Oral-dental composition comprising an abrasive filler
The oral-dental composition, featuring volcanic glasses or clays as abrasive fillers and a fluorine salt, addresses the need for effective cleaning without excessive abrasiveness and silica-free formulation, enhancing both cleaning efficacy and natural ingredient content.
Patent Information
- Application Number
- FR2023012943
- Authority / Receiving Office
- FR · FR
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2023-11-23
- Publication Date
- 2025-05-30
AI Technical Summary
There is a need for oral-dental compositions that provide good cleaning power without being excessively abrasive, while also being free from silica fillers and containing natural ingredients.
An oral-dental composition comprising at least one abrasive filler chosen from volcanic glasses and clays, combined with a fluorine salt, and free from mineral abrasive silica fillers.
The composition achieves cleaning power similar to silica-containing toothpastes, with improved organoleptic properties and a reduced concentration of non-natural ingredients, while being gentle on dental surfaces.
Abstract
Description
Title of the invention: Oral-dental composition comprising an abrasive filler Technical field of the invention
[0001] The present invention relates to an oral-dental composition comprising at least one abrasive filler chosen from the group comprising volcanic glasses and clays or a mixture of these fillers, and at least one fluorine salt, said composition being free of mineral abrasive silica fillers.
[0002] The present invention also relates to a method of non-therapeutic treatment of the oral cavity comprising the application to a dental surface of said oral-dental composition.
[0003] The present invention also relates to the use of the oral-dental composition for cleaning a dental surface in a human or an animal.
[0004] The present invention relates to a method of manufacturing an oral-dental composition
[0005] The present invention finds application, in particular in the cosmetic and oral-dental fields.
[0006] In the description below, the references in parentheses () refer to the list of references presented at the end of the text. Prior art
[0007] Oral-dental compositions such as toothpastes generally contain a dentally acceptable abrasive, humectant, water, and water-soluble polymer that serve as a thickener and binder for the ingredients. A variety of other ingredients such as flavorings, sweeteners, preservatives, and fluoride are also used at low levels.
[0008] The term "toothpaste" generally refers to formulations that are used to clean the surfaces of the oral cavity, particularly the teeth and gums. Toothpaste is an oral composition that is not intentionally swallowed for the purpose of systemic delivery of therapeutic agents, but is applied into the oral cavity, particularly to the tooth surface, and / or used to treat the oral cavity and then expectorated.
[0009] Toothpaste is generally used in conjunction with a cleaning instrument or device such as a toothbrush, usually by applying it to the bristles of the toothbrush and then brushing the accessible surfaces of the oral cavity. Toothpaste can exist in various forms, for example, as a paste, gel, powder, tablet, or liquid. Most commonly, toothpaste is present in the form of a paste or gel.
[0010] The function of toothpaste falls within the context of oral cleaning which is performed both by the mechanical action of brushing with a toothbrush and by the cleaning effects of the components of the toothpaste. In addition to this cleaning action, toothpaste can also perform other functions in the context of oral hygiene; for example, antibacterial action, remineralization of tooth enamel or strengthening of the gum can be mentioned. These functions are provided or promoted by different substances contained in the preparation which can contribute to the various aspects of oral care.
[0011] A component generally present in known oral-dental compositions is fluoride. It may in particular be in the form of a fluoride salt, in particular potassium, sodium and tin fluorides, amine fluorides and quaternary ammonium fluorides. It may in particular have a possible function, for example, as an anti-caries and remineralizing agent.
[0012] Another component generally present in known oral-dental compositions, particularly useful for mechanical cleaning and polishing of the dental surface of the teeth, is the abrasive. It is generally in the form of small insoluble particles which are contained in the oral-dental composition. The abrasive enhances the brushing action and may, in particular, have an effect on dental plaque and on unsightly discolorations of the dental surface.
[0013] The abrasive power of an oral composition, a toothpaste, can be determined by the value of the relative abrasion index of dentin or RDA ("Relative Dentin Abrasivity" in English) which has been defined since 1998 by the standard DIN EN ISO 11609 updated in June 2017 (Reference 1). It is known that a composition with RDA greater than 100 is considered highly abrasive. Furthermore, an oral composition with an RDA greater than 250 is not recommended for use. Generally, for daily use, including regular daily brushing, the abrasiveness of the oral composition, toothpaste, should be such that the RDA is between 20 and 70, oral compositions, including toothpaste, with an RDA greater than 70 are particularly recommended for targeted applications only.
[0014] It is also important to mention that the abrasive power of a composition does not depend solely on the abrasive included in said composition. Indeed, the nature and concentrations of other ingredients / components of said composition, for example thickeners and / or surfactants, may have an effect on the abrasive power / abrasivity of the composition, for example by increasing or decreasing the abrasive power / abrasivity of said composition.
[0015] It is known in the state of the art, in particular during daily brushing of the teeth with an oral-dental composition, for example a toothpaste, with excessive abrasiveness and / or abrasive power has negative effects on the tooth surface, for example can cause degradation of the dentin, or even the tooth enamel.
[0016] It is also known that the abrasiveness of an oral-dental composition, a toothpaste, does not make it possible to define the cleaning power of said composition. In order to determine the cleaning power of an oral-dental composition, a toothpaste, an evaluation of the "Pellicle Cleaning Ratio test" in English as described in Stookey, Burkhard and Schemehorn (J.Dent.Res. 61(11):1236-1239 (1982)) (Reference 7). PCR makes it possible in particular to determine in vitro the capacity of oral-dental compositions to remove superficial stains on the teeth.
[0017] There is therefore a real need in the state of the art to obtain an oral-dental composition, in particular a toothpaste, with good cleaning power, in particular suitable abrasiveness, during brushing without presenting a risk of damaging and / or altering the dental surface, in particular dentin and / or enamel. In particular, there is a real need in the state of the art to obtain an oral-dental composition comprising in particular an abrasive, said composition comprising good cleaning power without being too abrasive at the level of the enamel or dentin.
[0018] One of the most widely used abrasives in oral compositions, particularly toothpastes, is hydrated silica (or silicic acid), which is a derivative of silicon dioxide, in the form of particles. Another common abrasive is calcium carbonate, in the form of crystals. These compositions also include foaming agents, flavors or colorants.
[0019] Oral-dental compositions particularly appreciated by consumers are, for example, toothpastes which combine a remineralizing fluoride salt with silica particles as an abrasive. These compositions fulfill their function well in oral-dental hygiene, while respecting particularities for different consumer groups, such as, for example, their need for a toothpaste for sensitive teeth, irritated gums or enhanced cleaning power.
[0020] However, the components included in compositions for hygiene and care, for example oral-dental compositions, are viewed critically by consumers. 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”.
[0021] Also, there exists in the state of the art a need to find compositions and / or alternative ingredients and / or daily care products. In particular, there is a real need in the state of the art to find minimalist compositions, for example comprising a limited number of components and / or ingredients, and / or “natural” compositions.
[0022] Furthermore, there is a real need in the state of the art for compositions comprising a small number of ingredients and / or compounds and ingredients and / or compounds of natural origin.
[0023] There also exists in the state of the art a need for a composition not comprising compounds and / or considered, by the public and / or consumers, to be controversial, which could be harmful to health and / or the environment.
[0024] Commercially available oral-dental compositions are considered by consumers and / or the public to include in particular too many ingredients, in particular ingredients considered to be controversial as well as ingredients considered to be unnatural, in particular for example among foaming agents, abrasive agents, active agents, preservatives.
[0025] Among abrasives, an important class of increasingly controversial substances is notably represented by silicas.
[0026] Also, there exists in the state of the art a real need to obtain an oral-dental composition, in particular a toothpaste, not comprising silicas.
[0027] However, silicas are not easily substitutable, due to their well-adapted abrasive properties. In addition, any known alternatives are not compatible with other components of oral-dental compositions, in particular toothpastes, in particular with remineralizing components such as fluoride derivatives.
[0028] In particular, the possible alternative abrasives known and used in toothpastes, considered to be more "natural", are calcium salts such as for example calcium carbonate (CaCO3) or dicalcium phosphate (dicalcium phosphate, CaHPO4). However, these calcium salts are known to be poorly compatible with fluoride salts. Also, oral-dental compositions, in particular toothpastes, comprising calcium salts are, generally speaking, devoid of fluoride salt.
[0029] Furthermore, silicas are also useful in oral compositions, in solubilized form or in fine particle form as thickeners. Thus, oral compositions may comprise an abrasive silica and a texturizing silica, which makes the replacement and / or substitution of silicas in oral compositions even more difficult.
[0030] There is therefore a need in the state of the art to find oral-dental compositions not comprising silica while having suitable texture, abrasiveness and cleaning properties.
[0031] Furthermore, there is a real need in the state of the art to find a compound and / or means making it possible to replace and / or substitute silica in oral-dental compositions, for example toothpastes, while retaining the properties of said compositions, for example without negative effect, in particular on the texture, the cleaning power, the organoleptic properties of said composition, as well as its contribution to oral-dental health. Statement of the invention
[0032] The present invention aims precisely to meet these needs by providing an oral-dental composition comprising at least one abrasive filler chosen from the group comprising volcanic glasses and clays or a mixture of these fillers, and at least one fluorine salt, said composition being free of mineral abrasive silica fillers.
[0033] In particular, the inventors have demonstrated, surprisingly and unexpectedly, that the composition according to the invention, for example a toothpaste, has a cleaning power identical and / or similar to known toothpastes containing silica particles as an abrasive. Furthermore, surprisingly and unexpectedly, the inventors have demonstrated that the composition according to the invention has improved organoleptic properties, for example in terms of the viscosity and consistency obtained, in the absence of silicas.
[0034] Furthermore, the inventors have surprisingly demonstrated that the composition according to the invention also differs from comparable compositions of the prior art by the reduction in the concentration of ingredients, in particular non-natural ingredients.
