Oro-dental composition

An oral-dental composition using chitosan and fluoride salts, without silicones, addresses the need for natural and effective tooth protection, preventing caries and bacterial adhesion while promoting remineralization.

WO2025109287A1PCT designated stage expired Publication Date: 2025-05-30PIERRE FABRE MEDICAMENT SAS
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Patent Information

Application Number
PCT/FR2024/051544
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-11-23
Filing Date
2024-11-21
Publication Date
2025-05-30

AI Technical Summary

Technical Problem

There is a need for oral-dental compositions that are free of silicones, which are controversial due to environmental and health concerns, while still providing effective protection for teeth and prevention of carious lesions.

Method used

An oral-dental composition comprising at least one film-forming agent, such as chitosan and its derivatives, and at least one fluoride salt, without silicones, which forms a protective film on teeth, inhibits bacterial adhesion, and promotes remineralization.

Benefits of technology

The composition effectively protects teeth, prevents carious lesions, inhibits bacterial adhesion, and promotes remineralization, while meeting consumer demands for natural and minimalist ingredients, and adhering to environmental sustainability standards.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present invention relates to an oro-dental composition comprising at least one abrasive filler selected from the group comprising at least one film-forming agent, and at least one fluorine salt, said composition being free of silicone, to a method for the non-therapeutic treatment of the oral cavity, to the use of the oro-dental composition for remineralizing the teeth, and to the prevention and / or inhibition of formation of a biofilm on a surface. The present invention relates to a method for producing an oro-dental composition. The present invention finds an application in particular in the cosmetic and oro-dental fields.
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Description

[0001] DESCRIPTION

[0002] Title: Oral composition

[0003] Technical field of the invention

[0004] The present invention relates to an oral-dental composition comprising at least one film-forming agent, and at least one fluoride salt, said composition being free of silicone.

[0005] The present invention also relates to a method for non-therapeutic treatment of the oral cavity comprising applying said oral composition to a dental surface. The present invention also relates to the use of the oral composition for remineralizing teeth.

[0006] The present invention also relates to the use of the oral composition for the prevention and / or inhibition of the formation of a biofilm on a surface.

[0007] The present invention relates to a method of manufacturing an oral composition

[0008] The present invention finds application in particular in the cosmetic and oral-dental fields.

[0009] In the description below, the references in parentheses () refer to the list of references presented at the end of the text.

[0010] Prior art

[0011] The most common compositions for oral hygiene are toothpastes and mouthwashes. They are used in particular to clean the surfaces of the oral cavity, in particular the teeth and gums. Other forms of oral compositions are also known, for example in the form of varnishes, gels, foams or sealants, for example. All these compositions are oral compositions that are not intentionally swallowed for the purpose of systemic administration of therapeutic agents, but are applied to the oral cavity for local treatment. In addition to the well-known cleaning action, an oral composition can also fulfill other functions in the context of oral hygiene, for example an antibacterial effect, remineralization of the tooth enamel and / or strengthening of the gums.These functions are ensured or promoted by different substances contained in the preparation which can contribute to the various aspects of the maintenance of the oral-dental sphere.

[0012] An additive in oral hygiene compositions well known to the general public is fluoride, more precisely fluoride in the form of one of its salts. Fluoride salts are distinguished according to their compositions; they can be, for example, potassium, sodium and tin fluorides, amine fluorides and quaternary ammonium fluorides. Fluoride plays an important role in the mineralization of teeth, both during tooth formation and on a daily basis in the context of the demineralization / remineralization cycles of enamel. Indeed, it is known that dental enamel is frequently subject to risks of weakening by ionic mobilization, particularly under conditions of acidification of the oral pH during the intake of acidic or sugary foods, a phenomenon which is favored by the metabolic action of bacteria in the dental biofilm.Under these acidic conditions, some ions in tooth enamel are dissolved, including calcium phosphates, which represent the main part of the mineral body of teeth, in the form of hydroxyapatite. Depending on the concentrations of calcium and phosphate in saliva near the teeth, this demineralization may prevail over the remineralization of enamel that occurs after the rise in oral pH. A progressive degradation of tooth enamel and even dentin may then occur over time, leading to the appearance of carious lesions.

[0013] There is therefore a real need in the state of the art to find a means and / or an oral composition for protecting tooth enamel and / or dentin. There is therefore a real need in the state of the art to find a means and / or an oral composition for preventing carious lesions. It is known that the process described above can be inhibited or, preferably, even reversed, by measures that protect and strengthen tooth enamel. For example, fluoride exerts a preventive and curative action in this context: it protects tooth enamel by the formation of fluorapatite which is more acid-resistant than hydroxyapatite, and it contributes to enamel repair by accelerating the integration of calcium and phosphate into the mineral body of the teeth. The fluoride then shows beneficial activity both in reducing demineralization and in promoting remineralization of the teeth.It is also known that fluoride can have an effect in preventing the formation of caries via antibacterial activity in the oral flora.

[0014] Other components present in oral compositions are also known to contribute to the protection of teeth against the risk of demineralization, these may be, for example, film-forming agents. Known film-forming agents include polymers that form a film around the hard tissue of the teeth, thus providing possible protection, for example, against the action of bacteria and acids. Depending on their chemical nature, they may also promote the retention of ions, particularly calcium and phosphate, around the teeth and thus contribute to effective remineralization (Gullo Augusto et al 2022 (Reference 1)). In addition, some film-forming agents may also promote the action of fluoride in oral compositions that also contain this ingredient.

[0015] Among film formers, an important class of compounds is represented in particular by silicones, synthetic polymers based on silicon-oxygen chains, and in particular organosilicones which carry organic substitutes / residues. One of the film formers of the organosilicone class which is well known for its usefulness in oral compositions is in particular dimethicone, also called polydimethylsiloxane or PDMS. This product is thus found in combination with fluoride salts in various oral compositions, for example toothpaste, available commercially. However, silicones included in compositions for hygiene and care, for example in oral compositions, are viewed with a critical eye by consumers. In addition, silicones are increasingly controversial substances, especially by many consumers, especially in their use in oral compositions.In particular, there is a strong demand in the state of the art, particularly from consumers, for "natural" compositions and / or compositions in accordance with the concept of "Naturality", respect for natural resources and the concept of "clean beauty". Also, consumers are looking for alternative care products, with ingredients preferably of natural origin, known for their better tolerance, and with a low impact on natural resources and the environment.

[0016] Also, there exists in the state of the art a need to find alternative compositions and / or ingredients and / or daily care products. In particular, there exists in the state of the art a real need to find minimalist compositions, for example comprising a limited number of components and / or ingredients, and / or “natural” compositions.

[0017] Contrary to these trends, silicones are synthetic products that are suspected of accumulating in the environment and even harming health. However, silicones are not easily substituted, due to their well-adapted film-forming properties, particularly in toothpastes and mouthwashes.

[0018] There is therefore a real need in the state of the art to find alternative compositions and / or ingredients and / or daily care products. In particular, there is a real need to find compositions and / or ingredients and / or daily care products free of silicones.

[0019] There is also a real need in the state of the art to find compositions and / or ingredients and / or products free of silicone which advantageously, for example, promote the action of fluoride, and / or for example allow protection of dental enamel and / or allow prevention of the formation of cavities.

[0020] Statement of the invention

[0021] The present invention aims precisely to meet these needs by providing an oral-dental composition comprising at least one film-forming agent chosen from the group comprising chitosan and / or its derivatives, preferably chitosan mandelate, and at least one fluorine salt, said composition being free of silicone.

[0022] In particular, the inventors have demonstrated in a surprising and unexpected manner that the composition according to the invention advantageously allows protection of the teeth, prevention of carious lesions, inhibition and / or prevention of bacterial adhesion on the dental surface.

[0023] The inventors have also demonstrated, surprisingly and unexpectedly, that the composition according to the invention advantageously provides protection for the teeth, prevents carious lesions, inhibits and / or prevents bacterial adhesion to the dental surface, and advantageously promotes remineralization of the teeth.

[0024] Furthermore, the inventors have demonstrated in a surprising and unexpected manner that the composition according to the invention not comprising silicone advantageously allows protection of the teeth, prevention of carious lesions, inhibition and / or prevention of bacterial adhesion on the dental surface, and promotion of remineralization of the teeth.

[0025] Furthermore, the composition according to the invention advantageously makes it possible to respond to the concept of “conscious care” via in particular a reduction in the concentrations of the compounds and / or ingredients in the compositions, advantageously making it possible to increase the naturalness of said composition.

[0026] The composition according to the invention also advantageously makes it possible to meet the requirements of certification of the COSMOS standard as defined by Ecocert (registered trademark), which defines the criteria that must be respected to guarantee consumers that their products are genuine organic or natural products manufactured according to the highest possible sustainability practices.

[0027] Advantageously, the composition according to the invention comprises ingredients and / or compounds meeting the requirements of the COSMOS certification defined by Ecocert, in particular COSMOS organic. In addition, the composition according to the invention advantageously has a percentage of naturalness according to the ISO 16128 standard published in September 2017 (Reference 2) greater than 80%, preferably greater than 90%, even more preferably greater than 92%, for example greater than 94%.

[0028] The composition according to the invention may also meet one or more of the characteristics described below, implemented in isolation or in each of their technically effective combinations.

[0029] The ingredients contained in the composition according to the invention may independently be of natural origin. Preferably, the ingredients contained in the composition according to the invention are of natural origin.

[0030] Advantageously, the composition comprising ingredients of natural origin makes it possible in particular to meet a need of the state of the art in the field of care, for example cosmetics, namely compositions containing ingredients of natural origin.

[0031] According to the invention, the oral-dental composition may comprise at least 80%, for example at least 90%, for example at least 95%, of ingredients of natural origin.

[0032] In this document, the percentage of ingredients of natural origin present in the composition can be determined according to the process described in standard ISO 16128:2017 (Reference 2).

[0033] The inventors have also demonstrated, surprisingly and unexpectedly, that the composition according to the invention advantageously allows, in particular by the combination in the composition of at least one film-forming agent, for example of natural origin, for example chosen from the group comprising chitosan and / or its derivatives and at least one fluorine salt, said composition being free of silicone, a remineralization of the dental surface and / or teeth and synergistically to inhibit and / or prevent bacterial adhesion on the dental surface, while respecting the various expectations of consumers in terms of organoleptic qualities, namely in particular their sensation in the mouth, compatibility between components and reduction / decrease, for example compared to known oral-dental compositions, the number and / or concentrations of materials / ingredients in the composition.

