Composition for treating dry nose and mouth, nosebleeds and allergy symptoms

Abstract

The present invention discloses a therapeutic composition for treating dryness of the nose or mouth and allergy symptoms, and a method of using the same. The specific composition comprises xylitol, at least two humectants, an aqueous carrier, and other active ingredients such as potassium salts, sodium salts, and preservatives. The composition can be configured as a nasal or oral spray, and mouthwash, or nose gel.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Patent Application No. 17 / 685,574, filed March 3, 2022, the entire contents of which are incorporated herein by reference.

[0002] FIELD OF THEINVENTION The present disclosure relates to nasal or oral treatment compositions for treating dry nose, dry mouth, and allergy symptoms by applying the composition in and around the nasal or oral cavity. [Background technology]

[0003] The nostrils and paranasal sinuses (nasal cavities) are air-filled cavities within the skull around the forehead, cheeks, and nose. In healthy nasal cavities, a thin layer of mucus forms inside the sinuses to retain moisture and trap debris, pollen, bacteria, and fungi, helping to keep the sinuses from drying out and becoming inflamed. However, if the nasal passages are not properly lined with a mucus layer, the sinuses can dry out, causing an uncomfortable feeling of dryness in the nose and airways, swelling, sinus infections, and nosebleeds. The body also produces excess mucus to keep the nasal mucosa hydrated, which can further cause nasal congestion and inflammation.

[0004] Additionally, dry sinuses and dry nasal passages can result from allergic rhinitis, an inflammation of the nasal mucosa. Allergic rhinitis causes the body's immune system to recognize harmless airborne particles as potentially dangerous, causing the body to release histamines and other mediators that trigger an allergic reaction. Statistical surveys show that nasal dryness and allergy-related symptoms affect a large portion of the world's population every year, with an estimated 400-500 million people suffering from allergic rhinitis alone.

[0005] Xylitol is known to have certain therapeutic effects, allegedly having antiseptic properties. Particularly well known is the added effect of xylitol in nasal drops. The use of nasal sprays containing xylitol has been demonstrated to be effective in cleansing the nasal mucosa and flushing out harmful bacteria and pollutants that cause sinusitis, ear infections, and / or upper respiratory tract diseases. Thus, the use of xylitol has been shown to have a moisturizing effect by reducing nasal dryness and congestion to a greater extent than regular saline compositions. Humectants, or surfactants, have also been proven to be beneficial in nasal and oral formulations as effective moisturizers. Humectants have two effects: they create a protective barrier to prevent evaporation, and they also reduce inflammation of the mucosa while retaining moisture in the oral and nasal cavities. Summary of the Invention [Problem to be solved by the invention]

[0006] Heretofore, several problems remain in the field of nasal therapeutic compositions used to treat nasal dryness and relief of allergy symptoms. One such problem is the inability of conventional nasal therapeutic compositions to adequately relieve nasal dryness and congestion for the desired time interval. Another related problem occurs when the pH level of the composition is not fully optimized for the nose (pH 6.0-6.4). If the nasal pH level is not ideal, fungal infections may occur or the full benefits of the combination with steroid nasal sprays may not be obtained. Steroid nasal sprays rely on a specific pH level for maximum diffusion to the nasal mucosa, thereby affecting the effectiveness of the steroid.

[0007] It is therefore an object of the present invention to formulate a nasal therapeutic composition that optimizes the combination of humectant, pH, salt concentration, and xylitol to provide a nasal therapeutic composition that distributes better to the patient's tissues and maximizes moisture retention and dispersion of the antiseptic xylitol, humectant, and salt within the nasal cavity. [Means for solving the problem]

[0008] The present invention overcomes the shortcomings of the prior art by combining two to three approaches into a single nasal or oral treatment composition: utilizing at least two humectants to create a protective barrier that retains moisture within the nasal mucosa or oral cavity, with xylitol acting as a humectant / antiseptic, and a dual salt blend that works in conjunction with the body's natural sodium potassium pump to retain additional moisture. The disclosed compositions are adaptable for use as either a nasal spray, nasal gel, oral spray, or oral mist (e.g., mouthwash or mouthrinse).

[0009] Thus, the present disclosure provides a method for the preparation of a humectant comprising the steps of: + and K + The compositions include a nasal spray, a nasal spray, a nasal spray, a saline ...

[0010] According to certain aspects of the present disclosure, the at least two humectants include polyethylene glycol and propylene glycol, and the humectants are provided in the composition in a total amount of 10.0% to 50% by weight, based on the total weight percent of the composition.

[0011] According to certain aspects of the present disclosure, the at least two humectants may include 8% to 20% by weight polyethylene glycol and 2% to 30% by weight propylene glycol, based on the total weight percent of the composition.

[0012] According to certain embodiments of the present disclosure, xylitol is provided in the composition at 0.1% to 5% by weight, based on the total weight percent of the composition.