[0035] The present invention makes it possible to meet the needs of the state of the art and overcomes the disadvantages of known oral-dental compositions, in particular known toothpastes, by providing a silica-free oral-dental composition comprising mainly compounds and / or ingredients of natural origin, while having a texture and / or cleaning power as good as, or even better than, that of known oral-dental compositions, in particular known toothpastes.
[0036] 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.
[0037] Furthermore, the composition according to the invention advantageously comprises ingredients and / or compounds meeting the requirements of the COSMOS certification defined by Ecocert, in particular COSMOS organic. Furthermore, the composition according to the invention advantageously has a percentage of naturalness according to the ISO standard 16128 published in September 2017 (Reference 2) greater than 80%, preferably greater than 90%, still preferably greater than 94%, for example greater than 95%.
[0038] Advantageously, the inventors have also demonstrated that the composition according to the invention is suitable and / or can be used with any type of dental surface and / or teeth, for example sensitive teeth, stained and / or damaged teeth.
[0039] Furthermore, the present invention advantageously makes it possible to provide an oral-dental composition satisfying the requirements of toothpaste compositions in terms of their appearance, in particular their compatibility with formulations in the form of toothpaste or toothpaste gel.
[0040] In the present invention, the term "abrasive filler" or "abrasive" means any abrasive filler known to those skilled in the art suitable for use in an oral composition with the exception of silicas. In the present invention, an abrasive filler may be in the form of particles with a shape chosen from the group comprising rounded, angular, elongated or platelet. In the present invention, the shape of the particles may be determined by observation by Scanning Electron Microscopy (SEM).
[0041] According to the invention, said at least one abrasive filler may be in the form of particles with a surface area of from 2 to 15 m2 / g, for example from 2.5 to 11 m2 / g, for example from 2.8 to 10.8 m2 / g.
[0042] In the present invention, the surface area of the particles can be determined by nitrogen adsorption sorptometry and application of the Brunauer, Emmett and Teller (BET) model. The surface area of the particles can be measured by any suitable device known to those skilled in the art. This may be, for example, a Gemini VII Micromeritics - Surface area analyzer.
[0043] According to the invention, said at least one abrasive filler may be in the form of particles with a density of 2 to 4 g / cm3, for example 2.3 to 2.8 g / cm3.
[0044] In the present invention, the particle density can be determined by Helium Pycnometry. The particle density can be measured by any suitable method and / or device known to those skilled in the art. This may be, for example, the device marketed under the reference Micromeritics-AccuPyc 1340.
[0045] According to the invention, an abrasive filler may be in the form of particles with a specific volume surface area (VSSA) of from 5 to 35 m2 / cm3, for example from 6 to 30 m2 / cm3, for example from 6.81 to 29.8 m2 / cm3.
[0046] Herein the specific volume of the particles may be determined by any suitable method known to those skilled in the art. For example it may be determined by gas adsorption as described by Brunauer, Emmett and Teller, known as the "BET method or technique".
[0047] According to the invention, the median particle diameter d50 can be from 0.1 to 30 pm, for example from 0.2 to 20 pm, for example from 1 to 19 pm.
[0048] In the present invention, by median particle diameter is meant the particle size determined from which half (50%) of the particles present, for example present in a sample, are smaller and the other half (50%) of the particles present are larger. In the present invention, the median particle diameter may be determined by any suitable method and / or device known to those skilled in the art, for example by Transmission Electron Microscopy (TEM).
[0049] According to the invention, said at least one abrasive filler may be, for example, an abrasive filler of natural origin, with the exception of silicas. It may advantageously be in the form of particles. It may be, for example, an abrasive filler chosen from the group comprising particles of aluminum hydroxide, calcium carbonate, magnesium carbonate, sodium bicarbonate, calcium hydrogen phosphate, hydroxyapatite, coal powder, clays, volcanic glasses, microcrystalline cellulose, rice powder and rice starch or any mixture thereof. It may be, for example, an abrasive filler chosen 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.For example, it may be volcanic glass from Turkey. For example, volcanic glass may be perlite. For example, it may be commercially available perlite, for example, marketed by Imerys under the trade name Imercare (trademark) Perlwhite 19. For example, the abrasive filler may be commercially available perlite marketed by Imerys under the trade name Imercare (trademark) Perlwhite 19 with a median particle diameter of 19 μm.
[0050] For example, the clay may be kaolin. It may be, for example, commercially available kaolin, for example marketed by the company Imerys under the trade name Imercare (trademark) Kaobright. For example, the abrasive filler may be commercially available kaolin marketed by the company Imerys under the trade name Imercare (trademark) Kaobright with a median particle diameter equal to 1 μm.
[0051] For example, the oral composition may comprise at least one abrasive filler selected from the group consisting of volcanic glasses and clays. For example, the oral composition may comprise an abrasive filler selected from clays and volcanic glasses. For example, the oral composition may comprise an abrasive filler selected from the group consisting of kaolin and perlite. For example, the oral composition may comprise at least two abrasive fillers selected from the group comprising volcanic glasses and clays. In the present invention, the oral-dental composition may comprise at least one, at least two, at least three abrasive filler(s). For example, the oral-dental composition may comprise two abrasive fillers selected from clays and volcanic glasses. For example, the oral-dental composition may comprise as abrasive fillers kaolin and perlite, preferably in particulate form.
[0052] Advantageously, the oral-dental composition may comprise an abrasive filler chosen from the group comprising kaolin and perlite.
[0053] According to the invention, the concentration of said at least one abrasive filler in the oral-dental composition may be from 0.5 to 5% by weight relative to the total weight of the composition. For example, the concentration of said at least one abrasive may be from 0.8 to 3% by weight, for example from 1 to 2.5% by weight relative to the total weight of the composition. For example, when the abrasive filler is a clay, for example kaolin, the concentration of the abrasive filler may be from 0.5 to 5% by weight, for example from 0.8 to 3% by weight, for example from 1 to 2.5% by weight relative to the total weight of the composition. For example, when the abrasive filler is a volcanic glass, for example of natural origin, for example perlite, the concentration of the abrasive filler may be from 0.5 to 5% by weight, for example from 0.8 to 2% by weight, for example from 1 to 1.5% by weight, relative to the total weight of the composition.
[0054] 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. In addition, the concentration of abrasive filler advantageously makes it possible to adjust the abrasiveness of said oral-dental composition, advantageously allowing daily use of the oral-dental composition for cleaning the dental surface. In addition, advantageously, the concentration of abrasive filler makes it possible to confer good cleaning power, for example with a PCR value greater than 50 without at the same time having an excessively high abrasiveness index, i.e. with an RD A of less than 100, preferably less than 90, even more preferably less than 70 so as not to attack the integrity of the dental enamel.In other words, advantageously the concentration of abrasive filler makes it possible to obtain an oral-dental composition with good abrasive power and good cleaning power and advantageously to adapt the abrasive power and the good cleaning power of said composition according to the targeted consumer population, while being associated with a reasonable concentration of the ingredient and a reduced manufacturing cost of the composition.
[0055] According to the invention, the oral-dental composition is free from mineral abrasive silica fillers.
[0056] 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):
[0057] [Chem.l] J-
[0058] Formula I
[0059] in which:
[0060] R1 represents a hydrogen atom or a C1 to C6 alkyl group, for example RI is H;
[0061] R2 represents a group -CH2OH, -CO2R3, where R3 is a C1 to C6 alkyl group, CONH(CH2)2OH, or a group of formula (II)
[0062] [Chem.2] vx Z x Z7—NP
[0063] Formula (II), and
[0064] the R2 group is in position 2 or 3 (relative to the nitrogen atom).
[0065] By “C1 to C6 alkyl group” is meant a hydrocarbon chain saturated, linear or branched, 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.
[0066] 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: R1 is H and R2 is CH2OH and is in position 3 relative to the nitrogen.
[0067] According to the invention, the concentration of said at least one fluorine salt in the oral-dental 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 per relative to the total weight of the composition.
[0068] According to the invention, the oral-dental composition may comprise from 400 ppm to 1,500 ppm of fluoride, for example from 500 to 1,450 ppm of fluoride.
[0069] In the present term "silicas" or "silica" means silicon dioxide (SiO2), hydrated silica or salicylic acid, for example in the free state in its various crystalline or amorphous forms, with the exception of silicon dioxide in the state associated with other elements in respective silicates or glasses, or in similar complexes. This may be, for example, silica under the INCI names "Silica", "Hydrated Silica" or "Quartz".
[0070] In the present invention, 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 0.01% 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 a quantity less than 10 ppm, for example less than 5 ppm.
[0071] In the present term "free from silica mineral abrasive fillers" means a composition comprising a concentration of silica mineral abrasive fillers of less than 0.3% by weight, for example less than 0.1% by weight, for example less than 0.01% by weight, for example equal to 0% by weight of silica relative to the total weight of the composition. In other words, it means a composition comprising less than 10 ppm of silica mineral abrasive fillers, for example comprising 0 ppm of silica mineral abrasive fillers.
[0072] According to the invention, the oral-dental composition may be free of silica. For example, the concentration of silicas in the oral-dental composition may be less than 1% by weight, for example less than 0.3% by weight, for example less than 0.1% by weight, for example less than 0.01% by weight, for example equal to 0% by weight of silica relative to the total weight of the composition. In other words, the composition may comprise less than 10 ppm silicas, for example 0 ppm silicas. In other words, when the concentration of silicas in the oral-dental composition is less than 0.3%, preferably less than 0.1%, relative to the total weight of the composition, it may be in the form of contamination and / or manufacturing residues.
[0073] According to the invention, the oral-dental composition may be free of calcium carbonate and / or calcium hydrogen phosphate.
[0074] According to the invention, the oral-dental composition may be, for example, free calcium carbonate salt, for example calcium carbonate and / or calcium hydrogen phosphate.
[0075] 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 4).
