 0.12%, about 0.13%, about 0.14%, about 0.15%, about 0.16%, about 0.17%, about 0.18%, about 0.19%, about 0.2%, about 0.25%, about 0.3%, about 0.35%, about 0.4%, about 0.45%, or about 0.5% by weight of the composition. In other aspects of this embodiment, a composition manufactured according to a method or use disclosed herein comprises stable free available chlorine in an amount of, e.g., at least 0.10%, at least 0.11%, at least 0.12%, at least 0.13%, at least 0.14%, at least 0.15%, at least 0.16%, at least 0.17%, at least 0.18%, at least 0.19%, at least 0.2%, at least 0.25%, at least 0.3%, at least 0.35%, at least 0.4%, at least 0.45%, or at least 0.5% by weight of the composition. In yet other aspects of this embodiment, a composition manufactured according to a method or use disclosed herein comprises stable free available chlorine in an amount of, e.g., at most 0.10%, at most 0.11%, at most 0.12%, at most 0.13%, at most 0.14%, at most 0.15%, at most 0.16%, at most 0.17%, at most 0.18%, at most 0.19%, at most 0.2%, at most 0.25%, at most 0.3%, at most 0.35%, at most 0.4%, at most 0.45%, or at most 0.5% by weight of the composition. In still other aspects of this embodiment, a composition manufactured according to a method or use disclosed herein comprises stable free available chlorine in an amount of, e.g., about 0.10% to about 0.15%, about 0.10% to about 0.20%, about 0.10% to about 0.25%, about 0.10% to about 0.30%, about 0.10% to about 0.35%, about 0.10% to about 0.40%, about 0.10% to about 0.45%, about 0.10% to about 0.50%, about 0.20% to about 0.25%, about 0.20% to about 0.30%, about 0.20% to about 0.35%, about 0.20% to about 0.40%, about 0.20% to about 0.45%, about 0.20% to about 0.50%, about 0.30% to about 0.35%, about 0.30% to about 0.40%, about 0.30% to about 0.45%, about 0.30% to about 0.50%, about 0.40% to about 0.45%, about 0.40% to about 0.50%, or about 0.40% to about 0.50% by weight of the composition.

A composition manufactured according to a method or use disclosed herein may comprise a stable hypochlorous acid. A weak acid, the chemical formula of a stable hypochlorous acid is HOCl, while its molecular formula is written as HClO. As shown in Formula II, a stable hypochlorous acid is a simple molecule with the central oxygen connected to chlorine and hydrogen atoms through single bonds and has molar mass is 52.46 g/mol.

A stable hypochlorous acid is a colorless solution, and its exact physical properties are variable, depending on the concentration of hypochlorous in solution, pH, temperature, and other factors. A stable hypochlorous acid readily reacts with a variety of organic molecules, biomolecules, and other compounds.

A stable hypochlorous acid is in equilibrium with hypochlorite ions (OCl−) and dissolved chlorine gas (Cl2). The extent of the equilibrium is determined predominately by the salt concentration and pH of the solution. Temperature also impacts the ratio of the free chlorine component. Therefore, both FAC and pH need to be known to understand the amount of chlorine present as hypochlorous acid. In general, when the pH range is about 4.0 to about 5.6, approximately 100% of the available chlorine is present as HOCl. As the pH is lowered below about 4, there is an increase in dissolved chlorine gas (Cl2). Thus, at a pH of about 3, about 90% of the available chlorine is present as a stable hypochlorous acid, at a pH of about 2, about 75% of the available chlorine is present as a stable hypochlorous acid, at a pH of about 1.5, about 50% of the available chlorine is present as a stable hypochlorous acid, while at a pH of about 1, about 25% of the available chlorine is present as a stable hypochlorous acid. As the pH is increase above about 5.6, there is an increase in hypochlorite ions (OCl−). Thus, at a pH a pH of about 6.5, about 90% of the available chlorine is present as a stable hypochlorous acid, at a pH of about 7, about 75% of the available chlorine is present as a stable hypochlorous acid, at a pH of about 7.5, about 50% of the available chlorine is present as a stable hypochlorous acid, while at a pH of about 8, about 25% of the available chlorine is present as a stable hypochlorous acid.

In some embodiments, a composition manufactured according to a method or use disclosed herein comprises an amount of a stable hypochlorous acid that provides a desired beneficial effect to a composition manufactured according to a method or use disclosed herein. In some embodiments, when a composition manufactured according to a method or use disclosed herein comprising stable hypochlorous acid is formulated to be used in an undiluted state, the amount of stable hypochlorous acid used is an amount effective to clean, disinfect, sanitize, and/or sterilize. In some embodiments, when a composition manufactured according to a method or use disclosed herein comprising stable hypochlorous acid is formulated to be used in an undiluted state, the amount of stable hypochlorous acid used is a microbiostatic effective amount. A microbiostatic effective amount of stable hypochlorous acid is an amount that restrains, prohibits, or otherwise prevents microbial population growth without eradicating the microbes. In an aspect of this embodiment, a microbiostatic effective amount of stable hypochlorous acid is an amount that restrains, prohibits, or otherwise prevents microbial population growth without eradicating the microbes to a degree that achieves disinfection, sanitization, or sterilization. Alternatively, when a composition manufactured according to a method or use disclosed herein comprising stable hypochlorous acid will be diluted, the amount of stable hypochlorous acid used in such concentrated formulations can be any amount that does not cause precipitation of components in the composition disclosed herein or otherwise create unwanted effects that make the composition inoperable.

In aspects of this embodiment, a composition manufactured according to a method or use disclosed herein comprises a stable hypochlorous acid in an amount of, e.g., about 0.10%, about 0.11%, about 0.12%, about 0.13%, about 0.14%, about 0.15%, about 0.16%, about 0.17%, about 0.18%, about 0.19%, about 0.2%, about 0.25%, about 0.3%, about 0.35%, about 0.4%, about 0.45%, or about 0.5% by weight of the composition. In other aspects of this embodiment, a composition manufactured according to a method or use disclosed herein comprises a stable hypochlorous acid in an amount of, e.g., at least 0.10%, at least 0.11%, at least 0.12%, at least 0.13%, at least 0.14%, at least 0.15%, at least 0.16%, at least 0.17%, at least 0.18%, at least 0.19%, at least 0.2%, at least 0.25%, at least 0.3%, at least 0.35%, at least 0.4%, at least 0.45%, or at least 0.5% by weight of the composition. In yet other aspects of this embodiment, a composition manufactured according to a method or use disclosed herein comprises a stable hypochlorous acid in an amount of, e.g., at most 0.10%, at most 0.11%, at most 0.12%, at most 0.13%, at most 0.14%, at most 0.15%, at most 0.16%, at most 0.17%, at most 0.18%, at most 0.19%, at most 0.2%, at most 0.25%, at most 0.3%, at most 0.35%, at most 0.4%, at most 0.45%, or at most 0.5% by weight of the composition. In still other aspects of this embodiment, a composition manufactured according to a method or use disclosed herein comprises a stable hypochlorous acid in an amount of, e.g., about 0.10% to about 0.15%, about 0.10% to about 0.20%, about 0.10% to about 0.25%, about 0.10% to about 0.30%, about 0.10% to about 0.35%, about 0.10% to about 0.40%, about 0.10% to about 0.45%, about 0.10% to about 0.50%, about 0.20% to about 0.25%, about 0.20% to about 0.30%, about 0.20% to about 0.35%, about 0.20% to about 0.40%, about 0.20% to about 0.45%, about 0.20% to about 0.50%, about 0.30% to about 0.35%, about 0.30% to about 0.40%, about 0.30% to about 0.45%, about 0.30% to about 0.50%, about 0.40% to about 0.45%, about 0.40% to about 0.50%, or about 0.40% to about 0.50% by weight of the composition.

A composition manufactured according to a method or use disclosed herein may comprise a stable hypochlorite (also referred to as stable hypochlorite ions). In some embodiments, a composition manufactured according to a method or use disclosed herein comprises an amount of a stable hypochlorite that provides a desired beneficial effect to a composition manufactured according to a method or use disclosed herein. In some embodiments, when a composition manufactured according to a method or use disclosed herein comprising stable hypochlorite is formulated to be used in an undiluted state, the amount of stable hypochlorite used is an amount effective to clean, disinfect, sanitize, and/or sterilize. In some embodiments, when a composition manufactured according to a method or use disclosed herein comprising stable hypochlorite is formulated to be used in an undiluted state, the amount of stable hypochlorite used is a microbiostatic effective amount. A microbiostatic effective amount of stable hypochlorite is an amount that restrains, prohibits, or otherwise prevents microbial population growth without eradicating the microbes. In an aspect of this embodiment, a microbiostatic effective amount of stable hypochlorite is an amount that restrains, prohibits, or otherwise prevents microbial population growth without eradicating the microbes to a degree that achieves disinfection, sanitization, or sterilization. Alternatively, when a composition manufactured according to a method or use disclosed herein comprising stable hypochlorite will be diluted, the amount of stable hypochlorite used in such concentrated formulations can be any amount that does not cause precipitation of components in the composition disclosed herein or otherwise create unwanted effects that make the composition inoperable.