[0013] According to certain embodiments of the present disclosure, xylitol is provided in the composition at 3% to 4.5% by weight, based on the total weight percent of the composition.

[0014] According to certain aspects of the present disclosure, sodium and potassium salts may be added to the therapeutic composition, including sodium chloride and potassium chloride provided in the composition at 0.05% to 1.0% by weight, respectively, based on the total weight percent of the composition.

[0015] According to certain aspects of the present disclosure, a preservative may be added to the therapeutic composition. Examples of preservatives include benzalkonium chloride and / or sorbic acid provided in the composition at 0.01% to 0.5% by weight, based on the total weight percent of the composition.

[0016] According to certain embodiments of the present disclosure, the preservative comprises sorbic acid provided in the composition at 0.01% to 0.3% by weight based on the total weight percent of the composition. According to certain embodiments of the present disclosure, the preservative comprises benzalkonium chloride provided in the composition at 0.01% to 0.2% by weight based on the total weight percent of the composition.

[0017] According to certain embodiments of the present disclosure, the aqueous carrier comprises purified water provided in the composition at 25% to 89.9% by weight based on the total weight percent of the composition, and one or more thickening agents.

[0018] In some such embodiments, the therapeutic composition may be configured as a nasal spray, oral spray, or oral rinse, and the one or more thickening agents may include glycerin provided in the nasal therapeutic composition at 2% to 10% by weight, based on the total weight percent of the composition.

[0019] In other such embodiments, the therapeutic composition is configured as a nasal gel, and the one or more thickening agents are selected from the group consisting of glycerin, high molecular weight cross-linked polyacrylic acid polymers such as Carbopol® (e.g., Carbopol® 974P), sodium carboxymethylcellulose, and combinations thereof, and are provided in the composition at 5% to 25% by weight, based on the total weight percent of the composition.

[0020] According to certain aspects of the present disclosure, a buffering agent is added to the therapeutic composition, and at least one buffering agent may be selected from the group consisting of sodium phosphate dibasic anhydrous, potassium phosphate monobasic, or a combination thereof.

[0021] According to a particular embodiment of the present invention, the therapeutic composition has a pH of 5.5 to 7.5.

[0022] According to a particular embodiment of the present invention, the therapeutic composition has a pH of 6.0 to 6.5. Effect of the Invention

[0023] Thus, the present disclosure may be administered to a subject in a liquid formulation, such as a nasal spray, mist, or nebulizer, or as an oral spray or rinse, or in a concentrated formulation, such as a nasal gel. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0024] The objects of the invention will be realized and attained by means of the combinations particularly pointed out in the appended claims. The foregoing general description of the invention and the following detailed description are provided to illustrate various aspects of the invention and should not be taken in any way as limiting any of the described embodiments.

[0025] Definitions and Abbreviations Throughout this description and the appended claims, unless otherwise indicated, the use of the singular includes the plural and the plural encompasses the singular. For example, although reference is made herein to a "composition" or an "aqueous carrier," one or more of these components and / or other components described herein may be used.

[0026] The use of the word "comprising" and variations of the word "comprising" in this description and claims does not limit the invention and does not exclude any variations or additions. Additionally, although the invention is described in terms of "comprising," the processes, materials, and compositions detailed herein may also be described as consisting essentially of, or consisting of. For example, certain aspects of the invention are described in terms of compositions comprising xylitol, at least two humectants, and an aqueous carrier, but compositions comprising xylitol, at least two humectants, and an aqueous carrier that "consist essentially of" or "consist of" are also within the scope of the invention. In this context, "consisting essentially of" means that the additional components do not substantially affect the effectiveness of the method.

[0027] Additionally, unless otherwise specifically noted, all numerical values ​​expressing quantities of ingredients, etc. used herein are understood to be modified in all instances by the term "about." Accordingly, unless expressly indicated to the contrary, the numerical parameters set forth in the following specification are approximations that may vary depending upon the desired properties obtained by the present invention. 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 parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.

[0028] The numerical ranges and parameters setting forth the broad scope of the invention are approximations and, although reported as precisely as possible, they inherently contain certain errors necessarily resulting from the standard deviation found in their respective testing measurements. When ranges are specified, any of the endpoints of those ranges and / or numerical values ​​within those ranges can be combined within the scope of the invention.

[0029] As used herein, a "synergistic combination" or "synergy" is a combination of xylitol with a particular humectant, which uses the humectant to achieve an antimicrobial synergy that maximizes moisturization of the nasal passages or maximizes moisturization of the oral cavity while completely dispersing the xylitol throughout the nasal mucosa. A synergistic combination of xylitol and a humectant may result in improved therapeutic outcomes, which may be measured by a reduction in the total amount of bacteria (e.g., S. pneumoniae or other forms) that may be present, or an improvement in the duration of dryness of the nose or oral cavity or allergy symptoms, or other indicators of patient health. The synergistic combination of the present disclosure may combine a therapeutically effective amount of xylitol with a therapeutically effective amount of at least two desired humectants.

