Oral care compositions containing porous silica particles

Abstract

The present specification provides an oral care composition comprising porous silica particles having pores in the mesoporous range, the pores in the mesoporous range having an average pore size of about 7.0 to about 25.0 nm.

Description

[Technical field]

[0001] The present invention relates to oral care compositions containing silica. In particular, the present invention relates to oral care compositions comprising porous silica particles, which are useful in preventing the formation of dental cavities and dental caries. [Background technology]

[0002] The listing or discussion of any prior-published document in this specification should not necessarily be taken as an acknowledgement that the document is part of the state of the art or is common general knowledge.

[0003] Tooth (dental) decay, or the development of caries, occurs when tooth enamel is damaged, causing lesions within the tooth that can develop into dental cavities. Infection caused by dental cavities can lead to complications such as inflammation of the tissues surrounding the tooth, tooth loss, infection, and the formation of abscesses.

[0004] Dental caries can develop for a variety of reasons, notably when bacteria in the mouth metabolize sugars to produce acids that demineralize the hard tissues of the teeth (enamel and dentin). Such sugars may be present in the mouth as a direct result of food intake, or they may be generated in situ, for example by the action of amylase enzymes in saliva that break down starch into sugars (e.g., maltose). Bacteria then ferment these sugars to produce acids (e.g., lactic acid), which are damaging to tooth enamel.

[0005] Reducing the formation of caries is usually achieved by improving oral hygiene, the aim being to remove food from the mouth to remove sources of starch and sugar, and to reduce the number of bacteria in the mouth and the production of acids through fermentation. Brushing the teeth with toothpaste products usually aims to remove food, but can also have an antibacterial effect. A reduction in bacterial numbers can also be achieved by the use of mouthwash products that contain antibacterial agents and denaturing agents (such as alcohol).

[0006] Toothpastes are usually provided in the form of a paste or gel and contain one or more abrasives capable of removing food and plaque from the tooth surface. Such products may contain other agents to strengthen tooth enamel (e.g., fluoride), to enhance flavor, to alter the appearance of the product (e.g., colorants), to control breath odor, etc.

[0007] Abrasives commonly used in toothpaste products are typically in the form of solid particles and include particles of aluminum hydroxide (Al(OH)3), calcium carbonate (CaCO3), various calcium hydrogen phosphates, hydroxyapatite (Ca5(PO4)3OH), and silica materials (SiO2).

[0008] Porous silica particles have been used in a variety of healthcare applications, including loading drugs and providing a vehicle for the delivery of therapeutic agents. Porous silica particles are thermally and chemically stable and consist entirely of pure silicon dioxide.

[0009] These silica particles have regular porosity with controllable pore size, resulting in high surface area and large total pore volume. These properties, together with other properties such as stability and biocompatibility, make them particularly suitable for biomedical applications (see, for example, Wang, Y. et al., Nanomedicine Nanotechnology, Biol. Med. 11, 313-327 (2015)). Moreover, a similar substance has previously been approved as a food additive (European Center for Ecotoxicology and Toxicology of Chemicals Synthetic Amorphous Silica (CAS No. 7631-86-9), JACC No. 51, page 14 (ECETOC, 2006)).

[0010] WO2014 / 072363 discusses the use of highly structured porous silica materials with specific average pore sizes in the mesoporous range in the treatment of conditions such as obesity and dyslipidemia. No teaching is provided regarding oral hygiene, prevention or reduction of caries. Summary of the Invention

[0011] Detailed Description of the Invention We have discovered that certain porous silica materials having particular average pore sizes in the mesoporous range function effectively as molecular sieves for certain biomolecules in vivo, and therefore have properties useful in oral care, such as preventing or reducing the formation of dental caries.

[0012] In particular, the porous silica particles according to the present invention, as described herein, are designed to have certain physiochemical properties, which enable important biological effects related to the above mentioned applications. Controlling certain particle properties, such as the average pore size, has been unexpectedly found to provide these biological effects, such as enabling the absorption of salivary amylase enzymes in the mouth, which may result in a reduction in acid production by cariogenic bacteria that is detrimental to oral (e.g., tooth) health.

[0013] Oral Care Composition In a first aspect of the present invention, an oral care composition is provided comprising porous silica particles having pores in the mesoporous range, the pores in the mesoporous range having an average pore size of from about 7.0 to about 25.0 nm.

[0014] For the avoidance of doubt, the silica particles as defined in the first aspect of the invention (including all its embodiments and features) may be referred to as "the silica (or silica material or silica particle) of the invention (or of the first aspect of the invention)" etc. Similarly, the composition as defined in the first aspect of the invention (including all its embodiments and features) may be referred to as "the composition of the invention (or of the first aspect of the invention)" etc.

[0015] Unless otherwise defined, all technical and scientific terms used herein have the common meaning as understood by one of ordinary skill in the art to which this invention pertains.

[0016] When used herein in connection with a particular value (such as an amount), the term "about" (or similar terms such as "approximately") is understood to indicate that such value may vary by up to 10% (specifically, up to 5%, e.g., up to 4%, 3%, 2% or 1%) of the defined value. In each instance, it is contemplated that such terms may be replaced with notations such as "±10%" (or by indicating a variation of the particular amount calculated based on the relevant value). It is also contemplated that in each instance, such conditions may be omitted.

[0017] For the avoidance of doubt, those skilled in the art will understand that where percentages of certain features are defined as belonging to different (i.e. non-overlapping) groups, the sum of these percentages cannot exceed 100%. Similarly, a specified feature need not sum to 100% if such feature may belong to other unspecified groups.

[0018] Those skilled in the art will appreciate that the porous silica particles provided in the composition of the first aspect of the present invention may be referred to as a plurality thereof, and that the plurality may be referred to as a porous silica material.

[0019] Those skilled in the art will appreciate that the oral care compositions of the first aspect of the invention include any general type of composition suitable for cleaning (e.g., by use of brushing, scrubbing, washing and / or rinsing) oral surfaces.

[0020] Thus, one of skill in the art will understand that an oral care composition for purposes of the present invention may include compositions in the form of pastes, powders, liquids, gums, serums or other preparations suitable for cleaning (e.g., by brushing, scrubbing, washing, rinsing, etc.) teeth and / or other surfaces within the oral cavity.

[0021] In certain embodiments, the oral care composition of the first aspect of the present invention may be delivered in the form of a dentifrice (which may be in a semi-solid form, for example a paste, powder or gel) or a liquid.

[0022] Specifically, those skilled in the art will appreciate that the term dentifrice includes compositions in extrudable semi-solid forms, such as pastes (i.e., toothpastes) and gels, and powders (i.e., tooth powders) (including loose and compressed powders (e.g., loose powders)), which compositions may be suitable for use in brushing and / or polishing (e.g., brushing) the teeth (e.g., using a suitable tooth cleaning implement such as a toothbrush). Thus, the term dentifrice may refer to oral compositions as described above that are used to clean the (surfaces of) the oral cavity.

[0023] Those skilled in the art will also appreciate that the term gel can also refer to a material that has the physical properties of a liquid but has substantially zero flow.

[0024] In certain embodiments, the oral care composition can be in the form of a dentifrice, such as a toothpaste or tooth powder (eg, toothpaste), as these terms are known to those of skill in the art.

[0025] In such embodiments, the dentifrice can be said to be for brushing and / or polishing (e.g., brushing) surfaces of the oral cavity (e.g., teeth) in combination with an appropriate cleaning implement (e.g., a toothbrush), in accordance with the general understanding of users of such products.

[0026] In certain embodiments, the dentifrice may be in the form of a paste, i.e., toothpaste (or similarly, a gel), as known to those skilled in the art. In such embodiments, the composition may include, in addition to the porous silica particles described herein, one or more additional ingredients typically provided to form such compositions, including those described herein.

[0027] Thus, in certain embodiments, the oral care composition may be substituted for toothpaste, a term that one of skill in the art would understand to refer to a composition for use with an appropriate tooth cleaning implement, such as a toothbrush (e.g., in combination with such a composition to clean the teeth by brushing the teeth, e.g., for about 1-2 minutes).

[0028] In further embodiments, the composition may be in the form of a liquid, in which case the composition may be in the form of a mouthwash (or mouth / dental rinse). In such embodiments, the composition may include, in addition to the porous silica particles described herein, one or more additional ingredients typically provided to form such compositions, including those described herein.

[0029] Thus, in certain embodiments, the oral care composition may be replaced with a mouthwash (or mouthrinse, etc.), which term would be understood by one of skill in the art to refer to a composition for rinsing and / or cleaning (e.g., rinsing) the oral cavity (e.g., dental surfaces) by holding the composition in the mouth for a period of time (e.g., about one minute) and then expelling (spitting) the composition from the mouth, etc.

[0030] Thus, according to an embodiment of the present invention there is provided a mouthwash comprising the silica of the present invention.

[0031] In further embodiments, the composition may be in the form of a gel and may be suitable for use as described herein in relation to a dentifrice and / or mouthwash. Gels may include pastes, mousses, creams, and the like.

[0032] Those skilled in the art will understand that such compositions are typically not swallowed intentionally for systemic administration of therapeutic agents, but rather applied to the oral cavity and then expelled from the body through the mouth (e.g., spat out). Thus, the compositions described herein may be referred to as non-systemic, topical (as they relate to the oral cavity, e.g., oral topical), non-swallowable, non-edible, etc. When used in combination with a cleaning implement, such as a toothbrush, such compositions may be applied to the bristles of the toothbrush and then used in a manner that requires brushing an accessible surface of the oral cavity (e.g., an accessible surface of the teeth).

[0033] For the avoidance of doubt, rinsing the mouth after use of the mouthwashes and other products (such as pastes, gels, mousses, creams, etc.) described herein is optional.

