Oral treatment compositions to promote gum health.

Description

1 / 42 “COMPOSITION FOR ORAL TREATMENT AND USE FIELD OF THE INVENTION

[0001] The present invention relates to oral treatment compositions comprising a source of stannous ions and a taurate surfactant together with an amphoteric surfactant (e.g., betaines) to promote the oral health of a user's gums. In particular, such oral treatment compositions are useful for controlling plaque bacteria and / or protecting against bacterial / toxin invasion. BACKGROUND OF THE INVENTION

[0002] Dental plaque (also known as dental biofilm) is a sticky, colorless deposit of bacteria that constantly forms on the tooth surface. Dental plaque is generally composed of bacteria and extracellular polymeric substances (EPS). EPS are biopolymers of microbial origin in which biofilm microorganisms are embedded. J. Bacteriol. 2007, 189(22):7945. Saliva, food, and fluids combine to produce these deposits, which accumulate where teeth and gums meet. Plaque buildup is a major factor in poor oral health, which can lead to cavities and periodontal disease (in the gums), including gingivitis.One of the ways in which toothpaste compositions help prevent and control plaque is through the advantageous use of antibacterial agents; however, the disadvantage and challenge of the formulation is the unintentional reactivity of antibacterial agents with formulation ingredients. This can include oxidative degradation. Petition 870260028317, dated 03 / 26 / 2026, page 5 / 100 2 / 42 hydrolysis, adsorption or precipitation of oxyhydroxide species, any of which may affect the bioavailability of the antibacterial agent.

[0003] Sodium lauryl sulfate (SLS) is widely used in toothpaste formulations, offering benefits such as broad compatibility with other ingredients, a neutral taste, and good foaming properties. However, there is ongoing consumer interest in the development of oral care products that do not contain sodium lauryl sulfate. One concern has been that SLS may be a potential source of irritation, scaling, and epithelial barrier dysfunction in the gingiva. Having a strong gingival epithelial barrier function means the gingiva acts as a physical barrier separating biofilm from gingival tissue, providing the first line of defense against bacterial invasion in gingivitis or periodontal disease. Stannous fluoride has a bactericidal and bacteriostatic effect on plaque bacteria.It has also been shown to reduce the virulence of bacterial endotoxin biofilms, such as lipopolysaccharide (LPS) and lipoteichoic acid (LTA), which are associated with the initiation of inflammatory processes involved in periodontal disease and the disruption of epithelial barrier function. Brushing with stannous fluoride toothpaste leads to a reduction in gingivitis and, as a result, to the restoration of barrier function, making the gum tissue more resistant to bacterial attack.

[0004] Thus, there is a continuing need to provide enhanced stannous and fluoride-containing products to help control plaque bacteria on teeth and / or Petition 870260028317, dated 03 / 26 / 2026, p. 6 / 100 3 / 42 protect against the invasion of bacteria / toxins, which do not contain sodium lauryl sulfate, but nevertheless have adequate stability and aesthetics and do not irritate or compromise the gingival epithelium. SUMMARY OF THE INVENTION

[0005] The present invention relates to a composition for oral treatment, comprising: (a) from 0.01% to 5%, by weight of the composition, of a source of stannous ions; (b) from 0.1% to 5%, by weight of the composition, of a taurate surfactant represented by formula (I): OR, II r R, C—N—CH2—CH2—SO3-M+, (I) where Ri is a saturated or unsaturated alkyl chain, linear or branched with 6 to 18 C atoms; R2 is H or methyl, and M is H, sodium or potassium; and, (c) from 0.01% to 5%, by weight, of the composition of an amphoteric surfactant.

[0006] Significant disruption and destabilization of dental biofilm can be achieved by an aqueous oral treatment composition comprising a stannous ion source and a taurate surfactant along with an amphoteric surfactant, for example, betaines. An advantage of the present invention is the optimized deep penetration into the biofilm and / or extermination of bacteria. For this purpose, it has surprisingly been found that the penetration depth and / or penetration rate of Petition 870260028317, dated 03 / 26 / 2026, p. 7 / 100 4 / 42 Stannous ions in biofilms can be increased when combined with taurate. In summary, the synergistic combination of taurate, betaines, and the stannous ion source in the oral treatment composition may be such that an optimization of gum health benefits is achieved.

[0007] It is an advantage of the present invention to provide effective antibacterial properties by combining stannous with taurate surfactant and an amphoteric surfactant. It is a further advantage of the present invention to provide oral treatment compositions with improved deposition / penetration of Sn ions into the biofilm, as well as to provide impact toxin neutralization of HGE healing recovery.

[0008] Another advantage is that the oral treatment composition is a toothpaste and, preferably, provides pleasant sensory experiences, such as taste, foam, and mouthfeel.

[0009] It is also an additional advantage that the oral treatment composition exhibits good stability over a wide pH range. Another advantage is that the oral treatment compositions have physical and chemical stability over a range of manufacturing, handling, and storage conditions. Another advantage is that the oral treatment compositions have stable product quality (e.g., consistent visual appearance and no discoloration, etc.) even after three months of storage at 40 °C. Another advantage is that the oral treatment compositions of the present invention minimize the use of antibacterial agents. Petition 870260028317, dated 03 / 26 / 2026, page 8 / 100 5 / 42

[0010] Another additional advantage is that the oral treatment compositions of the present invention use a combination of taurate and betaine surfactants to reduce and / or eliminate the instability and / or discoloration problems of conventional tin-containing toothpastes, as described above. It is also a further advantage that the oral treatment composition of the present invention surprisingly provides an improved sensory profile and / or reduces potential astringency during and after brushing.

[0011] The present invention further encompasses a method for treating dental biofilm comprising the step of brushing teeth with an oral treatment composition of the present invention.

[0012] The invention further provides a method for preventing or mitigating plaque formation on dental enamel comprising the step of brushing teeth with an oral care composition of the present invention. DETAILED DESCRIPTION OF THE INVENTION Definitions

[0013] For use in the present invention, the indefinite articles "a" and "an," when used in a claim, are understood to mean one or more of the items claimed or described.

[0014] The terms relieve and relieving are used interchangeably and mean to minimize, avoid, delay and / or treat at least one symptom of gum disease to produce a positive change (i.e., a benefit) for the user. Petition 870260028317, dated 03 / 26 / 2026, page 9 / 100 6 / 42

[0015] The term biofilms for use in the present invention means a bacterial population embedded in a matrix that adheres to each other and / or to surfaces or interfaces in the oral cavity.

[0016] The term comprising, as used herein, means that steps and ingredients beyond those specifically mentioned may be added. This term encompasses the terms consisting of and essentially consisting of. The compositions of the present invention may comprise, consist of, and essentially consist 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.

[0017] The term oral care composition or oral care compositions for use in the present invention refers to a product that, in its normal use, is retained in the oral cavity for a sufficient time to come into contact with some or all of the dental surfaces and / or oral tissues for purposes of oral activity. In one example, the composition provides a gum care benefit when used in the oral cavity. The oral care composition of the present invention may be in various forms, including toothpaste, dentifrice, dental gel, dental powders, tablets, mouthwash, mouth rinse, subgingival gel, foam, mousse, chewing gum, lipstick, sponge, dental floss, prophylactic paste, petrolatum gel, denture adhesive or denture product. In one example, the oral composition exists in the form of a paste or gel. In another example, the oral composition exists in the form of a Petition 870260028317, dated 03 / 26 / 2026, page 10 / 100 7 / 42 toothpaste form. The mouthwash composition can also be incorporated into strips or films for direct application or fixation to oral surfaces, or incorporated into dental floss.

