CN116437891A

CN116437891A - Oral care articles comprising a water insoluble delivery vehicle and solid hydrophilic particles comprising an oral care active agent

Info

Publication number: CN116437891A
Application number: CN202180071212.7A
Authority: CN
Inventors: P·A·萨格尔; J·拉贾亚
Original assignee: Procter and Gamble Co
Current assignee: Procter and Gamble Co
Priority date: 2020-10-19
Filing date: 2021-09-22
Publication date: 2023-07-14
Also published as: EP4228585A1; JP2023545798A; CA3194943A1; AU2021364566A1; WO2022086663A1; MX2023004447A; AU2021364566A9

Abstract

The present invention relates to an article in the form of a strip for use in the oral cavity. The article comprises a water insoluble delivery vehicle comprising solid hydrophilic particles comprising at least one oral care active, wherein: (i) At least about 20 parts by weight of the solid hydrophilic particles (20) are dissolved in about 100 parts by weight of water, and/or (ii) wherein the solid hydrophilic particles (20) swell in water by at least about 50%. The active agent may include a bleaching agent, an antimicrobial agent, an anticalculus agent, a healing agent, an anticaries agent, a dentinal desensitizing agent, an anesthetic, an antifungal agent, a cooling agent, an anti-inflammatory agent, a selective H-2 antagonist, a nutrient, erythritol, a probiotic, a fluoride ion source, or a combination thereof.

Description

Oral care articles comprising a water insoluble delivery vehicle and solid hydrophilic particles comprising an oral care active agent

Technical Field

The present invention relates to oral care articles comprising a water insoluble delivery vehicle and solid hydrophilic particles comprising an oral care active suitable for use in the oral cavity.

Background

Currently on the market are dental articles with which various cosmetic and/or therapeutic actives are delivered to the teeth and oral cavity. Examples of such products include: tooth brushing aids, such as dentifrice products for delivering oral care actives, e.g., polyphosphates or fluorides; mouthwashes comprising a breath freshener or antibacterial active; and whitening strips for delivering bleaching actives to teeth. The use of dental strips to deliver cosmetic and therapeutic benefits to teeth and oral mucosal surfaces has been considered a convenient and economical method; such as tooth whitening strips, wherein the whitening composition is applied to the strip and then to the teeth to achieve continuous contact between the teeth and the whitening product.

Despite the above-described known methods for treating or ameliorating oral conditions, particularly methods for whitening teeth or applying fluoride, there remains a need to provide products with improved properties, such as increased whitening speed, improved bleaching efficacy, higher antibacterial effect, higher fluoride retention, reduced tooth sensitivity and/or reduced soft tissue irritation of the oral cavity. Previous attempts to address these problems have included increasing the level of active agent in the product. However, this approach may present some problems. The user may experience an increase in irritation and/or sensitivity that may be associated with an increase in the amount of active agent used. Thus, despite the above-described known methods for treating oral diseases, particularly for whitening teeth, there remains a need to provide products with improved bleaching efficacy, increased whitening speed, reduced tooth sensitivity, and/or reduced oral soft tissue irritation.

Disclosure of Invention

The present invention relates to an oral care article comprising:

a) A solid water-insoluble delivery vehicle in the form of a strip having a length and a width forming a first surface and having a thickness extending from the first surface to a second surface, wherein the solid water-insoluble delivery vehicle preferably has an average thickness of less than about 3 mm; and

b) Solid hydrophilic particles comprising an oral care active agent, wherein the active agent comprises at least one of a bleach, a healing agent, an anticalculus agent, an anticaries agent, an antimicrobial agent, a dentinal desensitizing agent, an anesthetic agent, an antifungal agent, a cooling agent, an anti-inflammatory agent, a selective H-2 antagonist, a nutrient, erythritol, a probiotic, a fluoride ion source, a tooth whitening agent, or a combination thereof;

wherein: (i) At least about 20 parts by weight of the solid hydrophilic particles are dissolved in about 100 parts by weight of water, and/or (ii) the solid hydrophilic particles increase in volume and/or weight by at least about 50% upon contact with water,

and wherein the solid hydrophilic particles release the active agent upon contact with water; wherein the solid hydrophilic particles are disposed and embedded in the solid water insoluble delivery vehicle, wherein the solid hydrophilic particles are disposed i) at least partially below the first surface of the solid water insoluble delivery vehicle, and ii) at least partially at or above the first surface, wherein greater than about 10% of the surface area of the solid hydrophilic particles are disposed at the first surface of the water insoluble delivery vehicle and exposed to the external environment surrounding the water insoluble delivery vehicle. The solid water-insoluble delivery vehicle may comprise a material having a cone penetration consistency value preferably less than 10, as measured by ASTM D937-07.

By applying the oral care active directly to the teeth and/or oral cavity, the articles of the present invention can be used in a method of delivering or can be used to deliver health, therapeutic or cosmetic benefits to the oral cavity. Preferably, the articles of the present invention are useful for reducing and/or removing dental caries, plaque, tartar and stains, promoting gum health, preventing and treating tooth decay, improving breath, promoting bleaching, providing an antibacterial effect, and/or combinations thereof.

The article may be provided as a kit, for example, with a device for enhancing the efficacy of an active agent, such as an electromagnetic radiation source.

The article may also be provided with instructions for use of the article.

The attachment of the article directly to the teeth or oral cavity, i.e. the adhesive function or attachment mechanism, may be provided directly by the article (e.g. the water insoluble delivery vehicle itself). For example, the article may optionally be of sufficient size such that, once applied, the article overlaps with the soft tissue of the oral cavity, thereby allowing more of the tooth surface to achieve the effect achieved with the active agent. The article may be attached to the oral cavity by physical interference or mechanical interlocking between the article and the oral cavity surfaces, including the teeth.

Drawings

FIG. 1A is a perspective view of an article 10 in the form of a strip having rounded corners, including solid hydrophilic particles 20 that are accessible to the environment; FIG. 1B shows a greater number of particles 20 at the first surface 14;

FIG. 2A is a cross-sectional view taken along section line 2-2 of article 10 of FIG. 1A; FIG. 2B is a cross-sectional view taken along section line 2-2 of article 10 of FIG. 1B;

FIG. 3 is a cut-away plan view showing the article 10 attached to a tooth 22;

FIG. 4 is a cross-sectional elevation view of the tooth taken along section line 4-4 of FIG. 3, showing the article 10 adhered to the tooth 22;

FIG. 5A is a photographic image of the article 10 in strip form formed as a tray (FIG. 5B) including the notches 18 (FIG. 5C);

FIG. 6 is Sup>A photographic image of Sup>A wax sheet useful as Sup>A water-insoluble delivery vehicle 12, comprising embedded solid hydrophilic particles 20 (example IV-A);

FIG. 7 is Sup>A microscope image of Sup>A wax sheet useful as Sup>A water-insoluble delivery vehicle 12, comprising embedded solid hydrophilic particles 20 (example IV-A);

fig. 8 shows an apparatus for delivering electromagnetic radiation to a tooth surface.

Detailed Description

It has been found that if the oral care active agent is provided as solid hydrophilic particles and combined with a water insoluble delivery vehicle to form an oral care article as disclosed herein, the oral care active agent can be effective at relatively low concentrations by weight of the oral care article. The oral care articles of the present invention may comprise from about 0.01% to about 50%, preferably from about 0.1% to about 30%, preferably from about 0.1% to about 25%, preferably from about 0.1% to about 15%, or preferably from about 0.3% to about 10%, by weight of the article, of solid hydrophilic particles comprising an oral care active agent; wherein the solid hydrophilic particles are soluble in water, swell upon contact with water and release the active agent upon contact with water or an aqueous liquid.