In aspects of this embodiment, a composition manufactured according to a method or use disclosed herein comprises a stable hypochlorite in an amount of, e.g., about 0.10%, about 0.11%, about 0.12%, about 0.13%, about 0.14%, about 0.15%, about 0.16%, about 0.17%, about 0.18%, about 0.19%, about 0.2%, about 0.25%, about 0.3%, about 0.35%, about 0.4%, about 0.45%, or about 0.5% by weight of the composition. In other aspects of this embodiment, a composition manufactured according to a method or use disclosed herein comprises a stable hypochlorite in an amount of, e.g., at least 0.10%, at least 0.11%, at least 0.12%, at least 0.13%, at least 0.14%, at least 0.15%, at least 0.16%, at least 0.17%, at least 0.18%, at least 0.19%, at least 0.2%, at least 0.25%, at least 0.3%, at least 0.35%, at least 0.4%, at least 0.45%, or at least 0.5% by weight of the composition. In yet other aspects of this embodiment, a composition manufactured according to a method or use disclosed herein comprises a stable hypochlorite in an amount of, e.g., at most 0.10%, at most 0.11%, at most 0.12%, at most 0.13%, at most 0.14%, at most 0.15%, at most 0.16%, at most 0.17%, at most 0.18%, at most 0.19%, at most 0.2%, at most 0.25%, at most 0.3%, at most 0.35%, at most 0.4%, at most 0.45%, or at most 0.5% by weight of the composition. In still other aspects of this embodiment, a composition manufactured according to a method or use disclosed herein comprises a stable hypochlorite in an amount of, e.g., about 0.10% to about 0.15%, about 0.10% to about 0.20%, about 0.10% to about 0.25%, about 0.10% to about 0.30%, about 0.10% to about 0.35%, about 0.10% to about 0.40%, about 0.10% to about 0.45%, about 0.10% to about 0.50%, about 0.20% to about 0.25%, about 0.20% to about 0.30%, about 0.20% to about 0.35%, about 0.20% to about 0.40%, about 0.20% to about 0.45%, about 0.20% to about 0.50%, about 0.30% to about 0.35%, about 0.30% to about 0.40%, about 0.30% to about 0.45%, about 0.30% to about 0.50%, about 0.40% to about 0.45%, about 0.40% to about 0.50%, or about 0.40% to about 0.50% by weight of the composition.

In some embodiments, a method or use disclosed herein, stabilizes free available chlorine in a manner that makes its detection and release delayed. In some embodiments, a method or use disclosed herein, produces intermediary or other compounds that aide in the stabilization of free available chlorine.

In some embodiments, a method or use disclosed herein stabilizes hypochlorous acid in a manner that makes its detection and release delayed. In some embodiments, a method or use disclosed herein, produces intermediary or other compounds that aide in the stabilization of hypochlorous acid.

In an embodiment, a method or use disclosed herein produces an odorless composition disclosed herein, one that masks, neutralizes or otherwise eliminates the smell of chlorine in a solution containing stable free available chlorine.

A composition manufactured according to a method or use disclosed herein may comprise one or more reactive oxygen species. A reactive oxygen species, includes, without limitation, oxygen gas (O2), superoxide (O2−), singlet oxygen (1O2), α-oxygen (α-O), protonated oxygen (HO2+), hydroperoxyl radical (HO2), hydroxyl radical (OH), peroxide (O2−2), ozone (O3), ozonide (O3−), another reactive oxygen species (ROS), or a combination thereof.

A method of manufacture disclosed herein produces a composition comprising a peroxide and a stable free available chlorine disclosed herein. Such a composition is useful in the methods disclosed herein. In addition, a composition manufactured according to a method or use disclosed herein can be further modified by adding additional components. Such modified compositions are also useful in the methods disclosed herein.

In some embodiments, exogenous hydrogen peroxide can be added to a composition manufactured according to a method or use disclosed herein. Such exogenous hydrogen peroxide is not created using a method or use disclosed herein. In some embodiments, the amount of hydrogen peroxide added is an amount that provides a desired beneficial effect to a composition disclosed herein. In some embodiments, when a composition manufactured according to a method or use disclosed herein comprising hydrogen peroxide is formulated to be used in an undiluted state, the amount of hydrogen peroxide used is an amount effective to clean, disinfect, sanitize, and/or sterilize. In some embodiments, when a composition manufactured according to a method or use disclosed herein comprising hydrogen peroxide is formulated to be used in an undiluted state, the amount of hydrogen peroxide used is a microbiostatic effective amount. A microbiostatic effective amount of hydrogen peroxide is an amount that restrains, prohibits, or otherwise prevents microbial population growth without eradicating the microbes. In an aspect of this embodiment, a microbiostatic effective amount of hydrogen peroxide is an amount that restrains, prohibits, or otherwise prevents microbial population growth without eradicating the microbes to a degree that achieves disinfection, sanitization, or sterilization. Alternatively, when a composition manufactured according to a method or use disclosed herein comprising hydrogen peroxide will be diluted, the amount of hydrogen peroxide used in such concentrated formulations can be any amount that does not cause precipitation of components in the composition disclosed herein or otherwise create unwanted effects that make the composition inoperable.

In aspects of this embodiment, a composition disclosed herein has hydrogen peroxide added to a final concentration of, e.g., 0.5%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9% or 10% by weight of the composition. In other aspects of this embodiment, a composition disclosed herein has hydrogen peroxide added to a final concentration of, e.g., at least 0.5%, at least 1%, at least 2%, at least 3%, at least 4%, at least 5%, at least 6%, at least 7%, at least 8%, at least 9% or at least 10% by weight of the composition. In yet other aspects of this embodiment, a composition disclosed herein has hydrogen peroxide added to a final concentration of, e.g., at most 0.5%, at most 1%, at most 2%, at most 3%, at most 4%, at most 5%, at most 6%, at most 7%, at most 8%, at most 9% or at most 10% by weight of the composition. In yet other aspects of this embodiment, a composition disclosed herein has hydrogen peroxide added to a final concentration of, e.g., about 0.5% to about 1%, about 0.5% to about 2%, about 0.5% to about 3%, about 0.5% to about 4%, about 0.5% to about 5%, about 0.5% to about 6%, about 0.5% to about 7%, about 0.5% to about 8%, about 0.5% to about 9%, about 0.5% to about 10%, about 1% to about 2%, about 1% to about 3%, about 1% to about 4%, about 1% to about 5%, about 1% to about 6%, about 1% to about 7%, about 1% to about 8%, about 1% to about 9%, about 1% to about 10%, about 2% to about 3%, about 2% to about 4%, about 2% to about 5%, about 2% to about 6%, about 2% to about 7%, about 2% to about 8%, about 2% to about 9%, about 2% to about 10%, about 3% to about 4%, about 3% to about 5%, about 3% to about 6%, about 3% to about 7%, about 3% to about 8%, about 3% to about 9%, about 3% to about 10%, about 4% to about 5%, about 4% to about 6%, about 4% to about 7%, about 4% to about 8%, about 4% to about 9%, about 4% to about 10%, about 5% to about 6%, about 5% to about 7%, about 5% to about 8%, about 5% to about 9%, about 5% to about 10%, about 6% to about 7%, about 6% to about 8%, about 6% to about 9%, about 6% to about 10%, about 7% to about 8%, about 7% to about 9%, about 7% to about 10%, about 8% to about 9%, about 8% to about 10%, or about 9% to about 10% by weight of the composition.

In some embodiments, one or more metallic particles can be added to a composition manufactured according to a method or use disclosed herein. A metallic particle can be composed of a single element, such as, e.g., copper, iron, silver, titanium or zinc or be a mixed metallic particle composed of various combinations of different elements, such as, e.g., various combinations of two or more of the following: copper, iron, silver, titanium or zinc. Non-limiting examples of a metallic particle includes a copper particle, an iron particle, a potassium particle, a silver particle, a titanium particle, and a zinc particle. Other non-limiting examples of a metallic particle include a metal acetate particle, a metal chloride particle, a metal nitrate particle, or a metal oxide particle. A metal acetate particle includes, without limitation, copper acetate, iron acetate, e.g. iron (II) acetate and iron (III) acetate, silver acetate, titanium acetate, zinc acetate, or any combination thereof. A metal nitrate particle includes, without limitation, copper nitrate, iron nitrate, e.g., iron (II) nitrate, iron (III) nitrate, silver nitrate, titanium nitrate, zinc nitrate, or any combination thereof. A metal chloride particle includes, without limitation, copper chloride, iron chloride, e.g., iron (II) chloride or iron (III) chloride, silver chloride, titanium chloride, zinc chloride, or any combination thereof. A metal oxide particle includes, without limitation, copper oxide particle, iron oxide particle, e.g., iron (II) oxide particle, iron (III) oxide particle, silver oxide particle, titanium dioxide particle, zinc oxide particle, copper zinc iron oxide particle, or any combination thereof.

