Preparations for the prevention of diseases transmitted through the oral cavity and pharynx.

Abstract

To provide preparations for prevention of diseases transmitted through oral cavity and pharynx.SOLUTION: The present invention includes toothpastes or other orally applied products to be used at least once daily to help prevent or inhibit the morbidity of several infections of the oral or pharyngeal tissues, including, among others, the "common cold". These compositions possess a combination of ingredients not found in other toothpastes or other orally applied products, and these ingredients work together to synergistically inhibit the morbidity of several pathogens. The toothpastes will have normal toothpaste ingredients known to prevent caries, as well as ingredients that reduce halitosis (i.e., bad breath) and prevent gingivitis. In addition, the toothpastes will contain one or more of: 1) GALALCOOL(R) as a separate compound, not as an extracted component; 2) zinc protoporphyrin IX; and 3) one or more other colorless or low-colored tannins, each as a separate compound, not as an extracted component.SELECTED DRAWING: None

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority to U.S. Patent Application No. 16 / 353,802, filed on Mar. 14, 2019, which is a partial continuation of U.S. Patent Application No. 15 / 701,465, filed on Sep. 12, 2017, and those are incorporated herein by reference.

[0002] The present invention relates to compositions and formulations for preventing or suppressing the acquisition of infections through the oral cavity, pharynx, and / or lungs, and methods of using and making these compositions and formulations. Specifically, the present invention relates to toothpaste in the form of a paste or gel, or a mouthwash or oral rinse, or chewable materials such as chewing gum, or other oral dosage forms, for preventing or suppressing colds or other respiratory and pharyngeal infections, and materials for administration by inhalation, and their use for administering these compositions and formulations for preventing or suppressing colds and / or other respiratory and pharyngeal infections to the mouth, pharynx, and / or lungs.

Background Art

[0003] Several toothpastes and mouthwashes already on the market are known to resist caries (usually through fluoride), reduce the incidence of gingivitis (usually through the action of triclosan and / or zinc salts such as zinc acetate, zinc gluconate, zinc lactate, or zinc chloride (M. Sanz, et al., Antiplaque and Antigingivitis toothpastes. Monograph Oral Sci (2013) 23:27-44)), help rinse the mouth of food particles, and provide "fresh breath." Therefore, while currently available over-the-counter toothpastes address the need for prevention of tooth decay (bacterial caries that cause cavities), gingivitis, improvement of sensitive teeth, and general oral hygiene, there is a need in the art for toothpastes and other oral formulations that would enhance the ability of toothpastes or formulations to prevent or suppress or reduce the incidence or likelihood of several conditions, including the common cold and numerous other conditions caused by pathogenic viruses, bacteria, and fungi, or sometimes other conditions (e.g., stomatitis, ear infections, etc.). Therefore, there is a need in the art for toothpastes, mouthwashes and other formulations that would function like most toothpastes and mouthwashes in preventing cavities and cleaning the mouth, while simultaneously preventing or suppressing or reducing the incidence or likelihood of several oral and pharyngeal infections. [Overview of the project]

[0004] Described herein are formulations that, when applied in one of their embodiments to the mouth, pharynx, or lungs, would help prevent or suppress the onset of many possible conditions resulting from interactions between pathogens such as viruses, bacteria, or fungi and tissues present in the mouth, pharynx, and / or lungs. In preferred embodiments of toothpaste or gel, the compositions and formulations described herein can be adequately delivered to the oral and pharyngeal surfaces. By brushing teeth at least daily, followed by minimal rinsing, or by the habit of simply spitting out the formulation, typically toothpaste, the user will be protected from contracting several conditions, particularly the common cold, or will have a lower incidence of them. In another preferred embodiment, the formulations and compositions described herein can be adequately delivered to the mouth, pharynx, and / or lungs by inhalation using an inhaler or nebulizer. As a result, the user will be protected from many conditions such as influenza, SARS, or COVID-19. They are protected from contracting viral infections or have a lower incidence of them.

[0005] Preferred components known in the art form the basis of embodiments of the present invention, to which components of a dissolved zinc salt and one or more astringent compounds selected from highly purified gallic acid tannin extracts or preparations (such as GALALCOOL® (sold by the France-based Laffort Company), a highly purified extract from tarapods; low-color tannins extracted from tara (Caesalpinia spinosa) are referred herein as "tara tannins"), another colorless or low-color tannin, and components of zinc protoporphyrin IX will be added.

[0006] In one embodiment, provided herein is a composition formulated as a toothpaste or other oral preparation for the prevention or suppression of the common cold or other respiratory and pharyngeal infections, comprising a toothpaste gel or paste containing a colorless or low-pigmentation tannin (including GALALCOOL®, a low-pigmentation tannin extracted from tarrapoda for addition to white wine and sold by the Laffort Company in France, or other mass-produced colorless, low-pigmentation, or white tannins, or combinations thereof). In some embodiments, the toothpaste or other oral preparation further comprises zinc protoporphyrin IX. In some embodiments, the toothpaste or other oral preparation further comprises a free zinc salt.