The solid hydrophilic particles are disposed on or in a water insoluble delivery vehicle and embedded therein to form the oral care articles of the present invention. The solid hydrophilic particles comprise at least one oral care active agent, wherein the concentration of the active agent at the first surface of the water insoluble delivery vehicle may be greater than the concentration of the active agent at the second surface when the solid hydrophilic particles are intercalated. Examples of at least one active agent for oral care include a healing agent, an anticalculus agent, an anticaries agent, an antimicrobial agent, a dentinal desensitizing agent, an anesthetic agent, an antifungal agent, a cooling agent, an anti-inflammatory agent, a selective H-2 antagonist, a nutrient, erythritol, a probiotic, a fluoride ion source, a hydrophilic bleaching agent, a tooth whitening agent, or a combination thereof, wherein bleaching agents, antimicrobial agents, and/or anticaries agents are preferred. Without being bound by theory, it is believed that when the article contacts one surface, preferably the first surface, of the tooth surface, solid hydrophilic particles embedded in a water insoluble delivery vehicle may be preferred to deliver the oral care active to the hydrophilic biofilm on the tooth surface. This may result in increased efficacy of the activity, such as whitening teeth, antibacterial and/or anticaries effects with lower total levels of active agent.

The term "delivery vehicle" as used herein includes materials in the form of strips for delivering an active agent from solid hydrophilic particles to a surface, such as a tooth surface. A delivery vehicle as used herein may be flat or preformed into a three-dimensional shape, such as the shape of an arch. The material of the "delivery vehicle" should be compatible with the oral cavity, comfortable for the user and water insoluble. Exemplary materials for the water-insoluble delivery vehicle include waxes, polymers, and combinations thereof.

The terms "hydrophobic" and "hydrophilic" are used herein according to common general knowledge. The term "hydrophilic" is used for objects, articles, molecules, compounds, entities that are attracted to water and other polar materials. Thus, the term "hydrophobic" is used for objects, articles, molecules, compounds, entities that are not attracted to and/or repelled by water and other polar materials.

As used herein, the term "strip" includes material 1) whose longest dimension length is generally greater than its width, and 2) whose width is generally greater than its thickness. The strips may be rectangular, arcuate, curved, semicircular, with rounded corners to avoid irritating soft tissues of the mouth. As used herein, "rounded" refers to one or more angles that are generally free of any sharp corners or points, such as 135 ° or less. Furthermore, the strip may be curved or shaped into a three-dimensional shape, such as an arch, or a combination thereof. The strip may be solid, textured, rigid, moldable, deformable, permanently deformable, or a combination thereof. The strips useful in the present invention may be suitably shaped to fit the oral cavity.

As used herein, the term "oral care article" refers to an article that is used in the oral cavity, preferably on teeth in the oral cavity. The oral care article preferably comprises a solid water insoluble delivery vehicle in combination with solid hydrophilic particles comprising at least one active agent.

As used herein, the term "unit dose article" refers to an article that is used once and then discarded.

As used herein, the term "removable article" refers to an article that is removed from the oral cavity after use.

As used herein, the term "stick product" refers to an article of a substantially solid strip of solid material held within a dispensing container that retains its structural integrity and shape when applied to a surface to be treated. When a portion of the stick is dragged across the surface, the film of the stick article is transferred to the surface. Examples include lip balms and lipsticks. Stick products are typically used several times and therefore cannot be considered unit dose articles as used herein. Furthermore, when a portion of the stick product is dragged across a surface, a film of stick composition is transferred to the surface, which is typically not and/or is not removable from the oral cavity after use.

As used herein, the term "moldable" refers to the material of the water insoluble delivery vehicle and/or article that conforms to the general shape of the dental arch when applied by a user. Examples of "moldable" water insoluble delivery vehicles include gauge 24 cast wax transparency cut into strips of about 0.51mm thick, about 22mm wide and about 62mm long (reference number 114009, provided by Freeman Manufacturing Company, ohio, USA).

As used herein, the term "wax" refers to an organic compound that is hydrophobic and solid at room temperature, such as a higher alkane. The wax may preferably have a drop melting point of about 60 ℃ to about 120 ℃, preferably about 70 ℃ to about 110 ℃, more preferably about 80 ℃ to about 100 ℃, more preferably about 90 ℃ to about 100 ℃, as measured by ASTM method D127-08, and/or a penetration consistency value of about 0.1 to about 100, preferably about 0.5 to about 50, more preferably about 1 to about 10, as measured by ASTM method D1321-16a, and/or a penetration consistency value of less than about 10, preferably about 1 to about 9, more preferably less than about 5, as measured by ASTM method D937-07.

As used herein, the term "penetration consistency value" refers to the depth in tenths of millimeters of a standard needle penetration into a sample under fixed mass, time, and temperature conditions. Penetration consistency values were measured according to ASTM method D1321-16 a.

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

As used herein, the term "particles" is a discrete solid material. The solid particles have a size greater than a single atom or molecule and are typically sub-micron to about five millimeters in their largest dimension. The particles may agglomerate into agglomerates of discrete particles.

As used herein, the term "solid hydrophilic particles" are solid particles that are soluble in water and/or swell (increase in volume and/or weight) when contacted with water and release an active agent when contacted with water. Furthermore, the solid hydrophilic particles are insoluble in the water insoluble delivery vehicle. The solid hydrophilic particles comprise an oral care active agent that is released from the solid hydrophilic particles upon contact with water. For example, the solid hydrophilic particles may contain bleaching agents, antimicrobial agents, and/or anticaries agents as active agents. If the active agent is released, the active agent may be a gas, a liquid, or a solid dissolved in a liquid. The solid hydrophilic particles may also comprise ingredients that are water soluble, water miscible, or a combination thereof, such as, for example: water, water-soluble solvents, alcohols, acrylic polymers, polyalkylene glycols, humectants, glycerin, sorbitol, xylitol, butylene glycol, polyethylene glycol, and propylene glycol, and mixtures thereof. If these ingredients are added to or present in the solid hydrophilic particles, the percentage of solid hydrophilic particles in the article is calculated by excluding these ingredients. If water-insoluble or water-immiscible fillers are added to the solid hydrophilic particles, the percentage of solid hydrophilic particles in the article is calculated by excluding these fillers.

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

As used herein, the term "solubility" is the maximum part by weight amount of a substance that is soluble in 100 parts by weight of the second substance.

As used herein, the term "embedded" or "embedded particles" means that the solid particles are arranged i) at least partially below the surface, and ii) at least partially at or above the surface of the solid water insoluble delivery vehicle. Examples of embedded particles include solid hydrophilic particles, such as gauge 24 cast wax transparency (reference number 114009, provided by Freeman Manufacturing Company, ohio, USA) pressed into the wax sheet surface for 60 seconds at, for example, 625 PSI.

As used herein, the term "active agent" is a component present in a solid hydrophilic particle that provides an oral care benefit. For example, the active agent may include a bleaching agent, an antimicrobial agent, and/or an anticaries agent.

As used herein, the term "bleach" is an active agent that provides a bleaching or whitening benefit. For example, if urea peroxide (also known as urea hydrogen peroxide adducts) is used as the solid hydrophilic particles, the hydrogen peroxide component of the urea peroxide is a bleach. Similarly, if a complex of hydrogen peroxide and polyvinylpyrrolidone (PVP) polymer is used as the solid hydrophilic particles, the hydrogen peroxide component of the complex of hydrogen peroxide and polyvinylpyrrolidone (PVP) polymer is a bleach.

As used herein, by "safe and effective amount" is meant an amount of a component that is high enough to significantly (explicitly) alter the condition being treated or affect the desired outcome, but low enough to avoid serious side effects (at a reasonable benefit/risk ratio), within the scope of sound medical/dental judgment. The safe and effective amount of the components will depend upon the particular condition being treated, the age and physical condition of the patient being treated, the severity of the condition, the duration of the treatment, the nature of the co-therapy, the particular form employed and the particular carrier in which the components are employed.

As used herein, "a period of time sufficient to achieve the desired effect of the active agent" refers to each application time that the participant may use or wear the active agent-containing article, or each application time that the participant may be instructed to use or wear the active agent-containing article is from about 10 seconds to about 24 hours, preferably from about 1 minute to about 2 hours, and most preferably from about 5 minutes to about 1 hour. The treatment may be administered from about 1 to about 10 times per day, preferably from about 1 to about 5 times per day, and most preferably from about 1 to about 3 times per day. The treatment may be administered for about 1 day to about 8 weeks, preferably about 1 day to about 4 weeks, and most preferably about 1 day to about 1 week. In addition, the length of treatment to achieve the desired benefit (e.g., tooth bleaching) may be continued for a specified period of time, which may be repeated if desired, for example, from about one day to about six months or continued. The optimal duration and frequency of administration will depend on the desired effect, the severity of all conditions to be treated, the health and age of the user, and the like.

