Oral care compositions and methods of use

Abstract

Disclosed are articles comprising 70 to 99 percent by weight of one or more plant-based oils that are solid at 25°C, the weight percent being based on the total weight of the article; and 0.5 to 10 percent by weight of fumed silica, the weight percent being based on the total weight of the article. Also included are methods of using the articles.

Description

SUMMARY

[0001] Disclosed herein is an article comprising 70 to 99 weight percent of one or more plant-based oils that are solid at room temperature (25 °C), the weight percent being based on the total weight of the article; and 0.5 to 10 weight percent of fumed silica, the weight percent being based on the total weight of the article, wherein the article is solid in form and homogenized.

[0002] Also disclosed is a method of preventing, inhibiting, disrupting, or any combination thereof, biofilm formation or maintenance in oral tissue, the method comprising contacting the oral tissue with the disclosed article.

[0003] Also disclosed is a method of affecting hydration loss in oral tissue, the method comprising contacting the oral tissue with the disclosed article.

[0004] Also disclosed is a method of affecting lubrication capacity or lubricity in oral tissue, the method comprising contacting the oral tissue with the disclosed article.

[0005] Also disclosed is a method of affecting oral dryness, xerostomia, or both, the method comprising contacting the oral tissue with the disclosed article.

[0006] The above summary of the application is not intended to describe each embodiment of the present disclosure. The details of one or more embodiments of the present disclosure are also set forth in the description below. Other features, objects, and advantages of the present disclosure will be apparent from the description and from the claims. BRIEF DESCRIPTION OF DRAWINGS

[0007] The present disclosure can be more fully understood by reading the following detailed description together with the accompanying drawings, in which:

[0008] Figure 1 Photos of the lozenges prepared above are shown. The top row shows Example 3 as well as Comparative Examples 1 and 2. The bottom row shows Examples 2 and 3 poured after the mixed solution was reheated to 80 °C. DETAILED DESCRIPTION

[0009] Xerostomia or dry mouth is a common condition caused by insufficient saliva. It is increasingly prevalent in the older population and is a side effect of many medications as well as cancer treatments. Severe cases of xerostomia are often associated with dysfunction of the salivary glands, known as Sjogren’s Syndrome (SS).

[0010] ​The lack of moisture and lubrication typically provided by saliva has a range of negative effects on oral tissue (soft tissue), ranging from mild discomfort to extreme pain and canker sores. Continued discomfort and dryness can also lead to greater health problems by causing sleep interruption and impairing a person's ability to speak (social, potentially affecting mental health) and eat (potentially affecting nutrition). Dry buccal tissue is less effective as a barrier and is more easily penetrated by physical irritants in food, beverages, and tobacco, such as toxins and carcinogens.

[0011] Saliva is also the primary defense of the oral cavity against tooth decay. Healthy saliva flow helps prevent tooth decay by physically removing bacteria from the oral cavity before they can attach to tooth and tissue surfaces and form protected biofilms. The flow of saliva also helps dilute sugars and acids introduced due to the ingestion of food and beverages. Buffering capacity can neutralize acids and aid in the digestive process. The presence of calcium and phosphate salts provides a continuous opportunity for the remineralization of tooth enamel, aiding in reversing the tooth decay process.

[0012] Many people with dry mouth use separate products to address hard tissue health and soft tissue comfort issues. To make soft tissue comfortable, saliva replacement products are typically designed to provide lubrication and moisture. These products come in a variety of forms and include viscous gels / pastes, sprays, mouthwashes, mentholated agents, and slow-release tablets. These products are applied multiple times per day or as needed for comfort. For hard tissue health, different treatments are used to directly address tooth decay prevention issues (antibacterial rinses, fluoride products, calcium / phosphate treatments). "Dry mouth friendly" products such as toothpaste and mouthwash are often recommended. Dry mouth friendly products typically have a neutral pH and are free of alcohol or other irritating ingredients (e.g., anionic surfactants or emulsifiers).