[0007] In another embodiment, provided herein are compositions formulated as chewing gum, oral rinse, mouthwash, or aerosol for the prevention or suppression of the common cold or other respiratory and pharyngeal infections, comprising a solvent or other vehicle containing GALALCOOL®, or tara tannin or another mass-produced, colorless, low-coloring, or white tannin, or a combination thereof. In some embodiments, the chewing gum, oral rinse, mouthwash, or aerosol further comprises zinc protoporphyrin IX. In some embodiments, the chewing gum, oral rinse, mouthwash, or aerosol further comprises a free zinc salt.

[0008] In another embodiment, provided herein are methods for preventing or suppressing or reducing the incidence or likelihood of contracting the common cold or other respiratory or pharyngeal infections by administering the compositions or formulations described herein to the mouth and / or pharynx of a subject.

[0009] In another embodiment, provided herein are compositions formulated for the prevention or suppression of viral infections and for administration by inhalation, comprising a solvent or other vehicle containing GALALCOOL®, tara tannin, one or more other colorless or low-color tannins, or a combination thereof. In some embodiments, the composition further comprises a free zinc salt. In some embodiments, the composition further comprises zinc protoporphyrin IX. Also provided herein are methods for preventing or suppressing or reducing the incidence or likelihood of a viral infection by administering the compositions or formulations described herein to a subject by inhalation.

[0010] In yet another aspect, this specification provides a method for preparing the compositions or formulations described herein.

[0011] Other features and advantages of the present invention will become apparent from the examples in the following detailed description. However, it should be understood that the detailed description and specific examples, while illustrating preferred embodiments of the present invention, are given by illustrative means only, as various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art from this detailed description. [Modes for carrying out the invention]

[0012] In the following detailed description, many specific details are provided to give a complete understanding of the invention. However, it will be understood by those skilled in the art that the invention can be carried out without these specific details. In other cases, well-known methods, procedures, and components are not described in detail so as not to obscure the invention.

[0013] In some embodiments, described herein are toothpastes in the form of pastes or gels, or mouthwashes or oral rinses, or chewable materials such as chewing gum, or base formulations having preferred ingredients known in the art such as fluorides, detergents (such as sodium lauryl sulfate), solvents (such as glycerol and / or propylene glycol), zinc salts, abrasives (such as fumed silica), antimicrobial agents (such as triclosan), flavorings including sweeteners, and other oral formulations which may contain any other preferred ingredients that may be useful or necessary for the composition or formulation. Additions to the base formulation or formulation are one or more of the following: (1) Astringent compounds, tannins called GALALCOOL (registered trademark) and / or tannins called tara tannins, (2) Astringent compounds, porphyrins called zinc protoporphyrin IX, and (3) Astringent compounds, GALALCOOL®, or colorless or low-coloring tannins other than tara tannin (for example, TANFRESH®, a low-coloring tannin preparation of proanthocyanidic tannin and oak ellagic tannin from the same company as GALALCOOL®).

[0014] The above ingredients will have their effect in preventing or suppressing the onset of several pathogens, including some potentially pathogenic oral bacteria, such as those that can cause gingivitis, oral fungi that can cause thrush, and viruses that cause the common cold, such as rhinovirus. Typically, when the user applies the toothpaste described herein with a toothbrush, they will brush with the toothpaste at least once a day, and immediately after brushing, they will either lightly spit out the preparation once and / or rinse with water.

[0015] The toothpaste or other embodiments of the present invention will function like most toothpastes and mouthwashes in preventing cavities and cleaning the mouth, while preventing or suppressing certain oral and pharyngeal infections or reducing their incidence or likelihood.

[0016] One of the inventors had suffered from colds for most of his life, typically getting three to four colds a year. However, he began to explore the correlation between his lower incidence of colds and the ingredients that a person might intentionally ingest. Some have developed plausible scientific evidence, while others are anecdotally related to the lower incidence of illness and include the following: 1. Salts of zinc, 2. Tin fluoride or other fluorides, 3. Sodium lauryl sulfate, and 4. Polyphenols such as tannins.

[0017] Several toothpastes and mouthwashes already on the market resist caries (usually through fluoride) and reduce the incidence of gingivitis (usually through the action of triclosan and / or zinc salts such as zinc acetate, zinc gluconate, zinc lactate, or zinc chloride (M. Sanz, et al., Antiplaque and Antigingivitis toothpastes. Monograph Oral Sci (2013) 23:27-44)) is known to help rinse the mouth of food particles and provide “fresh breath.” However, in embodiments of the present invention, the toothpaste or mouthwash does not have a single combination of ingredients, and in particular, the ingredients in the latter toothpaste provide a slower release of zinc salts. Zinc salts have been used for many years in some toothpastes to prevent gingivitis, but considering that zinc salts can also be used to reduce cold symptoms by significantly reducing the infectivity of the common cold virus to the mucous membranes, it makes sense to provide a more stable source of zinc ions by using the method described below to keep zinc salts in the oral cavity for a longer period than is usually achieved by brushing with current toothpastes. New toothpaste is typically used at least once a day through brushing with a toothbrush, but nevertheless, it may be used more than twice a day without adverse effects or reduced efficacy. After brushing, the user spits out the ingredients from their mouth with a single rinse with water, or even without rinsing partially or completely, in order to allow for proper retention of any toothpaste residue.

