Oral Care Composition, Method and Kit

Abstract

Compositions for mouthwash without rinsing. The present invention relates to a composition for mouthwash without rinsing to promote gum health, comprising a hyaluronic acid and a gum-strengthening polyol.

Description

"ORAL CARE COMPOSITION, METHOD AND KIT" FIELD OF THE INVENTION

[0001] The present invention relates to a no-rinse oral care composition for promoting the health of a user's gums. In particular, such oral care compositions comprising a hyaluronic acid and a gum-strengthening polyol are useful for providing the user with enhanced barrier / protective function and sensory experience. BACKGROUND OF THE INVENTION

[0002] Gum disease, such as gingivitis and / or periodontitis, causes acute and chronic inflammation of the gums in the oral cavity. Gingivitis is the milder form of the disease. Symptoms of gingivitis may include: bleeding gums; and redness, swelling, or tender gums. If left untreated, gingivitis can progress to periodontitis. With periodontitis, the gums recede from the teeth and form spaces called periodontal pockets that can become infected by pathogenic bacteria. Bacteria are present on the root surfaces of the teeth as biofilms. The bacteria in the biofilms can attack the gingival and underlying alveolar bone that supports the teeth. These attacks can cause serious damage to the soft tissue and bone that supports the teeth. In the later stages of gum disease (i.e., advanced periodontitis), more serious problems of loosening of the teeth and their eventual loss can occur.

[0003] Users with gum problems have typically been limited to brushing their teeth with antibacterial toothpaste as a home remedy. This mechanism Petition 870250052273, dated 06 / 23 / 2025, page 7 / 119 2 / 41 can help clean and control plaque and bacteria and challenge associated toxins in the host. However, due to the limited residence time of brushing, 2 minutes, there is little time to repair, or even strengthen, the host tissue. Consequently, users expect a regimen that can be applied to the host tissue for a longer time and repair, strengthen, and rejuvenate the gums. To meet the expectations of such users, various gel or ointment products that can be applied to the oral cavity have been developed to provide such benefits. For example, a user can apply a gel formulation product to the oral tissue, for example, the gum area, and leave it for some time before spitting or, alternatively, without spitting or rinsing.Desirable products must have sufficient adhesion and viscosity to allow application to the oral cavity, to adhere to oral tissues, and to release the beneficial oral care agents contained therein over an extended period of time. Desirable products are also required to provide enhanced gum health benefits to users (e.g., barrier / protective function benefits or healing of gingival wounds).

[0004] Therefore, there is a continuing need to provide a no-rinse composition that not only has good spreadability and / or adhesion to provide good sensory benefits to users, but also provides desirable benefits for gum health (e.g., barrier protection benefits or healing of gum wounds, etc.) for users. Petition 870250052273, dated 06 / 23 / 2025, page 8 / 119 3 / 41 SUMMARY OF THE INVENTION

[0005] An innovative technology for formulating a no-rinse oral care composition is developed by the inventors to satisfy at least some of the needs described above. In particular, it is a surprising discovery that a no-rinse oral care composition comprising hyaluronic acid and a gum-strengthening polyol provides enhanced gum health benefits for users, especially good protection / barrier function benefits. However, such an oral care composition described here provides users with a desirable sensory impression.

[0006] It is advantageous that the no-rinse oral care composition containing hyaluronic acid and a gum-strengthening polyol can provide users with an enhanced gum health benefit, such as the benefit of protecting the gum barrier.

[0007] Without adhering to any particular theory, it is believed that the no-rinse oral care composition of the present invention, which exhibits enhanced wound healing and barrier function benefits, may in turn help to relieve gingival pain, promote gingival regeneration, accelerate repair of mucosal / gingival damage and healing of wounds with gingival bleeding, and / or improve gingival immunity / resistance. The no-rinse oral care composition may also help to form a protective film over lesions and irritation caused by ill-fitting dentures. The no-rinse oral care composition may also help to repair or heal gingival damage of Petition 870250052273, dated 06 / 23 / 2025, page 9 / 119 4 / 41 post-scaling and root planing or gum grafting gum damage. The no-rinse oral care composition can also help improve mucosal hydration and even help relieve or mitigate dry mouth.

[0008] It is also advantageous for the composition for no-rinse oral care to have an ideal viscosity profile in order to provide good spreadability.

[0009] It is also advantageous that the composition for no-rinse oral care is not heavy, excessively sticky / clumpy and provides users with pleasant experiences, such as a refreshing, safe and effective sensation.

[0010] It is additionally advantageous to provide users with a pleasant mouthfeel and flavor for long-term use, which is recognized as a balancing effect between grip, adhesiveness and viscosity.

[0011] It is also advantageous to apply the no-rinse mouthwash after brushing your teeth, or as the last step in your oral hygiene routine. It is advantageous for the no-rinse mouthwash to be applied to the soft tissues of the mouth, left on for more than 2 minutes, preferably more than 10 minutes, and not removed by rinsing or spitting.

[0012] It is additionally advantageous to apply the no-rinse oral care composition to the gums using an application support, which may include tape, film material, dental tray, aligner, sponge material, applicator or mixtures thereof. Petition 870250052273, dated 06 / 23 / 2025, page 10 / 119 5 / 41

[0013] In one aspect, the present invention relates to an oral care composition comprising a) 30% to 85% by weight of the composition of total water content; b) from about 0.01% to about 10% by weight of the composition of hyaluronic acid or a salt thereof; c) from about 0.1% to about 20% by weight of the composition of a gum-strengthening polyol. Preferably, the oral care composition is substantially free of abrasives. Preferably, the oral care composition is a no-rinse composition. Preferably, the gum-strengthening polyol is selected from the group consisting of trehalose, raffinose, stachyose, verbascose, isomalt, maltitol, lactitol, maltotriitol, maltotetraitol, polyglycytol and combinations thereof. Preferably, the gum-strengthening polyol is present in an amount of about 0.5% to about 18%, preferably about 1% to about 15%, by weight of the composition.

[0014] In another aspect, the present invention relates to an oral care composition comprising a) from about 0.2% to about 2%, by weight of the composition, of hyaluronic acid or a salt thereof; b) from about 0.5% to about 5%, by weight of the composition, of polyacrylic acid; c) from about 0.5% to about 5%, by weight of the composition, of an additional; d) from about 0.5% to about 15%, by weight of the composition, of trehalose; e) from about 30% to about 75%, by weight of the composition, of a total water content; wherein the oral care composition is substantially free of abrasives; and wherein the Petition 870250052273, dated 06 / 23 / 2025, p. 11 / 119 6 / 41 oral care composition is a no-rinse composition in gel form.

[0015] In yet another aspect of the present invention, a method is provided for improving the gum health of an individual using the oral care composition as defined therein, comprising the step of applying the oral care composition to the individual's intraoral tissue, wherein the oral care composition is left unremoved for a period of time from 1 minute to 1000 minutes, preferably from 2 minutes to 200 minutes; optionally, the application step may be conducted as the last step of an oral hygiene regimen.