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

All percentages and ratios used herein are by weight (wt%) of the article, unless otherwise indicated. Unless otherwise indicated, all percentages, ratios, and levels of ingredients referred to herein are based on the actual amount of the ingredient, and do not include solvents, fillers, or other substances that may be used with the ingredients in commercially available products.

All measurements referred to herein are made at about 23 ℃ (i.e., room temperature), unless otherwise indicated.

The active ingredients and other ingredients useful herein may be categorized or described herein according to their cosmetic and/or therapeutic benefit or their presumed mode of action or mode of operation. However, it will be appreciated that in some instances, the active 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. Thus, the categorization herein is for convenience only and is not intended to limit the ingredients to the specific functions or activities listed.

The term "orally acceptable" 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 are capable of mixing but do not interact, which would significantly reduce the stability and/or efficacy of the article.

Oral care product

An oral care article as disclosed herein comprises a solid water insoluble delivery vehicle in combination with solid hydrophilic particles comprising at least one oral care active agent, the solid hydrophilic particles being disposed on or in, preferably embedded in, the water insoluble delivery vehicle. The active agent may be, for example, a bleaching agent, an antibacterial agent, or an anticaries agent. The solid hydrophilic particles have (i) a relatively high solubility in which at least about 20 parts by weight of the solid hydrophilic particles (20) are dissolved in about 100 parts by weight of water, and/or (ii) a relatively high swellability in which the solid hydrophilic particles (20) swell in water by at least about 50%. The components and properties of the solid hydrophilic particles and the water insoluble delivery vehicle are selected to allow for easy release of the active agent from the composition in an optimal manner.

The articles as disclosed herein may preferably comprise a solid hydrophobic and solid water insoluble delivery vehicle in combination with solid hydrophilic particles comprising at least one oral care active agent embedded in a water insoluble delivery vehicle.

The articles as disclosed herein may preferably comprise a solid thermoplastic water insoluble delivery vehicle in combination with solid hydrophilic particles comprising at least one oral care active agent embedded in a water insoluble delivery vehicle. Without being bound by theory, it is believed that when the inventive article is contacted with a tooth surface, the solid hydrophilic particles can deliver the active agent to the hydrophilic biofilm of the surface. The net effect that is possible is that the tooth treatment effect only starts after contact with the tooth surface to be treated. This means that the hydrophilic active agent can be protected from the environment, so the water insoluble delivery vehicle of the article keeps it stable before and during use. Thus, effects can be applied to tooth surfaces and hydrophilic active agents, such as bleaching agents, antibacterial agents, or anticaries agents, potentially shielding the oral environment during use. Thereby enhancing and/or accelerating the efficacy of the active agent.

Without being bound by theory, the present invention may improve delivery of hydrophilic active agents to oral surfaces such as tooth or gum surfaces due to the partially hydrophobic and partially hydrophilic nature of the article. Due to the driving force thus generated, the active agent can be driven toward the tooth surface. Thus, even with surprisingly low total active agent content, increased rates and/or increased efficacy of the active agent can be achieved. Thus, at a given total concentration, such as less than about 25 wt%, less than about 15 wt%, less than about 10 wt%, less than about 5 wt%, less than about 3 wt%, less than about 1 wt%, less than about 0.1 wt% or less of the oral care active agent, the present invention can provide a surprisingly high level of treatment efficacy, and thus, may require less administration to achieve the same degree of efficacy, or may require lower concentrations to achieve the same degree of efficacy, as compared to prior art administration. Without being bound by theory, it is believed that the present articles provide high efficacy, in part, because they may adhere to the oral cavity through physical or mechanical interference between the water insoluble delivery vehicle and the oral cavity surfaces including the teeth, or have self-adhesion or self-affinity to the teeth, and are resistant to rinsing by saliva or other liquids. This can keep active agents such as bleaching agents, antibacterial agents or anticaries agents in contact with oral surfaces (such as tooth surfaces) or in the oral cavity for a prolonged period of time, thereby achieving high efficacy. Notably, in general, substances that have an adhesive or affinity for the oral cavity are hydrophilic, as the surfaces in the oral cavity are wetted. It is also worth noting that some product forms, especially stick products, may require an added affinity reagent to adhere the product to surfaces in the oral cavity. However, it has been found that the articles of the present invention and/or the water-insoluble delivery vehicles of the present invention can adhere to the oral cavity by physical interference or mechanical interlocking between the water-insoluble delivery vehicle and the oral cavity surface including the teeth, or even without added adhesive (e.g., hydrophilic particles that become tacky when activated by moisture, or hydrophilic liquids) or added affinity agents, have self-adhesion or self-affinity to surfaces in the oral cavity, such as tooth surfaces. Achieving adhesion or affinity without the use of added hydrophilic binders or hydrophilic affinity reagents is particularly useful as it can help to make the article resistant to washing by saliva or other liquids, resulting in higher efficacy. This is because achieving adhesion or affinity without the use of an added hydrophilic binder or added hydrophilic affinity reagent may allow us to increase the content of hydrophobic components (capable of resisting washing away) and/or decrease the content of hydrophilic components (easy to wash away). Counterintuitively, this can help to increase the substantivity of the article, resulting in high concentrations of oral care active or bleach coming into contact with oral surfaces such as tooth surfaces or in the oral cavity for prolonged periods of time, which in turn results in high efficacy. Thus, preferably, the article of the invention and/or the water-insoluble delivery vehicle of the invention may be 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 affinity reagents, and more preferably substantially free of added hydrophilic liquid binders (e.g., glycerol). Preferably, the article of the present invention and/or the water-insoluble delivery vehicle of the present invention may be attached to the oral cavity by physical interference or mechanical interlocking between the water-insoluble delivery vehicle and the oral cavity surface including the teeth, or have self-adhesion or self-affinity to the oral cavity, such as the tooth surface.

It is also notable that some product forms, especially stick products, may require an added active substance releasing agent or an added peroxide releasing agent to improve the release of the active substance or peroxide trapped in the stick product. Generally, the active agent or peroxide release agent is a hydrophilic water-soluble or water-swellable polymer or hydrophilic liquid that can provide a hydration channel in the article, allowing water to penetrate the article and allowing the active agent or peroxide to leach out. The added peroxide release agent may help to break down the hydrophobic matrix due to microbubbles that may be generated when it is in contact with water; and such disruption may enhance the release of whitening or oral care actives such as hydrogen peroxide. However, the articles of the present invention are preferably self-releasing (e.g., they release active agents or peroxides even without added active agent releasing agents or added peroxide releasing agents).

Since the water-insoluble delivery vehicle resists saliva dilution and salivary enzymes that decompose active agents such as peroxides, retention of the article on the tooth surface can be improved. In addition, the water-insoluble delivery vehicle does not dehydrate the teeth, thereby creating an outward flux of water formed by many hydrophilic articles comprising hydrophilic binders such as polycarboxylic acids. Since the water insoluble delivery vehicle does not dehydrate the teeth, a surprisingly low level of tooth sensitivity can result even while providing a surprisingly high level of active efficacy, such as bleaching efficacy.

Water insoluble delivery vehicles may provide additional advantages. For example, a water-insoluble delivery vehicle may represent a stable matrix of ingredients that are soluble in the water-insoluble delivery vehicle. For example, many flavoring ingredients commonly used in oral products are soluble in water insoluble delivery vehicles. This means that any effect of the flavour ingredient by the hydrophobic active (e.g. bleach) in the oral care product can be avoided. Furthermore, during use of the article at a tooth surface, at least a portion of the water-insoluble delivery vehicle may be positioned towards soft oral tissue, such as mucous membranes, thereby presenting to the oral cavity ingredients, such as flavoring compounds, present in the water-insoluble delivery vehicle. For example, the flavoring ingredient may preferably be positioned on the second surface of the water-insoluble delivery vehicle such that the solid hydrophilic particles and optional flavoring ingredient are positioned on opposite sides of the water-insoluble delivery vehicle and may be released into the oral cavity independently. The water insoluble delivery vehicle may shield the active agent, such as bleach, from any effects of the oral cavity, such as dilution by saliva. The barrier effect may also be applied to the tooth surface itself, wherein the water insoluble delivery vehicle may provide greater hydration of the tooth surface.