[0018] Regarding zinc salts, it is currently known that zinc ions can prevent rhinovirus from attaching to cells, and that zinc-containing lozenges can reduce the symptoms and duration of the common cold (see WedMD.Cold, Flu & Cough Health Center - Zinc for Colds: Lozenges & Nasal Sprays, available at www.webmd.com / cold-and-flu / cold-guide / zinc-lozenges-cold-remedy, and National Institutes of Health Office of Dietary Supplements.Zinc Fact Sheet for Health Professionals, available at ods.od.nih.gov / factsheets / Zinc-HealthProfessional). However, one of the inventors observed that not exposing himself to such components for a day and a half resulted in him catching a cold again, suggesting that extending the residence time of anti-cold components in the mouth and pharynx can enhance the effectiveness of zinc compounds in preventing the common cold. Therefore, one of the inventors came up with a way to achieve the latter goal of toothpaste. Zinc is thought to be effective against other common viruses such as respiratory syncytial virus (available in Effect of Zinc Salts on Respiratory Syncytial Virus Replication - NCBI.www.ncbi.nlm.nih.gov / pmc / articles / PMC353050), and therefore it should be noted that extending the residence time of zinc salts would provide other health benefits of toothpaste.

[0019] Toothpaste containing zinc, applied to the oral cavity, gums, and pharynx, may inhibit the ability of numerous infectious viruses to infect individuals. Furthermore, zinc salts are known to possess antibacterial and antifungal properties, and they, along with fluoride salts, detergents, and other components, may also help reduce the frequency of fungal and bacterial infections. Thus, embodiments of the present invention address a wide range of medical conditions affecting the oral cavity and pharynx from local areas.

[0020] The property of zinc salts that correlates with their ability to prevent the common cold (rhinovirus and other viruses) is their astringent property (see www.britannica.com / science / astringent, accessed September 14, 2016). Zinc belongs to a class of astringents called "metallic astringents," which are astringent properties that affect the surface layer of cells. This belongs to the category of substances that cause a coagulation effect. This would suggest that protein coagulation is involved in the prevention or suppression of cold infection. Assuming that a protein coat called a capsid surrounds all viruses, the coagulation of proteins within the coat fundamentally prevents virions (individual viral particles) from attaching to their cellular host, which would be particularly true for host cells superficially exposed to the astringent on the surface. However, many viruses also have a lipid "envelope" surrounding the protein coat, which may interfere with the coagulation effect of astringents, and furthermore, such envelopes are thought to interfere with immune defense by preventing the binding of proteins (viruses) to proteins (antibodies). However, toothpaste, as well as other oral and pharyngeal preparations, contain highly efficient surfactants such as sodium lauryl sulfate, which thus help solubilize the lipid envelope of viruses, and thus result in exposure of the protein capsid to the astringent in the preparation. Therefore, the detergent environment appears to be a cofactor in the success of preventing infection from enveloped viruses with astringents (including zinc salts). Since most colds are caused by rhinoviruses, which are not enveloped viruses, the need for detergent cofactors to prevent infection with them in the pharynx is probably not significant.

[0021] Nevertheless, embodiments of the present invention are intended to prevent or suppress infection with other viruses that infect the mouth, pharynx, or lungs, not just the common cold virus, many of which are enveloped viruses. Among the enveloped viruses that embodiments of the present invention, such as toothpaste disclosed herein, may prevent or suppress include, in particular, herpes simplex I (oral herpes), varicella virus (chickenpox), influenza virus, coronaviruses such as severe acute respiratory syndrome-associated coronaviruses (members of which cause severe acute respiratory syndrome (SARS) and COVID-19), flaviviruses (hepatitis C), and respiratory syncytial viruses (medimoon.com / 2014 / 03 / list-of-some-common-viral-diseases-and-their-treatment). It should be noted that the point in time of initial viral infection does not necessarily represent the final distribution and symptoms of the virus. For example, a person may contract hepatitis C through the pharynx, but the primary site of the disease is the liver. Similarly, inner ear infections (otitis media) can occur secondarily from viral or bacterial infections that initially affect the pharynx. Accordingly, according to some embodiments, the toothpastes disclosed herein may prevent or suppress or reduce the incidence or likelihood of contracting coronavirus infections, particularly COVID-19 and other viral infections.