[0016] In yet another aspect of the present invention, a method is provided for improving the gum health of an individual, comprising at least two steps of: (a) brushing the teeth with a toothpaste, preferably an antibacterial toothpaste, more preferably a toothpaste containing tin, and even more preferably a toothpaste containing a source of stannous ion and an amino acid; and subsequently, preferably immediately followed by (b) applying the oral composition, as defined herein, onto the individual's intraoral tissue, preferably applying it along the gingival margin, sulcus or pockets, in which the oral care composition is left unremoved for a period of time from 1 minute to 1000 minutes.

[0017] In yet another aspect of the present invention, a kit is provided comprising an oral care composition of the present invention and a holder for Petition 870250052273, dated 06 / 23 / 2025, page 12 / 119 7 / 41 application, wherein the application support comprises tape, film material, dental tray, aligner, sponge material, applicator or mixtures thereof. In a preferred example, the kit comprises an oral care composition of the present invention and an applicator having a handle and a head. A kit comprising a toothpaste and the oral care composition of the present invention is also provided. In a preferred example, the kit comprises an antibacterial toothpaste and the oral care composition of the present invention, wherein the toothpaste is preferably a tin-containing toothpaste, more preferably a toothpaste comprising a stannous ion source and an amino acid. Preferably, the toothpaste and the oral care composition are applied separately and sequentially to improve gum health.

[0018] These and other features of the invention will become apparent to those skilled in the art upon review of the detailed description below, taken in conjunction with the accompanying examples. DETAILED DESCRIPTION OF THE INVENTION Definitions

[0019] For use in the present invention, the articles including "a" and "an," when used in a claim, are understood to mean one or more of what is claimed or described.

[0020] The term that includes, as used here, means that steps and ingredients beyond those specifically mentioned may be added. This term encompasses the terms that consists of and that consists of Petition 870250052273, dated 06 / 23 / 2025, page 13 / 119 8 / 41 essentially in. The compositions of the present invention may comprise, consist of, and consist essentially of the essential elements and limitations of the invention described herein, as well as any of the additional or optional ingredients, components, steps, or limitations described herein.

[0021] As used in the present invention, the words preferred, preferably and their variants refer to embodiments of the invention that provide certain benefits under certain circumstances. However, other embodiments may also be preferred under the same circumstances or under different circumstances. Furthermore, the mention of one or more preferred embodiments does not imply that other embodiments are not useful and is not intended to exclude other embodiments from the scope of the invention.

[0022] The term gingival gel or gel for gums, as used herein, means that a product or composition is in gel form intended to be applied primarily to an individual's gums, preferably with more than 50% of the product or composition applied to the gums.

[0023] As used herein, no-rinse means a product or composition that is used or applied to a surface for a certain period of time, for example, more than one minute, preferably more than two minutes. Preferably, a no-rinse gel means a gel product or composition that is intended not to be removed by rinsing or spitting. Petition 870250052273, dated 06 / 23 / 2025, page 14 / 119 9 / 41

[0024] The term gum care means those benefits that aim to relieve one or more symptoms of the early stage of gum disease (i.e., gingivitis), which includes: relief of red, swollen or tender gums; and / or bleeding from the gum trunk.

[0025] The term gum health, for use in the present invention, refers to inherent or promoted benefits of an oral care composition to provide gum treatment benefits that include at least optimizing the healing of gum injuries, as well as providing a further reduction in bacterial activity to mitigate the harmful effects of bacteria when referring to gum disease, including gingivitis, periodontitis or both.

[0026] The term promoter for use in the present invention means to promote and / or enhance the gum health benefits associated with the use of the oral care compositions of the present invention in the oral cavity.

[0027] The term substantially free, as used herein, refers to the presence of not more than 0.05%, preferably not more than 0.01% and, more preferably, not more than 0.001%, of a material indicated in a composition, by total weight of that composition.

[0028] The term essentially free of as used here means that the indicated material is not deliberately added to the composition or, preferably, is not present in analytically detectable amounts. This includes compositions in which the material Petition 870250052273, dated 06 / 23 / 2025, page 15 / 119 The indicated 10 / 41 is present only as an impurity in one of the other deliberately added materials.

[0029] The term oral hygiene regimen or regimen means the use of two or more separate and distinct treatment steps for oral health, for example, toothpaste, mouthwash, dental floss, toothpicks, spray, water irrigator, massager.

[0030] The term total water content, as used herein, means both free water and water that is bound by other components in the oral care composition.

[0031] All percentages, parts and proportions are based on the total weight of the compositions of the present invention, except where otherwise specified. All weights mentioned that refer to ingredients mentioned herein are based on the active content and therefore do not include solvents or by-products that may be included in commercially available materials, except where otherwise indicated.

[0032] All measurements mentioned in this invention are made at 25°C (i.e., room temperature) unless otherwise specified. Oral care compositions

[0033] The oral care composition described in the present invention is configured for application to gingival tissue as well as other soft tissues (e.g., buccal mucosa) within the oral cavity of an individual. It has been surprisingly discovered that an oral care composition that has both optimal viscosity and good adhesion efficacy and Petition 870250052273, dated 06 / 23 / 2025, page 16 / 119 11 / 41 retention provides a better sensory benefit for users, and is also particularly useful for promoting gum health benefits for users.

[0034] The oral care composition described herein is a no-rinse composition. The no-rinse composition is applied to the gingival tissue, for example, the gum line area, and left on for more than 2 minutes, preferably more than 10 minutes. In some examples, the composition is applied to the gingival tissue and left on for more than 15 minutes, or more than 30 minutes, or even more than 60 minutes. Preferably, the composition of the present invention is applied to the gingival tissue without rinsing. Preferably, the no-rinse composition is applied to the gingival tissue as the last step in the oral hygiene regimen. For example, the no-rinse composition of the present invention is applied after brushing the teeth and, optionally, after using mouthwash and / or dental floss.

[0035] In one aspect, the present invention relates to an oral care composition that is in gel form. It is desirable to have a gel for use in the present invention that allows for easy application, the formation of a thin layer, and that spreads evenly in the gingival sulci / pockets and along the gingival line. The oral care composition has a viscosity consistency coefficient K of about 50 Pa-s to about 250 Pa-s, as measured by the rheological test method described herein. Preferably, the oral care composition has a viscosity consistency coefficient K of about 50 Pa-s to about 200 Pa-s, preferably of Petition 870250052273, dated 06 / 23 / 2025, p. 17 / 119 12 / 41 approximately 50 Pa-s to approximately 150 Pa-s, with a preference for approximately 50 Pa-s to approximately 120 Pa-s. This ideal viscosity profile range provides the best sensory experience of spreadability for a user. If a product is too viscous, it would be difficult for a user to spread it evenly over the gingival tissue. If the product has too low a viscosity, it will be too runny and difficult to retain on the appropriate area with the fingers or applicator.

[0036] In one aspect, the oral care composition of the present invention has a desirable mucoadhesive property. Mucoadhesive can be defined as the adhesive interaction between two surfaces where one is at least mucous during a given period through interfacial forces with a consequent decrease in surface energy. Mucoadhesive polymers for oral care applications should ideally (1) readily retain hydrophilic and lipophilic active ingredients and not delay their release; (2) promote penetration and absorption of the active ingredient, (3) adhere as quickly as possible to the biological substrate and be retained for a period of time, (4) be safe, (5) be low cost and (6) provide users with an acceptable application.