[0034] The inventors have also demonstrated that the composition according to the invention, free of silicone, has remineralizing power and protective activity against demineralization of the teeth and / or the dental surface. The inventors have also demonstrated that the composition according to the invention, free of silicone, advantageously allows remineralization of the teeth and / or the dental surface and protective activity against demineralization of the teeth and / or the dental surface. The inventors have also demonstrated that the composition according to the invention, free of silicone, has an anti-biofilm action, advantageously an anti-bacterial biofilm action. In addition, said composition also differs from comparable compositions of the prior art by the reduction in the concentration of the ingredients, in particular of the non-natural ingredients.

[0035] In this document, the term "approximately" means that the value concerned may be 10% lower or higher, in particular 5%, in particular 1%, than the value indicated.

[0036] Herein, unless otherwise indicated, the percentages of components / ingredients, for example in a composition, are given by weight relative to the total weight of the composition.

[0037] As used herein by the notion that the composition according to the invention comprises an ingredient of a particular category, for example a film-forming agent or a fluorine salt, it is meant that the composition according to the invention comprises a single ingredient of this category or several ingredients of this category (mixture of these ingredients), for example film-forming agents or fluorine salts. This is sometimes, but not on every occasion, indicated by the term "at least one", for example at least one film-forming agent or at least one fluorine salt.

[0038] According to the invention, the composition may comprise at least one film-forming agent, preferably of natural origin, other than silicones.This may be, for example, at least one commercially available film-forming agent, for example chosen from glycolipid marketed under the trade reference Rheance (trademark) One by the company Evonik, polyvinylpyrrolidone (PVP) marketed under the trade reference Plasdone (trademark) K-29 / 32 Polymer by the company Ashland, lauroyl arginine marketed under the trade reference Amisafe (trademark) AL01, PVM / MA copolymer / lecithin / aqua marketed under the trade reference Gantrez (trademark) S97 BF, PVM / MA copolymer / aqua marketed under the trade reference Gantrez (trademark) S97 HSll, C15-19 alkane marketed under the trade reference Emogreen (trademark) L15 or L19, the glycerin / ethyl lauroyl arginate HCl mixture PVM / MA Aminat (trademark) G, chitosan mandelate sold under the name Chitosan MS.

[0039] According to the invention, said at least one film-forming agent may be chosen from chitin derivatives. It may be, for example, at least one film-forming agent chosen from chitosan or one of its derivatives.

[0040] In this invention, chitosan means a polysaccharide composed of D-glucosamine and N-acetyl-D-glucosamine. Chitosan can be produced by deacetylation from chitin found in various crustaceans or cephalopods, or from the cell wall of fungi. Thus, chitosan is a substance of natural origin within the meaning of the present invention.

[0041] In this document, the term "chitosan derivative" includes, in particular, spheres, solvates and salts, including acid addition salts. This may be, for example, a pharmacologically or cosmetically acceptable chitosan solvate or acid addition salt. This may be, for example, chitosan mandelate.

[0042] In this document, chitosan mandelate, also referred to as chitosan mandelate or chitosan & mandelic acid according to the INCI name, means chitosan mandelate, as marketed under the trade name Chitosan MS® by Kraeber & Co GmbH (Germany). In this document, chitosan mandelate may be a chitosan mandelate containing between 50 and 70% by weight of chitosan and between 30 and 50% of mandelic acid. The chitosan mandelate may be chosen from chitosan mandelate of marine origin, for example obtained from marine organisms, and / or of fungal origin, for example obtained from mushrooms, or a mixture thereof.

[0043] When the chitosan mandelate is chosen from chitosan mandelate of marine origin, for example obtained from marine organisms, and / or of fungal origin, for example obtained from mushrooms, it can be considered as a product of natural origin within the meaning of the present invention. Preferably, the chitosan mandelate can be chosen from chitosan mandelate of fungal origin. It can be, for example, chitosan mandelate marketed by the company Kraeber & Co GMBH under the commercial reference Chitosan MS.

[0044] According to the invention, the oral composition may comprise chitosan mandelate as a film-forming agent.

[0045] According to the invention, the concentration of said at least one film-forming agent in the oral-dental composition may be from 0.02 to 1% by weight, for example from 0.025 to 0.25% by weight, for example from 0.05 to 0.15%, for example equal to 0.1% by weight, relative to the total weight of the composition.

[0046] Advantageously, the inventors have demonstrated that, despite the low concentration of the film-forming agent, the film-forming agent present in the composition makes it possible to form a film. In addition, the concentration of the film-forming agent makes it possible to reduce / lower the manufacturing cost of the composition. In the present invention, by fluoride salt is meant any fluoride salt known to those skilled in the art and commercially available suitable for an oral composition. It may be, for example, a fluoride salt chosen from the group comprising potassium fluoride, tin fluoride, amine fluoride, sodium fluoride, quaternary ammonium fluoride. It may be, for example, amine fluoride. It may be, for example, an amine fluoride of the following formula (I):

[0047] [Chem 1]

[0048] Formula (I) in which:

[0049] R 1 represents a hydrogen atom or a C1 to C6 alkyl group, for example R1 is H ;

[0050] R 2 represents a group -CH2OH, -CO2R 3 , where R 3 is a C1-C6 alkyl group, CONH(CH2)2OH, OR a group of formula (II)

[0051] [Chem 2]

[0052] Formula (II), and the R group 2 is in position 2 or 3 (relative to the nitrogen atom).

[0053] The term “C1 to C6 alkyl group” means a saturated, linear or branched hydrocarbon chain comprising 1 to 6, in particular 1 to 4, carbon atoms. The C1 to C6 alkyl group may be chosen from the group comprising methyl, ethyl, propyl, isopropyl, butyl, isobutyl, sec-butyl, tert-butyl, pentyl and hexyl groups. The fluorine salt may be nicomethanol hydrofluoride (fluorinol (registered trademark)), also known as nicomethanol hydrofluoride, which corresponds to a compound of formula (I) in which: R 1 is H and R 2is CH2OH and is in position 3 relative to nitrogen.

[0054] According to the invention, the concentration of said at least one fluorine salt in the oral composition may be from 1% to 10% by weight relative to the total weight of the composition. For example, the composition may be from 1.6% to 5.4% by weight, for example from 1.75% to 5.2% by weight, for example equal to 5% by weight relative to the total weight of the composition.

[0055] According to the invention, the oral composition may comprise from 400 ppm to 1,500 ppm of fluoride, for example from 500 to 1,400 ppm of fluoride, for example 1,450 ppm of fluoride.

[0056] Advantageously, when the fluorine salt is nicomethanol hydrofluoride, for example "fluorinol" ("registered trademark"), the composition according to the invention advantageously allows for greater remineralization compared to that obtained with known compositions comprising mineral fluoride. In other words, when the composition comprises a film-forming agent as defined above and a fluorine salt, for example nicomethanol hydrofluoride, the inventors have demonstrated that it advantageously allows for inhibiting the demineralization of the dental surface, for example of dental enamel, for example due to acidifying bacteria in the oral cavity. In addition, the inventors have also demonstrated that it advantageously allows for increasing the mineralization of the dental surface, for example of dental enamel.

[0057] As used herein, "silicones" or "silicone" means any commercially available silicone suitable for use in an oral composition and / or any silicone known to those skilled in the art. Examples include polysiloxanes, for example polysiloxanes in which organic groups such as hydrocarbon residues are attached to silicon atoms. Examples include any silicones known in the context of care products to those skilled in the art. This may be, for example, any silicone known under the INCI name “Silicone”, and / or under the specific names of silicones which end in “-methicone” - for example Dimethicone, Cyclomethicone, Phenyltrimethicone, Cetyl dimethicone copolyol, Dimethicone / Phenyl Vinyl Dimethicone Crosspolymer, Diphenyl Dimethicone for example - or which end in “-siloxane” - for example Cyclopentasiloxane, Polysiloxane, Cyclotetrasiloxane,

[0058] Hexamethyldisiloxane, Octamethylcyclotetrasiloxane,

[0059] Hexamethyldisiloxane, Drometrizole Trisiloxane. Il peut s’agir par exemple de silicone choisi dans le groupe comprenant les dimethicones, les cyclomethicones, les phenyltrimethicones, le cetyl dimethicone copolyol, le dimethicone / phenyl vinyl dimethicone crosspolymer, le diphenyl dimethicone, le cyclopentasiloxane, le polysiloxane, le cyclotetrasiloxane, l’hexamethyldisiloxane, l’octamethylcyclotetrasiloxane, l’hexamethyldisiloxane, le drometrizole trisiloxane.

[0060] In this document, by composition "free from", "exempt from", "free from", "without" or "does not contain" is meant the fact that the proportion and / or concentration of the substance and / or compound concerned is less than 0.3% by weight, for example less than 0.1% by weight, preferably less than 0.05% by weight, for example less than 0.01% by weight, relative to the total weight of the composition. More preferably, the proportion and / or concentration of the substance and / or compound concerned is 0% by weight relative to the total weight of the composition. This does not exclude the possible presence of traces of the substance and / or compound in small quantities, for example in the form of contamination or as a degradation product, for example in quantities less than 10 ppm, for example less than 5 ppm.

[0061] As used herein, "silicone-free" means a composition comprising a silicone concentration of less than 0.05% by weight, for example less than 0.01%, for example equal to 0% by weight of silicone relative to the total weight of the composition. In other words, a composition comprising less than 10 ppm of silicone, for example comprising 0 ppm of silicone, is meant.

[0062] According to the invention, the oral composition may be free of free calcium salt, for example calcium carbonate (CaCOs) and / or dicalcium phosphate, for example dicalcium phosphate, CaHPO4 and / or calcium hydrogen phosphate.

[0063] As used herein, "free of free calcium salt" means a composition comprising a concentration of free calcium salt of less than 0.05% by weight, for example less than 0.01%, for example equal to 0% by weight of free calcium salt relative to the total weight of the composition.

[0064] According to the invention, the oral-dental composition may be free of ingredients which are nanomaterials according to the definition of Recommendation 2011 / 696 / EU of October 18, 2011 of the European Commission (Reference 3).