[0022] Therefore, the astringent properties are associated with stopping viral infection by mucosal cells. In embodiments of the present invention, an isolated tannin called GALALCOOL® is an ingredient that would be used to prevent the onset of pathological conditions caused by microorganisms, including viruses and bacteria, via the oral cavity and pharynx. This is at least in part due to its known astringent properties. It would act as a coagulant, as in the case of zinc. However, unlike zinc alone, it would have an affinity for mucus secretion that is not expected in the ionic form of zinc (from zinc salts). Therefore, it could potentially adhere to certain oral and pharyngeal surfaces for extended periods. Furthermore, it possesses beneficial anti-inflammatory properties, as shown in at least one study (P. Buzzini, et al., Antimicrobial and Antiviral Activity of Hydrolysable Tannins. Mini-Reviews in Medicinal Chemistry (2008) 8:1179-1187; Yuan-Jin Guo et al., Effect of Corilagin on Anti-inflammation in HSV-1 Encephalitis and HSV-1 Infected Microglias.European Journal of Pharmacology( (2010)635:79-86, J. Luoqi, et al., A Potential Anti-tumor Herbal Medicine, Corilagin, Inhibits Ovarian Cancer Cell Growth Through Blocking the TGF-β Signaling Pathways. BMC Complementary and Alternative Medicine (2013)13:33, N. Bismelah, et al., Journal of Medicinal Plants Studies (2016)4:18-23, A. Gupta, et al., Phytochemistry and Pharmacological Activities of Haritaki - A Review. Journal of Pharmacy Research (2010)3:417-424). Indian gooseberry extract has been proposed as a toothpaste ingredient (P Potduang,et al.,The Development of Phyllanthus emblica and Zanthoxylum limonella Toothpaste.The 6th International Conference on Natural Products for Health and Beauty (NATPRO6), January 21 - 23, 2016), and it has been proposed that the extract has corilagin as one of its constituent substances, but many other constituent substances are present in the extract. Furthermore, in that case, neither has corilagin been selected as the active ingredient in the formulation, nor has its mechanism of action as an antibacterial and anti - inflammatory agent been clarified. GALALCOOL (registered trademark), tara tannin, or other low - coloring or colorless tannins used in embodiments of the present invention is 0.03% by weight, which is much lower than the maximum extract concentration of 0.2% by weight in the toothpaste having the extract proposed by P Potduang, et al. However, it can be proven that much higher concentrations of tannin are optimal, and according to the claims of this patent, it can be up to 10% by weight of the toothpaste composition, much higher than 0.2%. In such a case, the concentration of pure tannin in embodiments of the present invention will exceed that in the Indian gooseberry toothpaste due to many factors.

[0023] Other astringent compounds, namely colorless or low-coloring tannins, would be alternative ingredients to GALALCOOL® or tara tannin, but one or more such tannins may also be used in conjunction with the latter to extend the efficacy of toothpaste. Among the polyphenol compounds of tannins, GALALCOOL® is just one example; tannins are found in relatively high concentrations in many edible plants. They are astringent and therefore typically result in protein precipitation, and this may be most important in removing viruses from free distribution in the mouth and throat, given that most viruses have a protein capsid (shell) that interacts with the external environment (A Manual of Materia Medica and Pharmacology, p.282. DMR Culbreck, Lea and Febiger, Philadelphia, 1927). Furthermore, this would suggest the ability, like zinc, to prevent certain viruses from attaching to mucosal cells, but its very low water solubility, unlike zinc salts, suggests it may preferentially isolate less moist substances in different locations within the mouth. Also, polyphenols (such as the flavonoid compound quercetin) have been reported to possess antimicrobial properties, thus retaining other potential benefits to oral health as well as potential antiviral agents (TPT Cushnie and AJ Lamb, Antimicrobial Activity of Flavonoids, International Journal of Antimicrobial). Agents (2005) 26:343). GALALCOOL® and tara tannin, along with other tannins, may be considered active ingredients in certain embodiments of the present invention. However, since tannins are typically dark-colored compounds, only certain tannins may be considered potential co-components in certain embodiments of the present invention, and tannins are typically, For staining tooth enamel, it is important that only colorless or lightly colored tannins (i.e., non-staining tannins) are used in certain embodiments of the present invention. They can also stain the bristles of a toothbrush, resulting in another psychologically unfavorable outcome. Thus, in certain embodiments of the present invention, only tannins that stain tooth enamel or the bristles of a toothbrush are included in the compositions described herein. GALALCOOL® (registered trademark), tara tannin, and / or other tannin or polyphenol astringent compounds (e.g., TANFRESH® (registered trademark)) used in embodiments of the present invention will potentially exhibit synergistic effects with the components of other constituents of embodiments of the present invention. The components in the compositions of embodiments of the present invention are at concentrations known to be non-toxic even if the product is inadvertently swallowed completely each time it is used. Regarding concerns about the toxicology of tannins, the Select Committee on GRAS Substances intervened as follows regarding the potential toxicity of tannic acid (as a hydrolyzable gallotannin prototype) (https: / / www.fda.gov / Food / IngredientsPackagingLabeling / GRAS / SCOGS / ucm261485.htm, accessed August 23, 2017): "Therefore, from the foregoing perspectives, the Select Committee concludes the following." The available information on tannic acid (hydrolyzable gallotannin) does not demonstrate or suggest reasonable grounds to suspect a danger to the public at the current levels and when used in the manner currently practiced. However, without additional data, it is not possible to determine whether a significant increase in consumption would cause a risk related to food."

