Nasal Hygiene Method and Formulation

Abstract

A composition for and method of practicing nasal hygiene to wash and moisturize the nasal passage. Where the nasal wash comprises a liquid homogenized compound of water, chlorine dioxide (or source thereof), olfactory stimulants, unsaturated fatty acids, and fixing agents. Where the unsaturated fatty acid component comprises from 0.01% to 1% by weight of the compound.

Claims

1. A system for rinsing a human nasal passage, the system comprising: a mixture comprising water, a source of chlorine dioxide, an olfactory stimulant, and a cannabinoid; and an apparatus for dispensing the mixture into a nasal passage as a mist.

2. The systems of claim 1, wherein said mixture further comprises a second cannabinoid and wherein the total concentration of all cannabinoids is in the range of 0.001% to 5% by weight.

3. The systems of claim 1, wherein the cannabinoid in the mixture comprises delta-8-tetrahydrocannabinol.

4. The system of claim 1, wherein the cannabinoid is delta-9-tetrahydrocannabinol.

5. The system of claim 1 wherein the mixture comprises at least five cannabinoids

6. A method of practicing nasal hygiene comprising the steps of applying to a person's nostril a mist of liquid nasal wash composition comprising the product of compounding under homogenizing conditions water, an amount of a source of chlorine dioxide, 0.1 to 1% by weight cannabinoid; 0.1 to 3% by weight of olfactory stimulant; and 0 to 5% by weight of at least one fixative compound; and blowing air out of the nostril.

7. A system for rinsing a human nasal passage, the system comprising: a mixture comprising water, olfactory stimulant, inorganic salt, and cannabinoid; and an apparatus for dispensing the mixture into a nasal passage as a mist and delivering 0.08 mL to 0.18 mL per each activation of the apparatus to the nose.

8. The system of claim 7, wherein the cannabinoid is a water-soluble isolate.

9. The system of claim 7, wherein the mixture is homogonous.

10. The system of claim 10, wherein the mixture remains homogonous for at least 90 days.

11. The system of claim 10, wherein the mixture remains homogonous for at least 180 days.

Description

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0024] The system and method of the inventions uses a mixture or composition that includes at least one cannabinoid. In particular, the cannabinoids: CBG (Cannabigerol), CBC (Cannabichromene), CBDA (Cannabidiolic acid synthase), CBDV (Cannbidivarin), Delta-8-tetrahydrocannabinol an isomer of delta-9-tetrahydrocannabinol (THC), CBN (Cannabinol), Delta-9-Tetrahydrocannabinol (THC), THCA (Tetrahydrocannabinolic acid), THCV (Tetrahydrocannabivarin), and CBD (Cannabidiol) are preferred.

[0025] In a preferred embodiment at least two cannabinoids are combined. Some embodiments also include cannabinoids (or combinations of cannabinoids) that are water soluble or water dispersible. Preferred embodiments include a combination of at least five cannabinoids that are water soluble or water dispersible to provide a full or broad spectrum of various cannabinoids. It is further preferred that the cannabinoids used in the composition are converted to isolate. The use of cannabinoid isolate removes most of the terpenes found in cannabis. It is preferable that the mixture or composition explicitly excludes terpenes found in traditional extractions of hemp because these are particularly irritating to the nose and nasal passages.

[0026] Some of the preferred embodiments of the invention include a source of chlorine dioxide. The inclusion of chlorine dioxide in nasal spray is described in U.S. Pat. No. 7,029,705 and is hereby incorporated by reference. The preferred embodiment includes sufficient chlorine dioxide source to provide 0.01 to 5% by weight chlorine dioxide upon conversion thereto. More preferably, 0.1 to 2% chlorine dioxide.

[0027] In one embodiment of the invention, only water-soluble isolate versions of cannabinoids are used as a component of the spray. Testing has show that use of water-soluble isolate prevents irritation, including watery eyes, ringing in the ears and lengthy discomfort in the nose.

[0028] In the preferred embodiments, the cannabinoids incorporated into the nasal spray are 100% water dispersible and combined with a natural emulsifier guaranteeing the cannabinoids maintain solubility providing consistent dosage in every dose. Examples of such water-soluble cannabis formulations include those disclosed in U.S. Pat. Nos. 9,907,823, 10,046,018, and 10,328,111 and U.S. patent application Ser. No. 16/977,200.

