MOUTHWASH/GARGLE, NASAL/ORAL/NASAL SPRAY COVID AND BACTERIOCIDE ARRANGEMENT

Abstract

An ethanol-free antimicrobial treatment composition, comprising: an antimicrobially effective amount of polyvinylpyrrolidone iodine (PVPI) ranging from 1.0% to a dilution-accommodating 3.5%; an inclusion of at least one room-temperature, water-insoluble, viscous membrane permeation-enhancing essential flavoring oil selected from the group consisting of: menthol in an amount of at least 15% by weight, spearmint oil in an amount of between 30% to 55% by weight, peppermint oil in an amount of at least 10% by weight, carvone, methyl salicylate, anethole, thymol, eugenol, coolants and cinnamic aldehydes; a Stevia sweetener pre-mixed in a microemulsion solution of dimethyl sulfoxide (DMSO); and

ion-free distilled water.

Claims

1. An ethanol-free virus treatment composition, comprising: an antimicrobially effective amount of polyvinylpyrrolidone iodine (PVPI) ranging from 1.0% to a dilution-accommodating 3.5%; inclusion of at least one room-temperature, water-insoluble, viscous membrane permeation-enhancing essential flavoring oil selected from the group consisting of: menthol in an amount of at least 15% by weight, spearmint oil in an amount of between 30% to 55% by weight, peppermint oil in an amount of at least 10% by weight, carvone, methyl salicylate, anethole, thymol, eugenol, coolants and cinnamic aldehydes; a Stevia sweetener pre-mixed in a microemulsion solution of dimethyl sulfoxide (DMSO); and ion-free distilled water.

2. The ethanol-free virus treatment composition as recited in claim 1, wherein the ratio of PVPI and DMSO solution to the inclusion of essential flavoring oil is 1:0010 to 1:0020.

3. The ethanol-free virus treatment composition as recited in claim 1, is a nasal spray.

4. The ethanol-free virus treatment composition as recited in claim 1, is a mouthwash.

5. The ethanol-free virus treatment composition as recited in claim 1, is formed into a lozenge.

6. The ethanol-free virus treatment composition as recited in claim 5, wherein the lozenge is comprised of multiple layered concentrations of the composition.

7. The ethanol-free virus treatment composition as recited in claim 1, wherein the microemulsion solution of DMSO is no greater than 1% by weight.

8. The ethanol-free virus treatment composition as recited in claim 1, wherein the treatment composition is contained in a compressible composition spray-dispersible capsule.

9. The ethanol-free virus treatment composition as recited in claim 8, wherein the compressible composition spray-dispersible capsule is supportively arranged on a face facing side of a medical face mask.

10.-12. (canceled)

13. An ethanol-free Covid-19 oral/nasal composition for the treatment of mammals in general, and farm animals in particular, consisting of: an antimicrobially effective amount of polyvinylpyrrolidone iodine (PVPI) ranging from 1.0% to a dilution-accommodating 3.5%; inclusion of at least one room-temperature, water-insoluble, viscous membrane permeation-enhancing essential flavoring oil selected from the group consisting of: menthol, spearmint oil, peppermint oil, carvone, methyl salicylate, anethole, thymol, eugenol, coolants and cinnamic aldehydes; a Stevia sweetener pre-mixed in a microemulsion solution of dimethyl sulfoxide (DMSO); and ion-free distilled water.

14. The ethanol-free Covid-19 oral/nasal treatment composition, as recited in claim 13, wherein the menthol is in the composition in an amount of at least 15% by weight, wherein the spearmint oil is in the composition in an amount of between 30% to 55% by weight, and wherein peppermint oil is in the composition in an amount of at least 10% by weight.

