Toothpaste composition

Abstract

An oral care composition comprising i) chlorhexidine and / or a salt thereof; ii) a vitamin B3 compound; the weight ratio of i) to ii) is 1: 30 to 1: 2.

Description

TECHNICAL FIELD

[0001] The present invention relates to oral care compositions having gingival health benefits. BACKGROUND

[0002] The oral epithelial barrier of the gingiva comprises underlying connective tissue and a stratified keratinized epithelium with a basement membrane. The oral epithelial barrier provides the first line of defense against chronic infection by pathogens, foreign substances and mechanical stress. Disruption of the gingival epithelial barrier and subsequent penetration of foreign pathogens can trigger an inflammatory response leading to gingival infection and gingival recession.

[0003] Chlorhexidine can be used in oral care compositions to exert beneficial physiological effects such as prevention or amelioration of gingivitis or periodontitis, prevention and treatment of dental caries, periodontal disease and other diseases of the oral cavity.

[0004] EP2100590 and EP185971 disclose oral care compositions comprising chlorhexidine and an alkylglucoside surfactant.

[0005] The present invention relates to oral care compositions that enhance the effectiveness of chlorhexidine and enhance the gingival barrier. SUMMARY

[0006] Thus, the present invention relates to a toothpaste composition comprising:

[0007] i) chlorhexidine and / or salts thereof;

[0008] ii) a vitamin B3 compound;

[0009] i) and ii) in a weight ratio of 1 :30 to 1 :2.

[0010] The present invention further relates to the composition as described above in a method for maintaining and / or enhancing the gingival barrier. DETAILED DESCRIPTION

[0012] Unless otherwise indicated in the examples or explicitly specified otherwise, all numbers indicating amounts of material or conditions of reaction, physical properties of materials, and / or use are optional to be understood as "about".

[0013] All amounts are by weight of the composition, unless otherwise specified.

[0014] It should be noted that where any range of values is specified, any upper value can be associated with any lower value.

[0015] Where a feature is disclosed in relation to a particular aspect of the invention (e.g. a composition of the invention), such disclosure is to be taken to apply mutatis mutandis to any other aspect (e.g. a method of the invention) mutatis mutandis.

[0016] Any ingredient mentioned in the present application as natural or naturally derived is from Europe.

[0017] The term "toothpaste composition" means a composition which is delivered to the surfaces of the oral cavity. The composition can be a product which is not intended for systemic administration or intentional swallowing during normal use, but which is retained in the oral cavity for a time sufficient to contact substantially all of the dental surfaces and / or oral tissues for the purposes of oral activity.

[0018] The dentifrice composition according to the present application comprises chlorhexidine or a salt of chlorhexidine. Preferably, the salt of chlorhexidine is chlorhexidine gluconate, chlorhexidine digluconate or a mixture thereof. More preferably, the salt of chlorhexidine is chlorhexidine digluconate.

[0019] The salt of chlorhexidine preferably comprises from 0.05 to 1 wt.%, more preferably from 0.07 to 0.7 wt.%, most preferably from 0.1 to 0.4 wt.% of the total composition.

[0020] The composition of the present application comprises a vitamin B3 compound. The vitamin B3 compound can be niacin, nicotinic acid or niacinamide, preferably niacinamide. Niacinamide is preferably present from 0.01 wt.% to 5 wt.%, more preferably from 0.5 wt.% to 3.5 wt.% of the total weight of the composition.

[0021] Preferably, the weight ratio of i) chlorhexidine and / or a salt thereof to ii) vitamin B3 compound is from 1 :25 to 1 :8, more preferably, the weight ratio of i) chlorhexidine and / or a salt thereof to ii) vitamin B3 compound is greater than 1 :12.

[0022] The composition of the present application is for cleaning the surfaces of the oral cavity.

[0023] The composition of the present application is in the form of a toothpaste. The term "toothpaste" denotes an oral composition for cleaning the surfaces of the oral cavity. Such a composition is not intended to be intentionally swallowed for systemic administration of a therapeutic agent, but is applied to the oral cavity for treatment of the oral cavity and then expectorated. Typically, such a composition is used in conjunction with a cleaning implement such as a toothbrush, usually by applying it to the bristles of a toothbrush which is then used to brush the accessible surfaces of the oral cavity.

[0024] The dentifrice / toothpaste is in the form of an extrudable semi-solid, such as a paste, a paste or a gel (or a mixture thereof).