[0076] 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 numerical size distribution, have one or more external dimensions lying between 1 nm and 100 nm" as mentioned in Recommendation 2011 / 696 / EU of 18 October 2011 of the European Commission (Reference 4).
[0077] According to the invention, the oral-dental composition may be free of compounds considered in the state of the art to be controversial, for example due to a potential risk, for example a possible side effect, for the consumer and / or the environment. For example, the oral-dental composition may be free of sodium Lauryl Sulfate (SLS). For example, the oral-dental 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. For example, the oral-dental composition may be free of acrylate-functional compound, for example copolymer of methyl methacrylate and ethylene glycol dimethacrylate.
[0078] For example, 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, alcohol, for example benzyl alcohol, phenoxyethanol.
[0079] For example, the oral-dental composition may be free of triclosan or 5-chloro-2-(2,4-dichlorophenoxy)phenol.
[0080] For example, the oral-dental composition may be free of titanium dioxide (TiO2).
[0081] For example, the oral-dental composition may be free of Poly Ethylene Glycols (PEGs).
[0082] According to the invention, the oral-dental composition may further comprise at least one thickener, also referred to as a stabilizer, with the exception of silicas. For example, the oral-dental composition may further comprise at least two thickeners. For example, the oral-dental composition may comprise at least one thickener chosen from the group comprising synthetic cellulose and / or derivatives of cellulose, for example cellulose gum, for example carboxymethylcellulose (CMC, INCI name Cellulose Gum), carboxyethylcellulose, methylcellulose, ethylcellulose, carboxymethylhydroxyethylcellulose, hydroxypropylmethylcellulose, hydroxyethylcellulose and hydroxypropylcellulose and 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.
[0083] Advantageously, when the oral-dental composition comprises at least one thickener, it advantageously makes it possible to thicken said composition by forming a network with water.
[0084] According to the invention, when the oral composition is free of silica, it is an example of silica as a thickener. In other words, advantageously, the composition may be free of silica as a thickener. Advantageously, the oral composition is free of silica, for example of silica mineral abrasive filler and silica as a thickening compound.
[0085] Advantageously, said at least one thickener can have a major effect on the viscosity and consistency of said composition, it can advantageously stabilize said composition and give it a characteristic texture, for example in semi-solid or solid form. In addition, the inventors have demonstrated that the nature and quantity of the thickeners advantageously allows optimization of the composition, advantageously making it possible to give the composition rheological properties adapted to the oral-dental composition.In particular, the consistency and viscosity of the oral composition may advantageously be adapted so that the composition, for example when 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 after application to said brushing device, for example the toothbrush, does not flow. not or does not fall from said device. 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 shift of the components of said composition during its storage.
[0086] 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.
[0087] 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 marketed by the company Ashland.
[0088] According to the invention, when the composition comprises at least one cellulose derivative as thickener, the concentration of said at least one cellulose derivative may be from 0.5 to 10% by weight, for example from 1 to 5% by weight, for example from 1.5 to 4% by weight, for example from 1.5 to 2.3% by weight, relative to the total weight of the composition.
[0089] Advantageously, said at least one thickener may be at least one polysaccharide 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.
[0090] 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.
[0091] In the present invention, said at least one thickener may be selected from the group comprising cellulose derivatives and polysaccharides of natural origin and mixtures thereof. For example, the oral-dental composition may comprise two thickeners, for example at least one cellulose derivative and at least one polysaccharide of natural origin. For example, the oral-dental 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 1.5 to 4% by weight, in particular from 1.8 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 1.5 to 4% by weight, in particular from 1.8 to 3.6% by weight, relative to the total weight of the composition.
[0092] 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
[0093] 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.
[0094] 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.
[0095] According to the invention, the oral composition may be free of silica as a thickener. For example, the concentration of silica as a thickener in the oral composition may be less than 1% by weight, for example less than 0.3% by weight, for example less than 0.1% by weight, for example less than 0.01% by weight, for example equal to 0% by weight of silica as a thickener relative to the total weight of the composition. In other words, the composition may comprise less than 10 ppm silica, for example 0 ppm silica.
[0096] 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 suitable for the oral-dental composition. In particular, the consistency and viscosity of the oral-dental 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, by example of 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.
[0097] According to the invention, the oral-dental composition may have a viscosity measured at 25°C of from 3500 mPa.s to 30000 mPa.s. For example, the oral-dental composition may have a viscosity measured at 25°C of from 4000 mPa.s to 30000 mPa.s, for example from 6000 to 25000 mPa.s, for example 8000 to 15000 mPa. These values were measured at 25°C with a Rheomat RM200 (Lamy Rheology Instruments, France) with a Mobile 3 type probe at a speed: 27.5s1. The formulation is packaged in a 150ml pot in order to take the measurement.
[0098] Advantageously, the inventors have demonstrated that the viscosity of the oral-dental composition according to the invention is constant over time. In particular, the inventors have demonstrated that the viscosity of the composition after manufacture (T0) remains constant for 2 months at 25°C / 65% RH with possible variation up to 10% or 15%. In another aspect, the viscosity determined after manufacture (T0) remains constant for 3 months at 25°C / 65% RH with possible variation up to 15%. In the present invention, the viscosity determined after manufacture (T0) remains constant for 2 months at 25°C / 65% RH with possible variation up to 10% and also for 3 months under the same conditions with possible variation up to 15%. In other words, advantageously, the oral-dental composition according to the invention is stable over time.
[0099] Advantageously, the inventors have demonstrated that the oral-dental composition does not exhibit any phase shift, for example at rest, for example during storage, for 2 months at 25°C / 65% RH or for 3 months at 25°C / 65% RH.
[0100] According to the invention, the oral-dental composition may have a consistency at 25°C of from 50 g to 240 g, for example from 60 g to 200 g, for example from 70 g to 150 g, for example from 70 g to 130 g. The measurement of the consistency may be carried out by penetrometry as described in the document Jachowicz, J. & YAO, K (1997) Characterization of cosmetic products by texture analysis. International conference of IFSCC and the 9th Hungarian Congress on Cosmetic and Household Chemical (Reference 8). For example, the consistency of a composition may be measured with a tex-turometer, for example TA.XT Plus in penetration mode with the following parameters: trigger 5g; distance: 25mm; pre-speed: 3mm / s; speed: 4mm / s; post speed: 4mm / s; probe: 25mm diameter, cylindrical. For example, consistency of a composition can be measured within 6 to 48 hours after manufacture, for example 24 hours after manufacture of the composition.
[0101] According to the invention, the oral-dental composition may have an abrasivity determined by measuring the relative abrasion of the dentin RDA (Relative Dentin Abrasivity) of from 15 to 100, for example from 20 to 70. The measurement of the abrasivity may be carried out by measuring the relative abrasion of the dentin RDA (Relative Dentin Abrasion in English) according to standard DIN EN ISO 11609:2017 (Reference 1).
[0102] 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. This may be, for example, foaming agents with an HLB of between 3 and 8, for example greater than 3 and less than 8.
[0103] 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 5), 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.
[0104] In the present invention, the foaming agent may be chosen 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 1200UP, 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.
[0105] According to the invention, the concentration of said at least one foaming agent can be comprised from 0.5 to 8% by weight, for example from 1 to 6% by weight, relative to the total weight of the composition.
[0106] 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.
[0107] 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.
[0108] As other examples of foaming agents, it may be at least one foaming agent chosen from the group comprising a non-ionic surfactant and an anionic surfactant.
[0109] 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. It 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. It 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.
[0110] The oral-dental composition may further comprise at least two non-ionic surfactants, preferably of plant origin, chosen from the group comprising alkyl glucosides in which the alkyl radical comprises from 8 to 16 carbon atoms, for example chosen from the group comprising octyl glucoside, lauryl glucoside and decyl glucoside. The oral-dental composition may comprise a single non-ionic surfactant chosen from alkyl glucosides in which the alkyl radical comprises from 8 to 16 carbon atoms, for example comprising from 10 to 14 carbon atoms. For example, the oral-dental composition may comprise lauryl glucoside as the only non-ionic surfactant.
[0111] 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.
[0112] 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 or pharmacologically acceptable salts. It may be, for example of 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 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 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.
[0113] 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.
[0114] 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.
[0115] 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.
[0116] 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.
[0117] Herein, the oral composition may comprise as foaming agents lauryl glucoside and disodium cocoyl glutamate.
[0118] In the present, the total concentration of said at least one non-ionic surfactant and of said at least one anionic surfactant may be comprised 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 comprised from 0.5 to 2, for example from 0.66 to 1.5, for example equal to 1.
[0119] 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.
[0120] According to the invention, the oral-dental composition may be free of sodium lauryl sulfate (SLS) and / or alkyl sulfate salt ("alkyl sulfate salt").
[0121] 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).
[0122] According to the invention, the oral-dental composition may further comprise at least one film-forming agent. This may be, for example, any film-forming agent known to those skilled in the art suitable for an oral-dental composition. Examples include a commercially available glycolipid marketed under the trade name Rheance One by Evonik, polyvinylpyrrolidone (PVP) marketed under the trade name Plasdone K-29 / 32 Polymer by Ashland, lauroyl arginine marketed under the trade name Amisafe AL01, PVM / MA Copolymer / Lecithin / Aqua marketed under the trade name Gantrez S97 BF, PVM / MA Copolymer / Aqua marketed under the trade name Gantrez S97 HSU, Cl5-19 Alkane marketed under the trade name Emogreen L15 or L19, Glycerin (and) Ethyl Lauroyl Arginate HCl mixture marketed under the trade name Aminat G.
[0123] According to the invention, the concentration of said at least one film-forming agent may be from 0.02 to 3% by weight, for example from 0.05 to 2% by weight relative to the total weight of the composition.
[0124] 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 55% by weight, for example from 5 to 50% by weight, for example from 8 to 45% by weight, for example from 10 to 40% by weight, relative to the total weight of the composition.