[0065] In this document, "nanomaterial" means "nanomaterial" "a natural, accidentally formed or manufactured material containing free particles, in aggregate form or in agglomerate form, of which at least 50% of the particles, in the number size distribution, have one or more external dimensions between 1 nm and 100 nm" as mentioned in Recommendation 2011 / 696 / EU of 18 October 2011 of the European Commission (Reference 4).

[0066] As used herein, "free from nanomaterials" means a composition comprising a concentration of nanomaterials of less than 0.3% by weight, for example less than 0.1% by weight, for example less than 0.05% by weight, for example less than 0.01%, for example equal to 0% by weight of nanomaterials relative to the total weight of the composition.

[0067] Advantageously, the composition according to the invention may be free of other substances and / or ingredients. For example, the oral-dental composition may be an example of substances and / or ingredients considered in the state of the art to be controversial. These may be, for example, compounds known to be able, for example, to induce and / or cause side effects and / or have a negative effect on the environment, for example ecotoxic.

[0068] According to the invention, the oral composition may be free of Sodium Lauryl Sulfate (SLS). For example, the oral composition may be free of anionic surfactants comprising at least one sulfate group, for example a -O-SO3H or -O-SO2-O' group, for example laureth sulfate or lauryl sulfate.

[0069] As used herein, "free from sodium Lauryl Sulfate (SLS)" means a composition comprising a concentration of sodium Lauryl Sulfate (SLS) of less than 0.05% by weight, for example less than 0.01% by weight relative to the total weight of the composition.

[0070] In the present term "free from anionic surfactants comprising at least one sulfate group, for example a -O-SO3H or -O-SO2-O' group, for example laureth sulfate or lauryl sulfate", is understood to mean a composition comprising a concentration of anionic surfactants comprising at least one sulfate group, for example a -O-SO3H or -O-SO2-O- group, for example laureth sulfate or lauryl sulfate of less than 0.05% by weight, for example less than 0.01%, for example equal to 0% by weight relative to the total weight of the composition

[0071] According to the invention, the oral composition may be free of acrylate-functional compound, for example copolymer of methyl methacrylate and ethylene glycol dimethacrylate.

[0072] As used herein, "free from acrylate-functional compound" means a composition comprising a concentration of acrylate-functional compound of less than 0.05% by weight, for example less than 0.01%, for example equal to 0% by weight of acrylate-functional compound relative to the total weight of the composition.

[0073] According to the invention, the oral-dental composition may be free of preservatives chosen from parabens, for example methylparaben, methyl 4-hydroxybenzoate, ethylparaben, ethyl 4-hydroxybenzoate, propylparaben, isopropylparaben, butylparaben, isobutylparaben, benzylparaben.

[0074] In this document, the term "free from preservatives chosen from parabens" means a composition comprising a paraben concentration of less than 0.05% by weight, for example less than 0.01%, for example equal to 0% by weight of paraben relative to the total weight of the composition.

[0075] According to the invention, the oral-dental composition may be free of benzyl alcohol and / or phenoxyethanol.

[0076] As used herein, "free from benzyl alcohol and / or phenoxyethanol" means a composition comprising a concentration of benzyl alcohol and / or phenoxyethanol of less than 0.05% by weight, for example less than 0.01%, for example equal to 0% by weight of benzyl alcohol and / or phenoxyethanol relative to the total weight of the composition.

[0077] According to the invention, the oral composition may be free of triclosan or 5-chloro-2-(2,4-dichlorophenoxy)phenol.

[0078] As used herein, "free from triclosan or 5-chloro-2-(2,4-dichlorophenoxy)phenol" means a composition comprising a concentration of triclosan or 5-chloro-2-(2,4-dichlorophenoxy)phenol of less than 0.05% by weight, for example less than 0.01%, for example equal to 0% by weight of triclosan or 5-chloro-2-(2,4-dichlorophenoxy)phenol relative to the total weight of the composition.

[0079] According to the invention, the oral composition may be free of titanium dioxide (TiC).

[0080] As used herein, "free from titanium dioxide (TiO2)" means a composition comprising a titanium dioxide (TiC) concentration of less than 0.05% by weight, for example less than 0.01%, for example equal to 0% by weight of titanium dioxide (TiC) relative to the total weight of the composition.

[0081] According to the invention, the oral composition may be free of Poly Ethylene Glycols (PEGs). In the present invention, the term "free of Poly Ethylene Glycols (PEGs)" means a composition comprising a concentration of Poly Ethylene Glycols (PEGs) of less than 0.05% by weight, for example less than 0.01%, for example equal to 0% by weight of Poly Ethylene Glycols (PEGs) relative to the total weight of the composition.

[0082] According to the invention, the oral composition may further comprise at least one humectant. This may be any humectant known to those skilled in the art suitable for an oral composition. It may be, for example, a polyol, for example chosen from the group comprising glycerol, sorbitol, polyethylene glycol, polypropylene glycol, propylene glycol, propane, 3-diol and any mixture thereof. For example, the humectant may be sorbitol, for example obtained from a hydrogenated starch hydrolysate. It may be, for example, a commercially available hydrogenated starch hydrolysate (INCI name hydrogenated starch hydrolysate), for example under the reference Neosorb 70 / 70B, marketed in 70% anhydrous form and comprising approximately 30% water.In other words, the humectant may be selected from the group comprising glycerol, sorbitol, hydrogenated starch hydrolyzate, polyethylene glycol, polypropylene glycol, propylene glycol, propane, 3 diol and mixtures thereof. For example, the composition may comprise a humectant selected from the group comprising glycerol, sorbitol, and hydrogenated starch hydrolyzate.

[0083] According to the invention, the concentration of said at least one humectant in the composition may be between 2 and 80% by weight, for example between 3 and 75% by weight, for example between 5 and 70% by weight relative to the total weight of the composition.

[0084] Certain polyols which act as humectants may, by virtue of their nature as an saccharide derivative, contribute to imparting a sweet taste to the composition. Advantageously, said at least one humectant may prevent the oral composition from drying out, for example in the form of toothpaste, by binding the water in the composition and thus preventing its evaporation and / or by attracting moisture from the air during storage. According to the invention, the oral composition may comprise at least one thickening agent. For example, the oral composition may further comprise at least two thickeners. In the present invention, thickening agent means any thickening agent known to a person skilled in the art that is suitable and commercially available, for example suitable for use in an oral composition. In the present invention, the thickening agent may also be referred to as thickener or stabilizer.For example, the oral composition may comprise at least one thickener selected from the group comprising synthetic cellulose and / or cellulose derivatives, for example cellulose gum, for example carboxymethylcellulose (CMC, INCI name Cellulose Gum), carboxyethylcellulose, methylcellulose, ethylcellulose, carboxymethylhydroxyethylcellulose, hydroxypropylmethylcellulose, hydroxyethylcellulose and hydroxypropylcellulose as well as their salts, carrageenans for example sodium carrageenan, sodium alginate or algin, guar gums, for example Cyamopsis Tetragonoloba Gum, xanthan gum or xanthan gum, gellan gum or gellan Gum, gum arabic, gum tragacanth, carbomers or carbomer.This may be, for example, a commercially available thickener, for example, carboxymethylcellulose marketed under the name Blanose cellulose gum 7MF PH or WALOCEL CRT 1000 PA 07, xanthan gum marketed under the name Rheocare XGN, sodium alginate marketed under the name Safic Care TA 80-400, acacia gum / xanthan gum mixture marketed under the name Solagum AX, carrageenans marketed under the name Algogel CG2801 or Algogel 2501, gellan gum marketed under the name Kelcogel CG LA.

[0085] According to the invention, the concentration of said at least one thickener may be from 0.2 to 10% by weight, for example from 0.25 to 5% by weight, for example from 0.3 to 4% by weight, relative to the total weight of the composition. Advantageously, said at least one thickener may be at least one cellulose derivative. The cellulose derivative(s) may be chosen from the group comprising hydroxyethylcellulose, ethylcellulose, hydroxypropylcellulose, carboxymethylcellulose, carboxymethylhydroxyethylcellulose and mixtures thereof. For example, it may be carboxymethylcellulose, also known as carmellose. Carboxymethylcellulose is a very hygroscopic cellulose ether, for example used in the form of its sodium salt, sodium carboxymethylcellulose. It may be commercially available sodium carboxymethylcellulose, for example Blanose 7MF PH sold by the company Ashland.

[0086] According to the invention, when the composition comprises at least one cellulose derivative as thickener, the concentration of said cellulose derivative may be from 0.5 to 10% by weight or from 1 to 5% by weight, preferably from 1.5 to 4% by weight, in particular from 1.5 to 3% by weight, relative to the total weight of the composition.

[0087] Advantageously, said at least one thickener may be at least one polysaccharide, preferably of natural origin, for example sodium alginate. Alginate is an anionic polymeric polysaccharide, widely present in the cell walls of brown algae. It may be commercially available sodium alginate, for example marketed by the company Safic Alcan under the commercial reference Safic Care TA80-400.

[0088] In the present invention, when the composition comprises sodium alginate as a thickener, the concentration of said sodium alginate may be more than 0.05 up to 3% by weight or from 0.1 to 2.5% by weight, preferably from 0.2 to 1% by weight, in particular from 0.3 to 0.6% by weight, for example equal to 0.4% relative to the total weight of the composition.

[0089] In the present invention, said at least one thickener may be chosen from the group comprising cellulose derivatives and polysaccharides, preferably of natural origin, and mixtures thereof. For example, the oral composition may comprise two thickeners, for example at least one cellulose derivative and at least one polysaccharide, preferably of natural origin. For example, the oral composition may comprise two thickeners, for example at least one cellulose derivative and sodium alginate. For example, the oral composition may comprise two thickeners, for example sodium carboxymethylcellulose and sodium alginate. When the composition comprises two thickeners, the total concentration of the two thickeners may be from 0.5 to 10% by weight or from 1 to 5% by weight, preferably from 1.2 to 4% by weight, in particular from 1.3 to 3.6% by weight, relative to the total weight of the composition.For example, when the composition comprises a cellulose derivative and sodium alginate as thickeners, the total concentration of the two thickeners may be from 0.5 to 10% by weight or from 1 to 5% by weight, preferably from 1.2 to 4% by weight, in particular from 1.3 to 3.6% by weight, relative to the total weight of the composition.

