Kit comprising an electromagnetic radiation source and a semi-solid multi-phase oral composition containing hydrophilic bleaching agent particles

Abstract

The present invention provides a kit comprising an electromagnetic radiation source and a semisolid multiphase oral composition in the form of a dispersion for whitening teeth.

Description

Technical Field

[0001] The present invention relates to a kit comprising an electromagnetic radiation source and a semi-solid multi-phase oral composition for whitening teeth. Background Art

[0002] Currently on the market are dental products that are used to deliver various cosmetic and / or therapeutic actives to the teeth and oral cavity. Examples of such products include: toothbrushing aids, such as dentifrice products for delivering oral care actives such as polyphosphates or fluoride; mouthwashes containing breath fresheners or antibacterial actives; and whitening strips for delivering bleaching actives to the teeth. In particular, the use of tooth strips to deliver cosmetic or therapeutic benefits to teeth and oral mucosal surfaces has been recognized as a convenient and economical method. For example, tooth whitening strips achieve continuous contact between the teeth and the whitening composition, wherein the whitening composition is first applied to the strip and then applied to the teeth.

[0003] Despite the above-mentioned known methods for treating oral diseases, especially for whitening teeth, there is still a need to provide products with improved bleaching efficacy, increased whitening speed, reduced tooth sensitivity and / or reduced oral soft tissue irritation. The prior art generally attempts to solve the improved bleaching efficacy and / or increased whitening speed by increasing the content of bleach in the composition. However, there are some problems with this method. First, participants may feel increased irritation and / or sensitivity, which is related to the increased amount of bleach used. In addition, some regulatory agencies and laws around the world do not allow the use of bleach in products above a certain concentration. Therefore, despite the above-mentioned known methods for treating oral diseases, especially for whitening teeth, there is still a need to provide products with improved bleaching efficacy, increased whitening speed, reduced tooth sensitivity and / or reduced oral soft tissue irritation. The present invention overcomes some limitations of the prior art and relates to a semi-solid multi-phase oral composition, which comprises hydrophilic bleach particles and a hydrophobic phase, wherein the hydrophobic phase is a major proportion relative to the hydrophilic bleach particles. Summary of the invention

[0004] The present invention provides a kit comprising: a) a semi-solid multi-phase oral composition comprising from about 0.01% to about 40% of hydrophilic bleaching agent particles, by weight of the semi-solid multi-phase oral composition; and at least about 60% of a hydrophobic phase, by weight of the semi-solid multi-phase oral composition; and b) an electromagnetic radiation source capable of directing electromagnetic radiation having one or more wavelengths in the range of from about 200 nm to about 1700 nm toward at least one tooth; wherein the hydrophobic phase and / or the semi-solid multi-phase oral composition has a cone penetration consistency value of from about 25 to about 300; and wherein the semi-solid multi-phase oral composition is a semi-solid dispersion.

[0005] The present invention can be used to deliver whitening benefits to the oral cavity by applying the composition directly to the teeth. In addition, the composition can be applied via a delivery carrier, such as a strip or film of material, a dental tray, a sponge material, or a mixture thereof. The delivery carrier can be attached to the teeth via the composition herein or the adhesion function can be provided independently of the composition herein (e.g., can be provided by a separate adhesive composition used together with the composition of the present invention and the delivery carrier).

[0006] The delivery vehicle can be attached to the teeth via an attachment device that is part of the delivery vehicle, for example, the delivery vehicle can optionally be of sufficient size so that upon application, the delivery vehicle and the oral soft tissue overlap, so that more tooth surface can be bleached. The delivery vehicle can also be attached to the oral cavity by physical interference or mechanical interlocking between the delivery vehicle and the oral surface including the teeth. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] Figure 1 is a perspective view of a delivery system 10 comprising a strip of material 12 having rounded corners when coated in a second layer 14 with a composition of the present invention.

[0008] Figure 2 For along Figure 1 A cross-sectional view taken along section line 2-2 of FIG. 1 shows an example of a strip.

[0009] Figure 3 is a cross-sectional plan view showing the delivery system 10 attached to a tooth 22 using a second layer 14 of composition positioned between the tooth 22 and the strip of material 12 .

[0010] Figure 4 is along Figure 3 A cross-sectional front view of a tooth taken along section line 4 - 4 showing the delivery system 10 adhered to the tooth 22 .

[0011] Figure 5 A dental tray 30 suitable for use with the composition of the present invention is shown.

[0012] Figure 6 Shown is a device for delivering electromagnetic radiation having a peak intensity wavelength of about 455 nm to a transparent mouthpiece to facilitate reproducible positioning of the electromagnetic radiation toward a tooth surface, according to certain embodiments of the present invention. DETAILED DESCRIPTION

[0013] Without being bound by theory, it has surprisingly been found that bleaching agents are effective at very low concentrations if present in a semi-solid multi-phase oral composition as disclosed herein. The semi-solid multi-phase oral composition of the present invention comprises from about 0.01% to about 40% of hydrophilic bleaching agent particles, and a hydrophobic phase; wherein the hydrophilic bleaching agent particles are soluble in water and / or swell upon contact with water.

[0014] The semi-solid multiphase composition can be a semi-solid dispersion of hydrophilic bleaching agent particles in a liquid or semi-solid hydrophobic phase. Without being bound by theory, it is believed that when the semi-solid dispersion contacts the surface of the teeth, the hydrophilic particles stabilized in the dispersion can deliver the bleaching agent to the hydrophilic biofilm on the tooth surface. This can result in increased whitening efficacy while lowering the total content of bleaching agent.

[0015] As used herein, by "oral care composition" is meant a product that is not intentionally swallowed for the purpose of systemic administration of a particular therapeutic agent during ordinary use, but is retained in the oral cavity for a sufficient period of time to contact the tooth surface or oral tissue. Examples of oral care compositions include dentifrices, tooth gels, subgingival gels, mouthwashes, mousses, foams, mouth sprays, lozenges, chewable tablets, chewing gums, tooth whitening strips, dental floss and dental floss coatings, breath freshening soluble strips, denture care products, or denture adhesive products. The oral care composition may also be incorporated into a strip or film for direct application or attachment to an oral surface.

[0016] Unless otherwise indicated, as used herein, term "dentifrices" include tooth or subgingival pastes, gels or liquid preparations. Dentifrice compositions can be single-phase compositions, or can be the combination of two or more independent dentifrice compositions. Dentifrice compositions can be in any desired form, such as deep stripes, shallow stripes, multilayers, gels or their combinations in any around the paste. In dentifrice comprising two or more independent dentifrice compositions, every kind of dentifrice compositions can be contained in physically independent dispenser compartments, and are distributed side by side.

[0017] As used herein, the term "immiscible" or "insoluble" means that less than 1 part by weight of a substance dissolves in 100 parts by weight of a second substance.

[0018] As used herein, the term "solubility" is the maximum number of parts by weight of a substance that can be dissolved in 100 parts by weight of a second substance.

[0019] As used herein, the term "phase" refers to one or more physically distinct regions, which may be continuous or discontinuous, having one or more properties that are different from another phase. Non-limiting examples of properties that may differ between phases include composition, viscosity, solubility, hydrophobicity, hydrophilicity, and miscibility. Examples of phases include solids, liquids, and gases.

[0020] As used herein, the term semisolid "multiphase oral composition" includes a mixture of two or more phases that are immiscible with each other, such as a dispersion of hydrophilic bleach particles in a hydrophobic phase. The phase can be continuous, discontinuous, or a combination thereof. Examples of semisolid multiphase oral compositions include dispersions, such as suspensions and sols. Semisolid multiphase oral compositions or the phases of a semisolid multiphase oral composition can be solid, liquid, semisolid, or a combination thereof. Specifically, a semisolid multiphase oral composition as disclosed herein is a semisolid. Examples of semisolid multiphase oral compositions also include compositions in which the phases are multiple continuous, including bicontinuous, layered, striped, marbled, ribbon-like, vortex-like, and combinations thereof.

[0021] As used herein, the term "dispersion" is an example of a semi-solid multi-phase oral composition wherein: 1) at least one of the phases is discontinuous, and 2) at least one of the phases is continuous. An example of a dispersion includes hydrophilic bleach particles dispersed in a hydrophobic phase. In this embodiment, the hydrophilic bleach particles and the hydrophobic phase will be immiscible with each other, the hydrophilic bleach particles will be the discontinuous phase, and the hydrophobic phase will be the continuous phase.

[0022] As used herein, the term "heterogeneous mixture" is a heterogeneous combination of two or more substances. Examples of heterogeneous mixtures include hydrophilic bleach particles dispersed in a hydrophobic phase. Heterogeneous mixtures do not include homogeneous mixtures (such as solutions in which a solute is uniformly dissolved in a solvent).

[0023] As used herein, the term "heterogeneous dispersion" is a heterogeneous combination of two or more substances. Examples of heterogeneous dispersions include hydrophilic bleach particles dispersed in a hydrophobic phase. Heterogeneous dispersions do not include homogeneous dispersions (such as solutions in which a solute is uniformly dissolved in a solvent).

[0024] As used herein, the term "particle" is a discrete, solid or semisolid material. Solid particles have a size greater than a single atom or molecule, and their maximum dimension is usually submicron to about one millimeter. In addition, the particles can be agglomerated into agglomerates of discrete particles. Preferred particles can have a size or number average equivalent diameter or volume average equivalent diameter of about 50nm to about 1mm.

[0025] As used herein, the term "solid" is a material that has the following properties at room temperature: 1) has a defined size even when it is not constrained in a container; or 2) retains its original shape when it is picked up from a surface and subsequently placed back on the surface. Examples of solids include carbamide peroxide, and a complex of hydrogen peroxide and a polyvinylpyrrolidone polymer.

[0026] As used herein, the term "preformed sheet" refers to a composition that has been formed into a sheet suitable for fitting into the oral cavity. The preformed sheet is solid once formed.

[0027] As used herein, the term "stick product" refers to a composition that is held within a dispensing container as a visibly firm strip of solid material that maintains its structural integrity and shape when applied to a surface to be treated. When a portion of the stick is dragged across a surface, a film of the stick composition is transferred to the surface. Examples include lip balms and lip glosses.

[0028] As used herein, the term "liquid" is a material that, at room temperature, has the properties of: 1) flowing under gravity, or 2) taking on the shape of the container it is placed in. Examples of liquids include mineral oil, water, and silicone oil.

[0029] As used herein, the term "semi-solid" is a material that has the following properties at room temperature: 1) has some solid-like properties and some liquid-like properties, or 2) its ability to meet the above definition of solid or liquid may depend on the amount of material being evaluated, for example, a small amount of petroleum jelly placed in a large container may not flow under the action of gravity, and it may not take the shape of the container (thus not meeting the definition of liquid); but a large amount of petroleum jelly placed in a large container may flow under the action of gravity, or it may take the shape of the container (thus meeting the definition of liquid). Examples of semi-solids include petroleum jelly, toothpaste, silicone gel, mayonnaise, lotion, and butter. Examples of semi-solids used herein include materials having a cone penetration consistency value of about 10 to about 500, preferably about 25 to about 300, more preferably about 50 to about 250, or more preferably about 100 to about 200 measured according to ASTM 937. Examples of semi-solids may also include materials having a melting point or drop melting point measured according to ASTM method D127 or a freezing point measured according to ASTM method D938 of about 40° C. to about 120° C., about 50° C. to about 100° C., about 50° C. to about 90° C., or about 60° C. to about 80° C. Specifically, semi-solids do not include stick-like products or visibly solid strips of solid material that are retained within a dispensing container and that maintain their structural integrity and shape when applied to a surface to be treated.

[0030] As used herein, the term "particulate semi-solid dispersion" is an example of a dispersion in which particles are dispersed in a semi-solid phase. Examples of particulate semi-solid dispersions include hydrophilic bleach particles dispersed in petrolatum.

[0031] As used herein, the term "hydrophilic bleach particles" are bleach particles having the following properties: a) comprising a bleaching agent, and b) being soluble in water, swelling (increasing in volume and / or weight) upon contact with water and / or releasing the bleaching agent upon contact with water. If the bleaching agent is released, the bleaching agent may be a gas, a liquid, or a solid dissolved in a liquid. In addition, the hydrophilic bleach particles are insoluble in the hydrophobic phase. The hydrophilic bleach particles or semi-solid multiphase oral compositions may also contain water-soluble, water-miscible, or a combination thereof, such as: water, a water-soluble solvent, an alcohol, an acrylic polymer, a polyalkylene glycol, a humectant, glycerol, sorbitol, xylitol, butylene glycol, polyethylene glycol, and propylene glycol, and mixtures thereof. The hydrophilic bleach particles may also contain water of hydration or a crystallization solvent. If these ingredients are added to or present in the hydrophilic bleach particles, the percentage of the hydrophilic bleach particles in the composition is calculated by excluding these ingredients. If water-insoluble or water-immiscible fillers are added to the hydrophilic bleach particles or the semisolid multiphase oral composition, the percentage of hydrophilic bleach particles in the composition is calculated by excluding these fillers.

[0032] As used herein, the term "bleaching agent" is the component of the bleaching agent granules that bleaches. For example, if carbamide peroxide (also known as urea hydrogen peroxide adduct) is used as the bleaching agent granules, the hydrogen peroxide component of the carbamide peroxide granules is the bleaching agent. Similarly, if a complex of hydrogen peroxide and a polyvinylpyrrolidone (PVP) polymer is used as the bleaching agent granules, the hydrogen peroxide component of the complex of hydrogen peroxide and a polyvinylpyrrolidone (PVP) polymer is the bleaching agent.

[0033] As used herein, the term "hydrophobic phase" refers to all components of a composition that is immiscible with water. In addition, the hydrophobic phase may be insoluble in water. In addition, the hydrophobic phase may also contain soluble, miscible, or combinations thereof components in the hydrophobic phase, such as hydrocarbon solvents that dissolve in the hydrophobic phase, polyethylene that dissolves in the hydrophobic phase, microcrystalline wax that dissolves in the hydrophobic phase, or mixtures thereof. Specifically, the hydrophobic phase is semisolid. If water-insoluble or water-immiscible fillers are added to the hydrophilic bleaching agent particles or the semisolid multiphase oral composition, the percentage of the hydrophobic phase in the composition is calculated by including these fillers as part of the hydrophobic phase.

[0034] As used herein, the term "petrolatum" refers to a semisolid mixture of hydrocarbons. Petrolatum may have a cone penetration consistency value measured according to ASTM method D937 of about 10 to about 500, preferably about 25 to about 300, more preferably about 50 to about 250, or more preferably about 100 to about 200. Petrolatum may have a melting point or drop melting point measured according to ASTM method D127 or a freezing point measured according to ASTM method D938 of about 40°C to about 120°C, preferably about 50°C to about 100°C, more preferably about 50°C to about 90°C, or more preferably about 60°C to about 80°C.

[0035] As used herein, the term "cone penetration consistency value" refers to the depth, in tenths of a millimeter, to which a standard cone will penetrate a sample under fixed conditions of mass, time, and temperature. Cone penetration consistency values ​​are measured according to ASTM method D937-07.

[0036] As used herein, the term "delivery vehicle" includes materials or devices used to hold a semi-solid multi-phase oral composition against the surface of a tooth. Examples of delivery vehicles include strips or trays.

[0037] As used herein, the term "strip" includes materials 1) whose longest dimension length is generally greater than its width, and 2) whose width is generally greater than its thickness. The strip can be rectangular, arched, curved, semicircular, with rounded corners, with slits cut into it, with notches cut into it, bent into a three-dimensional shape, or a combination thereof. The strip can be solid, semi-solid, textured, plastic, flexible, deformable, permanently deformable, or a combination thereof. The strip can be made of plastic sheets, including polyethylene or wax sheets. Examples of strips include polyethylene sheets that are about 66 mm long, 15 mm wide, and 0.0178 mm thick. Examples of permanently deformable strips include a cast wax sheet that is about 66 mm long, 15 mm wide, and 0.4 mm thick.

[0038] The semi-solid multiphase oral composition herein may be a particulate semi-solid dispersion useful for topical application, in particular for topical application in the mouth. For example, the composition may be an oral care composition.

[0039] As used herein, the word “or” when used as a conjunction of two or more elements is meant to include the elements individually or in combination; for example, X or Y means X or Y or both.

[0040] As used herein, the articles "a" and "an" are understood to refer to one or more materials being claimed or described, for example, "an oral care composition" or "a bleaching agent."

[0041] As used herein, the term "safe and effective amount" means that within the scope of reasonable medical / dental judgment, the amount of the component is high enough to significantly (definitely) change the condition to be treated or affect the desired whitening effect, but low enough to avoid serious side effects (at a reasonable benefit / risk ratio). The safe and effective amount of the component depends on the specific condition to be treated, the age and physiological state of the patient to be treated, the severity of the condition, the treatment period, the nature of the co-treatment, the specific form used, and the specific carrier of the component.

[0042] As used herein, so-called "a period of time sufficient to achieve whitening" refers to the use or wearing of the composition by a participant, or the use or wearing of the composition by a participant is indicated to be greater than about 10 seconds; or greater than about 1 minute, such as about 2.5 minutes to about 12 hours (e.g., overnight treatment), or about 3 minutes to about 180 minutes; or greater than about 5 minutes, such as about 5 minutes to about 60 minutes; or greater than about 10 minutes, such as about 10 minutes to about 60 minutes; or each application is about 1 minute, 5 minutes, 10 minutes 15 minutes to about 20 minutes, 30 minutes, 60 minutes, 120 minutes; or any other numerical range that is narrower and falls within such a wider numerical range, as such a narrower numerical range is all explicitly written in this article. In addition, the treatment can be applied about 1 time, 2 times or 3 times a day to about 4 times, 5 times, 6 times or 7 times a day. The treatment can be applied for about 1 day, 2 days, 3 days, 4 days, 5 days, 6 days or about 7 days to about 8 days, 9 days, 10 days, 11 days, 12 days, 13 days, 14 days, 21 days or 28 days, or any other numerical range that is narrower and falls within such a wider numerical range, as such a narrower numerical range is all explicitly written in this article. In addition, the treatment length to achieve the desired beneficial effect (e.g., teeth whitening) can be sustained for a specified time period, and if necessary, the time period can be repeated, for example, from about one day to about 6 months, specifically from about one day to about 28 days, or from about 7 to about 28 days. The optimal duration and frequency of application depend on the desired effect, the severity of all conditions to be treated, the health status and age of the user, and similar factors.

[0043] As used herein, the term "dispenser" refers to any pump, tube, or container suitable for dispensing an oral composition.

[0044] The unit "μm" or "micrometer" used herein means micrometer.

[0045] As used herein, the term "equivalent diameter" of a particle refers to the diameter of a sphere having the same volume as the particle.

[0046] Unless otherwise specified, all percentages and ratios used below are by weight of the total composition (wt%). Unless otherwise specified, all percentages, ratios and levels of ingredients mentioned herein are based on the actual amount of the ingredient and do not include solvents, fillers or other materials that may be used with these ingredients in commercially available products.

[0047] Unless otherwise indicated, all measurements mentioned herein were conducted at about 23°C (ie, room temperature).

[0048] Active ingredients and other ingredients useful herein may be classified or described herein according to their cosmetic and / or therapeutic benefits or their postulated modes of action or operation. However, it should be understood that in some cases, active substances and other ingredients useful in the present invention may provide more than one cosmetic and / or therapeutic benefit, or function or operate through more than one mode of action. Therefore, the classification herein is for convenience only and is not intended to limit the ingredients to the specific specified functions or activities listed.

[0049] As used herein, the term "tooth" refers to natural teeth as well as artificial teeth or dentures, and is interpreted as including one tooth or multiple teeth. As used herein, the term "tooth surface" refers to natural tooth surfaces as well as corresponding artificial tooth surfaces or denture surfaces.

[0050] The term "orally acceptable carrier" includes one or more compatible solid or liquid excipients or diluents suitable for use in the oral cavity. As used herein, "compatible" means that the components of the composition can be mixed but do not interact, and the interaction will significantly reduce the stability and / or efficacy of the composition.

[0051] The term "about" refers to ± 10%.

[0052] Semisolid multiphase oral composition

[0053] The semi-solid multi-phase oral composition as disclosed herein comprises hydrophilic particles dispersed in a hydrophobic phase.The semi-solid multi-phase oral composition as disclosed herein may be a semi-solid dispersion comprising hydrophilic bleach particles dispersed in a hydrophobic phase.

[0054] For dispersions containing hydrophilic bleach particles, the particle size of the hydrophilic bleach particles can be a factor in reducing oral / local irritation, reducing tooth sensitivity, or increasing bleaching efficacy. Without being bound by theory, if the size of the hydrophilic bleach particles is too large, it can result in large spots on the oral / local / tooth surfaces exposed to high concentrations of bleach, which in turn can result in oral / local irritation and / or tooth sensitivity. For example, the number average equivalent diameter, surface area average equivalent diameter, or volume average equivalent diameter of the hydrophilic bleach particles may not exceed about 0.001 microns, 0.01 microns, 0.1 microns, 1 micron, 5 microns, 10 microns, 50 microns, 100 microns, 500 microns, or 1000 microns, or any other numerical range that is narrower and falls within such broader numerical ranges, as if such narrower numerical ranges are all expressly written herein. Specifically, the number average equivalent diameter, surface area average equivalent diameter or volume average equivalent diameter of the hydrophilic bleach particles can be from about 0.001 micrometers to about 1000 micrometers, preferably from about 0.01 micrometers to about 1000 micrometers, more preferably from about 0.1 micrometers to about 100 micrometers, and most preferably from about 1 micrometer to about 100 micrometers, or any other numerical range that is narrower and falls within such broader numerical ranges, as if such narrower numerical ranges are all expressly written herein.

[0055] Compositions with high density of large hydrophilic bleach particles may lead to oral / local irritation and / or tooth sensitivity. For example, the two-dimensional density of hydrophilic bleach particles having a cross-sectional area greater than about 1000 square microns, 3000 square microns, 10000 square microns, 20000 square microns or 50000 square microns may be no more than about 100, 50, 25, 20, 15, 10, 9, 8, 7, 6, 5, 4, 3, 2, 1 or 0.5 per square centimeter of two-dimensional plane, or any other numerical range that is narrower and falls within such wider numerical ranges, as if such narrower numerical ranges are all explicitly written herein. Specifically, the two-dimensional density of hydrophilic bleach particles having a cross-sectional area greater than about 10000 square microns may be no more than about 25, preferably no more than 10, more preferably no more than 5, and most preferably no more than 1 per square centimeter of two-dimensional plane, or any other numerical range that is narrower and falls within such wider numerical ranges, as if such narrower numerical ranges are all explicitly written herein.

[0056] The components and characteristics of the hydrophilic bleach particles and the hydrophobic phase are selected to allow the bleach to be readily released from the composition.

[0057] Without being bound by theory, it is believed that when the present invention, such as a semi-solid dispersion of hydrophilic particles, is contacted with a tooth surface, the hydrophilic bleaching agent particles can deliver the bleaching agent to the hydrophilic biofilm on the tooth surface. The possible net effect is that the tooth whitening effect begins only after contact with the tooth surface to be treated. This means that the bleaching agent can be protected from environmental influences, thereby being stabilized by the hydrophobic phase of the semi-solid multi-phase oral composition until use and potentially by the hydrophobic phase in the form of a film or layer during use. Therefore, an active effect can be applied to the tooth surface and the active agent, for example, the bleaching agent can be potentially shielded from the oral environment during use. The efficacy of the whitening semi-solid multi-phase oral composition can thereby be enhanced and / or accelerated.

[0058] Without being bound by theory, the present invention can improve the delivery of whitening agents to the tooth surface, thereby achieving whitening performance due to the partial hydrophobic nature and partial hydrophilic nature of the composition. When the semi-solid multi-phase composition is in contact with the tooth surface, the hydrophilic bleaching agent particles in the semi-solid multi-phase composition can be pushed toward the tooth surface. Therefore, the whitening speed and bleaching agent efficacy can be improved at surprisingly low concentrations of bleaching agent. Therefore, at a given total bleaching agent concentration (such as less than 0.1 wt%, 0.1 wt%, 1 wt% or 5 wt% or less bleaching agent), the present invention can achieve surprisingly high levels of whitening efficacy, and may require fewer applications to obtain the same degree of whitening, or may require a lower gel loading (mg of gel per unit area) to obtain the same degree of whitening.