[0030] "Treating" or "treatment" refers to a prescribed treatment intended to slow (alleviate) an undesirable physiological change (such as an allergic reaction, inflammation, dryness of the nose or mouth, etc.) or disease, or to bring about a beneficial or desired clinical result during treatment. Subjects in need of treatment include those already exhibiting an undesirable physiological change or disease, as well as those prone to exhibiting a physiological change or disease (such as a rhinitis sufferer exhibiting sinusitis symptoms).

[0031] As used herein, the term "allergy symptoms" is understood to include sneezing, stuffy nose, runny nose, itchy eyes, nose, throat, etc. Although specific symptoms are listed, other symptoms known in the art are within the scope of this disclosure.

[0032] The phrase "therapeutically effective amount" as used herein refers to an amount sufficient to provide treatment as defined herein and may include an amount effective to inhibit the growth of bacteria associated with nasal or oral dryness or allergic symptoms, such as chronic sinusitis or allergic rhinitis. Thus, a therapeutically effective amount may refer to an amount of a composition sufficient to provide a desired biological, therapeutic, and / or prophylactic result. Desired results include elimination of nasal or oral dryness or allergic symptoms, or reduction and / or alleviation of the signs, symptoms, or causes of nasal or oral dryness or allergic symptoms, or other desired alteration of a biological system, such as those set forth above with respect to synergistic combinations and synergistic effects. With respect to pharmaceutical or veterinary compositions, an effective amount may be the dosage recommended for the regulation of a disease state or its signs or symptoms. The effective amount may vary depending on the composition used and the route of administration employed. The effective amount is usually optimized taking into account various factors of a particular patient, such as age, weight, sex, and the area affected by the disease or the nasal or oral dryness or allergic symptoms that cause the disease.

[0033] A "patient" includes any human or non-human animal. A "non-human animal" includes all vertebrates, e.g., mammals and non-mammals, e.g., non-human primates, sheep, dogs, cats, horses, cows, chickens, amphibians, reptiles, etc. A "patient" and a "subject" are used interchangeably herein.

[0034] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing described herein, suitable methods and materials are described below.

[0035] Detailed Description of the Invention The present invention includes a therapeutic composition for treating dry nose or mouth and allergy symptoms. Disclosed herein are various compositions comprised of xylitol, at least two humectants, an aqueous carrier, a dual salt, and optionally other active and / or inactive ingredients, which may be provided as a nasal spray, an oral spray or rinse, and / or a nasal gel delivered to the nasal and / or sinus passages.

[0036] The compositions and methods of the present disclosure can be used to relieve dryness and irritation in and around the nasal or oral cavity caused by: environmental conditions (including but not limited to dry indoor air, low humidity, dry winter air, etc.); allergic rhinitis (including but not limited to seasonal allergic rhinitis, perennial allergic rhinitis, non-allergic rhinitis); acute, recurrent or chronic sinusitis (formally called sinusitis); travel; nosebleeds; colds; flu; non-invasive ventilation (NIV) therapy (including but not limited to continuous positive airway pressure (CPAP) therapy and bilevel positive airway pressure (BiPAP) therapy); oxygen therapy; other medications; pharmacological and non-pharmacological therapies (including but not limited to antihistamines, prescription medications, natural products such as garlic, etc.).

[0037] The compositions and methods of the present disclosure can increase the ciliary beat frequency in patients with nasal congestion, which can lead to an increase in nasal mucociliary clearance time.It has been found that ciliary beat frequency (CBF) increases after the addition of small amounts of certain humectants, such as potassium chloride and / or propylene glycol.This indicates that the presence of both sodium, potassium, and even certain humectants can stimulate ciliary beat and improve the function of nasal mucociliary clearance.

[0038] Thus, certain active ingredients of the compositions disclosed herein may further include sodium and potassium salts, as well as buffering agents that maintain the pH within the optimal range for the nasal mucosa and allow for combination with other therapeutic agents such as steroids.

[0039] In order that the technical problem is solved by the present disclosure and the technical scheme and beneficial effects are more clearly understood, the present invention will be described in further detail herein. It should be understood that the specific embodiments described herein are not intended to limit the present invention and are only used to illustrate the present invention. Furthermore, it is expected that alternative embodiments and implementations can be made into ingestible products such as suspensions, lozenges, tablets, capsules, topical preparations, and / or teas and other beverages. In certain preferred embodiments, the composition can be formulated as an oral spray, oral mist, or for use similar to a mouthwash or mouthrinse. According to certain aspects, the oral spray or oral mist can be found to migrate or disperse to the nasal mucosa and provide a similar treatment to a nasal spray or nasal gel.