[0025] In addition to the ingredients specified above, the composition according to the present application can also comprise other ingredients to enhance performance and / or consumer acceptability.

[0026] The composition, in particular toothpaste, according to the present application preferably comprises a particulate abrasive, such as silica, alumina, calcium carbonate, dicalcium phosphate, calcium pyrophosphate, hydroxyapatite, tri-polyphosphate, insoluble hexa-metaphosphate and the like, including agglomerated particulate abrasives, in an amount typically from 3 to 60 wt% of the oral care composition.

[0027] In one embodiment of the present application, the composition comprises a silica abrasive. The preferred abrasive silica for use in the present application is a silica having a low refractive index. It can be used as the only abrasive silica or in combination with a low level of other abrasive silicas, such as those according to EP 236070. The low refractive index silica used as abrasive in the present application is preferably a silica having an apparent refractive index (R.I.) in the range of 1.41-1.47, preferably 1.435-1.445, preferably a weight average particle size of 5-15 mm, a BET (nitrogen) surface area of 10-100 m 2 / g and an oil absorption of about 70-150 cm 3 / 100g, although abrasive silicas with a lower apparent refractive index can also be used. Typical examples of suitable low refractive index abrasive silicas (e.g. R.I. between 1.435 and 1.445) are Tixosil 63 and 73 from Rhone Poulenc; Sident 10 from Degussa; Zeodent 113 from Zeofinn; Zeodent 124 from Evonik; Sorbosil AC 77 from PQ Corporation (R.I. of about 1.440). The amount of these silicas in the composition is typically from 5-60 wt%, usually from 5-20 wt%.

[0028] Another suitable abrasive is calcium carbonate. The natural calcium carbonate abrasive is typically finely ground limestone, which can optionally be refined or partially refined to remove impurities. The material preferably has an average particle size of less than 10 microns, such as 3-7 microns, for example about 5.5 microns. For example, the small particle silica can have an average particle size (D 50) of 2.5-4.5 microns. Because natural calcium carbonate can contain a high proportion of relatively large particles which are not carefully controlled, this can increase abrasivity unacceptably, so it is preferred that no more than 0.01 wt%, preferably no more than 0.004 wt%, of the particles do not pass through a 325 mesh sieve. The material has a strong crystalline structure and is therefore much harder and more abrasive than precipitated calcium carbonate. The tap density of the natural calcium carbonate is for example 1-1.5 g / cc, such as about 1.2, for example about 1.19 g / cc. There are different polymorphs of natural calcium carbonate, such as calcite, aragonite and vaterite, with calcite being preferred for the purposes of the present application.

[0029] Precipitated calcium carbonate has a different crystal structure than natural calcium carbonate. It is generally more brittle and porous, and therefore has lower abrasiveness and higher water absorption. For use in the present invention, the particles are small, for example, having an average particle size of 1-5 microns, and for example, no more than 0.1% by weight, and preferably no more than 0.05% by weight, of the particles will not pass through a 325 mesh sieve. The particles can, for example, have a D50 of 3-6 microns, for example, 3.8-4.9 microns, for example, about 4.3 microns; a D50 of 1-4 microns, for example, 2.2-2.6 microns, for example, about 2.4 microns; and a D10 of 1-2 microns, for example, 1.2-1.4 microns, for example, about 1.3 microns. The particles have a relatively high water absorption, for example, at least 25 g / 100 g, for example, 30-70 g / 100 g.

[0030] In some embodiments, additional calcium-containing abrasives are used, such as calcium phosphate abrasives, such as tricalcium phosphate, hydroxyapatite, or dicalcium phosphate dihydrate or calcium pyrophosphate, and / or silica abrasives, sodium metaphosphate, potassium metaphosphate, aluminum silicate, calcined alumina, or other siliceous materials, or combinations thereof.

[0031] The composition, particularly if it is a toothpaste, preferably comprises an inorganic or natural or synthetic thickener or gelling agent in a proportion of about 0.10 to about 15% by weight, depending on the material selected. These proportions of thickener in the dentifrice composition of the present invention form an extrudable shape-retaining product that can be squeezed from a tube onto a toothbrush and does not fall between the bristles of the toothbrush, but rather can substantially retain its shape thereon. Suitable thickeners or gelling agents that can be used in the practice of the present invention include inorganic thickening silica, such as amorphous silica available from Huber Corporation under the trade name Zeodent 165, Irish moss, iota carrageenan, tragacanth gum, and polyvinyl pyrrolidone.