[0013] It would be desirable to design a product that effectively and easily addresses both the need for relief from dry mouth symptoms (soft tissue comfort) and the benefits of oral health prevention (enamel and tooth decay protection). A fully ingestible lozenge-type product is well suited for this purpose. It addresses both hard and soft tissue health issues.

[0014] Disclosed herein are articles that can be used as, for example, oral articles. The disclosed articles can be in the form of, for example, a lozenge. The disclosed articles are not gels. Gels do not dissolve in the mouth of a user, whereas lozenges dissolve in the mouth of a user.

[0015] The disclosed article, one or more components of the article, or both can be characterized as edible. Referring to a component, composition, or article as edible can mean that the particular ingredient, composition, or article is safe for daily long-term ingestion at the recommended level of use. In some embodiments, the GRAS (generally recognized as safe) list of the U.S. Food and Drug Administration (FDA) can be used to determine whether a component is edible at the level used in the composition.

[0016] The disclosed article includes one or more useful oils and fumed silica.

[0017] The disclosed article includes one or more oils that are solid at room temperature (25 °C). In some embodiments, the useful oil does not include silicone-based oils (e.g., simethicone or dimethicone). The useful oil can include any oil, but in some embodiments can include a plant-based oil. Many plant-based oils can be hydrogenated to make them exist in solid form at room temperature. The article can include a single edible oil, or up to two, three, four, five, or more edible oils. Examples of suitable edible oils that are solid at room temperature can include, but are not limited to, hydrogenated plant-based oils, and the like, as well as mixtures or fractions thereof. Particular and non-limiting examples include cocoa butter.

[0018] The disclosed article can include not less than 70% of one or more oils that are solid at room temperature based on the total weight of the article, not less than 75% of one or more oils that are solid at room temperature based on the total weight of the article, not less than 76% of one or more oils that are solid at room temperature based on the total weight of the article, not less than 80% of one or more oils that are solid at room temperature based on the total weight of the article, or not less than 85% of one or more oils that are solid at room temperature based on the total weight of the article. The disclosed article can include not more than 99% of one or more oils that are solid at room temperature based on the total weight of the article, not more than 97% of one or more oils that are solid at room temperature based on the total weight of the article, or not more than 95% of one or more oils that are solid at room temperature based on the total weight of the article.

[0019] The disclosed article also includes fumed silica. In some embodiments, the disclosed article can include not less than 0.5% of fumed silica based on the total weight of the article, not less than 1% of fumed silica based on the total weight of the article, not less than 2% of fumed silica based on the total weight of the article, or not less than 4% of fumed silica based on the total weight of the article. In some embodiments, the disclosed article can include not more than 10% of fumed silica based on the total weight of the article, not more than 9% of fumed silica based on the total weight of the article, or not more than 8.5% of fumed silica based on the total weight of the article.

[0020] In some embodiments, the disclosed articles can also optionally include water. Water can be used to include water-soluble materials within the final article. In some embodiments, water can be added to the composition to make the disclosed articles in combination with a variety of different components, such as as a buffer solution. Exemplary materials can include minerals (e.g., calcium), sweeteners, and the like. In some embodiments, the disclosed articles can include not less than 0.5% water based on the total weight of the article, not less than 1% water based on the total weight of the article, or not less than 2% water based on the total weight of the article. In some embodiments, the disclosed articles can include not more than 10% water based on the total weight of the article, not more than 8% water based on the total weight of the article, or not more than 5% water based on the total weight of the article.

[0021] The disclosed articles can also optionally include additional components in addition to those described above. Exemplary optional components can include, for example, sweeteners (e.g., non-carcinogenic sweeteners), mineral salts, buffering components, flavorants, preservatives, humectants, or combinations thereof. Other optional beneficial ingredients can also be included at appropriate levels, such as aloe vera (multi-benefit), folic acid (in relation to B12), hyaluronic acid (lubricating, moisturizing), ceramides, amino acids (e.g., glycine, arginine), betaine or oxygenated glycerides, vitamin E (antioxidant), vitamin B12, EDTA, cetylpyridinium chloride , chlorhexidine, other preservatives, and the like or combinations thereof.