[0090] According to the invention, when the composition comprises two thickeners, the ratio of the concentrations of said thickeners may be from 1 / 7 to 1 / 3, preferably from 1 / 6 to 1 / 4. In other words, the ratio of the concentrations of said thickeners may be from 0.14 to 0.33, for example from 0.17 to 0.25, for example equal to 0.2. Advantageously, the concentration of the thickener in the composition allows good stabilization of the composition, while being associated with a reduced manufacturing cost of the composition.

[0091] Advantageously, when the composition comprises at least one thickener or thickening agent, said at least one thickening agent may also advantageously have a gelling effect. In other words, said at least one thickener or thickening agent may also have a gelling agent function. In this case, thickeners with the dual function of thickener and gelling agent are referred to in the context of the present application. These may be, for example, sodium carboxymethylcellulose and / or sodium alginate. Advantageously, when the oral composition comprises at least one thickener, it advantageously makes it possible to thicken said composition by forming a network with water.

[0092] The inventors have demonstrated that the nature and quantity of the thickeners advantageously allows an optimization of the composition, advantageously making it possible to give the composition rheological properties adapted to the oral composition. In particular, the consistency and viscosity of the oral composition can advantageously be adapted so that the composition, for example when it is included in a container, for example a tubular container, for example a tube, can advantageously be easily extracted from the container, for example the tube, for example by pressing, in a controlled manner, said composition being advantageously, for example when applied to a brushing device, for example a toothbrush, firm and cohesive on said toothbrush. Advantageously, said composition does not flow or fall off said brushing device, for example the toothbrush.Advantageously, the thickener(s) may be chosen according to their ability to stabilize the composition over time, for example in order to avoid a phase separation of the components of said composition during its storage.

[0093] According to the invention, the oral-dental composition may further comprise at least one foaming agent. This may be, for example, any foaming agent known to those skilled in the art belonging to the class of surfactants.

[0094] The person skilled in the art, from this general knowledge, knows the HLB (hydrophilic-lipophilic-balance) which can be measured according to the method described in Griffin WC, Classification of Surface-Active Agents by HLB, Journal of the Society of Cosmetic Chemists 1 (1949): 311 (Reference 4), and makes it possible to quantify the balance existing between the hydrophilic part and the lipophilic part of the molecule, a balance linked to the solubility in water. The measurement varies from 0 to 20; the higher the value, the greater the solubility in water.Herein the foaming agent may be selected from the glutamate family, for example sodium cocoyl glutamate, for example commercially available under the trade name Amisoft (registered trademark) CS11 by Unipex, disodium cocoyl glutamate for example commercially available under the trade name Amisoft (registered trademark) ECS22W, disodium cocoyl glutamate for example commercially available under the trade name Eversoft UCS100, sodium myristoyl glutamate for example commercially available under the trade name Amisoft (registered trademark) MS11, sodium lauroyl glutamate (registered trademark) for example commercially available under the trade name Amisoft (registered trademark) LS11.As other examples of foaming agents, it may be a foaming agent chosen from the group of glucosides such as lauryl glucoside, for example, commercially available under the trade name plantacare 1200LIP, decyl glucoside, for example, commercially available under the trade name plantacare 2000UP, coco glucoside, for example, commercially available under the trade name Plantacare 818UP, or the taurate family, the glycinate family, the sarcosinate family, the lactylate family with sodium lauroyl lactylate, or coco betaine, for example, commercially available under the trade name Dehyton AB30.

[0095] According to the invention, the concentration of said at least one foaming agent may be from 0.5 to 8% by weight, for example from 1 to 6% by weight, relative to the total weight of the composition.

[0096] Advantageously, the foaming agent allows the formation of foam, dispersion of a large volume of gas in a small volume of liquid which adsorbs at the water-air interface.

[0097] Advantageously, the concentration of the foaming agent makes it possible to obtain a composition comprising good foaming power and good quality of the foam formed, while being associated with a reduced manufacturing cost of the composition. According to the invention, said at least one foaming agent may be chosen from the group comprising a non-ionic surfactant and an anionic surfactant.

[0098] In the present invention, the oral-dental composition may further comprise at least one non-ionic surfactant, preferably of plant origin, as a foaming agent. This may be, for example, at least one non-ionic surfactant chosen from the group comprising alkyl glucosides, for example alkyl glucosides in which the alkyl radical comprises from 8 to 16 carbon atoms, for example from 10 to 14 carbon atoms. This may be, for example, a non-ionic surfactant chosen from the group comprising alkyl glucosides in which the alkyl radical comprises from 8 to 16 carbon atoms, for example from 10 to 14 carbon atoms, chosen from the compounds with the INCI names octyl glucoside, lauryl glucoside and decyl glucoside. For example, the composition may comprise lauryl glucoside as a non-ionic surfactant. Preferably, the composition according to the invention comprises lauryl glucoside as the only non-ionic surfactant.

[0099] According to the invention, the concentration of said at least one non-ionic surfactant may be from 0.5 to 5% by weight, for example from 1 to 3% by weight, relative to the total weight of the composition.

[0100] According to the invention, the oral-dental composition may further comprise at least one anionic surfactant, preferably of plant origin, for example as a foaming agent. It may be, for example, at least one anionic surfactant chosen from the group comprising acyl glutamic acids and their salts. It may be, for example, at least one anionic surfactant chosen from acyl glutamic acids and their cosmetically and / or pharmacologically acceptable salts. It may be, for example, at least one anionic surfactant chosen from acyl glutamic acids whose acyl group comprises a linear or branched, saturated or unsaturated hydrocarbon chain of 8 to 30 carbon atoms, for example of 10 to 20 carbon atoms, for example of 12 to 18 carbon atoms. The acyl group may in particular be chosen from the lauroyl, myristoyl, palmitoyl, stearoyl, olivoyl, cocoyl and oleoyl groups.The cosmetically or pharmacologically acceptable salt of acyl glutamic acid may be chosen from alkali metal salts, alkaline earth metal salts and ammonium salts. It may be chosen, for example, from sodium, potassium, lithium or magnesium salts, the sodium and potassium salts being particularly preferred in the context of the invention. Said at least one anionic surfactant may be chosen from acyl glutamic acids and their cosmetically and / or pharmacologically acceptable salts chosen from the group comprising sodium cocoyl glutamate, disodium cocoyl glutamate, sodium myristoyl glutamate, sodium lauroyl glutamate, potassium lauroyl glutamate, potassium cocoyl glutamate and sodium stearoyl glutamate.

[0101] According to the invention, the oral-dental composition may further comprise at least two anionic surfactants chosen from acyl glutamic acids and their cosmetically or pharmacologically acceptable salts.

[0102] According to the invention, the oral-dental composition may comprise a single anionic surfactant chosen from acyl glutamic acids and their cosmetically or pharmacologically acceptable salts.

[0103] According to the invention, the concentration of said at least one anionic surfactant may be from 0.5 to 5% by weight, for example from 1 to 3% by weight, relative to the total weight of the composition.

[0104] According to the invention, the oral-dental composition may comprise as foaming agent a combination or mixture of at least one non-ionic surfactant(s) and at least one anionic surfactant(s), preferably of plant origin. It may be, for example, a combination or mixture of at least one non-ionic surfactant chosen from alkyl glucosides in which the alkyl radical comprises from 8 to 16 carbon atoms, for example from 10 to 14 carbon atoms and at least one anionic surfactant chosen from acyl glutamic acids whose acyl group comprises a linear or branched, saturated or unsaturated hydrocarbon chain of 8 to 30 carbon atoms, for example from 10 to 20 carbon atoms, for example from 12 to 18 carbon atoms, and their salts. For example, the oral composition may include lauryl glucoside and disodium cocoyl glutamate.

[0105] According to the invention, the oral composition may comprise lauryl glucoside and disodium cocoyl glutamate as foaming agents.

[0106] According to the invention, the total concentration of said at least one non-ionic surfactant and said at least one anionic surfactant may be from 1 to 8% by weight, for example from 2 to 6% by weight, relative to the total weight of the composition. For example, the ratio between said at least one non-ionic surfactant and said at least one anionic surfactant may be from 1 / 2 to 2 / 1, preferably from 1 / 1.5 to 1.5 / 1, for example 1 / 1. In other words, the concentration ratio by weight in the composition between said at least one non-ionic surfactant and said at least one anionic surfactant may be from 0.5 to 2, for example from 0.66 to 1.5, for example equal to 1.

[0107] Advantageously, the choice of said non-ionic surfactant and said anionic surfactant and their concentrations makes it possible to obtain a composition comprising good foaming power and good quality of the foam formed, while being associated with a reduced manufacturing cost of the composition.

[0108] According to the invention, the oral composition may be free of sodium lauryl sulfate (SLS) and / or alkyl sulfate salt ("alkyl sulfate salt"). In the present invention, "free of sodium lauryl sulfate (SLS) and / or alkyl sulfate salt ("alkyl sulfate salt")" means a composition comprising a concentration of sodium lauryl sulfate (SLS) and / or alkyl sulfate salt ("alkyl sulfate salt") of less than 0.05% by weight, for example less than 0.01%, for example equal to 0% by weight of sodium lauryl sulfate (SLS) and / or alkyl sulfate salt ("alkyl sulfate salt") relative to the total weight of the composition.

[0109] According to the invention, the oral-dental composition may be free of cationic surfactant. In the present invention, the term "cationic surfactant" means any cationic surfactant known to those skilled in the art which may be cited in the INCI dictionary (International Nomenclature of Cosmetic Ingredients) published by the PCPC (Personal Care Products Council).

[0110] As used herein, "free of cationic surfactant" means a composition comprising a concentration of cationic surfactant of less than 0.05% by weight, for example less than 0.01%, for example equal to 0% by weight of cationic surfactant relative to the total weight of the composition.