[0040] Xylitol is a meso-configured pentitol (five-carbon sugar alcohol) obtained by reduction of the carbonyl group of xylose, represented by the formula (I). Its empirical formula is CH 12 It has a molecular weight of 152.15 g / mol and is a colorless or white crystalline solid that dissolves in water. It can be classified as a polyalcohol and a sugar alcohol, specifically an alditol. [ka]

[0041] Xylitol has been demonstrated to have various therapeutic effects and may provide synergistic effects with other ingredients of the formulation in the treatment and / or prevention of viral infections. In particular, xylitol has been confirmed to have a significant effect on the removal of microorganisms such as bacteria and viruses, and on moisturizing the nasal cavity, oral cavity, and paranasal sinuses. Without being limited by theory, this is believed to occur because xylitol can create a hyperosmotic solution that draws moisture from the surrounding tissues without producing mucus. Thus, combining xylitol with other ingredients may reduce mucus production, with the attendant antibacterial, antiviral, and other health benefits associated with xylitol. Xylitol can also enhance flavor or reduce unpleasant odor and aftertaste issues commonly found in conventional formulations. Additionally, providing a sugar-free sweetener that acts as an active agent in the formulation provides several benefits. For example, xylitol acts as a sweetener, but unlike common sweeteners, xylitol enhances the ability of other agents to treat bacterial infections by actively starving symptom-causing microbes, as opposed to agents that counteract the active ingredients of nasal or oral sprays or other therapeutic compositions by feeding the microbes, or agents that passively starve the microbes by providing a sweetener that is not consumed by the more common oral and pharyngeal pathogens. Thus, compositions that include xylitol may enhance the ability to treat a variety of symptoms that may be caused by microbes (including other symptoms that are not caused by microbes), and more importantly, enhance the ability to hydrate and fight the bacteria, viruses, and / or other microbes behind these symptoms.

[0042] The inventors have demonstrated that the combination of xylitol with a humectant and an aqueous carrier has even greater effectiveness than the prior art in treating nasal and oral dryness and allergy symptoms. Humectants are surface active molecules used to lower the surface tension of water. High surface tension of water creates problems in many applications where water needs to spread. Humectants increase the spreadability and permeability of liquids by lowering the surface tension, or the tendency of molecules to stick to each other at a surface. Humectants are composed of a variety of chemicals, all of which have this tension-lowering effect. Thus, studies have shown that humectants are effective in dispersing the steroid in a steroid spray to prevent excessive concentration and to create a barrier that protects against nasal irritants. Thus, humectants have the dual effect of retaining moisture in the nasal cavity to prevent evaporation while at the same time relieving irritation of the nasal mucosa.

[0043] In a preferred embodiment, the therapeutic composition may include at least two humectants. According to certain preferred aspects, the at least two humectants have different wetting angles or other physiochemical properties. Exemplary humectants include polyethylene glycol and propylene glycol, which may be included in an amount of 10-50 weight percent combined, based on the total weight of the composition. The inventors have discovered that this unique combination of humectants provides an optimal combination of odorlessness and wetting angle, an important aspect for nasal or oral formulations, thus maximizing the spreading and moisturizing ability of the composition while also providing the best "nose feel" (i.e., not overly thick, sticky, or slimy).

[0044] According to certain embodiments, the polyethylene glycol can be present in an amount of at least 8 weight percent, such as at least 9, 10, 11, 12, 13, 14, or 15 weight percent, based on the total weight of the composition. The polyethylene glycol can be present in an amount of up to 20 weight percent, such as up to 19, 18, 17, 16, 15, 14, 13, 12, or 10 weight percent, based on the total weight of the composition. Any combination of lower and upper amounts of polyethylene glycol can be included in the composition and is within the scope of the present disclosure. For example, the polyethylene glycol can be present in an amount of 8 to 10, or 10 to 25, or 10 to 20 weight percent, based on the total weight of the composition. According to certain preferred embodiments, the polyethylene glycol can be present in an amount of 8 to 20 weight percent, such as 15 weight percent, based on the total weight of the composition.

[0045] Polyethylene glycol (PEG) is a linear polymer formed by the addition reaction of ethylene glycol and ethylene oxide, and is commercially available with average molecular weights ranging from about 200 to over 20,000. Commercially available grades of polyethylene glycol are sold based on their average molecular weight, and the nomenclature of the grades is identified by the molecular weight. For example, PEG 400 represents a material with an average molecular weight of 400, and a material with an average molecular weight of 600 is known as PEG 600. PEG 200, 300, 400, and 600 are clear viscous liquids at room temperature. PEG 900, 1000, 1450, 3350, 4500, and 8000 are white waxy solids. The preferred polyethylene glycols for the compositions disclosed herein are PEG 400 to PEG 3350. More preferred polyethylene glycols are granular PEG 3300 or PEG 3350.