Notably, stick products can be unhygienic for repeated use in the mouth due to potential contamination or biofilm accumulation. Saliva or moisture can penetrate into the stick product when the stick composition is used in the oral cavity, and this can degrade active agents, especially bleaching agents such as peroxides, during storage between uses; and this degradation may be further accelerated by enzymes present in saliva. Furthermore, this degradation may be most pronounced at the end of the stick product that is in direct contact with saliva or moisture in the mouth, resulting in reduced efficacy when the stick product is next used. This "contact-degradation-contact" cycle can be repeated each time a stick product is used, resulting in poor results for most, if not all, of the applications after the first application.

Notably, the articles of the present invention may be provided in unit dosage forms that are used once and subsequently discarded. Such unit dosage forms may provide several advantages over other product forms (including stick products), such as: 1) a high level of hygiene protection, because it is used once and discarded, 2) because the unit dosage form provides a pre-measured dose of active agent, such as bleach, in each dose, a guesswork to estimate how much product to use (which guess may confuse or even fear a consumer unfamiliar with the product), and 3) because solid hydrophilic particles may be distributed throughout the article, it may minimize over-or under-treated spots, and 4) because the active agent, such as bleach, is not exposed to the environment or oral cavity until use, the effectiveness of the active agent, such as bleach, may be maintained for a longer period of time.

In another aspect, the articles of the present invention may be removed from the oral cavity after use. This allows the user to remove and discard any remaining active agent, such as bleach, after the end of the treatment period, as opposed to a stick product. The absorbent article of the present invention may be a single layer.

Water insoluble delivery vehicles

The articles as disclosed herein comprise a solid water insoluble delivery vehicle, preferably embedded solid hydrophilic particles comprising at least one oral care active agent. The water-insoluble delivery vehicle or article may be attached to the oral cavity by physical interference or mechanical interlocking between the water-insoluble delivery vehicle and the oral cavity surface including the teeth. For example, the water-insoluble delivery vehicle or article may be of sufficient size such that, once applied, the water-insoluble delivery vehicle overlaps the soft tissue of the oral cavity, thereby allowing more of the tooth surface to be treated. The basic form of the water-insoluble delivery vehicle or article is a strip having a length and a width that form first and second surfaces that are separated from one another by a thickness. Furthermore, the basic form of the water-insoluble delivery vehicle or article may also be formed into any shape or size suitable for contacting the desired oral surface, such as in the form of a dental arch. Furthermore, the water-insoluble delivery vehicle may be a monolayer.

The first surface may be substantially planar in form, may have irregularities due to embedded solid hydrophilic particles that may be embedded therein, may be shaped into a three-dimensional shape, such as the shape of a dental arch or tooth, or a combination thereof. Typically, the first and second surfaces of the water-insoluble delivery vehicle or article are similarly sized and shaped, adjacent or nested to one another, and preferably separated by an average distance of no more than about 3 mm. For example, the average distance between the first surface and the second surface of the water-insoluble delivery vehicle or article may be from about 0.01mm to about 3mm, preferably from about 0.1mm to about 2mm, or more preferably from about 0.15mm to about 1mm.

The basic form of the water-insoluble delivery vehicle or article is a strip having a length, width and thickness. The length of the water-insoluble delivery vehicle or article may range from about 35mm to about 100mm, preferably from about 40mm to about 90mm, more preferably from about 50mm to about 80mm. The width of the water-insoluble delivery vehicle may be in the range of about 3mm to about 30mm, preferably about 5mm to about 25mm, more preferably about 15mm to about 25mm.

Without wishing to be bound by theory, the average thickness of the water-insoluble delivery vehicle or article may be that which ensures the article: 1) Comfort during use, and/or 2) release an effective amount of oral care active per cm2 during use. In particular, for a given% of active agent, if the average thickness of the water-insoluble delivery vehicle or article is too low, the active agent will diffuse over a large area of the first surface and thus deliver a lower level of active agent per cm2, resulting in reduced efficacy. In contrast, if the average thickness of the water-insoluble delivery vehicle or article is too high, the article may be too bulky and uncomfortable during use. The average thickness of the water-insoluble delivery vehicle or article may range from 0.01mm to about 3mm, preferably from about 0.1mm to about 2mm, more preferably from about 0.15mm to about 1mm, and most preferably from about 0.25mm to about 0.75mm. The absorbent article of the present invention may be a single layer.

The water-insoluble delivery vehicle may be transparent or translucent to electromagnetic radiation having a wavelength of about 200nm to about 1700 nm.

Without wishing to be bound by theory, the drop melting point of the water-insoluble delivery vehicle may be to ensure that the article: 1) Do not melt or become tacky during storage, and/or 2) release an effective amount of active agent during use. In particular, if the drop melting point of the water-insoluble delivery vehicle is too low, the article may melt or become tacky during storage. In contrast, if the drop melting point of the water-insoluble delivery vehicle is too high, the article will not release an effective amount of the active agent during use. For example, the droplet melting point of a suitable water-insoluble delivery vehicle may be in the range of about 60 ℃ to about 120 ℃, preferably about 70 ℃ to about 110 ℃, more preferably about 80 ℃ to about 100 ℃, and more preferably about 90 ℃ to about 100 ℃.

Without wishing to be bound by theory, the penetration consistency value of the water-insoluble delivery vehicle may be that of ensuring the article: 1) Not becoming tacky during storage, and/or 2) release an effective amount of active agent during use. In particular, if the penetration consistency value of the water-insoluble delivery vehicle is too high, the article may become tacky during storage. In contrast, if the penetration consistency value of the water-insoluble delivery vehicle is too low, the article will not release an effective amount of the active agent during use. The penetration consistency value of the water insoluble delivery vehicle may be in the range of about 0.1 to about 100, preferably about 0.5 to about 50, and most preferably about 1 to about 10.

Without wishing to be bound by theory, the cone penetration consistency value of the water-insoluble delivery vehicle may be that of a guaranteed product: 1) Not becoming tacky during storage, and/or 2) release an effective amount of active agent during use. In particular, if the cone penetration consistency value of the water-insoluble delivery vehicle is too high, the article may become tacky during storage. In contrast, if the cone penetration consistency value of the water-insoluble delivery vehicle is too low, the article will not release an effective amount of the active agent during use. The water-insoluble delivery vehicle may have a cone penetration consistency value of less than about 10, preferably from about 1 to about 9, and most preferably less than about 5.

The water insoluble delivery vehicle or article of the present invention may be moldable. Moldability may allow the water-insoluble delivery vehicle to be shaped into the form of an arch or into the surface profile of a tooth. Optimal adaptation to the tooth surface allows 1) an effective release of the active agent and/or 2) a comfortable experience during use. Preferably, the permanent deformation occurs under a minimum normal force applied by the wearer, preferably the water-insoluble delivery vehicle or article substantially conforms to the shape of the teeth via permanent deformation under a pressure of less than about 250,000 pascals.

The water insoluble delivery vehicle of the present invention may be rigid. The stiffness of the water-insoluble delivery vehicle or article may be a factor that ensures 1) that it is easy to handle and accurately position during application, and/or 2) that it retains a given shape during use. Flexural stiffness is a property of a material that is a composite function of the thickness, width, and elastic modulus of the material. The test described below is a method of measuring the stiffness of strips and sheets. The method measures the bending resistance of a sample by using strain gauges fixed at the ends of a horizontal beam. The other end of the beam is pressed against the sample strip forcing a portion of the strip into a vertical recess on a horizontal platform (for resting the sample). The microammeter calibrated with deflection force is attached to the strain gauge with a wire. The stiffness coefficient of the sample can be read directly from the microammeter, expressed as grams per centimeter of sample strip width. In particular, if the flexural rigidity of the water insoluble delivery vehicle or article is too high, it may be non-moldable and may fracture during molding at the tooth surface. In contrast, if the flexural rigidity of the water-insoluble delivery vehicle or article is too low, handling and accurate positioning may not be easy during application. The flexural rigidity of the water-insoluble delivery vehicle as measured by ASTM D2923-95 may be greater than 50g/cm, preferably the flexural rigidity of the water-insoluble delivery vehicle may be greater than 60g/cm, more preferably from about 75g/cm to about 1000g/cm, more preferably from about 100g/cm to about 750g/cm, more preferably from about 200g/cm to about 500g/cm.