[0024] Finally, another component, zinc protoporphyrin IX (RF Labbe, et al., Zinc Protoporphyrin: A Metabolite with (a Mission. Clinical Chemistry (1999) 45:2060-2072) can be a component of orally administered products. It is yet another zinc source with respect to longer-lasting effects; in addition to being an astringent itself, it is a known carrier of divalent ions (such as zinc ions), thus assisting in the delivery of zinc to a wider area of ​​the mouth and pharynx, and itself assisting in prolonging the astringency in the latter area, creating a more sustained zinc source. Zinc salts are water-soluble and will be more easily washed away from the mouth and oral cavity, and beyond.

[0025] However, because each component has different physical and chemical properties, synergistic effects will likely occur despite their common astringency due to differences in their structural stability, affinity for one another, affinity for different surfaces in the mouth and pharynx, and tendency to associate with and adhere to different secretions.

[0026] While currently available over-the-counter toothpastes address the need for preventing cavities (bacterial caries that cause tooth decay), gingivitis, improving sensitive teeth, and general oral hygiene, the novel toothpastes described here may work synergistically through the combination of multiple ingredients. Because the surface affinity of each ingredient differs depending on the specific tissue (e.g., gums vs. pharyngeal mucosa vs. tooth enamel), different ingredients may be expected to work to create more complete exposure to the active ingredients in different tissues. Furthermore, because different strains of bacteria and viruses may differ significantly in their susceptibility to different ingredients, ingredient diversity should be more effective than simply using each known effective single ingredient at their highest safe concentrations. The ingredients in the novel toothpastes will likely exist in a unique combination containing components that would enhance the toothpaste's ability to prevent the onset of several conditions, including the common cold, as well as numerous other conditions caused by pathogenic viruses, bacteria, and fungi, or possibly other conditions (e.g., stomatitis, ear infections, etc.). Consumers of toothpaste should preferably brush their teeth once a day to achieve the desired results.

[0027] The following embodiments are provided to more fully illustrate preferred embodiments of the present invention. However, these embodiments should not be construed as limiting the broad scope of the present invention.