A metallic particle includes nanoparticles and microparticles. A nanoparticle has an average diameter of about 1 nm to about 1,000 nm. A microparticle has an average diameter of about 1 μm to about 1,000 μm.

In some embodiments, the amount of metallic particles added is an amount that provides a desired beneficial effect to a composition disclosed herein. In some embodiments, when a composition manufactured according to a method or use disclosed herein comprising metallic particles is formulated to be used in an undiluted state, the amount of metallic particles used is an amount effective to clean, disinfect, sanitize, and/or sterilize. In some embodiments, when a composition manufactured according to a method or use disclosed herein comprising metallic particles is formulated to be used in an undiluted state, the amount of metallic particles used is a microbiostatic effective amount. A microbiostatic effective amount of metallic particles is an amount that restrains, prohibits, or otherwise prevents microbial population growth without eradicating the microbes. In an aspect of this embodiment, a microbiostatic effective amount of metallic particles is an amount that restrains, prohibits, or otherwise prevents microbial population growth without eradicating the microbes to a degree that achieves disinfection, sanitization, or sterilization. Alternatively, when a composition manufactured according to a method or use disclosed herein comprising metallic particles will be diluted, the amount of metallic particles used in such concentrated formulations can be any amount that does not cause precipitation of components in the composition disclosed herein or otherwise create unwanted effects that make the composition inoperable.

In aspects of this embodiment, a composition disclosed herein has metallic particles added to a final concentration of, e.g., about 0.001%, about 0.005%, about 0.01%, about 0.05%, about 0.10%, about 0.11%, about 0.12%, about 0.13%, about 0.14%, about 0.15%, about 0.16%, about 0.17%, about 0.18%, about 0.19%, about 0.2%, about 0.25%, about 0.3%, about 0.35%, about 0.4%, about 0.45%, or about 0.5% by weight of the composition. In other aspects of this embodiment, a composition disclosed herein has metallic particles added to a final concentration of, e.g., at least 0.001%, at least 0.005%, at least 0.01%, at least 0.05%, at least 0.10%, at least 0.11%, at least 0.12%, at least 0.13%, at least 0.14%, at least 0.15%, at least 0.16%, at least 0.17%, at least 0.18%, at least 0.19%, at least 0.2%, at least 0.25%, at least 0.3%, at least 0.35%, at least 0.4%, at least 0.45%, or at least 0.5% by weight of the composition. In yet other aspects of this embodiment, a composition disclosed herein has metallic particles added to a final concentration of, e.g., at most 0.001%, at most 0.005%, at most 0.01%, at most 0.05%, at most 0.10%, at most 0.11%, at most 0.12%, at most 0.13%, at most 0.14%, at most 0.15%, at most 0.16%, at most 0.17%, at most 0.18%, at most 0.19%, at most 0.2%, at most 0.25%, at most 0.3%, at most 0.35%, at most 0.4%, at most 0.45%, or at most 0.5% by weight of the composition. In still other aspects of this embodiment, a composition disclosed herein has metallic particles added to a final concentration of, e.g., about 0.0010% to about 0.005%, about 0.0010% to about 0.010%, about 0.0010% to about 0.050%, about 0.0010% to about 0.10%, about 0.0010% to about 0.15%, about 0.0010% to about 0.20%, about 0.0010% to about 0.25%, about 0.0010% to about 0.30%, about 0.0010% to about 0.35%, about 0.0010% to about 0.40%, about 0.0010% to about 0.45%, about 0.0010% to about 0.50%, about 0.010% to about 0.050%, about 0.010% to about 0.10%, about 0.010% to about 0.15%, about 0.010% to about 0.20%, about 0.010% to about 0.25%, about 0.010% to about 0.30%, about 0.010% to about 0.35%, about 0.010% to about 0.40%, about 0.010% to about 0.45%, about 0.010% to about 0.50%, about 0.10% to about 0.15%, about 0.10% to about 0.20%, about 0.10% to about 0.25%, about 0.10% to about 0.30%, about 0.10% to about 0.35%, about 0.10% to about 0.40%, about 0.10% to about 0.45%, about 0.10% to about 0.50%, about 0.20% to about 0.25%, about 0.20% to about 0.30%, about 0.20% to about 0.35%, about 0.20% to about 0.40%, about 0.20% to about 0.45%, about 0.20% to about 0.50%, about 0.30% to about 0.35%, about 0.30% to about 0.40%, about 0.30% to about 0.45%, about 0.30% to about 0.50%, about 0.40% to about 0.45%, about 0.40% to about 0.50%, or about 0.40% to about 0.50% by weight of the composition.

In an embodiment, a composition disclosed herein does not comprise metallic particles.

In some embodiments, one or more metal salts can be added to a composition manufactured according to a method or use disclosed herein. A metal salt disclosed herein can be an alkali metal salt, an alkaline earth metal salt, a base metal salt, or a transition metal salt. An alkali metal salt includes a lithium salt, a sodium salt, a potassium salt, a rubidium salt, a cesium salt, and a francium salt. An alkaline earth metal salt includes a beryllium salt, a magnesium salt, a calcium salt, a strontium salt, a barium salt, and a radium salt. A basic metal salt includes an aluminum salt, a gallium salt, an indium salt, a tin salt, a thallium salt, a lead salt, and a bismuth salt. A transition metal salt includes a scandium salt, a titanium salt, a vanadium salt, a chromium salt, a manganese salt, an iron salt, a cobalt salt, a palladium salt, a silver salt, m a nickel salt, a copper salt, a zinc salt, a yttrium salt, Non-limiting examples of a metal salt includes a calcium salt, a copper salt, iron salt, a potassium salt, silver salt, titanium salt, and zinc salt.

In some embodiments, a composition may include calcium oxide obtained from an organic source like shells from oceanic organisms. In some embodiment, a composition may include calcium oxide obtain from an inorganic source like by a synthetic chemical process.

In some embodiments, the amount of metal salts added is an amount that provides a desired beneficial effect to a composition disclosed herein. In some embodiments, when a composition manufactured according to a method or use disclosed herein comprising metal salts is formulated to be used in an undiluted state, the amount of metal salts used is an amount effective to clean, disinfect, sanitize, and/or sterilize. In some embodiments, when a composition manufactured according to a method or use disclosed herein comprising metal salts is formulated to be used in an undiluted state, the amount of metal salts used is a microbiostatic effective amount. A microbiostatic effective amount of metal salts is an amount that restrains, prohibits, or otherwise prevents microbial population growth without eradicating the microbes. In an aspect of this embodiment, a microbiostatic effective amount of metal salts is an amount that restrains, prohibits, or otherwise prevents microbial population growth without eradicating the microbes to a degree that achieves disinfection, sanitization, or sterilization. Alternatively, when a composition manufactured according to a method or use disclosed herein comprising metal salts will be diluted, the amount of metal salts used in such concentrated formulations can be any amount that does not cause precipitation of components in the composition disclosed herein or otherwise create unwanted effects that make the composition inoperable.

In aspects of this embodiment, a composition disclosed herein has metal salts added to a final concentration of, e.g., about 0.001%, about 0.005%, about 0.01%, about 0.05%, about 0.10%, about 0.11%, about 0.12%, about 0.13%, about 0.14%, about 0.15%, about 0.16%, about 0.17%, about 0.18%, about 0.19%, about 0.2%, about 0.25%, about 0.3%, about 0.35%, about 0.4%, about 0.45%, or about 0.5% by weight of the composition. In other aspects of this embodiment, a composition disclosed herein has metal salts added to a final concentration of, e.g., at least 0.001%, at least 0.005%, at least 0.01%, at least 0.05%, at least 0.10%, at least 0.11%, at least 0.12%, at least 0.13%, at least 0.14%, at least 0.15%, at least 0.16%, at least 0.17%, at least 0.18%, at least 0.19%, at least 0.2%, at least 0.25%, at least 0.3%, at least 0.35%, at least 0.4%, at least 0.45%, or at least 0.5% by weight of the composition. In yet other aspects of this embodiment, a composition disclosed herein has metal salts added to a final concentration of, e.g., at most 0.001%, at most 0.005%, at most 0.01%, at most 0.05%, at most 0.10%, at most 0.11%, at most 0.12%, at most 0.13%, at most 0.14%, at most 0.15%, at most 0.16%, at most 0.17%, at most 0.18%, at most 0.19%, at most 0.2%, at most 0.25%, at most 0.3%, at most 0.35%, at most 0.4%, at most 0.45%, or at most 0.5% by weight of the composition. In still other aspects of this embodiment, a composition disclosed herein has metal salts added to a final concentration of, e.g., about 0.0010% to about 0.005%, about 0.0010% to about 0.010%, about 0.0010% to about 0.050%, about 0.0010% to about 0.10%, about 0.0010% to about 0.15%, about 0.0010% to about 0.20%, about 0.0010% to about 0.25%, about 0.0010% to about 0.30%, about 0.0010% to about 0.35%, about 0.0010% to about 0.40%, about 0.0010% to about 0.45%, about 0.0010% to about 0.50%, about 0.010% to about 0.050%, about 0.010% to about 0.10%, about 0.010% to about 0.15%, about 0.010% to about 0.20%, about 0.010% to about 0.25%, about 0.010% to about 0.30%, about 0.010% to about 0.35%, about 0.010% to about 0.40%, about 0.010% to about 0.45%, about 0.010% to about 0.50%, about 0.10% to about 0.15%, about 0.10% to about 0.20%, about 0.10% to about 0.25%, about 0.10% to about 0.30%, about 0.10% to about 0.35%, about 0.10% to about 0.40%, about 0.10% to about 0.45%, about 0.10% to about 0.50%, about 0.20% to about 0.25%, about 0.20% to about 0.30%, about 0.20% to about 0.35%, about 0.20% to about 0.40%, about 0.20% to about 0.45%, about 0.20% to about 0.50%, about 0.30% to about 0.35%, about 0.30% to about 0.40%, about 0.30% to about 0.45%, about 0.30% to about 0.50%, about 0.40% to about 0.45%, about 0.40% to about 0.50%, or about 0.40% to about 0.50% by weight of the composition.