[0034] As discussed herein, the oral care compositions may include additional ingredients typically present in compositions of the relevant type, and which ingredients are known to those of skill in the art.

[0035] For example, when the oral care composition is provided in the form of a toothpaste, the oral care composition comprises ingredients that include:

[0036] Structuring agents such as binders, thickeners, etc. The structuring agents may be present in an amount of about 0.1-1.0% by weight based on the total weight of the composition. Suitable binders or thickening agents that may be mentioned include carboxyvinyl polymers (such as polyacrylic acid crosslinked with polyallyl sucrose or polyallyl pentaerythritol), hydroxyethyl cellulose, hydroxypropyl cellulose, natural gums (such as carrageenan, karaya gum, guar gum, xanthan gum, gum arabic, tragacanth gum, etc.). Natural gum-based thickeners may also be mentioned, especially carrageenan.

[0037] Aqueous continuous phase, such as may be formed from a mixture of water and polyhydric alcohol (in various relative amounts), the amount of water generally ranging from about 10 to about 60% by weight (e.g., about 40%), based on the total weight of the composition, and the amount of polyhydric alcohol generally ranging from about 5 to about 70% by weight (e.g., about 30%), based on the total weight of the composition. Polyhydric alcohols that may be mentioned include humectants such as glycerol, sorbitol, polyethylene glycol, polypropylene glycol, propylene glycol, xylitol (and other edible polyhydric alcohols), hydrogenated partially hydrolyzed polysaccharides and mixtures thereof. More specifically, polyhydric alcohols that may be mentioned include glycerol and sorbitol (e.g., sorbitol). In certain embodiments, the amount of water and / or polyhydric alcohol is usually at least about 10% by weight, such as at least about 30% by weight, such as at least about 50% by weight, based on the total weight of the composition. In such embodiments, the water and / or polyhydric alcohol may be less than about 90% by weight of the total composition, such as less than about 85% by weight.

[0038] Abrasives. The abrasives may be present in an amount of about 0.5 to about 75.0% by weight, for example, about 3.0 to about 60% by weight, based on the total weight of the dentifrice. Particular abrasives (i.e., abrasive cleaners) that may be mentioned include silica xerogels, hydrogels, aerogels, precipitated particulate silica (wherein the silica(s) are present in addition to the porous silica material required in the first aspect of the invention), calcium carbonate, dicalcium phosphate, tricalcium phosphate, calcined alumina, sodium and potassium metaphosphate, sodium and potassium pyrophosphate, sodium trimetaphosphate, sodium hexametaphosphate, particulate hydroxyapatite, and mixtures thereof. For the avoidance of doubt, those skilled in the art will appreciate that the essential silica component of the first aspect of the invention may also function as an abrasive.

[0039] Thickening and / or gelling agents (in each case inorganic, natural or synthetic). The thickening and / or gelling agents may be present in an amount of about 0.1 to about 15.0% by weight of the total composition. Those skilled in the art will understand that the amount (and proportion) of thickening agent(s) is selected to form an extrudable, shape-retaining product that can be squeezed from a tube onto a toothbrush and does not fall between the bristles of the toothbrush, but rather substantially maintains its shape. Particular thickening and gelling agents that may be mentioned include fine silica (this silica(s) is present in addition to the porous silica material required in the first aspect of the invention), hectorite, calcium carbonate, colloidal magnesium aluminum silicate and mixtures thereof, and / or gums such as Irish moss, iota carrageenan, gum tragacanth, polyvinylpyrrolidone, etc. For the avoidance of doubt, those skilled in the art will understand that the essential silica component of the first aspect of the invention may also function as a thickening agent.

[0040] Metal ions such as stannous or zinc (e.g., zinc). Particular metal ions that may be mentioned include zinc ions, zinc chloride, zinc acetate, zinc gluconate, zinc sulfate, zinc fluoride, zinc citrate, zinc lactate, zinc oxide, zinc monoglycerate, zinc tartrate, zinc pyrophosphate, zinc maleate, and mixtures thereof.

[0041] Fluoride Sources. Particular fluoride sources that may be mentioned include sodium fluoride, stannous fluoride, sodium monofluorophosphate, ammonium zinc fluoride, ammonium stannous fluoride, calcium fluoride, ammonium cobalt fluoride, and mixtures thereof.

[0042] Further optional ingredients conventional in the art, such as antibacterial agents such as chlorhexidine, sanguinarine extract, metronidazole, quaternary ammonium compounds (e.g., cetylpyridinium chloride), bisguanides (e.g., chlorhexidine digluconate, hexetidine, octenidine, alexidine), halogenated bisphenol compounds (e.g., 2,2' methylene bis-(4-chloro-6-bromophenol)), anti-inflammatory agents such as ibuprofen, flurbiprofen, aspirin, indomethacin, anticaries agents such as sodium fluoride, stannous fluoride, amine fluorides, sodium monofluorophosphate, sodium trimetaphosphate, casein, plaque buffers such as urea, calcium lactate, calcium glycerophosphate, strontium polyacrylate, vitamins such as vitamins A, C, E, plant extracts, flavonoids, catechins, polyphenesin, glyceryl phosphate ... desensitizing agents such as potassium citrate, potassium chloride, potassium tartrate, potassium bicarbonate, potassium oxalate, potassium nitrate, strontium salts; anti-tartar agents such as alkali metal pyrophosphates, hypophosphorous acid containing polymers, organic phosphonic acids, citrate phosphates; biomolecules such as bacteriocins, antibodies, enzymes; flavorings such as peppermint, spearmint oil; proteinaceous materials such as collagen; preservatives; opacifying agents; amino acids such as arginine; colorants; sweeteners; pharma- ceutically acceptable carriers such as starch, sucrose (in addition to water or water / alcohol systems as described above); pH adjusters including buffers and salts to buffer the pH and ionic strength of the oral care composition; bleaching agents such as peroxy compounds (e.g., potassium peroxydiphosphate); effervescent systems such as sodium bicarbonate / citric acid systems; color altering systems.

[0043] Similarly, when the oral care composition is provided in the form of a liquid (e.g., a mouthwash), the oral care composition may further comprise ingredients including water, emollients (e.g., glycerol), sweeteners (e.g., xylitol), preservatives (e.g., sodium benzoate), and / or sodium fluoride.

[0044] Those skilled in the art will also appreciate that such mouthwash formulations may further comprise additional ingredients that may be desirable in some circumstances, such as antibacterial agents (such as alcohol), colorants, and / or flavorings (such as menthol).

[0045] Without wishing to be bound by theory, it is believed that the presence of surfactants commonly used in oral care compositions (e.g., toothpaste) may inhibit or reduce the effect of the silica particles, thus reducing the beneficial effects of the composition.

[0046] Thus, in certain embodiments, the oral care composition (eg, a dentifrice such as a toothpaste or mouthwash) is substantially free of surfactants.

[0047] Particular surfactants that may be mentioned are: anionic surfactants such as sodium lauryl sulfate, Zwitterionic (zero net charge) surfactants, such as cocamidopropyl betaine, Non-ionic surfactants such as polyethoxylated fatty acid sorbitan esters (e.g., polysorbate 80), ethoxylated fatty acids, esters of polyethylene glycols, ethoxylates of fatty acids, mono- and diglycerides, ethylene oxide / propylene oxide block polymers, and polyethylene glycol ethers of fatty alcohols, in particular polyethylene glycol ethers having 2 to 200 (e.g., 20 to 40) ethylene oxide groups per unit, e.g., polyoxyethylene (2 to 100, e.g., 4) lauryl ether, and "steareth" surfactants, e.g., steareth 30.

[0048] As used herein, those of skill in the art will understand that reference to being substantially free of surfactants means that ingredients classified as surfactants (such as those mentioned herein) are present at a concentration of about 0.5% or less by weight of the total composition, such as about 0.4, 0.3, 0.02, or especially 0.1% or less by weight of the total composition (e.g., about 0.09, 0.08, 0.07, 0.06 or 0.05% or less by weight of the total composition, especially less than about 0.04, 0.03, 0.02 or 0.01% by weight of the total composition).

[0049] In certain embodiments, one of skill in the art will understand that reference to being substantially free of surfactants refers to the absence (i.e., the absence of detectable levels) of components classified as surfactants and may indicate that preparation of such compositions does not include the addition of such components.

[0050] As used herein, being substantially free of a component may be indicated by stating that the composition "does not contain substantial concentrations of" or "does not contain," respectively, the component.

[0051] Those skilled in the art will also understand that the maximum amount of surfactant that may be present will vary depending on the nature of the surfactant component, and that such levels would be determined using routine techniques.

[0052] for example, With respect to anionic surfactants such as sodium lauryl sulfate, the surfactant may be present at a level of about 0.05% by weight or less (e.g., less than about 0.04, 0.03, 0.02, or especially less than 0.01% by weight), or may be referred to in terms of the absence of surfactant; For zwitterionic (zero net charge) surfactants, such as cocamidopropyl betaine, the surfactant may be present at a level of about 0.05% by weight or less; In the case of non-ionic surfactants, such as polyethoxylated fatty acid sorbitan esters (e.g., polysorbate 80), the surfactant may be present at a level of about 0.1 (or particularly 0.05)% by weight or less, or may be referred to in terms of the absence of surfactant.

[0053] In certain embodiments, when an amount of a particular surfactant is mentioned, the composition is substantially free of other surfactants.

[0054] Those skilled in the art will understand that oral care compositions can be provided in the form of mixtures of their various components. Specifically, those skilled in the art will understand that such mixtures can include both liquid (or gel) and solid (e.g., solid particulate) phase components, in which case the solid components can be substantially uniformly dispersed throughout the liquid (or gel) components upon use, and that in the case of liquid compositions, it may be necessary to agitate (e.g., shake) the composition prior to use.