[0037] The oral care composition of the present invention has a mucoadhesion index in the range of not less than about 0.6% IF, as measured by the mucoadhesion test method described herein. Preferably, the oral care composition has a mucoadhesion index of at least about 0.8% IF, more preferably at least about 1.0% IF. For example, the composition for Petition 870250052273, dated 06 / 23 / 2025, p. 18 / 119 13 / 41 oral care may have a mucoadhesion index of at least about 1.2% IF, or at least about 1.3% IF, or at least about 1.5% IF, or at least about 1.8% IF, or at least about 2.0% IF. Preferably, the oral care composition may have a mucoadhesion index of less than about 20% IF, preferably less than about 15% IF, and more preferably less than about 10% IF. Hyaluronic acid and salts

[0038] The oral care composition of the present invention comprises hyaluronic acid or a salt thereof. Hyaluronic acid is a polysaccharide present in the connective tissue of vertebrates, a polymer of glucuronic acid and N-acetylglucosamine, and is a member of the glucosamine family with a high molecular weight. Hyaluronic acid (hyaluronan) is an indispensable component of healthy and intact gingiva and oral mucosal tissue. It has many properties that make it a potentially ideal molecule to aid in wound healing by inducing early granulation tissue formation, inhibiting inflammation, promoting epithelial renewal, and also angiogenesis of connective tissue. Preferably, the hyaluronic acid used in the present invention has a weight-average molecular weight (WM) of about 900,000 Daltons to about 5,000,000 Daltons, preferably from about 900,000 Daltons to about 3,000,000 Daltons; more preferably, of about 900.000 Daltons to approximately 2,000,000 Daltons. The molecular weight of hyaluronic acid can be measured using the gel electrophoresis method. The hyaluronic acid of the present invention is present in an amount of 0.01% a. Petition 870250052273, dated 06 / 23 / 2025, page 19 / 119 14 / 41 5.0% by weight of the composition. Preferably, hyaluronic acid is present in an amount of 0.1% to 2%, more preferably 0.2% to 0.8% by weight of the composition. For example, hyaluronic acid is present in an amount of about 0.2%, or about 0.3%, or about 0.4%, or about 0.5%, or about 0.6%, or about 0.7%, or about 0.8%, or about 0.9%, or about 1.0% by weight of the composition. Any hyaluronic acid salt suitable for oral care products may be used in the present invention. Preferably, the hyaluronate salt may be sodium hyaluronate. Polyol for strengthening gums

[0039] The oral care composition of the present invention comprises a gum-strengthening polyol. The applicant has found that gum-strengthening polyols have been shown to further strengthen the barrier function of epithelial cells in the oral cavity.

[0040] The term gum-strengthening polyol may be a sugar alcohol, a disaccharide, a polysaccharide, and preferably a non-reducing sugar. Sugar alcohols are a class of polyols that can be obtained by hydrogenating sugar compounds with the formula (CHOH)nH2, where n is seven or more, such as isomalt, maltitol, lactitol, maltotriitol, maltotetraitol, polyglycitol, or combinations thereof. Preferably, n is from about 7 to about 12. Even more preferably, the gum-strengthening polyol is isomalt, maltitol, lactitol, or combinations thereof. Petition 870250052273, dated 06 / 23 / 2025, page 20 / 119 15 / 41

[0041] Non-reducing sugars are a class of saccharides that do not generate any compounds containing an aldehyde or ketone functional group. Non-reducing sugars are stable in water and do not react with weak oxidizing agents to produce sugar alcohols. Non-reducing sugars cannot donate electrons to other molecules, and are typically a di-, tri-, tetra-, or penta-saccharide, such as sucrose, trehalose, raffinose, stachyose, verbascose, or combinations thereof. Preferably, the gum-strengthening polyol is trehalose. The barrier properties of the gums can be obtained from a mixture of polyols, all having seven or more hydroxyl functional groups.

[0042] The oral care composition may comprise from about 0.025% to about 20%, from about 0.1% to about 18%, from about 0.2% to about 15%, from about 0.5% to about 15%, or from about 1% to about 12%, by weight of the oral care composition, of a gum-strengthening polyol.

[0043] The gum-strengthening property can be characterized by the barrier protection capability as described further in this document. For example, a polyol that exhibits barrier protection of more than 10% at a concentration of 0.5% by weight can be qualified as a gum-strengthening polyol. In other examples, gum-strengthening polyols may include polyols having five or more hydroxyl functional groups provided they can provide the barrier protection capability mentioned above. Petition 870250052273, dated 06 / 23 / 2025, page 21 / 119 16 / 41 Mucoadhesive polymer

[0044] The oral care composition of the present invention comprises polyacrylic acid as a mucoadhesive polymer. Polyacrylic acid polymer (PAA) is a generic term for synthetic polymers of high molecular weight acrylic acid. These can be homopolymers of acrylic acid, crosslinked with an allyl ether pentaerythritol, allyl ether sucrose or allyl ether propylene. And, in an aqueous solution at neutral pH, PAA is an anionic polymer, i.e., many of the PAA side chains lose their protons and acquire a negative charge. This makes the polyelectrolytes of PAAs capable of absorbing and retaining water and swelling many times their original volume. Polyacrylic acid is also called carbomer as a trade name. For example, Carbopol® type polymers, such as Carbopol®, Pemulen® and Noveon®, are acrylic acid polymers crosslinked with polyalkenyl ethers or divinyl glycol.Commercial carbomer codes, such as 940™, indicate the molecular weight and specific components of the polymer.

[0045] Preferably, the polyacrylic acid used in the invention is present in an amount of about 0.1% to about 10% by weight of the oral care composition. For example, polyacrylic acid is present in an amount of about 0.2% to about 5%, or about 0.5% to about 8%, or about 1.0% to about 5% by weight of the oral care composition. Additional polymer

[0046] The oral care compositions of the present invention may comprise an additional polymer. Petition 870250052273, dated 06 / 23 / 2025, p. 22 / 119 17 / 41 Preferably, the oral care composition comprises from about 0.1% to about 10%, preferably from about 0.5% to about 6%, more preferably from about 1% to about 5%, and even more preferably from about 1.3% to about 2.6%, by weight of the composition, of the additional polymer. The additional polymer is selected from natural gum, linear sulfated polysaccharide, anionic cellulose, non-ionic cellulose derivative, poly(vinylpyrrolidine), polymers comprising at least one polycarboxylated ethylene backbone, and combinations thereof.

[0047] Preferably, a natural gum is selected from the group consisting of karaya gum, gum arabic (also known as acacia gum), tragacanth gum, xanthan gum, and combinations thereof. More preferably, the natural gum is xanthan gum. Xanthan gum is a polysaccharide secreted by the bacterium Xanthomonas camestris. Generally, xanthan gum is composed of repeating units of pentasaccharides, comprising glucose, mannose, and glucuronic acid in a molar ratio of 2:2:1, respectively. The chemical formula (of the monomer) is C35H49O29. In one example, xanthan gum is available from CP Kelco Inc. (Okmulgee, USA).