15.-19. (canceled)

Description

DETAILED DESCRIPTION OF THE INVENTION

[0052] In one preferred embodiment, Composition 1, the invention provides a liquid oral/nasal care composition which is totally free of ethanol, comprising (i) an antimicrobially effective amount of polyvinylpyrrolidone iodine (PVPI); (ii) DMSO as a diluent, solvent, carrier and penetrant; and (ii) one or more flavoring oils which are substantially insoluble, e.g., less than 1% soluble, in water at room temperature but effectively soluble and capable of homogeneity in DMSO, wherein the ratio of the PVPI to the one or more flavoring oils is from 1:0010 to 1:0020 or such concentration as to provide a pleasant but not an overwhelming taste of essential flavoring oil, and for which the DMSO will act as a carrier/solvent and (iv) Stevia sweetener, and (v) water.

[0053] In general, the invention deploys standard hospital-quality pre-surgical PVPI antiseptic wash as used in the hospital operating theatre and throughout the medical community, and typically usually provided to the medical field in a 10% concentration. This concentration of PVPI product typically contains four or five stabilizing compounds which help to extend the homogeneity and the shelf life of the PVPI provided. The present invention does not contemplate changing these elements, but in using the PVPI “as it comes” from the provider along with its stabilizers and homogenizers. None of these have any negative or positive antimicrobial activity as determined by the manufacturing providers.

[0054] The present invention dilutes this 10% concentration to between 1.0%-3.5%. While it is microbiologically recognized, and well-documented by the PVPI manufacturers, that a 1% concentration of PVPI provides the highest and most rapid antimicrobial action, the present invention may use a higher concentration because within the confines of the nose, mouth and throat the PVPI will always become substantially diluted by saliva, mucous and other bodily fluids, and while it is impossible to estimate the actual dilution that will occur, given the variation of liquid in human mucosal tissues, the small amounts of PVPI present in the product may well be diluted by up to 50%. There is no way to know exactly what this will be, as the elements of individual human variation are infinite.

[0055] The present invention contemplates providing various concentrations of PVPI in its products. The consumer or physician's choice as to which concentration is chosen to be used will depend upon the medical condition and mucus/saliva production, among other factors, and the experience of the user or physician.