[0018] As used in the present invention, the term dentifrice means paste, gel, powder, tablets or liquid formulations, except where otherwise specified, that are used to clean the surfaces of the oral cavity. Preferably, the dentifrice compositions of the present invention are single-phase compositions, although the compositions may be two-phase or multi-phase compositions. An example of a dentifrice composition is toothpaste (for brushing teeth). The term teeth, as used in the present invention, refers to natural teeth as well as artificial teeth or dental prostheses.

[0019] The term partially soluble or partially soluble in water, as used herein, means that a compound has a solubility of 1 g / 1,000 ml or more in water at 25°C. The term insoluble, as used herein, means that a compound has a solubility of less than 0.1 g / 1,000 ml at 25°C.

[0020] The term effective amount, as used in the present invention, refers to an amount of a compound or composition sufficient to induce a positive benefit, or an oral health benefit, and / or an amount low enough to avoid serious side effects, that is, to provide an adequate benefit-risk ratio, within the good judgment of one skilled in the art. In one example, effective amount means at least 0.01% of the material, by weight of the composition, and alternatively, at least 0.1%. Petition 870260028317, dated 03 / 26 / 2026, page 11 / 100 8 / 42

[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 substantially free, as used herein, refers to an unintentional amount of that material that is added to the composition or an amount of a material that is less than 0.05%, 0.01% or 0.001% of the composition. The term essentially free of, as used herein, 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 indicated material is present only as an impurity of one of the other deliberately added materials. The term free, for use in the present invention, refers to the fact that no reasonably detectable amount of that material is present in the composition.

[0023] 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.

[0024] All percentages, parts and ratios are based on the total weight of the compositions of the present invention, except where otherwise specified. All weights Petition 870260028317, dated 03 / 26 / 2026, page 12 / 100 9 / 42 of the ingredients mentioned herein are based on the active ingredient content and therefore do not include solvents or by-products that may be included in commercially available materials, except where otherwise indicated. The term percentage by weight may be denoted as % by weight in this document. All molecular weights, as used in this document, are weight-average molecular weights expressed in grams / mol, except where otherwise specified.

[0025] All measurements mentioned in the present invention are made at 25°C (i.e., room temperature) unless otherwise specified. Oral treatment compositions

[0026] It has been surprisingly discovered that the combination of stannous ion (i.e., an antibacterial agent) and an amino acid-based taurate surfactant, along with an amphoteric surfactant, in a composition for oral treatment is particularly useful for controlling plaque bacteria and maintaining the integrity and barrier function of the gums, i.e., promoting gum health benefits for users. In particular, the surprising finding was that the penetration of stannous ions into biofilms is markedly optimized when combined with taurate and betaines. Without wanting to get bogged down in theory, the taurate surfactant is derived from an amino acid containing carboxylic and amine groups. It is believed that stannous ions can bind strongly to these chemical portions of the amino acid to positively influence the penetration of stannous ions into biofilms.

[0027] It was also surprisingly discovered that the depth of penetration and / or rate of penetration Petition 870260028317, dated 03 / 26 / 2026, p. 13 / 100 10 / 42 of stannous ions in biofilms can be increased, or markedly increased, when formulated with taurate surfactant, compared to other anionic surfactants such as SLS. In short, the presence of taurate and betaine surfactants in combination with a source of stannous ions in the composition aids in the effectiveness of the composition in mediating the harmful effects of bacteria in gingival biofilms.

[0028] In one aspect, the present invention is directed to a composition for oral treatment comprising: (a) from 0.01% to 5%, by weight of the composition, of a source of stannous ions; (b) from 0.1% to 5%, by weight of the composition, of a taurate surfactant represented by formula (I) o r2 II I Rj--C—N—CH2—CH2—SO3-M+, (D where Ri is a saturated or unsaturated alkyl chain, linear or branched, with 6 to 18 carbon atoms; R2 is H or methyl, and M is H, sodium or potassium; and, (c) from 0.01% to 5%, by weight, of the composition of an amphoteric surfactant. Source of stannous ions

[0029] The present invention relates to the oral treatment compositions mentioned above which comprise, in a preferred example, the stannous ion source present in an amount of 0.01% to 5%, preferably 0.05% to 4%, or more preferably 0.1% to 2%, by weight of the composition, for Petition 870260028317, dated 03 / 26 / 2026, p. 14 / 100 11 / 42 provide antibacterial efficacy. The stannous ion source used in the present invention may include any safe and effective stannous salt. Suitable examples of stannous ion sources are selected from soluble stannous salts and, preferably, selected from the group consisting of stannous chloride, stannous fluoride, stannous acetate, stannous gluconate, stannous oxalate, stannous sulfate, stannous lactate, stannous tartrate, stannous iodide, stannous chlorofluoride, stannous hexafluorozirconate, stannous citrate, stannous malate, stannous glycinate, stannous carbonate, stannous phosphate, stannous pyrophosphate, stannous metaphosphate and combinations thereof; preferably, the stannous ion source is selected from stannous chloride, stannous fluoride, or a combination thereof.

[0030] In a preferred example, the stannous ion source comprises stannous chloride. In another preferred example, the stannous ion source comprises stannous fluoride. In a particularly preferred example, the stannous ion source comprises a combination of stannous fluoride and stannous chloride.

[0031] In some examples, the oral treatment composition of the present invention is substantially free of stannous oxide from an insoluble stannous ion source, preferably essentially free of stannous oxide, more preferably free of stannous oxide. Surfactant taurate

[0032] The oral treatment composition of the present invention contains a taurate surfactant as the main surfactant. Taurate is represented by formula (I): Petition 870260028317, dated 03 / 26 / 2026, page 15 / 100 12 / 42 R2 II I Rj C—N—CH2—CH2—SO3-M+, (I) wherein Ri is a saturated or unsaturated alkyl chain, linear or branched with 6 to 18 C atoms; R2 is H or methyl, and M is H, sodium or potassium.

[0033] Preferably, Ri is a saturated or unsaturated, linear or branched alkyl chain with 8 to 18 C atoms. Optionally, but preferably, the taurate surfactant of the present invention comprises one or more selected from the group consisting of potassium cocoyl taurate, potassium methyl cocoyl taurate, sodium methyl caproyl taurate, sodium cocoyl taurate, sodium lauroyl taurate, sodium methyl cocoyl taurate, sodium methyl lauroyl taurate, sodium methyl myristoyl taurate, sodium methyl oleoyl taurate and combinations thereof. Secondary surfactant