[0048] Preferably, the linear sulfated polysaccharide is a carrageenan. Examples of carrageenan include kappa-carrageenan, iota-carrageenan, lambda-carrageenan, and combinations thereof. In one example, the linear sulfated polysaccharide is iota-carrageenan.

[0049] Preferably, the anionic cellulose is a carboxymethylcellulose (CMC). In one example, the CMC is Petition 870250052273, dated 06 / 23 / 2025, page 23 / 119 18 / 41 prepared from cellulose by treatment with alkali and monochloroacetic acid or its sodium salt. Different varieties are commercially characterized by viscosity. A commercially available example is Aqualon™ brand CMC available from Ashland Special Ingredients (e.g., Aqualon™ 7H3SF; Aqualon™ 9M3SF; Aqualon™ TM9A; Aqualon™ TM12A).

[0050] Preferably, the nonionic cellulose or derivatives thereof have a weight-average molecular weight range of 50,000 Daltons to 1,300,000 Daltons, and preferably a degree of polymerization of 300 to 4,800. More preferably, the nonionic cellulose or derivative thereof is hydroxyethylcellulose (HEC). In other examples, the nonionic cellulose may be hydroxypropylcellulose or hydroxymethylcellulose.

[0051] Preferably, the polymer comprising at least one polycarboxylated ethylene backbone is selected from the group consisting of: maleic anhydride copolymers with methyl vinyl ether having a weight-average molecular weight of 30,000 Daltons to 1,000,000 Daltons; and maleic acid and acrylic or methacrylic acid copolymers.

[0052] In one example, the GANTREZ™ series of polymers are copolymers of maleic anhydride and methyl vinyl ether having a weight-average molecular weight (MW) of about 30,000 Daltons to about 1,000,000 Daltons. These copolymers are available, for example, as GANTREZ™ AN139 (MW 500,000 Daltons), AN119 (MW 250,000 Daltons) and S-97 pharmaceutical grade (MW 70,000 Daltons), from Ashland Chemicals (Kentucky, USA). Petition 870250052273, dated 06 / 23 / 2025, page 24 / 119 19 / 41

[0053] In another example, the ACUSOL™ series and the SOKALAN series of polymers include acrylic acid homopolymers and maleic acid and acrylic or methacrylic acid copolymers. Examples are 0:1000 to 1000:0 copolymers of maleic acid and acrylic acid having a weight-average molecular weight (WM) of about 2,000 to about 1,000,000. These copolymers are commercially available as ACUSOL™ 445 and 44 5N, ACUSOL™ 531, ACUSOL™ 4 63, ACUSOL™ 44 8, ACUSOL™ 460, ACUSOL™ 465, ACUSOL™ 497, ACUSOL™ 490 from Dow Chemicals (Michigan, USA) and as Sokalan® CP 5, Sokalan® CP 7, Sokalan® CP 45 and Sokalan® CP 12 S from BASF (New Jersey, USA).

[0054] In some examples, the ratio between the mucoadhesive polymer and the additional polymer in the oral care composition of the present invention is from about 5:1 to about 1:5, preferably from about 3:1 to about 1:3. For example, the ratio between the polyacrylic acid and the additional polymer in the present oral care composition, by weight, is about 4:1, or about 3:1, or about 2:1, or about 1.5:1, or about 1:1, or about 1:1.5, or about 1:2, or about 1:2.5, or about 1:3, or about 1:4, or about 1:5. Water

[0055] The term acceptable oral vehicle, as used in this document, means a liquid or semi-solid vehicle, such as a paste or gel, that contains the active ingredients of the present invention and releases them into the oral cavity. Water is commonly used as a carrier material in oral compositions due to many benefits. For example, water is useful as an aid to Petition 870250052273, dated 06 / 23 / 2025, p. 25 / 119 20 / 41 processing, is benign to the oral cavity and aids in the rapid foaming of toothpastes. Water can be added as an ingredient itself or can be present as a vehicle in other common raw materials, for example, sorbitol and sodium lauryl sulfate. The term 'total water', for use in the present invention, means the total amount of water present in the oral care composition, whether added separately or as a solvent or vehicle for other raw materials, excluding, however, that which may be present as water of crystallization in certain inorganic salts.

[0056] The oral care compositions of the present invention comprise at least about 30% of a total water content. Preferably, the oral care composition comprises from more than about 35% to about 85% of a total water content. In other embodiments, the compositions include about 40% to about 80%, alternatively about 45% to about 75%, alternatively about 50% to about 70%, alternatively about 50% to about 60%, alternatively about 45% to about 55%, alternatively about 55% to about 65%, alternatively about 65% to about 75%, alternatively combinations thereof, of a water content. total. Abrasive-free

[0057] Preferably, the oral care composition of the present invention is substantially free of abrasives. The term abrasive, for the purpose of the present invention, includes calcium-containing abrasives and abrasives to Petition 870250052273, dated 06 / 23 / 2025, p. 26 / 119 21 / 41 silica base. Preferably, the calcium-containing abrasive can be selected from the group consisting of calcium carbonate, dicalcium phosphate, tricalcium phosphate, calcium orthophosphate, calcium metaphosphate, calcium polyphosphate, calcium oxyapatite, sodium carbonate, and combinations thereof. In one embodiment, the calcium-containing abrasive is calcium carbonate; the calcium carbonate can be selected from the group consisting of ground natural chalk, ground calcium carbonate, precipitated calcium carbonate, and combinations thereof. The silica-based abrasives can generally have an average particle size in the range of 0.1 to 30 µm and, preferably, 5 to 15 µm. The silica-based abrasive can be precipitated silica or silica gels such as the silica xerogels available under the trade name Syloid from WR Grace & Company, Davison Chemical Division, and precipitated silica materials such as those marketed by JMHuber Corporation under the trade name Zeodent®, especially the silicas with the designations Zeodent® 119, Zeodent® 118, Zeodent® 109 and Zeodent® 129.

[0058] Preferably, the oral care composition of the present invention contains low levels of abrasives. For example, the oral care composition may comprise from 0% to about 5%, by weight of the composition, of abrasives, alternatively from 0% to about 3%, alternatively from 0% to 2%, alternatively from 0% to about 1%, alternatively less than about 3%, or less than about 2%, or less than about 1%, or less than about 0.5%, by weight of the composition. Preferably, Petition 870250052273, dated 06 / 23 / 2025, page 27 / 119 22 / 41 The composition is essentially free of abrasives, more preferably free of abrasives. Humectants

[0059] The oral care compositions of the present invention may contain humectants. Humectants serve to prevent the oral care composition from hardening after exposure to air, to impart a moist sensation to the mouth and, in specific humectants, to impart a desirable sweetness of taste.

[0060] Suitable humectants for the present invention include edible polyhydric alcohols such as glycerin, sorbitol, xylitol, butylene glycol, poly(ethylene glycol), propylene glycol, and combinations thereof. In one embodiment, the humectant is selected from sorbitol, glycerin, and combinations thereof. In another embodiment, the humectant is glycerin. In yet another embodiment, the humectant is sorbitol. In one embodiment, the oral care composition comprises from about 1% to less than about 50%, preferably from about 10% to about 40%, by weight of the composition, of humectants. In yet another embodiment, the oral care composition contains from about 15% to about 30%, by weight of the oral care composition, of glycerin.