[0059] Without being bound by theory, it is believed that part of the reason for the high efficacy achieved by the semi-solid multi-phase oral composition of the present invention may be because they are self-adhesive or self-affinity to teeth and can resist being washed off in saliva or other liquids. This can keep the active agent or bleaching agent in contact with the oral surface (such as the tooth surface) or in the oral cavity for a long time, thereby achieving high efficacy. It is worth noting that, in general, materials with adhesiveness or affinity to the oral cavity are hydrophilic because the surface in the oral cavity is moistened. It is also worth noting that some product forms, especially stick-shaped products, may require added affinity agents to adhere the composition to the surface in the oral cavity. However, it has been surprisingly found that the semi-solid multi-phase oral composition of the present invention and / or the hydrophobic relative surface in the oral cavity of the present invention, such as the tooth surface, is self-adhesive or self-affinity, even without the added adhesive (e.g., hydrophilic particles that become sticky when activated by moisture, or hydrophilic liquid) or added affinity agents. Achieving adhesion or substantivity without the use of an added hydrophilic binder or hydrophilic substantivity agent is particularly useful because it can help make the semi-solid multi-phase oral composition resistant to being washed off in saliva or other liquids, resulting in higher efficacy. This is because achieving adhesion or substantivity without the use of an added hydrophilic binder or added hydrophilic substantivity agent can allow us to increase the content of hydrophobic components (resistant to being washed off) and / or reduce the content of hydrophilic components (easy to be washed off). Counterintuitively, this can help increase the substantivity of the semi-solid multi-phase oral composition, resulting in high concentrations of active agents or bleaching agents in contact with oral surfaces (such as tooth surfaces) or in the oral cavity for a long time, which in turn leads to high efficacy. In addition, without being bound by theory, it is believed that hydrophilic liquids may also leach from the semi-solid multi-phase oral composition and cause one or more components to macroscopically separate at temperatures (e.g., -7°C, 4°C, 23°C, 25°C, 30°C, 40°C, 50°C, or 60°C) and conditions to which the semi-solid multi-phase oral composition may be exposed during manufacture, filling, transportation, or storage (e.g., 1 day, 2 days, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months, 18 months, or 24 months) prior to use by a consumer. This is because the hydrophilic liquid may be repelled by the hydrophobic phase and expelled from the semi-solid multi-phase oral composition. Thus, in preferred embodiments, the semi-solid multi-phase oral composition of the present invention and / or the hydrophobic phase of the present invention are substantially free of added binders, preferably substantially free of added hydrophilic binders (e.g., hydrophilic particles that become tacky when activated by moisture) or added hydrophilic substantive agents, and more preferably substantially free of added hydrophilic liquid binders (e.g., glycerol). In particular, the semi-solid multi-phase oral composition of the present invention and / or the hydrophobic phase of the present invention are self-adhesive and / or self-substantive to the oral cavity, such as tooth surfaces.

[0060] It is also worth noting that some product forms, especially stick products, may require an added active substance release agent or an added peroxide release agent to improve the release of active substances or peroxides trapped in the stick product. Generally speaking, the active substance release agent or peroxide release agent is a hydrophilic water-soluble or water-swellable polymer or a hydrophilic liquid that can provide hydration channels in the composition, thereby allowing water to penetrate the composition and allow the active substance or peroxide to leach out. In certain embodiments, an added peroxide release agent (such as sodium percarbonate) can help destroy the hydrophobic matrix due to the microbubbles that can be generated when it comes into contact with water; and this destruction can enhance the release of whitening agents such as hydrogen peroxide. However, it has been surprisingly found that, in general, the semi-solid multiphase oral compositions of the present invention are self-releasing (e.g., they release active substances or peroxides even without an added active substance release agent or an added peroxide release agent). Achieving active or peroxide release without the use of an added hydrophilic active or peroxide release agent is particularly useful because it can help to make the semi-solid multiphase oral composition resistant to being washed off in saliva or other liquids, resulting in high efficacy. This is because achieving active or peroxide release without the use of an added hydrophilic active or peroxide release agent allows us to increase the content of hydrophobic components (resistant to being washed off) and / or reduce the content of hydrophilic components (easy to be washed off). Therefore, in a preferred embodiment, the semi-solid multiphase oral composition of the present invention is substantially free of an added active or peroxide release agent, preferably substantially free of an added hydrophilic active or peroxide release agent (e.g., a water-soluble or water-swellable polymer, a hydrophilic liquid, or sodium percarbonate). Generally speaking, the semisolid multiphase oral compositions of the present invention and / or the hydrophobic phase of the present invention are self-releasing (ie, they release the active substance or peroxide even in the absence of an added active substance-releasing agent or an added peroxide-releasing agent).

[0061] However, in certain embodiments, if the semi-solid multi-phase oral composition of the present invention comprises an added binder, an added hydrophilic binder, an added hydrophilic liquid binder, an added hydrophilic affinity agent, an added hydrophilic active substance releasing agent, or an added hydrophilic peroxide releasing agent, it may be present in a range of about 0%, 0.1%, 0.2%, 0.4%, 1%, 2%, 3%, 4%, 5% to about 0%, 0.1%, 0.2%, 0.4%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 20% by weight of the composition, or any other numerical range that is narrower and falls within such broader numerical ranges as if such narrower numerical ranges were all expressly written herein; preferably less than about 20%, more preferably less than about 10%, even more preferably less than about 5%, or most preferably less than about 0.5% by weight of the semi-solid multi-phase oral composition.

[0062] In addition, when the hydrophobic phase resists dilution by saliva and salivary enzymes that can decompose peroxides, the retention of the semi-solid multi-phase oral composition on the tooth surface can be improved. In addition, the hydrophobic phase may not dehydrate the teeth, thereby generating an outward flux of water formed by many hydrophilic compositions containing hydrophilic binders such as polycarboxylic acids. Since the hydrophobic phase may not dehydrate the teeth, surprisingly low levels of tooth sensitivity can result even if surprisingly high levels of whitening efficacy are achieved.

[0063] In addition, the hydrophobic phase can also provide other advantages. For example, the hydrophobic phase represents a stable matrix of components that are soluble in the hydrophobic phase. For example, many flavoring ingredients commonly used in oral compositions are soluble in the hydrophobic phase. This means that any influence of the flavoring ingredients by the active agent (e.g., bleaching agent) in the oral composition can be avoided. In addition, during the use of the oral composition at the tooth surface, without being bound by theory, at least a portion of the hydrophobic phase can be positioned toward soft oral tissues such as mucous membranes, thereby presenting components present in the hydrophobic phase to the oral cavity, such as flavoring compounds. In addition, the hydrophobic phase can shield active agents, such as bleaching agents from any influence of the oral cavity, such as being diluted by saliva. The shielding effect can also be applied to the tooth surface itself, wherein the hydrophobic phase can provide greater hydration of the tooth surface.

[0064] It is worth noting that, due to potential contamination or biofilm accumulation, stick products may be unhygienic for repeated use in the oral cavity. Saliva or moisture may penetrate into the stick composition when the stick composition is used in the oral cavity, and this may degrade active agents, especially bleaching agents, such as peroxides, during storage between two uses; and this degradation may be further accelerated by enzymes present in saliva. In addition, this degradation may be most obvious at the end of the stick product that is in direct contact with saliva or moisture in the oral cavity, resulting in reduced efficacy when the stick product is used next time. Whenever a stick product is used, the "contact-degradation-contact" cycle can be repeated, resulting in poor effects for most (if not all) applications after the first application. It is also worth noting that the stick product may require an added active substance release agent or an added peroxide release agent to improve the release of active substances or peroxides trapped in the stick product. Generally speaking, an active substance release agent or a peroxide release agent is a hydrophilic water-soluble or water-swellable polymer or a hydrophilic liquid, which can provide a hydration channel in the composition, thereby allowing water to penetrate the composition and allowing the active substance or peroxide component to leach out. However, these channels may also allow more saliva to penetrate into the composition, which may accelerate the degradation of the active substance or peroxide. Therefore, the stick product form is less preferred or unpreferred for the multi-phase oral composition of the present invention; therefore, the multi-phase oral composition of the present invention is substantially free of any compounds and ingredients that may promote the formation of a stick product, such as added wax.

[0065] It is noteworthy that multi-phase oral compositions in liquid form may exhibit macroscopic separation of one or more components due to differences in density of the phases. Specifically, compositions that are particles dispersed in one or more liquids may exhibit macroscopic separation of one or more components due to differences in density of the particles compared to the liquid. In addition, multi-phase oral compositions in liquid form may not be substantive and flow down the teeth or out of the delivery vehicle during application or during use. Therefore, liquid forms are less preferred or unpreferred for the multi-phase oral compositions of the present invention.

[0066] The multiphase oral composition of the present invention may be a paste, a cream, a gel, a semisolid or any combination thereof, preferably a semisolid; wherein a heterogeneous semisolid mixture and / or a heterogeneous semisolid dispersion is preferred.

[0067] Hydrophilic bleach particles

[0068] The semi-solid multi-phase oral composition of the present invention comprises a safe and effective amount of hydrophilic bleach particles, wherein the amount of hydrophilic bleach particles is provided on a molecular basis to provide available oxygen or chlorine for bleaching stains. For example, the maximum amount of hydrophilic bleach particles can be about 0.01%, 0.02%, 0.03%, 0.04%, 0.05%, 0.06%, 0.07%, 0.08%, 0.09%, 0.095%, 0.099995%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 0.10%, 0.11%, 0.12%, 0.13%, 0.14%, 0.15%, 0.16%, 0.17%, 0.18%, 0.19%, 0.20%, 0.21%, 0.22%, 0.23%, 0.24%, 0.25%, 0.26%, 0.27%, 0.28%, 0.29%, 0.30%, 0.31%, 0.32%, 0.33%, 0.34%, 0.35%, 0.36%, 0.37%, 0.38%, 0.39%, 0.40%, 0.41%, 0.42%, 0.43%, 0.44%, 0.45%, 0.46%, 0.47%, 0.48%, 0.49%, 0.50%, 0.51%, 0.52%, 0.53%, 0.54%, 0.55%, 0.56%, 0.57%, 0.58%, 0.59%, 0.60%, 0.61%, 0.6 .8, 0.9, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 47.5%, 50%, 60%, 70% or 80%, or any other numerical range that is narrower and falls within such broader numerical range, as if such narrower numerical ranges are all expressly written herein.

[0069] It has been surprisingly found that the solubility of the hydrophilic bleach particles in water, the ability to swell when in contact with water, or the ability to release the bleaching agent when in contact with water affects the bleaching efficacy of the composition. Specifically, at least about 20, 25, 30, 40, 50, 60, 70, or 80 parts by weight of the hydrophilic bleach particles are dissolved in about 100 parts by weight of water, or the hydrophilic bleach particles swell at least about 20%, 25%, 30%, 40%, 50%, 60%, 70%, or 80% when in contact with water. Without being bound by theory, it is surprising that the amount of water that can hydrate the hydrophilic bleach particles and release the bleaching ingredients is low on the buccal surfaces of the maxillary anterior teeth compared to the rest of the oral cavity. This is particularly important because the buccal surfaces of the maxillary anterior teeth are those that are most visible when smiling. Thus, the solubility of the hydrophilic bleaching agent particles in water, their ability to swell upon contact with water, or their ability to release bleaching agent upon contact with water may disproportionately affect the bleaching efficacy of the composition on the "smile teeth" (buccal surfaces of the maxillary anterior teeth).

[0070] Preferred examples of hydrophilic bleach particles include urea peroxide (also known as urea hydrogen peroxide, or urea hydrogen peroxide adduct), and a complex of hydrogen peroxide and a polyvinylpyrrolidone (PVP) polymer (also known as Peroxydone), and mixtures thereof.

[0071] Other examples of hydrophilic bleaching agent particles include providing bleaching effects, stain bleaching effects, stain removal effects, dyeing change effects, or any other effects that change or whiten the color of teeth. For example, the hydrophilic bleaching agent particles include a peroxide free radical source. In addition or alternatively, the hydrophilic bleaching agent particles may include peroxides, metal chlorites, perborates, percarbonates, peroxyacids, persulfates, compounds that form the aforementioned compounds in situ, and combinations thereof. Examples of peroxide compounds may include urea peroxide, calcium peroxide, urea hydrogen peroxide, and mixtures thereof. Examples of metal chlorites may include calcium chlorite, barium chlorite, magnesium chlorite, lithium chlorite, sodium chlorite, potassium chlorite, and mixtures thereof. Examples of hydrophilic bleaching agent particles may include hypochlorites (such as metal hypochlorites). Examples of persulfates may include salts of peroxymonosulfates, peroxydisulfates, and mixtures thereof. Examples of persulfates, perborates, percarbonates, and hypochlorites include corresponding salts of sodium, calcium, potassium, and other metals.

[0072] Additionally or alternatively, the hydrophilic bleach particles can be from about 0.001%, 0.01%, 0.02%, 0.03%, 0.04%, 0.05%, 0.06%, 0.07%, 0.08%, 0.09%, 0.095%, 0.099995%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 47.5%, 50%, 60%, 70% or 80% to about 0.001%, 0.01%, 0.02%, 0.03%, 0.04%, 0.05%, 0.06%, 0.07%, 0.08%, 0.09%, 0.095%, 0.099995%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 47.5%, 50%, 60%, 70% or 80% by weight of the semi-solid multi-phase oral composition. %, 35%, 40%, 45%, 47.5%, 50%, 60%, 70% or 80%, or any other numerical range that is narrower and falls within such broader numerical range, as if such narrower numerical ranges were all expressly written herein.

[0073] Specifically, the hydrophilic bleaching agent particles may be present in an amount of less than 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.9%, 0.8%, 0.7%, 0.6%, 0.5%, 0.4%, 0.3%, 0.2%, 0.1%, 0.099995%, 0.095% or 0.09% by weight of the semi-solid multi-phase oral composition, more specifically, less than 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.9%, 0.8%, 0.7%, 0.6%, 0.5%, 0.4%, 0.3%, 0.2%, 0.1%, 0.099995%, 0.095% or 0.09% by weight of the semi-solid multi-phase oral composition. Less than 0.9%, 0.8%, 0.7%, 0.6%, 0.5%, 0.4%, 0.3%, 0.2% or 0.1%, or from about 0.1% to about 0.9%, or from about 0.2% to about 0.8%, or from about 0.3% to about 0.7%, or any other numerical range narrower and falling within such broader numerical ranges, as if such narrower numerical ranges are all expressly written herein. Alternatively, the hydrophilic bleach particles can be from about 0.6% to about 10%, or from about 0.6% to about 6%, or from about 1% to about 5%, or from about 1% to about 3%, or any other numerical range narrower and falling within such broader numerical ranges, as if such narrower numerical ranges are all expressly written herein, based on the weight of the semi-solid multi-phase oral composition.

[0074] The amount of hydrophilic bleach particles can be present on a molecule basis to provide available oxygen or chlorine to bleach stains, respectively. In preferred embodiments, the amount of hydrophilic bleach particles is less than or at most about 0.1% by weight of the semi-solid multi-phase oral composition, in more preferred embodiments, less than about 0.09%, 0.08%, 0.07%, 0.06%, 0.05%, 0.04%, 0.03%, 0.02%, 0.01% or 0.001% by weight of the semi-solid multi-phase oral composition, or from about 0.01% to about 0.099995%, from about 0.01% to about 0.095%, or from about 0.05% to about 0.09% by weight of the semi-solid multi-phase oral composition, or any other numerical range that is narrower and falls within such broader numerical ranges, as if such narrower numerical ranges were all expressly written herein. Surprisingly, the hydrophilic bleach particles are remarkably effective even when used at low levels in a semisolid multiphase oral composition as disclosed herein, which may be in the form of a semisolid dispersion of particles.

[0075] For example, the maximum amount of the bleaching agent can be about 0.01%, 0.02%, 0.03%, 0.04%, 0.05%, 0.06%, 0.07%, 0.08%, 0.09%, 0.095%, 0.099995%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 47.5%, 50%, 60%, 70% or 80% by weight of the semi-solid multi-phase oral composition, or any other numerical range that is narrower and falls within such broader numerical range, as if such narrower numerical ranges are all expressly written herein.

[0076] Additionally or alternatively, the bleaching agent can be from about 0.001%, 0.01%, 0.02%, 0.03%, 0.04%, 0.05%, 0.06%, 0.07%, 0.08%, 0.09%, 0.095%, 0.099995%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 47.5%, 50%, 60%, 70%, or 80% to about 0.001%, 0.01%, 0.02%, 0.03%, 0.04%, 0.05%, 0.06%, 0.07%, 0.08%, 0.09%, 0.095%, 0.099995%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 47.5%, 50%, 60%, 70%, or 80% by weight of the semi-solid multi-phase oral composition. %, 35%, 40%, 45%, 47.5%, 50%, 60%, 70% or 80%, or any other numerical range that is narrower and falls within such broader numerical range, as if such narrower numerical ranges were all expressly written herein.

[0077] Specifically, the bleaching agent content can be less than 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.9%, 0.8%, 0.7%, 0.6%, 0.5%, 0.4%, 0.3%, 0.2%, 0.1%, 0.099995%, 0.095% or 0.09% by weight of the semi-solid multi-phase oral composition, more specifically less than 0.9%, 0.9%, 0.8%, 0.7%, 0.6%, 0.5%, 0.4%, 0.3%, 0.2%, 0.1%, 0.099995%, 0.095% or 0.09% by weight of the semi-solid multi-phase oral composition. 0.8%, 0.7%, 0.6%, 0.5%, 0.4%, 0.3%, 0.2% or 0.1%, or preferably from about 0.1% to about 0.9%, more preferably from about 0.2% to about 0.8%, more preferably from about 0.3% to about 0.7%, by weight of the semi-solid multi-phase oral composition, or any other numerical range that is narrower and falls within such broader numerical ranges, as if such narrower numerical ranges were all expressly written herein.

[0078] Hydrogen peroxide concentration ratio

[0079] In a preferred embodiment, the hydrophilic bleach particles deliver hydrogen peroxide by being an adduct or complex of hydrogen peroxide or a precursor of hydrogen peroxide. Therefore, they achieve a high ratio of the weight percent concentration of hydrogen peroxide present in the hydrophilic bleach particles to the weight percent concentration of hydrogen peroxide present in the overall semi-solid multi-phase oral composition. This is caused by the combination of the high weight percent concentration of hydrogen peroxide present in the hydrophilic bleach particles and the relatively low weight percent concentration of hydrogen peroxide present in the overall semi-solid multi-phase oral composition.

[0080] Without being bound by theory, in embodiments of the present invention comprising hydrogen peroxide, this surprising combination of seemingly contradictory parameters utilizes a high driving force to deliver hydrogen peroxide to the tooth surface, even when the overall concentration or amount of hydrogen peroxide delivered to the tooth surface is low. Thus, the high driving force achieves a surprisingly high level of bleaching efficacy and / or bleaching speed; while the low overall concentration or amount of bleaching agent delivered to the tooth surface can help reduce tooth sensitivity.

[0081] Additionally or alternatively, the ratio of the weight percent concentration of hydrogen peroxide present in the hydrophilic bleaching agent particles to the weight percent concentration of hydrogen peroxide present in the overall semisolid multiphase oral composition can be about 50,000, 35,000, 20,000, 17,500, 10,000, 5,000, 3,500, 2,000, 1,750, 1,160, 1,000, 875, 700, 580, 500, 430, 400, 380, 350, 200, 175, 111, 110, 105, 100, 90, 80, 70, 60, 50, 40, 30, 2 5, 10, 15, 10 or 5, or any other numerical range that is narrower and falls within such broader numerical range, as if such narrower numerical ranges were all expressly written herein.

[0082] In addition or alternatively, the ratio of the weight percent concentration of hydrogen peroxide present in the hydrophilic bleach particles to the weight percent concentration of hydrogen peroxide present in the overall semi-solid multi-phase oral composition can be at least or more than about 50,000, 35,000, 20,000, 17,500, 10,000, 5,000, 3,500, 2,000, 1,750, 1,160, 1,000, 8,75, 700, 5,80, 5,00, 4,30, 4,00, 3,80, 3,50, 2,00, 175, 1,100, 105, 100, 90, 80, 70, 60, 50, 40, 30, 20, 15, 10, or 5, or any other numerical range that is narrower and falls within such broader numerical range, as if such narrower numerical ranges were all expressly written herein.

[0083] The bleaching agents of the present invention are stabilized against degradation by the shielding effect of the hydrophobic phase.

[0084] Optional stabilizer for bleaching agents

[0085] The semi-solid multi-phase oral composition of the present invention may contain a stabilizer for the bleaching agent. The bleaching agent may be further stabilized against degradation caused by the semi-solid multi-phase oral composition. Therefore, a stabilizer may be added to the composition of the present invention. Suitable stabilizers are, for example, orthophosphoric acid, phosphates such as sodium hydrogen phosphate, pyrophosphates, organic phosphonates, ethylenediaminetetraacetic acid, ethylenediamine-N,N′-diacetic acid, ethylenediamine-N,N′-disuccinic acid, potassium stannate, sodium stannate, tin salts, zinc salts, salicylic acid, 1-hydroxyethylidene-1,1-diphosphonic acid, and combinations thereof. Specifically, stabilizers that exhibit additional oral care effects such as anticathallochemical effects may be used, the effects being produced by phosphates such as pyrophosphates, tripolyphosphates, hexametaphosphates, phytic acid, PO3(PO2) n Salts of PO3 (wherein n = 2-30), phosphoric acid, gantrez, zinc salts (including zinc citrate, zinc lactate, zinc chloride, zinc phosphate, zinc oxide), enzymes such as glucanases, xylanases, proteases, peroxides (including hydrogen peroxide, urea peroxide and sodium percarbonate), phosphonates such as diphosphonates, chelating agents such as EDTA, sodium calcium EDTA, citrate, citric acid, oxalic acid, oxalates, polymers (such as those disclosed in U.S. patent application Ser. No. 16 / 216,329), PVP, polyacrylic acid (acrylic acid polymers), polyacrylates, stannous salts, tin salts. The stabilizer may be present in the semisolid multiphase oral composition of the present invention in an amount of from about 0.0000001%, 0.000001%, or 0.00001% to about 0.00001%, 0.0001%, or 0.01%, or narrower and any other numerical range falling within such broader numerical ranges, based on the weight of the semisolid multiphase oral composition, as if such narrower numerical ranges were all expressly written herein. Specifically, the stabilizer may be present in the semisolid multiphase oral composition of the present invention in an amount of from about 0.0001% or 0.01% to about 0.01%, 0.1%, or about 1%, or narrower and any other numerical range falling within such broader numerical ranges, based on the weight of the semisolid multiphase oral composition, as if such narrower numerical ranges were all expressly written herein.

[0086] Stabilizers may also include chelating agents. Chelating agents may be copper, iron and / or manganese chelating agents or mixtures thereof. Suitable chelating agents may be selected from: diethylenetriamine pentaacetate, diethylenetriamine penta (methylphosphonic acid), ethylenediamine-N'N'-disuccinic acid, ethylenediamine tetraacetate, ethylenediamine tetra (methylenephosphonic acid), hydroxyethane di (methylenephosphonic acid), and any combination thereof. Suitable chelating agents may be selected from ethylenediamine-N'N'-disuccinic acid (EDDS), hydroxyethane diphosphonic acid (HEDP) or mixtures thereof. The stabilizer may include ethylenediamine-N'N'-disuccinic acid or its salt. Ethylenediamine-N'N'-disuccinic acid may be in the form of S, S enantiomers. The composition may include 4,5-dihydroxyisobenzene disulfonic acid disodium salt, glutamic acid-N,N-diacetic acid (GLDA) and / or its salt, 2-hydroxypyridine-1-oxide, Trilon P available from BASF (Ludwigshafen, Germany), TM Suitable chelating agents may also be calcium carbonate crystal growth inhibitors. Suitable calcium carbonate crystal growth inhibitors may be selected from: 1-hydroxyethanediphosphonic acid (HEDP) and its salts; N,N-dicarboxymethyl-2-aminopentane-1,5-dioic acid and its salts; 2-phosphonobutane-1,2,4-tricarboxylic acid and its salts; and any combination thereof.