[0029] In accordance with another invention, there is provided an improved method of practicing nasal hygiene comprising the steps of applying to a person's nostril a non-irritating hygienic composition consisting essentially of a product of compounding under homogenizing conditions water, 0.01% to 5% by weight, as chlorine dioxide, of a source of chlorine dioxide; 0.01% to 3% by weight of at least one olfactory stimulant; 0.001% to 5% by weight of cannabinoids; 0 to 5% by weight of at least one fixative compound less volatile than the olfactory stimulant 0.1 to 2.5% by weight of at least one inorganic salt selected from the group consisting of alkali metal chloride, alkali metal bicarbonate, and alkali metal chlorate; and 0.0002 to 0.006% (as aluminum) by weight of at least one water soluble aluminum compound, provided that the total concentration of inorganic salt is in the range from 0.6% by weight to 2.5% by weight, holding the composition within the nostril for a hygienic holding period, and discharging the composition from the treated nostril or gently inhaling the composition of Cannabinoids to achieve the desired absorption to achieve maximum bio-availability into the mucus membrane.

[0030] The olfactory stimulant ingredient can be a cycloaliphatic alcohol, a cycloaliphatic ketone, an aromaticnon-phenolic hydroxyl compound, an aromatic ether, a phenol having nine or more carbon atoms, or a mixture of such compounds. The olfactory stimulant ingredient can also be a mixture of volatile oils or ethereal oils derived from plant materials.

[0031] Illustrative cycloaliphatic alcohols include cyclododecanol, 3,3,5-trimethylcyclohexanol, and 4-t-butylcyclohexanol. Illustrative cycloaliphatic ketones include exaltone, fenchone, isophorone, muscone, and 3,3,5-trimethylcyclohexanone. Illustrative aromatic non-phenolic hydroxyl compounds include 1-phenylethanol, 2-phenylethanol, and 1-phenoxy-2-propanol. Illustrative aromatic ethers include diphenyl ether and 2-methoxynaphthalene. Illustrative phenols include p-t-octylphenol and 2,6-di-t-butyl-4-methylphenol.

[0032] Particularly preferred olfactory stimulant ingredients include thymol, eucalyptol, borneol, menthol, camphor, oil of eucalyptus, pine oil, and gum benzoin. Fixative compound when present is less volatile than the olfactory stimulant ingredient and can be, for example, an essential oil. Particularly preferred fixative compounds include oil of sweet birch, oil of spearmint, oil of pine, and cinnamon.

[0033] Certain oils extracted from plant materials include olfactory stimulants compounds as well as less volatile fixative type compounds and can serve as sources of both. Particularly preferred dual function oils of this type include basil, bergamot, lemon, citrus, jasmine, lemongrass, rosemary, sage, thyme, and vanilla.

[0034] The quantity of olfactory stimulant material in the composition of the invention is in the range from 0.01% to 3% by weight, preferably in the range from 0.05% to 1% by weight. The preferred embodiment includes at least three olfactory stimulants. The quantity of fixative material when present is in the range from 0.01% to 5% by weight, preferably in the range from 0.05% to 1% by weight.

[0035] The unsaturated fatty acid ingredient can be a monounsaturated fatty acid, such as omega-7 fatty acids and omega-9 fatty acids, or a polyunsaturated fatty acid, such as omega-3 fatty acids. The unsaturated fatty acid ingredient can also be a mixture of monounsaturated and polyunsaturated fatty acids. Preferably, the unsaturated fatty acids are derived from plant materials.

[0036] Illustrative unsaturated fatty acids include palmitoleic acid, vaccenic acid, paullinic acid, oleic acid, erucic acid, elaidic acid, gondoic acid, mead acid, nervonic acid, ximenic acid, hexadecatrienoic acid, a-linolenic acid, stearidonic acid, eicosatrienoic acid, eicosatetraenoic acid, eicosapentaenoic acid, heneicosapentaenoic acid, docosapentaenoic acid, clupanodonic acid, docosahexaenoic acid, tetracosapentaenoic acid, tetracosahexaenoic acid, linoleic acid, gamma-linolenic acid, calendic acid, eicosadienoic acid, dihomo-gamma-linolenic acid, arachidonic acid, docosadienoic acid, adrenic acid, osbond acid, tetracosatetraenoic acid, and tetracosapentaenoic acid.