[0061] In one example, the oral care composition of the present invention is substantially ethanol-free, preferably essentially ethanol-free. Ethanol is undesirable in some cases, as it can cause an irritating sensation for users. Petition 870250052273, dated 06 / 23 / 2025, page 28 / 119 23 / 41 Flavoring

[0062] The oral care compositions of the present invention may include from about 0.001% to about 5%, by weight of the composition, of a flavoring composition, alternatively from about 0.01% to about 4%, alternatively from about 0.1% to about 3%, alternatively from about 0.5% to about 2%, alternatively combinations thereof, of a flavoring composition, by weight of the oral care composition. The term flavoring composition is used in its broadest sense to include flavoring ingredients, sensory elements, sensory element agents, or combinations thereof. Flavoring ingredients may include those described in US Publication No. 2012 / 0082630A1, paragraph 39; and sensory elements or sensory element ingredients may include those described in paragraphs 40 to 45, incorporated herein by reference.

[0063] Examples of flavoring compositions or flavoring ingredients include: peppermint, marjoram, lemon, orange oils, propenyl guaetool, heliotropin, 4-cis-heptenal, diacetyl, methyl-p-tert-butylphenyl acetate, methyl salicylate, ethyl salicylate, 1-menthol acetate, oxanone, α-irisone, methyl cinnamate, ethyl cinnamate, butyl cinnamate, ethyl butyrate, ethyl acetate, methyl anthranilate, isoamyl acetate, isoamyl butyrate, allyl caproate, eugenol, eucalyptol, thymol, cinnamic alcohol, octanol, octanal, decanol, decanal, phenylethyl alcohol, benzyl alcohol, α-terpineol, linalool, limonene, citral, neral, geranial, Petition 870250052273, dated 06 / 23 / 2025, page 29 / 119 24 / 41 geraniol nerol, maltol, ethyl maltol, anethole, dihydroanethole, carvone, menthone, beta-damascenone, ionone, gamma-decalactone, gamma-nonalactone, γ-undecalactone, or combinations thereof. In general, suitable flavoring ingredients are chemicals containing structural features and functional groups that are less prone to redox reactions. These include derivatives of flavoring ingredients that are saturated or contain stable aromatic rings or ester groups.

[0064] Sensory element agents such as cooling, warming, and tingling agents are useful for providing signals to users. The best-known cooling agent is menthol, particularly l-menthol, which is found naturally in peppermint oil. Among synthetic cooling agents, many are derived from or structurally related to menthol, i.e., they contain the cyclohexane moiety and are derived with functional groups including carboxamide, ketal, ester, ether, and alcohol. Examples include p-menthanecarboxamide compounds, such as N-ethyl-p-menthan-3-carboxamide (commercially known as WS-3). An example of a synthetic carboxamide cooling agent that is not structurally related to menthol is N,2,3-trimethyl-2-isopropylbutanamide.Additional examples of synthetic cooling agents include alcohol derivatives such as 31-mentoxypropane-1,2-diol, isopulegol, p-menthane-3,8-diol; menthone glycerin acetal (commercially known as MGA); and menthyl esters such as menthyl acetate, menthyl acetoacetate, menthyl lactate, and monomenthol succinate. Petition 870250052273, dated 06 / 23 / 2025, page 30 / 119 25 / 41

[0065] Additional agents that are not structurally related to menthol but have been reported to have a similar physiological cooling effect include alpha-ketoenamine derivatives described in U.S. Patent No. 6,592,884, including 3-methyl-2-(1-pyrrolidinyl)-2-cyclopenten-1-one (3-MPC), 5-methyl-2-(1-pyrrolidinyl)-2-cyclopenten-1-one (5-MPC); 2,5-dimethyl-4-(1-pyrrolidinyl)3(2H)-furanone (DMPF); cillin (also known as AG-35, chemical name [142-hydroxyphenyl]-4-[2-nitrophenyl]1,2,3,6-tetrahydropyrimidin-2-one).

[0066] Some examples of heating elements include ethanol; nicotinate esters, such as benzyl nicotinate; polyhydric alcohols; nonanoyl vanillylamide; nonanoic acid vanillyl ether; alkyl ether derivatives of vanillyl alcohol, such as ethyl vanillyl ether, butyl vanillyl ether, pentyl vanillyl ether, and hexyl vanillyl ether; alkyl ethers of isovanillyl alcohol; alkyl ethers of ethyl vanillyl alcohol; veratryl alcohol derivatives; substituted benzyl alcohol derivatives; alkyl ethers of substituted benzyl alcohol; vanillin propylene glycol acetal; ethyl vanillin propylene glycol acetal; ginger extract; ginger oil; gingerol; zingerone; or combinations thereof.

[0067] Examples of tingling agents include capsaicin; homocapsaicin, jambu oleoresin, Zanthoxylum peperitum (Japanese pepper), saanshool-I, saanshool II, sanshoamide, piperine, piperidine, spilantol, 4-(1-methoxymethyl)-2-phenyl-1,3-dioxolane or combinations thereof. Petition 870250052273, dated 06 / 23 / 2025, p. 31 / 119 26 / 41

[0068] The oral care compositions of the present invention may additionally include herbal ingredients such as extracts of chamomile, oak bark, lemon balm, rosemary and sage. These, and some of the flavoring components derived from herbs, may be included in amounts just sufficient to provide a flavor contribution or may be added in higher amounts, such as 1% or more, in order to provide a greater therapeutic effect. Preservatives

[0069] The oral care composition of the present invention may comprise preservatives. The preservatives may be benzyl alcohol, phenoxyethanol, sorbitan caprylate (Velsan SC®), 1,2-hexanediol and caprylyl glycol (Symdiol 68®), parabens and / or combinations thereof. The paraben may comprise methylparaben or propylparaben, or a combination thereof. The levels of benzyl alcohol or phenoxyethanol may be present in an amount greater than about 0.10% to about 0.40%, preferably about 0.15% to about 0.30%, more preferably about 0.17% to about 0.23%, alternatively about 0.18% to about 0.22%, alternatively about 0.19% to about 0.21%, alternatively about 0.20%, by weight of the composition. The levels of Velsan C® may be present in an amount of about 0.10% to about 0.50%, preferably about 0.20% to about 0.40%, more preferably alternatively about 0.25% to about 0.30%.The content of Symdiol 68® may be from approximately 0.10% to approximately 0.80%, preferably from approximately 0.10% to approximately. Petition 870250052273, dated 06 / 23 / 2025, p. 32 / 119 27 / 41 of 0.50% and more preferably of about 0.20% to about 0.30%. Paraben contents may be present in the amount of about 0.01% to about 0.11%, preferably from about 0.02% to about 0.10%, preferably from about 0.03% to about 0.09%, by weight, of the total composition. In one embodiment, the composition comprises from about 0.005% to about 0.1%, preferably from about 0.01% to about 0.08% and, alternatively, from about 0.01% to about 0.05%, by weight of the composition, of propylparaben. In another embodiment, the composition comprises from about 0.01% to about 0.1%, preferably from about 0.02% to about 0.07%, or alternatively from about 0.03% to about 0.05%, by weight of the composition, of methylparaben.