[0028] Embodiments of the present invention include the following: 1. A composition formulated as a toothpaste or other oral preparation for the prevention or suppression of the common cold or other respiratory and pharyngeal infections, comprising a toothpaste gel or paste containing GALALCOOL®, tara tannin, one or more other colorless or low-staining tannins, or a combination thereof. 2. The composition according to Embodiment 1, further comprising a free zinc salt. 3. The composition according to Embodiment 2, wherein the zinc salt is an organic zinc salt. 4. The composition according to Embodiment 3, wherein the organic zinc salt is selected from the group consisting of zinc gluconate, zinc lactate, zinc acetate, and combinations thereof. 5. The composition according to Embodiment 4, wherein the organic zinc salt is zinc gluconate. 6. The composition according to Embodiment 2, wherein the zinc salt is an inorganic zinc salt. 7. The composition according to Embodiment 6, wherein the inorganic zinc salt is selected from the group consisting of zinc chloride, zinc sulfate, zinc carbonate, and combinations thereof. 8. The composition according to any one of Embodiments 1 to 7, wherein GALALCOOL® or tara tannin is present in an amount of 0.01% to 10% by weight of the composition. 9. The composition according to Embodiment 8, wherein GALALCOOL® or tara tannin is present in an amount of 0.03% by weight of the composition. 10. The composition according to any one of Embodiments 1 to 9, wherein another colorless or low-coloring tannin, or each of the other colorless or low-coloring tannins, is present in an amount of 0.01% to 10% by weight of the composition. 11. The composition according to Embodiment 10, wherein one or more other colorless or low-coloring tannins are each present in an amount of 0.03% by weight of the composition. 12. The composition according to Embodiment 10 or 11, wherein the concentration of GALALCOOL® is zero. 13. The composition according to any one of Embodiments 1 to 11, wherein the composition comprises a combination of GALALCOOL® or tara tannin and one or more other colorless or low-coloring tannins. 14. The composition according to Embodiment 13, wherein GALALCOOL® or tara tannin is present in an amount of 0.01% to 10% by weight of the composition, and another or each other colorless or low-coloring tannin is present in an amount of 0.01% to 10% by weight of the composition. 15. The composition according to Embodiment 13, wherein GALALCOOL® or tara tannin is present in an amount of 0.03% by weight of the composition, and another or each other colorless or low-coloring tannin is present in an amount of 0.03% by weight of the composition. 16. The composition according to any one of Embodiments 1 to 15, further comprising zinc protoporphyrin IX. 17. The composition according to Embodiment 16, wherein zinc protoporphyrin IX is present in an amount of 0.1% to 5% by weight of the composition. 18. The composition according to Embodiment 17, wherein zinc protoporphyrin IX is present in an amount of 0.5% by weight of the composition. 19. The composition according to any one of Embodiments 2 to 18, wherein the free zinc salt is in the range of 0.1% to 0.5% by weight of the composition. 20. The composition according to Embodiment 19, wherein the free zinc salt is 0.4% by weight of the composition. 21. The composition according to any one of Embodiments 1 to 20, further comprising a fluoride compound. 22. Compositions formulated as chewing gum, mouth rinse, mouthwash, or aerosol for the prevention or suppression of the common cold or other respiratory and pharyngeal infections. A composition comprising a solvent or other vehicle containing GALALCOOL®, tara tannin, one or more other colorless or low-coloring tannins, or a combination thereof. 23. The composition according to Embodiment 22, further comprising a free zinc salt. 24. The composition according to Embodiment 23, wherein the zinc salt is an organic zinc salt. 25. The composition according to Embodiment 24, wherein the organic zinc salt is selected from the group consisting of zinc gluconate, zinc lactate, zinc acetate, and combinations thereof. 26. The composition according to Embodiment 24, wherein the organic zinc salt is zinc gluconate. 27. The composition according to Embodiment 23, wherein the zinc salt is an inorganic zinc salt. 28. The composition according to Embodiment 27, wherein the inorganic zinc salt is selected from the group consisting of zinc chloride, zinc sulfate, zinc carbonate, and combinations thereof. 29. The composition according to any one of Embodiments 22 to 28, wherein GALALCOOL® or tara tannin is present in an amount of 0.01% to 10% by weight of the composition. 30. The composition according to Embodiment 29, wherein GALALCOOL® or tara tannin is present in an amount of 0.03% by weight of the composition. 31. The composition according to any one of Embodiments 22 to 30, wherein the concentration of one or more other colorless or low-coloring tannins is 0.01% to 10% by weight of the composition, each. 32. The composition according to Embodiment 31, wherein one or more other colorless or low-coloring tannins are each present in an amount of 0.01% by weight of the composition. 33. The composition according to any one of Embodiments 22 to 32, wherein the composition comprises a combination of GALALCOOL® or tara tannin and one or more other colorless or low-coloring tannins. 34. The composition according to Embodiment 33, wherein GALALCOOL® or tara tannin is present in an amount of 0.01% to 10% by weight of the composition, and one or more other colorless or low-coloring tannins are present in an amount of 0.01% to 10% by weight of the composition. 35. The composition according to Embodiment 34, wherein GALALCOOL® or tara tannin is present in an amount of 0.03% by weight of the composition, and one or more other colorless or low-coloring tannins are present in an amount of 0.03% by weight of the composition. 36. The composition according to any one of embodiments 22 to 35, further comprising zinc protoporphyrin IX. 37. The composition according to Embodiment 36, wherein zinc protoporphyrin IX is present in an amount of 0.1% to 5% by weight of the composition. 38. The composition according to Embodiment 37, wherein zinc protoporphyrin IX is present in an amount of 0.5% by weight of the composition. 39. The composition according to any one of embodiments 23 to 38, wherein the free zinc salt is in the range of 0.1% to 0.5% by weight of the composition. 40. The composition according to Embodiment 39, wherein the free zinc salt is 0.4% by weight of the composition. 41. The composition according to any one of embodiments 22 to 40, further comprising a fluoride compound. 42. The composition according to any one of Embodiments 1 to 21, further comprising a malleable or compressible tube in which the composition is stored. 43. The composition according to any one of Embodiments 1 to 21 or 42, wherein the composition is formulated as a toothpaste and as a translucent gel or paste. 44. A method for preventing or suppressing the onset of a common cold or other respiratory or pharyngeal infection, comprising administering toothpaste as described in any one of Embodiments 1-21 or 42-43. 