In an embodiment, a composition disclosed herein does not comprise metal salts.

In some embodiments, a phosphate buffer can be added to a composition manufactured according to a method or use disclosed herein. A phosphate buffer or phosphate buffer solution) is especially sensitive to pH changes, and thus is useful for biological applications. A phosphate buffer can be adapted to a variety of pH levels, including isotonic. This wide range is due to phosphoric acid having 3 dissociation constants (pKa) allowing for formulation of buffers near each of the pH levels of 2.15, 7.21, or 12.32. Monosodium phosphate and its conjugate base, disodium phosphate, are usually used to generate buffers of pH values around 7. Non-limiting examples of a phosphate buffer include a calcium phosphate buffer and a sodium phosphate buffer.

In an embodiment, a composition disclosed herein does not comprise a phosphate buffer. In an embodiment, a composition disclosed herein does not comprise a calcium phosphate buffer. In an embodiment, a composition disclosed herein does not comprise a sodium phosphate buffer.

Aspects of the present specification disclose a kit. In one embodiment, the kit can comprise a container that includes a composition disclosed herein. In another embodiment, a kit can comprise a plurality of containers, with each such container including a composition disclosed herein. For example, a kit can comprise 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 or more containers, with each such container including a composition disclosed herein. Each of the disclosed containers can comprise a single dose of a composition disclosed herein, multiple doses of a composition disclosed herein, or a combination thereof. In addition, each of the disclosed containers can contain a composition disclosed herein in liquid form or in dried form.

A kit disclosed herein can comprise a delivery or application system. The delivery or application system of the kit are useful for applying one or more compositions disclosed herein, and/or individual components disclosed herein to a site of interest. A delivery or application system disclosed herein, includes, without limitation, one or more of an applicator brushes, porous foam swab or pad, hollow tube, dipstick and the like or a combination thereof. In an embodiment, a kit comprises a single delivery or application system. In another embodiment, a kit comprises a plurality delivery or application systems. For example, in a 30-day supply kit, there can be 30 delivery or application systems, such that there is one delivery or application system per day for 30 days. Alternately, there can be 2, 10, 20, 30, 40, 50, 60, 90, 120, etc. delivery or application systems per kit. Within the kit, the delivery or application system may be packaged individually, or in sets of 2 or more. The delivery or application system can be packaged such that it remains sterile until use. In certain embodiments, a delivery or application system disclosed herein can be packaged in plastic sheaths. Further, to prevent contamination, delivery or application system disclosed herein is preferably single-use, disposable delivery, or application system.

The kit can also comprise a set of instructions. The instructions may include information useful to the end user such as, e.g., how to use a delivery system to apply a composition disclosed herein and/or how often to apply a composition disclosed herein. In addition, such instructions may include information regarding how to mix the individual components disclosed herein to form a composition disclosed herein, if provided as individual components to be combined before use. Such instructions can indicate that mixing should be done at a certain time before application, such as, e.g., just prior to use. Instructions disclosed herein may also include information regarding how to apply the individual components disclosed herein directly to a site of interest, and in what order the individual components should be applied to such sites of interest if multiple compositions are utilized as part of a regimen, for example.

A kit disclosed herein can comprise other components. For example, a kit disclosed herein can further include containers comprising a solvent, such as, e.g., water or a buffered solution, e.g. saline. A solvent disclosed herein is useful to reconstitute a dried form of a composition disclosed herein.

The contents of the kit, including the container including one or more compositions or components disclosed herein, the delivery or application system, and instructions, are enclosed in an outer casing. The outer casing can be a box, a sealed bag, a foil pouch, etc. In certain embodiments, the delivery system, container, and instructions are enclosed in a box. In other embodiments of the kit, the container and instructions are contained in a first box, the delivery system is contained in a second box, and the first and second box are contained together in a third box

Aspects of the present specification disclose a method to clean, disinfect, sanitize, and/or sterilize a device. In one embodiment, a method disclosed herein comprises applying a composition disclosed herein to a device for a specified amount of time, wherein application results in the cleaning, disinfecting, sanitizing, and/or sterilizing of the device. In another aspect of this embodiment, a method disclosed herein further comprises rinsing the cleaned, disinfected, sanitized, and/or sterilized device with a rinse solution disclosed herein. Other aspects of the present specification disclose a composition disclosed herein for use to clean, disinfect, sanitize, and/or sterilize a device, including a medical device. Yet other aspects of the present specification disclose a use of a disclosed composition to clean, disinfect, sanitize, and/or sterilize a device, including a medical device.

Aspects of the present specification disclose a method to clean, disinfect, sanitize, and/or sterilize an endoscope. In an aspect of this embodiment, a method disclosed herein comprises applying a composition disclosed herein to an endoscope for a specified amount of time, wherein application results in the cleaning, disinfecting, sanitizing, and/or sterilizing of the endoscope. In another aspect of this embodiment, a method disclosed herein further comprises rinsing the cleaned, disinfected, sanitized, and/or sterilized endoscope with a rinse solution disclosed herein. Other aspects of the present specification disclose a composition disclosed herein for use to clean, disinfect, sanitize, and/or sterilize an endoscope. Yet other aspects of the present specification disclose a use of a disclosed composition to clean, disinfect, sanitize, and/or sterilize an endoscope.

A device, including a medical device is cleaned by removal of visible soil, such as, e.g., organic and inorganic material, from objects and surfaces and normally is accomplished manually or mechanically. Thorough cleaning is essential before disinfection, sanitization, and sterilization because inorganic and organic materials that remain on the surfaces of a medical device interferes with the effectiveness of these processes.

A device, including a medical device is disinfected by eliminating many or all pathogenic microorganisms, except bacterial spores. Disinfection is less lethal than sterilization because it destroys most recognized pathogenic microorganisms but not necessarily all microbial forms (e.g., bacterial spores). A medical device is sterilized by destroying or eliminating all forms of microorganisms. Decontamination of a medical device removes pathogenic microorganisms from a medical device so that it is safe to handle, use, or discard.

A medical device is an instrument, apparatus, material, or other article, whether used alone or in combination, including software necessary for its application, intended by the manufacturer to be used for human beings for diagnosis, prevention, monitoring treatment, or alleviation of disease; diagnosis, monitoring, treatment, or alleviation of or compensation for an injury or handicap; investigation, replacement, or modification of the anatomy or of a physiologic process; or control of conception, and that does not achieve its primary intended action in or on the human body by pharmacologic, immunologic, or metabolic means but might be assisted in its function by such means. A medical device includes, without limitation, a surgical instrument, a respiratory therapy instrument, an anesthesia instrument, a catheter, an implant, a probe, an endoscope, an arthroscope, a laparoscope, a blade, a cystoscope, a spirometer, a CPAP mask and tubing, dialysis instrument and accessories, a heart-lung machine and accessories, a heart-lung bypass machine and accessories, and a diaphragm fitting ring. Non-limiting examples of a probe includes an ultrasound probe and an esophageal manometry probe. Non-limiting examples of a catheter includes a cardiac catheter, an urinary catheter, an anorectal manometry catheter. Non-limiting examples of an endoscope includes a gastrointestinal endoscope, a bronchoscope, and a nasopharyngoscope. Non-limiting examples of a blade includes a laryngoscope blade.

Aspects of the present specification disclose a method to clean, disinfect, sanitize, and/or sterilize a hard surface area. In an aspect of this embodiment, a method disclosed herein comprises applying a composition disclosed herein to a hard surface area for a specified amount of time, wherein application results in the cleaning, disinfecting, sanitizing, and/or sterilizing of the hard surface area. In another aspect of this embodiment, a method disclosed herein further comprises rinsing the cleaned, disinfected, sanitized, and/or sterilized surface with a rinse solution disclosed herein. Other aspects of the present specification disclose a composition disclosed herein for use to clean, disinfect, sanitize, and/or sterilize a hard surface area. Yet other aspects of the present specification disclose a use of a disclosed composition to clean, disinfect, sanitize, and/or sterilize a hard surface area. A hard surface area can be a porous surface area or a non-porous surface area.