[0070] In yet another embodiment, the paraben comprises a combination of methylparaben and propylparaben, and there is a greater ratio between the weight of methylparaben and the weight of propylparaben. In yet another embodiment, the paraben is methylparaben and propylparaben, wherein the ratio between the weight of methylparaben and the weight of propylparaben is from about 5:3 to about 30:3, preferably greater than from about 5:3 to about 20:3, more preferably from about 6:3 to about 15:3.

[0071] In one embodiment, the oral care compositions of the present invention are substantially free of triclosan (i.e., 5-chloro-2-(2,4-dichlorophenoxy)phenol), preferably free of triclosan. Petition 870250052273, dated 06 / 23 / 2025, p. 33 / 119 28 / 41 Sweetener

[0072] The oral care compositions of the present invention may include a sweetening agent. These sweetening agents include saccharin, dextrose, sucrose, lactose, xylitol, maltose, levulose, aspartame, sodium cyclamate, D-tryptophan, dihydrochalcones, acesulfame, sucralose, neotame, and mixtures thereof. The sweetening agents are generally used in the oral care compositions in amounts of 0.005% to about 5%, alternatively from about 0.01% to about 1%, by weight of the composition, alternatively from about 0.1% to about 0.5%, alternatively, combinations thereof. Coloring agents

[0073] The oral care compositions of the present invention may include a coloring agent (i.e., pigments, dyes, and opacifiers). The coloring agent may be in the form of an aqueous solution, preferably 1% coloring agent in a water solution. Titanium dioxide may also be added to the present oral care composition. Titanium dioxide is a white powder that imparts opacity to the oral care compositions. Titanium dioxide generally comprises from about 0.25% to about 5% by weight of the composition. It will be understood that the components selected for the compositions need to be chemically and physically compatible with each other. Anti-tartar agent

[0074] Oral care compositions may include an effective amount of an anti-tartar agent which, in one embodiment, may be present from about 0.05% to about 50%, by weight, of the oral care composition. Petition 870250052273, dated 06 / 23 / 2025, page 34 / 119 29 / 41 buccal, alternatively, from about 0.75% to about 25%, and alternatively, from about 0.1% to about 15%. Non-limiting examples include those described in US Publication No. 2011 / 0104081 A1 in paragraph 64 and those described in US Publication No. 2012 / 0014883 A1 in paragraphs 63 to 68, as well as the references cited therein. One example is a pyrophosphate salt as a source of pyrophosphate ion. In one embodiment, the composition comprises tetrasodium pyrophosphate (TSPP), disodium pyrophosphate, or combinations thereof, preferably having from 0.01% to 2%, more preferably from 0.1% to 1%, by weight of the composition, of the pyrophosphate salt. Without delving into theory, TSPP can provide not only calcium chelation, thus mitigating plaque formation, but can also offer the added benefit of stabilization by monofluorophosphate (in those formulations containing monofluorophosphate). Other ingredients

[0075] The present oral care composition may comprise another oral care active ingredient. For example, the oral care composition may comprise vitamins selected from vitamin C, vitamin E, vitamin B5, and combinations thereof. In the present invention, the term vitamin means said vitamins and all derivatives thereof. The ingredients may provide additional benefits to the oral care composition. The use of extracellular antioxidants, for example, ascorbate or α-tocopherol, as chain-breaking or radical-scavenging antioxidants, helps to control and modulate reactive oxygen species. Petition 870250052273, dated 06 / 23 / 2025, page 35 / 119 30 / 41 intracellular (ROS) that can cause damage to host tissue. The use of dexpanthenol can optimize epithelialization and induce the proliferation phase in wound healing of damaged tissue.

[0076] In some embodiments, the oral care composition may comprise from about 0.1% to about 10%, preferably from about 0.5% to about 8%, or from about 0.5% to about 5%, by weight of the composition, of vitamins selected from vitamin C, vitamin E, vitamin B5, or combinations thereof. The vitamins described in the present invention mean said vitamins and all derivatives thereof.

[0077] The present oral care composition may also include the usual and conventional auxiliary components, such as surfactants, antimicrobial agents, fluoride ions and other ingredients known to those skilled in the art. It will be understood that the components selected for the oral care compositions need to be chemically and physically compatible with each other. Method of use

[0078] The present invention also relates to methods for treating the oral cavity comprising applying to the intraoral tissue (e.g., oral mucosa, gingiva) of an individual's oral cavity, particularly the gingival tissue, leaving it to act for more than 2 minutes, preferably more than 10 minutes, more preferably more than 30 minutes, or more than 60 minutes or more. The method of use of the present invention comprises placing the oral mucosa of an individual (by Petition 870250052273, dated 06 / 23 / 2025, page 36 / 119 31 / 41 example, gingival margin or gingival sulci / pockets) in contact with the oral care composition according to the present invention.

[0079] The present invention further relates to a method for improving the gum health of an individual using the oral care composition described herein, comprising the step of applying the oral care composition to the intraoral tissue of an individual, preferably applying it along the gingival margin or sulcus at least once a day, preferably at least twice a day, more preferably each time immediately after brushing the teeth. The term "immediately" in the present invention means within 1 hour, preferably within 30 minutes, more preferably within 15 minutes, alternatively within 10 minutes. Preferably, the oral care composition may be applied to the intraoral tissue of an individual using an applicator, which applicator has a handle and a head, to spread the oral care composition along the gingival margin or sulcus of the individual.Ideally, the oral care composition is applied to the applicator head before being applied to the intraoral tissue.

[0080] The present invention further relates to a method for improving the gum health of an individual, comprising at least two steps: (a) brushing the teeth with an antibacterial toothpaste, preferably a tin-containing toothpaste, and followed immediately by (b) application of the oral composition, as described. Petition 870250052273, dated 06 / 23 / 2025, page 37 / 119 32 / 41 defined here, on the individual's intraoral tissue, preferably applying it along the gingival margin, sulcus, or pockets. Testing methods Test 1: Rheological test method

[0081] A rheological test method is described for evaluating the viscosity profile (and performed according to the manufacturer's instructions). Viscosity profiles are tested on a TA AR2000 rheometer (available from TA Instruments, Newcastle, USA) using a toothpaste macrorheology test procedure. The geometry used is a 40 mm parallel steel plate with a solvent capture device. The toothpaste is placed on the Peltier plate of the AR2000 rheometer and the gap setting is 1000 microns. The toothpaste macrorheology test consists of voltage sweep oscillation, frequency sweep oscillation, and steady-state flow tests. The main parameter settings are listed: (a) Voltage sweep step: (a) Oscillation voltage (Pa): 0.01 to 500; (b) Frequency (Hz): 1.0; (c) Frequency sweep stage: Frequency (Hz): 0.1 to 10, and controlled oscillation voltage (Pa): 1.5; (d) Steady-state flow stage 1: Shear rate (s-1): 0.01 to 100; and (e) Steady-state flow stage 2: Shear rate (s-1): 100 to 0.01.