[0022] In some embodiments, the disclosed articles can include a flavoring agent, including, for example, spearmint, peppermint, strawberry, butter, vanilla, coconut, almond, bubble gum, berry, fruit punch, butterscotch, caramel, or combinations thereof. In some embodiments, some flavoring agents, such as mint, citrus, and the like, can also be advantageous in that they stimulate saliva production when used in an article. Artificial sweeteners (e.g., stevia, aspartame, sucralose, neotame, acesulfame potassium (Ace-K), saccharin, and advantame) can also be used. In some embodiments, the disclosed articles can include one or more sweeteners, including, for example, non-cariogenic polyols or sugar substitutes (e.g., sucralose). In some embodiments, the disclosed articles can include a non-cariogenic polyol sweetener, such as xylitol, sorbitol, maltitol, erythritol, isomalt, or combinations thereof. In some embodiments, the disclosed articles can include a non-cariogenic polyol sweetener, such as xylitol, sorbitol, or combinations thereof. In articles that include an optional sweetener, the sweetener can be present in an amount of no less than 2.5% based on the total weight of the article, or no less than 1% based on the total weight of the article. In some embodiments, the optional sweetener can be present in an amount of no greater than 30% based on the total weight of the article, no greater than 20% based on the total weight of the article, no greater than 15% based on the total weight of the article, no greater than 10% based on the total weight of the article, or no greater than 8% based on the total weight of the article.

[0023] In some embodiments, the disclosed articles can optionally include one or more minerals that can be useful or beneficial to ingestion or oral health. Exemplary optional minerals that can be included in the disclosed articles can include calcium (Ca), phosphorus (P), magnesium (Mg), fluorine (F), iron (Fe), strontium (Sr), zinc (Zn), potassium (K), or combinations thereof. In some embodiments, some minerals can be provided by including magnesium chloride (MgCl2), calcium chloride (CaCl2), strontium chloride, zinc chloride, zinc gluconate, potassium nitrate, dipotassium hydrogen phosphate (KH2PO4), or combinations thereof. In some embodiments, where fluorine is included, it can be included as fluoride ions (F-) in the form of a salt (MgF2, CaF2, etc.) at a concentration of no greater than 4 milligrams per liter (mg / L).

[0024] In some embodiments, the disclosed articles can include one or more preservatives to render the article microbiologically stable, increase its microbiological stability, or some combination thereof. In some embodiments, useful preservatives can include those that act at neutral pH, do not adversely affect taste, are consumable, are effective against a variety of pathogens, or combinations thereof. Specific exemplary useful preservatives can include Preservatives, which are commercially available from Lonza (Basel, Switzerland) and include, for example, salicylic acid, benzyl alcohol, sodium benzoate, potassium sorbate, parabens, natural preservatives, polyglycerol esters, glyceryl monolaurate, 1,2-octanediol, caprylic / capric triglyceride, DHA, aloe vera, potassium sorbate, cetylpyridinium chloride (CPP), polyhexamethylene biguanide (PHMB), methylparaben, and chlorhexidine gluconate (CHG).

[0025] The disclosed articles can generally be formed by heating one or more oils that are solid at room temperature (25 °C) to a melt and then adding fumed silica. Optional ingredients can be dissolved in water, for example, with heating. The water-based composition can then be added to the oil-based composition, and the mixture can then be further mixed.

[0026] The disclosed articles can have varying properties. In some embodiments, the disclosed articles can be described by their pH, their viscosity, their stability, various other properties, or combinations thereof.