[0046] According to certain embodiments, propylene glycol can be present in an amount of at least 2 weight percent, such as at least 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 weight percent, based on the total weight of the composition. Propylene glycol can be present in an amount of up to 30 weight percent, such as up to 29, 28, 27, 26, 25, 24, 23, 22, 21, 20, 19, 18, 17, 16, 15, 14, 13, 12, 11, or 10 weight percent, based on the total weight of the composition. Any combination of lower and upper amounts of propylene glycol can be included in the composition and is within the scope of the present disclosure. For example, propylene glycol can be present in an amount of 2 to 10, 15 to 25, or 10 to 20 weight percent, based on the total weight of the composition. According to certain preferred embodiments, propylene glycol can be present in an amount of 2 to 30 weight percent, such as 5 weight percent or 20 weight percent, as propylene, based on the total weight of the composition.

[0047] In some embodiments, the treatment composition may include other forms of suitable humectants such as vegetable glycerin, phytosqualane, coco glucoside, biophytosebum, decyl glucoside, lauryl glucoside, sucrose cocoate, caprylyl, caprylyl / capryl glucoside 10-20%, or combinations thereof.

[0048] The therapeutic composition includes at least 0.1% by weight, such as at least 0.5, 1, 1.5, 2, 2.5, or 3% by weight, of xylitol based on the total weight of the composition. The therapeutic composition includes xylitol in an amount of up to 15 percent by weight, such as up to 14, 13, 12, 11, 10, 9, 8, 7, 6, 5, or 4 percent by weight, based on the total weight of the composition. Any combination of lower and upper amounts of xylitol may be used in the composition and is within the scope of the present disclosure. For example, xylitol may be present in an amount of 0.1-12 percent by weight, or 2-11 percent by weight, or 0.1-5 percent by weight, based on the total weight of the composition. According to certain preferred aspects, xylitol may be present in an amount of 0.1-5% by weight. Most preferably, xylitol may be present in an amount of 3-4.5% by weight, based on the total weight of the composition. Xylitol, when combined with at least two humectants, may enhance the synergistic effects mentioned elsewhere herein.

[0049] The inventors have found that the efficacy of the therapeutic compositions disclosed herein, which include at least two humectants and xylitol, can be significantly improved by formulating them in a suitable buffer or pH-adjusting composition, which can provide a suitable pH level for more effective combination of the steroid with other therapeutic preparations, and further improve the distribution or adsorption of xylitol in the nasal mucosa.

[0050] Thus, the therapeutic composition may be configured to maintain a desired pH level, such as by the addition of at least one buffering agent and / or an acid or base. According to certain embodiments, the at least one buffering agent is in the form of anhydrous dibasic sodium phosphate, monobasic potassium phosphate, or a combination thereof. According to other certain embodiments, the pH of the composition may be adjusted with a base, such as a hydroxide, e.g., sodium hydroxide or potassium hydroxide. Thus, the nasal therapeutic composition has a pH level of 5.5-7.5, preferably a pH level of 5.8-6.5, and most preferably a pH level of 6.0-6.4.

[0051] Additionally, the therapeutic composition may include both sodium and potassium salts. Most preferably, the sodium and potassium salts are added in the form of sodium chloride and potassium chloride, each of which may be present in an amount of 0.05 to 1.0 weight percent based on the total weight of the composition. In some embodiments, the nasal therapeutic composition may further include additional other forms of suitable salts, such as magnesium chloride and / or calcium chloride.

[0052] The therapeutic composition may include a preservative, which may be selected from benzalkonium chloride or sorbic acid, and may be present in an amount of 0.005 to 0.5 percent by weight, based on the total weight of the composition.

[0053] In a preferred embodiment, the preservative is benzalkonium chloride present in an amount of 0.01 to 0.3 percent by weight, based on the total weight of the composition. In some embodiments, the therapeutic composition may be comprised of other forms of preservatives, such as olive leaf extract, potassium sorbate (pH less than 6), biosecuris (citrus extract), rosemary extract, lactic acid bacteria ferment, magnolia bark extract, cranberry juice powder, chlorfensine, grapefruit seed extract, eucalyptus oil, or combinations thereof.

[0054] The therapeutic composition comprises an aqueous carrier consisting of purified water in an amount of 25 to 89.9 weight percent based on the total weight of the composition.

[0055] According to certain embodiments, the therapeutic composition may optionally include one or more thickening agents. Exemplary thickening agents include glycerin, polymeric cross-linked polyacrylic acid polymers such as Carbopol®, sodium carboxymethylcellulose, xanthan gum, guar gum, bentonite, magnesium aluminum silicate (pH 9-10), kelp extract, cassava flour, agar (pH 6.5-7.5), vegetable glycerin, papaya fruit skin extract, glucomannan, sodium alginate, sclerotium gum, soy lecithin, acacia gum (pH 4.4), cellulose gum, ocimum basilicum, salvia hispanica (chia), biosaccharide gum-1, oryza sativa starch, carrageenan, tribehinin, arrowroot, glycol stearate, sodium hyaluronate, cetearyl alcohol, glyceryl stearate, dexpanthenol, propolis extract, or combinations thereof. According to a preferred embodiment, the one or more thickening agents may be selected from the group consisting of glycerin, Carbopol® homopolymer (e.g., acrylic acid crosslinked with allyl sucrose or allyl pentaerythritol, e.g., Carbopol® 974P), sodium carboxymethylcellulose, and combinations thereof.