[0082] The shear flow test is a viscosity testing method used to measure viscosity at different shear rates. The steady-state flow test is a flow in which the velocity at each point does not vary with time. The three main parameters in this Petition 870250052273, dated 06 / 23 / 2025, page 38 / 119 33 / 41 tests are viscosity, shear rate, and shear stress. The power-law model is a well-known model used to characterize the relationship between viscosity or shear stress and shear rate in the range of shear rates where shear thinning occurs in a non-Newtonian fluid. This quantifies the overall viscosity range and the degree of deviation from Newtonian behavior. The power-law model is described as η = Kγη⁻¹, where η = viscosity and γ = shear rate. K is known as the viscosity consistency coefficient, describing the overall range of viscosities along the portion of the flow curve being modeled. The exponent n is known as the rate index. K and η can be determined by fitting the power-law model. Based on the rate index n, the power-law model describes three basic types of flow: n=1 Newtonian behavior n<1 Shear thinning (or pseudoplastic) n>1 Shear thickening

[0083] The viscosity profiles of the composition of the present invention are represented by the viscosity consistency coefficient K (Pa-s) determined by the power law model fitted with the shear rate range from 0.1 to 10 s-1. Test 2: Mucoadhesion test method

[0084] The mucoadhesion test method is provided. Test samples are labeled with fluorescein isothiocyanate (FITC) at room temperature. Petition 870250052273, dated 06 / 23 / 2025, page 39 / 119 34 / 41 for 1 hour. The resulting solutions are dialyzed in phosphate-buffered saline (PBS) for 48 hours to remove free FITC molecules. Silica pellets are treated with a mixture of ethanol / (3-aminopropyl)triethoxysilane (APTES) / ammonia solution (20:4:1, v / v / v) for 8 hours and are then rinsed with ethanol and water, and dried to obtain amino-functionalized silica pellets (NH2-SW). The NH2SW pellets are incubated in mucin solution for 8 hours at room temperature. Mucin-modified silica pellets are incubated with the test sample in PBS buffer on a shaker at 37 °C for 12 hours with subsequent rinsing with deionized water. Fluorescence images of mucin-modified silica pellets are taken using a fluorescence microscope and used to measure fluorescence intensity (FI) in ImageJ software (National Institutes of Health, USA, (https: / / imagej.nih.gov / ij / )).The percentage of fluorescent intensity (%FI), which is used to describe the mucoadhesion index, is equal to the fluorescent pixels relative to the total pixels in a normalized image field. Therefore, a first test sample having a higher %FI has stronger mucoadhesion compared to a second test sample having a lower %FI. Test 3: Adhesion test method

[0085] The adhesion of the samples is tested using the texture analyzer (TA Plus / 30), Stable Micro System (Surrey, United Kingdom). The procedure is described below: Petition 870250052273, dated 06 / 23 / 2025, page 40 / 119 35 / 41 1. Sample preparation: Pour the gel or ointment sample from the packaging in the amount of '0.03 ± 0.005 g' onto the test plate. 2. Perform the TA sequence to enable the instrument's action: the probe is compressed in each sample, following the predetermined programmed sequence (speed of 10 mm / s, force of 5 g for stage 2; speed of 1 mm / s, force of 200 g for stage 4 and the time is 1 s for stage 5). 3. Instrument and accessory configuration: 3.1 Try the test with the available probe options: round metal plate 3.2 Configuring TA as 'compression' 4. All analyses must be performed on 5 replicates. 5. Measurement: Adhesiveness: the work required to overcome the attractive forces between the sample surface and the probe surface. 6. Data calculation: Increase the advantage of macro-analysis of programmed TTA data (e.g., Force 5 g).

[0086] The adhesion values ​​(unit: gf*s) describe the energy required to overcome the attractive forces between the sample surface and the probe surface. Examples

[0087] The following examples and descriptions clarify in more detail the embodiments within the scope of the present invention. These examples are provided Petition 870250052273, dated 06 / 23 / 2025, p. 41 / 119 36 / 41 are for illustrative purposes only and should not be considered a limitation of the present invention, since many variations thereof are possible without departing from its character and scope. Example 1: Examples A and B

[0088] Examples A and B are the no-rinse oral care gel compositions shown in Table 1 below with the amounts of the components described as a weight percentage (%, by weight). These Examples are prepared according to conventional methods. Example A is a comparative gel composition containing sodium hyaluronate (as a source of hyaluronic acid), but without trehalose. Example B is a gel composition of the invention containing sodium hyaluronate and 10%, by weight, trehalose. Table 1: Examples A to B -- Gel compositions Ingredients Quantity (% by weight) Example Example of the comparative invention A B Glycerin 20 20 Propylparaben 0.03 0.03 Xylitol 2 2 Sodium saccharin 0.1 0.1 Sodium hydroxide (50% by weight) 0.9 0.9 PEG 300 0.5 0.5 Carbomer 1.5 1.5 PVPK90 1.5 1.5 Sodium hyaluronate 0.526 0.526 Petition 870250052273, dated 06 / 23 / 2025, page 42 / 119 37 / 41 Trehalose 0.10 Panthenol (powder) 0.5 0.5 Tocopherol acetate 0.5 0.5 Sodium ascorbyl phosphate 0.91 0.91 Sodium pyrophosphate 0.5 0.5 Preservatives 0.15 0.15 Flavoring 1.03 1.03 Water and secondary ingredients (e.g., coloring agent) QSQS Total 100 100 * Sodium hyaluronate with a weight-average molecular weight of ~1,400,000 From the. Example 2: Barrier protection test

[0089] The barrier protection test is described here. This test evaluates the barrier protection capacity of a no-rinse oral care composition using capsaicin to treat a cell coated with the sample. Cell culture:

[0090] Human Gingival Epithelial Cells (HGE) were maintained in an incubator at 37 °C with 5% CO2 saturation. Add 10% by weight of fetal calf serum and 1% by weight of penicillin-streptomycin to Dulbecco's Modified Eagle Medium (DMEM, Gibco) to produce the complete culture medium for these cells, which is changed every 2 to 3 days. Petition 870250052273, dated 06 / 23 / 2025, page 43 / 119 38 / 41 Analysis of barrier protection using a real-time cell analyzer (RTCA):

[0091] The xCELLigence RTCA DP real-time cell analyzer (RTCA) (ACEA Bioscience Inc., San Diego, CA, USA), based on impedance measurement, is used to monitor sample barrier protection. 50 pL of complete culture medium is added to E-plates to obtain background readings, followed by the addition of 100 pL of cell suspension. E-plates containing 28,000 cells / well are incubated at 37 °C with 5% CO2 for 22 to 24 hours, until the cells are confluent. The culture medium is changed to DMEM or DMEM with a 50-fold diluted sample (sample information is as per Table 2 below) and incubated at 37 °C, 5% CO2 for 2 h. The barrier disruptor (capsaicin up to a final concentration of 75 pM in this case) is added to the wells of the electronic plate. The impedance is reflected as a cellular index (CI) and recorded continuously for 16 to 24 h, and reported as a CI curve. Table 2: Sample information: Sample Name Details HA (%, by weight) Trehalose (%, by weight) Preservative System Polymer System C (Control) Trehalose Solution — 10 — — D (Comparative) Example A 0.5 — same quantity E (Of the invention) Example B 0.5 10 Petition 870250052273, dated 06 / 23 / 2025, page 44 / 119 39 / 41

[0092] The IC curve is normalized at the time point just before the addition of the samples. The normalized IC at 3 hours, after the addition of the barrier disruptor, is compared to the blank control and recorded. The percentage of barrier protection is calculated using the formula below.