[0087] The stabilizer may include a calcium carbonate crystal growth inhibitor such as 1-hydroxyethanediphosphonic acid (HEDP); N,N-dicarboxymethyl-2-aminopentane-1,5-dioic acid; 2-phosphonobutane-1,2,4-tricarboxylic acid; and salts thereof; and any combination thereof.

[0088] The stabilizer may comprise a hydroxamic acid chelating agent. "Hydroxamic acid" as used herein means hydroxamic acid or the corresponding salt, for example cocohydroxamic acid (Axis House RK 853).

[0089] Hydrophobic phase

[0090] The present invention comprises a safe and effective amount of a hydrophobic phase. For example, the semi-solid multi-phase oral composition of the present invention comprises a hydrophobic phase, wherein the hydrophobic phase may be at least or more than about 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, 99%, 99.1% or 99.5% by weight of the semi-solid multi-phase oral composition, or any other numerical range that is narrower and falls within such a wider numerical range, as if such a narrower numerical range is all explicitly written herein. Specifically, the hydrophobic phase may be at least about 95%, 96%, 97%, 98%, 99%, 99.1% or 99.5% by weight of the semi-solid multi-phase oral composition, or any other numerical range that is narrower and falls within such a wider numerical range, as if such a narrower numerical range is all explicitly written herein.

[0091] In addition, the hydrophobic phase can be a major proportion relative to the hydrophilic bleaching agent particles present in the semi-solid multi-phase oral composition. As used herein, "major proportion" means that the weight percentage of the hydrophobic phase of the semi-solid multi-phase oral composition exceeds the weight percentage of the hydrophilic bleaching agent particles of the semi-solid multi-phase oral composition.

[0092] The hydrophobic phase may be inert or at least partially inert.The hydrophobic phase may interact with other ingredients in the semisolid multiphase oral composition comprising the bleaching agent, such as flavoring agents or thickening agents, but in certain embodiments does not interact or interacts only slightly.

[0093] Suitable hydrophobic phases for the compositions disclosed herein may have an octanol / water partition coefficient (log P) greater than about 2, 3, 4, 5, or greater than about 5.5. ow ). In particular, the hydrophobic phase exhibits a log P greater than about 6, or any other range of values ​​that is narrower and falls within such broader range of values. ow , as if such narrower numerical ranges were all expressly written herein.

[0094] Without being bound by theory, the melting point, drop melting point, or freezing point of the hydrophobic phase may be a factor in ensuring that the composition: 1) is substantive and does not flow down the teeth or out of the delivery vehicle during application or during use, 2) inhibits macroscopic separation of one or more components at temperatures (e.g., -7°C, 4°C, 23°C, 25°C, 30°C, 40°C, 50°C, or 60°C) and conditions to which the semi-solid multi-phase oral composition may be exposed during manufacture, filling, shipping, or storage (e.g., 1 day, 2 days, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months, 18 months, or 24 months) prior to use by a consumer, or 3) releases an effective amount of the bleaching agent or active agent during use. Specifically, if the melting point, drop melting point, or solidification point of the hydrophobic phase is too low, the semi-solid multi-phase oral composition may not be substantive and flow down the teeth or out of the delivery vehicle during application or during use; or the semi-solid multi-phase oral composition may exhibit macroscopic separation of one or more components at temperatures (e.g., -7°C, 4°C, 23°C, 25°C, 30°C, 40°C, 50°C, or 60°C) and conditions to which the semi-solid multi-phase oral composition may be exposed during manufacture, filling, transportation, or storage (e.g., 1 day, 2 days, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months, 18 months, or 24 months) prior to use by a consumer. In contrast, if the melting point, drop melting point, or solidification point of the hydrophobic phase is too high, the semi-solid multi-phase oral composition may not release an effective amount of the bleaching agent or active agent during use. The melting point or drop melting point of the suitable hydrophobic phase measured according to ASTM method D127 or the solidification point measured according to ASTM method D938 may be in the range of about 40°C to about 120°C, about 50°C to about 100°C, about 50°C to about 90°C, or about 60°C to about 80°C, or any other numerical range that is narrower and falls within such broader numerical ranges, as if such narrower numerical ranges are all explicitly written herein. In addition or alternatively, the melting point or drop melting point of the hydrophobic phase measured according to ASTM method D127 or the solidification point measured according to ASTM method D938 may be about 40°C, 50°C, 60°C, 70°C, 75°C or 80°C to about 60°C, 70°C, 80°C, 85°C, 90°C, 95°C, 100°C or 120°C, or any other numerical range that is narrower and falls within such broader numerical ranges, as if such narrower numerical ranges are all explicitly written herein.

[0095] Without being bound by theory, the cone penetration consistency value of the hydrophobic phase or semisolid multiphase oral composition can be a factor in ensuring that the semisolid multiphase oral composition has the following properties: 1) is substantive and does not flow down the teeth or out of the delivery vehicle during application or during use, 2) inhibits macroscopic separation of one or more components at temperatures (e.g., -7°C, 4°C, 23°C, 25°C, 30°C, 40°C, 50°C, or 60°C) and conditions to which the semisolid multiphase oral composition may be exposed during manufacturing, filling, shipping, or storage (e.g., 1 day, 2 days, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months, 18 months, or 24 months) prior to use by a consumer, or 3) releases an effective amount of the bleaching agent or active agent during use. Specifically, if the cone penetration consistency value of the hydrophobic phase or the semisolid multiphase oral composition is too high, the semisolid multiphase oral composition may not be substantive and flow down the teeth or out of the delivery vehicle during application or use; or the semisolid multiphase oral composition may exhibit macroscopic separation of one or more components at temperatures (e.g., -7°C, 4°C, 23°C, 25°C, 30°C, 40°C, 50°C, or 60°C) and conditions to which the semisolid multiphase oral composition may be exposed during manufacture, filling, transportation, or storage (e.g., 1 day, 2 days, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months, 18 months, or 24 months) prior to use by the consumer. In contrast, if the cone penetration consistency value of the hydrophobic phase or the semisolid multiphase oral composition is too low, the semisolid multiphase oral composition may not release an effective amount of the bleaching agent or active agent during use, or the semisolid multiphase oral composition may not be in good contact with the teeth. It is worth noting that, in general: 1) hydrophobic phases with low cone penetration consistency values ​​tend to form stick products, especially when combined with powdered ingredients containing active agents or bleaching agents that are ground or manufactured to minimize particle size, such as by micronization, 2) wax-rich hydrophobic phases tend to have low cone penetration consistency values, 3) stick products tend to have low cone penetration consistency values, 4) hydrophobic phases with low cone penetration consistency values ​​(which tend to form stick products) can also inhibit the release of bleaching agents or active agents, and 5) stick products (which tend to have low cone penetration consistency values) can also inhibit the release of bleaching agents or active agents. It is also worth noting that multi-phase oral compositions with low cone penetration consistency values ​​or multi-phase oral compositions whose hydrophobic phases have low cone penetration consistency values ​​may make it difficult or impossible to manually dispense a suitable dose of the multi-phase oral composition from a tube. Thus, the cone penetration consistency value of the hydrophobic phase or semisolid multiphase oral composition may optimally range from about 10 to about 500, from about 25 to about 300, or from about 50 to about 250, preferably from about 100 to about 200.The cone penetration consistency value of the hydrophobic phase or semisolid multiphase oral composition can be from about 10, 25, 50, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190 to about 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 300, 400 or 500, or any other numerical range that is narrower and falls within such broader numerical range as if such narrower numerical ranges were all expressly written herein and as measured according to the methods specified herein.

[0096] Without being bound by theory, macroscopic separation of one or more components at temperatures (e.g., -7°C, 4°C, 23°C, 25°C, 30°C, 40°C, 50°C, or 60°C) and conditions to which the semi-solid multi-phase oral composition may be exposed during manufacture, filling, shipping, or storage (e.g., 1 day, 2 days, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months, 18 months, or 24 months) prior to use by a consumer may impair efficacy, safety, comfort, use experience, concentration of active substances or bleaching agents at the tooth surface over time, activity or bleaching efficacy, or compatibility between ingredients. For example, compositions that exhibit macroscopic separation of hydrophilic bleach particles or a phase comprising the bleach at temperatures (e.g., -7°C, 4°C, 23°C, 25°C, 30°C, 40°C, 50°C, or 60°C) and conditions to which the semi-solid multiphase oral composition may be exposed during manufacture, filling, transportation, or storage (e.g., 1 day, 2 days, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months, 18 months, or 24 months) prior to use by a consumer may result in concentrations of bleach that vary from one dose to another and / or over time. This may compromise efficacy, comfort, or the experience of use (e.g., via oral irritation or tooth sensitivity) at certain doses; and this may vary from dose to dose and / or over time. Specifically, if, for example, a substantial portion of the bleach particles have macroscopically separated into one phase, a dose that is disproportionately enriched in that phase may result in oral irritation or tooth sensitivity when it comes into contact with oral soft tissues or teeth. In contrast, if, for example, a substantial portion of the hydrophobic phase has macroscopically separated into one phase, a dose disproportionately enriched in that phase may have reduced bleaching efficacy. Both situations are undesirable, as one leads to higher discomfort and the other to lower efficacy.

[0097] The macroscopic separation of one or more components measured according to the methods specified herein at the temperatures (e.g., -7°C, 4°C, 23°C, 25°C, 30°C, 40°C, 50°C, or 60°C) and conditions to which the semi-solid multiphase oral composition may be exposed during manufacture, filling, shipping, or storage (e.g., 1 day, 2 days, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months, 18 months, or 24 months) prior to use by a consumer can be from about 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 15%, 20%, 25%, or 50% to about 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 15%, 20%, 25%, or 50%, or any other numerical range that is narrower and falls within such broader numerical range as if such narrower numerical ranges were all expressly written herein. Additionally or alternatively, the macroscopic separation of one or more components after storage at 23°C + / - 2°C for 1 day, 2 days, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months, 18 months, or 24 months as measured according to the methods specified herein may be from about 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 15%, 20%, 25%, or 50% to about 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 15%, 20%, 25%, or 50%, or any other numerical range that is narrower and falls within such broader numerical range, as if such narrower numerical ranges are all expressly written herein. Additionally or alternatively, the macroscopic separation of one or more components measured according to the methods specified herein after storage at 23°C + / - 2°C for 1 day, 2 days, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months, 18 months or 24 months may be no greater than or less than about 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 15%, 20%, 25% or 50%.

[0098] Specifically, the macroscopic separation of one or more components measured according to the method specified herein after storage at 23°C + / -2°C for 2 days may be about 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 15%, 20%, 25% or 50% to about 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 15%, 20%, 25% or 50%, or any other numerical range that is narrower and falls within such a wider numerical range, as if such a narrower numerical range is all explicitly written herein. In addition or alternatively, the macroscopic separation of one or more components measured according to the method specified herein after storage at 23°C + / -2°C for 2 days may not be greater than or less than about 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 15%, 20%, 25% or 50%.

[0099] Method for measuring the percent macroscopic separation of one or more components of a semisolid multiphase oral composition

[0100] 1. Transfer 50 ml of the semisolid multiphase oral composition to a 50 ml polypropylene conical tube (Falcon brand catalog number REF 352098, Corning Science, Tamaulipas, Mexico). If the semisolid multiphase oral composition exhibits macroscopic separation of one or more components prior to transfer to the conical tube, mix the semisolid multiphase oral composition in a Speedmixer ("Max 300 Long Cup Translucent", product number 501 218t, available from Flacktek Inc., Landrum, SC) (e.g., at 800 RPM for 2 minutes) and transfer to the conical tube, which then exhibits macroscopic separation of one or more components. If the semisolid multiphase oral composition has macroscopic bubbles or voids: 1) tap the conical tube on a hard surface until it is free of macroscopic bubbles or voids, or 2) use a different method to transfer the semisolid multiphase oral composition to the conical tube so that it is substantially free of macroscopic bubbles or voids. Screw the cap onto the conical tube. Repeat for a total of three conical tubes.

[0101] 2. Position all three conical tubes in a vertical orientation (eg, in a test tube rack) with the conical ends at the bottom and the caps at the top.

[0102] 3. All three conical tubes are left undisturbed in a vertical position in a room or chamber where the air is maintained at the stated temperature (e.g., -7°C, 4°C, 23°C, 25°C, 30°C, 40°C, 50°C, or 60°C) for a period of time after which macroscopic separation will be measured.

[0103] 4. At the end of the period of time (e.g., 1 day, 2 days, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months, 18 months, or 24 months) after which the macroscopic separation is to be measured in the vertical position, measure the volume of macroscopically separated material on the bottom of the conical tube (with the aid of the graduations on the conical tube). If the volume of macroscopically separated material on the bottom of the conical tube is greater than 25 ml, measure the volume of macroscopically separated material at the top of the conical tube.

[0104] Calculate the average volume of macroseparated material in all three tubes.

[0105] The volume of macroseparated material is assessed for tube-to-tube variation as follows: The volume of separated material in each tube must be within + / - 2.5 ml of the mean. If the volume of separated material in any one or more of the tubes is outside the + / - 2.5 ml range of the mean: This is an indication of sample-to-sample variation potentially due to macroseparation of one or more components prior to transfer to the conical tubes, and the method needs to be repeated starting from step 1 to minimize sample-to-sample variation.

[0106] 5. Calculate the percent macroseparation as: 100 x (average volume of macroseparated material measured and calculated in step 4 divided by 50 ml).

[0107] In order to validate the above method, it is necessary to measure and demonstrate that the macroscopic separation percentage of one or more components of the validation composition specified below is between 6% and 10%.

[0108] Validation composition for a method for measuring percent macroscopic separation (weight%) <![CDATA[35% aqueous solution of H2O2 1 > 1.43 <![CDATA[Sterile filtered water 2 > 4.24 <![CDATA[Aerosol OT 3 ]]> 1.00 <![CDATA[Mineral oil 4 > 93.33

[0109] 1Ultra-cosmetic grade, from Solvay, Houston, Texas

[0110] 2 Calbiochem catalog number 4.86505.1000, obtained from EMD Millipore Corporation, Billerica, Massachusetts

[0111] 3Aerosol OT-100, available from Cytec Industries, Princeton, NJ

[0112] 4 Paraffin oil Kaydol grade, obtained from Sonneborn LLC, Petrolia, Pennsylvania

[0113] Procedure for preparing validation compositions for use in methods for measuring percent macroscopic separation

[0114] A 175 gram batch of the validation composition was prepared by the following procedure:

[0115] a) 1.75 g of Aerosol OT and 163.33 g of mineral oil were weighed into a Speedmixer container ("Max 300 Long Cup Translucent", Product No. 501 218t, available from Flacktek Inc., Landrum, SC).

[0116] b) Heat the mixture in an oven and stir to dissolve the Aerosol OT in the mineral oil. This can be done by heating in an oven at 60°C to 70°C and mixing by hand vortexing or in a Speedmixer at 800 RPM for 2 minutes and repeating until the Aerosol OT is dissolved in the mineral oil.

[0117] c) In a separate plastic container, weigh 42.4 grams of sterile filtered water and 14.3 grams of a 35% H2O2 aqueous solution and vortex together. Weigh 9.92 grams of this diluted H2O2 solution in water into the Speedmixer container.

[0118] d) The contents of the Speedmixer container were stirred in the Speedmixer at 800 RPM for 2 minutes. The walls of the container were then scraped down with a plastic spatula, and the contents were stirred again at 800 RPM for 2 minutes. The walls of the container were then scraped down with a plastic spatula, and the contents were stirred a third time at 800 RPM for 2 minutes.

[0119] Without being bound by theory, for a semi-solid multi-phase oral composition comprising peroxide, the average residual peroxide concentration of the semi-solid multi-phase oral composition applied to the teeth can be a factor in ensuring that the semi-solid multi-phase oral composition has the following properties: 1) is substantive and does not wash off during use; and 2) still releases an effective amount of bleaching agent during use. Specifically, if the average residual peroxide concentration of the semi-solid multi-phase oral composition on the tooth surface is too low, the semi-solid multi-phase oral composition may not be substantive and wash off during use, or may not release an effective amount of bleaching agent during use. The average residual peroxide concentration of the semi-solid multiphase oral composition applied to the teeth measured using the procedure specified herein can be from about 1, 2, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 125, 150, 175, 200, or 225 to about 2, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 125, 150, 175, 200, or 225, or any other numerical range that is narrower and falls within such broader numerical range as if such narrower numerical ranges were all expressly written herein. Specifically, the average residual peroxide concentration of the semi-solid multi-phase oral composition applied to the teeth measured using the procedure specified herein can be from about 1 to about 200, preferably from about 10 to about 200, more preferably from about 50 to about 200, and most preferably from about 100 to about 200, or any other numerical range that is narrower and falls within such broader numerical range, as if such narrower numerical ranges are all expressly written herein.

[0120] Method for measuring the average residual peroxide concentration of a composition applied to teeth

[0121] 1. Cut a circular disc (7.5 mm to 7.8 mm diameter x 1.2 mm to 1.3 mm thickness) from the anterior surface of a human incisor. Leave the anterior surface intact but use sandpaper to flatten the posterior surface that has been cut from the tooth. Soak the dental disc in 15 ml to 20 ml of water that meets USP specifications in a glass vial for at least 24 hours. Remove the dental disc from the water and place it on a fresh paper towel with the anterior surface facing up.

[0122] 2. Weigh 290 to 310 grams of water meeting USP specifications into a cylindrical plastic container with a screw cap of 82 mm to 107 mm diameter x 106 mm to 108 mm height ("Max 200 Long Cup Translucent", Product No. 501 220t, available from Flacktek, Landrum, SC). Preheat the water in the container with the cap screwed on in a convection oven at an air temperature of 33C to 35C for at least 12 hours.

[0123] 3. Weigh 0.04 to 0.06 grams of the composition onto the tip of a disposable lip gloss applicator ("Flocked Doe Foot Lip Gloss Applicator" made of nylon and polystyrene, available from Qosmedix Inc., Ronkonkoma, NY, catalog number 74111).

[0124] 4. Transfer the composition to the tray by first rolling the lip gloss applicator loaded with composition over the front surface of the tray and then fanning out towards the annular edge.

[0125] 5. Pick up the tooth tray with tweezers. Make sure the tweezers only touch the rounded edge of the tooth tray and not the surface of the tooth tray coated with the composition. Tilt the plastic container and gently place the tooth tray in the water on the cylindrical wall of the container, where the cylindrical wall and the flat bottom meet. Make sure the treated surface of the tooth tray is facing up away from the cylindrical wall of the container.

[0126] 6. Place the cylindrical container on a roller mixer (Model TSRT9, available from Techne from VWR, Batavia, IL, Catalog No. 89132-186; or Product No. 04750-30, available from Cole-Parmer Inc., Vernon Hills, IL). Turn on the roller mixer - this will gently rotate the container at 12 to 14 RPM. The tooth plate should continue to remain immersed in the water and the treated surface should continue to face away from the rotating cylindrical wall. This rotational motion causes the water to flow gently over the tooth plate similar to the gentle movement of saliva and other liquids over the teeth in the mouth.

[0127] 7. After 58 to 62 minutes with the roller agitator off, take a fresh peroxide test strip (supplied by EMD Millipore Corporation, Billerica, MA, supplier number: 1.16974.0001; purchased from VWR, Batavia, IL, catalog number EM1.16974.0001) and start the timer.

[0128] 8. Capture a digital image of a peroxide test strip. The equipment and system configuration for capturing a digital image of a test strip are specified herein.

[0129] 9. Use tweezers to remove the crankset from the water. As before, make sure the tweezers only touch the rounded edge of the crankset and not the surface of the crankset coated with the composition. Place the crankset between your gloved fingertips. Make sure the surface of the crankset coated with the composition is facing upwards and away from your gloved fingertips.

[0130] 10. Place the peroxide test strip on the dental tray so that one of the reaction zones contacts the surface of the dental tray with the residual composition. Hold the peroxide test strip between the thumb and index finger against the dental tray and apply firm finger pressure between the thumb and index finger for 2 to 3 seconds.

[0131] 11. Move the peroxide test strip to a clean area of ​​the paper towel. Place filter paper (Whatman Grade 1 Premium Filter Paper Standard Grade, Round, 90 mm, Supplier No. 1001-090; available from VWR, Batavia, IL, Catalog No. 28450-081) on top of the test strip. Apply finger pressure on top of the filter paper. Pull the peroxide test strip out from under the filter paper in a single formation (while maintaining finger pressure on the filter paper) so that excess gel is wiped off on the filter paper and paper towel. Make sure the reaction area does not fall off the peroxide test strip.

[0132] 12. Capturing a digital image of a peroxide test strip. The apparatus and system configuration for capturing a digital image of a test strip are specified herein.

[0133] 13. Steps 7 to 12 must be completed within 3 minutes on the timer.

[0134] 14. Repeat steps 1 to 13 for a minimum of twelve teeth.

[0135] 15. Use Adobe Photoshop CS4 with the program specified herein to measure the mean and standard deviation of the RED intensity of the strip of Munsell N8 matte color film attached to the bracket used as the built-in Munsell N8 reference within each image. The mean RED intensity of the built-in Munsell N8 reference within each image should be 204 to 212, and the standard deviation should not exceed 3.

[0136] 16. Use Adobe Photoshop CS4 with the program specified herein to measure the average of the RED intensity of the reaction zone on all peroxide test strips at baseline (before being pressed against the tooth plate).

[0137] 17. Use Adobe Photoshop CS4 with the program specified herein to measure the average of the RED intensity of the reaction zone on all peroxide test strips after pressing against the toothed disc.

[0138] 18. Calculate the average residual peroxide concentration of the composition applied on the teeth as follows: First, calculate the average baseline RED intensity of each reaction zone in step-16 minus the average RED intensity of the same reaction zone after pressing the residual composition on the dental tray in step-17. Repeat this calculation for all reaction zones pressed against the dental tray and average the results. This is the average residual peroxide concentration of the composition applied on the teeth.

[0139] Additionally or alternatively, the density of the hydrophobic phase used in the semi-solid multi-phase oral composition of the present invention is in the range of about 0.8 g / cm3 to about 1.0 g / cm3, about 0.85 g / cm3 to about 0.95 g / cm3, or about 0.9 g / cm3, or any other numerical range that is narrower and falls within such broader numerical ranges, as if such narrower numerical ranges were all expressly written herein.

[0140] In addition or alternatively, the hydrophobic phase can be a non-toxic oil, such as a non-toxic edible oil. Specifically, the hydrophobic phase can include non-toxic edible oils, saturated or unsaturated fatty alcohols, aliphatic hydrocarbons, long-chain triglycerides, fatty acid esters, and mixtures thereof. In addition or alternatively, the hydrophobic phase can also include silicone, polysiloxane, and mixtures thereof. Preferably, the hydrophobic phase can be selected from mineral oil, vaseline, and mixtures thereof, more preferably using vaseline (e.g., white vaseline) as the hydrophobic phase of the composition of the present invention. Examples of petrolatum include Snow White Pet-C from Calumet Specialty Products (Indianapolis, IN), G-2191 from Sonneborn (Parsippany, NJ), G-2218 from Sonneborn, G-1958 from Sonneborn, G-2180 from Sonneborn, Snow White V28 EP from Sonneborn, Snow White V30 from Sonneborn, G-2494 from Sonneborn, and mixtures thereof. In a preferred embodiment, the semisolid multiphase oral composition may comprise petrolatum as a continuous phase, and more preferably petrolatum is the continuous phase of the semisolid multiphase oral composition.

[0141] Aliphatic hydrocarbons can comprise approximately 10, 12, 14 or 16 to approximately 16, 18, 20, 22, 24, 26, 28, 30, 36, 40 carbon atoms, such as decane, 2-ethyldecane, tetradecane, isotetradecane, hexadecane, eicosane and their mixture. Long chain triglycerides can comprise vegetable oil, fish oil, animal fat, hydrogenated vegetable oil, partially hydrogenated vegetable oil, semi-synthetic triglyceride, synthetic triglyceride and their mixture. Also can use the fractionation of these types, refining or the oil of purification. Examples of oils containing long-chain triglycerides include almond oil; babassu oil; borage oil; black currant seed oil; canola oil; castor oil; coconut oil; corn oil; cottonseed oil; emu oil; evening primrose oil; linseed oil; grapeseed oil; peanut oil; mustard oil; olive oil; palm oil; palm kernel oil; peanut oil; rapeseed oil; safflower oil; sesame oil; cod liver oil; soybean oil; sunflower oil; hydrogenated castor oil; hydrogenated coconut oil; hydrogenated palm oil; hydrogenated soybean oil; hydrogenated vegetable oil; a mixture of hydrogenated cottonseed oil and hydrogenated castor oil; partially hydrogenated soybean oil; a mixture of partially hydrogenated soybean oil and partially hydrogenated cottonseed oil; triolein; trilinolein; trilinolein; omega-3-polyunsaturated fatty acid triglycerides containing oils; and mixtures thereof. The oil containing long-chain triglycerides can preferably be selected from corn oil, olive oil, palm oil, peanut oil, safflower oil, sesame oil, soybean oil, castor oil, linseed oil, rapeseed oil, rice bran oil, coconut oil, hydrogenated castor oil; partially hydrogenated soybean oil; triolein; trilinolein; omega 3-polyunsaturated fatty acid triglycerides containing oil; and mixtures thereof.