[0125] 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. Humectants are additives which prevent the composition from drying out by binding the water in the composition and thus preventing its evaporation or by attracting moisture from the air during storage. The humectant may be a polyol, for example chosen from the group comprising glycerol, sorbitol, polyethylene glycol, polypropylene glycol, propylene glycol, propane 1,3 diol and mixtures thereof. For example, the humectant may be sorbitol, for example obtained from a hydrogenated starch hydrolyzate.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 chosen from the group comprising glycerol, sorbitol, hydrogenated starch hydrolysate, polyethylene glycol, polypropylene glycol, propylene glycol, propane 1,3 diol and mixtures thereof. For example, the composition may comprise a humectant chosen from the group comprising glycerol, sorbitol, and hydrogenated starch hydrolysate.
[0126] In the present invention, the concentration of said at least one humectant in the composition may be from 35 to 80% by weight, for example from 40 to 75% by weight, for example from 45 to 70% by weight relative to the total weight of the composition.
[0127] Certain polyols which act as humectants can, by virtue of their nature as an saccharide derivative, contribute to imparting a sweet taste to the composition.
[0128] The oral-dental composition may comprise one or more cosmetically or pharmaceutically acceptable carrier(s). In the present invention, the term "cosmetically or pharmaceutically acceptable carrier" means any cosmetic carrier known to those skilled in the art; it may be, for example, any cosmetic or pharmaceutical carrier that may be cited in the INCI dictionary (International Nomenclature of Cosmetic Ingredients) published by the PCPC (Personal Care Products Council).
[0129] The cosmetic composition according to the invention may comprise one or more adjuvants known to those skilled in the art. It may be, for example, one or more adjuvant(s) chosen from ester-type agents, moisturizing agents, emollient agents, thickening agents, organic thickening agents, associative or not, perfumes, preservatives, 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 listed in the INCI (International Nomenclature of Cosmetic Ingredients) dictionary published by the PCPC (Personal Care Products Council).
[0130] In the present invention, the oral-dental composition may further comprise any cosmetically or pharmacologically acceptable excipient known to those skilled in the art suitable for this type of composition.
[0131] 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.
[0132] Herein, the oral composition may, for example, be in any suitable form known to those skilled in the art. For example, the oral composition may be a liquid, a fluid, a gel, a paste or a solid. For example, the oral composition may be in the form of a toothpaste, for example in the form of a paste, a gel or a solid. For example, the oral composition may be in the form of a gel or a paste.
[0133] Advantageously, the inventors have demonstrated, when said abrasive filler is chosen from clays, preferably of natural origin, for example kaolin, the formulation of the oral-dental composition can advantageously be in paste form. In particular, the inventors have surprisingly demonstrated that clays, preferably of natural origin, for example kaolin, opacify the oral-dental composition and are particularly suitable for a composition in paste form.
[0134] Advantageously, the inventors have demonstrated, when said abrasive filler is chosen from volcanic glasses, preferably of natural origin, for example perlite, the formulation of the oral-dental composition can advantageously be in gel form. In particular, the inventors have surprisingly demonstrated that volcanic glasses, preferably of natural origin, for example perlite, have no effect on the appearance of the oral-dental composition and advantageously allow the production of a translucent composition and is particularly suitable for a composition in gel form.
[0135] The oral-dental 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.
[0136] This may be, for example, a method for manufacturing an oral-dental composition comprising the steps of: a) preparation of an oral-dental composition b) addition to the composition prepared in step a) of at least one abrasive filler chosen from the group comprising volcanic glasses and clays or a mixture of these fillers, c) addition to the composition prepared in step a) or b) of at least one fluorine salt, d) recovery of the oral-dental composition obtained,
[0137] said composition being free of mineral abrasive silica fillers.
[0138] 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 a mixture of, for example, at least one humectant, at least one thickening agent and water, and optionally at least one film-forming agent.
[0139] Step a) can be carried out at a temperature of 20 to 30°C, for example at 25°C.
[0140] According to the invention, step a) of preparing an oral-dental composition may comprise the steps of: a') preparation of a first composition base comprising a mixture of at least one humectant and at least one thickening agent, a”) preparation of a second composition base comprising a mixture of at least one humectant, water and optionally at least one film-forming agent, a'”) mixture of the first and second bases obtained in steps a') and a”), and a””) optionally addition to the composition base obtained in step a'” of at least one preservative and at least one sweetening agent.
[0141] According to the invention, preparation step a') can be carried out by any method known to those skilled in the art. It may, for example, be mixing with stirring.
[0142] According to the invention, preparation step a') can be carried out in any suitable container known to those skilled in the art.
[0143] According to the invention, preparation step a”) can be carried out by any method known to those skilled in the art. It may, for example, be a mixture with stirring.
[0144] According to the invention, preparation step a”) can be carried out in any suitable container known to those skilled in the art.
[0145] According to the invention, preparation step a'”) can be carried out by any method known to those skilled in the art. It may, for example, be mixing with stirring.
[0146] According to the invention, preparation step a'”) can be carried out in any suitable container known to those skilled in the art. It may be, for example, a step of introducing the first composition base obtained in step a') into the second base of composition obtained in step a”) with stirring until homogenization. For example, the duration of step a”') may be greater than 30 minutes, for example from 30 minutes to 40 minutes.
[0147] The addition of said at least one abrasive filler in step b) may be carried out by any suitable method known to those skilled in the art. It may, for example, involve adding said at least one abrasive filler to the composition or composition base obtained in step a), for example with stirring. For example, the duration of step b) may be greater than 15 minutes, for example from 15 minutes to 25 minutes.
[0148] The addition of said at least one fluorine salt of step c) may be carried out by any suitable method known to those skilled in the art. It may be, for example, an addition of said at least one fluorine salt to the composition or composition base obtained in step a) or to the composition obtained, for example with stirring. For example, the duration of step b) may be greater than 10 minutes, for example greater than 15 minutes, for example from 10 minutes to 20 minutes.
[0149] According to the invention, the process may comprise, prior to recovery step d), a step c') of adding to the composition obtained in step b) or c) a base comprising at least one foaming agent and optionally at least one colorant.
[0150] The oral-dental composition may be a composition used in a cosmetic treatment, for example a cosmetic treatment for cleaning the dental surface.
[0151] In the present, by "cosmetic care" is meant 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.
[0152] 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.
[0153] 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.
[0154] As used herein, dental surface means a surface of a natural tooth or a hard surface of an artificial denture, for example a crown, a cap, a filling, a bridge, a dental implant, etc. (
[0155] The present invention also relates to the use of the oral-dental composition according to the invention for the reduction and / or prevention of caries, dental plaque, gingivitis and / or combinations thereof.
[0156] The present invention also relates to a non-therapeutic cosmetic treatment kit for the oral cavity comprising an oral-dental composition according to the invention and a support comprising instructions for the use of the com- oral-dental position.
[0157] The support comprising instructions for the use of the oral-dental composition according to the invention may be a manual or a notice 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.
[0158] The cosmetic care kit may also comprise an applicator, for example a dynamic applicator, for example manual or electric, for example a brushing device, for example a manual or electric toothbrush.
[0159] Other advantages may still appear to those skilled in the art upon reading the examples below, given for illustrative purposes.
[0160] Example 1: Examples of compositions and physicochemical properties
[0161] The example below describes different examples of compositions according to the invention. The example below also discloses comparative tests with known compositions. A / Materials & Methods:
[0162] Different parameters, namely in particular the macroscopic appearance, the pH, the viscosity, the consistency, the colorimetry, the abrasiveness, the cleaning power (film cleaning) and the stability were evaluated in order to characterize the compositions from a functional, organoleptic and rheological point of view.
[0163] A study of the stability of the examples of oral-dental compositions according to the invention was carried out at 25°C / 60%RH for 2 or 3 months. Macroscopic appearance
[0164] A visual study of the macroscopic appearance of the compositions was carried out by visual inspection, in particular the macroscopically homogeneous character of the composition, i.e. the absence of phase shift and agglomerates in the composition, the visual appearance of the composition, for example opaque or translucent. PH
[0165] A pH measurement (direct measurement) was carried out with a Mettler Toledo pH meter. Viscosity
[0166] A measurement of the viscosity in mPa.s of the compositions was also carried out.
[0167] Viscosity is defined as the resistance to flow of a liquid, it has been assessed using a viscometer that measures the resistance to deformation caused by shear stress. Viscosity measurement provides information on the difficulty (or not) of squeezing the composition out of a container, for example toothpaste from a tube of toothpaste. Viscosity was assessed using Rheomat RM200 equipment according to the supplier's instructions with samples of the compositions in a 150ml jar. Viscosity is expressed in the unit mPa.s, equivalent to centipoise (cP or cps)
[0168] The measurement parameters were as follows: speed: 27.5 s 1 / temperature: 25°C / Mobile type probe 3. Consistency (Penetrometry)
[0169] A measurement of the consistency in g (penetration) was carried out. The consistency of compositions was evaluated using a TA.XT Plus texturometer in penetration mode according to the supplier's instructions with samples of the compositions in a 150ml pot, to measure compression forces (penetration). The measurement parameters were trigger 5g / distance: 25mm / pre-speed: 3mm / s / speed: 4mm / s / post speed: 4mm / s / Probe: 25mm diameter, cylindrical. In this measurement the consistency of the composition makes it possible to mimic the hold on a brushing device, for example a toothbrush, at rest of the composition. Colorimetry
[0170] A colorimetry measurement was also carried out. The objective was to verify that the composition has an opacity close to 100. The colorimetry was evaluated with a Konica Minolta CM-5 measuring device according to the supplier's instructions. The measured parameters were: L*: represents the lightness which takes values between 0 (black) and 100 (white); a*: represents the value on a green to red axis; b*: represents the value on a blue to yellow axis opacity Abrasiveness
[0171] RDA (“Relative Dentin Abrasion” in English)
[0172] Abrasivity measurements were performed by Radioactive Dentin Abrasion (RDA 'classical') or by optical profilometry (RDA-PE; "RDA-Profilometry equivalent") according to EN ISO 11609:2017 (Reference 1). These are the standardized methods for defining the abrasiveness of a toothpaste. This measurement simulates brushing of the dental surface, in particular human teeth.