[0027] In some embodiments, the disclosed articles can have an acceptable pH for use in a human's mouth, for example. In some embodiments, the disclosed articles can have a pH of, for example, 4.5 to 9.5. In some embodiments, the pH of the article can be in a more neutral range of, for example, 5.0-8.5 or 5.5-8.5, as patients with dry mouth can have a higher sensitivity to pH. The article can naturally have such a pH, or can be buffered to have a pH in the range that is usable, for example, "neutral."

[0028] In some embodiments, the disclosed articles can be described as being solid in form (e.g., the article does not flow at room temperature (25 °C)) and homogenized (e.g., the article does not have visible separation). In some embodiments, the disclosed articles can be described as being solid in form and homogenized even after rapid mixing, reheating, cooling, or any combination thereof. An article that is solid in form and homogenized even after any of reheating, cooling, or any combination thereof can be advantageous, as a user can subject the article to extreme environmental conditions (e.g., storing the article in a car that can subject it to extreme temperatures).

[0029] The disclosed articles can be packaged in any of a variety of common ways, including, for example, blister packs, pouches, and the like. The articles themselves can also be molded into virtually any size or shape.

[0030] In some embodiments, the disclosed articles can have a desired effect when in use. Such effects can include, for example, an effect of the article on a biofilm, an effect of the article on plaque accumulation, an effect of the article on dehydration, an ability of the article to retain or provide lubricating properties, resistance to being diluted or rinsed by saliva or water, or general ability to drink and eat, or a combination thereof.

[0031] In some embodiments, the disclosed articles are capable of preventing, inhibiting, disrupting biofilm formation or maintenance in an area contacted by the article. The area contacted can be in vivo or in vitro. In some embodiments, the article can prevent, inhibit, or disrupt biofilm formation or maintenance in a mouth when the article is administered into the mouth of a user (e.g., by placing the article in the mouth) when compared to a mouth without the article administered. In some embodiments, the article is capable of preventing, inhibiting, disrupting biofilm formation or maintenance in a container when the article is administered to the container by contact where biofilm is present and by contact. Prevention, inhibition, or disruption of biofilm formation or maintenance or some combination thereof can be measured using a modified version of the MBEC assay (described in ASTM E2799) which measures disruption of S. mutans biofilm grown on special pins in a microtiter plate. Biofilm grown on the pins is treated by periodic immersion in the test material and then washed in saliva and water. The amount of fluorescently labeled bacteria that elutes from the pins at the end of the treatment period can be measured to quantify the biofilm remaining on each pin after treatment (see Examples). In some embodiments, the disclosed articles can affect plaque accumulation in an area contacted by the article. The area contacted can be in vivo or in vitro. In some embodiments, the article can reduce plaque accumulation on at least one tooth in a mouth when the article is administered into the mouth of a user (e.g., by placing the article in the mouth) when compared to a mouth without the article administered. In some embodiments, the article can reduce plaque accumulation in a container when the article is administered to the container by pouring, spraying, etc. where plaque can form and by contact. Reduced plaque accumulation can be measured by a variety of in vivo methods including, for example, plaque scores, plaque staining, etc.

[0032] In some embodiments, the disclosed articles can affect hydration loss in an area contacted by the article. The area contacted can be in vivo or in vitro. In some embodiments, the article can reduce hydration loss in a mouth when the article is administered into the mouth of a user (e.g., by placing the article in the mouth) when compared to a mouth without the article administered. In some embodiments, the article can reduce hydration loss in a tissue when the article is administered to the tissue by contact where hydration can be lost and by contact.

[0033] In some embodiments, the disclosed articles can affect the lubricating ability or lubricity of an area in contact with the article. The area of contact can be in vivo or in vitro. In some embodiments, the article can maintain or increase the lubricating ability in the mouth in the case where the article is administered into the mouth of a user (e.g., by contacting the article into the mouth) when compared to a mouth without the administration of the article.