[0111] According to the invention, the oral composition may further comprise at least one abrasive or abrasive filler. This may be, for example, any abrasive and / or abrasive filler known to those skilled in the art suitable, for example, for use in an oral composition. This may be, for example, a cosmetically and / or pharmacologically acceptable abrasive or abrasive filler. This may be, for example, an abrasive or abrasive filler known to those skilled in the art that may be cited in the INCI (International Nomenclature of Cosmetic Ingredients) dictionary published by the PCPC (Personal Care Products Council). This may be, for example, an abrasive or abrasive filler chosen from a mineral abrasive filler or an organic abrasive filler or any mixture thereof.It may be, for example, an abrasive or abrasive filler selected from the group comprising silica, precipitated particulate silica, silicates, calcium carbonate, dicalcium phosphate, tricalcium phosphate, calcined alumina, sodium and potassium metaphosphate, sodium and potassium pyrophosphates, sodium trimetaphosphate, sodium hexametaphosphate, hydroxyapatite particles (in particles) and / or any mixture thereof. It may be an abrasive filler of mineral origin selected from the group comprising hydrated aluminosilicates, preferably of natural origin, for example volcanic glasses, preferably of natural origin, clays or clay minerals, preferably of natural origin or any mixture thereof. It may be, for example, volcanic glasses from Turkey. For example, volcanic glass may be perlite.This may be, for example, commercially available perlite, for example marketed by the company Imerys under the trade reference Imercare (trademark) Perlwhite 19. It may be, for example, an organic abrasive filler of plant origin, for example chosen from the group comprising rice powder (Oryza sativa), cellulose powder, preferably a microcrystalline cellulose powder, rice starch and any mixture thereof. It may be an organic abrasive filler of animal origin, for example chosen from the group comprising coral powder, shell powder, oyster shell powder and any mixture thereof.

[0112] According to the invention, the concentration of said at least one abrasive or abrasive filler in the composition may be from 0.1 to 20% by weight, for example from 0.5 to 10% by weight, 1 to 6% by weight relative to the total weight of the composition.

[0113] Advantageously, the concentration of abrasive filler in the composition makes it possible in particular to adapt the cleaning power of the oral-dental composition according to the invention. Advantageously, when the composition comprises abrasives or abrasive fillers, it can be useful for cleaning, for example mechanically and / or polishing the teeth and / or the dental surface. Advantageously, the composition can reinforce the action of brushing and advantageously makes it possible to eliminate and / or alter dental plaque and / or unsightly colorations on the teeth and / or the dental surface.

[0114] According to the invention, the oral-dental composition may further comprise water. This may be, for example, purified water. In the present invention, the water concentration may be from 3 to 95% by weight, for example from 5 to 90% by weight, for example from 10 to 90% by weight relative to the total weight of the composition.

[0115] The oral composition may comprise one or more cosmetically or pharmaceutically acceptable carrier(s). In this document, the term "cosmetically or pharmaceutically acceptable carrier" means any cosmetic carrier known to those skilled in the art; for example, it may be any cosmetic or pharmaceutical carrier that may be cited in the INCI (International Nomenclature of Cosmetic Ingredients) dictionary published by the PCPC (Personal Care Products Council).

[0116] The composition according to the invention may comprise one or more adjuvants known to those skilled in the art. This may be, for example, one or more adjuvant(s) chosen from ester-type agents, emollient agents, perfumes, ceramides and pseudo-ceramides, vitamins and provitamins, proteins, sequestering agents, alkalizing agents, acidifying agents, reducing agents, oxidizing agents, colorants, vitamins, flavorings, sweeteners, for example stevia, sodium saccharin, acesulfame potassium, xylitol or any other suitable adjuvant that may be cited in the INCI dictionary (International Nomenclature of Cosmetic Ingredients) published by the PCPC (Personal Care Products Council).

[0117] The composition may also comprise at least one preservative. This may be any preservative known to those skilled in the art suitable for use in an oral composition. This may be, for example, preservatives chosen from sodium benzoate, potassium sorbate, sodium propionate or antibacterial agents such as chlorhexidine, o-cymen 5 ol, cetylpyridinium chloride.

[0118] In the present invention, the concentration of said at least one preservative may be from 0.005 to 2% by weight, for example from 0.01 to 1.5% by weight, for example from 0.05 to 1% by weight relative to the total weight of the composition.

[0119] In the present invention, the oral-dental composition may comprise at least one cosmetically or pharmacologically acceptable excipient known to those skilled in the art suitable for this type of composition.

[0120] By "cosmetically or pharmacologically acceptable excipient" is meant any compound known to those skilled in the art useful in the preparation of a cosmetic or pharmaceutical composition which is generally safe, non-toxic and neither biologically nor otherwise undesirable and which is acceptable for use in human cosmetics or pharmaceuticals, including oral application.

[0121] By "cosmetically or pharmacologically acceptable" is meant any compound known to those skilled in the art useful in the preparation of a cosmetic or pharmaceutical composition which is generally safe, non-toxic and neither biologically nor otherwise undesirable and which is acceptable for use in human cosmetics or pharmaceuticals, including oral application.

[0122] Herein, the oral composition may, for example, be in any suitable form known to those skilled in the art. For example, the composition may be in liquid, semi-solid, or solid form. For example, the oral composition may be a liquid, fluid, gel, paste, or solid. For example, the oral composition may be in the form of a toothpaste, for example, in the form of a paste, gel, or solid. For example, the oral composition may be in the form of a gel or paste. For example, the composition may be in a liquid form, for example, in the form of a mouthwash.

[0123] For example, the composition according to the invention may be in the form of a toothpaste. It may be, for example, an oral composition that can be used in conjunction with a cleaning instrument, for example, a toothbrush, generally by applying it to the bristles of the toothbrush and then brushing the accessible surfaces of the oral cavity. It may be, for example, a toothpaste in the form of a paste, gel, powder, tablet, or liquid. For example, the composition according to the invention may be in the form of a toothpaste in the form of a paste or a gel.

[0124] When the composition is in the form of a toothpaste, it may further comprise at least one compound selected from the group comprising a thickener, a foaming agent, a non-ionic surfactant, an anionic surfactant, an abrasive filler, a humectant, water and any mixture thereof. The oral composition may be obtained by any suitable method known to those skilled in the art for the manufacture of a cosmetic and / or dermatological composition. It may be, for example, a simple mixture. It may be a mixture of surfactant materials in water.

[0125] This may be, for example, a method for manufacturing an oral-dental composition comprising the steps of: a) preparation of an oral-dental composition base, b) addition to the composition base prepared in step a) of at least one film-forming agent and at least one fluoride salt, c) recovery of the oral-dental composition obtained

[0126] Step a) may be carried out by any suitable method known to those skilled in the art. This may be, for example, any method for preparing an oral composition and / or oral composition base known to those skilled in the art. This may be, for example, a step comprising mixing, for example with stirring, for example, at least one humectant, at least one thickening agent and water. Step a) may be carried out at a temperature of 20 to 30°C, for example at 25°C.

[0127] According to the invention, preparation step a) can be carried out by any method known to those skilled in the art. This may, for example, involve mixing with stirring. The mixing in step a) can be carried out for a period of more than 10 minutes, for example from 10 minutes to 20 minutes. According to the invention, preparation step a) can be carried out in any suitable container known to those skilled in the art.

[0128] The addition of said at least one film-forming agent in step b) may be carried out by any suitable method known to those skilled in the art. This may, for example, involve adding said at least one film-forming agent to the composition or composition base obtained in step a), for example with stirring, for example until homogenization. The addition of said at least one fluorine salt in step b) may be carried out by any suitable method known to those skilled in the art. This may, for example, involve adding said at least one film-forming agent to the composition or composition base obtained in step a), for example with stirring, for example until homogenization.

[0129] For example, the duration of step b) may be longer than 15 minutes, for example between 15 minutes and 25 minutes.

[0130] According to the invention, the addition of said at least one film-forming agent and said fluorine salt in step b) may be concomitant or successive. For example, step b) may comprise the steps of: b') addition of said at least one film-forming agent, b”) mixing with stirring b'”) addition of said at least one fluorine salt in the mixture obtained in step b”) and b””) mixing with stirring

[0131] The addition of said at least one film-forming agent in step b') may be carried out by any suitable method known to those skilled in the art. This may, for example, involve adding said at least one film-forming agent to the composition or composition base obtained in step a) or to the composition obtained, for example with stirring.

[0132] For example, the duration of step b”) may be greater than 30 minutes, for example between 30 minutes and 40 minutes.

[0133] Step b”) can be carried out at a temperature of 20 to 30°C, for example at 25°C.

[0134] The addition of said fluorine salt in step b'”) may be carried out by any suitable method known to those skilled in the art. This may involve, for example, the addition of said at least one film-forming agent to the composition or mixture obtained in step b'”) or to the composition obtained.

[0135] For example, the duration of step b””) may be greater than 10 minutes, for example from 10 minutes to 20 minutes.

[0136] Step b”) can be carried out at a temperature of 20 to 30°C, for example at 25°C. According to the invention, the process can optionally comprise, prior to step c) of recovery, a step c') of adding to the composition obtained in step b) at least one abrasive or abrasive filler. The addition of said at least one abrasive or abrasive filler in step c') can be carried out by any suitable method known to those skilled in the art. This can be, for example, an addition with stirring.

[0137] For example, the duration of step c') may be greater than 5 minutes, for example from 5 minutes to 10 minutes.

[0138] Step c') can be carried out at a temperature of 20 to 30°C, for example at 25°C.

[0139] According to the invention, the method may comprise, prior to recovery step c), a step b1) of adding to the composition obtained in step b) a base comprising at least one foaming agent and optionally at least one colorant. The addition of the base comprising at least one foaming agent and optionally at least one colorant to step b1) may be carried out by any suitable method known to those skilled in the art. This may, for example, be an addition with stirring. For example, the duration of step b1) may be greater than 15 minutes, for example from 15 minutes to 25 minutes. Step b1) may be carried out at a temperature of 20 to 30°C, for example at 25°C.

[0140] The oral composition can be used in cosmetic care, for example, cosmetic care for cleaning the dental surface.

[0141] In this document, the term "cosmetic care" means, for example, the application to the dental surface of an oral-dental composition according to the invention, for example by means of an applicator, for example a brushing device, for example a toothbrush, for example a manual or electric toothbrush.

[0142] The present invention also relates to a method for non-therapeutic cosmetic treatment of the oral cavity comprising the application to a dental surface of a composition according to the invention. The present invention also relates to the use of the oral-dental composition according to the invention for cleaning a dental surface in a human or an animal.

[0143] As used herein, dental surface means a surface of a natural tooth or a hard surface of an artificial denture, for example a crown, cap, filling, bridge, dental implant, etc.

[0144] The present invention also relates to the composition according to the invention for its use in remineralizing teeth.

[0145] In this document, "remineralizing teeth" means in particular the repair of enamel by integrating calcium and phosphate in the form of hydroxyapatite and / or fluorapatite into the mineral body of the teeth.