[0056] For example, the invention provides [0057] 1.1. The liquid, oral/nasal care composition of Composition 1 wherein the ratio of the PVPI to the one or more essential flavoring oils is 1:0.0010 to 1:0.0020 or such concentration as would be necessary to provide a pleasant but not an overwhelming taste of essential flavoring oil. [0058] 1.2. The liquid oral/nasal care composition of Composition 1 wherein the PVPI and the one or more essential flavoring oils form a micelle microemulsion within the DMSO at room temperature prior to being added to water and PVPI. [0059] 1.3. The liquid oral/nasal care composition of the foregoing wherein the one or more essential flavoring oils, which serve both vasodilation and flavoring features of the invention, comprise peppermint oil. [0060] 1.4. The liquid, oral/nasal care composition of the foregoing Composition wherein the one or more flavoring oils comprise menthol, spearmint oil, peppermint oil, or combinations of any of these. [0061] 1.5. The liquid oral/nasal care composition of the foregoing Composition wherein the one of more flavoring oils are selected from one or more of menthol, spearmint oil, peppermint oil, carvone, methyl salicylate, anethole, thymol, eugenol, coolants, cinnamic aldehydes, and mixtures thereof. [0062] 1.6. The liquid oral/nasal care composition of the foregoing Composition wherein the one or more flavoring oils comprise a combination of menthol, spearmint oil and peppermint oil in a ratio to PVPI that may differ by 20-50% in either direction. [0063] 1.7. The liquid oral/nasal care composition of any of the foregoing Compositions that is free of ethanol and that comprises [0064] an antimicrobially effective amount of polyvinylpyrrolidone iodine in the range of 1.0% to 3.5% of the total volume; and [0065] an effective amount of an essential oil flavoring component the flavoring component comprising [0066] menthol, e.g. in an amount of at least 15%, 15-25%, e.g. about 20% by weight of essential oil flavoring component; [0067] peppermint oil (e.g., natural peppermint oil, synthetic peppermint oil, cornmint oil or mixtures thereof), e.g., in an amount of at least 10%, e.g., 10-20%, e.g., about 15% by weight of the essential oil flavoring component; [0068] spearmint oil, e.g., in an amount of 0-55%, e.g., 40-50%, about 45% by weight of flavoring component; [0069] 1.8. The liquid oral/nasal care composition of any of the foregoing Compositions (e.g. mouthwashes, toothpastes, throat sprays, and breath sprays) being free of ethanol and comprising an antimicrobially effective amount of a PVPI and essential oil vasodilators/flavorants in the following ratio: [0070] 1 part PVPI: [0071] 0.3-0.9, e.g., 0.5-0.7 parts menthol: [0072] 0.4-1.2, e.g., 0.5-0.8 parts spearmint oil: [0073] 0.1-0.5, e.g., 0.2-0.4 parts peppermint oil; [0074] and optionally further ingredients, e.g. further comprising one or more of additional flavorants, e.g., comprising one or more of anethole (e.g., trans-anethole), thymol, methyl salicylate, coolants (for example n-ethyl-p-methane-3-carboxamide, Optacool®), cinnamic aldehydes and mixtures thereof; [0075] non-caloric sweeteners, e.g., comprising Stevia, sugar alcohols (e.g., sorbitol), or mixtures thereof; [0076] water. [0077] 1.9. The liquid oral/nasal care composition of any of the foregoing Compositions in the form of a mouthwash and nasal/oral spray; [0078] 1.10. The liquid oral/nasal care composition of any of the foregoing Compositions comprising PVPI and an essential oil flavor component comprising flavorants in a ratio of PVPI and flavorants by weight is about 1 part PVPI about 0.3 parts menthol:about 0.7 parts spearmint oil:about 0.24 parts peppermint oil; wherein the composition may optionally comprise coolants and/or sweeteners in addition to the flavor component. [0079] 1.11 The liquid oral/nasal care composition of any of the foregoing Compositions wherein the flavor component comprises by weight of essential oil flavor component about 20% menthol, about 45% spearmint oil and about 15% peppermint oil; [0080] 1.12. The liquid oral/nasal care composition of any of the foregoing Compositions comprising L-menthol; [0081] 1.13. The liquid oral/nasal care composition of any of the foregoing Compositions comprising menthol in addition to the menthol in the essential oil flavoring component, e.g., 0.01-0.04, e.g., about 0.02% menthol by weight of the total composition, in addition to the menthol in the essential oil flavoring component; [0082] 1.14. A composition according to any of the preceding Compositions comprising 0.05-0.07% total menthol, e.g., including added menthol and menthol from peppermint oil and spearmint oil; [0083] 1.15. A composition according to any of the preceding embodiments wherein the flavoring component further comprises an anethole, e.g., trans-anethole, in an amount of 1-10%, e.g., 2-6%, e.g., about 4% by weight of flavoring component; or 0.001-0.01%, e.g., 0.002-0.006% e.g., about 0.004% by weight of the total composition; [0084] 1.16. A composition according to any of the preceding embodiments which is an aqueous solution, water-in-oil emulsion, water-in-oil microemulsion, or micellar system including its admixture with DMSO; [0085] 1.17. A composition according to any of the preceding embodiments which is a water-in-oil microemulsion; [0086] 1.18. A composition according to the preceding embodiments which is a micellar system; [0087] 1.19. A composition according to any of the preceding embodiments further comprising additional flavorants, e.g., comprising one or more of anethole (e.g., trans-anethole), thymol, coolants (for example comprising menthol, n-ethyl-p-methane-3-carboxamide, and combinations thereof), cinnamic aldehydes and mixtures thereof, for example coolant mixtures available commercially, e.g. Optacool® (Symrise); [0088] 1.20. A composition according to any of the preceding embodiments further comprising non-caloric sweeteners, e.g., comprising Stevia, sugar alcohols (e.g., sorbitol), or mixtures thereof. [0089] 1.21. A composition according to any of the preceding embodiments further comprising humectants, e.g., comprising propylene glycol, glycerin or mixtures thereof; [0090] 1.22. A composition according to any of the preceding embodiments comprising water, colorant, Stevia, PVPI, poloxamer, e.g., Pluronic. F-127, sorbitol, glycerin, propylene glycol, parabens, and menthol, wherein the composition is light brown or tan and substantially clear. [0091] 1.23. A composition according to any of the preceding embodiments further comprising non-ionic surfactants, e.g., poloxamers, e.g., poloxamer 470; [0092] 1.24. A composition according to any of the preceding embodiments which is an aqueous solution, water-in-oil emulsion, or water-in-oil microemulsion including DMSO.