[0032] Other suitable binders and thickeners may be present and include sodium carboxymethylcellulose, hydroxyethylcellulose Xanthan gum, gum arabic, etc., and synthetic polymers such as polyacrylates and carboxyvinyl polymers, e.g.

[0033] The composition according to the present invention may contain a polymeric deposition aid. Preferably, the composition comprises an anhydride polymer, particularly preferably a copolymer of maleic anhydride and methyl vinyl ether, wherein the anhydride portion may be in a partially or completely hydrolyzed or alcoholized form. Preferred copolymers include Gantrez(R) polymers, for example:

[0034] Gantrez S-95: molecular weight 216,000; free acid;

[0035] Gantrez S-96: molecular weight 700,000; free acid;

[0036] Gantrez S-97: molecular weight 1,500,000; free acid; and

[0037] Gantrez MS-955: molecular weight 1,060,000; calcium / sodium salt.

[0038] Particularly preferred copolymers of maleic acid and methyl vinyl ether have a molecular weight of 1,000,000 or greater, and a particularly preferred material is Gantrez S-97.

[0039] The composition according to the present application can comprise a tooth whitening agent. The whitening agent preferably comprises a green and / or blue pigment. In the context of the present application, a pigment is generally understood to be a colour tone / material which is not soluble in the relevant medium at the relevant temperature. This is in contrast to a soluble dye. In the context of the present application, the "relevant medium" is human saliva, the liquid medium when using the composition at the temperature of the mouth during brushing, i.e. a temperature of at most 37°C. As a reasonable approximation, the relevant medium can be considered to be water, and the relevant temperature is 25°C.

[0040] Preferably, the blue pigment is Pigment Blue 15, more preferably Pigment Blue 15:1, 15:2, 15:3, 15:4, 15:5 or 15:6, most preferably 15:1. A preferred pigment is a blue pigment which is a phthalocyanine blue pigment, CI number 74160, Covarine Blue.

[0041] A preferred green pigment is a phthalocyanine green, preferably phthalocyanine green CI-74260.

[0042] Preferably, the total content of pigment in the composition is 0.01-3% by weight, more preferably 0.02-2% by weight.

[0043] If the composition is a toothpaste, it can be a dual phase paste, with the whitening pigment present in one phase.

[0044] The composition according to the present application can comprise a source of water-soluble or sparingly water-soluble metal salt. Preferred are zinc ions, such as zinc chloride, zinc acetate, zinc gluconate, zinc sulphate, zinc fluoride, zinc citrate, zinc lactate, zinc oxide, zinc monoglycinate, zinc tartrate, zinc pyrophosphate and zinc maleate; also preferred are stannous ions, such as stannous fluoride and stannous chloride.

[0045] The compositions according to the present application can comprise an oral care enzyme system, such as a hydrogen peroxide generating enzyme system (e.g. oxidoreductase glucose oxidase), amylase, dextranase and / or mutanase (optionally in the presence of a compound providing zinc ions and / or an 8-hydroxyquinoline derivative), lactoperoxidase, lactoferrin, lysozyme and mixtures thereof.

[0046] The compositions of the present application can comprise a fluoride source such as sodium fluoride, stannous fluoride, sodium monofluorophosphate, ammonium zinc fluoride, ammonium tin fluoride, calcium fluoride, cobalt ammonium fluoride and mixtures thereof. The fluoride ion source can be added to the composition at a level of from about 0.001 wt % to about 10 wt %, for example, from about 0.003 wt % to about 5 wt %, 0.01 wt % to about 1 wt % or about 0.05 wt %. In some embodiments, stannous fluoride is present in an amount of 0.1 wt % to 2 wt % (0.1 wt % to 0.6 wt %) of the total composition weight. The fluoride ion source can be added to the composition at a level of from about 0.001 wt % to about 10 wt %, for example, from about 0.003 wt % to about 5 wt %, 0.01 wt % to about 1 wt % or about 0.05 wt %. It will be appreciated, however, that the weight of fluoride salt providing the appropriate level of fluoride ion can vary significantly based on the weight of the counterion in the salt, and such amounts can be readily determined by one skilled in the art. In some embodiments, the fluoride source is a fluoride salt (e.g. sodium fluoride (e.g. about 0.32 wt %)) present in an amount of 0.1 wt % to 2 wt % (0.1 wt % to 0.6 wt %) of the total composition weight.