[0034] The oral treatment compositions in this document may include a secondary surfactant, other than the surfactant Taurate. Preferably, the secondary surfactant is an amphoteric surfactant, for example, selected from the group consisting of betaine surfactants. The composition may include a secondary surfactant in a content of about 0.01% to about 10%, about 0.025% to about 9%, about 0.05% to about 5%, about 0.1% to about 2.5%, about 0.5% to about 2%, or about 0.1% to about 1%, by weight, of the composition. Non-limiting examples of the amphoteric surfactant may be a betaine or a sultaine selected from the group consisting of: almondamidopropyl Petition 870260028317, dated 03 / 26 / 2026, p. 16 / 100 13 / 42 betaine, apricotamidopropyl betaine, avocadamidopropyl betaine, babassuamidopropyl betaine, behenamidopropyl betaine, canolamidopropyl betaine, capryl / capramidopropyl betaine, cocoamidopropyl betaine, coco / oleamidopropyl betaine, coco / girassolamidopropyl betaine, cupuassuamidopropyl betaine, isostearamidopropyl betaine, lauramidopropyl betaine, meadowfoamamidopropyl betaine, milkamidopropyl betaine, visionamidopropyl betaine, myristamidopropyl betaine, oatamidopropyl betaine, oleamidopropyl betaine, olivamidopropyl betaine, palmamidopropyl betaine, palmitamidopropyl betaine, almond palmamidopropyl betaine, ricinoleamidopropyl betaine, sesameamidopropyl betaine, shea butteramidopropyl betaine, sojaamidopropyl betaine, stearamidopropyl betaine, seboamidopropyl betaine, undecyleneamidopropyl betaine, wheat germamidopropyl betaine, cocamidopropyl hydroxysultain (CAPHS), lauramidopropyl hydroxysultain (LAPHS), oleamidopropyl hydroxysultain (OAPHS),seboamidopropyl hydroxysultain (TAPHS), and combinations thereof, preferably selected from the group consisting of cocoamidopropyl betaine, lauramidopropyl betaine, oleamidopropyl betaine, seboamidopropyl betaine, cocamidopropyl hydroxysultain and combinations thereof; and more preferably, selected from cocoamidopropyl betaine, lauramidopropyl betaine or a combination thereof.

[0035] In one aspect, the composition of the present invention is substantially free of sodium lauryl sulfate (SLS). Preferably, the composition of the present invention is essentially free of, more preferably free of, sodium lauryl sulfate (SLS). Without wanting to get bogged down in Petition 870260028317, dated 03 / 26 / 2026, page 17 / 100 14 / 42 theory, such an approach may provide an improvement in the consumer's sensory experience, reducing irritation of the oral tissue. Free from sources of insoluble zinc ions.

[0036] Preferably, the oral treatment composition of the present invention is substantially free of, preferably essentially free of, more preferably free of any insoluble or moderately soluble zinc compounds. Insoluble or moderately soluble zinc compounds, such as zinc oxide, zinc phosphate, or zinc carbonate, are not suitable as a source of zinc for the oral composition of the present invention.

[0037] In some embodiments, the oral treatment composition of the present invention may comprise from 0% to 2% of a soluble or partially soluble zinc ion source, such as zinc citrate, zinc chloride, zinc sulfate, zinc gluconate, zinc lactate, and combinations thereof. In some examples, the oral treatment composition comprises from 0.2% to 2% of a soluble or partially soluble zinc ion source. In some other examples, the oral treatment composition is substantially free of any zinc ion source, preferably free of any zinc ion source. Source of fluoride ions

[0038] The compositions may optionally, but preferably, include an effective amount of an anticaries agent, such as a source of fluoride ions. The fluoride ion may be present in a sufficient amount to result in a fluoride ion concentration in the composition at 25 °C and / or, in one embodiment, may be used in levels Petition 870260028317, dated 03 / 26 / 2026, page 18 / 100 15 / 42 of about 0.0025% to about 5%, by weight, of the composition, preferably from about 0.005% to about 2.0%, preferably from 0.5% to about 1.5%, by weight, of the composition, to provide anticaries efficacy. Representative sources of fluoride ions include stannous fluoride, sodium fluoride, potassium fluoride, sodium monofluorophosphate, or mixtures thereof. In one aspect, the oral treatment compositions of the present invention may have a dual source of fluoride ions, specifically sodium monofluorophosphate and an alkali metal fluoride. Alternatively, the oral treatment compositions of the present invention may contain a dual source of fluoride ions that is a combination of stannous fluoride and sodium fluoride. Without delving into theory, such an approach may provide an enhancement in average fluoride absorption.

[0039] In some preferred examples, the source of fluoride ions is selected from stannous fluoride, sodium monofluorophosphate, sodium fluoride, or combinations thereof.

[0040] In one aspect, the oral treatment composition of the present invention does not contain amine fluoride (also called olaflur) due to regulatory restrictions in some regions. Abrasive containing calcium

[0041] The compositions of the present invention may optionally, and in some respects preferably, comprise from about 5% to about 50%, preferably from about 10% to about 50%, by weight of the composition, of a calcium-containing abrasive, wherein the calcium-containing abrasive is preferably selected from the group consisting of Petition 870260028317, dated 03 / 26 / 2026, page 19 / 100 16 / 42 in calcium carbonate, calcium glycerophosphate, dicalcium phosphate, tricalcium phosphate, calcium orthophosphate, calcium metaphosphate, calcium polyphosphate, calcium oxyapatite, sodium carbonate and mixtures thereof; wherein, more preferably, the calcium-containing abrasive is calcium carbonate. Preferably, the composition comprises from about 15% to about 50%, preferably from about 15% to about 40%, preferably from about 15% to about 25%, by weight, of the composition, of a calcium-containing abrasive.

[0042] Preferably, the abrasive containing calcium is calcium carbonate. More preferably, the abrasive containing calcium is selected from the group consisting of finely ground natural chalk, ground calcium carbonate, precipitated calcium carbonate, and combinations thereof. Some non-limiting examples of the percentages by weight of the calcium-containing abrasive include: about 15%, about 20%, about 25%, or about 30%, by weight of the composition, preferably wherein the calcium-containing abrasive is calcium carbonate. Silica-based abrasive

[0043] Dental abrasives based on silica, of various types, are preferred due to their unique benefits of exceptional tooth cleaning and polishing performance without undue abrasion of enamel or dentin. The silica-based abrasive polishing materials of the present invention, as well as other abrasives, generally have an average particle size in the range of about 0.1 to about 30 microns, preferably about 5 to about 15 microns. For example, the silica-based abrasives used in the present invention are silica Petition 870260028317, dated 03 / 26 / 2026, page 20 / 100 17 / 42 precipitated (e.g., sodium silicate solution by destabilizing with acid to produce very fine particles), such as those of the ZEODENT® series from Huber Engineered Materials (e.g., ZEODENT® 103, 124, 113, 115, 163, 165, 167). It is recognized that some of these silicas (e.g., synthetic amorphous silica) can perform both thickening and abrasive functions, but are included in the present invention under the term abrasive for the purposes of the present invention. Preferably, the oral treatment composition comprises from 1% to 35%, more preferably from 5% to 25%, by weight of the composition, of abrasive. pH

[0044] The pH of the oral treatment composition may vary from about 4.0 to about 9.0, preferably from about 4.3 to about 8.0, more preferably from about 4.6 to about 7.5. In some examples, the composition has a pH ranging from 4.0 to 4.9. In alternative examples, the composition may have a pH ranging from 5.0 to 6.0. In other examples, the composition has a pH ranging from 6.1 to 7.3. In some other examples, the composition may have a pH ranging from 7.5 to 9.0. A method for evaluating the pH of the oral treatment is described below. For clarification purposes, although the analytical method describes testing the mouthwash composition when freshly prepared, for the purposes of the present invention claim, the pH can be taken at any time during the reasonable life cycle of the product (including, but not limited to, the time when the product is purchased from a store and taken to the user's home). Petition 870260028317, dated 03 / 26 / 2026, page 21 / 100 18 / 42 pH modifying agent