[0093] The invention further provides methods of prophylaxis and/or treatment of a disease or condition selected from one or more of infection by enveloped, non-enveloped and other viral entities, dry mouth, halitosis, gingivitis, tooth decay, and cavities, comprising administering an effective amount of a composition as hereinbefore described, e.g. any of Compositions 1, 1.1, et seq., to a subject in need thereof.

[0094] The invention further provides the use of polyvinylpyrrolidone iodine (PVPI) and one or more flavoring oils which are substantially insoluble in water at room temperature, however, in this invention they are effectively dissolved in DMSO and used in the manufacture of a liquid oral/nasal care composition, e.g. any of Compositions 1, 1.1 et seq., for prophylaxis and/or treatment of a disease or condition selected from one or more of infection by enveloped, non-enveloped and other viral entities, dry mouth, halitosis, gingivitis, tooth decay, and cavities.

[0095] The invention further provides a method of making a composition e.g. any of Compositions 1, 1.1, et seq., comprising adding flavoring oils, dissolved in a small amount of DMSO, to an aqueous solution comprising polyvinylpyrrolidone iodine and mixing until the composition is clear, e.g., a method comprising adding DMSO to water and mixing, then adding Stevia, and PVPI and mixing.

[0096] As used throughout, ranges are used as shorthand for describing each and every value that is within the range. Any value within the range can be selected as the terminus of the range. In addition, all references cited herein are hereby incorporated by reference in their entireties. In the event of a conflict in a definition in the present disclosure and that of a cited reference, the present disclosure controls.

[0097] In another preferred embodiment, as shown in the drawing of FIG. 1, a human medical face mask 10 is shown with a pair of ear encircling loops 12 and 14 on each end thereof. The mask 10 has a face facing portion 16 when the mask 10 is being worn by a person. At least one perforated or foraminous pocket 18 is arranged on the face facing side of thee mask 10. The pocket is arranged to hold an ampule or capsule 20 containing the PVPI product. The ampule or capsule 20 is squeezable or crushable for a mask wearer or user to squeeze and release a spray of PVPI product towards onto or into the mask wearer's mask 10 or his/her nasal/oral area for enabling masked distribution of an antimicrobial product of the present invention.

[0098] Unless otherwise specified, all percentages and amounts expressed herein and elsewhere in the specification should be understood to refer to percentages by weight. The amounts given are based on the active weight of the material.

EXAMPLE 1

Comparative Compositions

[0099] Compositions of varying strengths are prepared with different essential flavoring oils as follows:

[0100] Ex A: Mouthrinse composition Ingredients: PVPI, Stevia, Essential Flavoring Oil,

[0101] DMSO, Water.

[0102] Ex B: Flavoring component Ingredients: L-menthol, North American peppermint oil, North American spearmint oil, Synthetic peppermint oil, Cornmint oil, N-ethyl-p-methane, carboxamide, Trans-anethole, Eugenol, Thymol, Cinnamic aldehydes, Methyl salicylate

EXAMPLE 2

Consumer Testing

[0103] The Compositions of the previous examples (in various formulations) were tested with consumers to measure flavor liking and purchase intent. It was found that the more acceptable Compositions had higher levels of menthol and peppermint oil relative to spearmint oil. Spearmint oil and peppermint oil differ, inter alia, in that peppermint oil has higher amounts of menthol.