[0142] The saturated or unsaturated fatty alcohols may have from about 6 to about 20 carbon atoms, cetearyl alcohol, lauryl alcohol, and mixtures thereof, for example, Lipowax (cetearyl alcohol and ceteareth-20) supplied and manufactured by Lipo Chemical.

[0143] General information on silicone fluids, gums and resins, and the manufacture of silicones can be found in Encyclopedia of Polymer Science and Engineering, Vol. 15, Second Edition, pages 204-308, John Wiley & Sons Inc., 1989 and Chemistry and Technology of Silicones, Walter Noll, Academic Press Inc (Harcourt Brue Javanovich, Publishers, New York), 1968, pages 282-287 and 409-426.

[0144] The semi-solid multi-phase oral compositions as disclosed herein may comprise additional ingredients which may be optionally added and are described in further detail below.

[0145] Preferably, the semi-solid multi-phase oral composition of the present invention may not contain a dispersant. Even when a dispersant is not used, a semi-solid multi-phase oral composition that may be in the form of a semi-solid dispersion of particles may be formed. Without being bound by theory, it is believed that a low content of hydrophilic bleach particles combined with the rheological properties, flow properties, melting point, drop melting point, freezing point and / or cone penetration consistency value of the hydrophobic phase and / or the preparation method of the composition may help disperse the hydrophilic bleach particles into the hydrophobic phase and maintain their dispersion even without the use of a dispersant, especially a dispersant having double or triple covalent bonds between adjacent carbon atoms, which is exposed to temperatures (e.g., 1 day, 2 days, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months, 18 months or 24 months) during the manufacture, filling, transportation or storage period (e.g., 1 day, 2 days, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months, 18 months or 24 months) of the semi-solid multi-phase oral composition before it is used by a consumer. Such as -7 ° C, 4 ° C, 23 ° C, 25 ° C, 30 ° C, 40 ° C, 50 ° C or 60 ° C) and conditions have the following characteristics: 1) can damage the efficacy, comfort, use experience, the concentration of active substances or bleaching agents at the tooth surface over time, the activity or bleaching efficacy, or the compatibility between the ingredients, or 2) can react with other ingredients, degrade other ingredients, cause foam or pressure accumulation, reduce the affinity of the semi-solid multi-phase oral composition to the teeth, cause the semi-solid multi-phase oral composition to thicken or harden, or make it difficult or impossible to manually dispense a suitable dose of the semi-solid multi-phase oral composition from the tube, or cause one or more components of the semi-solid multi-phase oral composition to separate macroscopically. As understood herein, "substantially free of dispersants" means that the composition contains less than 0.001% by weight of dispersants. More preferably, the semi-solid whitening multi-phase oral composition of the present invention does not contain a dispersant, that is, does not contain any dispersant.

[0146] Additionally or alternatively, the semi-solid multi-phase oral composition can be substantially free of ingredients, such as water, hydrophilic liquids, glycerin, hydrophilic particles that become tacky when activated by moisture, hydroxyl groups, or combinations thereof, that are exposed to temperatures (e.g., -7°C, 4°C, 23°C, 25°C, 30°C, 40°C, 50°C, or 60°C) during manufacture, filling, shipping, or storage (e.g., 1 day, 2 days, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months, 18 months, or 24 months) before the semi-solid multi-phase oral composition can be used by a consumer. and conditions that: 1) may impair efficacy, comfort, use experience, concentration of active substances or bleaching agents at the tooth surface over time, activity or bleaching efficacy, or compatibility between ingredients, or 2) may react with other ingredients, degrade other ingredients, cause foam or pressure buildup, reduce the affinity of the semi-solid multi-phase oral composition to teeth, cause the semi-solid multi-phase oral composition to thicken or harden, or make it difficult or impossible to manually dispense an appropriate dose of the semi-solid multi-phase oral composition from a tube, or cause macroscopic separation of one or more components of the semi-solid multi-phase oral composition.

[0147] The semisolid multiphase oral composition may comprise 0% to about 0.1%, about 0.1% to about 4%, about 0.1% to about 3%, or about 0.5% to about 1.5% water, a hydrophilic liquid, glycerin, hydrophilic particles that become tacky when activated by moisture, or a combination thereof, by weight of the semisolid multiphase oral composition. In preferred embodiments, the semisolid multiphase oral composition may comprise less than about 0.001%, 0.01%, 0.1%, 0.2%, 0.5%, 1%, 2%, 3%, 4%, 5%, 10%, or 20% water, a hydrophilic liquid, glycerin, hydrophilic particles that become tacky when activated by moisture, or a combination thereof. In more preferred embodiments, the semisolid multiphase oral composition may comprise 0% water, and even more preferably the semisolid multiphase oral composition is non-aqueous, substantially free of added water, or anhydrous.

[0148] In addition, the semi-solid multi-phase oral composition can be substantially free of ingredients with strong odors, such as alcohols, solvents, ethyl acetate, heptane, or ingredients with a boiling point below 99° C. Without being bound by theory, it is believed that the reduction in surface tension produced by alcohol can reduce the retention time of hydrophilic bleach particles on the tooth surface, thereby reducing the efficacy of the oral care active substance. The presence of acid may conflict with the active substance and / or may produce adverse side effects at the tooth surface, such as allergies, etc. Therefore, the semi-solid multi-phase oral composition of the present invention is preferably free of acid, alcohol, or mixtures thereof. Specifically, the semi-solid multi-phase oral composition may contain less than 0.001% of acid and / or alcohol by weight of the composition, preferably no acid and / or alcohol. In addition or alternatively, the hydrophobic phase of the semi-solid multi-phase oral composition may be substantially free of ingredients that can react with other ingredients, such as bleach.

[0149] Additionally or alternatively, the semi-solid multi-phase oral composition can be substantially free of ingredients such as fumed silica, sodium tripolyphosphate, polyorganosiloxanes, condensation products of silicone resins and organosiloxanes, polymers of styrene, polymers of ethylene, polymers of propylene, polyvinylpyrrolidone, glycerol, tin fluoride, or combinations thereof, which ingredients may be exposed to temperatures during manufacture, filling, transportation, or storage (e.g., 1 day, 2 days, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months, 18 months, or 24 months) prior to use by a consumer. (e.g., -7°C, 4°C, 23°C, 25°C, 30°C, 40°C, 50°C or 60°C) and conditions have the following characteristics: 1) may impair the efficacy, comfort, use experience, concentration of active substances or bleaching agents at the tooth surface over time, activity or bleaching efficacy, or compatibility between ingredients, or 2) may react with other ingredients, degrade other ingredients, cause foam or pressure accumulation, reduce the affinity of the semi-solid multi-phase oral composition to the teeth, cause the semi-solid multi-phase oral composition to thicken or harden, or make it difficult or impossible to manually dispense a suitable dose of the semi-solid multi-phase oral composition from the tube.

[0150] Additionally or alternatively, the semisolid multiphase oral composition can be easily manually dispensed from the tube after being kept at -7°C, 4°C, 23°C, 25°C, 30°C, 40°C, 50°C or 60°C for 1 day, 2 days, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months, 18 months or 24 months.

[0151] Method test for determining whether a composition is easy to dispense manually from a tube

[0152] 1. Select a metal sheet laminate tube with the following dimensions:

[0153] a. Total length from the nozzle end to the bottom of the barrel: about 112mm

[0154] b. Inner diameter of cylinder: about 28mm

[0155] c. Nozzle length: about 21mm

[0156] d. Nozzle inner diameter: Half of the length of the nozzle attached to the barrel is about 9.7 mm, and the other half of the nozzle leading to the nozzle outlet is about 4.2 mm.

[0157] 2. Fill about 35 grams to about 40 grams of the composition into the tube of step 1 through the bottom of the cylinder. Seal the bottom of the cylinder using an ultrasonic sealer.

[0158] 3. The tube is left undisturbed in a room or chamber where the air is maintained at the stated temperature (e.g. -7°C, 4°C, 23°C, 25°C, 30°C, 40°C, 50°C or 60°C) for a period of time after which the ease of dispensing will be measured.

[0159] 4. Allow the tubes to equilibrate at about 23°C for at least one day.

[0160] 5. Pick up the tube between the thumb and fingers of one hand. While holding the tube in the air, squeeze the tube firmly between the thumb and fingers for about 10 seconds. Measure the length of the bead of composition dispensed from the nozzle of the tube.

[0161] 6. If at least 1 inch of product is dispensed in step 5, the composition is considered to be readily dispensed manually from the tube after being held at the specified temperature for the specified period of time.

[0162] Additionally or alternatively, the semisolid multi-phase oral composition can be substantially free of fumed silica, as it can reduce the stability of the bleaching agent.

[0163] The product information document (form number 52-1052B-01, August 9, 2016) from the supplier (Dow Corning Corporation) states that BIO-PSA standard silicone adhesives are supplied using heptane or ethyl acetate as solvents, both of which have strong odors that make them unsuitable for use in the mouth. The European Chemicals Agency (March 2016) states that cyclic siloxane D4 is persistent, bioaccumulative and toxic, and cyclic siloxane D5 is very persistent, very bioaccumulative.

[0164] Additionally or alternatively, the semi-solid multi-phase oral composition can be substantially free of ingredients such as silicone adhesives, cyclic silicones, silicones, silicone fluids, dimethicone, paraffin oils, mixtures of silicones and hydrocarbons, mixtures of liquid silicones and liquid hydrocarbons, trimethylsiloxysilicate / dimethiconol crosspolymers, or combinations thereof, which may be exposed to temperatures (e.g., -7°C, 4°C, 7°C, 8°C, 10°C, 15°C, 20°C, 25°C, 30°C, 40°C, 50°C, 80°C, 100°C, 25°C, 30°C, 50°C, 60°C, 150°C, 200°C, 300°C, 40°C, 50°C, 60°C, 100°C, 250°C, 300°C, 400°C, 500°C, 60°C, 150°C, 200°C, 300°C, 400°C, 500°C, 600°C, 100°C, 200°C, 300°C, 400°C, 500°C, ℃, 23℃, 25℃, 30℃, 40℃, 50℃ or 60℃) and conditions have the following characteristics: 1) may impair the efficacy, comfort, use experience, concentration of active substances or bleaching agents at the tooth surface over time, activity or bleaching efficacy, or compatibility between ingredients, or 2) may react with other ingredients, degrade other ingredients, cause foam or pressure accumulation, reduce the affinity of the semi-solid multi-phase oral composition to the teeth, cause the semi-solid multi-phase oral composition to thicken or harden, or make it difficult or impossible to manually dispense an appropriate dose of the semi-solid multi-phase oral composition from the tube, or cause one or more components of the semi-solid multi-phase oral composition to separate macroscopically.

[0165] Additionally or alternatively, the semi-solid multi-phase oral composition can be substantially free of ingredients, such as molecules having double or triple covalent bonds between adjacent carbon atoms, which ingredients have a molecular weight of more than 100 μg / cm2 at temperatures (e.g., -7°C, 4°C, 23°C, 25°C, 30°C, 40°C, 50°C, or 60°C) and conditions to which the semi-solid multi-phase oral composition may be exposed during manufacture, filling, transportation, or storage (e.g., 1 day, 2 days, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months, 18 months, or 24 months) prior to use by a consumer. The following properties: 1) may impair the efficacy, comfort, use experience, concentration of active substances or bleaching agents at the tooth surface over time, activity or bleaching efficacy, or compatibility between ingredients, or 2) may react with other ingredients, degrade other ingredients, cause foam or pressure buildup, reduce the affinity of the semi-solid multi-phase oral composition to the teeth, cause the semi-solid multi-phase oral composition to thicken or harden, or make it difficult or impossible to manually dispense an appropriate dose of the semi-solid multi-phase oral composition from a tube, or cause macroscopic separation of one or more components of the multi-phase oral composition.

[0166] Thickeners, viscosity modifiers or particulate fillers

[0167] The semisolid multiphase oral composition of this paper can comprise the thickener, viscosity modifier or particulate filler of safe and effective amount.Thickener can also provide the rheological characteristics of acceptable composition.Viscosity modifier can also be used to suppress the sediment and separation of component or control sediment in the mode that is conducive to redispersion, and can control the flow property of composition.In addition, thickener or viscosity modifier can be conducive to the present composition and suitable application device such as strip, film or dental tray to use together by increasing the retention on the application device surface.As described herein, thickener can also be used as adhesive.

[0168] When a thickener is present, the viscosity modifier or particulate filler may be present at a level of about 0.01% to about 99%, about 0.1% to about 50%, about 1% to about 25%, or about 1% to about 10% by weight of the semisolid multiphase oral composition.

[0169] Suitable thickeners, viscosity modifiers or particulate fillers for use herein include organically modified clays, silica, synthetic polymers such as crosslinked silicones, cellulose derivatives (e.g., methylcellulose, carboxymethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxy-propylmethylcellulose, etc.), carbomer polymers (e.g., crosslinked polyacrylic acid copolymers or homopolymers and copolymers of acrylic acid crosslinked with polyalkenyl polyethers), natural and synthetic gums, karaya gum, guar gum, gelatin, alginate, sodium alginate, tragacanth gum, chitosan, polyethylene oxide, acrylamide polymers, polyacrylic acid, polyvinyl alcohol, polyamines, polyquaternary ammonium compounds, ethylene oxide polymers, polyvinyl pyrrolidone, cationic polyacrylamide polymers, waxes (including paraffin waxes and microcrystalline waxes), polyethylene, fumed silica, polymethacrylates, olefin copolymers, hydrogenated styrene-diene copolymers, styrene polyesters, rubber, vinyl chloride, nylon, fluorocarbons, polyurethane prepolymers, polyethylene, polystyrene, alkylated polystyrene, polypropylene, cellulosic resins, acrylic resins, elastomers, poly(n-butyl vinyl ether), poly(styrene-co-maleic anhydride), poly(alkyl fumarate-co-vinyl acetate), poly(tert-butyl styrene), and mixtures thereof.

[0170] Examples of polyethylene include AC 1702 or A-C6702 made by Honeywell Corp. (Morristown, NJ), which have permeation values ​​of about 98.5 and about 90.0, respectively, according to ASTM D-1321. The Performalene series of polyethylenes available from Baker Hughes; this includes the polyethylene Performalene 400 available from Baker Hughes Inc. (Houston, TX). Examples of microcrystalline waxes include the Multiwax series available from Sonneborn (Parsippany, NJ), Crompton (Witco); these include Multiwax 835, Multiwax 440, Multiwax 180, and mixtures thereof.

[0171] Examples of polymethacrylates include, for example, polyacrylate-co-methacrylate, polymethacrylate-co-styrene, or combinations thereof. Examples of elastomers include, for example, hydrogenated styrene-co-butadiene, hydrogenated styrene-co-isoprene, ethylene-ethylene-propylene polymers, ethylene-propylene polymers, styrene-ethylene-ethylene-propylene-styrene polymers, or combinations thereof. Examples of rubbers include hydrogenated polyisoprene. Other examples of viscosity index improvers can be found in "Chemistry and Technology of Lubricants," Chapman and Hall (2nd ed., 1997).

[0172] Suitable carbomers include homopolymers of acrylic acid crosslinked with pentaerythritol alkyl ethers or sucrose alkyl ethers. Series are commercially available from BFGoodrich, such as Carbopol 934, 940, 941, 956, and mixtures thereof. Homopolymers of polyacrylic acid are described, for example, in U.S. Pat. No. 2,798,053. Other examples of useful homopolymers include Ultrez 10, ETD 2050 and 974P polymers, which are available from The BFGoodrich Company (Greenville, SC). These polymers are homopolymers of unsaturated, polymerizable carboxyl monomers such as acrylic acid, methacrylic acid, maleic acid, itaconic acid, maleic anhydride, and the like.

[0173] Additionally or alternatively, the semi-solid multiphase oral composition and / or the hydrophobic phase of the present invention may be substantially free of a structure building agent, for example an amphiphilic copolymer, such as polyvinyl pyrrolidone-vinyl acetate, polyvinyl pyrrolidone-co-polyvinyl butyrate or polyvinyl pyrrolidone-co-polyvinyl propionate copolymer, which can not only thicken the oral care composition, but also make the oral care composition homogeneous or maintain the oral care composition in a homogeneous state. This is because structure building agents such as amphiphilic copolymers 1) have at least one hydrophilic monomer, and this can make the semi-solid multiphase oral composition easier to wash off in saliva or other liquids, or 2) can make the oral care composition homogeneous, and this can reduce the concentration of active substances or bleaching agents at the tooth surface over time.

[0174] Optional Additional Oral Care Actives

[0175] The compositions of the present invention may contain a safe and effective amount of an additional oral care active, such as any material generally recognized as safe for use in the oral cavity and that provides a change in the overall appearance or health of the oral cavity. Suitable additional oral care actives include one or more anticalculus agents, fluoride ion sources, antimicrobial agents, remineralizing agents, dentin desensitizing agents, anesthetics, antifungal agents, anti-inflammatory agents, selective H-2 antagonists, anticaries, nutrients, erythritol, probiotics, prebiotics, resolvins (including Eicosapentaenoic acid (EPA) and Docosahexaenoic acid (DHA) and Docosapentaenoic acid(DPA), oleic acid, Resolvin D: RvD1 (7S, 8R, 17S-trihydroxy-DHA), RvD2 (7S, 16R, 17S-trihydroxy-DHA), RvD3 (4S, 7R, 17S-trihydroxy-DHA), RvD4 (4S, 5, 17S-trihydroxy-DHA), RvD5 (7S, 17S-dihydroxy-DHA) and RvD6 (4S, 17S-dihydroxy-DHA) and Resolvin E: RvE1 (5S, 12R, 18R-trihydroxy-EPA), 18S-Rv1 (5S, 12R, 18S-trihydroxy-EPA), RvE2 (5S, 18R-dihydroxy-EPA) and RvE3 (17R, 18R / S-dihydroxy-EPA)), tranexamic acid, glycine, retinol, amino acids such as histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, valine, alanine, asparagine, aspartic acid, glutamic acid, arginine, cysteine, glutamine, tyrosine, glycine, ornithine, proline and serine, peptides, calcium salts of amino acids and peptides, niacinamide, human growth factor, and mixtures thereof. The additional oral care actives may include actives in an amount such that when the active is applied directly, the beneficial effects sought by the user are promoted without damaging the oral surfaces to which it is applied. Examples of oral conditions addressed by these actives include, but are not limited to, changes in tooth appearance and structure, stain removal, plaque removal, tartar removal, caries prevention and treatment, gum redness and / or bleeding, mucosal damage, lesions, ulcers, aphthous ulcers, chilblain ulcers, dental abscesses, and elimination of oral malodor caused by the above and other causes (e.g., microbial growth). The additional oral care actives that can be used in the semisolid multiphase oral composition may be present in an amount of from about 0.01% to about 50%, from about 0.1% to about 20%, from about 0.5% to about 10%, or from about 1% to about 7%, or any other numerical range that is narrower and falls within such broader numerical ranges, as if such narrower numerical ranges were all expressly written herein.

[0176] For example, the additional oral care active agent may be a healing agent that promotes or enhances the healing or regeneration process. Such healing agents may include hyaluronic acid or salts, glucosamine or salts, allantoin, curcumin, D-panthenol, niacinamide, ellagic acid, flavonoids (including fisetin, quercetin, luteolin, apigenin), vitamin E, ubiquinone, or mixtures thereof.

[0177] Additionally or alternatively, the additional oral care active agent may be one or more probiotics selected from the group consisting of Lactobacillus reuteri ATCC 55730; Lactobacillus salivarius strain TI12711 (LS1); Lactobacillus paracasei ADP-1; Streptococcus salivarius K12; Bifidobacterium DN-173 010; a filtrate of a Lactobacillus paracasei strain (pro-t-action TM); oral Streptococcus KJ3, rat Streptococcus JH145S, uberis KJ2; lactobacillus reuteriprodentis; Lactobacillus salivarius LS1; Lactobacillus paracasei; Lactobacillus paracasei ADP1; Streptococcus salivarius M18, K12 or BLIS K12 and BLIS M18; Bacillus amyloliquefaciens; Bacillus clausii; Bacillus coagulans; Bacillus subtilis; Bacillus subtilis: E-300; Bifidobacterium animalis; Bifidobacterium B6; Bifidobacterium bifidum; Bifidobacterium breve (Bb-03); Bifidobacterium DN-173 010; Bifidobacterium GBI 30 6068; Bifidobacterium infantis; Bifidobacterium lactis; Bifidobacterium lactis Bb-12; Bifidobacterium longum; Bifidobacterium thermophilus; Enterococcus faecalis; Enterococcus faecium; Enterococcus faecium NCIMB 10415; Enterococcus LAB SF 68; Lactobacillus reuteri ATCC 55730 and ATCC PTA 5289; Lactobacillus reuteri ATCC 55730 and ATCC PTA 5289 (10:1); Lactobacillus acidophilus; Lactobacillus acidophilus ATCC 4356 and Bifidobacterium bifidum ATCC 29521; Lactobacillus acidophilus; Bifidobacterium longum; Bifidobacterium bifidum; Bifidobacterium lactis; Lactobacillus brevis; Lactobacillus casei (subgenus Casi); Lactobacillus casei Shirota strain; Lactobacillus fusion; Lactobacillus crispatus YIT 12319; Lactobacillus curvatum; Lactobacillus delbrueckii Bulgaricus PXN39; Lactobacillus fermentum; Lactobacillus fermentum YIT 12320; Lactobacillus gasseri; Lactobacillus gasseri YIT 12321; Lactobacillus helveticus; Lactobacillus johnsonii; Lactobacillus kimchii; Lactobacillus lactis LIA; Lactobacillus paracasei (Lpc37); Lactobacillus paracasei GMNL-33; Lactobacillus pentosus; Lactobacillus plantarum; Lactobacillus plantarum; Lactobacillus Protectus; Lactobacillus reuteri; Lactobacillus reuteri ATCC 55730; Lactobacillus reuteri SD2112 (ATCC55730); Lactobacillus rhamnosus (GG); Lactobacillus rhamnosus GG; Lactobacillus rhamnosus GG; Lactobacillus rhamnosus LC705; Propionibacterium freudenreichii; Propionibacterium shea; Lactobacillus rhamnosus L8020; Lactobacillus rhamnosus LB21; Lactobacillus salivarius; Lactobacillus salivarius WB21; Sporolactobacillus; Lactococcus diacetyllacti; Lactococcus lactis; Lactococcus lactis; Lactococcus acidilactici; Pediococcus pentosaceus; Saccharomyces boulardii; Saccharomyces cerevisiae; Streptococcus uberis KJ2sm; Streptococcus oralis KJ3sm; Streptococcus ratis JH145; Streptococcus mitis YIT 12322; Streptococcus oralis KJ3; Streptococcus ratis JH145; Streptococcus salivarius (BLIS K12 or BLIS M18); S. salivarius K12; S. thermophilus; S. uberis KJ2; Thermus thermophilus; Weissella sinusoids CMS2; Weissella sinusoids CMS3; and Weissella sinusoids CMU.