[0173] The tests were carried out with a V8 brushing simulator with the following parameters: brush tension: 150 g, brushing device, namely a brush of medium hardness and length of 10 mm using a suspension of an example composition according to the invention or control compositions in water (suspension: 25 g of composition in 40 ml of water, 8 suspensions per composition) on dentin supports prepared from healthy human teeth by embedding in a methyl methacrylate or epoxy resin (EpoFix, Struers) and polishing at 4000 grit, by carrying out 1500 brushings (conventional RDA) or 4000 brushings (RDA-PE (“RDA-Profilometry equivalent”) back and forth (180° rotation every 500 cycles).
[0174] For the Radioactive Dentin Abrasion (“classical RDA”) method, the dentin scaffolds were irradiated with neutrons to create radioactive phosphorus (32P) in the superficial layers before the brushing test. Dentin abrasion was assessed by measuring the 32P level in the brushing fluid at the end of brushing (1 ml brushing fluid in 5 ml Ultima Gold scintillation fluid, counting the radioactive signal by counting with a liquid scintillation counter). For optical profilometry measurement (RDA-PE), dentin supports were used, part of each support was covered with adhesive tape (PRO067-7, Argon Masking Inc., Monrovia, CA, USA) before the abrasion test in order to expose a defined dentin area (3x6 mm2). Profilometric assessments of dentin wear were performed by laser scanning microscopy (VK-X, Keyence Deutschland GmbH, Neu-Isenburg, Germany).The average abrasion depth was measured as the height difference between the brushed-treated dentin area and the reference area (covered area on the sample surface). In other words, the RDA was determined by comparison with a calcium pyrophosphate (Ca2P2O7) sample as a reference abrasive according to the AD A method (American Dental Association; reference sample preparation by dilution in 0.5% carboxymethylcellulose (CMC) solution in 10% glycerin: 10 g of the ADA reference material in 50 ml 0.5% CMC / glycerin solution), according to the following calculation: .
[0175] [Math.l] Depth of the innovative support of the same size. eoJrtsositiàri Èuceo — total £3.4 =-----:--:--7--------:--:---------------------- x 100« Average abrasion depth of dentin supports by the reference unit
[0176] Cleaning: pellicle cleaning ratio
[0177] Determination of the cleaning power and / or cleaning properties and / or The cleaning efficiency of a composition was performed by measuring the pellicle cleaning ratio (PCR). In this test, dental brackets were used and the dental enamel of the brackets was stained with staining solutions, and then brushed with a suspension of compositions 1 and 1 bis described below.
[0178] The coloration of the supports was measured by colorimetry before and after brushing. The lightening induced by brushing with toothpaste could thus be compared with the lightening by brushing with a standard sample of calcium pyrophosphate (Ca2P2O7) as a reference abrasive. The supports used were dental enamel labial supports prepared from healthy human teeth fixed in polystyrene bowls using a methacrylate resin. The supports were polished and acid-treated to facilitate the absorption of the dyes, and stained in a specially designed staining apparatus for approximately 4 days (at 50°C). The supports were rotated in and out of a solution containing soy tryptone, tea, coffee, red wine, tobacco extract and iron (III) chloride at a speed of 1 rpm until uniform coloring is obtained (average values of L* 48).
[0179] Brushing was performed with a V8 brushing simulator (brush tension: 150 g, 47H type flat toothbrushes) by performing 800 brushing cycles with the ADA reference abrasive (standard sample; 10 g calcium pyrophosphate in 50 ml 0.5% CMC / 10% glycerin solution, see above) or with the suspensions of the test compositions (1 g of composition in 1.6 g of deionized water; 8 suspensions for each composition). The color of the stained enamel substrates before and after brushing (L*, a*, b*; values as defined for the CIE 1976 L*a*b* or CIELAB color space) was measured using a Konica-Minolta CM-700d spectrophotometer.
[0180] The lightening after brushing was determined according to the CIELAB equation:
[0181] [Math.2] Delta E(Æ) = [(Æ*)2 + (Aa*)2 + (Ab*)2]1 !2.
[0182] The PCR (pellicle cleaning ratio) of the toothpastes was calculated according to the following formula:
[0183] [Math.3] PCR = (Average AE of the test sample / Average AE of the standard sample) x 100. B / Results:
[0184] 1. Examples of composition and physicochemical properties (TO BE VERIFIED / TO VALIDATE)
[0185] In the present example, a basic composition was prepared by mixing the different components described in the table.
[0186] The compositions described in the tables were prepared according to the general process comprising the following steps: a. Optionally, preparation of a mixture A comprising glycerin (humectant), thickeners, for example of the carboxymethylcellulose type, for example sodium alginate, b. Homogenization of said mixture 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 optionally at least one colorant, d. In a main reactor, for example a glass beaker of suitable size, optionally introduce sorbitol, for example in the form of hydrogenated starch hydrolysate, purified water and optionally a film former, and optionally the previously prepared mixture A, were introduced. It was stirred using a Rayneri paddle stirrer. for at least 30 min at room temperature, i.e. 20°C. Once the mixture is homogeneous, optionally the preservative and sweetener are added. The resulting mixture C was homogenized using a Rayneri paddle stirrer for at least 10 min. e. Introduction of the fluorine salt into mixture D and stirring for homogenization, for example for at least 10 min, for example for at least 15 minutes, and obtaining a mixture E, f. Introduction of the abrasive load into the mixture E and stirring, for example for at least 15 minutes, until completely homogenized and a mixture F is obtained, g. Introduction of mixture B with stirring for at least 15 min until the final formula is completely homogenized. The step of introducing mixture B may be before or after the step of introducing the abrasive load. h. Optionally introduction of flavoring ingredients to the final formula.
[0187] Composition 1 described below was prepared by the above method in which mixture A comprises a mixture of carboxymethylcellulose, sodium alginate and glycerin, mixture B the foaming compounds namely lauryl glucoside and disodium cocoyl glutamate, the fluorine salt is nico-methanol hydrofluoride, the abrasive filler is kaolin, the final mixture obtained was left under stirring until completely homogenized. The composition obtained is a glossy white homogeneous toothpaste.
[0188] Composition 3 described below was prepared by the above method, mixture A comprises a mixture of carboxymethylcellulose, sodium alginate and glycerin, in mixture B the foaming compounds are lauryl glucoside and disodium cocoyl glutamate, the fluorine salt is nicomethanol hydrofluoride, the abrasive filler is perlite, the final mixture obtained was left stirring until completely homogenized. The composition obtained is a bright green homogeneous toothpaste.
[0189] Tables 1, 3, 5, 7, 9, 11 and 13 describe examples of compositions according to the invention.
[0190] Composition 1: opaque white-yellow paste type composition, odorous
[0191]
[0192]
[0193]
[0194]
[0195]
[0196] [Tables 1] Ingredients INCI Name Quantity in % relative to the total weight of the composition (%)% Cellulose gum 2-3 Sodium alginate 0.4 - 0.6 Lauryl glucoside 1.5 - 2.5 Disodium cocoyl glutamate 2-2.5 Film former 0.1 - 1 Nicomethanol hydrofluoride 5.0 Kaolin 0.5 - 1.5 Aroma 0.5 - 1.5 Sweetener 0.01 - 0.5 Water 20-30 Glycerin QSP 100% Percentage of naturalness according to ISO16128 standard: 97% The pH of the composition was 5.23 with a viscosity of 10962mPa.s, a consistency of 113.226g (test carried out at T0, therefore 24 hours after manufacture). The results regarding the stability of composition 1 are shown in Table 2 below: [Tables 2] Composition 1 T2 months T3 months 25°C / 65%HR 40°C / 75%HR 25°C / 65%HR 40°C / 75%HR Macroscopic appearance Compliant paste Compliant paste Compliant paste Compliant paste PH 5.40 5.51 5.31 5.59 Viscosity 10968 9791 10660 8789 Composition 2: opaque white-yellow paste type composition, odorous
[0197] [Tables3] Ingredients INCI Name Quantity in % relative to the total weight of the composition (%) Cellulose gum 1.5-2 Sodium alginate 0.3 - 0.5 Kaolin 1-2 Lauryl glucoside 1-2 Disodium cocoyl glutamate 1.5 - 2.5 Film former 0.1-2 Preservative 0.05 - 0.5 Nicomethanol hydrofluoride 5 Sweetener 0.01 - 0.5 Aroma 0.5 - 1.5 Glycerin 20-30 Sorbitol (as Hydrogenated starch hydrolysate), aqua Qsp 100% Water 20-30
[0198] Percentage of naturalness according to ISO16128 standard: 96.8%.
[0199] The pH of the composition was 5.07 with a viscosity of 11062mPa.s, a consistency (penetrometry) of 98.5g (test carried out at T0, 24 hours after manufacture).
[0200] The results concerning the stability of composition 2 are indicated in Table 4 below:
[0201] [Tables4] Composition 2 T2 months 25°C / 65%HR 40°C / 75%HR Macroscopic appearance Compliant paste Compliant paste PH 5.32 5.39 Viscosity (rnPa.s) 11352 10823
[0202] Composition 3: Green, shiny, odorous gel-type composition
[0203] [Tables5] Ingredients INCI Name Quantity in % relative to the total weight of the composition (%) Cellulose gum 1.5-2 Sodium alginate 0.3 - 0.4 Perlite 0.5 - 1 Lauryl glucoside 1.5-2 Disodium cocoyl glutamate 1 - 1.5 Film former 0.1-2 Nicomethanol hydrofluoride 1.786 Sweetener 0.01 - 0.5 Aroma 0.1 - 1 Sorbitol / Hydrogenated starch hydrolysate, aqua Qsp 100% Color 0.001 - 1 Glycerin 8-15 Preservative 0.05 - 0.5 Water 15-25
[0204] Percentage of naturalness according to ISO16128 standard: 96%
[0205] The pH of the composition was 5.43 with a viscosity of 9894mPa.s, a consistency (penetrometry) of 81g (test carried out at T0, 24 hours after manufacture).