[0047] Some embodiments of the present application do not contain a fluoride source, i.e. the composition comprises less than 0.01 wt % of a fluoride source.

[0048] In one embodiment, the preferred class of oral care active included in the compositions of the present application includes agents for tooth remineralization. In the context of the present application, the term "remineralization" means the in situ production of hydroxyapatite on the teeth.

[0049] A specific example of a suitable agent for tooth remineralization is a mixture of a calcium source and a phosphate source which results in the in situ generation of hydroxyapatite on the teeth when delivered to the teeth.

[0050] Exemplary examples of the type of calcium source (hereinafter "remineralizing calcium source") that can be used in the present application include, for example, calcium phosphate, calcium gluconate, calcium oxide, calcium lactate, calcium glycerophosphate, calcium carbonate, calcium hydroxide, calcium sulfate, calcium carboxymethylcellulose, calcium alginate, calcium salt of citric acid, calcium silicate and mixtures thereof. Preferably, the remineralizing calcium source is calcium silicate.

[0051] The amount of remineralising calcium source (e.g. calcium silicate) in the compositions of the present application is typically in the range of 1 to 30%, preferably 5 to 20% by total weight of the remineralising calcium source, based on the total weight of the oral care composition.

[0052] Exemplary examples of phosphate source types (hereinafter "remineralising phosphate sources") which can be used in the present application include, for example, monosodium phosphate, disodium hydrogen phosphate, sodium pyrophosphate, tetrasodium pyrophosphate, sodium tripolyphosphate, sodium hexametaphosphate, potassium dihydrogen phosphate, trisodium phosphate, tripotassium phosphate and mixtures thereof. Preferably, the remineralising phosphate source is a mixture of trisodium phosphate and sodium dihydrogen phosphate.

[0053] The amount of remineralising phosphate source (e.g. trisodium phosphate and sodium dihydrogen phosphate) in the compositions of the present application is typically in the range of 2 to 15%, preferably 4 to 10% by total weight of the remineralising phosphate source, based on the total weight of the oral care composition.

[0054] In some embodiments, the oral care composition comprises an effective amount of one or more antibacterial agents, for example comprising an antibacterial agent selected from halogenated diphenyl ethers (e.g. triclosan), triclosan monophosphate, herbal extracts and essential oils (e.g. rosemary extract, tea extract, magnolia extract, thymol, menthol, eucalyptol, geraniol, carvacrol, citral, hinokitol, magnolol, ursolic acid, ursic acid, catechin, methyl salicylate, epigallocatechin gallate, epigallocatechin, gallic acid, miswak extract, sea buckthorn extract), bisguanide disinfectants (e.g. alexidine or octonidine), quaternary ammonium compounds (e.g. cetylpyridinium chloride (CPC), CPC-clay benzalkonium chloride, tetradecylpyridinium chloride (TPC), N-tetradecyl-4-ethylpyridinium chloride (TDEPC)), phenolic disinfectants, hexetidine furanones, bacteriocins, ethyl lauroyl arginate, arginine bicarbonate, camellia sinensis extract, flavonoids, flavans, halogenated diphenyl ethers, creatine, sanguinarine, povidone-iodine, delmopinol, salifluor or metal ions (e.g. zinc salts, stannous salts, copper salts, iron salts), propolis and oxygen-containing s agents (e.g. hydrogen peroxide, buffered sodium perborate or peroxy carbonates), phthalic acid and salts thereof, monoperphthalic acid and salts and esters thereof, ascorbyl stearate, oleoyl sarcosine, alkyl sulphates, dioctyl sulfosuccinate, salicylanilide, domiphen bromide, delmopinol, octonidol and other piperidinyl derivatives, nisin preparations, chlorite salts; parabens, e.g. methyl or propyl paraben, and mixtures of any of the foregoing. One or more additional antibacterial or antiseptic agents can optionally be present in the composition in a total amount of from about 0.01 wt% to about 0.5 wt%, optionally from about 0.05 wt% to about 0.1 wt% or about 0.3 wt% by total weight of the composition.