A hard surface area can include any items present in a residence or a commercial, industrial and/or agricultural facility, such as, e.g., a hospital, a laboratory, a restaurant, an educational center, a food-processing facility, a dairy-processing facility, an airport, an oil field system, a sport facility, a shipping dock, a freight transport center, or any other commercial or industrial setting. A surface area can include any type of transportation carrier, such as, e.g., a water vessel like a boat, barge or ship, an aircraft like an airplane or helicopter, a ground vehicle like a motorcycle, car, truck or train, A surface area may be made of any material including brass, copper, aluminum, stainless steel, carbon steel, rubber, plastic, glass, wood, painted surface, or any combination thereof. A surface area includes, without limitation, a table top, counter top, floor, wall, ceiling, window, bed, gurney, door, door handle, shower, bath, sink, faucet, toilet, toilet seat, drain, equipment, machinery, personal protective gear, personal biohazard gear, and the like. A surface area may comprise a medical, dental, pharmaceutical, veterinary or mortuary device. A surface area may comprise human skin.

A composition disclosed herein can be applied according to a method or use disclosed herein to a hard surface area. Application of a composition disclosed herein can be by rubbing, pouring, sprinkling, misting, or spraying on, or otherwise applied to a hard surface area. A composition disclosed herein can be applied by introducing the composition into or onto a solid support such as, e.g., a wipe, a towelette, a towel, a mitt, a glove, or a mask and then applying the composition to a hard surface area. A composition disclosed herein can be applied by using a delivery device, such as, e.g., an aerosol dispenser, a pump spray, a trigger spray, or a squeeze bottle to apply the composition to a hard surface area.

A composition or component disclosed herein can be applied to a hard surface area according to a method or use disclosed herein as often as needed and/or desired. A composition disclosed herein can be applied to a hard surface area daily, every other day, every third of day, once a week, multiple times per week, once a month, multiple times per month, once a year or multiple times per year, as desired. A composition disclosed herein can be applied to a hard surface area multiple times per day, e.g., twice a day, three times a day, four time a day, five times a day, six times a day or as often as desired.

The presently disclosed compositions are useful in any application involving treating an individual. The presently disclosed compositions are useful in any application involving medical use, veterinarian use, or both. In one embodiment, a composition disclosed herein is useful in any application were hypochlorous acid is applied or administered.

In one embodiment, the presently disclosed compositions are useful in any application involving treating a tissue in an individual. For example, the compositions disclosed herein can be used to treat a wound by enhancing angiogenesis in an area in and around a wound, or promoting rapid healing of a wound.

In one embodiment, the presently disclosed compositions are useful in any application involving treating a wound in an individual. For example, the compositions disclosed herein can be used to treat a wound by enhancing angiogenesis in an area in and around a wound, or promoting rapid healing of a wound. A wound can be an open wound, a closed wound or a burn. Non-limiting examples, of an open wound include a laceration, an abrasion, an incision, a puncture, an avulsion, an ulcer, and a tear. Non-limiting examples, of a closed wound includes a bruise, a contusion and a hematoma.

Aspects of the present specification disclose a method of cleaning, disinfecting, sanitizing, and/or sterilizing a wound in an individual. In an aspect of this embodiment, a method disclosed herein comprises applying a composition disclosed herein to a wound for a specified amount of time, wherein application results in the cleaning, disinfecting, sanitizing, and/or sterilizing of the wound. In another aspect of this embodiment, a method disclosed herein further comprises rinsing the cleaned, disinfected, sanitized, and/or sterilized wound with a rinse solution disclosed herein. Other aspects of the present specification disclose a composition disclosed herein for use to clean, disinfect, sanitize, and/or sterilize a wound. Yet other aspects of the present specification disclose a use of a disclosed composition to clean, disinfect, sanitize, and/or sterilize a wound.

Aspects of the present specification disclose a method of treating a wound in an individual. In an aspect of this embodiment, a method disclosed herein comprises applying a composition disclosed herein to a wound for a specified amount of time, wherein application promotes healing of the wound. In another aspect of this embodiment, a method disclosed herein further comprises rinsing the treated wound with a rinse solution disclosed herein. Other aspects of the present specification disclose a composition disclosed herein for use to treat a wound. Yet other aspects of the present specification disclose a use of a disclosed composition to treat a wound. A wound can be an external wound on, e.g., a surface area of an individual or an internal wound located in the body or body cavity of an individual. A body cavity can be a space, compartment, or lumen, or potential space, compartment or lumen in the body. A body cavity may include any space, compartment or lumen that contains organs, limbs, tissues, and surfaces within the body, or any space, compartment or lumen within organs, limbs, or tissues. A body cavity may include areas with the organs, for example an airway within the lungs, a nasal cavity, an oral cavity, a lumen of the gastrointestinal or excretory system including urethra and ureter, and spaces within the reproductive organs. A body cavity may be exposed to the outside of the body or may not be exposed to the outside space of the body. A body cavity any space created in the body. A body cavity may also include a space created in the body from injury or surgery or other artificial means.

In one embodiment, the presently disclosed compositions are useful in any application involving a microbial infection in an individual. A microbial infection includes a viral infection, a bacterial infection and a fungal infection. A microbial infection can be an external infection on, e.g., a surface area of an individual or an internal infection, e.g., a mercer infection or sepsis, located in the body or body cavity of an individual.

Aspects of the present specification disclose a method of cleaning, disinfecting, sanitizing, sterilizing, and/or prevent a microbial infection in an individual. In an aspect of this embodiment, a method disclosed herein comprises applying a composition disclosed herein to a microbial infection for a specified amount of time, wherein application results in a cleaning, disinfecting, sanitizing, and/or sterilizing of the microbial infection. In another aspect of this embodiment, a method disclosed herein further comprises rinsing the cleaned, disinfected, sanitized, and/or sterilized microbial infection with a rinse solution disclosed herein. Other aspects of the present specification disclose a composition disclosed herein for use to clean, disinfect, sanitize, and/or sterilize a microbial infection. Yet other aspects of the present specification disclose a use of a disclosed composition to clean, disinfect, sanitize, and/or sterilize a microbial infection.

In one embodiment, a composition disclosed herein is used to clean, disinfect, sanitize, and/or treat a body part of an individual. Non-limiting examples of uses for a composition disclosed herein include cleaning/disinfecting tissue in wound care, pre-operative preparation, and surgery or other invasive procedure, cleaning/disinfecting a skin region in dermatological applications, cleaning/disinfecting the nasal or oral cavity, cleaning/disinfecting the lungs and respiratory tissues in respiratory applications, and cleaning/disinfecting the eye in ophthalmological applications.

Aspects of the present specification disclose a method of treating a microbial infection in an individual. In an aspect of this embodiment, a method disclosed herein comprises applying a composition disclosed herein to a microbial infection for a specified amount of time, wherein application results in a reduction, elimination and/or killing microbes causing the microbial infection. In another aspect of this embodiment, a method disclosed herein further comprises rinsing the treated microbial infection with a rinse solution disclosed herein. Other aspects of the present specification disclose a composition disclosed herein for use to treat a microbial infection. Yet other aspects of the present specification disclose a use of a disclosed composition to treat a microbial infection.

A respiratory application refers to cleaning, disinfecting, treating the lungs, oral, nasal, and airways of an individual of a microbial infection, such as, e.g., a viral, bacterial or fungal infection. A Respiratory application also refers to cleaning, disinfecting, treating the lungs, oral, nasal, and airways of an individual to prevent a microbial infection, such as, e.g., a viral, bacterial or fungal infection. Non-limiting examples of a microbial infection include a respiratory infection, an oral infection, a nasal infection, and a sinus infection.

An ophthalmological application refers to cleaning, disinfecting, treating an eye of an individual of a microbial infection, such as, e.g., a viral, bacterial or fungal infection. Non-limiting examples of a microbial infection of an eye include a bacterial conjunctivitis, a viral conjunctivitis, an epidemic keratoconjunctivitis, a pharyngoconjunctival fever, a stye, a blephartis, an episcleritis, a keratitis, a trachoma, and a corneal ulcer.

The presently disclosed compositions are useful in any application involving treating and/or providing relief of an inflammation, an ache, and/or a pain in an individual.

Aspects of the present specification disclose a method of treating an inflammation, an ache, and/or a pain in an individual. In an aspect of this embodiment, a method disclosed herein comprises applying a composition disclosed herein to an area of inflammation, an ache and/or a pain for a specified amount of time, wherein application results in a reduction and/or elimination of the pain. In another aspect of this embodiment, a method disclosed herein further comprises rinsing the treated area with a rinse solution disclosed herein. Other aspects of the present specification disclose a composition disclosed herein for use to treat an inflammation, an ache and/or a pain. Yet other aspects of the present specification disclose a use of a disclosed composition to treat an inflammation, an ache, and/or a pain.

The presently disclosed compositions are useful in enteral and parenteral applications, including oral, injectable and topical applications. For example, the compositions disclosed herein can be used to clean, disinfect, sanitize, or sterilize a body region injured by a wound or infected with a microbe.