[0178] Probiotics can be used in the semi-solid multi-phase oral composition of the present invention to promote positive oral health effects, such as reducing caries and plaque, promoting gum health, improving breathing and promoting whitening. The efficacy of probiotics in semi-solid multi-phase oral compositions can be determined, for example, by measuring one or more of the following: a reduction in the content of salivary mutans Streptococcus; a reduction in gingival crevicular fluid; a reduction in periodontal pathogens (C.rectus and P.gingivitis) in subgingival plaque; a reduction in the number of yeasts; a decrease in the prevalence of oral Candida; a decrease in oral volatile sulfur compounds (VSCs); and a reduction in TNF-α and IL-8 production. It is believed that one or more of the above-mentioned positive oral health effects can be achieved by producing bacterial toxins, which can remove or reduce certain types of bacteria in the oral cavity; in addition, one or more of the above-mentioned positive oral health effects can also be achieved by bacteria producing one or more enzymes, which inhibit the production of biofilms or sticky deposits that can cause oral health problems or dissolve / loosen the biofilms or sticky deposits.

[0179] Because the semi-solid multi-phase oral composition of the present invention is directed to bleaching tooth surfaces and removing or reducing stains attached thereto, in addition or alternatively, a safe and effective amount of at least one anticalculus agent may be added to the composition as disclosed herein. The amount may be from about 0.01% to about 40%, from about 0.1% to about 25%, from about 4.5% to about 20%, or from about 5% to about 15% by weight of the semi-solid multi-phase oral composition, or any other numerical range that is narrower and falls within such a wider numerical range, as if such a narrower numerical range is all explicitly written herein. The anticalculus agent may also be compatible with other components of the semi-solid multi-phase oral composition, specifically the whitening agent. The anticalculus agent may be selected from polyphosphates and salts thereof; polyaminopropanesulfonic acid (AMPS) and salts thereof; polyolefin sulfonates and salts thereof; polyvinyl phosphates and salts thereof; polyolefin phosphates and salts thereof; diphosphonates and salts thereof; phosphonoalkane carboxylic acids and salts thereof; polyphosphonates and salts thereof; polyvinyl phosphonates and salts thereof; polyolefin phosphonates and salts thereof; polypeptides; and mixtures thereof, wherein the salt is typically an alkali metal salt. Specifically, the anticalculus agent used in the semisolid multiphase oral composition of the present invention also exhibits a stabilizing effect on bleaching agents such as pyrophosphates, polyphosphates, polyphosphonates and mixtures thereof.

[0180] For example, the anticalculus agent may be a polyphosphate. Although some cyclic polyphosphate derivatives may exist, polyphosphates are generally considered to contain two or more phosphate molecules arranged primarily in a linear configuration. A linear polyphosphate conforms to the formula (X PO3) n wherein n is from about 2 to about 125, wherein n is preferably greater than 4, and X is, for example, sodium, potassium, etc. For (X PO3)n , when n is at least 3, the nature of the polyphosphate is glassy. The counterions of these phosphates can be alkali metals, alkaline earth metals, ammonium, C2-C6 alkanolammonium and mixtures of salts. The polyphosphates commonly used are water-soluble alkali metal salts, such as potassium salts, sodium salts, ammonium salts, and mixtures thereof, which are all or partially neutralized. Inorganic polyphosphates include alkali metal (e.g., sodium) tripolyphosphates, tetrapolyphosphates, dialkyl metal (e.g., disodium) dibasic acids, trialkyl metal (e.g., trisodium) monobasic acids, potassium hydrogen phosphate, sodium hydrogen phosphate and alkali metal (e.g., sodium) hexametaphosphates, and mixtures thereof. Polyphosphates greater than tetrapolyphosphates generally appear as amorphous glassy substances, such as those manufactured by FMC Corporation, which are commercially known as Sodaphos (n≈6), Hexaphos (n≈13), Glass H (n≈21), and mixtures thereof. If present, the compositions of the present invention will generally comprise from about 0.5% to about 20%, specifically from about 4% to about 15%, more specifically from about 6% to about 12%, by weight of the composition, of polyphosphate.

[0181] Pyrophosphates used in the present composition include alkali metal pyrophosphates, di-, tri- and monopotassium or sodium pyrophosphates, dialkali metal pyrophosphates, tetraalkali metal pyrophosphates, and mixtures thereof. For example, the pyrophosphates are selected from: trisodium pyrophosphate, disodium dihydrogen pyrophosphate (Na2H2P2O7), dipotassium pyrophosphate, tetrasodium pyrophosphate (Na4P2O7), tetrapotassium pyrophosphate (K4P2O7), and mixtures thereof, wherein tetrasodium pyrophosphate is preferred. In the present composition, tetrasodium pyrophosphate may be in anhydrous salt form or decahydrate form, or any other type that is stable in solid form. The salt is in the form of solid particles, which may be in a crystalline and / or amorphous state, and the particle size of the salt is preferably small enough to be aesthetically acceptable and easily soluble in use. The content of the pyrophosphate in the composition of the present invention may be from about 1.5% to about 15%, specifically from about 2% to about 10%, and more specifically from about 3% to about 8%, by weight of the composition.

[0182] Phosphate sources include, but are not limited to, polyphosphates and pyrophosphates, which are described in more detail in Kirk and Othmer, Encyclopedia of Chemical Technology, Fourth Edition, Vol. 18, Wiley-Interscience Publishers (1996), pp. 685-707.

[0183] Polyolefin phosphonates include those in which the olefin group contains 2 or more carbon atoms. Polyvinyl phosphonates include polyvinyl phosphonic acid. Diphosphonates and their salts include azacycloalkane-2,2-diphosphonic acid and its salts, ions of azacycloalkane-2,2-diphosphonic acid and its salts (e.g., those in which the alkane portion has five, six or seven carbon atoms, wherein the nitrogen atom is unsubstituted or carries a low alkyl substituent, such as methyl), azacyclohexane-2,2-diphosphonic acid, azacyclopentane-2,2-diphosphonic acid, N-methyl-azacyclopentane-2,3-diphosphonic acid, EHDP (ethane hydroxy-1,1-diphosphonic acid), AHP (azacyclopentane-2,2-diphosphonic acid, aka 1-azacycloheptadiene-2,2-diphosphonic acid), ethane-1-amino-1,1-diphosphonate, dichloromethane-diphosphonate, and the like. The acylalkane carboxylic acid or its alkali metal salt includes PPTA (phosphonopropanetricarboxylic acid), PBTA (phosphonobutane-1,2,4-tricarboxylic acid), each in the form of an acid or an alkali metal salt.

[0184] Additionally or alternatively, antimicrobial anti-plaque agents may also be present in the compositions of the present invention. Such agents may include, but are not limited to, triclosan, Hop acids from hop extracts (such as hop alpha acids, including humulone, near-humulone, Humulone, humulone-like, metahumulone, prohumulone and combinations thereof, or hop beta acids, including lupulone, parahumulone Ketones, lupulones and combinations thereof),5-Chloro-2-(2,4-dichlorophenoxy)-phenol as described in The Merck Index 11th edition (1989) p. 1529 (Catalog No. 9573), U.S. Pat. No. 3,506,720 and European Patent Application No. 0,251,591; chlorhexidine (Merck Index No. 2090), Alexidine (Merck Index No. 222); hexetidine (Merck Index No. 4624); sanguinarine (Merck Index No. 8320); benzalkonium chloride (Merck Index No. 1066); salicylanilide (Merck Index No. 8299); domethacin (Merck Index No. 4624); sanguinarine (Merck Index No. 8320); benzalkonium chloride (Merck Index No. 1066); salicylanilide (Merck Index No. 8299); Index No. 3411); cetylpyridinium chloride (CPC) (Merck Index No. 2024); tetradecylpyridinium chloride (TPC); N-tetradecyl-4-ethylpyridinium chloride (TDEPC); decanedioctylamine; delmopinol, octylpiperidine alcohol and other piperidinyl derivatives; cocoamidopropyl betaine, sodium cocoamidoglutamate, sodium lauryl sarcosinate, GTF inhibitor, polyvinylpyrrolidone iodine delmopinol, propolis, phthalic acid and its salts, monoperphthalic acid and its salts and esters, ascorbyl stearate, oleyl sarcosine, alkyl sulfate. Additionally or alternatively, there may be present an effective antimicrobial amount of essential oils, herbal extracts, and combinations thereof, such as citral, geranial, rosemary extract, tea extract, magnolia extract, eucalyptus geraniol, carvacrol, citral, hinokitiol, catechol, methyl salicylate, epigallocatechin gallate, epigallocatechin, gallic acid, miswak extract, sea buckthorn extract, and combinations of menthol, eucalyptus, thymol, and methyl salicylate; antimicrobial metals and salts thereof; such as those providing zinc ions, stannous ions, copper ions, and / or mixtures thereof; biguanides, or phenols; antibiotics such as vogelmontin, amoxicillin, tetracycline, doxycycline, minocycline, and metronidazole; and analogs and salts of the above antimicrobial antiplaque and / or antifungal agents, such as those used to treat Candida albicans. If present, these agents are generally present in a safe and effective amount, for example from about 0.1% to about 5% by weight of the compositions of the present invention.

[0185] The composition of the present invention may contain a safe and effective amount of anticaries agents and mixtures thereof. The anticaries agents may be selected from fluoride, sodium fluoride, potassium fluoride, titanium fluoride, hydrofluoric acid, amine fluoride, sodium monofluorophosphate, ammonium fluoride, stannous fluoride, stannous chloride, stannous gluconate, cupric salts, cupric chloride, cupric glycinate, zinc chloride, zinc lactate, zinc citrate, zinc phosphate, sodium iodide, potassium iodide, calcium chloride, calcium lactate, calcium phosphate, hydroxyapatite, fluoroapatite, amorphous calcium phosphate, crystalline calcium phosphate, sodium bicarbonate, sodium carbonate, calcium carbonate, oxalic acid, dipotassium oxalate, potassium sodium oxalate, casein phosphopeptide, casein phosphopeptide coated hydroxyapatite, containing one or more of SiO2, CaO, Na2O, P2O5, CaF2, B2O3, K2O, MgO bioglass, such as those disclosed in US 5,735,942. If present, the ready-to-use compositions, when used with the compositions as disclosed herein, provide from about 50 ppm to 10,000 ppm, more preferably from about 100 ppm to 3000 ppm, of fluoride ions in the composition that contacts the tooth surface.

[0186] Cooling agents, desensitizing agents and numbing agents can be used as optional ingredients in the compositions of the present invention, for example, at a level of about 0.001% to about 10%, more specifically about 0.1% to about 1%, by weight of the composition. Cooling agents, desensitizing agents and numbing agents can reduce potential adverse sensations, such as stinging, burning, etc. Cooling agents can be any of a wide variety of materials. Included in the present invention are amides, menthols, ketals, diols, and mixtures thereof. The optional cooling agents in the compositions of the present invention can be p-menthane carbamoyl agents, such as N-ethyl-p-menthane-3-carboxamide (referred to as "WS-3"), N,2,3-trimethyl-2-isopropylbutanamide (referred to as "WS-23"), menthol, 3-1-menthoxypropane-1,2-diol (referred to as TK-10), menthone glycerol acetal (referred to as MGA), menthyl lactate (referred to as Frescolat), and mixtures thereof. As used herein, the terms menthol and menthyl include dextrorotatory and levorotatory isomers of these compounds and their racemic mixtures. Desensitizers or analgesics may include, but are not limited to, strontium chloride, potassium nitrate, natural herbs such as gallnut, asarum, cubeb, galangal, scutellaria, dandelion, angelica dahurica, etc. Suitable numbing agents include benzocaine, lidocaine, clove bud oil, and ethanol.

[0187] In addition or alternatively, an anti-inflammatory agent may be present in a semi-solid multiphase oral composition as disclosed herein. Such agents may include, but are not limited to, non-steroidal anti-inflammatory agents such as aspirin, ketorolac, flurbiprofen, ibuprofen, naproxen, indomethacin, acetaminophen, acetylsalicylic acid, steroids, ketorolac, naproxen, ketoprofen, piroxicam and meclofenamic acid, COX-2 inhibitors such as valdecoxib, celecoxib and rofecoxib, and mixtures thereof. If present, the anti-inflammatory agent is generally present in an amount of about 0.001% to about 5% by weight of the composition.

[0188] Additionally or alternatively, nutrients such as minerals can improve teeth and tooth surfaces and thus can be included in the compositions disclosed herein. Suitable minerals are, for example, calcium, phosphorus, fluorine, zinc, manganese, potassium, and mixtures thereof. These minerals are disclosed, for example, in "Drug Facts and Comparisons" (loose-leaf pharmaceutical information service), Wolters Kluer Company, St. Louis, Mo., on pages 10-17;

[0189] In addition or alternatively, the composition as disclosed herein may optionally include a safe and effective amount of flavoring agent. Suitable flavoring agents include wintergreen oil, peppermint oil, spearmint oil, clove bud oil, menthol, p-propenylanisole, methyl salicylate, eucalyptol, 1-menthyl acetate, sage, eugenol, parsley oil, hydroxyphenyl butanone, α-ionone, oregano, lemon, orange, propenyl ethyl guaiacol, cinnamon, vanillin, thymol, linalool, cinnamaldehyde glycerol acetal (referred to as CGA), and mixtures thereof. If present, the amount of flavoring agent is generally about 0.01% to about 30% by weight of the composition, specifically about 1% to about 20%, more specifically about 1.5% to about 15%.

[0190] In addition or alternatively, the compositions of the present invention may optionally contain sweeteners, including sucralose, sucrose, glucose, saccharin, dextrose, levulose, lactose, mannitol, sorbitol, fructose, maltose, xylitol, saccharin salts, afritosine, aspartame, D-tryptophan, dihydrochalcone, acesulfame and cyclamate, especially sodium cyclamate and sodium saccharin, and mixtures thereof. If present, the composition contains from about 0.1% to about 10%, specifically from about 0.1% to about 1% of these agents by weight of the composition.

[0191] In addition or alternatively, dyes, pigments, colorants and mixtures thereof may be optionally included in the compositions of the present invention to give the compositions herein a colored appearance. The advantage of adding pigments and / or colorants to the compositions herein is that it enables the user to see whether the composition covers their teeth evenly and completely, because coverage is easier to see if a colored composition is used. In addition, the colorant can provide a color similar to the color of bleached teeth. The colorants that can be used in the present invention are stable with bleaching agents and are generally recognized as safe. The content of the dyes, pigments and colorants optionally used herein is in the range of about 0.05% to about 20%, specifically about 0.10% to about 15%, and more specifically about 0.25% to about 5% by weight of the composition.

[0192] It has been surprisingly found that two or more oral care actives that are usually incompatible with each other can be mixed in the same composition of the present invention. For example, the present invention may include a combination of hydrophilic bleach particles and additional oral care actives, which can further improve the bleaching efficacy of the composition. Examples of such embodiments include a combination of hydrophilic bleach particles and additional oral care actives, which can provide a driving force to increase pH when in contact with water. Specifically, examples of such embodiments include hydrophilic bleach particles containing peroxide mixed with sodium bicarbonate (baking soda). It is worth noting that US 5,814,303 claims: "When in contact, peroxide and baking soda react with each other. Therefore, these ingredients must be kept separately until use. A distribution package has been developed that physically isolates peroxide and baking soda by separating them into different compartments." It has now been surprisingly found that peroxide and baking soda can actually be mixed in the same composition, thereby eliminating the need for different compartments. Without wishing to be bound by theory: It is hypothesized that dispersing particles of two or more hydrophilic oral care actives that are typically incompatible with one another in a hydrophobic phase can keep the particles substantially separated from one another and with the hydrophobic phase between the particles, and that this separation can minimize or eliminate incompatibility even on a microscopic scale. Further, it is hypothesized that when particles of one of the hydrophilic oral care agents come into contact with moisture, such as when used in the oral cavity, components of the particles can at least partially dissolve or swell and come into direct contact with components of the particles of the other oral care agent; however, this may occur primarily when used in the oral cavity and only minimally or not at all in the composition prior to this. Thus, in certain embodiments, the semi-solid multiphase oral compositions of the present invention can include two or more oral care actives that are typically incompatible with one another.

[0193] Bleaching effect

[0194] The bleaching efficacy of the present invention as measured according to the clinical protocol as disclosed herein and calculated as -Δb* may be at least about 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9 or 10 or narrower and any other numerical range falling within such broader numerical range, as if such narrower numerical ranges are all expressly written herein.

[0195] Specifically, the bleaching efficacy of the present invention as measured according to the clinical protocol disclosed herein and calculated as -Δb* may be at least about 0.25, preferably at least about 0.5, more preferably at least about 1.0, even more preferably at least about 1.5, even more preferably at least about 2, even more preferably at least about 2.5, even more preferably at least about 3, even more preferably at least about 3.5, and even more preferably at least about 4, or any other numerical range that is narrower and falls within such a wider numerical range, as if such a narrower numerical range is all explicitly written herein. Generally speaking, a change in yellowness of at least 0.25 as measured according to the clinical protocol disclosed herein and calculated as -Δb* is significant.

[0196] The present invention can achieve surprisingly high ratios of the bleaching efficacy of the present invention as measured according to the clinical protocol disclosed herein and calculated as -Δb* to the weight percent of bleaching agent present in the overall semi-solid multi-phase oral composition. For example, for a composition comprising 3% bleaching agent, a -Δb* of 1.5 will achieve a ratio of 0.5 of the bleaching efficacy as measured according to the clinical protocol disclosed herein and calculated as -Δb* to the weight percent of bleaching agent present in the overall semi-solid multi-phase oral composition.

[0197] Additionally or alternatively, the ratio of the bleaching efficacy of the present invention as measured according to the clinical protocol disclosed herein and calculated as -Δb* to the weight percent of bleaching agent present in the overall semi-solid multi-phase oral composition can be at least about 0.25, 0.5, 1, 1.5, 2, 2.5, 5, 10 or 15, or any other numerical range that is narrower and falls within such broader numerical ranges, as if such narrower numerical ranges were all expressly written herein.

[0198] Specifically, the ratio of the bleaching efficacy of the present invention as measured according to the clinical protocol disclosed herein and calculated as -Δb* to the weight percent of the bleaching agent present in the overall semi-solid multi-phase oral composition can be at least about 2.5, preferably at least about 5, more preferably at least about 10, even more preferably at least about 15.

[0199] Additionally or alternatively, the bleaching efficacy of the present invention as measured according to the clinical protocol disclosed herein and calculated as -Δb* can be at least about 10%, at least about 100%, at least about 1000%, or at least about 10,000% greater than the bleaching efficacy of a comparative oral care composition in the form of an aqueous solution or aqueous gel. The comparative oral care composition comprises the same bleaching agent at the same overall concentration dissolved in an aqueous solution or aqueous gel.

[0200] The present invention can achieve: 1) a surprisingly high ratio of bleaching efficacy as measured according to a clinical protocol as disclosed herein and calculated as -Δb* to the proportion of participants reporting oral irritation or being observed to have oral irritation that can or possibly be attributed to the tested composition; 2) a surprisingly high ratio of bleaching efficacy of the present invention as measured according to a clinical protocol as disclosed herein and calculated as -Δb* treated to the proportion of participants reporting tooth sensitivity that can or possibly be attributed to the composition; or 3) a surprisingly high ratio of bleaching efficacy of the present invention as measured according to a clinical protocol as disclosed herein and calculated as -Δb* to the proportion of participants reporting tooth sensitivity or reporting oral irritation or being observed to have oral irritation that can or possibly be attributed to the composition.

[0201] Additionally or alternatively, the ratio of the bleaching efficacy of the present invention as measured according to the clinical protocol as disclosed herein and calculated as -Δb* to the proportion of participants reporting tooth sensitivity that can or possibly be attributed to the present invention may be at least about 6, 7, 8, 9, 10, 15, 20, 25, 50 or 100, or any other numerical range that is narrower and falls within such broader numerical range, as if such narrower numerical ranges were all expressly written herein.

[0202] Specifically, the ratio of the bleaching efficacy of the present invention as measured according to the clinical protocol disclosed as described herein and calculated as -Δb* to the proportion of participants reporting tooth sensitivity that can or could be attributed to the present invention can be at least about 6, preferably at least about 7, more preferably at least about 8, even more preferably at least about 9, even more preferably at least about 10, even more preferably at least about 15, even more preferably at least about 20, even more preferably at least about 25, and even more preferably at least about 50, or any other numerical range that is narrower and falls within such broader numerical range, as if such narrower numerical ranges are all expressly written herein.

[0203] Additionally or alternatively, the ratio of the bleaching efficacy of the present invention as measured according to a clinical protocol as disclosed herein and calculated as -Δb* to the proportion of participants reporting oral irritation or being observed to have oral irritation that can or possibly be attributed to the present invention may be at least about 6, 7, 8, 9, 10, 15, 20, 25, 50 or 100, or any other numerical range that is narrower and falls within such broader numerical range, as if such narrower numerical ranges were all expressly written herein.

[0204] Specifically, the ratio of the bleaching efficacy of the present invention as measured according to the clinical protocol as disclosed herein and calculated as -Δb* to the proportion of participants reporting oral irritation or being observed to have oral irritation that can or possibly be attributed to the present invention may be at least about 6, preferably at least about 7, more preferably at least about 8, even more preferably at least about 9, even more preferably at least about 10, even more preferably at least about 15, even more preferably at least about 20, even more preferably at least about 25, and even more preferably at least about 50, or any other numerical range that is narrower and falls within such broader numerical range, as if such narrower numerical ranges are all expressly written herein.

[0205] Additionally or alternatively, the ratio of the bleaching efficacy of the present invention as measured according to the clinical protocol as disclosed herein and calculated as -Δb* to the proportion of participants reporting tooth sensitivity or reporting oral irritation or being observed to have oral irritation that can or possibly be attributed to the present invention may be at least about 6, 7, 8, 9, 10, 15, 20, 25, 50 or 100, or any other numerical range that is narrower and falls within such broader numerical range, as if such narrower numerical ranges were all expressly written herein.

[0206] Specifically, the ratio of the bleaching efficacy of the present invention as measured according to the clinical protocol as disclosed herein and calculated as -Δb* to the proportion of participants reporting tooth sensitivity or reporting oral irritation or being observed to have oral irritation that can or could be attributed to the present invention can be at least about 6, preferably at least about 7, more preferably at least about 8, even more preferably at least about 9, even more preferably at least about 10, even more preferably at least about 15, even more preferably at least about 20, even more preferably at least about 25, and even more preferably at least about 50, or any other numerical range that is narrower and falls within such broader numerical range, as if such narrower numerical ranges are all expressly written herein.

[0207] Clinical Program

[0208] The bleaching efficacy of the semisolid multiphase oral compositions was measured using the following clinical protocol. For each treatment group, 17 to 25 participants were recruited to complete the clinical study when the test composition had less than about 1% bleaching agent, and 8 to 25 participants were recruited to complete the clinical study when the test composition had at least about 1% bleaching agent. Enrolled participants must have four natural maxillary anterior teeth with all measurable facial sites. The average baseline L* for the participant group must be 71 to 76, and the average baseline b* for the participant group must be 13 to 18. In addition, maxillary anterior malocclusion, severe or atypical intrinsic discoloration, such as caused by tetracycline, fluorosis, or malcalcification, crowns or restorations to the facial surfaces of the maxillary anterior teeth, self-recorded history of melanoma, current smoking or tobacco use, photosensitivity or skin pigment abnormalities, self-recorded tooth sensitivity, or previous teeth whitening using professional treatments, over-the-counter kits, or investigational products were excluded from the study. Participants were provided with a home kit with Crest Cavity Protection toothpaste and an Oral-B indicator soft manual toothbrush (both from Procter & Gamble, Cincinnati, OH, USA) to use twice daily in the usual manner.

[0209] Prior to treatment with the semi-solid multiphase oral composition, the participant brushed their teeth with water for 30 seconds using a toothbrush ("Anchor 41 tuft whitening toothbrush" from Team Technologies, Inc. Morristown, TN, USA). The maxillary anterior teeth of each participant were treated with the semi-solid multiphase oral composition once daily for 60 minutes using polyethylene strips as a delivery vehicle. The polyethylene strips had a size of 66 mm x 15 mm and a thickness of 0.0178 mm. Prior to application to the maxillary anterior teeth, 0.6 g to 0.8 g of the semi-solid multiphase oral composition was applied to each polyethylene strip.