[0045] The oral treatment compositions of the present invention may include an effective amount of a pH modifying agent, wherein, preferably, the pH modifying agent is a pH buffering agent. The pH modifying agents, as used in the present invention, refer to agents that can be used to adjust the pH of the oral treatment compositions to the pH range identified above. The compositions may comprise from about 0.001% to about 5%, by weight of the composition, of pH modifying agent. The pH modifying agents may include alkali metal hydroxides, ammonium hydroxide, organic ammonium compounds, carbonates, sesquicarbonates, borates, silicates, phosphates, imidazole, and mixtures thereof.Specific pH adjusters include monosodium phosphate (monobasic sodium phosphate, or MSP), trisodium phosphate (tribasic sodium phosphate dodecahydrate, or TSP), sodium benzoate, benzoic acid, sodium hydroxide, potassium hydroxide, alkali metal carbonate salts, sodium carbonate, imidazole, pyrophosphate salts, tripolyphosphate salts, sodium gluconate, lactic acid, sodium lactate, citric acid, sodium citrate, and phosphoric acid. Without delving into theory, phosphate may also have calcium ion chelating activity and therefore provide some stabilization of monofluorophosphate (in those formulations containing monofluorophosphate).

[0046] A method for evaluating the pH of oral treatment is described. The pH is measured using a pH meter with Petition 870260028317, dated 03 / 26 / 2026, page 22 / 100 19 / 42 automatic temperature compensation (ATC) probe. The pH meter is capable of reading down to 0.001 pH units. The pH electrode can be selected from one of the following (i) combinations of Orion Ross Sure-Flow: Glass body - VWR #34104-834 / Orion #8172BN or VWR#10010-772 / Orion #8172BNWP; Epoxy body - VWR #34104-830 / Orion #8165BN or VWR#10010770 / Orion #8165BNWP; Semimicro, epoxy body - VWR #34104837 / Orion #8175BN or VWR#10010-774 / Orion #3175BNWP; or (ii) combination of Orion Perfect: glass body, semimicro VWR #34104-843 / Orion #8203BN; or (iii) suitable equivalent. The probe with automatic temperature compensation is a Fisher Scientific, Cat. No. 13-620-16.

[0047] A 25% by weight aqueous mouthwash paste is prepared with deionized water and then centrifuged for 10 minutes at 15,000 revolutions per minute using a SORVALL RC 28S centrifuge and an SS-34 rotor (or equivalent gravitational force, at 24149g of force). The pH is assessed in the supernatant after one minute, or when the reading stabilizes. After each pH assessment, the electrode is washed with deionized water. Any excess water is wiped off with a laboratory-grade tissue. When not in question, the electrode is kept immersed in a pH 7 buffer solution or an appropriate electrode storage solution. Humectants

[0048] The oral treatment compositions of the present invention may include humectants present in amounts of 0% to 70% or 15% to 55% by weight of the compositions. The humectants prevent the oral treatment compositions from hardening after exposure to air, and certain Petition 870260028317, dated 03 / 26 / 2026, page 23 / 100 20 / 42 Humectants can also impart a desirable sweetness of taste to oral treatment compositions. Suitable examples of humectants may include glycerin, sorbitol, polyethylene glycol, propylene glycol, xylitol, trimethyl glycine, and mixtures thereof. Other examples may include other edible polyhydric alcohols. In some examples, the humectant is selected from sorbitol, glycerin, and combinations thereof. In a preferred example, the humectant is sorbitol. In another preferred example, the humectant is glycerin. In one example, the composition comprises from 10% to 66%, or alternatively, from 20% to 55%, of humectant, by weight of the composition. Water

[0049] The oral treatment compositions described herein may include from 10% to 60%, by weight of the composition, of the total water content. In some examples, the oral treatment compositions may include from 10% to 50%, or preferably from 10% to 40%, by weight of the composition, of the total water content. The term total water content, for use in the present invention, means the total amount of water present in the composition, added separately or present as a solvent or vehicle for other raw materials, but excluding that which may be present as water of crystallization in certain inorganic salts. Preferably, the water is USP water.

[0050] Water is commonly used as a carrier material in oral care compositions due to its many benefits. For example, water is useful as a processing aid, is benign to the oral cavity, and helps in the rapid foaming of toothpastes. Water can Petition 870260028317, dated 03 / 26 / 2026, p. 24 / 100 21 / 42 can be added as a standalone ingredient or may be present as a carrier for other common raw materials, for example sorbitol. Thickening system

[0051] The oral treatment compositions of the present invention may comprise a thickening system. Preferably, the oral treatment composition comprises from about 0.5% to about 10%, preferably from about 0.8% to about 5%, more preferably from about 1% to about 5%, by weight of the composition, of a thickening system. More preferably, the thickening system comprises a thickening polymer, a thickening silica, or a mixture thereof. Even more preferably, when the thickening system comprises a thickening polymer, the thickening polymer is selected from a carboxymethylcellulose, a linear sulfated polysaccharide, a natural gum, or mixtures thereof.Even more preferably, when the thickening system comprises a thickening polymer, the thickening polymer is selected from the group consisting of: (a) from about 0.01% to about 3% of a carboxymethylcellulose (CMC), by weight, of the composition, preferably from about 0.1% to about 2.5%, more preferably from about 0.5% to about 1.7%, by weight, of the composition, of CMC; (b) from about 0.01% to about 2.5%, preferably from about 0.05% to about 2%, more preferably from about 0.1% to about 1.5%, by weight, of the composition, of a linear sulfated polysaccharide, preferably wherein the linear sulfated polysaccharide is a carrageenan; (c) from about 0.01% to about 3% of... Petition 870260028317, dated 03 / 26 / 2026, page 25 / 100 22 / 42 preferably, from about 0.1% to about 2%, more preferably from about 0.2% to about 1.8%, by weight, of the composition, of a natural gum; or (d) mixtures thereof.

[0052] The thickening polymer may also include non-colloidal microcrystalline cellulose, colloidal microcrystalline cellulose, or a mixture thereof. Non-colloidal microcrystalline cellulose, typically called microcrystalline cellulose or MCC, is a purified, partially depolymerized cellulose, for example, AVICEL® PH 102 or PH 105. Colloidal microcrystalline cellulose is obtained by reducing the particle size of microcrystalline cellulose and stabilizing the particles to prevent the formation of hard aggregates, for example, AVICEL® CL 611 or RC 591.

[0053] Preferably, when the thickening system comprises a thickening silica, the thickening silica is from about 0.01% to about 8%, preferably from about 0.1% to about 5%, preferably from about 1% to about 3%, by weight, of the composition.

[0054] Preferably, the linear sulfated polysaccharide is a carrageenan (also known as carrageenan). Examples of carrageenan include kappa-carrageenan, iotacarrageenan, lambda-carrageenan, or mixtures thereof.

[0055] In one aspect, thickening silica is obtained from a sodium silicate solution by destabilizing it with acid to produce very fine particles. A commercially available example is the ZEODENT® brand silicas, available from Huber Engineered Materials (e.g., ZEODENT® 103, 124, 113, 115, 163, 165 and 167). Petition 870260028317, dated 03 / 26 / 2026, p. 26 / 100 23 / 42

[0056] In one aspect, CMC is 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 from Ashland Special Ingredients (e.g., Aqualon™ 7H3SF; Aqualon™ 9M3SF; Aqualon™ TM9A; Aqualon™ TM12A).