In an aspect of this embodiment, a method or use disclosed herein comprises applying a composition disclosed herein to an individual for a specified amount of time, wherein application results in the cleaning, disinfecting, sanitizing and/or sterilizing of a microbial infection in the individual. Other aspects of the present specification disclose a composition disclosed herein for use to clean, disinfect, sanitize, and/or sterilize a microbial infection in an individual. Yet other aspects of the present specification disclose a use of a disclosed composition to clean, disinfect, sanitize, and/or sterilize a microbial infection in an individual. Still other aspects of the present specification disclose a composition disclosed herein for the manufacture of a medicament to clean, disinfect, sanitize, and/or sterilize a microbial infection in an individual.

A method or use disclosed herein applies a composition disclosed herein to an individual. An individual refers to any animal including, without limitation, a fish, an amphibian, a bird and a mammal. A mammal includes a human, a horse, a cow, a sheep, a dog and a cat. As such, a method or use disclosed herein is for human use as well as veterinarian use.

In applications to an individual, a composition disclosed herein can be applied to a skin surface or can be internally administered. In one embodiment, a composition disclosed herein is applied topically to a skin region of an individual in order to clean, disinfect, sanitize, and/or sterilize the skin region. A skin region, includes, without limitation, the face, forehead, lips, scalp, neck, shoulder, arms, hands, thighs, legs, knees, feet, chest, breast, back, groin, buttocks, and the like.

In one embodiment, a composition disclosed herein is internally administered to an individual. Such routes of administration include enteral routes of administration and parenteral routes of administration.

A composition disclosed herein can be applied according to a method or use disclosed herein to a skin region or body cavity, or body tissue. Application of a composition disclosed herein can be by rubbing, pouring, sprinkling, misting, nebulizing, or spraying on, or otherwise applied to the human body. A composition disclosed herein can be applied by introducing the composition into or onto a solid support such as, e.g., a wipe, a towelette, a towel, a mitt, a glove, or a mask and then applying the composition to a skin region. A composition disclosed herein can be applied by using a delivery device, such as, e.g., an aerosol dispenser, a misting dispenser, a nebulizing dispenser, a pump spray, a trigger spray, a squeeze bottle, a topical patch, a transdermal patch, or a dermal implant to apply the composition to a skin region.

A composition disclosed herein can be applied to an individual according to a method or use disclosed herein as often as needed and/or desired. A composition disclosed herein can be applied to an individual multiple times per day. A composition disclosed herein can be applied to an individual daily, every other day, every third of day, once a week, multiple times per week, once a month, multiple times per month, once a year or multiple times per year, as desired. A composition disclosed herein can be applied to an individual multiple times per day, e.g., twice a day, three times a day, four time a day, five times a day, six times a day or as often as desired.

The presently disclosed compositions are useful in food product, poultry, meat, fruit, vegetable production. For example, the compositions disclosed herein can be used to clean, disinfect, sanitize, or sterilize machinery, instruments, tables, rooms, including floors, ceilings and walls and any other hard surface from microbial contamination.

The presently disclosed compositions are useful in formulations on plants as a preservative or pesticide. For example, the compositions disclosed herein can be used to clean, disinfect, sanitize, or sterilize a plant injured by a wound or infected with a microbe.

The presently disclosed compositions are useful in formulations on cut flowers to prolong freshness and health. For example, the compositions disclosed herein can be used to clean, disinfect, sanitize, or sterilize a cut flower at a wound or to prevent microbial infection.

A disclosed method or use applies a composition disclosed herein for specified amount of time. In one embodiment, a specified amount of time is a time sufficient to clean a medical device, a surface, or an individual. In another embodiment, a specified amount of time is a time sufficient to disinfect a medical device, a surface, or an individual. In yet another embodiment, a specified amount of time is a time sufficient to sterilize a medical device, a surface, or an individual.

In aspects of this embodiment, a composition disclosed herein is applied to a device, like a medical device, a surface, or an individual for, e.g., about 15 seconds, about 30 seconds, about 45 seconds, about 1 minute, about 5 minutes, about 10 minutes, about 15 minutes, about 20 minutes, about 25 minutes, about 30 minutes, about 35 minutes, about 40 minutes, about 45 minutes, about 50 minutes, about 55 minutes, about 60 minutes, about 70 minutes, about 80 minutes, about 90 minutes, about 100 minutes, about 110 minutes, or about 120 minutes. In other aspects of this embodiment, a composition disclosed herein is applied to a device, like a medical device, a surface, or an individual for, e.g., at least 15 seconds, at lease 30 seconds, at least 45 seconds, at least 1 minute, at least 5 minutes, at least 10 minutes, at least 15 minutes, at least 20 minutes, at least 25 minutes, at least 30 minutes, at least 35 minutes, at least 40 minutes, at least 45 minutes, at least 50 minutes, at least 55 minutes, at least 60 minutes, at least 70 minutes, at least 80 minutes, at least 90 minutes, at least 100 minutes, at least 110 minutes, or at least 120 minutes. In yet other aspects of this embodiment, a composition disclosed herein is applied to device, like a medical device, a surface, or an individual for, e.g., at most 15 seconds, at most 30 seconds, at most 45 seconds, at most 1 minute, at most 5 minutes, at most 10 minutes, at most 15 minutes, at most 20 minutes, at most 25 minutes, at most 30 minutes, at most 35 minutes, at most 40 minutes, at most 45 minutes, at most 50 minutes, at most 55 minutes, at most 60 minutes, at most 70 minutes, at most 80 minutes, at most 90 minutes, at most 100 minutes, at most 110 minutes, or at most 120 minutes.

A disclosed composition, method or use disclosed herein are less harsh on a medical device resulting in a longer lifetime use of a medical device. In aspects of this embodiment, a medical device can be cleaned, disinfected, sanitized, and/or sterilized, e.g., about 50 times, about 60 times, about 70 times, about 80 times, about 90 times, about 100 times, about 110 times, about 120 times, about 130 times, about 140 times, about 150 times, about 160 times, about 170 times, about 180 times, about 190 times, about 200 times, about 210 times, about 220 times, about 230 times, about 240 times, about 250 times, about 260 times, about 270 times, about 280 times, about 290 times, or about 300 times. In other aspects of this embodiment, a medical device can be cleaned, disinfected, sanitized, and/or sterilized, e.g., at least 50 times, at least 60 times, at least 70 times, at least 80 times, at least 90 times, at least 100 times, at least 110 times, at least 120 times, at least 130 times, at least 140 times, at least 150 times, at least 160 times, at least 170 times, at least 180 times, at least 190 times, at least 200 times, at least 210 times, at least 220 times, at least 230 times, at least 240 times, at least 250 times, at least 260 times, at least 270 times, at least 280 times, at least 290 times, or at least 300 times. In yet other aspects of this embodiment, a medical device can be cleaned, disinfected, sanitized, and/or sterilized, e.g., at most 50 times, at most 60 times, at most 70 times, at most 80 times, at most 90 times, at most 100 times, at most 110 times, at most 120 times, at most 130 times, at most 140 times, at most 150 times, at most 160 times, at most 170 times, at most 180 times, at most 190 times, at most 200 times, at most 210 times, at most 220 times, at most 230 times, at most 240 times, at most 250 times, at most 260 times, at most 270 times, at most 280 times, at most 290 times, or at most 300 times.

In still other aspects of this embodiment, a medical device can be cleaned, disinfected, sanitized, and/or sterilized, e.g., about 50 times to about 60 times, about 50 times to about 70 times, about 50 times to about 80 times, about 50 times to about 90 times, about 50 times to about 100 times, about 50 times to about 110 times, about 50 times to about 120 times, about 50 times to about 130 times, about 50 times to about 140 times, about 50 times to about 150 times, about 50 times to about 175 times, about 50 times to about 200 times, about 50 times to about 225 times, about 50 times to about 250 times, about 50 times to about 275 times, about 50 times to about 300 times, about 75 times to about 90 times, about 75 times to about 100 times, about 75 times to about 110 times, about 75 times to about 120 times, about 75 times to about 130 times, about 75 times to about 140 times, about 75 times to about 150 times, about 75 times to about 175 times, about 75 times to about 200 times, about 75 times to about 225 times, about 75 times to about 250 times, about 75 times to about 275 times, about 75 times to about 300 times, about 100 times to about 110 times, about 100 times to about 120 times, about 100 times to about 130 times, about 100 times to about 140 times, about 100 times to about 150 times, about 100 times to about 175 times, about 100 times to about 200 times, about 100 times to about 225 times, about 100 times to about 250 times, about 100 times to about 275 times, about 100 times to about 300 times, about 125 times to about 150 times, about 125 times to about 175 times, about 125 times to about 200 times, about 125 times to about 225 times, about 125 times to about 250 times, about 125 times to about 275 times, about 125 times to about 300 times, about 150 times to about 175 times, about 150 times to about 200 times, about 150 times to about 225 times, about 150 times to about 250 times, about 150 times to about 275 times, about 150 times to about 300 times, about 175 times to about 200 times, about 175 times to about 225 times, about 175 times to about 250 times, about 175 times to about 275 times, about 175 times to about 300 times, about 200 times to about 225 times, about 200 times to about 250 times, about 200 times to about 275 times, about 200 times to about 300 times, about 225 times to about 250 times, about 225 times to about 275 times, about 225 times to about 300 times, about 250 times to about 275 times, about 250 times to about 300 times, or about 275 times to about 300 times.