[0206] The results concerning the stability of composition 3 are indicated in the table 6 below:
[0207] [Tableauxô] Composition 3 T2 months T3 months 25°C / 65%RH 40°C / 75%RH 25°C / 65%RH 40°C / 75%RH Macroscopic appearance Gel conforms Gel conforms Gel conforms Gel conforms PH 5.20 5.19 5.33 5.26 Viscosity (mPa.s) 9673 7614 10064 6054
[0208] Composition 4: Blue-green, shiny, odorous gel-type composition
[0209] [Tables?] Ingredients INCI Name Quantity in % relative to the total weight of the composition (%) Cellulose gum 2-3 Sodium alginate 0.4 - 0.6 Perlite 0.5 - 1 Lauryl glucoside 1 - 1.5 Disodium cocoyl glutamate 1.5-2 Film former 0.1-2 Nicomethanol hydrofluoride 3.571 Sweetener 0.01 - 0.5 Aroma 0.1 - 1 Color 0.001 - 1 Glycerin 10-20 Sorbitol / Hydrogenated starch hydrolysate, aqua Qsp 100% Preservative 0.05 - 0.5 Aqua 20-30
[0210] Percentage of naturalness according to ISO16128 standard: 96%
[0211] The pH of the composition was 5.42 with a viscosity of 9903mPa.s, a consistency (penetrometry) of 81.76g (test carried out at T0, 24 hours after manufacture).
[0212] The results concerning the stability of composition 4 are indicated in Table 8 below:
[0213] [Tables8] Composition 4 T2 months T3 months 25°C / 65%HR 40°C / 75%HR 25°C / 65%HR 40°C / 75%HR Macroscopic appearance Gel conforms Gel conforms Gel conforms Gel conforms PH 5.38 5.37 5.38 5.36 Viscosity (mPa.s) 9318 7308 8887 6040
[0214] Composition 5: Black colored gel type composition
[0215] [Tables9] Ingredients INCI Name Quantity in % relative to the total weight of the composition (%) Cellulose gum 2-3 Sodium alginate 0.4 - 0.6 Perlite 0.8 - 1.2 Lauryl glucoside 1.5-2 Disodium cocoyl glutamate 1 - 1.5 Film former 0.1-2 Nicomethanol hydrofluoride 5 Sweetener 0.01 - 0.5 Colour 0.001 - 1 Aroma 0.1 - 1 Glycerin 7 - 12 Sorbitol / Hydrogenated starch hydrolysate, aqua Qsp 100% Preservative 0.05 - 0.5 Aqua 15-25
[0216] Percentage of naturalness according to ISO16128 standard: 95%
[0217] The pH of the composition was 5.33 with a viscosity of 10185mPa.s, a consistency (penetrometry) of 72.9g (test carried out at T0, 24 hours after manufacture).
[0218] The results concerning the stability of composition 5 are indicated in the table 10 below: Composition 5 T2 months T3 months 25°C / 65%HR 40°C / 75%HR 25°C / 65%HR 40°C / 75%HR Macroscopic appearance Gel conforms Gel conforms Gel conforms Gel conforms PH 5.34 5.25 5.32 5.22 Viscosity (mPa.s) 9404 7803 9891 7696
[0220] Composition 6: Light blue-green gel-like composition
[0221] [T ables 11] Ingredients INCI Name Quantity in % relative to the total weight of the composition (%) Cellulose gum 1.5-2 Sodium alginate 0.3 - 0.5 Perlite 0.5-1 Active 0.01-0.1 Lauryl glucoside 1-2 Disodium cocoyl glutamate 1-2 Film former 0.1-2 Nicomethanol hydrofluoride 5 Sweetener 0.01 - 0.5 Aroma 0.1 - 1 Colorant 0.001 - 1 Glycerin 8 - 10 Hydrogenated starch hydrolysate, aqua Qsp 100% Preservative 0.05 - 0.5 Aqua 20-25
[0222] Percentage of naturalness according to ISO16128 standard: 95%
[0223] The pH of the composition was 5.43 with a viscosity of 10131mPa.s, a consistency (penetrometry) of 83g (test carried out at T0, 24 hours after manufacture).
[0224] The results concerning the stability of composition 6 are indicated in Table 12 below:
[0225] [Tablesl2] Composition 6 Tl months T2 months 25°C / 65%HR 40°C / 75%HR 25°C / 65%HR 40°C / 75%HR Macroscopic appearance Gel conforms Gel conforms Gel conforms Gel conforms PH 5.44 5.42 5.40 5.34 Viscosity (mPa.s) 9526 8732 9093 7161
[0226] Composition 7: Toothpaste-type composition
[0227] [Tables 13] Ingredients INCI Name Quantity in % relative to the total weight of the composition (%) Cellulose gum 1.5-2 Sodium alginate 0.3 - 0.5 Perlite 0.8 - 1.2 Nicomethanol hydrofluoride 5 Lauryl glucoside 1-2 Disodium cocoyl glutamate 1-2 Aroma 0.1 - 1 Glycerin 20-35 Water 8 - 12 Mentha piperita leaf extract 8 - 12 Sorbitol / Hydrogenated starch hydrolysate, aqua Qsp 100%
[0228] 2. Comparative examples concerning physicochemical properties of examples of composition according to the invention and of known compositions
[0229] Comparative tests concerning viscosity, consistency and pH between examples of compositions according to the invention and known compositions were carried out. The known compositions, composition 1 bis, 3 bis to 6 bis, are mentioned in tables 14 to 18 below. The examples of compositions according to the invention correspond to compositions 1 to 7 described above. Table 19 includes all the results obtained.
[0230] Composition 1 bis: composition in the form of a shiny white odorous paste
[0231] [Tables 14] INCI Name Quantity in % relative to the total weight of the composition (%) Aqua Qsp 100% Nicomethanol hydrofluoride 5 Sweetener 0.01 - 0.5 Hydrated Silica 4.5 - 5.5 Hydrated Silica 10- 12 Colorant 0.001 - 1 Film former 0.1-2 Glycerin 5 - 10 Sodium lauryl sarcosinate 4-6 Cellulose gum 0.2- 1 Aroma 0.1 - 1 Sorbitol / Hydrogenated starch hydrolysate, aqua 30-50
[0232] Composition 3 bis: composition in the form of a transparent green gel, mint scent INCI Name Quantity in % relative to the total weight of the composition (%) Aqua 15-30 Nicomethanol hydrofluoride 5 Sweetener 0.01 - 0.5 Hydrated Silica 3.5-5 Hydrated Silica 11 - 14 Preservative 0.05 - 0.5 Film-forming agent 0.1-2 Sodium lauryl sarcosinate 2-4 Cellulose gum 0.2- 1 Aroma 0.1 - 1 Colorant 0.001 - 1 Sorbitol / Hydrogenated starch hydrolysate, aqua QSP100%
[0234] Composition 4a: composition in gel form. INCI Name Quantity in % relative to the total weight of the composition (%) Nicomethanol hydrofluoride 5 Sweetener 0.01 - 0.5 Hydrated Silica 3-3.5 Hydrated Silica 13-15 Film former 0.1-2 Colorant 0.001 - 1 Sodium lauryl sarcosinate 2-3 Cellulose gum 0.2- 1 Preservative 0.05 - 0.5 Aroma 0.1 - 1 Sorbitol / Hydrogenated starch hydrolysate, aqua Qsp 100%
[0236] Composition 5 bis: composition in gel form INCI Name Quantity in % relative to the total weight of the composition (%) Nicomethanol hydrofluoride 3.57 Sodium saccharin 0.01 - 0.5 Hydrated Silica 3-4 Hydrated Silica 10-15 Film former 0.1-2 Colorant 0.001 - 1 Sodium lauryl sarcosinate 2-5 Cellulose gum 0.2- 1 Preservative 0.05 - 0.5 Aroma 0.1-2 Sorbitol / Hydrogenated starch hydrolysate, aqua Qsp 100%
[0238] Composition 6 bis: composition in the form of a brilliant blue-green gel INCI Name Quantity in % relative to the total weight of the composition (%) Aqua Qsp 100% Nicomethanol hydrofluoride 5 Active 0.01-0.1 Sodium saccharin 0.01-0.5 Hydrated Silica 4-5 Hydrated Silica 10-12 Film-forming 0.1-2 Glycerin 5-8 Sodium methyl cocoyl taurate 1-2 Cellulose gum 0.2-1 Preservative 0.05-0.5 Aroma 0.1-1 Sorbitol / Hydrogenated starch hydrolysate, aqua 40-50
[0240] Table 19 below includes the viscosity and consistency values obtained for examples of compositions according to the invention and known compositions.
[0241] The viscosity measurements were carried out at 25°C at different times, namely: T0: 24 hours after manufacture, T2: 2 months after manufacture and T3: 3 months after manufacture. Composition n° Viscosity Consistency T0 T2 25° T3 25° (T0) 1 10962 10968 10660 113.226g 2 11062 11352 nd 98.5g 3 9894 9673 10064 81g 4 9903 9318 8887 81.76g 5 10185 9404 9891 72.9g 6 10131 9526 9093 83g Ibis 9500 nd nd nd 3bis 29500 nd nd nd 4bis 40000 nd nd nd 5bis 45500 nd nd nd 6bis 6826 na na na
[0243] In the table above, nd means not determined.