[0057] 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 mixtures thereof. Preferably, the natural gum is xanthan gum. Xanthan gum is a polysaccharide secreted by the bacterium Xanthomonas camestris. In general, xanthan gum is composed of repeating pentasaccharide units 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 aspect, xanthan gum is available from CP Kelco Inc. (Okmulgee, USA).

[0058] In one aspect, the thickening polymer is selected from the group consisting of a carboxymethylcellulose, a linear sulfated polysaccharide, a natural gum and mixtures thereof. Viscosity

[0059] Preferably, the oral treatment compositions of the present invention have a viscosity range of about 200,000 centipoises to about 850,000 centipoises (cP). A method for evaluating viscosity is described. The viscometer is a Brookfield® DV-I Prime viscometer with a Helipath support. Petition 870260028317, dated 03 / 26 / 2026, p. 27 / 100 24 / 42 Brookfield. The viscometer is placed on the Helipath stand and leveled using a bubble level. Spindle E is fixed, and the viscometer is set to 2.5 RPM. Detach the spindle, zero the viscometer, and install spindle E. Then, lower the spindle until the crosshead is partially submerged in the paste before starting the measurement. Simultaneously turn on the power switch on the viscometer and the helipath to start the spindle's downward rotation. Set a timer for 48 seconds and turn on the timer at the same time as the motor and the helipath. Take a reading after 48 seconds. The reading is in cP. Dye

[0060] The compositions of the present invention may include a colorant. Titanium dioxide is an example of a colorant. Titanium dioxide is a white powder that imparts opacity to the compositions. The colorant, for example, titanium dioxide, may generally comprise from about 0.25% to about 5% by weight of the composition. Flavoring agent

[0061] The toothpaste composition of the present invention may include from 0.01% to 5%, preferably from 0.1% to 2%, by weight of the composition, of a flavoring agent. Examples of suitable flavoring agents that may be used in the toothpaste composition include those described in U.S. Patent No. 8,691,190; Haught, JC, from column 7, line 61, to column 8, line 21. In some examples, the flavoring agent may be selected from methyl salicylate, menthol, eugenol, and cineole. In some examples, the toothpaste composition may comprise a flavor mixture. Petition 870260028317, dated 03 / 26 / 2026, page 28 / 100 25 / 42 and flavoring that is free or substantially free of methyl salicylate, menthol, eugenol and cineole. Sweetener

[0062] The toothpaste compositions of the present invention may include a sweetening agent. The sweetening agent is generally present in the toothpaste compositions in proportions of 0.005% to 5% by weight of the composition. Suitable examples of sweeteners include saccharin, dextrose, sucrose, lactose, xylitol, maltose, levulose, aspartame, sodium cyclamate, D-tryptophan, dihydrochalcones, acesulfame, sucralose, neotame, and mixtures thereof. Other examples of suitable sweeteners are described in U.S. Patent No. 8,691,190; Haught, JC, Column 9, line 18 to Column 10, line 18. Other ingredients

[0063] The present composition for oral treatment may comprise the usual and conventional auxiliary components known to those skilled in the art. Optional ingredients include, for example, but are not limited to, anti-plaque agent, anti-sensitivity agent, bleaching and oxidizing agent, anti-inflammatory agent, anti-calculus agent, chelating agent, tooth-adhering agent, analgesic and anesthetic agent. It will be understood that the components selected for the compositions for oral treatment need to be chemically and physically compatible with each other.

[0064] Preferably, the oral treatment composition of the present invention is essentially free of glycyrrhetinic acid and its salt. Petition 870260028317, dated 03 / 26 / 2026, page 29 / 100 26 / 42 Method of use

[0065] In one aspect, the present invention relates to a method for treating dental biofilm. The method comprises the step of brushing / cleaning the teeth with an oral treatment composition according to the present invention. The method comprises placing a subject's teeth in contact with the oral treatment compositions according to the present invention.

[0066] In another aspect, the present invention also relates to a method for controlling plaque bacteria in an individual, comprising administering to an individual's oral cavity an oral treatment composition according to the present invention, preferably wherein the administration occurs at least once a day, more preferably at least twice a day. Testing methods Test method 1: Barrier protection test

[0067] The barrier protection test is described here. This test evaluates the barrier protection capacity of a no-rinse mouthwash composition using capsaicin to treat a cell coated with the sample. Cell culture:

[0068] Human gingival epithelial (HGE) cells 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 870260028317, dated 03 / 26 / 2026, page 30 / 100 27 / 42 Analysis of barrier protection using a real-time cell analyzer (RTCA):

[0069] 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 μL of complete culture medium is added to E-plates to obtain background readings, followed by the addition of 100 μL 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 μM 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.

[0070] 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:

[0071] Percentage of barrier protection = (Normalized CI of sample - Normalized CI of capsaicin) / Normalized CI of blank. Petition 870260028317, dated 03 / 26 / 2026, page 31 / 100 28 / 42 Test method 2: Assay for measuring enhanced endotoxin neutralization of the antibacterial agent in biofilms

[0072] To determine the enhanced endotoxin neutralization of the antibacterial agent in biofilms, the following assay is used to evaluate the LPS binding efficiency of stannous ions via measurement of a fluorescent dye that is bound to LPS lipid A in plaque biofilms in situ for oral treatment compositions of the present invention and controls. Details of the invention are described below. l. Substrate for biofilm growth

[0073] Hydroxyapatite (HA) discs are used for in situ biofilm growth. HA discs are designed with three parallel grooves (i.e., 200 μm wide; 200 μm deep for the two-sided grooves; while 500 μm wide and 500 μm deep for the intermediate groove) on each disc. When fixing the discs in an individual's mouth, these grooves are kept vertical to mimic the interproximal space between teeth, the hard-to-clean area where plaque tends to accumulate. This design allows for the collection of undisturbed plaque from the grooves. HA discs are manufactured by Shanghai Beierkang Biomedicine Limited. 2. Use of the splint

[0074] Human individuals use the splint. Each patient uses up to 12 HA discs in the splint to ensure that at least 9 HA discs are available after 48 hours. In a specific example, and with reference to Figure 2, the HA disc has three parallel grooves (the grooves on both sides). Petition 870260028317, dated 03 / 26 / 2026, page 32 / 100 29 / 42 are 300 μm wide and 300 μm deep; while the intermediate groove (between the two lateral grooves) is 500 μm wide and 500 μm deep. The intermediate groove is designed wider and deeper than the two lateral grooves so that the HA disc can be more easily separated into two identical half-discs for head-to-head comparison purposes. Further details of HA discs are described in US2017 / 0056531 (e.g., paragraphs

[0019] to

[0020] ).