A method or use disclosed herein may further comprises a rinsing step using a rinse solution. Typically, the rinse solution is used to rinse a cleaned, disinfected, sanitized, and/or sterilized medical device or surface. The rinse solution is preferably a sterile solution. In one embodiment, a rinse solution disclosed herein comprises water. In another embodiment, a rinse solution disclosed herein comprises hypochlorous acid or free available chlorine and water. In another embodiment, a rinse solution disclosed herein does not comprises hypochlorous acid and/or free available chlorine. When present in a kit disclosed herein, the rinse solution is present in a separate container.

EXAMPLES

The following non-limiting examples are provided for illustrative purposes only in order to facilitate a more complete understanding of representative embodiments now contemplated. These examples should not be construed to limit any of the embodiments described in the present specification, including those pertaining to the compounds, compositions, or methods and uses disclosed herein.

Preparation of Stable Free Available Chlorine Solution

A solution comprising one or more stable free available chlorine species and one or more peroxides was produced by a hydrolysis procedure. Initially, a aqueous solution is prepared by adding about 0.04% to 0.1% sodium peroxide to purified water. Chlorine gas (Cl2) was then introduced to the solution for about 30 minutes to 60 minutes to produce a reaction solution. Analysis of this first reaction solution revealed that it comprised about 10 ppm to about 40 ppm of one or more free available chlorine species and about 10 ppm to about 40 ppm of one or more peroxides and had a pH of about 3.3. Once this reaction step was completed, an additional 0.001% to 0.03% sodium peroxide was added to the first reaction solution. Analysis indicated that this peroxide addition had the effect of increasing the pH to above 9 and eliminating the detection of the one or more free available chlorine species previously produced. Chlorine gas was then introduced to the first reaction solution for about 10 minutes to about 20 minutes to produce a second reaction solution. Analysis of this second reaction solution revealed that it comprised about 120 ppm to about 240 ppm of one or more free available chlorine species and about 120 ppm to about 240 ppm of one or more peroxides. The resulting reactions produced a solution comprising stably containing free available chlorine species and peroxides together.

In further experiments, the peroxide addition and chlorine gassing process was conducted a third time. In this step, once this second reaction step was completed, an additional 0.001% to 0.02% sodium peroxide was added to the second reaction solution. Analysis indicated that this peroxide addition had the effect of increasing the pH to above 9 and eliminating the detection of the one or more free available chlorine species previously produced. Chlorine gas was then introduced to the second reaction solution for about 2 minutes to about 10 minutes to produce a third reaction solution. Analysis of this third reaction solution revealed that it comprised 160 ppm to 300 ppm of one or more free available chlorine species and 160 ppm to 300 ppm of one or more peroxides. The resulting reaction produced a solution comprising stably containing free available chlorine species and peroxides together.

In an alternative method of producing a solution comprising one or more stable free available chlorine species and one or more peroxides, an aqueous solution is prepared by adding about 0.03% to 0.1% sodium chloride (NaCl) to purified water. Both chlorine (Cl2) and oxygen (O2) gases are then introduced to the solution for about 30 minutes to 60 minutes to produce a first reaction solution. Analysis of this first reaction solution reveals that it comprises about 10 ppm to about 40 ppm of one or more free available chlorine species and about 10 ppm to about 40 ppm of one or more peroxides and had a pH of about 3.3. Once this reaction step is completed, an additional 0.01% to 0.03% sodium chloride (NaCl) is added to the first reaction solution. Both chlorine (Cl2) and oxygen (O2) gases are then introduced to the first reaction solution for about 10 minutes to 20 minutes to produce a second reaction solution. Analysis of this second reaction solution reveals that it comprises about 120 ppm to about 240 ppm of one or more free available chlorine species and about 120 ppm to about 240 ppm of one or more peroxides. The resulting reactions will produce a solution comprising stable free available chlorine species and peroxides.

In another alternative method of producing a solution comprising one or more stable free available chlorine species and one or more peroxides, an aqueous solution is prepared by adding about 0.03% to 0.1% of one or more peroxides and sodium hydroxide to purified water. Chlorine (Cl2) gas is then introduced to the solution for about 30 minutes to 60 minutes to produce a first reaction solution. Analysis of this first reaction solution reveals that it comprises about 10 ppm to about 40 ppm of one or more free available chlorine species and about 10 ppm to about 40 ppm of one or more peroxides and had a pH of about 3.3. Once this reaction step is completed, an additional 0.01% to 0.03% of one or more peroxides and sodium hydroxide is added to the first reaction solution. Chlorine (Cl2) a gas is then introduced to the first reaction solution for about 10 minutes to 20 minutes to produce a second reaction solution. Analysis of this second reaction solution reveals that it comprises about 120 ppm to about 240 ppm of one or more free available chlorine species and 120 ppm to 240 ppm of one or more peroxides. The resulting reactions will produce a solution comprising stable free available chlorine species and peroxides.

Formulated Compositions

This example illustrates exemplary formulations manufactured according to a method or use disclosed herein and the amounts of peroxides and stable free available chlorine present in the compositions (see Tables 1-2).

Formulated Compositions

This example illustrates exemplary compositions manufactured according to a method or use disclosed herein and the amounts of peroxides and stable free available chlorine (see Tables 3-10).

Formulated Compositions

This example illustrates how to formulate a composition using a composition manufactured according to a method or use disclosed herein. Hydrogen peroxide is added to a manufactured composition as described in Example 3 accounting to the percent amounts as indicated in Formulations HPF1-HPF48 in Tables 11-18 below. The components listed below were mixed at ambient temperature using a high shear mixer until the mixture was uniform.

Hydrogen Peroxide Determination

This example illustrates hydrogen peroxide and FAC concentrations using a commercial hydrogen peroxide assay kit employing colorimetric reaction techniques. All formulations mentioned below were tested for hydrogen peroxide (ppm) and FAC (ppm).

Bacterial Viability Assays

This example illustrates how to conduct a bacterial viability assay using a composition disclosed herein.

Fresh 24-hour culture ofStaphylococcus aureus(ATCC 29213) was prepared on Tryptic Soy Agar (TSA) at 36±1° C. A bacterial inoculum was prepared using a colorimeter to confirm a yield of 1×107CFU/mL.

The following three samples, AX-275, 115HP and 115HP-P were tested againstS. aureusin presence of 2% serum for a time-point of 5 minutes. All three samples had a Free Available Chlorine (FAC) concentration of 160 ppm. AX-275 was diluted with water to achieve an FAC of approximately 160 ppm.

Samples were tested as follows: Each assay contained 100 μL of pathogenic bacteria suspension, 200 μL of serum and 9,700 μL of a composition formulation disclosed herein. Samples were exposed for 5 minutes prior to neutralizing agent was used to inhibit the activity of the microbial agent; plates were incubated at 30° C. to 35° C. for up to 2 days. The presence of viable bacteria was then measured by counting the number of colonies observed on the agar medium and bacterial log reduction in comparison to growth control was calculated and results are shown in Table 20.

A separate experiment was designed where AX-275 at a FAC of 147 ppm and pH adjusted to 5.12. The sample was then tested as described above. The pH adjustment required the addition of HCl. The results have shown 6.28 log reduction ofS. aureus.

Quantitative Odor Test

Two test samples; AX-275 (FAC adjusted to 147 ppm, pH=5.12) and 115HP (150 ppm, pH=5.69) were blinded and used for the following odor test. Five subjects were asked to grade the odor for the presence of chlorine smell. The grading was based on a scale of 1-4, where Grade 1 indicated no smell detected, Grade 2 indicated slight chlorine smell, Grade 3 indicated moderate chlorine smell and Grade 4 indicated high levels of chlorine smell. The containers were opened it in front of both nostrils and sniffed. Table 21 bellow includes the Quantitative Odor Test.

Equine Respiratory Experience

It is known that inhalation of chlorine and chlorine related species at higher concentrations may induce toxicity. A preliminary study was undertaken to evaluate the efficacy of our novel SPC-069 formulation which contains both chlorine in form of free available chlorine and reactive oxygen species including peroxide on the respiratory system function of horses. This study was performed to determine differentiated therapeutic results as compared to historical toxicity results expected and associated with inhalation of higher concentrations of chlorine and chlorine related species and possible mixtures of peroxide and reactive oxygen species. A primary problem in athletic horses frequently involves their respiratory system. This includes show horses, working horses, performance horses and especially, racehorses. There are many factors that adversely affect the normal function and structure of the various parts of the horses' upper and lower respiratory system. The underlying causes for these changes can be both infectious and non-infectious in nature. These causes often manifest themselves by producing inflammation. Horse respiratory tract inflammation is purported to occur in 20% to 50% of athletic horses. This results in interference and reduction in training days and impaired performance. These factors and the cost of therapy result in a large economic loss to the horse owner. The many causes that create this airway inflammation and decrease in lung function include allergy related airway changes, constant airway trauma from inhalation of airway contaminants (dust, pollutants, grass/hay debris, viruses, bacteria and other pathogens), systemic stresses that decrease the immune system function and the immune competence of the horse.