The water insoluble delivery vehicle of the present invention is hydrophobic. The water insoluble delivery vehicle of the present invention may preferably comprise waxes, polymers or combinations thereof. The wax may be thermoplastic. Suitable waxes that may be used in the water insoluble delivery vehicle may include microcrystalline waxes or combinations of waxes and polymers. 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. Suitable polymers that can be combined to form the water-insoluble delivery vehicle can be, for example, polyethylene. Examples of polyethylenes include a-C1702 or a-C6702 manufactured by Honeywell 25Corp. (Morristown, NJ), having a permeation value of about 98.5 and about 90.0, respectively, according to ASTM D-1321; polyethylene Performalene series from Baker Hughes; this includes polyethylene performane 400 from Baker Hughes inc (Houston, TX). For example, the ratio of the weight percent of polymer divided by the weight percent of wax may be from about 0.01 to about 100, from about 0.1 to about 10, from about 0.5 to about 2. Preferred examples of the water insoluble delivery vehicle of the present invention are waxes, most preferably casting waxes provided by Freeman Manufacturing Company, ohio, USA, such as those listed in the following table or combinations thereof.

Supplier reference number	Thickness (specification)	Average thickness mm +/-10%
			114024	14	1.58
114026	18	1.02
			114007	20	0.86
114009	24	0.51
			114010	26	0.39
114011	28	0.30
			114012	30	0.25

These wax flakes are moldable and readily conform to the shape of a dental arch or tooth under manual pressure.

As used herein, the delivery system may include adhesive means such that they are capable of adhering to oral surfaces, particularly teeth. The adhesive means may be provided by the articles of the invention herein, or the adhesive means may be provided separately from the articles herein (e.g., the adhesive means is a separate phase from the articles herein, wherein the articles may also have adhesive means). The water-insoluble delivery vehicle can be easily removed from the oral surface without the use of instruments, chemical solvents or agents, or excessive friction.

The water-insoluble delivery vehicle may be held in place on the oral surface by the adhesive means and/or the attachment provided by the water-insoluble delivery vehicle itself. For example, the water insoluble delivery vehicle can extend, attach and adhere to the oral soft tissue. In addition, the adhesive may be applied to the portion of the water insoluble delivery vehicle that may attach the article to the soft tissue of the oral cavity. The water-insoluble delivery vehicle may also be attached to the oral cavity by physical interference or mechanical interlocking between the water-insoluble delivery vehicle and the oral cavity surface including the teeth. Furthermore, the water-insoluble delivery vehicle may be held in place by an adhesive means independent of the inventive article herein, as disclosed in WO 03/015656.

Suitable adhesive means are known to the skilled person. When the adhesive means (if present) is provided by an adhesive, the adhesive may be any adhesive that can be used to adhere a material to a tooth surface or to a surface of an oral cavity surface. Suitable adhesives include, but are not limited to, skin, gum and mucoadhesive, and should be able to withstand moisture, chemicals and enzymes in the oral environment long enough for the oral care active and/or bleach to be effective, but then be dissolvable and/or biodegradable. Suitable adhesives may include, for example, water-soluble polymers, hydrophobic and/or non-water-soluble polymers, pressure and moisture sensitive adhesives, such as dry adhesives that become tacky upon contact with the oral environment, such as under the influence of moisture, chemicals or enzymes in the oral cavity, and the like. Suitable binders include natural gums, synthetic resins, natural or synthetic rubbers, those listed above as "thickeners" and polymers and various other tacky substances of the type used in known tapes, which are known from US2,835,628.

Solid hydrophilic particles

The article of the present invention comprises a safe and effective amount of solid hydrophilic particles. The solid hydrophilic particles comprise an active agent for oral treatment as disclosed herein. For example, the amount of solid hydrophilic particles in the article may be from about 0.01% to about 50%, preferably from about 0.1% to about 30%, most preferably from about 0.2% to about 25%, by weight of the article.

The solid hydrophilic particles are insoluble in the water insoluble delivery vehicle of the present invention. However, it has surprisingly been found that the solubility of solid hydrophilic particles in water, the ability to swell upon contact with water, or the ability to release an active agent for oral treatment upon contact with water affects the efficacy of the article. For example, at least about 20, 25, 30, 40, 50, 60, 70, or 80 parts by weight of the solid hydrophilic particles may be dissolved in about 100 parts by weight of water; preferably at least about 30 parts by weight of the solid hydrophilic particles are soluble in about 100 parts by weight of water, more preferably 50 parts by weight, more preferably 70 parts by weight, even more preferably 80 parts by weight of the solid hydrophilic particles are soluble in about 100 parts by weight of water. Without wishing to be bound by theory, the higher the solubility of the solid hydrophilic particles, the more effective they may be. Particles with higher solubility can be more effectively delivered from the water insoluble delivery vehicle to the tooth surface, thereby enhancing the intended efficacy, such as, for example, bleaching. Another parameter of the solid hydrophilic particles that affects the efficacy of the article may be the degree of swelling. For example, the solid hydrophilic particles may swell at least about 50%, 55%, 60%, 65%, 70%, 75% or 80% when contacted with water, preferably the solid hydrophilic particles may swell at least about 60%, more preferably at least about 70%, more preferably at least about 80% when contacted with water. Without wishing to be bound by theory, it appears that the ability to release oral care active agents from solid hydrophilic particles upon contact with water may depend on the swellability and/or solubility of the solid hydrophilic particles in water. The solid hydrophilic particles can be hydrated on the buccal surface of the anterior maxillary tooth and the amount of water to release the active ingredient is low compared to the rest of the oral cavity. This may be particularly important for bleaching, as the buccal surfaces of the anterior maxillary teeth are those most visible when smiling. Thus, the solubility of the solid hydrophilic particles in water, their ability to swell upon contact with water, and/or their ability to release oral care actives upon contact with water may disproportionately affect the efficacy of the article on "smiling teeth" (the buccal surface of the anterior maxillary teeth).

When using bleaching agents, the size of the individual solid hydrophilic particles may be a factor in reducing oral/topical irritation or increasing the desired effect such as bleaching efficacy. Without being bound by theory, if the size of the solid hydrophilic particles is too large, it can result in large spots on the oral/topical/dental surfaces that are exposed to high concentrations of oral care active, which in turn can result in oral/topical irritation and/or dental sensitivity. For example, the number average equivalent diameter or volume average equivalent diameter of the solid hydrophilic particles can be from about 0.001 microns to about 5000 microns, preferably from about 0.01 microns to about 2000 microns, and most preferably from 1 micron to about 1000 microns. The number average equivalent diameter or volume average equivalent diameter of the solid hydrophilic particles can be measured according to methods and apparatus known in the art, such as those from Malvern Panalytical ltd (e.g., malvern Mastersizer 3000 particle size analysis apparatus) or Horiba ltd (e.g., laser-based particle size analysis apparatus).

In one aspect, the article of the present invention comprises solid hydrophilic particles embedded in a solid water insoluble delivery vehicle. If the solid hydrophilic particles are contained in the water-insoluble delivery vehicle by intercalation, the solid hydrophilic particles may become flattened during intercalation into the water-insoluble delivery vehicle. In one aspect, the particles may be pressed into an irregular disc shape during the embedding process. Thus, the surface area of the solid hydrophilic particles exposed to the external environment (e.g., the surface area of the solid hydrophilic particles at the first surface of the water insoluble delivery vehicle) may be increased, potentially resulting in more active agent being released and more efficacious. If the thickness of the water-insoluble delivery vehicle is too large, this positive effect can be negatively impacted. In one aspect, it has surprisingly been found that the ratio of the average thickness of the water-insoluble delivery vehicle and/or article divided by the number average equivalent diameter or volume average equivalent diameter of the solid hydrophilic particles can help to increase the efficacy of the oral care active. For example, the ratio of the average thickness of the water-insoluble delivery vehicle and/or article to the number average equivalent diameter or volume average equivalent diameter of the solid hydrophilic particles can be from about 0.001 to about 1000, from about 0.01 to about 100, or from about 0.1 to about 10.