[0056] In one embodiment in which the therapeutic composition is formulated as a nasal or oral spray or rinse, the therapeutic composition includes one or more thickening agents in an amount of 2 to 10 weight percent based on the total weight of the composition. According to a preferred aspect, the one or more thickening agents included in the nasal or oral spray include glycerin.

[0057] In one embodiment in which the therapeutic composition is configured as an oral spray or rinse, the therapeutic composition may further include colorants and flavoring agents commonly known in the art.

[0058] In another embodiment in which the therapeutic composition is configured as a nasal gel, the therapeutic composition includes one or more thickening agents in an amount of 5 to 25 weight percent based on the total weight of the composition. According to a preferred embodiment, the one or more thickening agents included in the nasal gel are selected from the group consisting of glycerin, high molecular weight cross-linked polyacrylic acid polymers, sodium carboxymethylcellulose, and combinations thereof.

[0059] Those skilled in the art will appreciate that changes can be made to the details of the above embodiments without departing from the underlying principles presented herein. For example, the compositions disclosed herein can be administered via drops from a dropper, topically (possibly using a cotton swab or the like), orally, via a mister or atomizer, by spraying, and / or via any other suitable method of administration. Additionally, alternative compositions and methods of treatment are contemplated in which the preferred nasal spray, oral spray or wash, and / or nasal gel can be replaced with suspensions, lozenges, tablets, capsules, topical preparations, and / or ingestible products, such as teas or other beverages. Additionally, any suitable combination of the various embodiments or features thereof is contemplated.

[0060] Any of the methods disclosed herein may include one or more steps or actions for carrying out the described method. The steps and / or actions of the methods may be interchanged with one another. In other words, unless a particular order of steps or actions is required for proper operation of an embodiment, the order and / or use of certain steps and / or actions may be modified.

[0061] Throughout this specification, references to "one embodiment," "one embodiment," or "the present embodiment" mean that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, references to phrases or variations thereof throughout this specification are not necessarily all referring to the same embodiment.

[0062] Similarly, in the description of the above embodiments, it should be understood that various features may be grouped together in a single embodiment or description thereof for the purpose of streamlining the disclosure. However, this method of disclosure should not be interpreted as reflecting an intention that more features are required than are expressly recited in the claims. Rather, inventive aspects lie in combinations of fewer than all features of a single foregoing disclosed embodiment. Those skilled in the art will recognize that changes can be made to the details of the above-described embodiments without departing from the underlying principles described herein.

[0063] Similarly, advantages, other benefits, and solutions to problems have been described above with respect to various embodiments, however, the advantages, benefits, solutions to problems, and elements that may cause the advantages, benefits, or solutions to occur or be evident are not to be construed as critical, necessary, or essential features or elements.

[0064] The present application discloses the following aspects.

[0065] Aspect 1: A nasal or oral treatment composition comprising at least two humectants, xylitol, a dual salt, and an aqueous carrier, for treating dry nose, dry mouth, and allergy symptoms by applying the composition to the nasal or oral cavity for absorption by the nasal mucosa.

[0066] Aspect 2: The composition of aspect 1, wherein the at least two humectants include polyethylene glycol and propylene glycol, and the humectants are provided in the composition at 10.0% by weight to 50% by weight based on the total weight percent of the composition.

[0067] Aspect 3: The composition of aspect 1 or 2, wherein the at least two humectants comprise 8% by weight to 20% by weight of polyethylene glycol and 2% by weight to 30% by weight of propylene glycol, based on the total weight percentage of the composition.

[0068] Aspect 4: The composition of any one of aspects 1 to 3, wherein the xylitol is provided in the composition at 0.1% by weight to 5% by weight, based on the total weight percent of the composition.

[0069] Aspect 5: The composition of any one of aspects 1 to 4, wherein the xylitol is provided in the composition at 3% by weight to 4.5% by weight, based on the total weight percent of the composition.

[0070] Aspect 6: The composition of any one of Aspects 1-5, further comprising a sodium salt and a potassium salt, the sodium salt and potassium salt comprising sodium chloride and potassium chloride provided in the composition at 0.05% by weight to 1.0% by weight, respectively, based on the total weight percent of the composition.

[0071] Aspect 7: The composition of any one of Aspects 1-6, further comprising a preservative, the preservative comprising benzalkonium chloride or sorbic acid provided in the composition at 0.01% by weight to 0.5% by weight, based on the total weight percent of the composition.

[0072] Aspect 8: The composition of Aspect 7, wherein the preservative comprises benzalkonium chloride provided in the composition at 0.01% by weight to 0.3% by weight, based on the total weight percent of the composition.