[0055] For the avoidance of doubt, in the case of liquid compositions (e.g., mouthwashes), the silica particles may be inhomogeneous with the liquid composition, such that the particles may settle during storage. Thus, use of the composition may require mixing (e.g., by shaking and / or inversion) prior to use.

[0056] For the avoidance of doubt, those skilled in the art will understand that references to particles forming part of a composition herein include only particles of an appropriate size that are considered to form part of the composition (i.e. particles that may be capable of functioning as components of the composition).

[0057] One skilled in the art can determine the amount of silica of the present invention needed in the composition of the present invention to provide the effects described herein, which may depend on the type of composition used.

[0058] In certain embodiments, the silica of the present invention may be present in the composition of the present invention in an amount of from about 0.1 to about 20.0% by weight.

[0059] For example, the silica of the present invention may be present in the composition of the present invention in an amount of about 0.5% by weight (eg, about 0.44% by weight).

[0060] As used herein, the term "consisting essentially of" may indicate that the relevant composition consists of at least 90% by weight (e.g. at least 95% by weight, at least 99% by weight, particularly at least 99.9%) of the relevant material.

[0061] In certain embodiments of the first aspect of the invention, for example when the composition is in the form of a toothpaste, the composition consists (or consists essentially of) porous silica particles as defined herein (i.e. a plurality of such particles).

[0062] In an alternative embodiment of the first aspect of the present invention, the porous silica particle content (or, alternatively, the silica particle content) in the composition consists (or consists essentially of) silica particles as defined herein (i.e. components other than porous silica material may be present).

[0063] Those skilled in the art will appreciate that the properties of the silica of the present invention may not require the use of other enzyme-inhibiting / modifying and / or adsorbent materials / substances (i.e., the compositions of the present invention may produce the effects described herein without requiring the presence of such agents).

[0064] In a particular embodiment of the first aspect of the invention, the composition comprises a porous silica material (as defined in the first aspect of the invention) as the only (i.e. the only) component capable of adsorbing an enzyme.

[0065] Thus, in a further embodiment of the first aspect of the invention, the composition is substantially free of other enzyme-adsorbing components.

[0066] When used in relation to other enzyme-adsorbing components, the term substantially free refers to the essential substance (e.g., the referenced composition) being free of significant amounts (i.e., clinically significant amounts) of the referenced other substance (e.g., other therapeutically active ingredients), which can refer to the presence of less than 10% by weight (e.g., less than 5% by weight, e.g., less than 2% by weight, less than 1% by weight, less than 0.5% by weight, or particularly less than 0.1% by weight, less than 0.01% by weight, or less than 0.001% by weight) of the other substance, or more specifically, the absence of detectable amounts of the other substance.

[0067] Porous Silica Particles Those skilled in the art will understand that, in this specification, references to pores being of a certain size refer to the average diameter of the relevant pores (i.e., the average diameter of the individual pores taking into account the dimensions of the pores). For the avoidance of doubt, those skilled in the art will understand that references to the average pore size can in particular refer to the average size of the opening of each pore (or, in the case of pores whose pore channels traverse the particle body internally, the average size of all the openings to the pore(s), which can be referred to as the pore window(s) (or pore window(s)).

[0068] For the avoidance of doubt, unless otherwise stated, averages referred to herein are calculated as arithmetic means.

[0069] Unless otherwise stated, the pore sizes described herein are measured by nitrogen adsorption and calculated using density functional theory (DFT) methods (see, for example, the methods described in Landers, J. et al., Colloids and Surfaces A: Physicochem. Engineering Aspects, 437, 3-32 (2013)). Thus, unless otherwise stated, references to average pore size herein refer to pore sizes measured by nitrogen adsorption and calculated using density functional theory (DFT).

[0070] Alternatively, pore size may be measured by nitrogen adsorption and calculated using the Barrett-Joyner-Halenda (BJH) model (see Barrett, EP; Joyner, LS; and Halenda, PP, J. Am. Chem. Soc. 73, 373-380 (1951)); pore size measurements calculated in this manner will be denoted as such.

[0071] Those skilled in the art will appreciate that references to the percentage of pores present being in a particular range may be understood to refer to the pore size distribution (PSD) of such particles, and thus references to the percentage of pores present being in a particular range refer to the total volume of pores present in each range as a percentage of the total pore volume of the relevant pore group(s) (e.g., pores in the mesoporous range).

[0072] For the avoidance of doubt, reference to particles having a particular average pore size may, in certain cases, include reference to pores that are functionally equivalent to particles having such average pore size (e.g., as used in the methods described herein).

[0073] Those skilled in the art will appreciate that the pore size distribution of silica materials can be measured using DFT pore size distribution curves, a technique well understood by those skilled in the art (see, for example, Olivier, JP, Conklin, WB and Szombathely, MV, Studies in Surface Science and Catalysis, 87, 81-89 (1994)). The percentage of pores is calculated from the DFT cumulative pore size distribution curve.

[0074] Those skilled in the art will understand that reference to porous silica particles having pores in the mesoporous range is intended to refer to porous silica particles in the usual sense in the art, i.e. having (or containing / including) pores in the range of 2-50 nm in diameter, and the material may be referred to as mesoporous and the pores as mesopores.

[0075] For the avoidance of doubt, a person skilled in the art will understand that the porous silica material referred to in the first aspect of the present invention may also have (i.e. further contain / comprise) pores with diameters outside the mesoporous range, such as having micropores (i.e. pores with a diameter of less than 2 nm) and / or macropores (i.e. pores with a diameter of more than 50 nm).

[0076] For the avoidance of doubt, unless otherwise stated, pore percentage as used herein refers to volume percentage.

[0077] In certain embodiments, at least about 40% (ie, 40% by volume) of the pores present in the silica material of the present invention are in the mesoporous range.

[0078] In more particular embodiments, at least about 50%, such as at least about 60%, especially at least about 70% of the pores present in the silica material of the present invention are in the mesoporous range.

[0079] Those skilled in the art will understand that for pores within a given range, the average (i.e., arithmetic mean) pore size can also be calculated. As described herein, such average pore size is measured by nitrogen adsorption techniques and calculated using density functional theory (DFT) known to those skilled in the art (see Olivier, JP, Conklin, WB and Szombathely, MV, Studies in Surface Science and Catalysis, 87, 81-89 (1994); Landers, J., et al., Colloids and Surfaces A: Physicochem. Eng. Aspects, 437, 3-32 (2013)). Thus, unless otherwise stated, the average pore size herein refers to the average pore size measured by nitrogen adsorption and calculated using DFT.

[0080] In certain embodiments, the average pore size of the pores in the mesoporous range is from about 7.0 to about 22.0 nm.

[0081] In a more specific embodiment, the average pore size of the pores in the mesoporous range is from about 7.0 to about 21.0 nm.

[0082] Moreover, in a more specific embodiment, the average pore size of the pores in the mesoporous range is from about 7.0 to about 20.0 nm.

[0083] For example, in one embodiment, the average pore size of the pores in the mesoporous range is as follows: Approximately 7.0~19.0nm, Approximately 7.0~18.0nm, Approximately 7.0~17.0nm, Approximately 7.0~16.0nm, Approximately 7.0~15.0nm, Approximately 7.0~14.0nm, About 7.0 to about 13.0 nm, or Approximately 7.0~12.0nm.

[0084] In one particular embodiment, the average pore size of the pores in the mesoporous range is from about 8.0 to about 13.0 nm.

[0085] In a more specific embodiment, the average pore size of the pores in the mesoporous range is from about 8.0 to about 12.0 nm.

[0086] In a more specific embodiment, the average pore size of the pores in the mesoporous range is from about 8.0 to about 11.0 nm.

[0087] In an alternative embodiment, the average pore size of the pores in the mesoporous range is from about 9.0 to about 11.0 nm.

[0088] Moreover, in a more specific embodiment, the average pore size of the pores in the mesoporous range is from about 9.2 to about 11.0 nm.

[0089] Moreover, in a more specific embodiment, the average pore size of the pores in the mesoporous range is from about 9.4 to about 10.8 nm.

[0090] Moreover, in a more specific embodiment, the average pore size of the pores in the mesoporous range is from about 9.5 to about 10.7 nm.

[0091] Moreover, in a more specific embodiment, the average pore size of the pores in the mesoporous range is from about 9.6 to about 10.7 nm.

[0092] Moreover, in a more specific embodiment, the average pore size of the pores in the mesoporous range is from about 9.5 to about 10.6 nm.

[0093] In a most particular embodiment, the average pore size of the pores in the mesoporous range is from about 9.6 to about 10.6 nm.

[0094] Those skilled in the art will appreciate that in addition to referring to the (arithmetic) average pore size as described herein, the silica materials of the present invention can also be defined with reference to a pore size distribution, such as the pore size distribution of pores in the mesoporous range.

[0095] In certain embodiments of the first aspect of the invention, at least 21% (e.g., at least 22%, at least 23%, at least 24%, at least 25%, at least 26%, at least 27%, at least 28%, or at least 29%) of the pores within the mesoporous range (by volume) have a diameter within the specified range of average pore size (i.e. the range specified for the average pore size).

[0096] In a more particular embodiment of the first aspect of the present invention, at least about 30% of the pores in the mesoporous range have a diameter within the average pore size range.

[0097] Further, in a more particular embodiment of the first aspect of the present invention, at least about 35% (at least 40% or at least 45%) of the pores in the mesoporous range have diameters within the average pore size range.

[0098] Furthermore, in more particular embodiments of the first aspect of the present invention, at least about 50% (e.g. at least 55%, at least 60%, at least about 65%, at least about 70%, or in particular at least about 72%) of the pores in the mesoporous range have a diameter within the average pore size range (i.e. the range given for the average pore size of the pores in the mesoporous range defined herein).