[0055] In some embodiments, the oral care composition further comprises at least one flavoring agent, which can be used, for example, to enhance the taste of the composition. Any orally acceptable natural or synthetic flavoring agent can be used, including, but not limited to, essential oils and various flavoring aldehydes, esters, alcohols and similar materials, tea flavors, vanillin, sage, marjoram, parsley oil, spearmint oil, cinnamon oil, oil of wintergreen, peppermint oil, clove oil, bay oil, anise oil, eucalyptus oil, citrus oils, fruit oils, artificial flavors, including those derived from lemon, orange, lime, grapefruit, apricot, banana, grape, apple, strawberry, cherry, pineapple, etc., bean- and nut-derived flavors, e.g., coffee, cocoa, cola, peanut, almond, etc., adsorbed and encapsulated flavorants, and the like. Flavorings in the present application also include ingredients that provide a cooling and / or other sensory effect in the mouth. Such ingredients illustratively include menthol, carvyl ketone, menthyl acetate, menthyl lactate, camphor, eucalyptus oil, eucalyptol, anethole, eugenol, cassia, oxanone, a-irisone, thymol, linalool, benzaldehyde, cinnamaldehyde, N-ethyl-p-menthyl-3-carboxamide, N,2,3-trimethyl-2-isopropylbutanamide, 3-(l- menthoxy)-propane-l,2-diol, cinnamaldehyde glycerol acetal (CGA), menthone glycerol acetal (MGA), and the like. One or more flavoring agents are optionally present at from about 0.01 wt% to about 5 wt%, e.g., from about 0.03 wt% to about 2.5 wt%, optionally from about 0.05 wt% to about 1.5 wt%, further optionally from about 0.1 wt% to about 0.3 wt%, by total weight of the composition, and in some embodiments from about 0.01 wt% to about 1 wt%, from about 0.05 wt% to about 2 wt%, from about 0.1 wt% to about 2.5 wt%, and from about 0.1 wt% to about 0.5 wt% in total.

[0056] In some embodiments, the oral care composition comprises at least one sweetener, which can be used, for example, to enhance the taste of the composition. Sweeteners useful herein include dextrose, polydextrose, sucrose, maltose, dextrin, dried invert sugar, mannose, xylose, ribose, fructose, levulose, galactose, corn syrup, partially hydrolyzed starch, hydrogenated starch hydrolyzate, ethyl alcohol, sorbitol, mannitol, xylitol, maltitol, isomalt, aspartame, neotame, saccharin and its salts (e.g., sodium saccharin), sucralose, dipeptide-based intense sweeteners, cyclamates, dihydrochalcones.

[0057] One or more sweeteners are optionally present in an amount that depends strongly on the particular sweetener selected, but generally from 0.005% to 5% by weight of the total composition, optionally from 0.005% to 0.2% by weight of the total composition, further optionally from 0.05% to 0.1% by weight of the total composition.

[0058] In some embodiments, the oral care composition further comprises an agent that interferes with or prevents bacterial attachment, such as ethyl lauroyl arginiate (ELA), solbrol, or chitosan, and plaque dispersing agents such as enzymes (papain, glucoamylase, etc.).

[0059] Mixtures of any of the above materials can also be used.

[0060] The compositions according to the present application can comprise other ingredients common in the art, such as:

[0061] Antimicrobial agents, such as chlorhexidine, sanguinarine extract, metronidazole, quaternary ammonium compounds, such as cetylpyridinium chloride; cetylpyridinium chloride clay complex bisguanides, such as chlorhexidine digluconate, hexetidine, octonidine, alexidine; and halogenated bisphenolic compounds, such as 2,2'-methylenebis-(4-chloro-6-bromophenol);

[0062] Anti-inflammatory agents, such as ibuprofen, flurbiprofen, aspirin, indomethacin, and the like;

[0063] Anticaries agents, such as sodium fluoride and stannous fluoride, amine fluoride, sodium monofluorophosphate, sodium trimeta phosphate, and casein;

[0064] Plaque buffering agents, such as urea, calcium lactate, calcium glycerophosphate, and strontium polyacrylate;

[0065] Vitamins, such as vitamins A, C, D, B (preferably B3), and E;

[0066] Plant extracts;

[0067] Plant-derived antioxidants, such as flavonoids, catechins, polyphenols, and tannin compounds, and mixtures thereof;

[0068] Desensitizing agents, such as potassium citrate, potassium chloride, potassium tartrate, potassium bicarbonate, potassium oxalate, potassium nitrate, and salts of strontium;