[0073] Aspect 9: The composition of any one of Aspects 1 to 8, wherein the aqueous carrier comprises purified water provided in the composition at 25% by weight to 89.9% by weight based on the total weight percent of the composition, and one or more thickeners.

[0074] Aspect 10: The composition of any one of aspects 1 to 9, configured as a nasal or oral spray or oral rinse, wherein the one or more thickening agents include glycerin provided in the composition at 2% by weight to 10% by weight, based on the total weight percent of the composition.

[0075] Aspect 11: The composition described in any one of aspects 1 to 9, configured as a nasal gel, wherein the one or more thickening agents are selected from the group consisting of glycerin, carbopol 974P, sodium carboxymethylcellulose, and combinations thereof, and are provided in the composition at 5% by weight to 25% by weight, based on the total weight % of the composition.

[0076] Embodiment 12: The composition according to any one of embodiments 1 to 11, further comprising at least one buffering agent.

[0077] Embodiment 13: The composition of embodiment 11, wherein the at least one buffering agent is selected from the group consisting of sodium phosphate dibasic anhydrous, potassium phosphate monobasic, or a combination thereof.

[0078] Aspect 14: The composition according to any one of aspects 1 to 13, having a pH of 5.5 to 7.5, for example 6.0 to 6.5, or 6.1 to 6.4.

[0079] Aspect 16: A nasal or oral cavity treatment composition comprising, based on the total weight percent of the composition, 10.0% to 50% by weight of a humectant; 0.1% to 5% by weight of xylitol; 0.05% to 0.5% by weight of sodium salts and potassium salts, respectively; 0.01% to 0.5% by weight of a preservative; and an aqueous carrier, which is applied to the nasal or oral cavity and absorbed into the nasal mucosa to treat dryness and allergic symptoms in the nasal or oral cavity.

[0080] Aspect 17: The composition described in Aspect 16, wherein the humectant comprises 8% by weight to 20% by weight of polyethylene glycol and 2% by weight to 30% by weight of propylene glycol, based on the total weight percentage of the composition.

[0081] Aspect 18: The composition according to aspect 16 or 17, comprising between 3% by weight and 4.5% by weight of xylitol, based on the total weight% of the composition.

[0082] Aspect 19: The composition according to any one of aspects 16 to 18, wherein the preservative is selected from benzalkonium chloride or sorbic acid.

[0083] Aspect 20: A composition described in any one of aspects 16 to 19, configured as a nasal or oral spray or mouthwash, wherein the aqueous carrier comprises 25% to 89.9% by weight of purified water, and the composition further comprises 2% to 10% by weight of one or more thickening agents.

[0084] Aspect 21: A composition described in any one of aspects 16 to 19, configured as a nasal gel, wherein the aqueous carrier comprises 25% by weight to 89.9% by weight of purified water, and the composition further comprises 5% by weight to 25% by weight of one or more thickening agents.

[0085] Aspect 22: The composition described in aspect 20 or 21, wherein the one or more thickening agents are selected from the group consisting of glycerin, carbopol 974P, sodium carboxymethylcellulose, and combinations thereof.

[0086] Aspect 23: A method for treating dry nose or mouth and allergic symptoms in a subject in need thereof, comprising administering to the subject a composition according to any one of aspects 1 to 22.

Claims

1. 1. A nasal or oral treatment composition comprising: at least two wetting agents; 3% to 15% by weight of xylitol; Sodium and potassium salts; and Water-based carrier Including, the sodium and potassium salts include sodium chloride and potassium chloride, each of which is provided in the composition at 0.05% to 0.5% by weight, based on the total weight of the composition; A composition for treating dryness and allergic symptoms in the nasal or oral cavity by applying the composition to the nasal or oral cavity.

2. 10. The composition of claim 1, wherein the at least two humectants comprise polyethylene glycol and propylene glycol, and the humectants are provided in the composition at 10.0 wt. % to 50 wt. % based on the total weight % of the composition.

3. 10. The composition of claim 1, wherein the at least two humectants comprise, based on the total weight percent of the composition, 8% to 20% by weight of polyethylene glycol and 2% to 30% by weight of propylene glycol.

4. 10. The composition of claim 1, wherein xylitol is provided in the composition at 0.1% to 5% by weight, based on the total weight percent of the composition.

5. 10. The composition of claim 1, wherein xylitol is provided in the composition at 3% to 4.5% by weight, based on the total weight percent of the composition.

6. 10. The composition of claim 1, further comprising a preservative, wherein the preservative comprises benzalkonium chloride or sorbic acid, provided in the composition at 0.01% to 0.5% by weight, based on the total weight percent of the composition.

7. 7. The composition of claim 6, wherein the preservative comprises benzalkonium chloride provided in the composition at 0.01% to 0.3% by weight, based on the total weight percent of the composition.