In articles in which solid hydrophilic particles are embedded in a water-insoluble delivery vehicle, the configuration (e.g., shape or position) of the embedded particles may be a factor ensuring that: 1) The embedded particles do not detach from the water insoluble delivery vehicle during storage, transport, or handling, and/or 2) the embedded particles release an effective amount of bleach during use. In particular, in articles in which solid hydrophilic particles are embedded in a water-insoluble delivery vehicle, if the embedded particles are configured such that a majority (e.g., greater than about 50%) of the embedded particles are above the surface of the water-insoluble delivery vehicle, the embedded particles may become detached from the water-insoluble delivery vehicle during storage, transport, or handling. Furthermore, if a majority of the embedded particles protrude above the surface of the water-insoluble delivery vehicle, the roughness of that surface may be increased (e.g., like sandpaper in appearance or texture) and give the impression of discomfort that may result in sensitive oral tissue even before use by the consumer, or even may dig into sensitive oral tissue and cause discomfort during application or use. In this regard, it is preferred that less than about 50%, preferably less than about 40%, preferably less than about 30%, preferably less than about 20% of the volume of the embedded solid hydrophilic particles is disposed above the surface of the water insoluble delivery vehicle.

Furthermore, if the embedded particles are configured such that a majority of the embedded particles (e.g., greater than 50%) are below the surface of the water-insoluble delivery vehicle and not directly exposed to the external environment, they may not release an effective amount of bleach. In one aspect, it has surprisingly been found that in an article in which solid hydrophilic particles are embedded in a water insoluble delivery vehicle, the embedded particles can be configured such that 1) a majority of the embedded particles are below the surface of the water insoluble delivery vehicle, and 2) a majority of the surface of the embedded particles are directly exposed to the external environment. This counterintuitive property configuration may 1) prevent the embedded particles from escaping the water-insoluble delivery vehicle, and 2) release an effective amount of bleach from the embedded particles. For example, when the particles are embedded in a water-insoluble delivery vehicle by spreading the particles over the surface of the water-insoluble delivery vehicle and pressing the particles into the water-insoluble delivery vehicle under high pressure (e.g., in a hydraulic press, between two rollers, or between a roller and a hard surface), 1) a majority of the particles may be disposed below the surface, and 2) the particles themselves may be at least partially flattened at or near the surface of the water-insoluble delivery vehicle such that a majority of the surface of the particles is directly exposed to the external environment, resulting in release of an effective amount of bleach.

In an article in which solid hydrophilic particles are embedded in a water insoluble delivery vehicle, 1) greater than about 50%, preferably greater than about 75%, preferably greater than about 95%, most preferably 100% of the volume of the embedded particles may be disposed below or at the surface of the water insoluble delivery vehicle, and/or 2) greater than about 10%, preferably greater than about 20%, preferably greater than about 30% of the surface area of the embedded particles are disposed at the surface of the water insoluble delivery vehicle, thereby being directly exposed to the external environment surrounding the water insoluble delivery vehicle.

The size of the solid hydrophilic particles, the thickness of the solid water-insoluble delivery vehicle, or the applied pressure may affect the configuration (e.g., shape or location) of the embedded particles. The solid hydrophilic particles may be embedded in the water insoluble delivery vehicle by spreading the particles over the surface of the water insoluble delivery vehicle and pressing the particles into the water insoluble delivery vehicle under a pressure of at least about 50 pounds Per Square Inch (PSI), preferably at least about 500PSI, preferably at least about 5000PSI, most preferably at least about 50,000PSI or about 50PSI to about 50,000PSI, preferably about 50PSI to about 5000PSI, most preferably about 500PSI to about 5000 PSI.

The oral care active agent per unit of solid hydrophilic particle may be from about 1% to about 95%, preferably from about 10% to about 50%, most preferably from about 15% to about 40% by weight of the solid hydrophilic particle.

It has surprisingly been found that the level of oral care active required to achieve the desired effect in the present invention is surprisingly low, e.g. lower than the concentration of active typically used in previous commercial products. For example, the concentration of the oral care active may be from about 0.001% to about 25%, preferably from about 0.01% to about 15%, more preferably from about 0.01% to about 10%, more preferably from about 0.01% to about 5%, more preferably from about 0.01% to about 3%, more preferably from about 0.01% to about 0.09%, and most preferably less than 0.1%.

The articles of the present invention may comprise several different oral care active agents as disclosed herein. The level of some active agents may be regulated and/or limited due to regulatory requirements. For example, if a bleach is used as the active agent, the appropriate level of active agent is calculated not only from the intended effect, but must also meet regulatory requirements. For example, suitable total concentrations of bleach as active agent may be from about 0.01% to about 0.1%, less than about 0.1%, from about 0.01% to about 0.099995%, from about 0.01% to about 0.095%, from about 0.05% to about 0.09%. The bleaching agent provided by the solid hydrophilic particles is effective even at very low levels for use in the articles disclosed herein. If higher levels of bleach, for example up to about 15% by weight of the article meet regulatory requirements, the total concentration of bleach as active agent may be less than 15% by weight of the article, preferably from about 0.1% to about 10% by weight of the article, most preferably from about 0.5% to about 3% by weight of the article. The concentration of the active agent may be from about 0.001% to about 25%, preferably from about 0.01% to about 10%, more preferably from about 0.01% to about 3%, more preferably from about 0.01% to about 0.09%, and most preferably less than 0.1%.

In one aspect, without wishing to be bound by theory, it is believed that by delivering the oral care active directly to the surface to be treated, surprisingly high efficacy delivered by very low concentrations of the oral care active can be achieved. Thus, the concentration of the oral care active at the first surface, typically the surface of the article intended to contact the oral surface to be treated, can be measured. For example, the concentration of the at least one oral care active at the first surface may be in the range of from about 1 microgram/cm 2 to about 10000 microgram/cm 2, preferably from about 10 micrograms/cm 2 to about 5000 micrograms/cm 2, most preferably from about 50 micrograms/cm 2 to about 3000 micrograms/cm 2, measured according to the methods specified herein.

If solid hydrophilic particles are introduced into the water insoluble delivery vehicle by intercalation, the concentration of the oral care active at the second surface of the article, generally opposite the first surface, may be significantly lower than the concentration at the first surface. For example, the concentration of the at least one oral care active at the second surface may be from about 0.001 micrograms/cm 2 to about 500 micrograms/cm 2, preferably from about 0.01 micrograms/cm 2 to about 200 micrograms/cm 2, most preferably from about 0.1 micrograms/cm 2 to about 100 micrograms/cm 2, measured in accordance with the methods specified herein.

If solid hydrophilic particles are introduced into the water insoluble delivery vehicle by intercalation, the ratio of the concentration of the oral care active or bleach at the first surface divided by the concentration of the oral care active or bleach at the second surface, measured according to the procedure specified herein, may be greater than 1, preferably from about 2 to about 10000, preferably from about 2 to about 1000, and preferably from about 2 to about 100. In one aspect, it has surprisingly been found that even better efficacy results can be obtained if the solid hydrophilic particles are unevenly located in the water insoluble delivery vehicle, e.g. a larger number of particles are located at the surface of the article intended to contact the oral surface to be treated, and a smaller number of particles are located at the distal surface. Thus, the number of solid hydrophilic particles per cm2 may be a factor in reducing oral/topical irritation, reducing tooth sensitivity, and/or improving efficacy during use. Without wishing to be bound by theory, the non-uniform distribution concentrates the oral care active at the intended site of action, thereby reducing the amount of oral care active and the undesirable and sometimes adverse side effects. Thus, if the size or number of solid hydrophilic particles is too large, then large spots on the oral/topical/dental surfaces exposed to high concentrations of oral care active agents may result, which in turn, in oral/topical irritation and/or dental sensitivity, and if the size or number of solid hydrophilic particles is too low, then efficacy may be too low. The number of solid hydrophilic particles per cm2 at the first surface may be at least 5, preferably from about 5 to about 10000, preferably from about 10 to about 1000, or from about 10 to about 100. If the solid hydrophilic particles are introduced into the water insoluble delivery vehicle by intercalation, the number of solid hydrophilic particles at the second surface may be lower than the number of solid hydrophilic particles at the first surface. For example, the average number of solid hydrophilic particles per cm2 at the second surface may be up to 200, preferably from about 0.01 to about 100, most preferably from 1 to about 10.