[0069] Anticalculus agents, such as alkali metal pyrophosphates, hypophosphite- containing polymers, organic phosphonates, and phosphanocitrates, and the like;

[0070] Biomolecules, such as bacteriocins, antibodies, enzymes, and the like;

[0071] Flavouring agents, such as peppermint and spearmint oil;

[0072] Proteinaceous materials, such as collagen;

[0073] Preservatives;

[0074] Sunscreen agents;

[0075] Hyaluronic acid;

[0076] Amino acids, such as arginine;

[0077] Colouring agents;

[0078] pH adjusting agents;

[0079] Sweeteners;

[0080] Texture agents

[0081] Pharmaceutically acceptable carriers, such as starch, sucrose, water or water / alcohol systems, etc;

[0082] Surfactants, such as anionic, non-ionic, cationic and zwitterionic or amphoteric surfactants;

[0083] Humectants, such as glycerol, sorbitol, propylene glycol, xylitol, lactitol, etc;

[0084] The application will now be illustrated by the following non-limiting examples. Examples of the application are illustrated by numbers, comparative examples by letters. DETAILED DESCRIPTION

[0085] Example

[0086] Table 1

[0087]

[0088] Incubation with SkinEthic maintenance medium (without hydrocortisone) at 37°C, 5% C02 Overnight with human gingival epithelial cells (HGE).

[0089] The upper surface of the HGE tissue was treated with toothpaste slurry or endotoxin-free water (negative control) and incubated for 4 minutes at room temperature, then the upper surface of the culyure was washed to remove the test material. All treatments were repeated to provide triplicates. After washing, the HE were incubated for 24 hours at 37°C, 5% C02.

[0090] The HGE tissue was harvested and RNA was extracted.

[0091] qPCR was performed on the RNA extracted from the tissue (keratin 13).

[0092] Table 2

[0093] Example Relative gene expression Standard deviation A 0% B3 0.46 0.38 1 1% B3 0.77 0.36 2 2% B3 1.29 0.31 3 3% B3 0.63 0.14 B 4% B3 0.34 0.06 C 5% B3 0.41 0.24

[0094] Gene expression of keratin 13 (or cytokeratin 13). Keratin 12 is a protein encoded by the KRT13 gene in humans and found in the gingival barrier. Keratin 13 is a key structural protein found in oral epithelial cells and is a known marker of keratinocyte differentiation.

[0095] Higher relative gene expression of keratin 13 is involved in improved differentiation and enhanced gingival barrier, thus embodiments of the present invention have improved gingival barrier properties.

[0096] Table 3

[0097] Ingredient wt% Example Sorbitol 12 Sodium fluoride 0.05 PEG-40 hydrogenated castor oil 2.5 Fragrance 0.4 Saccharin sodium dihydrate 0.06 Chlorhexidine digluconate 0.12 Nicotinamide 2 Potassium citrate 0.55 Sodium benzoate 0.5 Water and minors to 100

[0098] Table 3 is a further embodiment of the present invention.

Claims

1. A toothpaste composition comprising: i) chlorhexidine and / or its salts; ii) vitamin B3 compounds; The weight ratio of i) to ii) is 1:30 to 1:

2.

2. The toothpaste composition according to claim 1, wherein the vitamin B3 compound is niacinamide.

3. The toothpaste composition according to claim 1 or claim 2, wherein the weight ratio of i) chlorhexidine and / or its salt to ii) the vitamin B3 compound is 1:25 to 1:

8.

4. An oral care composition according to any one of the preceding claims, wherein the weight ratio of i) chlorhexidine and / or its salt to ii) the vitamin B3 compound is greater than 1 :

12.

5. A toothpaste composition according to any one of the preceding claims, wherein niacinamide is present in an amount of from 0.5% to 3.5% by weight of the total composition.

6. A toothpaste composition according to any one of the preceding claims, wherein the chlorhexidine is present in an amount of 0.05% to 0.5% by weight of the oral composition.

7. A toothpaste composition according to any preceding claim further comprising a nonionic surfactant.

8. A toothpaste composition according to any preceding claim further comprising an anionic surfactant.

9. A toothpaste composition according to any preceding claim, wherein the composition further comprises abrasive silica.

10. A toothpaste composition according to any one of the preceding claims for use in a method of maintaining and / or strengthening the gingival barrier.

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