[0034] Also disclosed herein are methods of using the disclosed articles. The disclosed methods can include contacting an oral cavity or oral cavity tissue with a disclosed article. The step of contacting an oral cavity or oral cavity tissue can be accomplished by administering the article in any manner, such as by simply placing the article in the mouth. The disclosed methods can be used to prevent, inhibit, disrupt, or any combination thereof, biofilm formation or maintenance in an area in contact with the article; to affect hydration loss in an area in contact with the article; to affect the lubricating ability or lubricity of an area in contact with the article; to affect or alleviate the effects of oral dryness, mouth dryness, or both.

[0035] Unless otherwise defined, all scientific and technical terms used herein have the meanings that are commonly understood by one of ordinary skill in the art. The definitions provided herein will be useful in understanding certain terms used frequently herein and are not meant to limit the scope of the disclosure.

[0036] As used in the specification and the appended claims, the singular forms "a," "an" and "the" encompass plural referents unless the context clearly dictates otherwise.

[0037] As used in the specification and the appended claims, the term "or" is generally employed in its sense of "and / or" unless the content clearly dictates otherwise. The term "and / or" means one or all of the listed elements or a combination of any two or more of the listed elements.

[0038] As used herein, "have," "having," "include," "including," "contain," "containing," and the like, are used in their open, conventional sense, and generally mean "including, but not limited to." It will be understood that "consisting essentially of," "consisting of," and the like, are subsumed in "comprising" and like phrases. For example, a composition "comprising" silver can be a composition "consisting essentially of" or "consisting of" silver.

[0039] As used herein, "consisting essentially of when in reference to a composition, device, system, method, etc., means that the composition, device, system, method, etc. is limited to the enumerated elements in any other elements that do not materially affect the basic and novel characteristics of the composition, device, system, method, etc.

[0040] The words “preferred” and “preferably” refer to embodiments of the invention that can provide certain benefits under certain circumstances. However, other embodiments can also be preferred under the same or other circumstances. Additionally, the references herein to one or more preferences do not imply that

[0041] Further, herein, ranges of values expressed through endpoints include all values included within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, 5, etc., or 10 or less, including 10, 9.4, 7.6, 5, 4.3, 2.9, 1.62, 0.3, etc.). When a range of values “up to” a certain value is recited, that value is included in the range.

[0042] The use of “first,” “second,” etc. in the above description and claims does not necessarily imply that there are two enumerated quantities. For example, “second” base is merely intended to distinguish from another base, such as “first” base. The use of “first,” “second” in the above description and claims also does not necessarily imply that one precedes the other in time.

[0043] Exemplary articles and techniques according to the present disclosure will be illustrated by the following non-limiting examples.

[0044] Examples

[0045] Table 1. Materials

[0046]

[0047]

[0048] Method

[0049] Method for preparing pastilles: The oil was heated to 80°C, mixed with fumed silica, and placed in a container compatible with a high speed mixer. The sugar alcohol (e.g., xylitol) and other optional ingredients were dissolved in DPBS by heating (80°C) and stirring, then added to the container. The weight % of CaCl2, MgCl2-6H2O, KCl, KH2PO4, NaCl, Na2HPO4-7H2O, and H2O in the table were calculated based on the known amount of DPBS buffer added and the amount of components therein. The solution was cooled to about 40°C and placed in a high speed mixer (FlackTek, Inc. DAC 150.1 FVZ; Landrum, SC) at 3500 rpm for 30 seconds to 1 minute. The mixed solution was then transferred to silicone molds or left in its original high speed mixer container and set at room temperature. The mixed solution was then reheated to 45°C for 5-10 minutes, then returned to room temperature to observe if separation occurred. These pastille samples did not observe significant weight loss due to the low initial water weight.

[0050] Examples 1-3 and Comparative Examples C1 and C2

[0051] Example pastilles 1, 2, and 3, and comparative examples C1 and C2 were prepared according to the following Table 2.