Oral care active agent

The articles of the present invention comprise a safe and effective amount of at least one oral care active agent, e.g., the solid hydrophilic particles comprise a safe and effective amount of one or more oral care active agents, and/or one or more additional active agents may be added to the water insoluble delivery vehicle separate from the solid hydrophilic particles. Suitable oral care actives include any material that is generally considered safe for use in the oral cavity and provides an overall appearance and/or health change to the oral cavity. For example, suitable oral care actives may include one or more bleaching agents, tooth whitening agents, healing agents, anticalculus agents, fluoride ion sources, antimicrobial agents, remineralizing agents, dentin desensitizing agents, anesthetics, antifungal agents, cooling agents, anti-inflammatory agents, selective H-2 antagonists, anticaries agents, nutrients, erythritol, probiotics, resolvins (including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), and docosapentaenoic acid (DPA), elapsing 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 RvE (5S, 12R, 18R-trihydroxy-EPA), 18S-Rv1 (5S, 12R, 18S-trihydroxy-EPA), rvE2 (5S, 18R-dihydroxy-EPA) and RvE (17R, 18R/S-dihydroxy-EPA)), tranexamic acid, glycine, retinol, amino acids such as histidine, isoleucine, leucine, lysine, tryptophan, phenylalanine, threonine, valine, alanine, asparagine, aspartic acid, arginine, cysteine, serine, ornithine, proline, glutamine, amino acid, glutamine, proline, calcium salt, glutamine, calcium salt, human, and the like, and mixtures and/or combinations thereof. The solid hydrophilic particles may comprise at least one oral care active in an amount that, when used directly, promotes the intended benefit without damaging the oral surface to which they are applied. Examples of oral conditions addressed by these actives include, but are not limited to: changes in the appearance and structure of teeth, such as reduction and/or removal of caries, plaque, tartar and stains, providing antibacterial action, preventing and treating caries, treating gum redness and/or bleeding, mucosal lesions, ulcers, aphthous ulcers, herpes labialis, tooth abscesses, and eliminating oral malodor caused by the above-mentioned conditions and other causes such as microbial proliferation and improving mouth odor.

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

The oral care active agent may be one or more anti-inflammatory agents including, but not limited to, non-steroidal anti-inflammatory agents such as acetylsalicylic acid, 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. Anti-inflammatory agents, if present, typically comprise from about 0.001% to about 5% by weight of the product.

The oral care active agent may be one or more probiotics selected from lactobacillus reuteri ATCC 55730; lactobacillus salivarius strain TI12711 (LS 1); lactobacillus paracasei ADP-1; streptococcus salivarius K12; bifidobacterium DN-173010; filtrate of Lactobacillus paracasei strain (pro-t-action) ^TM ) The method comprises the steps of carrying out a first treatment on the surface of the Streptococcus stomatae KJ3, streptococcus rat JH145, streptococcus uberis KJ2; lactobacillus reuteri Prodentis; lactobacillus salivarius LS1; lactobacillus paracasei; lactobacillus paracasei ADP1; streptococcus salivariusM18, 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-173010; bifidobacterium GBI 306068; bifidobacterium infantis; bifidobacterium lactis; bifidobacterium lactis Bb-12; bifidobacterium longum; bifidobacterium thermophilum; enterococcus faecalis; enterococcus faecium; enterococcus faecium NCIMB 10415; enterococcus LAB SF 68; lactobacillus reuteri ATCC55730 and ATCC PTA 5289; lactobacillus reuteri ATCC55730 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 (subgenera Casi); lactobacillus casei field-replacing strain; fusing lactobacillus; lactobacillus crispatus YIT 12319; lactobacillus curvatus; lactobacillus buchneri lactobacillus bulgaricus PXN 39; fermenting lactobacillus; lactobacillus fermentum YIT 12320; lactobacillus gasseri; lactobacillus gasseri YIT 12321; lactobacillus helveticus; lactobacillus johnsonii; lactobacillus used for pickle; lactobacillus L1A; lactobacillus paracasei (Lpc 37); lactobacillus paracasei GMNL-33; lactobacillus pentosus; lactobacillus plantarum; lactobacillus plantarum; protective lactobacillus; lactobacillus reuteri; lactobacillus reuteri ATCC 55730; lactobacillus reuteri SD2112 (ATCC 55730); lactobacillus rhamnosus (GG); lactobacillus rhamnosus GG; lactobacillus rhamnosus GG; lactobacillus rhamnosus LC705; propionibacterium freudenreichii subspecies; propionibacterium scherzeri; lactobacillus rhamnosus L8020; lactobacillus rhamnosus LB21; lactobacillus salivarius; lactobacillus salivarius WB21; lactobacillus sporogenes; lactococcus diacetylactis; lactococcus lactis; lactic acid; pediococcus acidilactici; pediococcus pentosaceus; saccharomyces baumannii; saccharomyces cerevisiae; streptococcus uberis KJ2sm; streptococcus stomatae KJ3sm; streptococcus rat JH145; streptococcus mitis YIT 12322; streptococcus stomatae KJ3; streptococcus rat JH145; streptococcus salivarius (BLIS K12 or BLIS M18); streptococcus salivarius K12; streptococcus thermophilus; streptococcus uberis KJ2; thermophilic thermus sp; weissella antrum CMS2; weissella antrum CMS3; and Weissella antrum CMU.

Probiotics may be used in the articles of the present invention to promote positive oral health effects such as reducing caries and plaque, promoting gum health, improving breath, and promoting whitening. The efficacy of the probiotic in the article may be determined, for example, by measuring one or more of the following: reduction of salivary streptococcus mutans content; reduction of gingival crevicular fluid; reduction of periodontal pathogens (c.structures and p.gingivicis) in subgingival plaque; a reduction in the amount of yeast; the prevalence of candida stomatitis decreases; a reduced oral Volatile Sulfur Compound (VSC) content; and a reduction in TNF-alpha and IL-8 production. It is believed that one or more of the positive oral health effects described above may be achieved by producing a bacterial toxin that removes or reduces certain types of bacteria in the oral cavity; in addition, one or more of the positive oral health effects described above may also be achieved by bacteria producing one or more enzymes that inhibit the production of or dissolve/relax biofilm or adhesive deposits that may cause oral health problems.

For example, at least one anticalculus agent may be used in the articles disclosed herein. The anticalculus agent is selected from polyphosphate and salts thereof; polyaminopropane sulfonic Acid (AMPS) and salts thereof; polyolefin sulfonates and salts thereof; polyvinyl phosphate and salts thereof; polyolefin phosphate esters and salts thereof; bisphosphonates and salts thereof; phosphonoalkane carboxylic acids and salts thereof; polyphosphonates and salts thereof; polyvinyl phosphonate and salts thereof; polyolefin phosphonates and salts thereof; a polypeptide; and mixtures thereof, wherein the salt is typically an alkali metal salt. For example anticalculus agents such as pyrophosphates, polyphosphates, polyphosphonates and mixtures thereof, may also exhibit a stabilizing effect on solid hydrophilic oral care actives, for example if bleach is used as the active.

The anticalculus agent may be, for example, a polyphosphate. Although some cyclic polyphosphate derivatives may be present, it is generally believed that the polyphosphate comprises two or more phosphate molecules arranged primarily in a linear configuration. The linear polyphosphate corresponds to formula (X PO ₃ ) _n Wherein n is from about 2 to about 125, wherein n is preferably greater than 4, and X is, for example, sodium, potassium, or the like. For (X PO ₃ ) _n When n is at least 3, the polyphosphate is glassy in nature. The counter ion of the phosphate can be alkali metal, alkaline earth metal, ammonium, C ₂ -C ₆ A mixture of ammonium alkanols and salts. Polyphosphates are generally used as their wholly or partially neutralized water-soluble alkali metal salts, such as potassium, sodium, ammonium salts, and mixtures thereof. Inorganic polyphosphates include alkali metal (e.g., sodium) tripolyphosphate, tetrapolyphosphate, dialkyl metal (e.g., disodium) dibasic acid, trialkyl metal (e.g., trisodium) monobasic acid, potassium hydrogen phosphate, sodium hydrogen phosphate, and alkali metal (e.g., sodium) hexametaphosphate, and mixtures thereof. Polyphosphates greater than tetraphosphates generally appear as amorphous glassy materials, such as those manufactured by FMC corporation, commercially known as Sodaphos (n.apprxeq.6), hexaphos (n.apprxeq.13), glass H (n.apprxeq.21), and mixtures thereof. The polyphosphate may preferably be present in the articles of the present invention in an amount of about 1.5% to about 10%, such as about 2% to about 10%, and more preferably about 6% to about 10%, by weight of the article.