[0210] If the semisolid multiphase oral composition is used with electromagnetic radiation:

[0211] 1) applying electromagnetic radiation to the buccal surface of the maxillary anterior teeth for 10 minutes after treatment with the semi-solid multiphase oral composition on the strip for 50 minutes,

[0212] 2) directing electromagnetic radiation through the strip and through the semisolid multiphase oral composition toward the maxillary anterior teeth,

[0213] 3) the strip needs to allow at least about 90% of electromagnetic radiation between 400nm and 500nm to pass through, and

[0214] 4) Electromagnetic radiation was delivered via four fiber optic cables (Model M71L01, obtained from Thorlabs, Newton, NJ, USA) connected to four high-power LEDs with a peak intensity wavelength of 455 nm (Model M455F1, obtained from Thorlabs, Newton, NJ, USA), such as Figure 6 As shown. Each of the four LEDs is operated at 1000mA using an LED driver and hub (models DC4104 and DC4100-HUB, available from Thorlabs, Newton, NJ, USA). The exit ends of the four fiber optic cables are mounted behind a transparent interface tube to help reproducibly position the electromagnetic radiation in close proximity to the outer surface of the strip. The exit ends of the four fiber optic cables are approximately 7 mm away from the exit surface of the interface tube, through which the electromagnetic radiation passes. The articulator of the interface tube is offset so that the transparent window through which the electromagnetic radiation passes toward the maxillary anterior teeth is 7.4 mm high. In addition, the transparent window through which the electromagnetic radiation passes toward the maxillary anterior teeth is 40 mm long, measured in a straight line from end to end (excluding curves). The exit ends of the fiber optic cables are positioned and angled so that the cone of electromagnetic radiation emanating from the fiber optic cables is centered in the transparent window, through which the electromagnetic radiation passes toward the maxillary anterior teeth, as shown. Figure 6 In addition, the outlet ends of the four fiber optic cables are spaced apart so that the cones of electromagnetic radiation are spaced apart throughout the length of the transparent window through which the electromagnetic radiation passes toward the maxillary anterior teeth, as shown in FIG. Figure 6 The intensity of 400nm to 500nm electromagnetic radiation measured at the central axis of each cone of electromagnetic radiation emitted at the exit face of the transparent window through which the electromagnetic radiation passes toward the maxillary anterior teeth needs to be about 175mW / cm 2 to about 225mW / cm 2 , as measured by the methods disclosed herein.

[0215] Once the 60 minute treatment with the semisolid multiphase oral composition is complete, the strip is removed.The treatment is used once daily for a minimum of 7 days for compositions having less than about 1% bleaching agent and for a minimum of 3 days for compositions having at least about 1% bleaching agent.

[0216] Tooth color change due to treatment with the semisolid multiphase oral composition was measured using the procedure described below, the day after the 7th treatment for compositions having less than about 1% bleaching agent and the day after the 3rd treatment for compositions having at least about 1% bleaching agent.

[0217] Tooth color was measured using a digital camera (Camera Model CANON EOS 70D from Canon Inc., Melville, NY, with a NIKON 55 mm micro-NIKKOR lens with adapter) with a lens equipped with a polarizing filter. The light system was provided by a Dedo lamp (Model DLH2) equipped with a 150 Watt, 24V bulb model (Xenophot Model HLX64640), positioned approximately 30 cm apart (measured from the center of the outer circular surface of one to the other of the glass lenses through which the light exits), and aimed at a 45 degree angle so that the light paths intersected at the vertical plane of the chin rest approximately 36 cm in front of the focal plane of the camera. Each light had a polarizing filter (Lee 201 filter) and an achromatic filter (Rosco 7 mil Thermashield filter, obtained from Rosco, Stamford, CT, USA).

[0218] At the intersection of the optical paths, a fixed chin rest is mounted for repositioning in the light field. The camera is placed between the two lights so that its focal plane is approximately 36 cm from the vertical plane of the chin rest. Before starting to measure tooth color, the color standards are imaged to establish the calibration set point. First, the Munsell N8 gray standard is imaged. The white balance of the camera is adjusted so that the RGB value of gray is 200. The color standards are imaged to obtain the standard RGB values ​​of the color chip. The color standards and gray standards are listed in the fiber (obtained from Munsell Color, a division of X-rite, Grand Rapids, MI, USA). Each color standard is labeled with the Munsell nomenclature. To create a grid of color standards, they can be arranged in the following manner. This allows multiple color standards to be included in a single image of the grid that captures the color standards.

[0219] Color Standard Grid 1

[0220] 7.5R 6 8 2.5R 6 10 10YR 6.5 3 Polarization check 5R 7 8 N 3.5 0 7.5RP 6 6 10R 5 8 5YR 7 3 2.5Y 8.5 2 2.2YR 6.47 4.1 7.5YR 7 4 5YR 8 2 N 8 0 10R 7 4 N 8 0 5YR 7.5 2.5 2.5Y 8 4 5YR 7 3.5 5YR 7 2.5 5YR 5 2 5YR 7.5 2 N 6.5 0 N 9.5 0

[0221] Color Standard Grid 2

[0222] 5YR 7.5 3.5 2.5Y 6 4 10YR 7.5 3.5 2.5R 7 8 7.5R 7 8 10YR 7.5 2 10YR 7.5 2.5 N 5 0 2.5R 6 8 10YR 7 2 5R 7 4 10YR 7 2.5 N 6.5 0 7.5RP 6 8 7.5R 8 4 5Y 8 1 7.5YR 8 2 2.2YR 6.47 4.1 N 5 0 2.5Y 8 4 10YR 7 3 N 9.5 0 10RP 7 4 2.5Y 7 2

[0223] Color Standard Grid 3

[0224] 5R 6 10 N 8.5 0 10YR 6.5 3.5 10RP 6 10 N 8 0 7.5YR 7 3 2.5Y 3.5 0 10YR 7 3.5 5Y 8.5 1 5YR 8 2.5 5YR 7.5 3 5R 5 6 10YR 7.5 3 5YR 6.5 3.5 2.5YR 5 4 2.5Y 8 2 10YR 8 2 2.5Y 7 2 2.5R 6 6 5R 7 6 10YR 8 2.5 10R 5 6 N 6.5 0 7.5YR 8 3

[0225] For baseline tooth color, participants brushed their teeth with water using a toothbrush ("Anchor 41 tuft white toothbrush" from Team Technologies, Inc. Morristown, TN, USA) to remove debris from the teeth. Each participant then used a cheek retractor (from Scientific Camera Company, Sumner, WA, USA; treated with a frosted matte surface at A&B Deburring Company, Cincinnati, OH, USA) to pull their cheeks back and illuminate the facial surfaces of their teeth. Each participant was instructed to bite their teeth together so that the incisor edges of the maxillary incisors contacted the incisor edges of the mandibular incisors. The participant was then positioned on the chin rest at the intersection of the optical paths in the center of the camera's field of view, and the dental images were captured. After imaging all participants, the images were processed using image analysis software (Optimas manufactured by Media Cybernetics of Silver Spring, MD). The middle four incisors were separated and the average RGB values ​​of the teeth were extracted.

[0226] After the participant used the whitening product, but before capturing the participant's teeth image, the system was set to the baseline configuration and calibrated as previously discussed. After calibration, each participant was imaged a second time using the same procedure as before, ensuring that the participant was in the same physical position as the pre-processed image, including the orientation of the teeth. The image was processed using image analysis software to obtain the average RGB value of the middle four maxillary incisors. The RGB values ​​of all images were then mapped to the CIE L*'a*b* color space using the RGB values ​​and the L*a*b* values ​​of the color chips on the color standard. Using the same lighting conditions described for capturing digital images of facial dentition, the L*a*b* values ​​of the color chips on the color standard were measured using the Photo Research SpectraScan PR650 from Photo Research Inc., LA. The PR650 was positioned at the same distance from the color standard as the camera. According to the manufacturer's instructions, after calibration, the L*a*b* of each chip was measured separately. Then the RGB values ​​were converted into L*a*b* values ​​using a regression equation, such as:

[0227] L*=25.16+12.02*(R / 100)+11.75*(G / 100)–2.75*(B / 100)+1.95*(G / 100) 3

[0228] a*=-2.65+59.22*(R / 100)-50.52*(G / 100)+0.20*(B / 100)–29.87*(R / 100) 2+20.73*(G / 100) 2 +8.14*(R / 100) 3 -9.17(G / 100) 3 +3.64*[(B / 100) 2 *[R / 100]

[0229] b* = -0.70 + 37.04*(R / 100) + 12.65*(G / 100) - 53.81*(B / 100) - 18.14*(R / 100) 2 +23.16*(G / 100)*(B / 100) + 4.70*(R / 100) 3 –6.45*(B / 100) 3

[0230] R of L*, a*, and b* 2 should be > 0.95. Each study should have its own formula.

[0231] These formulas are generally valid conversions in the area of tooth color (60 < L* < 95, 0 < a* < 14, 6 < b* < 25). Then, the data from the set of images from each participant are used to calculate the product whitening performance based on the changes in L*, a*, and b* - the standard method for evaluating the beneficial whitening effect. When evaluating compositions with less than about 1% bleaching agent: The change in L* is defined as ΔL* = L* 7次处理后那天 - L* 基线 , where a positive change indicates an improvement in brightness; the change in a* (red - green balance) is defined as Δa* = a* 7次处理后那天 - a* 基线 , where a negative change indicates teeth with less red; the change in b* (yellow - blue balance) is defined as Δb* = b* 7次处理后那天 - b* 基线 , where a negative change indicates that the teeth become less yellow. When evaluating compositions with at least about 1% bleaching agent: The change in L* is defined as ΔL* = L* 3次处理后 - L* 基线 , where a positive change indicates an improvement in brightness; the change in a* (red - green balance) is defined as Δa* = a* 3次处理后 - a* 基线 , where a negative change indicates teeth with less red; the change in b* (yellow - blue balance) is defined as Δb* = b* 3次处理后 - b* 基线 , where a negative change indicates that the teeth become less yellow. -Δb* is used as the main measure of bleaching efficacy. The overall color change is given by the formula = ΔE(ΔL* 2 + Δa* 2 + Δb* 2 )1 / 2 to calculate.

[0232] After using the whitening product, the color change in the CIE Lab color space was calculated for each participant based on the given formula.

[0233] To validate the above clinical protocol, the bleaching efficacy (calculated as -Δb*) of the validation composition specified below (delivered on a strip and used with electromagnetic radiation as disclosed herein) needs to be measured the day after the 7th treatment and confirmed to be >0.5.

[0234] Validated compositions for clinical protocols (weight%) <![CDATA[35% aqueous solution of H2O2 1 > 0.2857 <![CDATA[Vaseline 2 > 99.7143 total 100.00 <![CDATA[H2O2% in the total oral composition]]> 0.099995 ratio* 350.02

[0235] *Ratio of the weight percent concentration of H2O2 present in the aqueous phase to the weight percent concentration of H2O2 present in the overall composition

[0236] 1Ultra-cosmetic grade, obtained from Solvay, Houston, Texas

[0237] Grade 2G-2191, available from Sonneborn, LLC., Parsippany, NJ

[0238] Procedure for preparing validation compositions for clinical protocols

[0239] A 500 gram batch of the validation composition was prepared by weighing an aqueous solution of hydrogen peroxide (H2O2) and petrolatum into a Speedmixer container ("Max300 Long Cup Translucent", Product No. 501 218t, available from Flacktek Inc., Landrum, SC) and stirring in the Speedmixer at 800 RPM for 5 seconds, 1200 RPM for 5 seconds, and 1950 RPM for 2 minutes. The walls of the container were then scraped down with a plastic spatula, and the contents were stirred again at 800 RPM for 5 seconds, 1200 RPM for 5 seconds, and 1950 RPM for 2 minutes. The walls of the container were then scraped down with a plastic spatula, and the contents were stirred a third time at 800 RPM for 5 seconds, 1200 RPM for 5 seconds, and 1950 RPM for 2 minutes.

[0240] Optional application system

[0241] In addition, the present invention may also be directed to a delivery system for delivering the composition of the present invention to the tooth surface. For example, the composition of the present invention can be applied directly to the teeth without using a delivery carrier system to deliver whitening benefits to the oral cavity. In addition, the present invention may include a delivery system, which includes a combination of the composition of the present invention and a delivery carrier. For example, the delivery system may include a first layer of a carrier material and a second layer comprising a semi-solid multiphase oral composition as described herein, whereby the bleaching agent is releasably located in the composition of the present invention. A suitable first layer may include a delivery carrier, which includes a material strip, a dental tray, a sponge material, and a mixture thereof. Specifically, the delivery carrier may be a material strip, such as a permanently deformable strip. Suitable material strips or permanently deformable strips are disclosed, for example, in U.S. Patents; 6,136,297, 6,096,328, 5,894,017, 5,891,453 and 5,879,691; and in U.S. Patents 5,989,569 and 6,045,811; and patent application US2014 / 0178443A1.

[0242] The delivery vehicle can be attached to the teeth via an attachment device that is part of the delivery vehicle, for example, the delivery vehicle can be of sufficient size so that upon application, the delivery vehicle and the oral soft tissue overlap, so that more tooth surface can be bleached. The delivery vehicle can also be attached to the oral cavity by physical interference or mechanical interlocking between the delivery vehicle and the oral surface including the teeth.

[0243] The delivery vehicle can be transparent or translucent to electromagnetic radiation having a wavelength of about 200 nm to about 1700 nm. For example, the delivery vehicle allows about 10%, 20%, or 30% to about 40%, 50%, 60%, 70%, 80%, 90%, or 100% of electromagnetic radiation having a wavelength of about 400 nm to about 500 nm to pass through to reach the tooth surface.

[0244] When the delivery carrier is a strip of material, the second layer of composition can be applied to the strip, or applied to the strip by the user, or applied to the teeth by the user, and then the strip is placed over the coated teeth. The amount of composition applied to the strip or teeth may depend on the size and capacity of the strip, the concentration of the active substance, and the desired beneficial effect; for example, about 0.0001 grams, 0.001 grams or 0.01 grams to about 0.01 grams, 0.1 grams, 1 grams or 5 grams, or a composition that is narrower and falls within any other numerical range within such a wider numerical range, as such narrower numerical ranges are all explicitly written herein, specifically, about 0.001g to about 0.5g or about 0.1g to about 0.4g of a semi-solid multiphase oral composition can be used. In addition, about 0.0001, 0.001 or 0.01 grams to about 0.01, 0.1, 0.5 or 1 grams of composition / square centimeter of material (g / cm2 ), or any other numerical range that is narrower and falls within such broader numerical range, as if such narrower numerical ranges are all expressly written herein; in a preferred embodiment, less than about 0.2 g / cm 2 , about 0.0001g / cm 2 To about 0.1g / cm 2 , or about 0.01g / cm 2 To about 0.04g / cm 2 Additionally or alternatively, from about 1 microgram to about 5000 micrograms of bleach per square centimeter of material (μg / cm2), preferably from about 10 μg / cm2 to about 500 μg / cm2, and more preferably from about 50 μg / cm2 to about 100 μg / cm2 of bleach per square centimeter of material may be used.

[0245] Referring now to the drawings, and more particularly to Figure 1 , shows an embodiment of a suitable delivery system 10, representing a delivery system for delivering a bleaching active provided by a semi-solid multi-phase oral composition as disclosed herein to teeth and the oral cavity. The delivery system 10 includes a material in the form of a strip 12 of material, which is substantially flat and may have rounded corners. On the strip 12, a second layer 14 is releasably applied, the second layer comprising the semi-solid multi-phase oral composition of the present invention. The second layer 14 can be uniform and can be evenly applied to the strip 12, as Figure 2 In addition, the second layer 14 comprising the composition of the present invention can be a coating only along the longitudinal axis of a portion of the material strip 12, or can be applied in stripes, dots and / or other patterns. However, alternatively, the second layer 14 can be a laminate or separate layers of components, an amorphous mixture of components, separate strips or dots or other graphics of different components, or a combination of these structures, which includes a coating of the second layer 14 along the longitudinal axis of a portion of the material strip 12.

[0246] In addition or alternatively, the second layer 14 may contain an active substance, or it is an active substance, such as a composition, compound or mixture that can affect the appearance or structure of the surface in contact with it or can achieve a desired change in the appearance or structure of the surface in contact with it. As previously discussed, exemplary active substances include: hydrogen peroxide, urea peroxide, sodium fluoride, sodium monofluorophosphate, pyrophosphates, chlorhexidine, polyphosphates, triclosan and enzymes. Examples of changes in appearance and structure include, but are not limited to, whitening, stain bleaching, stain removal, remineralization to form fluorapatite, plaque removal and tartar removal.

[0247] In addition, the second layer 14 composition can include an adhesive component to stably attach the delivery system 10 to the tooth surface. The compositions disclosed herein can provide the desired tack and adhesive properties by themselves, for example, by selecting a hydrophobic phase that provides adhesive properties by adding an adhesive material to the composition of the present invention, or both. If added, the adhesive can provide additional properties, such as thickening / rheology modification properties.

[0248] Figure 3 and 4 The delivery system 10 of the present invention is shown applied to the tooth surface of a plurality of adjacent teeth. A plurality of adjacent teeth 22 are embedded in adjacent soft tissue 20. Adjacent soft tissue 20 is defined herein as the soft tissue surface surrounding the tooth structure, including: the gingival papilla, marginal gingiva, gingival sulcus, interdental gingiva, and the muco-gingival junction (including the junction) from the gingival structure on the lingual and buccal surfaces up to the palate.

[0249] exist Figure 3 and Figure 4 , the delivery system 10 represents a strip 12 and a second layer 14, which includes a composition of the present invention, wherein the second layer 14 is located on the side of the material strip 12 facing the teeth 22. The composition of the second layer 14 can be pre-applied to the material strip 12, or can be applied to the material strip 12 by the user before being applied to the teeth. Alternatively, the composition of the second layer 14 can be applied directly to the teeth 22 by the user and then covered by the strip 12. In any case, the material strip 12 can have a thickness and bending stiffness so that it can conform to the surface contours of the teeth 22 and adjacent soft tissues 20. Therefore, the material strip 12 can have sufficient flexibility to be formed into the contours of the oral surface, which is a plurality of adjacent teeth 22. When the delivery system 10 is applied, the strip 12 can also easily conform to the tooth surface and the interdental space without permanent deformation. The delivery system 10 can be applied without significant pressure.

[0250] The first layer 12 of the delivery system 10 can be composed of a strip of material. Such first layer materials are described in more detail in U.S. Patents; 6,136,297, 6,096,328, 5,894,017, 5,891,453, and 5,879,691; and U.S. Patents 5,989,569 and 6,045,811; and patent application US 2014 / 0178443 A1. The strip 12 acts as a protective barrier to the bleaching agent in the second layer 14. It prevents the second layer 14 from being leached or corroded, for example, by the tongue, lips, and saliva of the user. This allows the active agent in the second layer 14 to act on the tooth surfaces 22 of the oral cavity and last for a desired period of time, such as a few minutes to a few hours.

[0251] The following description of the material strip is applicable to the Figures 1 to 4The delivery system 10 of the strip layer 12 or any form of strip is shown. The material strip may include polymers, natural and synthetic woven materials, non-woven materials, foils, paper, rubber, and combinations thereof. The material strip may be a single layer of material or a laminate of more than one layer of material. Regardless of the number of layers, the material strip may be substantially water-insoluble. The material strip may also be water-impermeable. Suitable strip materials may be any type of polymer or combination of polymers that meets the required bending stiffness coefficient and is compatible with the oral care substance. Suitable polymers include, but are not limited to, polyethylene, ethyl vinyl acetate, polyesters, ethyl vinyl alcohol, and combinations thereof. Examples of polyesters include and fluoroplastics such as All are produced by DuPont. Specifically, the material used as the material strip is polyethylene. The material strip can be less than about 1 mm (millimeter) thick, less than about 0.05 mm thick, or about 0.001 to about 0.03 mm thick. The polyethylene material strip can be less than about 0.1 mm thick, or about 0.005 to about 0.02 mm thick.

[0252] In addition or alternatively, the present invention may include a soluble film that can adhere to the oral cavity to release active substances, the soluble film comprising a water-soluble polymer, one or more polyols and one or more active substances. In addition to one or more active substances, the soluble film may also include a combination of certain plasticizers or surfactants, coloring agents, sweeteners, flavoring agents, flavor enhancers or other excipients commonly used to change the taste of the preparation intended to be applied to the oral cavity. The resulting soluble film is characterized by instant wettability, which makes the soluble film soften very quickly after being applied to the mucosal tissue, thereby preventing the user from experiencing any long-term unpleasant sensations in the oral cavity, and having a tensile strength suitable for normal coating, cutting, slitting and packaging operations.

[0253] The dissolvable film may include a water-soluble polymer or a combination of water-soluble polymers, one or more plasticizers or surfactants, one or more polyols, and an active substance.

[0254] The polymer used for soluble film comprises hydrophilic and / or water dispersible polymer.The example of spendable polymer comprises polymer, and it is water-soluble cellulose derivative, such as hydroxypropyl methylcellulose, hydroxyethyl cellulose or hydroxypropyl cellulose, and it is single or their mixture.Other optional polymers comprise polyvinyl pyrrolidone, carboxymethyl cellulose, polyvinyl alcohol, sodium alginate, polyethylene glycol, natural gum such as xanthan gum, tragacanth gum, guar gum, acacia gum, gum arabic, water dispersible polyacrylate such as polyacrylic acid, methyl methacrylate copolymer, carboxyvinyl copolymer.The concentration of water-soluble polymer in finished film can be between 20% and 75% (weight / weight), or change between 50% and 75% (weight / weight).

[0255] The surfactant that can be used for soluble film can be one or more nonionic surfactants. When a combination of surfactants is used, the first component can be a polyoxyethylene sorbitan fatty acid ester or an α-hydrogen-ω-hydroxy poly(oxyethylene) poly(oxypropylene) poly(oxyethylene) block copolymer, and the second component can be a polyoxyethylene alkyl ether or a polyoxyethylene castor oil derivative. If present, the HLB value of the polyoxyethylene sorbitan fatty acid ester should be between 10 and 20, and thus a range of 13 to 17 can also be used. The α-hydrogen-ω-hydroxy poly(oxyethylene) poly(oxypropylene) poly(oxyethylene) block copolymer can contain at least about 35 oxypropylene units, and preferably not less than about 50 oxypropylene units.

[0256] The polyoxyethylene alkyl ether may have an HLB value between 10 and 20, and preferably, an HLB value of not less than 15 may be used. The polyoxyethylene castor oil derivative may have an HLB value of 14-16.

[0257] To achieve the desired instant wettability, the ratio between the first component and the second component of the binary surfactant mixture may be maintained within 1:10 and 1:1, or between 1:5 and 1:3.

[0258] The total concentration of surfactant in the soluble film depends on the nature of the other ingredients but may typically be between 0.1% and 5% (w / w).

[0259] Polyols can be used to achieve the desired level of softness of the soluble film. Examples of polyols include glycerol, polyethylene glycol, propylene glycol, monoglycerides with fatty acids or other pharmaceutically used polyols. The concentration of the polyol in the dry film is typically in the range of 0.1% to 5% (weight / weight).

[0260] The shape of the material strip can be any shape or size that covers the desired oral surface. For example, the material strip can have rounded corners to avoid irritating the soft tissue in the oral cavity. As used herein, "rounded corners" refers to generally without any sharp corners or points, such as one or more angles of 135° or less. The length of the material strip can be from about 2 cm (centimeter) to about 12 cm, or from about 4 cm to about 9 cm. The width of the material strip can also depend on the oral surface area to be covered. The width of the material strip can be from about 0.5 cm to about 4 cm, or from about 1 cm to about 2 cm. The material strip can be worn as a patch on one or more teeth to treat localized conditions.

[0261] The material strip may include dimples. When the semi-solid multi-phase oral composition is applied to the material strip, the bleaching agent and / or oral care active material fills the dimples to provide a reservoir for additional bleaching agent and / or oral care active material. In addition, the dimples also help provide texture to the delivery system. The material strip may have a series of dimples. The dimples are generally about 0.4 mm wide and about 0.1 mm deep. When the dimples are included in the material strip and the semi-solid multi-phase oral composition of the present invention is applied thereto with different thicknesses, the overall thickness of the delivery system is specifically less than about 1 mm, and more specifically the overall thickness is less than about 0.5 mm.