[0104] Without being bound by theory it is hypothesized that the relatively higher levels of poorly soluble menthol permit formation of a spontaneous microemulsion or micellar system incorporating the PVPI, reducing the perception of bitter taste from the PVPI. At the same time, the PVPI allows the composition to contain higher levels of poorly soluble oils such as menthol, which themselves have antibacterial properties, thereby enhancing the efficacy of the composition. The invention contemplates to use always DMSO as a solvent/carrier for the relatively immiscible oils and to assist in the homogenization of the final product. Perfect homogenization does not occur.

[0105] The invention thus comprises an ethanol-free virus treatment composition, comprising: an antimicrobially effective amount of polyvinylpyrrolidone iodine (PVPI) ranging from 1.0% to a dilution-accommodating 3.5%; inclusion of at least one room-temperature, water-insoluble, viscous membrane permeation-enhancing essential flavoring oil selected from the group consisting of: menthol in an amount of at least 15% by weight, spearmint oil in an amount of between 30% to 55% by weight, peppermint oil in an amount of at least 10% by weight, carvone, methyl salicylate, anethole, thymol, eugenol, coolants and cinnamic aldehydes; a Stevia sweetener pre-mixed in a microemulsion solution of dimethyl sulfoxide (DMSO); and ion-free distilled water. The ratio of PVPI and DMSO solution to the inclusion of essential flavoring oil is 1:0010 to 1:0020. The ethanol-free virus treatment composition may be a nasal spray. The ethanol-free virus treatment composition may be a mouthwash. The ethanol-free virus treatment composition may be formed into a lozenge. The lozenge may comprise multiple layered concentrations of the composition. The microemulsion solution of DMSO is preferably no greater than 1% by weight. The ethanol-free virus treatment composition may be contained in a compressible composition spray-dispersible capsule. The compressible composition spray-dispersible capsule may be supportively arranged on a face facing side of a medical face mask.

[0106] The invention also comprises a method of making an ethanol-free Covid-19 oral/nasal treatment composition, comprising the steps of: mixing an antimicrobially effective amount of polyvinylpyrrolidone iodine (PVPI) ranging from 1.0% to a dilution accommodating 3.5% with an inclusion of at least one room-temperature, water-insoluble, viscous membrane permeation-enhancing essential flavoring oil selected from the group consisting of: menthol in an amount of at least 15% by weight, spearmint oil in an amount of between 30% to 55% by weight, peppermint oil in an amount of at least 10% by weight, carvone, methyl salicylate, anethole, thymol, eugenol, coolants and cinnamic aldehydes; with a Stevia sweetener pre-mixed in a microemulsion solution of dimethyl sulfoxide (DMSO); and a measure of ion-free distilled water until the color of the treatment composition is a light tan. The method of making an ethanol-free Covid-19 oral/nasal treatment composition, may include the step of: mixing an antimicrobially effective amount of polyvinylpyrrolidone iodine (PVPI) ranging from 1.0% to a dilution accommodating 3.5% with an inclusion of at least one room-temperature, water-insoluble, viscous membrane permeation-enhancing essential flavoring oil selected from the group consisting of: menthol in an amount of at least 15% by weight, spearmint oil in an amount of between 30% to 55% by weight, peppermint oil in an amount of at least 10% by weight, carvone, methyl salicylate, anethole, thymol, eugenol, coolants and cinnamic aldehydes; with a Stevia sweetener pre-mixed in a microemulsion solution of dimethyl sulfoxide (DMSO); and a measure of ion-free distilled water until the color of the treatment composition is a light tan, for inclusion into a lozenge. The method of making an ethanol-free Covid-19 oral/nasal treatment compos may include the step of: mixing an antimicrobially effective amount of polyvinylpyrrolidone iodine PVPI ranging from 1.0% to a dilution accommodating 3.5% with an inclusion of at least one room-temperature, water-insoluble, viscous membrane permeation-enhancing essential flavoring oil selected from the group consisting of: menthol in an amount of at least 15% by weight, spearmint oil in an amount of between 30% to 55% by weight, peppermint oil in an amount of at least 10% by weight, carvone, methyl salicylate, anethole, thymol, eugenol, coolants and cinnamic aldehydes; with a Stevia sweetener pre-mixed in a microemulsion solution of dimethyl sulfoxide (DMSO); and a measure of ion-free distilled water until the color of the treatment composition is a light tan, and into a face mask-attachable compressible composition spray-dispersible capsule.