[0244] Table 20 below includes the pH values obtained for examples of compositions according to the invention and known compositions. Composition n° PH T0 T2 25° T3 25° 1 5.23 5.40 5.31 2 5.07 5.32 nd 3 5.43 5.2 5.33 4 5.42 5.38 5.38 5 5.33 5.34 5.32 6 5.43 5.44 5.40 Ibis 5.5 nd nd 2bis 5.6 nd nd 3bis nd nd nd 4bis nd nd nd 5bis 4.9 nd nd
[0246] In the table above, nd means not determined.
[0247] The pH measurements were carried out at 25°C at different times, namely: T0: 24 hours after manufacture, T2: 2 months after manufacture, and T3: 3 months after manufacture.
[0248] As demonstrated in Tables 19 and 20 above, the compositions according to the invention have at T0, namely 24 hours after manufacture, consistency values ranging from 72.9 g (Composition 5) to 113.2 g (Composition 1), and a viscosity ranging from 9894 mPa.s (Composition 3) to 10962 mPa.s (Composition 1). These values are within the targeted range. On the contrary, the results demonstrate that the viscosity of the known compositions is very variable and is ranging from 6826 mPa.s (Composition 5bis) to 45500 (Composition 4bis). These results clearly demonstrate that the known compositions have a very variable viscosity. The above results surprisingly demonstrate that examples of compositions according to the invention are less viscous while being stable over time.In particular, the results obtained demonstrate an absence of phase shift of the composition according to the invention and homogeneity (macroscopic inspection) after three months of storage. In addition, the results in Table 19 clearly demonstrate that the viscosity of examples of composition according to the invention are stable, in particular the results clearly demonstrate that the variability of the viscosity at 25° / 65% RH is less than 10% after 2 months of storage and less than 15% after 3 months of storage.
[0249] Also surprisingly, the results obtained and described in Table 20 clearly demonstrate that the pH of examples of compositions according to the invention does not vary or does not vary significantly.
[0250] 3. Determination of the abrasiveness of compounds and composition examples according to the invention
[0251] A study of the abrasiveness of compounds was carried out by measuring the RDA-PE according to the method described above. The compounds were cellulose fibers sold under the name Sensocel dental p-30c by the company CFF GmbH & Co. KG at 14%, microcrystalline cellulose sold under the name Vivapur CS9FM at 14%, rice starch powder (Oryza Sativa (Rice) Starch) sold under the name Remytec F-Eco at 14%, Kaolin (Imercare Kaobright) 14%, by weight, relative to the total weight of the composition. A combination of silicas, namely Tixosil 43 silica (thickener) 12% and an abrasive silica having Tixosil 73 4% were also tested. The measurement of the RDA was carried out by the RDA-PE method (see above).The products were tested in a toothpaste composition base comprising a mixture of foaming agents at 3.4% - 4.5% by weight, a mixture of thickeners at 0.7% - 1.9% by weight, a mixture of flavoring agents at 0.6% by weight, water at 20% by weight, glycerol at 40% by weight, and sorbitol at 19.7% - 24.2% (qsp 100%) by weight, based on the total weight of the composition. The RDA-PE results (±standard deviation) are shown in Table 21 below.
[0252] [Tables21] Compounds RDA-PE Vivapur CS9FM 14% 6.8 + 2.3 Control Silicas (abrasive silica 4%, thickening silica 12%) 46.6 + 18.3 Without abrasive filler 10.3 + 5.0 Remytec F-Eco 14% 7.2 + 4.5 Sensocel dental p-30c 14% 9.2 + 5.1 Kaolin 14% 171.6 + 17.4
[0253] As demonstrated in Table 21 above, the RDA-PE result obtained from a clay, for example kaolin, clearly demonstrates that it is abrasive.
[0254] A study of the abrasiveness of a clay, in particular kaolin, as a function of its concentration in a composition was carried out. For this, the determination of the RDA-PE obtained with a composition namely a mixture of thickeners at 2.1% by weight, a mixture of foaming agents at 3% by weight, distilled water at 21% by weight and of glycerol at 64.2% - 71.4% (qsp 100%) by weight relative to the total weight of the composition comprising different concentrations of kaolin, namely: 2.5%, 5% and 10% by weight relative to the total weight of the composition was produced. A control composition comprising a mixture of aromas at 0.6%, a mixture of thickeners at 0.7% by weight, a mixture of foaming agents at 3% by weight, distilled water at 20% by weight and a mixture of humectants (glycerol and sorbitol) 59.7% by weight relative to the total weight of the composition as well as abrasive silica (Tixosil 73, Solvay, 4% by weight) and silica as a thickener (Tixosil 43, Solvay, 12% by weight) was also used. The results obtained, namely RDA-PE value (+ standard deviation) are shown in Table 22 below.
[0255] [Tables22] Concentration (% by weight relative to the total weight of the composition) RDA-PE 2.5% kaolin 76+14.1 5% kaolin 101 + 21.4 10% kaolin 136 + 20.1 Silica control 43 and 73 54+16.4
[0256] As demonstrated in Table 22 above, a composition comprising an abrasive filler selected from a clay, for example kaolin, is an abrasive composition. Furthermore, this example clearly demonstrates that at low concentration, for example 2.5% by weight relative to the total weight of the composition, the measured RDA-PE is higher than the RDA-PE value of a composition comprising silica as an abrasive filler. This example therefore clearly and surprisingly demonstrates that the abrasive effect of kaolin advantageously makes it possible to obtain an abrasiveness similar to that of silica while reducing the concentration of the abrasive filler in the composition.
[0257] The determination of the abrasiveness of an example of a composition according to the invention, for example composition 1 (Table 1 above), composition 3 (Table 5 above), was carried out according to the method described above. The measured RDA values (by 'classical' RDA) were respectively 46.62 ± 2.41 (composition 1), 57.09 (composition 3). The RDA values of the known compositions, for example compositions 1bis, 2bis and 5bis above are respectively equal to 59, 59 and 67.
[0258] 4. Determination of the cleaning power / properties of composition examples according to the invention
[0259] A study of the cleaning power / properties of composition 1 (Table 1 above) and composition Ibis was carried out by PCR measurement according to the method described above. The measured cleaning power / property was related to the RDA of each of the compositions.
[0260] The PCR results ± standard deviation obtained were as follows: - Ibis composition (prior art): RDA equal to 59 and PCR equal to 46.48 ± 7.6 - composition 1 (table 1): RDA equal to 46.62 and PCR equal to 62.56 ± 9.58.
[0261] As demonstrated, surprisingly and unexpectedly, the composition according to the invention not comprising a silica mineral filler and comprising an abrasive filler chosen from the group comprising volcanic glasses and clays or a mixture of these fillers has better cleaning power than the known composition Ibis comprising silica mineral fillers. In particular, the results obtained demonstrate a statistically significant difference concerning the cleaning power / property of the composition. Furthermore, the results obtained demonstrate surprisingly and unexpectedly that the composition according to the invention, with lower abrasiveness, has a cleaning power / property superior to that of the known compositions.The results therefore clearly demonstrate that the composition according to the invention not comprising a silica mineral abrasive filler has superior cleaning power compared to known compositions comprising a silica mineral abrasive filler.
[0262] The results obtained therefore clearly demonstrate that the compositions according to the invention can advantageously be used instead of the known compositions. Furthermore, the results clearly demonstrate that examples of compositions according to the invention have better cleaning power while respecting lower abrasiveness than the known compositions comprising silica mineral abrasive fillers.
[0263] Advantageously, the results therefore clearly demonstrate that examples of compositions according to the invention are less abrasive but more cleaning than the known compositions, and are therefore advantageously and surprisingly more respectful of dental enamel than the known compositions comprising in particular mineral abrasive silica fillers.
[0264] 5. Study of rheological properties, viscosity and penetrometry of examples of composition according to the invention
[0265] An evaluation of a possible effect of thickening compounds on the rheological aspect, viscosity and penetrometry (consistency / elasticity) of the compositions according to the invention and comparative tests was carried out. The measurement of the penetrometry (g) and viscosity (mPa.s) of the compositions were carried out according to the methods mentioned above. The viscosity and penetrometry measurements were carried out after manufacture of the composition, i.e. 24 hours, 2 months and 3 months after manufacture.
[0266] The compositions used are as described in Tables 23 and 24 below. below.
[0267] [Tables23] Composition A Composition A without cellulose gum Composition A without alginate (% by weight relative to the total weight of the composition) (% by weight relative to the total weight of the composition) (% by weight relative to the total weight of the composition) Cellulose gum 2 2 Sodium alginate 0.4 0.4 Lauryl glucoside 1.5 - 2.5 1.5 - 2.5 1.5 - 2.5 Disodium cocoyl glutamate 2-3 2-3 2-3 Film former 0.1 - 1 0.1 - 1 0.1 - 1 Nico-methanol hydrofluoride 3-5 3-5 3-5 Kaolin 1.5 1.5 1.5 Aroma 0.1 - 1 0.1 - 1 0.1 - 1 Sweetener 0.01 - 0.5 0.01 - 0.5 0.01 - 0.5 Water (“Aqua”) 10-30 10-30 10-30 Glycerin (“Glycerin”) QSP 100% QSP 100% QSP 100%
[0268] [Tableaux24] Composition B Composition B without cellulose gum Composition B without alginate (% by weight relative to the total weight of the composition) (% by weight relative to the total weight of the composition) (% by weight relative to the total weight of the composition) Cellulose gum 2 2 Sodium alginate 0.4 0.4 Lauryl glucoside 1.5-2 1.5-2 1.5-2 Disodium cocoyl glutamate 1 - 1.5 1 - 1.5 1 - 1.5 Film former 0.1 - 1 0.1 - 1 0.1 - 1 Nico-methanol hydrofluoride 1.7 - 3.7 1.7 - 3.7 1.7 - 3.7 Perlite 1 1 1 Aroma 0.1 - 1 0.1 - 1 0.1 - 1 Sweetener 0.01 - 0.5 0.01 - 0.5 0.01 - 0.5 Preservative 0.1 - 1 0.1 - 1 0.1 - 1 Colorant 0.001-0.1 0.001 - 0.1 0.001-0.1 Sorbitol / Hydrogenated starch hydrolysate, aqua QSP 100% QSP 100% QSP 100% Water ("Aqua") 10-30 10-30 10-30 Glycerin ("Glycerin") 8 - 15 8 - 15 8 - 15
[0269] The results obtained are presented in Table 25 below.