[0052] Table 2 (all amounts are shown in wt%)

[0053]

[0054]

[0055] Figure 1 Photos of the pastilles prepared above are shown. The top row shows Example 3, and Comparative Examples 1 and 2. The bottom row shows Examples 2 and 3 poured after the mixed solution was reheated to 80°C. The pastilles of Example 2 remained homogenized, but Comparative Example 1 had visible xylitol separation in the middle of the pastille even after reheating and pouring.

[0056] Examples 4-8 and Comparative Examples 3-7

[0057] Example pastilles 4-8, and comparative examples 3-7 were prepared according to the following Tables 3 and 4.

[0058] Table 3 (all amounts are provided in wt% based on the total weight of the article)

[0059]

[0060] Table 4 (all amounts are provided in wt% based on the total weight of the article)

[0061]

[0062] Upon inverting the container after high speed mixing, which had undergone a re-heat (45 °C) and cool (room temperature) cycle, it was found that the samples that did not contain fumed silica (Comparative Examples 3-7) had undergone separation and the aqueous phase was trapped at the bottom of the container. When the sample was removed from the container, there was a visible aqueous phase present in Comparative Examples 3-7, but there was no visible aqueous phase present in Examples 4-8.

[0063] Exemplary embodiments include, but are not limited to, the following embodiments:

[0064] An article comprising: 70 to 99 percent by weight of one or more plant-based oils that are solid at 25 °C (room temperature), the weight percent being based on the total weight of the article; and 0.5 to 10 percent by weight of fumed silica, the weight percent being based on the total weight of the article, wherein the article is solid in form and homogenized.

[0065] The article according to any of the above embodiments, wherein the one or more oils that are solid at room temperature are selected from hydrogenated vegetable oils.

[0066] The article according to any of the above embodiments, wherein the one or more oils that are solid at room temperature are present in an amount of 75 to 99 percent by weight based on the total weight of the article.

[0067] The article according to any of the above embodiments, wherein the one or more plant-based oils are present in an amount of 80 to 85 percent by weight based on the total weight of the article.

[0068] The article according to any of the above embodiments, wherein the fumed silica is present in an amount of 1 to 9 percent by weight based on the total weight of the article.

[0069] The article according to any of the above embodiments, wherein the fumed silica is present in an amount of 2 to 8.5 percent by weight based on the total weight of the article.

[0070] The article according to any of the above embodiments, wherein the fumed silica is present in an amount of 4 to 8.5 percent by weight based on the total weight of the article.

[0071] The article according to any of the above embodiments, further comprising water in an amount of 0.5 to 10 percent by weight based on the total weight of the article.

[0072] The article according to any of the above embodiments, further comprising water in an amount of 1 to 8 percent by weight based on the total weight of the article.

[0073] The article of any of the above embodiments, further comprising water in an amount of 2 to 5 wt.%, based on the total weight of the article.

[0074] The article of any of the above embodiments, further comprising a sweetener, a mineral salt, a buffering component, a flavorant, a preservative, a humectant, or a combination thereof.

[0075] The article of any of the above embodiments, further comprising aloe vera, folic acid, hyaluronic acid, ceramides, glycine, arginine, betaine or oxygenated triglycerides, vitamin E, vitamin B12, EDTA, cetylpyridinium chloride , chlorhexidine, other preservatives, or a combination thereof.

[0076] The article of any of the above embodiments, wherein the article comprises 1 to 20 wt.% of a sweetener, based on the total weight of the article.

[0077] The article of any of the above embodiments, wherein the article is in a solid form.

[0078] The article of any of the above embodiments, wherein the article is homogenized.

[0079] The article of any of the above embodiments, wherein the article is in a solid form and homogenized after being subjected to heating to 45°C, followed by high speed mixing at 3500 RPM, and followed by cooling to 25°C.

[0080] The article of any of the above embodiments, wherein the article is in a solid form and homogenized after being subjected to heating to 80°C.