[0107] The invention may also comprise an ethanol-free Covid-19 oral/nasal treatment composition, consisting of: an antimicrobially effective amount of polyvinylpyrrolidone iodine (PVPI) ranging from 1.0% to a dilution-accommodating 3.5%; an inclusion of at least one room-temperature, water-insoluble, viscous membrane permeation-enhancing essential flavoring oil selected from the group consisting of: menthol, spearmint oil, peppermint oil, carvone, methyl salicylate, anethole, thymol, eugenol, coolants and cinnamic aldehydes; a Stevia sweetener pre-mixed in a microemulsion solution of dimethyl sulfoxide (DMSO); and ion-free distilled water. The menthol is in the composition preferably is in an amount of at least 15% by weight, wherein the spearmint oil is in the composition in an amount of between 30% to 55% by weight, and wherein peppermint oil is in the composition in an amount of at least 10% by weight.

[0108] The invention also may comprise an ethanol-free antimicrobial hand-sanitizer treatment composition, comprising: an antimicrobially effective amount of polyvinylpyrrolidone iodine (PVPI) ranging from 1.0% to a dilution-accommodating 3.5%; an inclusion of a microemulsion solution of dimethyl sulfoxide (DMSO); an inclusion of Guar gum in a ratio of between 1:4 and 1:6 times the volume of DMSO; and ion-free distilled water wherein the distilled water comprises a range of 6 to 12 times the volume of DMSO.

[0109] The invention also comprises an ethanol-free antimicrobial eye treatment composition, for eye dropper to eye application, the composition comprising: an antimicrobially effective amount of polyvinylpyrrolidone iodine (PVPI) ranging from about 1.0% to about 2.5% by volume of the composition; an inclusion of a microemulsion solution of dimethyl sulfoxide (DMSO) ranging between 1% to 44% of the total volume of the composition; and an inclusion of a volume of ion-free distilled water to bring the total volume of the inclusive PVPI and DMSO composition to 100%.

[0110] The invention also comprises a human-face-attachable virus-inhibiting face mask having a first or outer side and a second or face facing side, the second side having a compressible virus-destroying composition-containing spray-facilitating capsule-supporting foraminous pocket thereon, so as to enable a mask wearer to manually compress the capsule contained within the foraminous pocket to spray release the virus-destroying composition containing capsule against a nasal or oral facial area of the mask wearer. The human-face-attachable virus-inhibiting face mask virus-destroying composition preferably comprises an ethanol-free virus treatment composition, comprising: an antimicrobially effective amount of polyvinylpyrrolidone iodine (PVPI) ranging from 1.0% to a dilution-accommodating 3.5%; an inclusion of at least one room-temperature, water-insoluble, viscous membrane permeation-enhancing essential flavoring oil selected from the group consisting of: menthol in an amount of at least 15% by weight, spearmint oil in an amount of between 30% to 55% by weight, peppermint oil in an amount of at least 10% by weight, carvone, methyl salicylate, anethole, thymol, eugenol, coolants and cinnamic aldehydes; a Stevia sweetener pre-mixed in a microemulsion solution of dimethyl sulfoxide (DMSO); and ion-free distilled water.