[0146] The inventors have demonstrated, surprisingly and unexpectedly, that the composition according to the invention advantageously makes it possible to delay or inhibit the formation of bacterial biofilm on a surface, for example a biotic surface, for example the dental surface. The inventors have also demonstrated, surprisingly and unexpectedly, that the composition according to the invention has an effect on the initial formation of the biofilm, for example the adhesion and adhesion stages, for example by preventing the adhesion of bacteria to the surface.

[0147] Also, the present invention also relates to the composition according to the invention for its use for the prevention and / or inhibition of the formation of a biofilm on a surface.

[0148] In this document, by biofilm is meant any biofilm known to those skilled in the art formed by a microorganism, for example it may be a bacterial biofilm. In this document, by bacterial biofilm is meant any biofilm known to those skilled in the art capable of being formed by a bacterium. It may be, for example, a biofilm formed by a bacterium chosen from the group comprising Streptococcus mutans, Streptococcus salivarius and Streptococcus sanguinis.

[0149] In this context, by surface is meant any surface known to those skilled in the art on which a biofilm can form. This may be, for example, a biotic surface, for example a biotic surface chosen from the group comprising the skin, mucous membranes, teeth, preferably the dental surface.

[0150] In this case, the bacterial biofilm may be the dental biofilm.

[0151] The present invention also relates to a non-therapeutic cosmetic treatment kit for the oral cavity comprising an oral composition according to the invention and a support comprising instructions for the use of the oral composition.

[0152] The support comprising instructions for the use of the oral-dental composition according to the invention may be a manual or a leaflet which may have the function in particular of explaining to the user the manner and frequency of application of the composition of said present invention.

[0153] The cosmetic care kit may also include an applicator, for example a dynamic applicator, for example manual or electric, for example a brushing device, for example a manual or electric toothbrush.

[0154] Other advantages may still appear to those skilled in the art upon reading the examples below, given for illustrative purposes.

[0155] Example 1: Examples of oral compositions in the form of toothpaste

[0156] The example below describes different examples of compositions (Tables 1 to 4) according to the invention in the form of toothpaste.

[0157] Table 1: Oral composition in the form of toothpaste [Table 1]

[0158]

[0159] Table 2: Oral composition in the form of toothpaste [Table 2]

[0160] Table 3: Oral composition in the form of toothpaste [Table 3] Table 4: Oral composition in the form of a green, shiny, odorous gel [Table 4]

[0161] In the present example, the composition described in Table 4 below was prepared according to the general method comprising the following steps: a) preparation of a mixture A comprising at least one thickener, for example cellulose gum and / or sodium alginate, and glycerin (humectant). b) Homogenization of said mixture A by stirring with a Rayneri paddle stirrer or by magnetic stirring c) Preparation of a mixture B comprising at least one foaming agent, for example lauryl glucoside and / or disodium cocoyl glutamate and optionally at least one colorant d) In a main reactor, namely a glass beaker of suitable size, introduce sorbitol, for example in the form of hydrogenated starch hydrolyzate, purified water and a film-forming agent, for example chitosan mandelate e) Stir using a Rayneri paddle stirrer for at least 30 min at room temperature,namely 20°C in order to obtain a homogeneous mixture C, f) Optionally adding at least one preservative to mixture C, and at least one sweetener, g) Introduction of the fluoride salt into mixture C and stirring for homogenization, for example for at least 10 min, for example for at least 15 minutes, and obtaining a mixture D, h) Introduction of mixture A with stirring for at least 15 min until complete homogenization of the final formula. The step of introducing mixture A may be prior to or subsequent to the step of introducing the abrasive filler, i) Introduction of the abrasive filler into mixture D and stirring, for example for at least 15 minutes, until complete homogenization and obtaining a mixture F, j) Introduction of mixture B with stirring for at least 15 min until complete homogenization of the final formula.,

[0162] For example, the composition described in Table 4, in the main reactor, namely a glass beaker of suitable size, sorbitol (Hydrogenated starch hydrolysate, aqua), purified water and chitosan mandelate were added. The whole was stirred using a Rayneri paddle stirrer until completely homogenized at room temperature, namely 20°C. Once the mixture was homogeneous, translucent without agglomerates, in the mixture the sweetener, the preservative, the colorants and the nicomethanol hydrofluoride were solubilized. In an additional reactor, namely a glass beaker, a gel of carmellose sodium ("cellulose gum") and sodium alginate with glycerin was prepared and stirred using a Rayneri paddle stirrer until completely homogeneous.

[0163] In the main reactor, the gel previously prepared above was prepared. Then the abrasive was added and stirring at 800 rpm was maintained for at least 15 minutes to have a perfect dispersion of the powder. While stirring, the aroma was added and finally added the foaming agents, for example lauryl glucoside and disodium cocoyl glutamate type. The composition obtained was a shiny homogeneous toothpaste.

[0164] Example 2: Examples of oral compositions in the form of mouthwash

[0165] The example below describes an example of an oral composition (Table 5) according to the invention in the form of toothpaste.

[0166] Table 5: Oral composition in the form of a green, shiny, odorous gel

[0167] [table 5]

[0168] Example 3: Study of the anti-biofilm effect of film-forming agent

[0169] In the example below, an evaluation of the anti-biofilm effect, in particular the inhibition of bacterial adhesion to a surface, of a film-forming agent was carried out.

[0170] In this example an in vitro test involving the use of film-forming agent against bacterial adhesion was carried out. The bacteria used was Streptococcus mutans (S. mutans), strain CIP 103220T A / Material

[0171] Bacterial culture was carried out in Columbia agar medium comprising 5% sheep red blood cells (Biomérieux) by incubation at 36 ± 1 °C, under anaerobic conditions.

[0172] The saliva used was human saliva collected with the Salivette device (trademark) then centrifuged at 3600 rpm for 10 minutes, pooled and immediately filtered through a sterile 0.45 µm membrane.

[0173] The hydroxyapatite pellet corresponding to the support used had a diameter of 9.4 mm, thickness: 1.8 mm (Supplier: Clarkson Chromatography Products Inc, USA). The support was sterilized at 121 °C for 15 to 20 minutes.

[0174] A neutralizing medium was used and included Tween 80, (10% by weight), saponin (2% by weight), lecithin (2% by weight), sodium thiosulfate (0.5% by weight) and Trypcase Soy Broth (qs 100% by weight (Laboratory Preparation)).

[0175] A modified biofilm medium or minimal medium used was prepared according to the procedure below. Preparation of modified biofilm medium 10x (FeSO4, 7H2O 0.005g / L, Na2HPO412.5g / L, KH2PO4 5g / L, (NH4)2SO4 1g / L and glucose 0.5g / L - Laboratory preparation) addition of MgSO4 100x (20g / L - Laboratory preparation) diluted just before the tests to the concentration used (Modified Biofilm Broth, MBB).

[0176] The conditions for counting adherent or suspended cells were as follows: Schaedler Broth (Schaedler Agar), incubation for 72 hours at 36 ± 1 °C, under anaerobic conditions, then counting of colony-forming units (CFU).

[0177] The film-forming agents used were Chitosan Mandelate (Chitosan & mandelic acid; chitosan MS, Kraeber & Co GmbH, Germany) at 0.1% or 0.05% and siliglycol (silicone) at 1%.

[0178] Bl Methods Evaluation of the adhesion of S. mutans on a surface

[0179] Steps before the assessment:

[0180] - Preparation of hydroxyapatite pellets (supports) by covering them with human saliva (1 mL) for 16 hours at room temperature.

[0181] - Preparation of S. mutans inoculum with sterile distilled water at 10 8 CFU / mL

[0182] - Homogenization of the compositions to be tested (see below) by stirring for 5 minutes before the test.

[0183] Treatment of hydroxyapatite pellets (supports) with test compositions (including film-forming products, see below) and incubation with S. mutans:

[0184] - the supports were deposited in microplate wells (24-well plates). 2 mL of different compositions comprising at least one film-forming agent, namely compositions comprising different concentrations of chitosan mandelate or 1% siliglycol, were added. The compositions were preheated to 32°C before addition. Distilled water was used as a control. Two hydroxyapatite pellets per condition (product / concentration) were treated to evaluate them over different incubation times, namely 2, 4, 8 or 24 hours.

[0185] - After 1 minute of contact, the supports were removed without rinsing, then introduced into a new well containing 2mL of MBB and 100pL of S. mutans at 10 7 CFU / mL. For this incubation with S. mutans the film-forming agent present in the form of a film on the hydroxyapatite supports remains. The effect of the presence of the film-forming agent on the surface in the form of a film on the adhesion of bacteria was then evaluated as described below:

[0186] - The microplates were incubated for 1 h at 36 ± 1 °C, under anaerobic conditions. The supernatant was then aspirated and replaced again with 2 mL of MBB and 100 mL of S. mutans at 10 7 CFU / mL.

[0187] - A count of the aspirated supernatant was carried out for each condition (product / concentration) in order to detect a possible bactericidal effect of the products independent of the film-forming effect: reduction in the number of bacteria in the supernatant (planktonic cells) compared to the control well.

[0188] - The microplates were again incubated at 36 ± 1 °C, under anaerobic conditions, for 2h, 4h, 8h and 24h. Incubation in MBB medium (minimal medium) allowed proliferation of bacteria only in conditions of adhesion to the support: in the medium, non-adherent cells survive, but do not proliferate (unlike adhering cells). In the presence of the film-forming agent, a study of the possible effect of the latter, particularly on adhesion, was studied. This involved studying whether a decrease in the adhesion of bacteria to the surface, namely to the surface of hydroxyapatite pellets (supports) was observed. In other words, a study of the possible inhibition of the adhesion of bacteria to the hydroxyapatite support compared to the control wells as a function of incubation time was carried out.

[0189] - After each incubation time, the supports corresponding to the incubation time T were removed from their respective wells and rinsed 3 times with 2 mL of sterile distilled water. Then, each support was scraped in the presence of 2.5 mL of sterile distilled water. The suspensions and supports were homogenized by vortexing (30 seconds) and CFU counts were performed using Schaedler Broth (preparation of the different dilutions of the suspensions to include the dilution adapted to the number of CFU of the condition, inclusion of 1 mL of each dilution in Schaedler Broth).

[0190] - A CFU count of the supernatant in different wells was also carried out after each incubation time. This count was carried out again as a control in order to detect a potential impact of the pretreatment on the inoculum, independent of the film-forming effect.