[0075] The discs can be positioned so that the indentation is in the interdental space between the teeth (since this area is prone to plaque formation (given the difficulty of cleaning, etc.)). Individuals remove the splint only during meals (the splint is stored in an opaque container under humid conditions) and to perform oral hygiene procedures. Immediately afterwards, the splint is used again. Individuals are asked to use a straw when drinking. 3. In situ biofilm release from HA disc

[0076] All HA discs are removed from the splint after 48 hours using forceps. The forceps are used to hold the edge of the HA chips and transfer the HA disc to a 2 mL centrifuge tube containing phosphate-buffered saline (PBS). The forceps are thoroughly washed (water; 75% alcohol; and then deionized water) before each disc transfer. 4. Preparation of the toothpaste supernatant

[0077] 15 grams of deionized water are added to 5 grams of toothpaste from test samples. After vigorous shaking, the mixture is centrifuged to Petition 870260028317, dated 03 / 26 / 2026, page 33 / 100 30 / 42 12,000 rpm for 20 minutes. The supernatant is prepared one day before use and stored at 4°C. 5. Confocal laser scanning microscopy

[0078] After the HA discs are removed from the splint. The HA discs are used for ex vivo treatment by the different compositions of the invention and control. After being treated with the supernatant in question and labeled with the microbial fluorescent probe and the stannous fluorescent probe, the biofilms in the grooves are measured by confocal laser scanning microscopy (CLSM) (as described below). Preferably, the neutralized LPS fluorescent probe is BODIPY-TR-cadaverine (BC) (available from Thermo Fisher). Preferably, the microbial fluorescent probe is the Molecular Probes™ LIVE / DEAD® BacLight™ system (available from Thermo Fisher). 6. Disc preparation

[0079] The HA discs are rinsed in PBS solution, and each HA disc is divided into two halves using forceps. After that, each disc half is placed statically in 500 to 1,000 μl of PBS solution for 1 minute. Each disc is treated for two minutes with PBS solution or toothpaste supernatant. Each disc is washed, each held by forceps, shaken ten times back and forth in 1 ml of PBS solution, and then this washing cycle is repeated. Then, each disc is immersed statically in 500 to 1,000 μl of PBS solution for 5 minutes. 7. Fluorescence staining and microscopy

[0080] The neutralizing effect of LPS is evaluated using BODIPY-TR-cadaverine (BC), a fluorescent dye that is bound to lipid A, thereby suppressing its Petition 870260028317, dated 03 / 26 / 2026, page 34 / 100 31 / 42 Fluorescence. BC is displaced by agents with an affinity for this lipid. When LPS is bound by other ions, for example, tin, BC is released from the LPS and its fluorescence is proportional to the amount of free (unbound) BC present. Therefore, the fluorescence level indicates the amount of neutralized (bound) LPS versus free (unbound) LPS, and the effectiveness of an antibacterial agent in reducing biofilm toxicity. The greater the amount of bound LPS, the lower its toxicity.

[0081] After treatment and immersion, each disc is stained with the BODIPY-TR-cadaverine (BC) probe together with the Syto-9 probe (containing 5 μM BC probe and 5 μM Sn probe) for 30 minutes in the dark. After staining, each disc is immersed in 500 to 1000 µl of PBS solution statically for 2 minutes. The discs are washed again, holding each disc with tweezers, agitated five times back and forth in 1 ml of PBS solution, and then the cycle is repeated. For samples stained with SYTO-9 / BC dye, the following parameters are used: Xex = 488 nm / 543 nm, Xem = 500 / 580 nm, 20X objective lens and scanning from the bottom of the bacteria to the surface to 60 µm with a step size of 3 µm. 8. Confocal Laser Scanning Microscopy

[0082] The Leica™ TCS SP8 AOBS spectral confocal microscope is used. The confocal system consists of a Leica™ DM6000B upright microscope and a Leica™ DMIRE2 inverted microscope. An upright stand is used for applications involving slide-mounted samples, while the inverted stand, with a 37°C incubation chamber and CO2 enrichment accessories, provides applications of Petition 870260028317, dated 03 / 26 / 2026, page 35 / 100 32 / 42 live cells. The microscopes share an interchangeable laser scanning head and, in addition to their own electromotor-driven stages, a high-precision galvanometer-driven Z-stage, which facilitates rapid focal plane (Z) imaging. Besides epifluorescence, the microscopes support various transmitted light contrast methods, including bright field, polarizing light, and differential interference contrast, and are equipped with Leica™ 5x, 20x, 40x, 63x (oil and dry), and 100x (oil) objective lenses.

[0083] The laser detection and scanning system is described. The TCS SP8 AOBS confocal system is equipped with four lasers (one diode laser, one argon laser, and two helium lasers), thus enabling the excitation of a wide range of fluorochromes within the UV, visible, and ultraviolet ranges of the electromagnetic spectrum. The laser scanning head design, which incorporates tunable acoustic-optical filters (AOTF), an acoustic-optical dichroic beam (AOBS), and four prism spectrophotometer detectors, enables the simultaneous excitation and detection of three fluorochromes. The upright microscope also has a light transmission detector that makes it possible to superimpose a transmitted light image onto a fluorescence recording.

[0084] Leica™ Confocal software is used. Confocal microscopy is controlled via a standard Pentium PC equipped with two monitors and running Leica™ Confocal software. Leica Confocal software provides an interface for capturing, processing, and analyzing multidimensional image series, including reconstruction and measurement. Petition 870260028317, dated 03 / 26 / 2026, page 36 / 100 33 / 42 in 3D, physiological recording and analysis, time-lapse, fluorochrome colocalization, photo brightening techniques such as FRAP and FRET, spectral mixing, and multicolor restoration. Regarding image analysis, samples stained with the SYTO-9 / BC probe are chosen to quantify the fluorescence intensity of the red and green pixels. Efficacy of neutralizing LPS endotoxin

[0085] Using the software, the fluorescence intensity ratio (FIR) bound LPS / bacterial cell is calculated. This fluorescence intensity ratio indicates the relative amount of bound (neutralized) LPS per unit of bacteria, and the effectiveness of an agent in reducing biofilm toxicity. The higher the fluorescence intensity ratio, the greater the effectiveness in neutralizing LPS endotoxin. Rate of penetration of the active ingredient into the biofilm.

[0086] Using the software, the pixel overlap of the green bacterial probes and the red stannous probes is identified, and then this value is divided by all non-black pixels (which includes non-overlapping stannous probes) to provide a percentage of stannous colocalization in the bacteria. Generally, the higher this stannous colocalization percentage, the greater the effectiveness of the oral care product in delivering stannous to the bacteria. (See Xiang J, Li H, Pan B, Chang J, He Y, He T, Strand R, Shi Y, Dong W. (2018) Penetration and Bactericidal Efficacy of Two Oral Care Products in an Oral Biofilm Model. Am J Dent, Vol. 31, Issue 1: 53-60). Petition 870260028317, dated 03 / 26 / 2026, page 37 / 100 34 / 42 Test Method 3: RCTA Test --- 2D cell-based method for cell barrier disruption

[0087] Cell barrier stability is monitored non-invasively and label-free by continuous impedance measurement using the xCELLigence® cell-based microelectronic biosensor system for assays. Continuous monitoring quantifies cell health, proliferation, morphological change, and provides real-time kinetic assay of barrier function. (1) Cell culture:

[0088] Human gingival epithelial cells (HGE) were maintained in an incubator at 37 °C with 5% CO2 saturation. Dulbecco's modified Eagle medium (DMEM, Gibco) containing 10% fetal calf serum, 1% penicillin-streptomycin, is used as the complete culture medium, which is changed every 2 to 3 days. (2) Toothpaste preparation:

[0089] 6 + / -0.001 g of toothpaste is added to 18 ml of DMEM in a sterilized 100 ml beaker. The sample is stirred at 500 rpm for 20 min using a magnetic stir bar. The paste is then transferred to a sterilized 50 ml tube and centrifuged at 15,000 rpm for 15 min. The supernatant is collected and further diluted with 0.05% DMEM. (3) Analysis of the barrier function by real-time cell analyzer (RTCA):

[0090] The xCELLigence RTCA DP real-time cell analyzer (RTCA) (ACEA Bioscience Inc., San Diego, CA), based on impedance measurement, is used Petition 870260028317, dated 03 / 26 / 2026, page 38 / 100 35 / 42 to monitor barrier disruption of samples. 50 μL of complete culture medium is added to electronic plates (E-plates) to obtain background readings, followed by the addition of 100 μL of cell suspension. E-plates containing 40,000 cells / well are incubated at 37°C, 5% CO2 for 22–24 h until the cells are confluent to form a monolayer barrier. The culture medium is changed to DMEM or DMEM with 0.05% prototypes and incubated at 37°C, 5% CO2 for 2 h. Impedance, as reflected by the Cell Index (CI), is continuously recorded. (4) Cellular impedance assessment:

[0091] The IC curve is normalized at the time point immediately before the addition of the sample prototypes. The normalized IC at 2 h after the addition of prototypes is compared to the blank control to generate the percentage of the barrier function for comparison and analysis. Statistical analysis is performed using JMP's Student's t-test. Examples

[0092] The following examples and descriptions clarify in more detail the embodiments within the scope of the present invention. These examples are provided 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 A: Preparing Examples 1 to 5

[0093] Examples 1 to 5 are toothpaste compositions shown below with component quantities in weight percentage. Examples 1 and 2 are Petition 870260028317, dated 03 / 26 / 2026, p. 39 / 100 36 / 42 comparative stannous-free formulations containing sodium lauryl sulfate (SLS) surfactant and taurate surfactant, respectively. Examples 3 and 4 are stannous formulations containing sodium lauryl sulfate (SLS) surfactant and taurate surfactant, respectively. Example 5 is a formulation of the present invention according to the present invention, which contains a stannous ion source, a taurate surfactant (SMCT), and an amphoteric surfactant (cocamidopropyl betaine). All compositions are prepared by mixing the components described in Table 1 in the indicated proportions. A commercial comparative formulation containing insoluble zinc ion and a stannous ion source is prepared, i.e., Example 6. In addition, a commercial comparative formulation containing insoluble zinc ion, soluble zinc ion, and a surfactant combination of a taurate and cocamidopropyl betaine is also prepared, i.e., Example 7. Table 1: Examples 1 to 5 Ingredients Comp. 1 Comp. 2 Comp. 3 Comp. Example 4 of the present invention: Water q.s. q.s. q.s. q.s. q.s. q.s. q.s. Glycerin _ _ 27.000 27.000 27.000 Sorbitol (70%) 65.200 65.200 35.000 35.000 35.000 Stannous fluoride _ _ 0.454 0.454 0.454 Stannous silica chloride (10%) _ _ 0.562 0.562 0.562 Sodium fluoride 0.321 0.321 _ _ _ Sodium gluconate _ _ 1.150 1.150 1.150 Sodium hydroxide (50%) _ _ 0.740 0.740 0.740 Monosodium phosphate 0.400 0.400 _ _ _ Petition 870260028317, dated 03 / 26 / 2026, page 40 / 100 37 / 42 Trisodium phosphate 0.930 0.930 _ _ _ Sodium saccharin 0.300 0.300 0.500 0.500 0.500 Xanthan gum _ _ 0.613 0.613 0.613 Carrageenan _ _ 1.050 1.050 1.050 Carbomer 0.220 0.220 _ _ _ Sodium carboxymethyl cellulose (CMC) 0.700 0.700 _ _ _ Sodium citrate _ _ 1.550 1.550 1.550 Zinc citrate _ _ _ _ _ Titanium dioxide _ _ _ _ _ Hydrated silica 16.000 16.000 15.000 15,000 15,000 Sodium lauryl sulfate (29%) 5,000 _ 5,000 _ _ Sodium methyl cocoyl taurate (29%) _ 5,000 _ 5,000 5,000 Cocamidopropyl betaine _ _ _ _ 2,000 Flavoring 1,000 1,000 1,000 1,000 1,000 Total 100,000 100,000 100,000 100,00 100,000 Example B: Improving endotoxin neutralization and stannous penetration (Sn) in biofilm

[0094] Test method 2 is conducted to measure bacterial endotoxin neutralization in biofilm from examples of the present invention and comparators, as well as to measure the penetration rate of active Sn in biofilm that neutralizes endotoxin. The results are presented in Table 2 and Table 3. Table 2 - Neutralization of bacterial endotoxins in biofilm Treatment Fluorescence intensity ratio (FIR) Grouping * Petition 870260028317, dated 03 / 26 / 2026, page 41 / 100 38 / 42 LPS bound / Bacterial cell Negative control (Phosphate buffer solution) 0.1033 E Example 1 0.1267 E Example 2 0.1300 E Example 3 1.0600 C Example 4 1.3767 B Example 5 2.1400 A 1 Example 6 0.8500 D 2 Example 7 0.1467 E Means for groups in homogeneous subsets, those that do not share a letter are significantly different (alpha = 0.05) and average sample size = 6. Student-Newman-Keuls Method1Comparative Example 5 Colgate® Total™ SF toothpaste (LOT 1249US56C1), with the ingredients: Water, sorbitol, hydrated silica, glycerin, PEG-12, tetrasodium pyrophosphate, flavor, sodium lauryl sulfate, zinc phosphate, cellulose gum, sodium citrate, stannous fluoride, microcrystalline cellulose, sodium saccharin, cocamidopropyl betaine, xanthan gum, citric acid, sucralose, titanium dioxide. Example 6: Colgate® Miracle Repair Toothpaste (2014CN59 EXP20250114), with the following ingredients: glycerin, water, hydrated silica, sodium methyl cocoyl taurate, flavor, arginine, zinc oxide, cocamidopropyl betaine, cellulose gum, zinc citrate, tetrasodium pyrophosphate, xanthan gum, benzyl alcohol, sodium saccharin, sodium fluoride, phosphoric acid. Table 3 - Rate of penetration of active Sn into biofilm Treatment % of Sn penetration Grouping * Negative control (Phosphate buffer solution) 0.1067 E Example 1 1.5333 E Petition 870260028317, dated 03 / 26 / 2026, page 42 / 100 39 / 42 Example 2 1.6667 E Example 3 75.907 C Example 4 90.913 B Example 5 95.673 A 2 Example 6 64.001 D 2 Example 7 1.9700 E 2. Same as above. * Same as above.1 Same as above.

[0095] The results in Table 2 demonstrate the The Fluorescence Intensity Ratio (FIR) of bound LPS / bacterial cell is significantly higher with biofilms treated with Examples 4 (i.e., compositions containing Sn + Taurate) compared to Comparative Example 3 (i.e., Sn + SLS compositions) and Example 6 (containing Sn, SLS, and co-surfactant cocoamidopropyl betaine). More surprisingly, Example 5 of the present invention (containing Sn + taurate + cocoamidopropyl betaine) has greater bacterial toxin neutralization than Example 4 of Sn + taurate alone. Furthermore, Comparative Examples 1 and 2 (i.e., without a Sn source) have no effect on endotoxin neutralization, regardless of the type of surfactant, taurate or SLS.