[0099] For example, in certain embodiments, at least about 50% (e.g., at least 55%, at least 60%, at least about 65%, at least about 70%, or more particularly at least about 72%) of the pores in the mesoporous range have diameters within the range of about 7.0 to about 25.0 nm.

[0100] In certain embodiments, up to about 100% (or up to about 99%, about 95%, or about 90%) of the pores in the mesoporous range have a diameter within the range of the average pore size (i.e., the range of average pore sizes defined herein).

[0101] In certain embodiments, about 21% to about 100% (or more particularly about 25% to about 99% or 100%) of the pores in the mesoporous range have diameters within the average pore size range.

[0102] Further, in more particular embodiments of the first aspect of the present invention, at least about 30% (eg, from about 30% to about 99% or 100%) of the pores in the mesoporous range have diameters within the average pore size range.

[0103] Further, in more particular embodiments of the first aspect of the present invention, at least about 35% (eg, about 35% to about 99%) of the pores in the mesoporous range have diameters within the average pore size range.

[0104] Further, in a more particular embodiment of the first aspect of the present invention, about 40% to about 90% (or about 99% or 100%) of the pores in the mesoporous range have diameters within the average pore size range.

[0105] In certain embodiments of the first aspect of the invention, about 50% to about 90% (or about 99% or 100%) of the pores in the mesoporous range have diameters within the average pore size range.

[0106] In certain embodiments of the first aspect of the invention, about 55% to about 90% (or about 99% or 100%) of the pores in the mesoporous range have diameters within the average pore size range.

[0107] In certain embodiments of the first aspect of the invention, about 60% to about 90% (or about 99% or 100%) of the pores in the mesoporous range have diameters within the average pore size range.

[0108] For example, in certain embodiments (i.e., certain embodiments of the first aspect of the present invention), at least about 25% (e.g., about 25% to about 99%, about 50% to about 99%, or 100%, etc.) of the pores in the silica particles are mesopores with sizes ranging from about 7.0 to about 25.0 nm (e.g., about 7.0 to about 18.0 nm, or about 7.0 to about 13.0 nm).

[0109] Similarly, in certain embodiments, at least about 50% (e.g., about 50% to about 99%, about 50% to about 90%, etc.) of the pores in the silica particles are mesopores with sizes ranging from about 7.0 to about 25.0 nm (e.g., about 7.0 to about 18.0 nm, or about 7.0 to about 13.0 nm).

[0110] In certain embodiments (i.e., certain embodiments of the first aspect of the present invention), at least about 50% (e.g., about 50% to about 99%) of the pores of the silica particles are mesopores having a size ranging from about 9.0 to about 12.0 nm.

[0111] In a further embodiment, at least about 25% (eg, at least about 50%, about 60%, or about 70%) of the pores of the silica particles are mesopores in the size range of about 9.0 to about 10.2 nm.

[0112] In a further embodiment, at least about 25% (e.g., at least about 50%, about 55%, about 60%, about 65%, or about 70%) of the pores of the silica particles are mesopores with sizes ranging from about 9.0 to about 11.0 nm.

[0113] In more particular embodiments, at least about 25% (eg, about 25% to about 99%) of the pores of the silica particles are mesopores having a size ranging from about 9.0 to about 11.0 nm.

[0114] Further, in more specific embodiments, at least about 25% (eg, about 25% to about 99%) of the pores of the silica particles are mesopores having a size ranging from about 9.0 to about 10.2 nm.

[0115] Those skilled in the art will understand that when referring to porous silica particles having pores in the mesoporous range, it is necessary that such particles are porous, including particles that exhibit porous behavior. Thus, porous silica particles refer to particles that have significant porosity, and in certain embodiments may be defined with reference to characteristics such as the pore volume and / or surface area of ​​the particles, for example, with reference to parameters defined herein (the characteristics described herein, as well as other characteristics described herein, may be used alone or in combination).

[0116] One skilled in the art will also appreciate that the total volume of pores within each particle can affect the surface area of ​​the particle, and thus preparing particles with a larger pore volume allows for, and may be defined in terms of, a larger particle surface area.

[0117] Those skilled in the art will appreciate that the surface area of ​​a particle (or a sample of particles) can be calculated using the Brunauer-Emmett-Teller (BET) theory, a technique known to those skilled in the art (see, e.g., Brunauer, S., Emmett, PH, and Teller, E., J. Am. Chem. Soc., 60(2), 309-319 (1938)).

[0118] In certain embodiments, the silica particles have a particle size of at least about 150 μm. 2 / g BET surface area.

[0119] In a more particular embodiment, the silica particles have a particle size of at least about 200 mm. 2 / g BET surface area.

[0120] In yet a more particular embodiment, the silica particles have a particle size of at least about 300 mm. 2 / g (e.g., at least about 350 m 2 / g) BET surface area.

[0121] In yet a more particular embodiment, the silica particles have a particle size of at least about 400 mm. 2 / g (e.g., at least about 450 m 2 / g) BET surface area.

[0122] In certain embodiments, the silica particles have a particle size of at least about 500 mm. 2 / g BET surface area.

[0123] In certain embodiments, the BET surface area is up to about 1500 m 2 / g(maximum approx. 1200m 2 / g or 1000m 2 / g, etc.).

[0124] For example, in certain embodiments, the silica particles have a particle size of about 200 to about 1500 mm. 2 / g BET surface area.

[0125] In a further embodiment, the silica particles have a solubility of about 500 to about 1200 m 2 / g BET surface area.

[0126] In yet a more specific embodiment, the silica particles have a solubility of about 600 to about 1200 μm. 2 / g BET surface area.

[0127] In an alternative embodiment, the silica particles have a particle size of about 600 to about 1000 mm. 2 / g BET surface area.

[0128] In a further alternative embodiment, the silica particles have a particle size of about 500 to about 900 μm. 2 / g, for example, about 550 to about 900 m 2 / g BET surface area.

[0129] In yet a further alternative embodiment, the silica particles have a solubility of about 600 to about 850 μm. 2 / g BET surface area.

[0130] One of ordinary skill in the art will appreciate that the porous silica particles can be provided in a variety of shapes.

[0131] In certain embodiments, the silica particles have a substantially non-spherical morphology (ie, an aspect ratio greater than 1:1, eg, greater than 1.1:1).

[0132] In more particular embodiments, the aspect ratio of the silica particles is greater than 1.5:1, such as greater than 1.8:1.

[0133] Moreover, in a more particular embodiment, the aspect ratio of the silica particles is 2:1 or greater.

[0134] As used herein, the term "aspect ratio" is understood to refer to the ratio between the maximum and minimum cross-sectional diameters of a silica particle.

[0135] Alternatively, such particles (i.e., particles having a substantially non-spherical morphology) may be described as having at least one asymmetric (i.e., the morphology of the particle differs about the plane) plane (i.e., a plane that divides the particle evenly in half).

[0136] In more particular embodiments, the silica particles have an essentially rod-like morphology. Thus, in particular embodiments, the porous silica particles can be characterized by having an essentially rod-like morphology as observed by electron microscopy (e.g., using techniques known to those skilled in the art, such as scanning electron microscopy (SEM) or transmission electron microscopy (TEM)), e.g., the rods have lengths of about 0.5 to about 5.0 μm.

[0137] As used herein, the term essentially rod-like is understood to refer to particles that are elongated in shape resembling a rod, which may be straight or curved (e.g., such rod-like particles may be substantially straight).

[0138] In alternative embodiments, the silica particles of the present invention may be substantially spherical (or may be referred to as spherical). Thus, in certain embodiments, the silica particles of the present invention may have an aspect ratio (or average aspect ratio) of about 1:1.

[0139] In a further embodiment, the silica particles of the present invention may be in amorphous form.

[0140] Those skilled in the art will understand that the term average particle size, as used herein, refers to the average diameter of the particle at its largest point (e.g., its length in the case of rod-shaped particles, its diameter in the case of spherical particles), which can be measured using techniques described by those skilled in the art, such as electron microscopy techniques (e.g., by scanning electron microscopy (SEM) or transmission electron microscopy (TEM) techniques known to those skilled in the art). In certain embodiments, particle size is determined using electron microscopy (e.g., SEM).

[0141] In certain embodiments, such as, for example, if the particle is spherical, the particle size may be defined in terms of its diameter.

[0142] In certain such embodiments, the silica particles have an average particle size of from about 0.1 to about 20.0 μm.

[0143] In a more specific embodiment, the silica particles have an average particle size of from about 0.1 to about 15.0 μm.

[0144] In yet a more specific embodiment, the silica particles have an average particle size of from about 0.1 to about 10.0 μm.

[0145] In yet a more specific embodiment, the silica particles have an average particle size of from about 0.5 to about 10.0 μm.

[0146] In yet a more specific embodiment, the silica particles have an average particle size of about 0.5 to about 5.0 μm.

[0147] In one particular embodiment, the silica particles have an average particle size of about 0.5 to about 4.5 μm.

[0148] In certain embodiments, the silica particles have an average particle size of about 1.0 to about 10.0 μm.

[0149] In certain embodiments, the silica particles have an average particle size of about 1.0 to about 5.0 μm.

[0150] In a more specific embodiment, the silica particles have an average particle size of from about 1.0 to about 4.0 μm.

[0151] In a more specific embodiment, the silica particles have an average particle size of from about 1.0 to about 4.0 μm.

[0152] In yet a more specific embodiment, the silica particles have an average particle size of about 2.0 to about 4.0 μm.

[0153] In yet a more specific embodiment, the silica particles have an average particle size of about 3.0 to about 4.0 μm.

[0154] In further embodiments, such as where the particle is rod-shaped, the particle size may (or may also) be defined in terms of its width (referring to the diameter at its narrowest point).