[0191] - After incubation for 72 hours at 36 ± 1 °C, under anaerobic conditions, the CFU were counted. For cells adherent to the support, namely the hydroxyapatite pellets, the CFU values ​​are expressed as Log CFU / pellet.

[0192] - The tests were carried out in duplicate.

[0193] Cl Results

[0194] The results obtained concerning the adhesion of bacteria on the surface as a function of incubation with the compositions are shown in Tables 6 and 8 below. a) In a first series, the compositions used corresponded to:

[0195] - three compositions comprising a film-forming agent in purified water:

[0196] Chitosan MS 0.1%: Chitosan mandelate (Chitosan & mandelic acid; chitosan MS) at 0.1% by weight relative to the total weight of the composition

[0197] Chitosan MS 0.05%: Chitosan mandelate (Chitosan & mandelic acid; chitosan MS) at 0.05% by weight relative to the total weight of the composition

[0198] Siliglycol 1%: Siliglycol (silicone) 1% by weight relative to the total weight of the composition

[0199] - Control: purified water

[0200] The results obtained are shown in Table 6 below.

[0201] [table 6]

[0202] As demonstrated in Table 6 above, a delay or inhibition of biofilm formation (adherent cells on support) was observed for the compositions comprising chitosan mandelate at 0.1% by weight and 0.05% by weight. This delay or inhibition of bacterial development clearly and unexpectedly demonstrates a film-forming effect of chitosan mandelate with an effect on bacterial adhesion at these concentrations. When the composition comprises chitosan mandelate at a concentration of 0.1% by weight, a delay or inhibition of adhesion was observed for up to 8 hours of incubation. When the composition comprises chitosan mandelate at a concentration of 0.05% by weight, a delay or inhibition of adhesion was observed for up to 4 hours of incubation. The results obtained clearly demonstrate that incubation with a solution comprising 1% by weight of siliglycol has no effect on bacterial adhesion.

[0203] Two additional solutions comprising respectively Chitosan Mandelate (Chitosan & mandelic acid; chitosan MS) at 0.25% and 0.5% by weight relative to the total weight of the composition were used. The results obtained demonstrated a bactericidal effect of the composition, namely a reduction in the number of bacteria in the supernatant compared to control conditions. This bactericidal effect did not allow an independent quantitative evaluation of a possible film-forming effect (results not provided).

[0204] As demonstrated, the results clearly and unexpectedly demonstrate that chitosan mandelate at the tested concentration advantageously delays or inhibits bacterial adhesion to a surface, for example, a hydroxyapatite surface. The results also clearly demonstrate that chitosan mandelate advantageously delays or inhibits biofilm formation on a surface, for example, a hydroxyapatite surface, by inhibiting bacterial adhesion to said surface. b) In a second series of tests, a comparative test was carried out. The compositions used were:

[0205] - an example of an oral-dental composition according to the invention, namely toothpaste comprising 0.1% by weight of chitosan mandelate relative to the total weight of the composition, said composition being free of silicone (“Composition A”),

[0206] - an example of an oral-dental composition in the form of a toothpaste comprising a silicone, namely siliglycol, as a film-forming agent at a concentration of 1% by weight relative to the total weight of the composition (“Composition B”), and

[0207] - a composition (“0.1% chitosan ms solution”) comprising chitosan mandelate in purified water at a concentration of 0.1% by weight relative to the total weight, and

[0208] - an example of an oral composition in the form of a toothpaste without silicone and without chitosan mandelate (“Composition A without film-forming agent”).

[0209] The tested compositions are described in Table 7 below. The concentrations mentioned in Table 7 are expressed as a percentage by weight relative to the total weight of the composition.

[0210] Table 7: tested compositions [table 7]

[0211] Table 8 below represents the results of the anti-adhesion tests in Log CFU / Support carried out with each composition listed in Table 7. NT corresponds to the results obtained after incubation in the absence of compositions (control). [Table 8]

[0212] As demonstrated in Table 8 above, an example of a composition in the form of a toothpaste according to the invention advantageously and surprisingly inhibits bacterial adhesion to a surface. Furthermore, the results clearly demonstrate that the example of a composition in the form of a toothpaste makes it possible to reduce by a factor of 2.8 the quantity of bacteria adhered to the surface compared to the known composition, for example comprising a silicone as a film-forming agent. In other words, surprisingly, the anti-adhesion effect is 2.8 times greater for an example of an oral composition according to the invention comprising 0.1% chitosan mandelate as a film-forming agent compared to a composition of the prior art comprising 1% siliglycol (silicone) as a film-forming agent.Furthermore, the results clearly demonstrate that the present invention makes it possible to obtain an anti-adhesion effect at least twice as high with a composition comprising a concentration of film-forming agent 10 times lower.

[0213] Example 4: Study of the remineralizing power and / or remineralization of teeth

[0214] In this example, a study of the remineralization, in other words the remineralizing power, of a combination of fluorine and a film-forming agent was carried out.

[0215] A / Solution test

[0216] The aim is to test the remineralizing power of a fluoride salt solution in the presence of chitosan mandelate, in comparison with a fluoride salt solution without this product.

[0217] In this example the Nicomethanol Hydrofluoride came from Pierre Fabre Oral Care (France).

[0218] In this example, chitosan mandelate was the product sold under the name Chitosan MS by Kraeber & Co GmbH (Germany).

[0219] Two solutions were prepared in demineralized water:

[0220] - Nicomethanol Hydrofluoride Solution 5% by weight relative to the total weight of the composition (1400 ppm)

[0221] - Nicomethanol Fluorhydrate solution 5% by weight relative to the total weight of the composition (1400ppm) comprising 0.1% by weight relative to the total weight of the chitosan mandelate composition.

[0222] As a positive control, a prior art commercial mouthwash, namely the product sold under the name Eluday Sensibilité (Pierre Fabre Oral Care), not comprising chitosan mandelate, and comprising nicomethanol hydrofluoride at 225 ppm was used. Purified water was used as a negative control.

[0223] Human enamel samples were studied in a cyclic treatment model including treatment with the test products and storage in artificial saliva solution. Time-of-flight secondary ion mass spectrometry (TOF-SIMS) analysis was performed to compare fluoride uptake at the surface and in the upper layers of the enamel: up to approximately 4 pm depth (see below).

[0224] Human enamel samples were obtained from human molars (assessment on 3 teeth / condition) separated into samples using a diamond blade saw, embedded in epoxy resin and then polished.

[0225] First, the polished enamel samples were subjected to 1% citric acid (pH 3.8) for 15 minutes. In other words, the polished enamel samples were incubated for 15 minutes in a solution comprising a concentration of 1% by weight of citric acid, the pH of the solution was pH 3.8. This step corresponds to an "early erosion" type demineralization, simulating the reality of the human oral environment, for example during food intake.

[0226] In a cyclic procedure, samples were treated twice daily for 10 days (20 treatments in total) with the test product for 1 min and rinsed with deionized water. Between treatments, human enamel samples were preserved in artificial saliva. Product preparations were renewed at each cycle.

[0227] Artificial saliva was prepared by mixing the following ingredients:

[0228] ■ Mucin (pig stomach) 2.5 g / L

[0229] ■ Sodium chloride 3.5 g / L ■ Potassium chloride 0.2 g / L

[0230] ■ Calcium chloride dihydrate 0.2 g / L

[0231] ■ Yeast extract 2.0 g / L

[0232] ■ Beef extract 1.0 g / L

[0233] ■ Proteose peptone 5.0 g / L then autoclaved for 15 min at 121°C, then added 1.25 mL of 40% urea, and obtained a solution corresponding to artificial saliva.

[0234] Time-of-flight secondary ion mass spectrometry (TOF-SIMS) is a highly sensitive technique for analyzing the surface of a sample. This method allows analysis of the uppermost layers, for example, down to a depth of 4 pm. In other words, the very first layers are examined (a few pm). Indeed, the use of a sputtering ion gun allows the removal of a surface and the subsequent analysis of a freshly opened "new" surface, generating depth profiling with a resolution of nm accuracy.

[0235] Depth profiling was performed by TOF-SIMS (M6, lontof, Germany) with a measuring area of ​​70x70 pm 2 and a sputter time of 0 to 7000 seconds (s) to identify the fixation of fluoride (F-) on the surface and in depth of the enamel.

[0236] The applied spray time of 7000 seconds corresponds to a surface depth of approximately 4 to 4.5 pm. In general, a longer spray time corresponds to a greater depth. For further interpretation and quantification, the average values ​​of the respective fluoride intensities (F _ ) were calculated for each sample between 500 and 7000 s, 1500 and 2500 s as well as 5000 and 7000 s (areas which represent layers of different depths).

[0237] Statistical evaluation was performed by one-way ANOVA and Bonferroni post-hoc test, as well as analysis of variance by Brown-Forsyth test. Data were expressed as fluoride signal intensity of the averaged profile: mean obtained from 3 samples, signal intensity expressed in counts (arbitrary units) over the selected sputter time (seconds). The results obtained from depth profiling by TOF-SIMS are presented in Table 9 for the entire profile evaluated (500-7000 s) as well as for selected sputter time zones: 1500-2500 s and 5000-7000 s.

[0238] [table 9]

[0239] The results clearly demonstrate that the averaged profiles for all the products applied the F' intensities are higher than the results obtained for the control group (water), clearly demonstrating a fixation of fluoride in the enamel and therefore a remineralization.

[0240] The results also clearly demonstrate that the compositions in the form of a solution comprising 5% by weight of nicomethanol hydrofluoride allow obtaining intensities higher than the reference mouthwash (225 ppm F'). This may mainly be a concentration effect: the greater the quantity of fluoride present in the tested solution, the greater the quantity of fluoride fixed on the enamel.

[0241] As demonstrated, for all tested compositions, the intensity decreases with increasing spraying time corresponding to deeper layers in the enamel.

[0242] The results also clearly and surprisingly demonstrate that the presence of chitosan mandelate in the composition advantageously increases the F' intensity, clearly demonstrating an increase in fluoride fixation and therefore an increase in remineralization.