[0262] Bending stiffness is the property of the material, which is a comprehensive function of the thickness, width and elastic modulus of the material strip. The test described below is a method for measuring the stiffness of films, such as polyolefin films and polyolefin sheets. The method measures the bending resistance of the sample by using a strain gauge fixed at the end of a horizontal beam. The other end of the beam is pressed horizontally on the sample strip, forcing a part of the strip to enter the vertical groove on the horizontal platform (for placing the sample). The microammeter calibrated with the deflection force is connected to the strain gauge with a wire. The rigidity coefficient of the sample can be read directly from the microammeter, which is expressed as grams / cm sample strip width. The material strip suitable for use as a delivery carrier of the composition disclosed herein can show a bending stiffness less than about 5g / cm measured on a feel tester (model 211-300, purchased from Thawing-Albert Instrument Company, Philadelphia, PA) according to the test method ASTM D2923-95. The strip may have a bending stiffness of less than about 3 g / cm, less than about 2 g / cm, or a bending stiffness of about 0.1 g / cm to about 1 g / cm. In general, the bending stiffness of the material strip can be substantially constant and does not change during normal use. For example, the material strip does not need to be combined with water to achieve a low bending stiffness within the above range. This relatively low hardness allows the material strip to cover the contour of the oral surface with a little force. This means that the consistency of the material strip with the contour of the user's oral surface can be maintained because the residual stress in the material strip is very small, which causes the material strip to return to its shape before use, such as a substantially flat shape. For example, the flexibility of the material strip allows it to be in contact with soft tissue for a long time without irritating the soft tissue; so that the material strip does not require pressure to remain close to the oral surface.

[0263] As used herein, delivery system can include adhesive parts so that they can adhere to oral surfaces, especially teeth. This adhesive part can be provided by the present composition of this paper, or described adhesive part can provide independently of the composition of this paper (for example described adhesive part is the separation phase with this composition, wherein described composition can also have adhesive parts). For example, material strip is maintained in the proper position on oral surfaces by the adhesion provided by the composition of the present invention. Semi-solid multiphase oral compositions can cause strip to adhere to oral surfaces to the viscosity of dry surface and general viscosity, and can not significantly slide because of the friction force produced by lips, teeth, tongue and other oral surfaces friction material strips when speaking, drinking etc. However, this adhesion to oral surfaces can be low enough to allow the wearer to easily remove material strips by simply peeling off material strips using his fingers. Described delivery system can be easily removed from oral surfaces, without the need to utilize instrument, chemical solvent or reagent or excessive friction.

[0264] In addition, the material strip can be maintained in the proper position on the oral surface by the adhesive components and adhesion that the delivery carrier itself provides.For example, the material strip can extend, adhere and adhere to the oral soft tissue.In addition, adhesive can be applied to the part of the material strip that the delivery system is attached to the oral soft tissue.The delivery carrier can also be attached to the oral cavity by physical interference or mechanical interlocking between the delivery carrier and the oral surface including the tooth.In addition, the material strip can be maintained in the proper position by the adhesive components that are independent of the present composition of this paper, as disclosed in WO 03 / 015656.

[0265] Suitable adhesive components are known to the technician. When adhesive components (if present) are provided by adhesive, the adhesive can be any adhesive that can be used for adhering material to the surface of tooth surface or oral cavity surface. Suitable adhesive includes but is not limited to skin, gums and mucosal adhesives, and should be able to resist moisture, chemical substances and enzymes in the oral cavity environment for a long enough time, so that oral care active substances and / or bleaching agents are effective, but then soluble and / or biodegradable. For example, suitable adhesive can include water-soluble polymers, hydrophobic and / or non-water-soluble polymers, pressure and moisture-sensitive adhesives, such as contacting the oral cavity environment, for example, the dry adhesive that becomes sticky in the oral cavity, the influence of moisture, chemical substances or enzymes etc. Suitable adhesive includes natural gums, synthetic resins, natural or synthetic rubbers, those gums and polymers listed as "thickening agents" above and various other viscous materials of this type used in known adhesive tapes, which are known from US2,835,628.

[0266] A delivery vehicle, such as a strip, as e.g. Figures 1 to 4As shown, it can be formed by several film-making methods known in the art. For example, the polyethylene strip is made by a method of blowing or casting. Other methods are also feasible, including extrusion or methods that do not affect the flexural rigidity of the material strip. In addition, the present composition of the second layer formed to the strip can be attached to the strip during the strip processing and / or the present composition can be a laminated layer on the strip. The second layer of the strip attached to this type of delivery system as disclosed above comprises a safe and effective amount of the composition as described herein.

[0267] In addition, the delivery system may include an optional release liner. Such release liner may be formed by any of the following materials, and the affinity shown by the material with the second layer of the composition is less than the affinity shown by the second layer of the composition with itself and with the first layer of the material strip. Release liner includes a rigid sheet material, such as polyethylene, paper, polyester or other materials, and the material is coated with a non-stick material. Release liner may be cut into a size and shape substantially identical to the material strip, or release liner may be cut into a larger size than the material strip, thereby facilitating the user to separate the liner material from the material strip. Release liner is made of fragile material so that it can split when the strip is bent, or it is made of multi-piece material or of a scored material. Alternatively, release liner may be in the form of two folded in half, such as a typical adhesive bandage design. The description of the material suitable for use as a release agent is found in Kirk-Othmer, Encyclopedia of Chemical Technology, 4th edition, volume 21, in page 207-218.

[0268] For example, the delivery vehicle can be a permanently deformable strip of material having a yield point and thickness such that the strip of material substantially conforms to the shape of the teeth via permanent deformation at a pressure of less than about 250,000 Pascals, as it has been found that the wearer will press the strip against each tooth using one fingertip having a surface area of ​​about one square centimeter. They typically apply force at each tooth for one second or less with a typical applied pressure in the range of about 100,000 Pascals to about 250,000 Pascals.

[0269] Specifically, the strip of material has viscoelastic properties which enable it to creep and bend so as to conform around a number of teeth and an arcuate portion of the wearer's mouth. It is important that the necessary permanent deformation occurs under a minimum normal force applied by the wearer.

[0270] The semi-solid multi-phase oral composition can also be applied to the tooth surface and can be covered with the deformable strip before or after the deformable strip is formed. In addition or alternatively, the semi-solid multi-phase oral composition can be applied to the deformable strip as a pre-coat and can be applied to the tooth surface together with the strip before or after the deformable strip is formed, wherein the strip is applied so that when the delivery system is placed on the tooth surface, the semi-solid multi-phase oral composition contacts the tooth surface, thereby providing active substances on the tooth surface. In addition or alternatively, the deformable material strip can be applied to the tooth with a force sufficient to shape the delivery vehicle so that it is at least partially adapted to the shape of the tooth, and then the shaped material strip can be removed from the tooth surface, the oral care composition can be applied to the shaped material strip, and the shaped material strip can be reapplied to the tooth surface so that it is at least partially applied to the shape of the tooth and contacts the oral care composition close to the tooth surface. If the deformable strip is applied to the tooth surface together with the semi-solid multi-phase oral composition, the semi-solid multi-phase oral composition may also include a binder to hold the delivery system in place and for a sufficient time to allow the active substance of the semi-solid multi-phase oral composition to act on the surface. If used with the deformable strip, the semi-solid multi-phase oral composition may have an extrusion resistance sufficient to withstand the normal force applied to shape the deformable material strip, so that during manual shaping of the deformable material strip, the substance is not substantially extruded from between the deformable material strip and the surface. By "substantially extruded from..." is meant that at least 50% or more of the semi-solid multi-phase oral composition is extruded from between the deformable material strip and the tooth and adjacent soft tissue surface.

[0271] The strip of deformable material may be made of a permanently deformable material, such as wax, putty, tin, or foil, in a single layer or a combination of layers or materials, such as a laminate. Specifically, the deformable strip may be a wax, such as #165 flake wax, formulated and manufactured by Freeman Mfg. & Supply Co. of Cleveland, Ohio. This particular wax readily conforms to the shape of the teeth under a pressure of about 133,000 Pascals, which is the pressure generated when a wearer applies a normal force of about 3 pounds (1.36 kg) over an area of ​​about 1 square centimeter. The strip of deformable material may have a nominal film thickness of about 0.8 mm, wherein the deformable strip may be substantially flat and rectangular in shape with rounded corners. The strip of deformable material may have a length sufficient to cover a plurality of adjacent teeth while conforming to the curves of the wearer's mouth and spaces between adjacent teeth. If the deformable material strip comprises a semi-solid multi-phase oral composition applied thereto, the semi-solid multi-phase oral composition may have an overall thickness of less than about 1.5 mm. The deformable strips as disclosed herein may also be used as Figures 1 to 4 The material of the material strip 12 shown. Therefore, as described above, for example Figures 1 to 4The general features of the material strips described also may be applicable to deformable material strips. In addition, release liner and / or dimples may also be combined with deformable material strips.

[0272] The compositions of the present invention may be used in combination with a delivery vehicle including a dental tray and / or a foam material. Dental trays are well known in the art of whitening and an exemplary dental tray 30 is shown in FIG. Figure 5 The general process for preparing the dental tray 30 is known in the art. Dentists traditionally use three dental appliances to bleach teeth.

[0273] The first category is a rigid appliance that precisely fits the dental arch of the user. For example, an alginate impression is made, which records all tooth surfaces and the gingival margin area, from which a cast can be quickly made. If a reservoir is required, it is prepared by making a layer of rigid material on the cast on the specific tooth surface to be treated. The dental tray can then be vacuum formed from the modified mold using conventional techniques. Once formed, the dental tray is preferably trimmed to remove the gingival margin on the buccal and lingual surfaces. Sufficient dental tray material should be left to ensure that all teeth are covered to about the gingival margin on the finished and beveled dental tray perimeter. 1 / 4 to approx. 1 / 3mm. The dental tray is fanned along the interdental papillae so that the finished dental tray does not cover them. All the edges of the dental tray are preferably smooth in shape so that the lips and tongue cannot feel the edge protrusion. The resulting dental tray provides a perfect fit to the user's teeth, and the dental tray optionally has a reservoir or a space for a rigid material to be placed on the mold. The dental tray can be made of a soft, transparent vinyl material with a thickness of about 0.1cm to about 0.15cm. The soft material makes it more comfortable for the patient to wear. A material with a higher hardness (or a thicker plastic material) can also be used to make the dental tray.

[0274] The second type of rigid custom dental appliance is an "oversized" rigid custom dental appliance. The manufacture of a rigid custom dental appliance requires making a cast of an impression of the user's dental arch, and heating and vacuum forming a thermoplastic sheet to conform to the cast of the user's dental arch. Thermoplastic films are sold as rigid or semi-rigid sheets and are available in a variety of sizes and thicknesses. The dental laboratory manufacturing technique for oversized rigid dental appliances involves augmenting the tooth surface over the cast with materials such as die spacer materials or cured acrylic resins (cured / micro-cured). The thermoplastic sheet is then heated and then vacuum formed around the augmented cast of the dental arch. The net effect of this method results in an "oversized" rigid custom dental appliance.

[0275] The third, less commonly used, category of rigid custom dental devices is a rigid bi-layer custom dental device fabricated from layered materials ranging from soft porous foams to rigid non-porous films. These bi-laminated dental devices have a non-porous, rigid thermoplastic outer shell that encases and supports an inner layer of soft porous foam.

[0276] The fourth type of dental tray replaces the rigid custom dental device with a disposable U-shaped soft foam dental tray that can be individually packaged and saturated with a pre-measured amount of the composition of the present invention. The soft foam material is generally an open-cell plastic material. This type of device is sold by Cadco Dental Products located in Oxnard, Calif. under the trade name VitalWhite TM Commercially available. TM These soft foam dental trays may include a backing material (e.g., a closed-cell plastic backing material) to minimize the outflow of bleach from the device into the oral cavity, thereby minimizing the patient's intake and / or stimulation of the oral tissue. Alternatively, the soft foam dental tray is encapsulated by a non-porous flexible polymer, or the open-cell foam is attached to the front inner wall of the dental device and / or the open-cell foam is attached to the rear inner wall of the dental device. Those of ordinary skill in the art will readily recognize and appreciate that the present composition must be viscous enough not to easily flow out of the open-cell structure of the foam, and must be thin enough to slowly flow through the open-cell foam for a long time. In other words, the open-cell foam material has an internal structure spacing relative to the viscosity of the composition, and enables the composition to flow through.

[0277] An example of a closed cell material is a closed cell polyolefin foam sold under the trade name Volora by Sekisui America Corporation, Voltek Division of Lawrence, Mass., in thicknesses from 1 / 32" to 1 / 8". Closed cell materials also include flexible polymeric materials. An example of an open cell material is an open cell polyethylene foam sold under the trade name Opcell by Packaging Industries Group, Inc., Sentinel Foam Products Division of Hyannis, Mass., in thicknesses from 1 / 16" to 3 / 8". Other open cell foams useful in the present invention include hydrophilic open cell foam materials such as hydrogel polymers (e.g., Medicell ®, TM Foam, available from Hydromer, Inc. Branchburg, JJ). Open cell foams are also hydrophilic open cell foam materials that have been imbibed with agents to render them highly absorbent to fluids, such as polyurethane or polyvinyl pyrrolidone chemically imbibed with a variety of agents.

[0278] Preparation of the semi-solid multi-phase oral composition of the present invention

[0279] Mainly, the preparation of particle semi-solid dispersions is well known in the art, and any suitable manufacturing method can be used to prepare a semi-solid multi-phase oral composition that can be in the form of a particle semi-solid dispersion. Generally speaking, these components are divided into those of hydrophilicity and those of hydrophobicity. The two phases are then mixed, if necessary under heating conditions, and the product is stirred and then optionally cooled. After merging the phases, the semi-solid multi-phase oral composition of the present invention that can be in the form of a particle semi-solid dispersion can be stirred or sheared by various methods, including shaking, intermittent shaking, high shear mixing or by using a high-speed mixer, blender, colloid mill, homogenizer or ultrasonic technology.

[0280] The semisolid multiphase oral composition in the form of a semisolid dispersion of particles as disclosed herein can be prepared as follows: prepare hydrophilic bleach particles and a hydrophobic phase; combine the hydrophilic bleach particles and the hydrophobic phase in a mixing container and mix thoroughly using any method known in the art, for example, Speedmixer (available from Flacktek Inc., Landrum, SC) can be used to prepare the semisolid multiphase oral composition of the present invention in the form of a semisolid dispersion of particles. Speedmixer TM The series of mixing procedures are based on the dual rotation of the mixing cup using dual asymmetric centrifugal mixing. This combination of centrifugal forces acting at different levels enables very rapid mixing of the entire cup. Optionally, if necessary, the composition can be heated to facilitate mixing. The composition is continuously stirred until uniform. When the active substance is included in the form of solid particles, the addition of an optional viscosity modifier such as silicon dioxide may be suitable for keeping the particles dispersed and suspended in the composition. Flavoring agents or sweeteners may also be added to one phase of the composition as required. The composition may then be added to a delivery vehicle as required.

[0281] Semisolid Multiphase Oral Composition Hypothetical Formulation Example

[0282] The following non-limiting hypothetical formulation examples further describe embodiments contemplated to be within the scope of the present invention. Many variations of these examples are possible without departing from the scope of the present invention.

[0283] Hypothetical Formulation Example I

[0284] Hypothetical Formulation Example I can be prepared using any suitable procedure disclosed above and is formulated with carbamide peroxide. These examples show compositions that can be prepared with 1) the concentration of carbamide peroxide in the overall composition ranging from 0.0277% to 33.1872%, 2) the concentration of H2O2 (incorporated into carbamide peroxide) in the overall composition ranging from 0.01% to 12%, and 3) the ratio of the weight percent concentration of H2O2 present in the hydrophilic bleach particles to the weight percent concentration of H2O2 present in the overall composition ranging from 3.01 to 3615.85.

[0285]

[0286] *Ratio of the weight percent concentration of H2O2 present in the hydrophilic bleach particles to the weight percent concentration of H2O2 present in the overall composition

[0287] #Theoretical value calculated from the molecular formula

[0288] 1 Urea hydrogen peroxide adduct, catalog number L13940, obtained from Alfa Aesar, Ward Hill, MA. Solubility in water at 20°C is 800 g / L (80 parts per 100 parts water) according to the supplier's safety data sheet. Sieve through U.S. Standard Test Sieve No. 40 with 425 micron openings.

[0289] Grade 2G-2218, available from Sonneborn, LLC., Parsippany, NJ

[0290] Hypothetical Formulation Example II

[0291] Hypothetical Formulation Example II can be prepared using any suitable procedure disclosed above and is formulated with carbamide peroxide. These examples show compositions that can be prepared with: 1) the concentration of the complex of hydrogen peroxide and polyvinyl pyrrolidone (PVP) polymer in the overall composition ranging from 0.0541% to 64.8649%, 2) the concentration of H2O2 (incorporated into the complex of hydrogen peroxide and polyvinyl pyrrolidone (PVP) polymer) in the overall composition ranging from 0.01% to 12%, and 3) the ratio of the weight percent concentration of H2O2 present in the hydrophilic bleach particles to the weight percent concentration of H2O2 present in the overall composition ranging from 1.54 to 1850.

[0292]

[0293] *Ratio of the weight percent concentration of H2O2 present in the hydrophilic bleach particles to the weight percent concentration of H2O2 present in the overall composition

[0294] #Mid-range value provided by the supplier's manual

[0295] 1 Peroxydone K-30, available from Ashland Global Specialty Chemicals Inc., Covington, Ky. Sieved through U.S. Standard Test Sieve No. 40 with 425 micron openings.

[0296] Grade 2G-2218, available from Sonneborn, LLC., Parsippany, NJ

[0297] Methods of using the compositions and / or delivery systems

[0298] The present invention can be applied to a consumer's teeth by a dental professional in a dental office, or can be used by the consumer at home. Generally speaking, the recommended treatment time is a period of time sufficient to achieve whitening.

[0299] In the implementation of the present invention, the user applies the composition of the present invention comprising a bleaching agent to one or more teeth to obtain a desired effect, such as whitening. The composition can be applied with a brushing device, a syringe or a unit dose syringe, a squeeze tube, a brush, a pen or a brush tip applicator, a deer foot applicator swab, a lip gloss applicator, a strip removed after application, a tray removed after application, or even applied with a finger. The composition can also be combined with a delivery carrier such as a material strip, a dental tray and / or a sponge material, and then applied to the teeth. In a preferred embodiment, when applied to teeth, the composition or delivery system of the present invention is almost imperceptible. After the desired time period, any residual composition can be easily removed by wiping, scrubbing or rinsing the oral surface.

[0300] Generally, it is not necessary to prepare the teeth prior to applying the composition of the present invention. For example, the user may choose to brush the teeth or rinse the mouth prior to applying the composition of the present invention, but the oral surfaces need not be cleaned nor excessively moistened with saliva or water prior to application. However, it is believed that adhesion to the enamel surface will be improved if the teeth are dry prior to application.

[0301] The dental tray device can be used as follows. The user or dental professional disperses the present composition in a soft or rigid dental appliance, and the participant then places the appliance on the participant's dental arch (or fits the device over his or her teeth to hold the dental tray in place). Generally speaking, the recommended treatment time is a period of time sufficient to achieve whitening as disclosed above. At the end of the treatment time, the dental appliance is removed, cleaned with water to remove any remaining composition, and then stored until the next use.

[0302] The above-mentioned composition and delivery system can be combined in a kit, the kit comprising: 1. the composition of the present invention and 2. instructions for use; or it comprises: 1. the composition of the present invention, 2. instructions for use, and 3. a delivery vehicle. In addition, if the teeth should be irradiated by electromagnetic radiation, the kit may also include an electromagnetic radiation source of appropriate wavelength and instructions for use, so that the consumer can use the kit in a convenient manner.

[0303] Optional electromagnetic radiation treatment

[0304] Semi-solid multi-phase oral compositions as disclosed herein can be used to whiten teeth and / or remove stains from tooth surfaces. In addition, the whitening effect can be further increased by directing electromagnetic radiation of a suitable wavelength to at least one tooth. Apparatus suitable for providing such electromagnetic radiation, such as Figure 6As shown. Suitable wavelengths can be any wavelength corresponding to the maximum absorption band of the teeth and / or the tooth stains to be bleached. For example, the semi-solid multi-phase oral composition can be irradiated with electromagnetic radiation having one or more wavelengths in the range of about 200nm to about 1200nm. The electromagnetic radiation can be directed to at least one tooth. In addition, more than one tooth can be irradiated. Specifically, the electromagnetic radiation can have a peak intensity at a wavelength in the range of about 400, 405, 410, 415, 420, 425, 430, 435, 440, or 445, 446nm to about 450, 455, 460, 465, 470, 475, 480, 481, 485, 490, 495, or 500nm, or any other numerical range that is narrower and falls within such a wider numerical range, as if such narrower numerical ranges are all explicitly written herein. More specifically, the electromagnetic radiation has a peak intensity at a wavelength in the range of about 425 nm to about 475 nm, about 445 nm to about 465 nm, or wherein the peak intensity wavelength of the electromagnetic radiation is similar to the wavelength at which the stain absorbs the maximum electromagnetic radiation. The electromagnetic radiation may be directed to at least one tooth during part or all of the wearing time of the composition; or after the composition has been removed from the tooth. The electromagnetic radiation may be applied for a period of time at least sufficient for whitening, such as at least about 1 minute, such as at least about 5 minutes, such as at least about 10 minutes. The electromagnetic radiation may be applied using the procedures disclosed in US 2013 / 0295525. Preferably, a semi-solid multi-phase oral composition as disclosed herein is applied to at least one tooth and maintained on the at least one tooth for a first period of time; after the first period of time, electromagnetic radiation is directed to at least one tooth and continued for a second period of time, wherein the first period of time has a duration greater than 50%, preferably 80% of the total duration of the first and second period of time; and finally, the semi-solid multi-phase oral composition is removed from the at least one tooth.

[0305] Suitable sources of electromagnetic radiation include those described herein in the section entitled "Clinical Protocols."

[0306] Semi-solid multi-phase oral compositions as disclosed herein can be transparent or translucent for electromagnetic radiation having a wavelength of about 400nm to about 500nm. For example, when applied at a thickness of about 0.0001cm, 0.001cm or 0.01cm to about 0.01cm, 0.1cm or 0.5cm thick, the semi-solid multi-phase oral compositions as disclosed herein allow about 10%, 20% or 30% to about 40%, 50%, 60%, 70%, 80%, 90% or 100% of electromagnetic radiation of about 400nm to about 500nm to pass through, as measured by a spectrophotometer. Specifically, when the semi-solid multi-phase oral composition is applied at a thickness of about 0.1cm, about 80% to about 100% of electromagnetic radiation of about 400nm to about 500nm passes through, as measured by a spectrophotometer. When applied to a surface area of ​​about 5 cm2 in an amount of about 0.0001 g, 0.001 g, or 0.01 g to about 0.01 g, 0.1 g, 1 g, or 5 g, the 2 To about 20cm 2 When placed on a delivery vehicle or dental tray, the semi-solid multi-phase oral compositions disclosed herein can allow about 10%, 20%, or 30% to about 40%, 50%, 60%, 70%, 80%, 90%, or 100% of electromagnetic radiation from about 400 nm to about 500 nm to pass through.

[0307] Within the wavelength range of about 400 nm to about 500 nm, the intensity of the electromagnetic radiation waves impinging on the tooth surface or the outer surface of the carrier (which can be a strip) can be in the range of about 5, 10, 25, 50, 75 or 100 mW / cm2 to about 500, 250, 225, 205, 200, 175, 150, 125, 100, 75, 50, 25, 10 or 5 mW / cm2, or any other numerical range that is narrower and falls within such broader numerical range, as if such narrower numerical ranges are all expressly written herein.

[0308] Procedure for measuring the intensity of electromagnetic radiation

[0309] The intensity of electromagnetic radiation can be measured using a photometer (USB 2000+ from Ocean Optics) connected to a UV-VIS 200 microfiber cable with a cosine corrector (OP 200-2-UV-VIS from Ocean Optics) at its tip. The photometer is connected to a computer running the photometer software (Oceanview 1.3.4 from Ocean Optics). The tip of the fiber optic cable is kept pointed at the light source at the location where the light intensity is to be measured. The photons collected on the detector surface are guided to a charge-coupled device in a photometer (CCD) via a fiber optic cable. The CCD counts the photons that arrive at the CCD during a predetermined time period at each wavelength from 200nm to 1100nm and converts these photon counts into spectral irradiance (mW / cm 2 The spectral irradiance is integrated from 200nm to 1100nm by software to generate absolute irradiance (mW / cm 2 ), which is the intensity of electromagnetic radiation from 200nm to 1100nm. The spectral irradiance is integrated from 400nm to 500nm by software to produce the absolute irradiance (mW / cm 2 ), which is the intensity of electromagnetic radiation from 400nm to 500nm.