A preliminary subjective evaluation of the effect of SPC-069, veterinary hypochlorous solution, on the horses' airway tract function, administered via nebulization was undertaken. The horse population chosen was one that routinely and historically has a significant portion of the young horses stressed and exhibiting upper and lower respiratory tract symptoms (coughs, fever, off feed, mucus/mucopurulent (pus) nasal discharge, decrease performance, lost training days, etc. This population of horses was a group of two-year old thoroughbreds brought to a training center. These horses often develop respiratory tract inflammation and mucus as a result of the stress of their new environments, routines, new population of other horses, and other factors.

Study Design: One week prior to a track work-out a group of seven, two-year old thoroughbreds in training were nebulized with 20 ml of SPC-069 for 20 minutes. This was done in the morning for each of the seven days before their official work. After their official work, the seven horses were given a veterinary respiratory tract endoscopic evaluation.

Study Results: Six of the horses scored zero out of five on a score of the amount of mucus and were considered clean. One horse had a mild mucus presence and scored 0.5 out of 5, and was considered good. A nationally known and respected thoroughbred trainer was in charge during the complete program. During the training the trainer did not notice or document any respiratory tract inflammation or negative symptoms. The trainer said that in these situations in the past 20-70% of thoroughbreds would have some mucus or other respiratory tract signs.

Due to the success with the initial seven horses, the trainer opted to repeat the trial with the next group of horses, using the same protocol. In this study, 13, 2-year-old thoroughbreds in training were included. Results for all 13 horses scoped zero out of five for mucus and were considered clean.

Study Conclusion. SCP-069 had no apparent ill effect on the horse respiratory tract tissue. In fact, SPC-069 may have improved airway function ability, decreased airway resistance and inflammation, improved lung flexibility, and decreased the effort of breathing. This preliminary study supports the more formal evaluation of this product in horses.

In closing, foregoing descriptions of embodiments of the present invention have been presented for the purposes of illustration and description. It is to be understood that, although aspects of the present invention are highlighted by referring to specific embodiments, one skilled in the art will readily appreciate that these described embodiments are only illustrative of the principles comprising the present invention. As such, the specific embodiments are not intended to be exhaustive or to limit the invention to the precise forms disclosed. Therefore, it should be understood that embodiments of the disclosed subject matter are in no way limited to a particular element, compound, composition, component, article, apparatus, methodology, use, protocol, step, and/or limitation described herein, unless expressly stated as such.

In addition, groupings of alternative embodiments, elements, steps and/or limitations of the present invention are not to be construed as limitations. Each such grouping may be referred to and claimed individually or in any combination with other groupings disclosed herein. It is anticipated that one or more alternative embodiments, elements, steps and/or limitations of a grouping may be included in, or deleted from, the grouping for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is deemed to contain the grouping as modified, thus fulfilling the written description of all Markush groups used in the appended claims.

Furthermore, those of ordinary skill in the art will recognize that certain changes, modifications, permutations, alterations, additions, subtractions and sub-combinations thereof can be made in accordance with the teachings herein without departing from the spirit of the present invention. Furthermore, it is intended that the following appended claims and claims hereafter introduced are interpreted to include all such changes, modifications, permutations, alterations, additions, subtractions and sub-combinations as are within their true spirit and scope. Accordingly, the scope of the present invention is not to be limited to that precisely as shown and described by this specification.

The words, language, and terminology used in this specification is for the purpose of describing particular embodiments, elements, steps and/or limitations only and is not intended to limit the scope of the present invention, which is defined solely by the claims. In addition, such words, language, and terminology are to be understood not only in the sense of their commonly defined meanings, but to include by special definition in this specification structure, material or acts beyond the scope of the commonly defined meanings. Thus, if an element, step or limitation can be understood in the context of this specification as including more than one meaning, then its use in a claim must be understood as being generic to all possible meanings supported by the specification and by the word itself.

The definitions and meanings of the elements, steps or limitations recited in a claim set forth below are, therefore, defined in this specification to include not only the combination of elements, steps or limitations which are literally set forth, but all equivalent structure, material or acts for performing substantially the same function in substantially the same way to obtain substantially the same result. In this sense it is therefore contemplated that an equivalent substitution of two or more elements, steps and/or limitations may be made for any one of the elements, steps or limitations in a claim set forth below or that a single element, step or limitation may be substituted for two or more elements, steps and/or limitations in such a claim. Although elements, steps or limitations may be described above as acting in certain combinations and even initially claimed as such, it is to be expressly understood that one or more elements, steps and/or limitations from a claimed combination can in some cases be excised from the combination and that the claimed combination may be directed to a sub-combination or variation of a sub-combination. As such, notwithstanding the fact that the elements, steps and/or limitations of a claim are set forth below in a certain combination, it must be expressly understood that the invention includes other combinations of fewer, more or different elements, steps and/or limitations, which are disclosed in above combination even when not initially claimed in such combinations. Furthermore, insubstantial changes from the claimed subject matter as viewed by a person with ordinary skill in the art, now known or later devised, are expressly contemplated as being equivalently within the scope of the claims. Therefore, obvious substitutions now or later known to one with ordinary skill in the art are defined to be within the scope of the defined elements. Accordingly, the claims are thus to be understood to include what is specifically illustrated and described above, what is conceptually equivalent, what can be obviously substituted and also what essentially incorporates the essential idea of the invention.

Unless otherwise indicated, all numbers expressing a characteristic, item, quantity, parameter, property, term, and so forth used in the present specification and claims are to be understood as being modified in all instances by the term “about.” As used herein, the term “about” means that the characteristic, item, quantity, parameter, property, or term so qualified encompasses a range of plus or minus ten percent above and below the value of the stated characteristic, item, quantity, parameter, property, or term. Accordingly, unless indicated to the contrary, the numerical parameters set forth in the specification and attached claims are approximations that may vary. For instance, as mass spectrometry instruments can vary slightly in determining the mass of a given analyte, the term “about” in the context of the mass of an ion or the mass/charge ratio of an ion refers to +/−0.50 atomic mass unit. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical indication should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.

Notwithstanding that the numerical ranges and values setting forth the broad scope of the invention are approximations, the numerical ranges and values set forth in the specific examples are reported as precisely as possible. Any numerical range or value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements. Recitation of numerical ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate numerical value falling within the range. Unless otherwise indicated herein, each individual value of a numerical range is incorporated into the present specification as if it were individually recited herein.

When used in the claims, whether as filed or added per amendment, the open-ended transitional term “comprising”, variations thereof such as, e.g., “comprise” and “comprises”, and equivalent open-ended transitional phrases thereof like “including”, “containing” and “having”, encompass all the expressly recited elements, limitations, steps, integers, and/or features alone or in combination with unrecited subject matter; the named elements, limitations, steps, integers, and/or features are essential, but other unnamed elements, limitations, steps, integers, and/or features may be added and still form a construct within the scope of the claim. Specific embodiments disclosed herein may be further limited in the claims using the closed-ended transitional phrases “consisting of” or “consisting essentially of” (or variations thereof such as, e.g., “consist of”, “consists of”, “consist essentially of”, and “consists essentially of”) in lieu of or as an amendment for “comprising.” When used in the claims, whether as filed or added per amendment, the closed-ended transitional phrase “consisting of” excludes any element, limitation, step, integer, or feature not expressly recited in the claims. The closed-ended transitional phrase “consisting essentially of” limits the scope of a claim to the expressly recited elements, limitations, steps, integers, and/or features and any other elements, limitations, steps, integers, and/or features that do not materially affect the basic and novel characteristic(s) of the claimed subject matter. Thus, the meaning of the open-ended transitional phrase “comprising” is being defined as encompassing all the specifically recited elements, limitations, steps and/or features as well as any optional, additional unspecified ones. The meaning of the closed-ended transitional phrase “consisting of” is being defined as only including those elements, limitations, steps, integers, and/or features specifically recited in the claim, whereas the meaning of the closed-ended transitional phrase “consisting essentially of” is being defined as only including those elements, limitations, steps, integers, and/or features specifically recited in the claim and those elements, limitations, steps, integers, and/or features that do not materially affect the basic and novel characteristic(s) of the claimed subject matter. Therefore, the open-ended transitional phrase “comprising” (and equivalent open-ended transitional phrases thereof) includes within its meaning, as a limiting case, claimed subject matter specified by the closed-ended transitional phrases “consisting of” or “consisting essentially of.” As such, the embodiments described herein or so claimed with the phrase “comprising” expressly and unambiguously provide description, enablement, and support for the phrases “consisting essentially of” and “consisting of.”