[0243] The results demonstrate that the average F' signal obtained over the overall depth (500-7000 seconds) increases, when the composition includes chitosan mandelate, by 62%. The results also clearly demonstrate a significant increase in the F- signal obtained for the analysis of the 1500 - 2500 s and 5000 - 7000 s spraying time windows with an increase factor of 5.27 and 9.53, respectively. The largest difference (factor of about 10) is therefore observed in the 5000 - 7000 s area which corresponds to the deepest enamel layers examined.The results clearly and surprisingly demonstrate that an example of an oral-dental composition according to the invention comprising at least one film-forming agent chosen from the group comprising chitosan and / or its derivatives, and at least one fluorine salt, said composition being free of silicone, advantageously and surprisingly allows the remineralization of the teeth to be increased, for example it advantageously allows an increase in the incorporation of fluorine into the deeper regions of the enamel. Furthermore, even more surprisingly, the results were obtained with a composition comprising a very low concentration, namely 0.1% by weight of film-forming agent. B / Test in a toothpaste base.

[0244] In this example, a test of the remineralizing power of the compositions described in Table 10 below was carried out. The compositions differ only in the fluorine salt present (NaF or nicomethanol hydrofluoride). The quantities of fluorine present in the compositions are identical (1400 ppm). The compositions tested are described in Table 10 below.

[0245] Table 10: Oral-dental compositions in the form of toothpaste [table 10]

[0246] Human enamel samples were studied in a cyclic treatment model including treatment with the test products and storage in artificial saliva solution. Time-of-flight secondary ion mass spectrometry (TIF) analysis was performed.

[0247] TOF-SIMS) was performed to compare fluoride fixation, and therefore remineralization, on the surface and in the upper layers of the enamel (approximately 3 pm depth).

[0248] The Materials and Method correspond to that described above in Part A except for the preparation of the samples of the compositions in the form of toothpaste which were prepared as suspensions of toothpaste in demineralized water: 1 part of toothpaste to 2 parts of demineralized water, vol / vol to mimic the conditions of use. The treatment time in the cyclic treatment model of human enamel samples, namely each human enamel sample treated twice a day for 10 days - 20 treatments in total - with the tested product, evaluation on 3 human enamel samples / tested product, was 2 min for each cycle.

[0249] For the interpretation of the results, the mean values ​​of the respective F' intensities per sample (data expressed as fluoride signal intensity of the averaged profile: mean obtained from 3 samples, signal intensity expressed in counts (arbitrary units)) were calculated for the different depths: between 50 and 250 nm, 750 and 1500 nm as well as 2000 and 3000 nm. Measurements were carried out after 1 single treatment and after 20 treatments.

[0250] The results of the F' intensities measured according to the different depths in the enamel selected after a single treatment are presented in Table 11.

[0251] Table 11: F- intensity measured after treatment [table 11]

[0252] The results of the F' intensities measured according to the different depths in the enamel selected after 20 treatments are presented in Table 12.

[0253] Table 12: F' intensity measured after 20 treatments [table 12]

[0254] As demonstrated in Table 12 above, a comparison of the intensities as a function of depth shows higher F' intensities for both compositions in toothpaste form compared to the control group (water). The results obtained clearly demonstrate that compositions, for example in toothpaste form, comprising chitosan fluoride and mandelate induce remineralization from the first treatment

[0255] The results surprisingly demonstrate that after 20 treatments, the toothpaste composition including Nicomethanol Hydrofluoride demonstrates a significantly higher remineralizing power than the same base with NaF, for all depths analyzed. This difference is more pronounced for the deepest area analyzed.

[0256] The results clearly and surprisingly demonstrate that examples of oral-dental composition according to the invention comprising at least one film-forming agent chosen from the group comprising chitosan and / or its derivatives, and at least one fluorine salt, said composition being free of silicone, advantageously and surprisingly allows to increase the remineralization of the teeth, for example it advantageously allows an increase in the incorporation of fluoride in the deeper regions of the enamel. Furthermore, even more surprisingly, the results were obtained with a composition comprising a very low concentration, namely 0.1% by weight of film-forming agent. In addition, the results demonstrate that the example of composition according to the invention comprising a fluorine salt or nicomethanol hydrofluoride and chitosan mandelate advantageously allows an incorporation of fluoride in the enamel.Furthermore, the results demonstrate that examples of the composition according to the invention comprising a fluorine salt or nicomethanol hydrofluoride and chitosan mandelate advantageously allow fluoride incorporation into the enamel, and in particular in deeper regions, for example after several applications of the composition. The results also surprisingly demonstrate that fluoride incorporation was higher after several applications when the composition comprises nicomethanol hydrofluoride, compared with NaF as the fluoride source.

[0257] The results clearly and surprisingly demonstrate that an example of an oral-dental composition according to the invention comprising at least one film-forming agent chosen from the group comprising chitosan and / or its derivatives, and at least one fluoride salt, said composition being free of silicone, advantageously and surprisingly allows for increased remineralization and / or remineralization of the teeth, for example it advantageously allows for an increase in the incorporation of fluoride into the enamel. Example 5: Study of the remineralizing power and / or remineralization of teeth

[0258] In this example, a study of the remineralization, in other words the remineralizing power, of a combination of fluorine and a film-forming agent was carried out.

[0259] A test of the remineralizing power of the compositions described in Table 13 below was carried out. The compositions differ only in the presence or absence of active ingredients and in the concentrations of aroma and coloring. The quantities of fluoride present in the compositions were identical (1400 ppm). The compositions tested are described in Table 13 below.

[0260] Table 13: Oral-dental compositions in the form of toothpaste [table 13]

[0261] Human enamel samples were studied in a cyclic treatment model including treatment with the test products and storage in artificial saliva solution. Time-of-flight secondary ion mass spectrometry (TOF-SIMS) analysis was performed to compare fluoride uptake, and thus remineralization, in enamel layers down to approximately 5 μm in depth.

[0262] The Materials and Method correspond to those described above in Part B of Example 4 above.

[0263] For the interpretation of the results, the mean values ​​of the respective F' intensities per sample (data expressed as fluoride signal intensity of the averaged profile: mean obtained from 3 samples, signal intensity expressed in counts (arbitrary units)) were calculated for the different depths: between 100 and 500 nm, 500 and 2000 nm as well as 2000 and 5000 nm. Measurements were carried out after 1 single treatment and after 20 treatments.

[0264] In this example, the fluoride (F-) signal intensities (counts) have been normalized to the total negative ion counts in the sample. In other words, the F' ion signal is expressed as a ratio of the F' ion intensity signal (counts) to the sum of the negative ion intensities (counts) present in the sample. The contribution of F- ions to the total negative ion signal (sum of intensities) can be neglected, and the total negative ion signal (sum of intensities) is considered representative for the sample size in question. This normalization minimizes errors induced by possible variability in sample size. The results of the normalized F' intensities, measured as a function of the different enamel depths selected after a single treatment, are presented in Tables 14 and 15.

[0265] Table 14: Normalized F- intensity, measured after one (1x) or twenty (20x) treatments for composition C

[0266] [table 14]

[0267] Table 15: Normalized F- intensity, measured after one (1X) or twenty (20X) treatments for composition D [Table 15]

[0268] As demonstrated in Tables 14 and 15 above, a comparison of intensities as a function of depth shows higher normalized F' intensities for both compositions in toothpaste form compared to the control group (water).

[0269] Furthermore, the results clearly demonstrate, by measuring the F' intensity (normalized counts ± SD), that both compositions induce fluoride incorporation (compared with water as a negative control), including in the deeper layers of the enamel, namely from 2000 nm to 5000 nm in depth, from the 1 èreuse. This effect is accentuated with repeated use: the use of 20 treatments induces a stronger incorporation of fluoride, including for the deeper layers of the enamel.

[0270] The results obtained demonstrate that examples of oral-dental compositions according to the invention comprising nicomethanol hydrofluoride and chitosan mandelate advantageously allow remineralization from the first treatment.

[0271] The results also demonstrate that examples of oral-dental composition according to the invention comprising chitosan mandelate, and nicomethanol hydrofluoride, said composition being free of silicone, makes it possible to increase the remineralization of the teeth, for example it advantageously allows an increase in the incorporation of fluoride in the deeper regions of the enamel, in particular after several applications of the composition. Furthermore, more surprisingly, the results were obtained with a composition comprising a very low concentration, namely from 0.05 to 0.15% by weight of film-forming agent

[0272] REFERENCES

[0273] 1. Gullo Augusto et al, Film-Forming Polymers for Tooth Erosion Prevention, Polymers 14 (2022): 4225

[0274] 2. ISO 16128 standard published in September 2017 3. Recommendation 2011 / 696 / EU of 18 October 2011 of the

[0275] European Commission

[0276] 4. Griffin WC, Classification of Surface-Active Agents by HLB, Journal of the Society of Cosmetic Chemists 1 (1949): 311

Claims

CLAIMS 1. Oral-dental composition comprising at least one film-forming agent chosen from the group comprising chitosan and / or chitosan mandelate, and at least one fluorine salt, said composition being free of silicone.

2. Composition according to claim 1, in which the concentration of said at least one film-forming agent is from 0.02 to 1% by weight relative to the total weight of the composition.

3. Composition according to claim 1 or 2, in which the concentration of said at least one fluorine salt is from 1% to 10% by weight relative to the total weight of the composition.

4. Composition according to any one of claims 1 to 3, wherein the composition further comprises at least one humectant preferably selected from the group comprising glycerol, sorbitol, polyethylene glycol, polypropylene glycol, propylene glycol, propane, 3 diol and any mixture thereof.

5. Composition according to any one of claims 1 to 4, the composition further comprises at least one thickening agent 6. Composition according to any one of claims 1 to 5, wherein said at least one fluorine salt is chosen from the group comprising potassium fluoride, tin fluoride, amine fluoride, sodium fluoride, preferably amine fluoride.

7. Composition according to any one of claims 1 to 6 in which said at least one fluorine salt is nicomethanol hydrofluoride.

8. Composition according to any one of claims 1 to 7, said composition being free of free calcium salt, preferably free of calcium carbonate and / or calcium hydrogen phosphate.

9. Method for non-therapeutic treatment of the oral cavity comprising the application to a dental surface of a composition according to one of claims 1 to 8.

10. Composition according to any one of claims 1 to 8 for its use in remineralizing teeth.

11. Oral-dental composition according to any one of claims 1 to 8 for its use for the prevention and / or inhibition of the formation of a biofilm on a surface.

12. Method for manufacturing an oral-dental composition according to any one of claims 1 to 8 comprising the steps of: a) preparation of an oral-dental composition base, b) addition to the composition base prepared in step a) of at least one film-forming agent and at least one fluorine salt, c) recovery of the oral-dental composition obtained.

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