[0310] For consumer convenience, the semisolid multiphase oral compositions as disclosed herein can be provided as a kit comprising a bleaching composition as disclosed herein, a delivery vehicle for easier application, an electromagnetic radiation source emitting electromagnetic radiation of a suitable wavelength, and instructions for use.

[0311] The compositions of the present invention may be used for both human and other animal (eg, pets, zoo animals, or livestock) applications.

[0312] Example

[0313] The following non-limiting examples further describe preferred embodiments within the scope of the present invention. Many variations of these examples are possible without departing from the scope of the present invention. Unless otherwise stated, all examples are carried out at room temperature (RT) and atmospheric pressure. These semi-solid multi-phase oral compositions are prepared as previously or as described below.

[0314] Preparation of semisolid multiphase compositions

[0315] 500 gram batches of Examples I and II were prepared by weighing urea peroxide (Example I) or a complex of hydrogen peroxide and polyvinylpyrrolidone polymer (Example II) (hydrophilic bleaching agent particles) and petrolatum into a Speedmixer container ("Max 300 Long Cup Translucent", Product No. 501 218t, available from Flacktek Inc., Landrum, SC) and stirring in the Speedmixer at 800 RPM for 5 seconds, 1200 RPM for 5 seconds, and 1950 RPM for 2 minutes. The walls of the container were then scraped down with a plastic spatula, and the contents were stirred a second time at 800 RPM for 5 seconds, 1200 RPM for 5 seconds, and 1950 RPM for 2 minutes. The walls of the container were then scraped down with a plastic spatula, and the contents were stirred a third time at 800 RPM for 5 seconds, 1200 RPM for 5 seconds, and 1950 RPM for 2 minutes.

[0316] A 50 gram batch of Example II was prepared by weighing a complex of hydrogen peroxide and polyvinylpyrrolidone polymer (hydrophilic bleach particles) and petrolatum into a Speedmixer container ("Max 100 Long Cup Translucent", Product No. 501 221Lt, available from Flacktek Inc., Landrum, SC) and stirring in the Speedmixer at 800 RPM for 5 seconds, 1200 RPM for 5 seconds, and 1950 RPM for 2 minutes. The walls of the container were then scraped down with a plastic spatula, and the contents were stirred a second time at 800 RPM for 5 seconds, 1200 RPM for 5 seconds, and 1950 RPM for 2 minutes. The walls of the container were then scraped down with a plastic spatula, and the contents were stirred a third time at 800 RPM for 5 seconds, 1200 RPM for 5 seconds, and 1950 RPM for 2 minutes.

[0317] A 50 gram batch of Example III was prepared by weighing a complex of hydrogen peroxide and polyvinylpyrrolidone polymer (hydrophilic bleach particles), sodium bicarbonate, mineral oil, and petrolatum into a Speedmixer container ("Max 100 Long Cup Translucent", Product No. 501 221Lt, available from Flacktek Inc., Landrum, SC) and stirring in the Speedmixer at 800 RPM for 5 seconds, 1200 RPM for 5 seconds, and 1950 RPM for 2 minutes. The walls of the container were then scraped down with a plastic spatula, and the contents were stirred a second time at 800 RPM for 5 seconds, 1200 RPM for 5 seconds, and 1950 RPM for 2 minutes. The walls of the container were then scraped down with a plastic spatula, and the contents were stirred a third time at 800 RPM for 5 seconds, 1200 RPM for 5 seconds, and 1950 RPM for 2 minutes.

[0318] A summary of Examples I-III is provided in Table 1.

[0319] Table I: Examples I to III

[0320]

[0321]

[0322] 1 Urea hydrogen peroxide adduct, catalog number L13940, obtained from Alfa Aesar, Ward Hill, MA. Solubility in water at 20°C is 800 g / L (80 parts per 100 parts water) according to the supplier's safety data sheet. Sieve through U.S. Standard Test Sieve No. 40 with 425 micron openings.

[0323] 2Peroxydone K-30, available from Ashland Global Specialty Chemicals Inc., Covington, KY. Solubility > 40 parts per 100 parts water (estimated from information provided in the product data sheet for polyvinylpyrrolidone polymer K-30 from the supplier). Sieve through U.S. Standard Test Sieve No. 40 with 425 micron openings.

[0324] Grade 3G-2218, available from Sonneborn, LLC., Parsippany, NJ

[0325] 4 USP No. 2 grade, obtained from Genesis Specialty Alkali LLC, Philadelphia, PA

[0326] 5 Kaydol paraffin oil grade, available from Sonneborn, LLC., Parsippany, NJ

[0327] Comparative Example I

[0328] A 500 gram batch of Comparative Example I was prepared by weighing sodium percarbonate (hydrophilic bleach granules) and petrolatum into a Speedmixer container ("Max 300 Long Cup Translucent", product number 501 218t, obtained from Flacktek Inc., Landrum, SC) and stirring in the Speedmixer at 800 RPM for 5 seconds, 1200 RPM for 5 seconds, and 1950 RPM for 2 minutes. The walls of the container were then scraped down with a plastic scraper, and the contents were stirred a second time at 800 RPM for 5 seconds, 1200 RPM for 5 seconds, and 1950 RPM for 2 minutes. The walls of the container were then scraped down with a plastic scraper, and the contents were stirred a third time at 800 RPM for 5 seconds, 1200 RPM for 5 seconds, and 1950 RPM for 2 minutes. A summary of Comparative Example I is provided in Table II.

[0329] Table II: Comparative Example I

[0330] Comparative Example I (weight%) <![CDATA[Sodium percarbonate 1 > 9.2320 <![CDATA[Vaseline 2 > 90.7680 total 100.00 <![CDATA[H2O2% (calculated value) in the total oral composition]]> 3.0 <![CDATA[H2O2% in sodium percarbonate (theoretical value calculated from the molecular formula)]]> 32.50 ratio* 10.84 Solubility of sodium percarbonate in water (parts by weight per 100 parts by weight of water) 15

[0331] *Ratio of the weight percent concentration of H2O2 present in the hydrophilic bleach particles to the weight percent concentration of H2O2 present in the overall composition

[0332] 1 Sodium percarbonate, catalog number A16045, available from Alfa Aesar, Ward Hill, MA. Solubility in water 150 g / L (15 parts per 100 parts water) - information from Wikipedia published on May 21, 2018. Sieved through U.S. Standard Test Sieve No. 40 with 425 micron openings.

[0333] Grade 2G-2218, available from Sonneborn, LLC., Parsippany, NJ

[0334] Comparative Example II

[0335] Comparative Example II is a commercially available Crest Whitestrips whitening product with 5.25% H2O2 (obtained from Procter & Gamble, Cincinnati, OH, USA). This is an aqueous gel containing 5.25% hydrogen peroxide (H2O2); and since it is an aqueous gel, the ratio of the weight percent concentration of H2O2 present in the aqueous phase to the weight percent concentration of H2O2 present in the overall composition is 1.

[0336] Unless otherwise stated, all examples were conducted at room temperature (RT) and atmospheric pressure.

[0337] In vitro procedure to measure bleaching efficacy

[0338] 1. Cut a disc (7.5mm to 7.8mm diameter x 1.2mm to 1.3mm thickness) from the anterior surface of a human incisor. Leave the buccal surface intact and flatten the lingual surface that has been cut from the tooth. Soak the dental disc in 15ml to 20ml of water that meets USP specifications in a glass vial for at least 24 hours. Repeat the process for a total of 12 teeth. Using a handheld spectrophotometer KonicaMinolta 700d, measure the baseline L* and b* of the 12 dental discs on three separate days, and average the values ​​for all three days.

[0339] 2. Treat a set of 12 dental trays with the composition to be evaluated. Specifically, discs of approximately 19.1 mm diameter are cut from the same polyethylene strips specified in the clinical protocol. Approximately 0.05 grams of the composition are applied to the polyethylene tray in the form of discs of approximately 9.5 mm diameter. Remove the dental tray from the water and place the composition and polyethylene tray on the buccal surface of the dental tray while it is still wet so that the composition is sandwiched between the dental tray and the polyethylene tray. Only slight pressure is applied to the polyethylene tray to simulate a strip positioned on the teeth. The sandwich structure is placed in an oven set to approximately 34°C (to simulate the conditions of the buccal surface of the maxillary anterior teeth) for approximately 60 minutes.

[0340] 3. If the semi-solid multiphase oral composition is used with electromagnetic radiation:

[0341] After 50 minutes of treatment with the semi-solid multiphase oral composition, electromagnetic radiation is applied to the buccal surface of the dental tray for 10 minutes,

[0342] • Directing electromagnetic radiation through the strip and through the semi-solid multi-phase oral composition towards the dental tray.

[0343] The electromagnetic radiation is delivered via a fiber optic cable (Model M71L01, obtained from Thorlabs, Newton, NJ, USA) connected to a high-power LED (Model M455F1, obtained from Thorlabs, Newton, NJ, USA) with a peak intensity wavelength of 455 nm. The LED is operated at 1000 mA using an LED driver (Model DC2100, or DC4104 paired with a DC4100-HUB, obtained from Thorlabs, Newton, NJ, USA). The exit end of the fiber optic cable is mounted to facilitate reproducible positioning of the electromagnetic radiation close to the outer surface of the strip. The exit end of the fiber optic cable is approximately 7 mm from the tooth surface. The intensity of the electromagnetic radiation of 400 nm to 500 nm measured at the central axis of the cone of electromagnetic radiation at this distance needs to be approximately 175 mW / cm 2 to about 225mW / cm 2 , as measured by the methods disclosed herein.

[0344] The radiation was applied to each tooth plate for about 10 minutes.

[0345] 4. Once the 60-minute treatment with the semi-solid multi-phase oral composition was completed, the polyethylene tray was removed and the residual composition on the tray was cleaned using a paper towel and water.

[0346] 5. After each treatment, soak the tray in 15 ml to 20 ml of water meeting USP specifications in a glass vial for at least about 24 hours.

[0347] 6. Finally, measure the post-treatment b*. This is done on three separate days and the average is taken for all three days.

[0348] 7. Calculate the average change in yellowness from baseline (Δb*).

[0349] Bleaching effect

[0350] The bleaching efficacy of Examples I-III and Comparative Example I delivered on a strip and used with an electromagnetic radiation source and measured according to the in vitro procedure is listed in Table 3.

[0351] Table 3: Bleaching efficacy

[0352]

[0353]

[0354] Table 3 shows that Example-I achieves a greater reduction in yellowness (-Δb*) than Comparative Example I.

[0355] These results clearly demonstrate the surprisingly high efficacy of Example-I (prepared with carbamide peroxide) compared to Comparative Example I (prepared with sodium percarbonate), even though both compositions have the same content of H2O2 (3%).

[0356] In particular, these results clearly show the surprisingly high efficacy of a composition prepared with hydrophilic bleach particles (urea peroxide) having a solubility of 80 parts by weight in 100 parts by weight of water (Example I) compared to a composition prepared with hydrophilic bleach particles (sodium percarbonate) having a solubility of only 15 parts by weight in 100 parts by weight of water (Comparative Example I), even though both compositions have the same content of H2O2 (3%).

[0357] These results clearly show that the solubility of the hydrophilic bleach particles has a surprisingly large impact on bleaching efficacy.

[0358] Table 3 also shows that Example II [prepared with hydrophilic bleach particles (complex of hydrogen peroxide and polyvinylpyrrolidone polymer) having a solubility of >40 parts by weight in 100 parts by weight of water] achieves a surprisingly large reduction in yellowness (-Δb*) of 2.57, while Comparative Example I [prepared with hydrophilic bleach particles (sodium percarbonate) having a solubility of only 15 parts by weight in 100 parts by weight of water] achieves a reduction in yellowness (-Δb*) of only 0.84, even though both compositions have the same content of H2O2 (3%). These results clearly show that the solubility of the hydrophilic bleach particles has a surprisingly large impact on the bleaching efficacy.

[0359] Table 3 also shows that Example III achieves a greater reduction in yellowness (-Δb*) than Example II. These results clearly demonstrate the surprisingly high efficacy of Example III (prepared with a complex of hydrogen peroxide and polyvinyl pyrrolidone polymer mixed with sodium bicarbonate) compared to Example II (prepared with a complex of hydrogen peroxide and polyvinyl pyrrolidone polymer, but without sodium bicarbonate), even though both compositions have the same amount of H2O2 (3%). In particular, these results clearly demonstrate the surprisingly high efficacy of a composition prepared with two or more oral care actives that are usually incompatible with each other mixed in the same composition (Example III) compared to a composition prepared with only one oral care active (Example II). These results also clearly demonstrate that sodium bicarbonate has a surprisingly large impact on bleaching efficacy when mixed with hydrophilic bleach particles.

[0360] Clinical bleaching efficacy of Example II and Comparative Example II

[0361] The bleaching efficacy of Example II was measured according to the clinical protocol specified herein. Specifically, this was a single-center clinical study conducted on adults who had never undergone professional, over-the-counter, or investigational tooth bleaching treatments. All participants were at least 18 years old, had all four measurable maxillary incisors, and had no self-reported tooth hypersensitivity.

[0362] Example II (20 participants, average L* of 72.7 and average b* of 15.4)

[0363] The participants' maxillary anterior teeth were treated with the oral composition once daily for 60 minutes using polyethylene strips as a delivery vehicle. The polyethylene strips were 66 mm x 15 mm in size and 0.0178 mm thick. 0.6 to 0.8 grams of the oral composition were applied throughout each polyethylene strip prior to application to the maxillary anterior teeth.

[0364] The distribution of the maxillary strips and all applications were supervised by clinical site staff. For each treatment, participants wore the strips with the oral composition for a total of 60 minutes. After 50 minutes of each strip being worn, a trained hygienist applied electromagnetic radiation to the facial surfaces of the maxillary anterior teeth for 10 minutes. The electromagnetic radiation passed through the strips and was directed toward the teeth through the oral composition. The electromagnetic radiation was delivered using a source of electromagnetic radiation described herein in the section entitled "Clinical Protocol." The intensity of 400nm to 500nm electromagnetic radiation measured at the central axis of each cone of electromagnetic radiation emitted at the exit face of the transparent window through which the electromagnetic radiation passed toward the maxillary anterior teeth was measured to be approximately 175mW / cm 2 to about 225mW / cm 2 , as measured by the procedures disclosed herein. Digital images were collected at baseline and on the day after the 1st, 2nd, and 3rd treatment.

[0365] Participants treated with Example II demonstrated a statistically significant (p<0.001) decrease in yellowness increment (-Δb*) relative to baseline at all tested time points; in addition, an increase in lightness (ΔL*) was observed in this group on the day following the 2nd and 3rd treatments (p<0.001).

[0366] The bleaching efficacy of a second comparative composition (Comparative Example II - Crest Whitestrips whitening product with 5.25% H2O2) containing a final concentration of 5.25% H2O2 in an aqueous gel was measured in a clinical study. Specifically, the study of Comparative Example II was a controlled single-center clinical trial. The target population was adult participants who had no previous teeth whitening examples. Participants were treated with the above-mentioned comparative aqueous gel (Comparative Example II) with 5.25% H2O2 delivered to a polyethylene strip. The group (20 participants, with an average L* of 72.8 and an average b* of 16.4) wore the strip once a day for 60 minutes for 14 days. Digital images were obtained at baseline and on the day after the 7th and 14th treatments. The results of the group wearing Comparative Example II (aqueous gel with 5.25% H2O2) delivered on the strip and for 60 minutes (the same length of time as Example II in the previously described clinic) are shown in Table 4.

[0367] Table 4: Clinical bleaching efficacy

[0368]

[0369] After 7 treatments, Comparative Example II (aqueous gel with 5.25% H2O2 delivered on a strip for 60 minutes) produced an average change in yellowness of -0.985, while Example II (also delivered on a strip and used with an electromagnetic radiation source) achieved an average change in yellowness of -1.14 after only 1 treatment, despite having a lower H2O2 concentration than the aqueous gel used in Comparative Example II (3% H2O2 vs. 5.25% H2O2). Similarly, after 14 treatments, Comparative Example II produced an average change in yellowness of -1.43, while Example II achieved an average change in yellowness of -1.73 after only 2 treatments, despite having a lower H2O2 concentration than the aqueous gel (3% H2O2 vs. 5.25% H2O2). These results also clearly demonstrate the surprisingly high efficacy of Example II (delivered on a strip and used with an electromagnetic radiation source as disclosed herein), despite its lower H2O2 concentration (3% H2O2 versus 5.25% H2O2) compared to the comparative aqueous gel used in Comparative Example II.

[0370] The dimensions and values ​​disclosed herein are not to be understood as being strictly limited to the exact numerical values ​​cited. Instead, unless otherwise indicated, each such dimension is intended to represent the stated value and a functionally equivalent range around that value. For example, a dimension disclosed as "40 mm" is intended to mean "about 40 mm".

Claims

1. A kit comprising a) a semi-solid multi-phase oral composition, the semi-solid multi-phase oral composition comprising: i) from 0.01% to 40%, by weight of the semi-solid multi-phase oral composition, of hydrophilic bleach particles; and ii) at least 60%, by weight of the semisolid multiphase oral composition, of a hydrophobic phase; b) an electromagnetic radiation source capable of directing electromagnetic radiation having one or more wavelengths in the range of 200 nm to 1700 nm toward at least one tooth; and wherein the hydrophobic phase and / or the semisolid multiphase oral composition has a cone penetration consistency value of 25 to 300; wherein the semisolid multiphase oral composition is a semisolid dispersion; wherein the semisolid multiphase oral composition is non-aqueous, contains no added water and / or is anhydrous; and At least 40 parts by weight of the hydrophilic bleaching agent particles are dissolved in 100 parts by weight of water, and wherein the hydrophilic bleaching agent particles are selected from urea peroxide, a complex of hydrogen peroxide and a polyvinyl pyrrolidone polymer, or a mixture thereof.

2. The kit according to claim 1, wherein the cone penetration consistency value of the hydrophobic phase and / or the multi-phase oral composition is 50 to 250 as measured by ASTM 937, and / or wherein the drop melting point of the hydrophobic phase is 50°C to 100°C as measured by ASTM D127-08.

3. The kit according to claim 2, wherein the hydrophobic phase and / or the multi-phase oral composition has a cone penetration consistency value of 100 to 200 as measured by ASTM 937.

4. The kit according to claim 2, wherein the hydrophobic phase has a drop melting point of 50°C to 90°C as measured by ASTM D127-08.

5. The kit according to claim 2, wherein the hydrophobic phase has a drop melting point of 60 to 80°C as measured by ASTM D127-08.

6. The kit according to any one of claims 1 to 5, wherein the hydrophilic bleach particles have a number average equivalent diameter, surface area average equivalent diameter or volume average equivalent diameter of 0.001 micrometers to 1000 micrometers.

7. The kit according to any one of claims 1 to 5, wherein the hydrophilic bleach particles have a number average equivalent diameter, surface area average equivalent diameter or volume average equivalent diameter of 0.01 micrometers to 1000 micrometers.

8. The kit of any one of claims 1-5, wherein the hydrophilic bleach particles have a number average equivalent diameter, surface area average equivalent diameter, or volume average equivalent diameter of 0.1 micrometer to 100 micrometers.

9. The kit of any one of claims 1-5, wherein the hydrophilic bleach particles have a number average equivalent diameter, surface area average equivalent diameter or volume average equivalent diameter of 1 micron to 100 microns.

10. The kit of any one of claims 1-5, wherein the hydrophilic bleaching agent particles are insoluble in the semi-solid multi-phase oral composition.

11. The kit according to any one of claims 1 to 5, wherein the hydrophobic phase is insoluble in water.

12. The kit according to any one of claims 1 to 5, wherein the hydrophobic phase comprises at least one of the following: mineral oil, mineral oil thickened with wax, mineral oil thickened with polyethylene, and / or petrolatum.

13. The kit according to any one of claims 1-5, wherein the hydrophobic phase comprises at least one of the following: mineral oil thickened with wax, mineral oil thickened with polyethylene, and / or petrolatum.

14. The kit of any one of claims 1-5, wherein the hydrophobic phase comprises petrolatum.

15. A kit according to any one of claims 1 to 5, wherein the hydrophilic bleach particles having a cross-sectional area greater than 10,000 square microns can have a two-dimensional density of no more than 25 per square centimeter of two-dimensional surface.

16. A kit according to any one of claims 1 to 5, wherein the hydrophilic bleach particles having a cross-sectional area greater than 10,000 square microns can have a two-dimensional density of no more than 10 per square centimeter of two-dimensional surface.

17. A kit according to any one of claims 1 to 5, wherein the hydrophilic bleach particles having a cross-sectional area greater than 10,000 square microns can have a two-dimensional density of no more than 5 per square centimeter of two-dimensional surface.

18. A kit according to any one of claims 1 to 5, wherein the hydrophilic bleach particles having a cross-sectional area greater than 10,000 square microns can have a two-dimensional density of no more than 1 per square centimeter of two-dimensional surface.

19. The kit of any one of claims 1-5, wherein the semisolid multi-phase oral composition comprises less than 0.1% bleaching agent by weight of the semisolid multi-phase oral composition.

20. The kit of any one of claims 1-5, wherein the semisolid multi-phase oral composition comprises less than 0.099995% bleaching agent by weight of the semisolid multi-phase oral composition, less than 0.095% bleaching agent by weight of the semisolid multi-phase oral composition, or less than 0.09% bleaching agent by weight of the semisolid multi-phase oral composition.

21. The kit according to any one of claims 1 to 5, wherein the semi-solid multiphase oral composition is free of added binders, added substantivity agents, added active substance releasing agents, added peroxide releasing agents, dispersants and / or mixtures thereof.

22. The kit according to claim 21, wherein the binder, the affinity agent, the active substance releasing agent, the peroxide releasing agent, the dispersant and / or a mixture thereof are hydrophilic.

23. The kit of any one of claims 1-5, wherein the semi-solid multiphase oral composition is free of silicone adhesives, cyclic silicones, silicones, silicone fluids, polydimethylsiloxanes, paraffin oils, mixtures of silicones and hydrocarbons, mixtures of liquid silicones and liquid hydrocarbons, trimethylsiloxysilicate / dimethiconol crosspolymers, condensation products of silicone resins and organosiloxanes, or combinations thereof.

24. The kit of any one of claims 1-5, further comprising an additional oral care agent.

25. The kit of claim 24, wherein the additional oral care agent comprises stannous fluoride, stannous chloride, or a combination thereof.

26. The kit of any one of claims 1-5, wherein the electromagnetic radiation source emits electromagnetic radiation in the range of 400 nm to 500 nm.

27. The kit of claim 26, wherein the electromagnetic radiation in the range of 400 nm to 500 nm impinging on the outer surface of the delivery vehicle is at 175 mW / cm 2 Up to 225mW / cm 2 within the range.

28. The kit according to any one of claims 1-5, further comprising a delivery vehicle (10).

29. The kit according to claim 28, wherein the delivery vehicle (10) is a transparent or translucent delivery vehicle (10).

30. The kit according to claim 28, wherein the delivery vehicle (10) is transparent or translucent to electromagnetic radiation having a wavelength of 200 nm to 1700 nm.

31. A kit according to claim 28, wherein the delivery vehicle (10) allows 10%, 20% or 30% to 40%, 50%, 60%, 70%, 80%, 90% or 100% of electromagnetic radiation between 400nm and 500nm to pass through to reach the surface of the tooth.

32. The kit of claim 28, wherein the delivery vehicle comprises at least one of a strip, a film of material, a sponge material, or a dental tray.

33. A cosmetic and non-therapeutic method for whitening teeth, the cosmetic method comprising use of a kit according to any one of the preceding claims, comprising: a) applying the semisolid multiphase oral care composition to at least one tooth surface such that the semisolid multiphase oral care composition contacts the at least one tooth surface; as well as b) directing electromagnetic radiation having one or more wavelengths in the range of 200 nm to 1700 nm towards the at least one tooth.

34. A cosmetic and non-therapeutic method according to claim 33, wherein the wavelength is in the range of 400nm to 500nm.

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