45. A method for reducing the incidence or likelihood of a common cold or other respiratory or pharyngeal infection, comprising administering toothpaste as described in any one of Embodiments 1-21 or 42-43. 46. ​​Embodiment 44 or 45, in which the administration step includes brushing the teeth in question. Methods used. 47. The composition according to any one of Embodiments 22 to 41, wherein the composition is formulated as an oral rinse or mouthwash. 48. A method for preventing or suppressing the onset of a common cold or other respiratory or pharyngeal infection, comprising administering the oral rinse or mouthwash described in Embodiment 47 to the subject. 49. A method for reducing the incidence or likelihood of a common cold or other respiratory or pharyngeal infection, comprising administering the oral rinse or mouthwash described in Embodiment 47 to the target. 50. The method according to Embodiment 48 or 49, wherein the administration step includes rinsing the mouth of the subject with an oral rinse or mouthwash. 51. The composition according to any one of embodiments 22 to 41, wherein the composition is formulated as chewing gum. 52. A method for preventing or suppressing the onset of a common cold or other respiratory or pharyngeal infection, comprising administering the chewing gum described in Embodiment 51 to a subject. 53. A method for reducing the incidence or likelihood of a common cold or other respiratory or pharyngeal infection, comprising administering the chewing gum described in Embodiment 51 to the subject. 54. The method according to Embodiment 52 or 53, wherein the administration step includes chewing gum. 55. The composition according to any one of Embodiments 22 to 41, wherein the composition is formulated as an aerosol to be sprayed into the mouth and / or pharynx. 56. A method for preventing or suppressing the onset of a common cold or other respiratory or pharyngeal infection, comprising administering the aerosol described in Embodiment 55 to a target. 57. A method for reducing the incidence or likelihood of a common cold or other respiratory or pharyngeal infection, comprising administering the oral rinse or mouthwash described in Embodiment 55 to the target. 58. The method according to embodiment 56 or 57, wherein the administration step includes spraying an aerosol into the mouth and / or pharynx of the subject. 59. The method according to any one of embodiments 44-55, 52-55, or 57-58, wherein the infection is the common cold. 60. The method according to any one of Embodiments 44-55, 52-55, or 57-58, wherein the infection is an upper respiratory tract or pharyngeal infection other than the common cold. 61. The method according to any one of embodiments 44-55 or 52-55 or 57-58, wherein the infection is influenza. 62. The method according to any one of Embodiments 44-55, 52-55, or 57-58, wherein the infection is a coronavirus infection. 63. The method according to embodiment 62, wherein the coronavirus infection is COVID-19. 64. A composition formulated for the prevention or suppression of viral infections and for administration by inhalation, comprising a solvent or other vehicle containing GALALCOOL®, tara tannin, one or more other colorless or low-coloring tannins, or a combination thereof. 65. The composition according to embodiment 64, further comprising a free zinc salt. 66. The composition according to Embodiment 65, wherein the zinc salt is an organic zinc salt. 67. The composition according to Embodiment 66, wherein the organic zinc salt is selected from the group consisting of zinc gluconate, zinc lactate, zinc acetate, and combinations thereof. 68. The composition according to Embodiment 66, wherein the organic zinc salt is zinc gluconate. 69. The composition according to Embodiment 65, wherein the zinc salt is an inorganic zinc salt. 70. The composition according to Embodiment 69, wherein the inorganic zinc salt is selected from the group consisting of zinc chloride, zinc sulfate, zinc carbonate, and combinations thereof. 71. The composition according to any one of Embodiments 64 to 70, wherein GALALCOOL® or tara tannin is present in an amount of 0.01% to 10% by weight of the composition. 72. The composition according to Embodiment 71, wherein GALALCOOL® or tara tannin is present in an amount of 0.03% by weight of the composition. 73. The composition according to any one of Embodiments 64 to 72, wherein the concentration of one or more other colorless or low-coloring tannins is 0.01% to 10% by weight of the composition, each. 74. The composition according to Embodiment 73, wherein one or more other colorless or low-coloring tannins are each present in an amount of 0.01% by weight of the composition. 75. The composition according to any one of Embodiments 64 to 74, wherein the composition comprises a combination of GALALCOOL® and one or more other colorless or low-coloring tannins. 76. The composition according to Embodiment 75, wherein GALALCOOL® is present in an amount of 0.01% to 10% by weight of the composition, and one or more other colorless or low-coloring tannins are present in an amount of 0.01% to 10% by weight of the composition. 77. The composition according to Embodiment 76, wherein GALALCOOL® is present in an amount of 0.03% by weight of the composition, and one or more other colorless or low-coloring tannins are present in an amount of 0.03% by weight of the composition. 78. The composition according to any one of embodiments 64 to 77, further comprising zinc protoporphyrin IX. 79. The composition according to Embodiment 78, wherein zinc protoporphyrin IX is present in an amount ranging from 0.1% to 5% by weight of the composition. 80. The composition according to Embodiment 79, wherein zinc protoporphyrin IX is present in an amount of 0.5% by weight of the composition. 81. The composition according to any one of embodiments 65 to 80, wherein the free zinc salt is in the range of 0.1% to 0.5% by weight of the composition. 82. The composition according to Embodiment 81, wherein the free zinc salt is 0.4% by weight of the composition. 83. The composition according to any one of embodiments 64 to 82, further comprising a fluoride compound. 84. A method for preventing or suppressing a viral infection, comprising administering the composition described in any one of embodiments 64 to 83 by inhalation. 85. A method for reducing the incidence or likelihood of viral infection, comprising administering the composition described in any one of embodiments 64 to 83 by inhalation. 86. The method according to embodiment 84 or 85, wherein the viral infection is the common cold. 87. The method according to embodiment 84 or 85, wherein the viral infection is an upper respiratory tract or pharyngeal infection other than the common cold. 88. The method according to embodiment 84 or 85, wherein the viral infection is influenza. 89. The method according to embodiment 84 or 85, wherein the viral infection is a coronavirus infection. 90. The method according to embodiment 89, wherein the coronavirus infection is COVID-19. 91. The method according to any one of Embodiments 83 to 90, wherein the composition is administered once daily. 92. The method according to any one of Embodiments 83 to 90, wherein the composition is administered twice daily. 93. A delivery device comprising an inhaler or nebulizer containing the composition described in any one of embodiments 65 to 80. [Examples]