[0155] In certain such embodiments, the silica particles have an average width of from about 0.05 to about 0.6 μm.

[0156] In a more specific embodiment, the silica particles have an average width of from about 0.1 to about 0.6 μm.

[0157] In yet a more specific embodiment, the silica particles have an average width of about 0.1 to about 0.4 μm.

[0158] In yet a more specific embodiment, the silica particles have an average width of about 0.2 to about 0.4 μm.

[0159] Those skilled in the art will understand that porous silica materials of the type described in the present invention are typically non-crystalline. Thus, in certain embodiments, the porous silica particles can be described as substantially non-crystalline porous silica particles (and materials formed of a plurality of such particles can be similarly described). Thus, the porous silica particles can be described as non-crystalline porous silica particles.

[0160] In an alternative embodiment, the silica material present in the particles according to the first aspect of the present invention may be described as amorphous. In such an embodiment, the term amorphous is understood to indicate that the structure of the silica material (except for the pores present therein) does not have substantial order, such as that which may be present in crystalline materials (i.e., the porous silica particles, or silica material, may be referred to as non-crystalline).

[0161] As described herein, those skilled in the art will understand that the silica material of the present invention is porous.Thus, the silica particles of the present invention can be said to have a certain minimum total pore volume, or a range of such volumes, measured using nitrogen adsorption (e.g., taken as the volume adsorbed at the highest value of P / P0, e.g., P / P0=0.995).

[0162] In certain embodiments, the total pore volume is at least about 0.2 cm 3 / g (e.g., at least about 0.3, 0.4, 0.5, 0.6, or 0.7 cm 3 / g).

[0163] In certain embodiments, the total pore volume is from about 0.2 to about 2.5 cm 3 / g.

[0164] In a more specific embodiment, the total pore volume is from about 0.2 to about 2.0 cm 3 / g.

[0165] Further, in certain embodiments, the total pore volume is from about 0.5 to about 1.5 cm 3 / g.

[0166] In yet a more specific embodiment, the total pore volume is from about 0.6 to about 1.4 cm 3 / g.

[0167] For example, in certain embodiments, the total pore volume is from about 0.7 to about 1.3 cm 3 / g.

[0168] Use and Process As described herein, the oral care composition of the first aspect of the invention may be useful in providing oral care, such as the prevention (or prophylaxis) of dental caries, plaque buildup, periodontal disease, periodontitis, and / or tooth loss, in a subject in need thereof.

[0169] In some embodiments, the oral care composition of the first aspect of the invention may be useful in providing oral care, such as preventing (or preventing) dental caries, plaque buildup, periodontal disease, and / or tooth loss, in a subject in need thereof.

[0170] In a second aspect of the invention there is provided use of an oral care composition as defined in the first aspect of the invention in the prevention (or prophylaxis) of dental caries, plaque buildup, periodontal disease, periodontitis and / or tooth loss.

[0171] In some embodiments, the use of the oral care composition is in the prevention (or prophylaxis) of dental caries, plaque buildup, periodontal disease, and / or tooth loss.

[0172] In an alternative second aspect of the invention, there is provided an oral care composition as defined in the first aspect of the invention for use in the prevention (or prophylaxis) of dental caries, plaque buildup, periodontal disease, periodontitis and / or tooth loss.

[0173] In some embodiments, the oral care composition is one that is used to prevent (or prevent) dental caries, plaque buildup, periodontal disease, and / or tooth loss.

[0174] In a further alternative second aspect of the invention there is provided a method of preventing (or preventing) caries formation, plaque accumulation, periodontal disease, periodontitis and / or tooth loss in a subject in need thereof comprising the step of using (or administering / applying to the oral cavity, i.e. mouth, such as to the surfaces of the teeth and gums) an effective amount of an oral care composition defined in the first aspect of the invention.

[0175] In some embodiments, there is provided a method of preventing (or preventing) caries formation, plaque accumulation, periodontal disease, and / or tooth loss in a subject in need thereof, comprising the step of using (or administering / applying to the oral cavity, i.e. mouth, such as to surfaces of the teeth and gums) an effective amount of an oral care composition defined in the first aspect of the invention.

[0176] As used herein, the term "prevention" (and similarly, "preventing") includes prevention of a condition (and vice versa). Specifically, such a term can refer to achieving a reduction in the likelihood that a subject will develop the condition (e.g., at least a 10% reduction, at least a 20%, 30% or 40% reduction, etc., e.g., at least a 50% reduction).

[0177] For the avoidance of doubt, a person skilled in the art will understand that such uses and methods are carried out in a subject in need thereof, and the need for such uses and methods for a subject can be assessed by one of skill in the art using routine techniques.

[0178] As used herein, reference to a subject refers to a living organism to be treated, including a mammalian (e.g., human) patient. Specifically, a subject refers to a human, such as a human of adult age (i.e., a human over the age of 18).

[0179] Those skilled in the art will appreciate that the uses and methods relating to the oral care composition of the first aspect of the invention may include further steps that may be appropriate for use in the form provided.

[0180] For example, where the oral care composition is provided in the form of a dentifrice, such uses and methods may include the step(s) of applying the composition to a suitable cleaning implement (e.g., a toothbrush) and then using it to clean (brush or polish, brush, etc.) the teeth, such as brushing or polishing (i.e., cleaning, e.g., by brushing) the teeth.

[0181] Similarly, where the oral care composition is provided in the form of a liquid (e.g., a mouthwash), such uses and methods may include a step(s) of using the composition to rinse or cleanse (e.g., rinse) the mouth, such as by taking an appropriate amount of the composition into the mouth and holding it in the mouth (and optionally moving it around the mouth) for a period of time (e.g., about 30 seconds to about 60 seconds), and then expelling the composition from the mouth.

[0182] As described herein, the composition of the present invention can be in the form of a powder or gel (e.g., mousse), and can be used according to the general use of such products as known in the art.For example, in the form of a mousse, the composition is applied to the oral cavity for a certain period of time (e.g., about 1 minute), and then the oral cavity may or may not be rinsed with water (e.g., the oral cavity is not rinsed, in which case the composition may be called non-rinse type).

[0183] As described herein, the compositions according to the first aspect of the invention may be used generally for oral care, such as cleaning the oral cavity (e.g. cleaning the surfaces of the teeth by brushing, polishing, rinsing, washing, etc.).

[0184] In a third aspect of the invention there is provided the use of a composition as described in the first aspect of the invention as an oral care product.

[0185] Those skilled in the art will understand that reference to oral care products includes reference to oral hygiene products (i.e. products for promoting oral health), such as products for the prevention or prophylaxis of plaque buildup, periodontal disease, periodontitis, and / or tooth loss, as well as the treatment or prevention (or prophylaxis) of infections in the oral cavity.

[0186] In a fourth aspect of the invention there is provided the use of a composition according to the first aspect of the invention in cleaning (eg by brushing, polishing, rinsing or washing) the oral cavity (eg teeth, surfaces thereof etc).

[0187] A person skilled in the art will appreciate that the method of cleaning the oral cavity (i.e. the inside of the mouth, e.g. the surfaces of the teeth and gums) described herein may comprise the step of applying to the oral cavity a composition described in the first aspect of the invention.

[0188] Those skilled in the art will appreciate that the oral care composition described in the first aspect of the invention can be prepared using standard techniques known in the art, such as by mixing the ingredients thereof.

[0189] Thus, in a further aspect of the present invention, there is provided a process for preparing an oral care composition comprising bringing the ingredients of the composition into the form of a mixture, such as a substantially homogenous mixture.

[0190] Moreover, in a further aspect of the present invention there is provided the use of a silica material as defined in relation to the first aspect of the present invention for the manufacture of a composition as defined herein (e.g. the first and second aspects of the present invention).

[0191] Without wishing to be bound by theory, it is believed that the use of certain porous silica materials having specific average pore sizes in the mesoporous range that can effectively function as molecular sieves for biomolecules in vivo allows for the preparation of oral care compositions with improved properties in other aspects of reducing caries formation and improving oral hygiene.

[0192] Specifically, as described herein, the use of mesoporous silica particles having a particular average pore size within the mesoporous range is believed to allow for effective absorption of salivary amylase enzymes in the mouth that is not observed in silica particles lacking such pores, thus providing advantages over oral care compositions known in the art. Additionally, the use of such mesoporous silica particles is believed to reduce the formation of cariogenic bacterial biofilms, with further benefits in improving oral health. [Brief description of the drawings]