[0096] The results in Table 3 demonstrate a significantly greater penetration of Sn ion into the biofilm for Examples 4 (i.e., compositions containing Sn + taurate) vs. Comparative Examples 3 (i.e., containing Sn + SLS) and Example 6 (Sn + SLS + betaine). More surprisingly, Example 5 of the present invention (containing Sn + taurate + cocoamidopropyl betaine) has greater stannous penetration than Example 4 of Sn + taurate alone. Petition 870260028317, dated 03 / 26 / 2026, page 43 / 100 40 / 42

[0097] The surprising combination of Stannous and the combination of taurate and cocoamodipropyl betaine surfactants has a significant improvement in neutralizing bacterial endotoxin from stannous ion penetration into the biofilm. Example 3: RCTA Barrier Breakthrough Test

[0098] Test Method 3 is conducted to measure the barrier breakdown of a formula. The higher the numerical score, the better, showing that the cell barrier is more tolerant / less irritated and not impaired. Table 4 - RCTA barrier rupture test Treatment % of cell barrier deterioration in 2h Grouping * Example 2 0.9168 B Example 4 0.9315 B Example 5 0.9603 A 2 Example 7 0.7772 C Same as above.2 Same as above.

[0099] The results in Table 4 demonstrate the significantly greater tolerance to deterioration of the gingival barrier of human gingival epithelial cells for Examples 5 of the present invention (containing Sn + taurate + cocamidopropyl betaine) maintains the integrity of the cell barrier deterioration better than those formulation compositions containing Taurate surfactants Examples 4 and 2, and also the commercial comparative Example 7 (composition containing Zn + taurate + cocamidopropyl betaine).

[0100] The surprising combination of Stannous and the combination of surfactants Taurate and cocoamidopropyl betaine Petition 870260028317, dated 03 / 26 / 2026, page 44 / 100 41 / 42 significantly improves the neutralization of bacterial endotoxin by preventing the penetration of stannous ions into the biofilm and reduces the deterioration of the gingival epithelium's cellular barrier, which, if compromised, can allow bacterial toxins to infiltrate and cause gingival inflammation.

[0101] The dimensions and values ​​disclosed herein should not be understood as strictly limited to the exact numerical values ​​mentioned. Instead, except where otherwise specified, each of these dimensions is intended to mean both the value mentioned and a range of functionally equivalent values ​​around that value. For example, a dimension disclosed as 40 mm is intended to mean approximately 40 mm.

[0102] 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 into the present invention 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 in this document and any meaning or definition of the same term in a document incorporated by reference, the meaning Petition 870260028317, dated 03 / 26 / 2026, p. 45 / 100 42 / 42 or the definition assigned to that term in this document shall prevail.

[0103] 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 are within the scope of the present invention. Petition 870260028317, dated 03 / 26 / 2026, p. 46 / 100

Claims

1 / 4 CLAIMS 1. Oral treatment composition characterized by comprising: (a) 0.01% to 5% by weight of the composition of a source of stannous ions; (b) 0.1% to 5% by weight of the composition of a taurate surfactant represented by the formula OR, II Γ R, C—N—CH2—CH2 —SO3'M+, wherein Ri is a saturated or unsaturated alkyl chain, linear or branched with 6 to 18 C atoms; R2 is H or methyl, and M is H, sodium or potassium; and, (c) 0.01% to 5% by weight of the composition of an amphoteric surfactant.

2. Oral hygiene composition, according to claim 1, characterized in that Ri is a saturated or unsaturated alkyl chain, linear or branched, with 8 to 18 C atoms, optionally wherein the taurate surfactant comprises one or more of potassium cocoyl taurate, potassium methyl cocoyl taurate, sodium methyl caproyl taurate, sodium cocoyl taurate, sodium lauroyl taurate, sodium methyl cocoyl taurate, sodium methyl lauroyl taurate, sodium methyl myristoyl taurate, sodium methyl oleoyl taurate.

3. Oral hygiene composition, according to any of the preceding claims, characterized in that the amphoteric surfactant is a betaine surfactant selected from the group consisting of cocamidopropyl betaine, lauramidopropyl betaine, oleamidopropyl betaine, seboamidopropyl betaine, cocamidopropyl hydroxysultaine and combinations thereof; and more preferably, selected from cocamidopropyl betaine, lauramidopropyl betaine or a combination thereof, wherein the betaine surfactant is present at a level of 0.02% to 4%, preferably 0.1% to 3% by weight of the composition.

4. Oral hygiene composition, according to any of the preceding claims, the oral hygiene composition being characterized by being substantially free of any source of insoluble zinc ions, more preferably free of any source of zinc ions.

5. Oral treatment composition, according to any of the preceding claims, characterized in that the source of stannous ions is selected from soluble stannous salts and, preferably, selected from the group consisting of stannous chloride, stannous fluoride, stannous acetate, stannous gluconate, stannous oxalate, stannous sulfate, stannous lactate, stannous tartrate, stannous iodide, stannous chlorofluoride, stannous hexafluorozirconate, stannous citrate, stannous malate, stannous glycinate, stannous carbonate, stannous phosphate, stannous pyrophosphate, stannous metaphosphate and combinations thereof.

6. Oral hygiene composition, according to any of the preceding claims, characterized in that the source of stannous ions is stannous chloride and, optionally, stannous fluoride. Petition 870260028317, dated 03 / 26 / 2026, page 48 / 100 3 / 4 7. Oral treatment composition, according to any of the preceding claims, characterized by additionally comprising 0.5% to 5%, preferably 0.5% to 1.5%, by weight of the composition, of a source of fluoride ions; wherein the source of fluoride ions is selected from the group consisting of stannous fluoride, sodium fluoride, potassium fluoride, sodium monofluorophosphate or mixtures thereof.

8. Oral treatment composition, according to any of the preceding claims, characterized in that the oral treatment composition comprises from 10% to 60%, preferably from 10% to 40%, by weight of the composition, of the total water content.

9. Oral treatment composition, according to any of the preceding claims, characterized by further comprising from 0.01% to 5%, by weight of the composition, of a thickening system, the thickening system being selected from a thickening polymer, a thickening silica or a combination thereof.

10. Oral treatment composition, according to any of the preceding claims, characterized by further comprising from 1% to 35%, more preferably from 5% to 25%, by weight of the composition, of an abrasive, wherein the abrasive is selected from a calcium-containing abrasive, a silica-based abrasive or a combination thereof; and more preferably the abrasive being a silica-based abrasive.

11. Oral treatment composition, according to any of the preceding claims, Petition 870260028317, dated 03 / 26 / 2026, page 49 / 100 4 / 4, characterized in that the composition is free of glycyrrhetinic acid and its salt.

12. Oral treatment composition, according to any of the preceding claims, characterized in that the composition has a pH ranging from 4.0 to 9.0, preferably from 4.3 to 7.

6.

13. Oral treatment composition, according to any of the preceding claims, characterized in that the oral treatment composition is a single-phase toothpaste.

14. Use of a composition for oral treatment, as defined in any one of claims 1 to 13, characterized in that it is for preparing a composition for treating dental biofilm.

15. Use of a composition for oral treatment, as defined in any of claims 1 to 13, characterized by being for preparing a composition to prevent or mitigate plaque formation on dental enamel. Petition 870260028317, dated 03 / 26 / 2026, page 50 / 100