[0029] Example 1 First, quercetin was tested as a tannin component for toothpaste and added to a base toothpaste. It was visually determined that 20 μg of quercetin per 135 grams of base toothpaste was not sufficient, and that any more quercetin could not be added without risking cumulative staining of the user's toothbrush and ultimately the user's teeth. Next, highly purified extracts of gallic acid tannin, which is relatively inexpensive and commercially available in large quantities, were used. The product (i.e., GALALCOOL®) was used. It has been found that 500 mg of GALALCOOL® can be added to a 135-gram tube of toothpaste without causing any staining, even after 6 months of daily use.

[0030] In another experiment, a 6% aqueous suspension of a highly purified extract of gallic acid tannin (GALALCOOL®) and pure quercetin were prepared. One clear nylon-bristled toothbrush was placed in each suspension and heated in a 1100W microwave for 150 seconds (2.5 minutes). Separately, a concentrated aqueous paste of the highly purified extract of gallic acid tannin (GALALCOOL®) at a dilution of 20 times that of the quercetin suspension was also prepared. Another toothbrush was similarly heated in its GALALCOOL® paste. The toothbrushes were then rinsed with tap water. The two toothbrushes exposed to GALALCOOL® showed no staining, while the toothbrush immersed in quercetin had a yellowish residual stain. Furthermore, water from cups containing the 6% aqueous suspension was decanted. The quercetin cup showed a clear precipitate, while the GALALCOOL® cup did not show such a precipitate.

[0031] Example 2 The inventors have developed a toothpaste to combat the common cold by inactivating pre-infectious viruses in the oral cavity. The approach is to inactivate the virus upon contact through the use of selective tannins. Tannins are known to precipitate proteins, and viruses are covered with proteins. Therefore, tannins can cause damage to individual virions, especially if they are water-soluble and hydrolyzable. Furthermore, they are sufficient to aggregate virions that are too large to pass through membrane tissue, otherwise the virions would cause active infection.

[0032] When a mixture of selective tannin and a small amount of zinc gluconate is added to a standard toothpaste base, a coating is formed that safely provides two mechanisms of action when brushed onto the tooth surface daily and foams in the mouth: Firstly, a barrier is constructed to inhibit the penetration of virions through the oral membrane. Secondly, the tannin precipitates the proteins of the virions, causing them to aggregate and become inactive. The zinc salt provides zinc ions that can help the tannin adhere in the mouth. The zinc ions themselves can crosslink the tannin to proteins and therefore act synergistically on the aggregated virions, and can also block proteins that act as ligands in binding virions to cell receptors required for their entry into their host cells.

[0033] coronavirus: Extracting the active ingredients (tannins and zinc ions), safely adapting them to an inhalation form, and dispersing them into the lungs can agglutinate coronavirus virions (or other virions such as influenza virions), effectively inactivating the virus with minimal toxicological risk.

[0034] To illustrate the interaction between tannin molecules and virions, a base is coated with the active ingredients (tannin and zinc ions), and then coated with virions. The viral surface and their aggregation are observed in micrographs created under an electron microscope. Inhalers containing these components are tested on animals to evaluate them in case of toxicological or respiratory irritation problems. Such inhalers would likely be used once daily. Animal models are then used to demonstrate the efficacy of these components against lung-incubatable viruses.

[0035] This is a novel approach that is not a vaccine-based (i.e., strain-specific) approach. It involves virion aggregation, which allows the immune system to better identify the virus and... While it allows for the induction of antibody and immune responses in the system based on virus-specific evidence, virion aggregation is a novel method for inactivating pre-infection virions independently of the virus, even without the induction of antibody and immune responses. As a result, one advantage of this approach over vaccine-based approaches is its ability to suppress other lung-incubating virions, including mutations in novel COVID-19 coronavirus strains.

[0036] As preferred embodiments of the present invention are described, it should be understood that the present invention is not limited to specific embodiments, and that various changes and modifications can be implemented by those skilled in the art without departing from the scope or spirit of the invention, as defined in the appended claims.

Claims

1. In the manufacture of toothpaste for the prevention or suppression of the common cold or other upper respiratory tract and pharyngeal infections, (1) A gallic acid tannin extract or tara tannin purified from tarapods that does not stain tooth enamel; and (2) Use of a composition containing free zinc salt.

2. The use according to claim 1, wherein the zinc salt is an organic zinc salt selected from the group consisting of zinc gluconate, zinc lactate, zinc acetate, and combinations thereof.

3. The use according to claim 2, wherein the organic zinc salt is zinc gluconate.

4. The use according to claim 1, wherein the zinc salt is an inorganic zinc salt selected from the group consisting of zinc chloride, zinc sulfate, zinc carbonate, and combinations thereof.

5. The use according to claim 1, wherein the gallic acid tannin extract or tara tannin purified from the tara pod is present in an amount of 0.01% to 10% by weight of the composition.

6. The use according to claim 1, wherein the free zinc salt is in the range of 0.1% to 0.5% by weight of the composition.

7. The use according to claim 1, wherein the composition further comprises a fluoride compound.

8. The use according to claim 1, wherein the composition is stored in a malleable or compressible tube.

9. The use according to claim 1, wherein the tara tannin is an extract purified from pods derived from Caesalpinia spinosa.

10. The use according to claim 1, wherein the infection is a coronavirus infection.

11. The use according to claim 10, wherein the coronavirus infection is COVID-19.