[0093] Percentage of barrier protection = (Normalized CI of the sample - Normalized CI of capsaicin) / Normalized CI of the blank. Table 3: Barrier protection results Sample (diluted) Percentage of barrier protection Control capsaicin (75 uM) 0% C (Control) 0% D (Comparative) 22% E (Of the invention) 67%

[0094] The results in Table 3 show that Sample C (i.e., a trehalose-only control with a final concentration of 0.2% by weight) does not show any barrier protection compared to the capsaicin control (i.e., barrier switch). Sample D (i.e., Comparative Example A containing hyaluronic acid but without trehalose) exhibits some level of barrier protection at 22%. Notably, Sample E (i.e., Example of the invention B), which contains both hyaluronic acid and trehalose, exhibits significant barrier protection at 67%, which is more than three times higher than that of Sample D. These results show that Petition 870250052273, dated 06 / 23 / 2025, page 45 / 119 40 / 41 significantly incremental barrier protection by those no-rinse oral care compositions combining hyaluronic acid and gum-strengthening polyol such as trehalose.

[0095] The dimensions and values ​​disclosed herein should not be understood as being strictly limited to the exact numerical values ​​mentioned. Instead, except where otherwise specified, each of these dimensions is intended to mean either the value mentioned or a range of functionally equivalent values ​​around that value. For example, a dimension disclosed as 40 mm should mean approximately 40 mm.

[0096] Each document cited in the present invention, including any patent or patent application referenced or related, and any patent application or patent in which the present application claims priority or benefit thereof, is hereby incorporated in its entirety herein by reference, except where expressly excluded or otherwise limited. Reference to any document is not an admission that it constitutes prior art with respect to any invention disclosed or claimed herein, nor that it, by itself or in any combination with any other reference or references, teaches, suggests or discloses such invention. Furthermore, if there is a conflict between any meaning or definition of a term mentioned herein and any meaning or definition of the same term in a document incorporated by reference, it shall be considered a conflict. Petition 870250052273, dated 06 / 23 / 2025, p. 46 / 119 41 / 41 precedes the meaning or definition assigned to this term in this document.

[0097] Although specific embodiments of the present invention have been illustrated and described, it will be evident to those skilled in the art that various other alterations and modifications can be made without departing from the spirit and scope of the invention. Therefore, it is intended to cover in the appended claims all such alterations and modifications that fall within the scope of the present invention.

Claims

CLAIMS 1. Oral care composition, characterized in that it comprises: a) 30% to 85% by weight of the composition of a total water content; b) 0.01% to 10% by weight of the composition of hyaluronic acid or a salt thereof; and c) 0.5% to 20% by weight of the composition of a gum-strengthening polyol, wherein the gum-strengthening polyol comprises trehalose; wherein the oral care composition is substantially free of abrasives; and wherein the oral care composition is a no-rinse composition.

2. Oral care composition according to claim 1, characterized in that the gum-strengthening polyol further comprises raffinose, stachyose, verbascose, isomalt, maltitol, lactitol, maltotriitol, maltotetraitol, polyglycytol, or combinations thereof.

3. Oral care composition according to claim 2, characterized in that the gum-strengthening polyol comprises isomalt.

4. Oral care composition according to claim 1, characterized in that it further comprises, from 0.1% to 10% by weight of the composition, a polyacrylic acid.

5. Oral care composition, according to claim 1, characterized in that the hyaluronic acid has a weight-average molecular weight of Petition 870250052273, dated 06 / 23 / 2025, page 90 / 119 2 / 4 900,000 Daltons to 5,000,000 Daltons.

6. Oral care composition, according to claim 1, characterized in that it further comprises an additional polymer selected from the group consisting of xanthan gum, carrageenan, carboxymethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxymethylcellulose, hydroxypropylcellulose, hydroxymethylcellulose, poly(vinylpyrrolidine), maleic anhydride copolymers with methyl vinyl ether having a weight-average molecular weight of 30,000 to 1,000,000 Daltons, and combinations thereof.

7. Oral care composition according to claim 1, characterized in that the total water content is 40% to 80% by weight of the composition.

8. Oral care composition according to claim 1, characterized in that it further comprises a humectant selected from the group consisting of glycerin, sorbitol, xylitol, erythritol, butylene glycol, polyethylene glycol, propylene glycol and combinations thereof.

9. Oral care composition according to claim 1, characterized in that the oral care composition is substantially free of ethanol.

10. Oral care composition according to claim 1, characterized in that it further comprises a vitamin selected from the group consisting of vitamin C, vitamin E, vitamin B5 and combinations thereof.

11. Oral care composition, according to claim 1, characterized in that the gum-strengthening polyol Petition 870250052273, dated 06 / 23 / 2025, page 91 / 119 3 / 4 is present in an amount of about 0.5% to about 18% by weight of the composition.

12. Oral care composition, according to claim 1, characterized in that hyaluronic acid is present in an amount of about 0.1% to about 5.0%, by weight, of the composition.

13. Oral care composition according to claim 6, characterized in that the additional polymer is present in an amount of about 0.1% to about 10% by weight of the composition.

14. Oral care composition according to claim 8, characterized in that the humectant is present in an amount of about 1% to about 50% by weight of the composition.

15. A method for improving the gum health of an individual, characterized in that it comprises the step of applying the oral care composition, as defined in claim 1, to the individual's intraoral tissue, and leaving the oral care composition on the intraoral tissue for a period of time from 1 minute to 1000 minutes; and optionally, wherein the application step may be conducted as the last step of an oral hygiene regimen.

16. Method according to claim 15, characterized in that the oral care composition is applied to the individual's intraoral tissue with an applicator comprising a handle and a head for spreading the oral care composition on the individual's intraoral tissue.

17. Method for improving the gum health of an individual characterized in that it comprises the steps of: (a) brushing the individual's teeth with an antibacterial toothpaste; and (b) subsequently applying the oral care composition, as defined in claim 1, to the individual's intraoral tissue and leaving the oral care composition on for a period of 2 minutes.

18. Method, according to claim 17, characterized in that the composition is applied to the intraoral tissue of the individual with an applicator comprising a handle and a head for spreading the oral care composition onto the intraoral tissue of the individual.

19. Kit characterized in that it comprises a toothpaste and an oral care composition, as defined in claim 1.

20. Kit characterized in that it comprises an oral care composition, as defined in claim 1, and an application support, wherein the application support comprises tape, film material, dental tray, aligner, sponge material, applicator, or mixtures thereof.