[0193] [Figure 1.1] (A)-(D) Nitrogen adsorption analysis. Adsorption-desorption isotherms of various types of silica described in Example 1 (Figs. 1.1(A) and 1.1(B)) and pore size distributions derived from the adsorption curves using DFT modeling (Figs. 1.1(C) and 1.1(D)). [Figure 1.2] 1 is a SEM micrograph of the silica of Example 1. [Figure 2.1]Silica in toothpaste effectively inhibits carbohydrate digestion. Different types of silica were formulated in toothpaste without surfactants (TP1) to test their effect on inhibiting carbohydrate digestion by human salivary amylase. The same toothpaste formulation without any silica (no silica) was included as a control, which represents the basal digestion level (dotted line). Data are presented as mean ± standard error (SE) (n=2). [Figure 2.2] Silica in a surfactant-free mouthwash formulation effectively inhibits carbohydrate digestion. Different types of silica were formulated in a surfactant-free mouthwash (MW1) to test their effect on inhibiting carbohydrate digestion by human salivary amylase. The same mouthwash formulation without silica (no silica) was included as a control, which represents basal digestion levels (dotted line). Data are presented as mean ± SE (n=2). [Figure 2.3] Mouthwashes containing surfactants reduce the efficacy of silica in inhibiting carbohydrate digestion. Various types of silica were formulated in mouthwash formulations containing polysorbate 80 (A, MW2) or PEG-40 castor oil (B, MW3) and tested for their effectiveness in inhibiting carbohydrate digestion by human salivary amylase. Data are presented as mean ± SE (n=2). [Figure 2.4] Effect of cocamidopropyl betaine in carbohydrate digestion assay. Silica 3 was suspended in various concentrations of cocamidopropyl betaine solution (surfactant) to evaluate its effect on inhibiting carbohydrate digestion by human salivary amylase. The same concentration of cocamidopropyl betaine solution without silica (no silica) was also evaluated to obtain basal levels of digestion at those concentrations. Data are presented as mean ± SE (n=2). [Figure 2.5]Effect of polysorbate 80 in a carbohydrate digestion assay. Silica 3 was suspended in various concentrations of polysorbate 80 solution (surfactant) to assess its effect on inhibiting carbohydrate digestion by human salivary amylase. Polysorbate 80 solutions of the same concentrations without silica (no silica) were also evaluated to obtain basal levels of digestion at those concentrations. Data are presented as mean ± SE (n=2). [Figure 2.6] Effect of polyoxyethylene (4) lauryl ether in a carbohydrate digestion assay. Silica 3 was suspended in various concentrations of polyoxyethylene (4) lauryl ether solution (surfactant) to evaluate its effect on inhibiting carbohydrate digestion by human salivary amylase. The same concentrations of polyoxyethylene (4) lauryl ether solution without silica (no silica) were also evaluated to obtain basal levels of digestion at those concentrations. Data are presented as mean ± SE (n=2). [Figure 2.7] A silica with a similar average pore size as the silica of the present invention, but with a broader pore size distribution (Silica 8), was unable to inhibit carbohydrate digestion. The "no silica" sample represents a basal level of digestion, and the digestion level of Silica 8 is no different from the basal level. Data are presented as mean ± SE (n=2). [Diagram 3] Silica inhibits carbohydrate digestion by salivary amylase in human saliva. Two different types of silica were incubated with human saliva and their inhibitory effects on carbohydrate digestion were examined. Data are presented as mean ± standard deviation (SD) (n = 4). [Figure 4.1](A)-(E) Effect of different silicas on the growth of cariogenic bacteria. Silicas 3 and 4 were pre-incubated with human salivary amylase and then subjected to carbohydrate digestion assays. After inactivation of the enzyme, the starch digestion products were fed to S. mutans cultures. Several measurements were made: bacterial growth during the first 8 h (A, B), the amount of undigested starch in the digestion mixture after salivary amylase inactivation at various time points (C), bacterial mass after 24 h of exposure to the digestion products (D), and the amount of undigested starch in the culture medium after 24 h of exposure to the digestion products (E). Data are presented as mean ± SE (n=28). [Figure 4.2] (A)-(E) Effect of different silicas on the growth of cariogenic bacteria in 1% starch medium. Silicas 3 and 4 were pre-incubated with human salivary amylase. The pre-incubation mixture was added to S. mutans cultures containing 1% starch. Several measurements were made: bacterial growth (A, B), the amount of undigested starch in the culture medium after exposure to the pre-incubation mixture at various times (C), bacterial mass after 24 h of exposure to the pre-incubation mixture (D), and the amount of undigested starch in the culture medium after 24 h of exposure to the pre-incubation mixture (E). Data are presented as mean ± SE (n=28). [Figure 4.3] (A)-(E) Effect of various silicas on the growth of cariogenic bacteria in culture medium containing 1% starch. Silicas 3, 5 and 7 were pre-incubated with human salivary amylase. The pre-incubation mixture was added to S. mutans cultures containing 1% starch. Several measurements were made: the bacterial growth during the first 8 hours (A-C), the bacterial mass 24 hours after the addition of the pre-incubation mixture (D), and the amount of undigested starch in the culture medium 24 hours after the addition of the pre-incubation mixture (E). Data are presented as mean ± SE (n=11). [Diagram 5]Effect of different silicas on the formation of cariogenic bacterial biofilm. Silicas 3, 5 and 7 were pre-incubated with human salivary amylase. The amylase in the pre-incubation mixture was added to S. mutans cultures containing 1% starch. Several measurements were made: bacterial growth 24 hours after the addition of the pre-incubation mixture (A), the amount of undigested starch in the culture medium 24 hours after the addition of the pre-incubation mixture (B), and the amount of biofilm formed 24 hours after the addition of the pre-incubation mixture (C). Data are presented as mean ± SE (n=22). DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS EXAMPLES

[0194] The present invention will be further described with reference to the following examples, which are not intended to limit the scope of the invention.

[0195] Example 1: Preparation / characterization of porous silica materials material Silica 1, silica 2 and silica 3 were prepared according to previously described processes (Waara, ER et al., Adv. Healthcare Mater. 9(11), e2000057(2020) and Baek, J et al., Nanomedicine (2021), see in particular the experimental procedures described therein).

[0196] Briefly, mesostructured templating agent (P123, average molecular weight = 5800 gmol -1 Triblock copolymer, PEO 20 PPO 70 PEO 20) was dissolved in hydrochloric acid (HCl) with an acid concentration equivalent to 1.6 M. After complete dissolution of P123, tetraethylorthosilicate (TEOS) was added under vigorous stirring at 40 °C. The final molar ratio of P123:TEOS in the solution was 0.02:1.00, and the molar ratio of TEOS:HCl:H2O was 1:6:235 (silica 1), 1:7:250 (silica 2) or 1:7:230 (silica 3). The synthesis was kept quiescent at 40 °C for 20 h and further hydrothermally treated at 100 °C for 20 h (silica 1), 85 °C for 1.3 h (silica 2) or 100 °C for 10 h (silica 3).

[0197] Silica 4 was Kromasil 100-13-SIL purchased from Nouryon Pulp and Performance Chemicals AB.

[0198] Silica 5 (Sylodent) was Sylodent SM850C, a non-porous silica commonly used in toothpastes, obtained from WRGrace & Co.

[0199] Silica 6 was Sunsphere H-31 obtained from AGC Si-Tech.

[0200] Silica 7 was Sunsphere NP-30 obtained from AGC Si-Tech.

[0201] Silica 8 was LO-VEL 6200 obtained from PPG Industries, Inc.

[0202] Nitrogen Adsorption Analysis Brunauer-Emmett-Teller (BET) surface areas were calculated from the adsorption isotherms at relative pressures (p / p°) < 0.2 (graphs in Figure 1.1A and Figure 1.1B). Total pore volumes were recorded at relative pressures (p / p°) = 0.995. Average pore size and pore size distribution were derived from the adsorption curves using density functional theory (DFT) methods or from the desorption curves using the Barrett-Joyner-Halenda (BJH) method. Pore size distribution data for silica particles obtained from adsorption curves using DFT and the cylindrical pore-oxide surface model are shown in Figure 1.1C and Figure 1.1D. Measurements were performed at liquid nitrogen temperature (-196 °C) using a TriStar II volumetric adsorption analyzer and data analysis was performed using the software MicroActive for TriStar II version 2.03 (Micromeritics Instrument Corp., GA, USA).

[0203] Particle size Scanning electron microscopy using JSM-7401F (JEOL Ltd., Tokyo, Japan) was used to characterize particle size and morphology from SEM micrographs (Figure 1.2). The average particle size (length and width for rod-shaped particles Silica 1, Silica 2 and Silica 3, diameter for spherical particles Silica 4, Silica 6 and Silica 7) was analyzed from more than 50 particles using ImageJ (Fiji; see Schindelin J, Arganda-Carreras I, Frise E et al., Fiji: an open-source platform for biological-image analysis., Nat. Methods, 9(7), 676-682(2012)). Various properties of the tested silica materials were measured using the above techniques and operating conditions. The identified characteristics are listed in Table 1 below. [Table 1] An analysis of the properties of these silica materials is also shown in Figures 1.1(A)-(D) and 1.2 described herein.

[0204] Example 2: Carbohydrate Digestion Assay Preparation of working solutions and standard curve samples Prior to the assay, several working solutions were prepared. First, 60–80 mg of mesoporous silica or control silica was weighed and dried overnight at 120 °C. The next day, the silica was weighed again to obtain the exact weight after drying, and a 20 mg / mL silica suspension was prepared using double-distilled water (ddH2O). In the case of silica 3, sonication was required to obtain a homogenous suspension. Briefly, a 2 mm microtip (Vibra cell) was attached to an ultrasonicator (Vibra cell) and the silica suspension was sonicated for 3 min at 40% amplitude without pulses. After sonication, the silica suspension was mixed several times by inversion and visually inspected. If silica clumps still remained, the sonication was repeated once more. Generally, two sonications yielded a dispersion with little or no clumps remaining. 1× PBS was prepared by dissolving one PBS tablet (Medicago, 09-2052-100) in 200 mL of ddH2O. After dissolution, the pH was adjusted to 5.4. Lyophilized human salivary amylase was rehydrated with ddH2O to make a stock solution of 40 mg / mL. On the day of the experiment, a working solution (8 mg / mL) was freshly prepared by diluting the required amount of stock solution with 1x PBS (pH 5.4). Starch stock solution (6 mg / mL) was prepared by mixing pure starch powder (Generation Ucan) in 1x PBS (pH 5.4). Because starch does not dissolve easily in PBS, the starch solution was heated in a microwave oven several times (10-20 seconds each time) until the starch solution started to boil and the starch powder did not sink to the bottom. After everything was dissolved, the starch solution remained opaque. When performing the digestion portion of the assay, the starch stock solution was equilibrated to room temperature before starting the digestion. Starch standard curve samples (300 μL each) were prepared by serial dilutions using 1x PBS (pH 5.4). The concentrations of the standard curve samples were 1.5, 0.75, 0.375, 0.1875, 0.0938, 0.0465, and 0 mg / mL. After serial dilution, 75 μL of 1N HCl (Sigma Aldrich, 1090571000) was added to each standard curve sample. Surfactant (cocamidopropyl betaine, polysorbate 80, polyoxyethylene (4) lauryl ether) stock solutions (1.0 wt%) were prepared using ddH2O.