[0081] The article of any of the above embodiments, wherein the article is capable of preventing, inhibiting, disrupting, or any combination thereof, biofilm formation or maintenance in an area in contact with the article.

[0082] The article of any of the above embodiments, wherein the article is capable of affecting hydration loss in an area in contact with the article.

[0083] The article of any of the above embodiments, wherein the article is capable of affecting lubricating ability or lubricity of an area in contact with the article.

[0084] A method of preventing, inhibiting, disrupting, or any combination thereof, biofilm formation or maintenance in oral tissue, the method comprising contacting the oral tissue with any of the above embodiments of the article.

[0085] A method of affecting hydration loss in oral tissue, the method comprising: contacting the oral tissue with any of the above-embodied articles.

[0086] A method of affecting lubrication capacity or lubricity in oral tissue, the method comprising:

[0087] contacting the oral tissue with any of the above-embodied articles.

[0088] A method of affecting the effects of oral dryness, xerostomia, or both, the method comprising contacting the oral tissue with any of the above-embodied articles.

[0089] Accordingly, embodiments of oral compositions and methods of use are disclosed. The above-mentioned embodiments, as well as other embodiments, are within the scope of the following claims. Those skilled in the art will appreciate that the disclosure can be embodied by an embodiment other than the embodiments disclosed. This disclosure is merely illustrative in nature and is not intended to limit the disclosure as to the scope, spirit, and principles thereof.

Claims

1. A lozenge comprising: an oil phase comprising one or more plant-based oils present in an amount of 70% to 99% by weight; an aqueous phase comprising water; and fumed silica present in an amount of 0.5% to 10% by weight, wherein the one or more plant-based oils are solid at 25°C, wherein the tablet is solid and homogenous, and Each weight % is relative to the weight of the tablet.

2. The lozenge according to claim 1, wherein the one or more vegetable-based oils are hydrogenated vegetable oils.

3. The tablet of claim 1, wherein the one or more plant-based oils are present in an amount of 75% to 85% by weight relative to the weight of the tablet.

4. The tablet of claim 1, wherein the fumed silica is present in an amount of 4 to 8.5 weight percent relative to the weight of the tablet.

5. The tablet of claim 1, further comprising water in an amount of 0.5% to 10% by weight relative to the weight of the tablet.

6. The lozenge of claim 1 further comprising a sweetener, a mineral salt, a buffer component, a flavoring agent, a preservative, a wetting agent, or a combination thereof.

7. The lozenge of claim 1, further comprising aloe vera, folic acid, hyaluronic acid, ceramide, glycine, arginine, betaine or oxygenated triglycerides, vitamin E, vitamin B12, EDTA, a preservative, or a combination thereof.

8. The lozenge of claim 1 further comprising cetylpyridinium chloride Chlorhexidine or a combination thereof.

9. The tablet of claim 1, wherein the tablet is solid and homogenous after being subjected to heating to 80°C.

10. The lozenge of claim 1, wherein the lozenge achieves one or more of prevention, inhibition, and disruption of biofilm formation or maintenance in areas in contact with the lozenge.

11. The lozenge of claim 1 , wherein the lozenge reduces hydration loss in areas in contact with the lozenge.

12. The lozenge of claim 1, wherein the lozenge increases the lubricity or lubricity of areas in contact with the lozenge.

13. A lozenge according to any one of claims 1 to 11 for use in the manufacture of a medicament for one or more of preventing, inhibiting or disrupting the formation or maintenance of biofilm in oral tissue.

14. A lozenge according to any one of claims 1 to 11 for use in the manufacture of a medicament for reducing hydration loss in oral tissue.

15. A lozenge according to any one of claims 1 to 11 for use in the manufacture of a medicament for increasing lubricity or lubricity in oral tissue.

16. A lozenge according to any one of claims 1 to 11 for use in the manufacture of a medicament for reducing the effects of xerostomia, dry mouth or both.

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