[0270] [Tables25] Composition A Composition A without cellulose gum Composition A without alginate Composition B Composition B without cellulose gum Composition B without alginate Penetrometry (g) 113 24 42 81 24 62 Viscosity (mPa.s) 10962 198 5821 9894 293 7152
[0271] As demonstrated in Table 25 above, thickeners, for example cellulose gum and sodium alginate, advantageously make it possible to obtain oral-dental compositions not comprising silica mineral fillers with a viscosity measured at 25°C of from 3500 mPa.s to 30000 mPa.s.
[0272] Surprisingly and unexpectedly, the results clearly demonstrate that the combination of cellulose gum and sodium alginate has a synergistic effect on the viscosity of the compositions (compositions 1 and 3). In particular, the results clearly demonstrate that the viscosity of compositions 1 and 3 is clearly higher compared to the sum of the respective viscosities of the compositions comprising only one of the two thickeners.
[0273] Furthermore, as demonstrated in Table 25 above, thickeners, for example cellulose gum and sodium alginate, advantageously make it possible to obtain oral compositions not comprising silica mineral fillers with a consistency (Penetrommetry (g)) of 50 g to 240 g, or even 60 g to 200 g, in particular 70 g to 150 g, or even 70 g to 130 g.
[0274] Surprisingly and unexpectedly, the results clearly demonstrate that the combination of cellulose gum and sodium alginate has a synergistic effect on the consistency (Penetromycetes (g)) of the compositions. In particular, the results clearly demonstrate that the consistency (Penetromycetes (g)) of composition A is clearly higher compared to the sum of the respective viscosities of the compositions comprising only one of the two thickeners.
[0275] A determination of the parameters of the specific volume surface area (VSSA) (m2 / cm 3), the specific surface area (m2 / g) and the density (g / cm3) VSSA as described below was carried out.
[0276] Material and method
[0277] Nitrogen adsorption sorbotometry: Surface area measurement by and application of the Brunauer, Emmett and Teller (BET) model to measure the specific surface area. Sorptometry measurement was performed using a Gemini VII Micromeritics -Surface area analyzer. The specific surface area measurement (m2 / g) was performed via the adsorption isotherm of the tested sample. The isotherm was determined by the physical adsorption of nitrogen molecules on the surface of the substrate at 77 Kelvin. To determine the specific surface area, the BET (Brunauer, Emmett and Teller) method was applied to the adsorption isotherm in the validity range of the law, i.e. between 0.05 and 0.30 P / P0. The BET transform was thus plotted and the specific surface area is deduced.The assumptions of the BET model were: the molecules of the last adsorbed layer are in equilibrium with the surrounding vapor, no lateral interaction between the adsorbed molecules, a single type of adsorption site, an energetically homogeneous surface, and an identical probability of adsorption of the molecule for all layers. The acceptance parameters were a positive BET constant C and a correlation coefficient > 0.995. Specific Surface Area measurements by BET were performed according to ISO 9277:2010 (reference 9).
[0278] Helium Pycnometry allows the measurement of the real density, in particular the density in g / cm3. The measurements carried out by Pycnometry were carried out according to the ISO 12154:2014 standard (reference 6) adapted in the example. Gas (Helium) Pycnometry is a process based on the relationship of ideal gases according to the following ideal gas law formula:
[0279] [Math.4] Gas Law By fact: Pl(VCELL-VSAMP) = nCRTa
[0280] With nc=number of moles of gas in VCELL / R=Perfect Gas Constant (8.3144621 J.moE'.K1) / Ta=Ambient temperature, VCELL:Empty volume of the measuring cell, VSAMp:Volume of the sample to be determined and Pi.Pressure in Pascal.
[0281] Helium Pycnometry allows the exact volume of a sample to be measured, excluding inter- and intra-granular porosity. Knowing the mass of the sample, the actual density (g / cm3) can be calculated. The measurement was carried out using a Micromeritics-AccuPyc 1340.
[0282] Scanning Electron Microscopy (SEM) equipped with an EDX microprobe which allows local semi-quantitative chemical observations and analyses to be carried out.
[0283] Granulometric Distribution in number by Field Emission Scanning Electron Microscopy (FEG / SEM) coupled with an EDX microprobe allowing local chemical observations and analyses to be carried out. semi-quantitative. Scanning Electron Microscopy (SEM) and determination of particle size distribution in number was performed with a Zeiss pressure-controlled SEM-FEG
[0284] The principle of scanning electron microscopy consists of emitting an electron beam onto the surface of a sample, then analyzing the interactions between it and the material.
[0285] The electrons are generated by a field effect gun. Compared to a beam emitted via a filament, the latter is finer and its brightness increased. The emission can thus be more targeted on the surface and the information obtained of better quality. Three types of “matter / electron” interactions are exploited by this technique:
[0286] Secondary electrons (SE). Images obtained via secondary electrons (SE mode) provide access to the topographic contrast of the sample.
[0287] Backscattered electrons (BSD). The image obtained (BSD mode) is called chemical composition contrast.
[0288] X-RAYS (EDX mode).
[0289] The analysis of these rays makes it possible to access the chemical nature of the atoms constituting the sample, via an EDX probe. The spectra thus obtained indicate from a semi-quantitative point of view the elementary chemical compositions. Results
[0290] The results obtained are presented in Table 26 below.
[0291] Table 26: Specific surface area by BET and density measurement by pycnometry at helium - Calculation of the Specific Surface Area Volume (SSAV) and the SSA Diameter.
[0292] [Tables26] Specific surface area (m2 / g) Density (g / cm3) VSSA (m2 / cm3) Kaolin 10.75 2.77 29.8 Perlite 2.87 2.37 6.81 REFERENCES
[0293] Reference 1: DIN EN ISO 11609 updated in June 2017
[0294] Reference 2: ISO 16128 standard
[0295] Reference 3: Wohlleben W; Mielke J; Bianchin A; Ghanem A; Freiberger H; Rauscher H; Gemeinert M; Hodoroaba D. Reliable nanomaterial classification of powders using the volume-specified surface area method. JOURNAL OF NANO-PARTICLE RESEARCH 19 (61); 2017. JRC101198
[0296] Reference 4: Commission recommendation of 18 October 2011 on the definition of nanomaterials: 2011 / 696 / EU
[0297] Reference 5: Griffin WC, Classification of Surface-Active Agents by HLB, Journal of the Society of Cosmetic Chemists 1 (1949): 311
[0298] Reference 6: ISO 12154:2014 standard
[0299] Reference 7: Stookey, Burkhard and Schemehorn (J.Dent.Res. 61(11):1236-1239 (1982))
[0300] Reference 8: Jachowicz, J. & YAO, K (1997) Characterization of cosmetic products by texture analysis. International conference of IFSCC and the 9th Hungarian Congress on Cosmetic and Household Chemical
[0301] Reference 9: ISO 9277:2010
Claims
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12. Claims Oral-dental composition comprising at least one abrasive filler chosen from the group comprising volcanic glasses and clays or a mixture of these fillers, and at least one fluorine salt, said composition being free of mineral abrasive silica fillers. Composition according to claim 1, wherein the concentration of said at least one abrasive filler is from 0.5 to 5% by weight relative to the total weight of the composition. 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. A composition according to any one of claims 1 to 3, wherein said at least one abrasive is a volcanic glass. The composition of claim 4, wherein said volcanic glass is perlite. A composition according to any one of claims 1 to 3, wherein said at least one abrasive is a clay. The composition of claim 6, wherein said clay is kaolin. Composition according to any one of claims 1 to 7, wherein the composition further comprises at least one thickener, preferably chosen from the group comprising cellulose derivatives, polysaccharides of natural origin and any mixture thereof. Composition according to any one of claims 1 to 8, wherein the composition further comprises at least one foaming agent with an HLB of from 3 to 8. Composition according to any one of claims 1 to 9 wherein said at least one fluorine salt is selected from the group comprising potassium fluoride, tin fluoride, amine fluoride, sodium fluoride, preferably amine fluoride. Composition according to any one of claims 1 to 10 wherein said at least one fluorine salt is nicomethanol hydrofluoride or nicomethanol hydrofluoride Composition according to any one of claims 1 to 11, said composition having an abrasiveness determined by measuring abrasion. relative dentin or RD A between 15 and 100.
13. A composition according to any one of claims 1 to 12, said composition being free of calcium carbonate and / or calcium hydrogen phosphate.
14. A composition according to any one of claims 1 to 13 wherein the composition is in the form of a toothpaste, preferably in the form of a paste or gel.
15. A composition according to any one of claims 1 to 14 wherein the composition has a viscosity at 25°C of from 3500 mPa.s to 30000 mPa.s.
16. A composition according to any one of claims 1 to 15 for use in cleaning a dental surface in a human or animal.
17. A method of manufacturing an oral-dental composition according to any one of claims 1 to 15 comprising the steps of: a) preparation of an oral-dental composition b) addition to the composition prepared in step a) of at least one abrasive filler chosen from the group comprising volcanic glasses and clays or a mixture of these fillers, c) addition to the composition prepared in step a) or b) of at least one fluorine salt, d) recovery of the oral-dental composition obtained, said composition being free of mineral abrasive silica fillers.
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