[0205] Preparation of test formulations Test formulations were prepared by mixing 40 μl of silica suspension in water (20 mg / mL) with 140 μl of the original solution or stock gel (concentrations according to Table 2). [Table 2]

[0206] Adsorption of salivary amylase by silica. Prior to the starch digestion step, each sample was first incubated with salivary amylase at 37°C for 15 min to allow for enzyme adsorption / trapping.

[0207] For the mouthwash formulation, an incubation mixture was prepared by mixing 20 μL of salivary amylase solution (8 mg / mL) and 180 μL of silica-containing mouthwash formulation (prepared according to Table 2) in a 1.5 mL microcentrifuge tube. The incubation mixture was incubated at 37° C. for 15 min with vertical rotation by a rotator (Harvard Apparatus, 74-2302).

[0208] For the toothpaste formulation, an incubation mixture was prepared by mixing 15 μL of salivary amylase solution (8 mg / mL) and 135 μL of toothpaste formulation containing silica (prepared according to Table 2) in a 1.5 mL microcentrifuge tube. This incubation mixture was incubated in a 37 °C water bath with horizontal shaking (200 rpm).

[0209] To test the individual surfactant solutions, stock solutions (1.0 wt%) of surfactants (cocamidopropyl betaine, polysorbate 80, polyoxyethylene (4) lauryl ether) were diluted to concentrations of 0.5, 0.25, 0.1, and 0.05 wt% using ddH2O, and silica was dispersed in each solution at a concentration of 4 mg / mL. Incubation mixtures were prepared by mixing 20 μL of salivary amylase solution (8 mg / mL) with 180 μL of diluted surfactant solution containing silica (4 mg / mL) in a 1.5 mL microcentrifuge tube. The incubation mixtures were incubated at 37 °C for 15 min with vertical rotation on a rotator (Harvard Apparatus, 74-2302).

[0210] To test silica 8, 40 μl of silica suspension in water (20 mg / mL) was mixed with 140 μl of 1× PBS solution to create a 4 mg / mL silica dispersion. An incubation mixture was prepared by mixing 20 μL of salivary amylase solution (8 mg / mL) with 180 μL of silica suspension (4 mg / mL) in a 1.5 mL microcentrifuge tube. The incubation mixture was incubated at 37 °C for 15 min with vertical rotation by a rotator (Harvard Apparatus, 74-2302).

[0211] After incubation, 150 μL of the incubation mixture was mixed with 1.45 mL of ddH2O and 3.4 mL of 1x PBS (pH 5.4) to prepare the diluted incubation mixture. In each carbohydrate digestion assay, a blank sample (no silica sample) was always included to monitor the basal digestion level. In this sample, ddH2O was added to the test formulation instead of the silica suspension.

[0212] Starch digestion Starch digestion was performed for various periods of time: 0, 5, or 20 min. For each time point, reaction mixtures (800 μL) were prepared, which contained a 1:1 ratio of starch (6 mg / mL) and diluted incubation mixture. For each time point, 400 μL of starch stock solution (6 mg / mL) was dispensed into a 1.5 mL microcentrifuge tube. 400 μL of diluted incubation mixture was then added to each tube. At time 0 min, 200 μL of 1N HCl was first added to the starch solution, followed by 400 μL of diluted incubation mixture. Each reaction mixture was mixed by inversion immediately and then incubated in a 37° C. water bath with horizontal shaking (200 rpm) for the respective time period. Digestion was terminated by adding 200 μL of 1N HCl immediately after the incubation was completed.

[0213] Colorimetric determination of digested starch The amount of digested starch was quantified at various time points using 5 mM iodine (Merck, 1.09099.1003). Each reaction mixture was vortexed briefly before dispensing into a 96-well plate (Corning, CLS3370). 75 μL of each reaction mixture (silica samples and standard curve samples) was dispensed in duplicate. 75 μL of 5 mM iodine solution was dispensed into each well using a multichannel pipette and absorbance was read at 570 nm.

[0214] Calculating the amount of digested starch The amount of digested starch indicates the inhibitory effect of a given silica on digestion. The concentration of undigested starch in each sample was estimated from the slope and intercept of the starch standard curve. The percentage of undigested starch was then calculated, with 0 min time point being 100% undigested starch. The percentage of digested starch was calculated by subtracting the percentage of undigested starch from 100. The percentage of digested starch at 5 min (all digestion assays except for Silica 8 test) or 20 min (Silica 8 test) was plotted as a bar graph. In all digestion assays, no silica samples were included, which represented the basal digestion level.

[0215] The results of these experiments are also shown in Figures 2.1, 2.2, 2.3(A)-(B), 2.4, 2.5, 2.6 and 2.7, as described herein.

[0216] Example 3: Carbohydrate digestion assay using human saliva Preparation of 2x PBS 2x PBS was prepared by dissolving 2 PBS tablets (Medicago, 09-2052-100) in 200 mL of double distilled water (ddH2O). After dissolution, the pH was adjusted to 5.4.

[0217] Collection and preparation of human saliva Human saliva (2–3 mL) was collected in a test tube. Immediately after collection, the saliva samples were centrifuged at 5000 rpm for 5 min to remove particles and sediments. The supernatant (250 μL per sample) was collected and stored at -20 °C until analysis. On the day of analysis, the saliva samples were thawed and diluted 1:50 using 2 × PBS (pH 5.4). This was called the saliva working solution.

[0218] Preparation of silica and its working solution Approximately 60-80 mg of mesoporous silica was weighed and dried overnight at 120 °C. The next day, the silica was weighed again to obtain the exact weight after drying, and a 20 mg / mL silica suspension was prepared using ddH2O. Sonication of the silica suspension was necessary to homogenously disperse the silica. A microtip (Vibra cell, 630-0423) was attached to an ultrasonicator (Vibra cell, VCX 130) and the silica suspension was sonicated for 3 min at 40% amplitude without pulses. Generally, two rounds of sonication yielded a homogenous solution with few lumps remaining.

[0219] Preparation of starch solution and DNS reagent Starch solution (3 mg / mL) was prepared by mixing pure starch powder (Sigma Aldrich, 33615) in 1x PBS (pH 7.4). Because starch does not readily dissolve in PBS, the starch solution was heated in a microwave oven several times (10-20 seconds each time) until the starch solution began to boil and the starch powder did not sink to the bottom. After everything was dissolved, the starch solution remained opaque. When performing the digestion portion of the assay, the starch solution was equilibrated to room temperature before starting the digestion. 3,5-Dinitrosalicylic acid (DNS, Sigma Aldrich, D0550, 0.2 μM) was prepared by dissolving 1 g of DNS in 20 mL of 2 M NaOH. To this solution was added 30 g of sodium tartrate. The solution was brought to a final volume of 100 mL by adding ddH2O. The solution was constantly stirred with a magnetic stirrer and heated at 50 °C for 2 h. The final solution was filtered and stored at 4°C.

[0220] Adsorption of salivary amylase by silica. Various silica concentrations (0.312-20mg / mL, 60μL each) were prepared by serial dilution in a 96-well PCR plate (VWR, 732-2387) using ddH2O. 60μL of saliva working solution was dispensed into each well. The plate was sealed (Bio-rad, MSB1001) and incubated for 30 minutes at 37°C while rotating using a rotator (Harvard Apparatus, 74-2302). Once incubation was complete, the plate was centrifuged at 2000×g for 5 minutes at room temperature. The supernatant from each well (30μL) was transferred to a new 96-well PCR plate.

[0221] Colorimetric determination of reducing sugars To each well containing the supernatant, 30 μL of starch solution (3 mg / mL) was added. The plate was sealed and incubated for 30 min at 37°C while rotating using a rotator. At the end of the incubation, 60 μL of DNS solution (0.2 μM) was added to each well. The plate was sealed and incubated again for 7 min at 95°C using a PCR machine. After the final incubation, 100 μL of the solution was transferred to a 96-well plate (Corning, CLS3370) and the absorbance was read at 540 nm.

[0222] The results of these experiments are also shown in FIG. 3 as described herein.

[0223] Example 4: Measurement of cariogenic bacterial growth Preparation of working solutions 1x PBS: 1x PBS was prepared by dissolving one PBS tablet (Medicago, 09-2052-100) in 200 mL double distilled water (ddH2O). After dissolution, the pH was adjusted to 5.4. The solution was then autoclaved (121°C, 20 min).

[0224] Brain Heart Infusion (BHI) Broth: 37 g of BHI powder (BD Diagnostic Systems, 237500) was dissolved in 1 L of ddH2O. To prepare BHI broth containing 1% starch, 10 g of starch powder (Generation Ucan) was added to the BHI broth. The broth was then autoclaved (121°C, 20 min).

[0225] Starch stock solution (6 mg / mL): To prepare the starch stock solution, starch powder was sterilized by heating at 120 °C for 6 hours. The sterilized starch powder was added to autoclaved 1x PBS (pH 5.4) to make a 6 mg / mL stock solution. Because starch does not dissolve easily in PBS, the solution was heated in a microwave oven several times (10-20 seconds each time) until the solution began to boil and the starch powder no longer settled to the bottom. After everything was dissolved, the starch solution remained opaque.