[0037] Particularly preferred unsaturated fatty acid ingredients include walnut oil, clary sage seed oil, algal oil, flaxseed oil, pomegranate seed oil, borage seed oil, and sea buckthorn oil. These oils may also operate as a fixative compound.

[0038] The quantity of unsaturated fatty acid in the composition of the invention is in the range from 0.01% to 1% by weight, preferably in the range from 0.05% to 1% by weight.

[0039] Preferred cannabinoids include CBD (Cannabidiol), CBG (Cannabigerol), CBC (Cannabichromene), CBDA (Cannabidiolic acid synthase) CBDV (Cannbidivarin) CBN (Cannabinol), Delta-9-Tetrahydrocannabinol (Δ9 THC), Delta-8-Tetrahydrocannabinol (Δ8 THC), THCA (Tetrahydrocannabinolic acid), THCV (Tetrahydrocannabivarin). The total concentration of cannabinoids is 0.001% to 5% by weight. It is best incorporated into the composition as an oil or aqueous extract of hemp. Preferably the concentration of psychoactive Delta-9-Tetrahydrocannabinol is 3% by weight or less. Most preferably the concentration of Delta-9-Tetrahydrocannabinol is between 0.001% and 0.3% by weight.

[0040] Various combinations of cannabinoids have been found to be particularly useful in reducing inflammation as part of the disclosed composition or mixture. Cannabidiol (CBD) in combination with Delta-8-Tetrahydrocannabinol (48 THC) is effective at reducing inflammation. In particular, 1% to 4% of CBD combined with 0.04% to 0.08% 48 THC was found to be particularly effective at washing nasal passages and reducing inflammation. Concentrations of CBD at 0.3% by weight were found to provide effective pain relief during testing.

[0041] The inorganic salt ingredients of the composition, i.e. alkali metal chloride, alkali metal bicarbonate, and alkali metal chlorate, can be lithium salts, potassium salts, sodium salts, and mixtures thereof. When salts of different metals are used together, for example a sodium salt and a potassium salt, ionization in the solution can associate a metal ion with the anion of a different salt from that supplied with the metal. Thus, a solution in which potassium bicarbonate and sodium chloride are dissolved contains potassium chloride as well as potassium bicarbonate, and sodium bicarbonate as well as sodium chloride.

[0042] Without intending to be bound by any theory, it is believed that the inorganic salt ingredient of the composition provides a multiplicity of functions, including adjusting the osmotic strength and the pH of the composition, and limiting the amount of water passing into the mucous membrane while enhancing the cleansing effect. It is therefore preferred to use a combination of two or more inorganic salts according to the invention.

[0043] The quantity of each inorganic salt in the composition of the invention is in the range from 0.1% to 2.5% by weight, preferably from 0.3% to 2% by weight, provided that the combined quantity of inorganic salts in the composition of the invention is in the range from 0.6% to 2.5% by weight.

[0044] In one preferred embodiment, the inorganic salt sodium chloride is avoided and other inorganic salts, including magnesium chloride, calcium carbonate, and potassium phosphate are used. It is preferable to keep the concentration of sodium chloride below 0.2% by weight.

[0045] Optional adjuvants that can be included in low concentrations, typically less than 0.5%, in the composition of the invention to impart desired characteristics include colorants illustrated by sodium copper chlorophyllin, surface active materials illustrated by Polysorbate 80 (an ethoxylated sorbitan ester), and chelating agents illustrated by sodium citrate.

[0046] It is a feature of the invention that the practice of nasal hygiene according to the invention requires only moderate and convenient quantities of the composition. It is sufficient for the user to place a convenient quantity of the composition, which can range from about 0.3 to 3 milliliters, into each nostril and retain it for a holding period which can range from a fraction of a minute to about ten minutes or as long as comfortable, and then remove it as by blowing the nose. Any suitable applicator can be used to place the composition inside the user's nose. The preferred method of application is to insert the atomizer tip into the nasal entry point a quarter of an inch but no more than half an inch.

[0047] The preferred embodiments use a bottle of 50 mL or less to hold the composition or mixture for application. Preferably the bottle is topped by a manual atomizer pump applicator. Preferably the applicator delivers the composition or mixture as a fine mist. More preferably the manual atomizer pump dispenses 0.08 mL to 0.18 mL of total volume per pump. And, the preferred method dispenses one to two pumps per nostril.