8. 10. The composition of claim 1, wherein the aqueous carrier comprises purified water, and one or more thickeners, provided in the composition at 25% to 89.9% by weight based on the total weight percent of the composition.

9. 10. The composition of claim 8, configured as a nasal or oral spray, wherein the one or more thickening agents include glycerin provided in the nasal treatment composition at 2% to 10% by weight, based on the total weight percent of the composition.

10. 10. The composition of claim 8, configured as a nasal gel, wherein the one or more thickening agents are selected from the group consisting of glycerin, high molecular weight cross-linked polyacrylic acid polymers, sodium carboxymethylcellulose, and combinations thereof, and are provided in the composition at 5% to 25% by weight, based on the total weight percent of the composition.

11. The composition of claim 1 further comprising at least one buffering agent.

12. 12. The composition of claim 11, wherein the at least one buffering agent is selected from the group consisting of anhydrous dibasic sodium phosphate, monobasic potassium phosphate, or a combination thereof.

13. The composition of claim 11, wherein the pH is from 5.5 to 7.

5.

14. The composition of claim 11, wherein the pH is 6.0 to 6.

5.

15. 1. A nasal or oral treatment composition comprising: Based on the total weight percent of the composition: 10.0% to 50% by weight of a humectant; 0.1% to 15% by weight of xylitol; 0.05% to 0.5% by weight each of sodium and potassium salts; and Water-based carrier Including, The composition is applied to the nasal cavity or oral cavity and absorbed into the nasal mucosa, thereby treating dryness and allergic symptoms in the nasal cavity or oral cavity.

16. 16. The composition of claim 15, wherein the humectant comprises 8% to 20% by weight of polyethylene glycol and 2% to 30% by weight of propylene glycol, based on the total weight percent of the composition.

17. 16. The composition of claim 15, comprising 3% to 4.5% by weight of xylitol, based on the total weight percent of the composition.

18. 16. The composition of claim 15, configured as a nasal spray, wherein the aqueous carrier comprises 25% to 89.9% by weight of purified water, based on the total weight percent of the composition, and the composition further comprises 2% to 10% by weight of a thickening agent.

19. 16. The composition of claim 15, configured as a nasal gel, wherein the aqueous carrier comprises 25% to 89.9% by weight of purified water, based on the total weight percent of the composition, and the composition further comprises 5% to 25% by weight of a thickening agent, the thickening agent being selected from the group consisting of glycerin, high molecular weight cross-linked polyacrylic acid polymers, sodium carboxymethylcellulose, and combinations thereof.

20. 16. The composition of claim 15, further comprising 0.01% to 0.5% by weight of a preservative selected from benzalkonium chloride or sorbic acid, based on the total weight percent of the composition.

21. 1. A nasal or oral spray composition comprising: Based on the total weight percent of the composition: 8% to 20% by weight of polyethylene glycol; 2% to 30% by weight of propylene glycol; 3% to 4.5% by weight of xylitol; 0.05% to 1.0% by weight of a sodium salt; 0.05% to 1.0% by weight of a potassium salt; 2% to 10% by weight of a thickener; 0.01% to 0.3% by weight of a preservative; and 25% to 89.9% by weight of an aqueous carrier containing at least one buffering agent Including, The pH of the composition is 6.0 to 6.

5. A composition for treating dryness and allergic symptoms in the nasal or oral cavity by applying the composition to the nasal or oral cavity.

22. 1. A nasal gel composition comprising: Based on the total weight percent of the composition: 8% to 20% by weight of polyethylene glycol; 2% to 30% by weight of propylene glycol; 3% to 4.5% by weight of xylitol; 0.05% to 1.0% by weight of a sodium salt; 0.05% to 1.0% by weight of a potassium salt; 5% to 25% by weight of a thickener; 0.01% to 0.3% by weight of a preservative; and 25% to 89.9% by weight of an aqueous carrier containing at least one buffering agent Including, The pH of the composition is 6.0 to 6.

5. The composition is applied to the nasal cavity to treat nasal dryness and allergy symptoms.

23. 23. The composition of claim 21 or 22, wherein the one or more thickening agents are selected from the group consisting of glycerin, high molecular weight cross-linked polyacrylic acid polymers, sodium carboxymethylcellulose, and combinations thereof.

24. 23. The composition of claim 21 or 22, wherein the at least one buffering agent is selected from the group consisting of anhydrous dibasic sodium phosphate, monobasic potassium phosphate, or a combination thereof.

25. 23. The composition of claim 21 or 22, wherein the preservative comprises benzalkonium chloride or sorbic acid-based.

26. 22. A method of treating nasal dryness and allergy symptoms in a subject in need thereof, comprising administering to the subject the nasal or oral spray of claim 9, 18 or 21.

27. 26. A method of treating nasal dryness and allergy symptoms in a subject in need thereof, comprising administering to the subject the nasal gel of claim 10, 19 or 22.