[0226] Silica (20 mg / mL): 60–80 mg of mesoporous silica or control silica was weighed and dried overnight at 120 °C. The next day, the silica was weighed again to obtain the exact weight after drying, and autoclaved ddH2O was used to prepare a 20 mg / mL silica suspension. In the case of silica 3, sonication was required to obtain a homogenous suspension. Briefly, a 2 mm microtip (Vibra cell) was attached to an ultrasonicator (Vibra cell) and the silica suspension was sonicated for 3 min at 40% amplitude without pulses. After sonication, the silica suspension was mixed several times by inversion and visually inspected. If any silica clumps still remained, sonication was repeated once more. Generally, two rounds of sonication yielded dispersions with little or no clumps remaining.

[0227] Human salivary amylase: Lyophilized human salivary amylase (Sigma Aldrich, A1031) was rehydrated with ddH2O to make a stock solution of 40 mg / mL. On the day of the experiment, a working solution (8 mg / mL) was freshly prepared by diluting the required amount of stock solution with autoclaved 1x PBS (pH 5.4).

[0228] Preparation of Streptococcus mutans culture Mutans streptococcus (S. mutans) is one of the main cariogenic bacteria inhabiting the oral cavity and contributes greatly to dental caries. Lyophilized S. mutans (American Type Culture Collection (ATCC), 25175) was rehydrated in 5 mL of BHI broth. 0.5 mL of the suspension was dispensed into four autoclaved test tubes, and then 4.5 mL of BHI broth was added to all test tubes. The inoculated tubes were incubated at 37°C with constant agitation (shaker set at 120 rpm) for at least 30 h. After incubation, culture samples were stored at -80°C in 10 or 20% glycerol (Sigma Aldrich, G9012). S. mutans was cultured in BHI broth or BHI broth containing 1% starch. 45 mL of each culture was inoculated with S. mutans in a 10% glycerol stock and incubated at 37°C for 24–30 h with constant agitation. Cultures were stored at 4°C until the day of the experiment, but not for longer than 48 h. On the day of the experiment, 40 mL of each culture was added to the cultures and incubated at 37°C for 1 h on a rotating platform. After incubation, the bacterial cultures were diluted with the respective cultures and the OD600 was adjusted to approximately 0.1 (early logarithmic growth phase).

[0229] Adsorption of salivary amylase by silica. Prior to the starch digestion step, each silica sample was first incubated with salivary amylase for enzyme adsorption. The incubation mixture was prepared by mixing 140 μL of 1× PBS (pH 5.4), 40 μL of silica (4 mg / mL) and 20 μL of salivary amylase working solution (8 mg / mL) in a 1.5 mL microcentrifuge tube. As a control, a blank sample (sample without silica) was always included, where ddH2O was added instead of silica. The incubation mixture was incubated at 37 °C for 15 min with vertical rotation using a rotator (Harvard Apparatus, 74-2302). After incubation, 150 μL of the incubation mixture was diluted with 1.48 mL of ddH2O and 3.4 mL of 1× PBS (pH 5.4).

[0230] Starch digestion and uptake of starch digestion products by S. mutans 400 μL of the diluted incubation mixture was mixed with 400 μL of autoclaved starch stock solution (6 mg / mL) and incubated for 10 minutes in a 37°C water bath with horizontal shaking (200 rpm). The samples were then incubated at 95°C for 45 minutes to inactivate the salivary amylase. After inactivation, the samples were centrifuged at 5000 rpm for 5 minutes at room temperature. The supernatant was then transferred to a new 1.5 mL microcentrifuge tube. The final concentrations of this reaction mixture were as follows: 60 μg / mL silica, 12 μg / mL salivary amylase, and 3 mg / mL starch.

[0231] 150 μL of bacterial culture was dispensed into a 96-well plate (Corning, CLS3370) and 50 μL of reaction mixture was added to each well. As a control, 100 μL of 1× PBS was added instead of the reaction mixture. Cultures were incubated at 37°C for 24 h with constant agitation. Bacterial growth was monitored by measuring OD600 every 30 min during the first 8 h. After 24 h, the final OD600 was measured. The amount of undigested starch was also quantified after 24 h by colorimetric measurement using iodine.

[0232] Growth of S. mutans while starch degradation occurs in real time during cultivation In this setup, S. mutans was cultured in BHI broth containing 1% starch. The diluted salivary amylase-silica incubation mixture was added to the bacterial culture, and starch digestion in the BHI broth occurred in real time. Adsorption of salivary amylase by silica was performed as described above. After enzyme adsorption by silica, the incubation mixture was centrifuged at 5000 rpm for 5 min at room temperature. Then, 150 μL of the supernatant was diluted with 1.48 mL of ddH2O and 3.4 mL of 1× PBS (pH 5.4) to prepare the diluted salivary amylase-silica incubation mixture. In a 96-well plate, 150 μL of bacterial culture (BHI broth containing 1% starch) was dispensed into each well, and 50 μL of the diluted salivary amylase-silica incubation mixture was added. As a control, 50 μL of 1× PBS (pH 5.4) was added instead of the incubation mixture. Cultures were grown at 37°C with constant agitation for up to 24 hours. Bacterial growth was monitored by OD600 measurements every 30 minutes for the first 8 hours, with final OD600 readings taken after 24 hours. Plates were prepared at representative incubation time points (0, 4, 8 and 24 hours) to quantify the amount of undigested starch in the cultures over the incubation period. The amount of undigested starch was quantified by colorimetric measurement using iodine.

[0233] Colorimetric determination of undigested starch The amount of undigested starch in the cultures was quantified using iodine (Merck, 1.09099.1003). Briefly, 30 μL of cultures were transferred to a new 96-well plate, and then 45 μL of ddH2O was dispensed into each well. Then, 75 μL of 5 mM iodine was added to all wells, and the absorbance was read at 570 nm.

[0234] These experimental results are also shown in Figures 4.1(A)-(E), 4.2(A)-(E) and 4.3(A)-(E), as described herein.

[0235] Example 5: Biofilm formation assay Preparing bacterial cultures for biofilm formation Streptococcus mutans bacterial cultures were prepared and seeded in 96-well plates (Corning, CLS3370). 50 μL of pre-incubation reaction mixture was added to each well as described in the bacterial growth assessment. Cultures were incubated at 37°C for 24 h without agitation.

[0236] Colorimetric measurement of biofilm mass After 24 h of incubation, the plates were inverted to remove the S. mutans culture medium, and the wells were washed with 150 μL of 1× PBS. The plates were inverted to discard the PBS, and the remaining solution in each well was removed with a 200 μL pipette. To fix the biofilms, 200 μL of methanol (Sigma Aldrich, 179957) was added to all wells, and the plates were left at room temperature for 20 min. After the methanol was removed by inverting the plates, the plates were left open at room temperature for approximately 10 min to allow the remaining methanol in each well to evaporate. After the methanol had evaporated and the wells were dry, 200 μL of 0.002% crystal violet solution was added to each well to stain the biofilms. The 0.002% crystal violet solution was prepared by diluting 1% crystal violet stock solution (Sigma Aldrich, V5265) with ddH2O. After adding the 0.002% crystal violet, the plates were covered with aluminum foil and left at room temperature for 40 min. After incubation, the plates were inverted to discard the 0.002% crystal violet solution and the remaining solution was removed with a 200 μL pipette. 200 μL of 98% ethanol (Sigma Aldrich, 1009831011) was added to each well, the plate was covered with aluminum foil and incubated for 30 min at room temperature on a shaking platform. The amount of biofilm formed was assessed by measuring the OD in the wells at a wavelength of 590 nm immediately after the ethanol decolorization step.

[0237] Other measurements After 24 hours of incubation, bacterial growth was assessed (by measuring OD at 600 nm) as described above. After measurement, 30 μL of culture medium was transferred to a new 96-well plate and 45 μL of ddH2O was dispensed into each well. To quantify the level of undigested starch remaining in the medium, 75 μL of 5 mM iodine was added and a colorimetric measurement was performed as described above.

[0238] The results of these experiments, as described herein, are also shown in Figures 5(A)-(C).

Claims

1. An oral care composition comprising porous silica particles having pores in the mesoporous range, wherein the pores in the mesoporous range have an average pore size of from about 7.0 to about 25.0 nm.

2. 10. The composition of claim 1, wherein the oral care composition is a dentifrice.

3. The composition of claim 1 , wherein the composition is a toothpaste, a tooth powder, or a mouthwash.

4. The composition of claim 1 or 2, wherein the composition is substantially free of surfactants.

5. 3. The composition of claim 1, wherein the average pore size of the pores in the mesoporous range is from about 7.0 to about 22.0 nm.

6. 3. The composition of claim 1, wherein the average pore size of the pores in the mesoporous range is from about 7.0 to about 20.0 nm.

7. 3. The composition of claim 1, wherein the average pore size of the pores in the mesoporous range is from about 8.0 to about 13.0 nm.

8. 3. The composition of claim 1 or 2, wherein at least about 40% of the pore volume is in the mesoporous range.

9. The silica particles have a particle size of at least about 200 m ２ 3. The composition of claim 1, having a BET surface area of ​​1 / g.

10. The composition of claim 1 or 2, wherein the silica particles have an average particle size of about 0.1 to about 20.0 μm.

11. The composition of claim 1 or 2, wherein the silica particles have an average particle size of about 1.0 to about 5.0 μm.

12. The silica particles have a size of about 0.7 to about 1.3 cm ３ 3. The composition of claim 1 or 2, having a total pore volume of 1 / g.

13. prevention of dental caries, plaque buildup, periodontal disease, periodontitis and / or tooth loss, or Treating or preventing oral infections An oral care composition according to any one of claims 1 to 12 for use in

14. Use of a composition according to any one of claims 1 to 12 as an oral care product.

15. Use of a composition according to any one of claims 1 to 12 in a method for rinsing the oral cavity.

Images