Pyrophosphates useful in the articles of the present invention include alkali metal pyrophosphate salts, di-, tri-and mono-potassium or sodium pyrophosphates, dialkali metal pyrophosphate salts, tetra-alkali metal pyrophosphate salts, and mixtures thereof. For example, the pyrophosphate may be selected from trisodium pyrophosphate, disodium dihydrogen pyrophosphate (Na ₂ H ₂ P ₂ O ₇ ) Dipotassium pyrophosphate, tetrasodium pyrophosphate (Na) ₄ P ₂ O ₇ ) Tetrapotassium pyrophosphate (K) ₄ P ₂ O ₇ ) And mixtures thereof, of which tetrasodium pyrophosphate is preferred. In the preparation of the present invention, tetrasodium pyrophosphate may be in the anhydrous salt form or in the decahydrate form, or any other species that is stable in solid form. The salt is in its solid particulate form, which may be in its crystalline and/or amorphous state, the particle size of the salt preferably being small enough to be aesthetically acceptable and readily soluble in use. The pyrophosphate salt may be present in the articles of the present invention in an amount of about 1.5% to about 10%, such as about 2% to about 10%, and more preferably about 3% to about 8%, by weight of the article. Phosphate sources include, but are not limited to, polyphosphates and pyrophosphates, whichDescribed in more detail in Kirk and Othmer, encyclopedia of Chemical Technology, fourth edition, volume 18, wiley-Interscience Publishers (1996), pages 685-707.

Polyolefin phosphonates include those wherein the olefin group contains 2 or more carbon atoms. The polyvinyl phosphonate includes polyvinyl phosphonic acid. Bisphosphonates and salts thereof include azacycloalkane-2, 2-diphosphonic acid and salts thereof, such as those in which the alkane moiety has five, six or seven carbon atoms, and in which the nitrogen atom is unsubstituted or bears a lower alkyl substituent such as methyl, azacycloalkane-2, 2-diphosphonic acid, azacyclopentane-2, 2-diphosphonic acid, N-methyl-azacyclopentane-2, 3-diphosphonic acid, EHDP (ethane hydroxy-1, 1-diphosphonic acid), AHP (azacycloalkane-2, 2-diphosphonic acid, also known as 1-azacycloheptylidene-2, 2-diphosphonic acid), ethane-1-amino-1, 1-diphosphonate, dichloromethane-diphosphonate, and the like. Acyl alkane carboxylic acids or alkali metal salts thereof include PPTA (phosphonopropane tricarboxylic acid), PBTA (phosphonobutane-1, 2, 4-tricarboxylic acid), each in the form of an acid or alkali metal salt.

Antimicrobial antiplatelet agents useful as suitable oral care active agents in The present invention and may include, but are not limited to, triclosan, lupulic acids from lupulus extracts (such as lupulone alpha acids including humulone, near humulone, isohumulone, post-humulone, pre-humulone, and combinations thereof, or lupulone beta acids including lupulone, colupulone, lupulone, and combinations thereof), 5-chloro-2- (2, 4-dichlorophenoxy) -phenol, as described in The Merck Index 11 th edition (1989) page 1529 (cataloged running water 9573), U.S. patent 3,506,720, and european patent application 0,251,591; chlorhexidine (Merck Index number 2090); alexidine (Merck Index number 222); zygotedine (Merck Index number 4624); sanguinarine (Merck Index No. 8320); benzalkonium chloride (Merck Index 1066); salicylanilide (Merck Index No. 8299); dumet (Merck Index No. 3411); cetyl Pyridinium Chloride (CPC) (Merck Index No. 2024); tetradecylpyridinium chloride (TPC); n-tetradecyl-4-ethylpyridine chloride (TDEPC); decabine; delmopinol, octupiferol and other piperidino derivatives; cocoamidopropyl betaine, sodium cocoamidoglutamate, sodium lauryl sarcosinate, GTF inhibitors, polyvinylpyrrolidone iodimopinol, propolis, phthalic acid and its salts, monopoly phthalic acid and its salts and esters, ascorbyl stearate, oleoyl sarcosine, alkyl sulfate. The article of manufacture may comprise an effective antimicrobial amount of essential oils, herbal extracts, and combinations thereof, such as citral, geranial, rosemary extract, tea extract, magnolia extract, eucalyptol, carvacrol, citral, sabinol, catechol, methyl salicylate, epigallocatechin gallate, epigallocatechin, gallic acid, miswak (miswak) extract, sea buckthorn extract, and combinations of menthol, eucalyptol, 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 Wo Gemeng, amoxicillin, tetracycline, doxycycline, minocycline, and metronidazole; and analogs and salts of the above-described antimicrobial antiplaque agents and/or antifungal agents, such as those used in the treatment of candida albicans. If present, these active agents are generally present in safe and effective amounts, for example, from about 0.1 to about 5% by weight of the articles of the present invention.

In another aspect, anticaries agents may be suitable oral care active agents for use in the articles of the present invention. The anticaries agent is selected from fluoride, sodium fluoride, potassium fluoride, titanium fluoride, hydrofluoric acid, amine fluoride, sodium monofluorophosphate, ammonium fluoride, stannous chloride, stannous gluconate, copper salt, copper chloride, copper 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, sodium potassium oxalate, casein phosphopeptide-coated hydroxyapatite, siO-containing, and the like ₂ 、CaO、Na ₂ O、P ₂ O ₅ 、CaF ₂ 、B ₂ O ₃ 、K ₂ O, mgO of one or more ofBioglass, such as those disclosed in US 5,735,942. The ready-to-use article, if present, provides about 50ppm to 10,000ppm, preferably about 100ppm to 3000ppm, of fluoride ions in the article as disclosed herein.

In addition, nutrients such as minerals may improve teeth and tooth surfaces and thus may be used as suitable oral care actives with the articles 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, wolters Kluer Company, st.louis, mo.,

1997, pages 10-17.

Bleaching agent

The solid hydrophilic particles may comprise a bleach as an oral care active and preferably deliver hydrogen peroxide as an adduct or complex of hydrogen peroxide, or a precursor of hydrogen peroxide. Examples of hydrophilic bleach particles include providing a bleaching effect, stain removal effect, stain change effect, or any other effect that changes or whitens tooth color. For example, the hydrophilic bleach particles comprise a peroxide radical source. Hydrophilic bleach particles can include peroxides, metal chlorites, peroxyacids, persulfates, compounds that form the foregoing compounds in situ, and combinations thereof. Examples of peroxide compounds may include urea peroxide (also known as carbamide peroxide or urea hydrogen peroxide adducts) and mixtures thereof. Examples of metal chlorites can include calcium chlorite, barium chlorite, magnesium chlorite, lithium chlorite, sodium chlorite, potassium chlorite, and mixtures thereof. Examples of hydrophilic bleach particles may include hypochlorites (such as metal hypochlorites). Examples of persulfates may include salts of peroxomonosulfates, peroxodisulfates, and mixtures thereof. Examples of persulfates and hypochlorites include salts of the corresponding sodium, calcium, potassium, and other metals. Examples of preferred solid hydrophilic bleach particles include, but are not limited to, complexes of hydrogen peroxide and polyvinylpyrrolidone (PVP) polymers (also known as peroxone), carbamide peroxide and mixtures thereof, with complexes of hydrogen peroxide and polyvinylpyrrolidone (PVP) polymers being most preferred.

Thus, the ratio of the weight percent concentration of an oral care active agent, such as hydrogen peroxide, present in the solid hydrophilic particles to the weight percent concentration of the active agent present in the entire article as delivered by the articles disclosed herein is high. This is caused by the combination of a high weight percent concentration of active agent present in the solid hydrophilic particles with a relatively low weight percent concentration of active agent present throughout the article. Without being bound by theory, in aspects of the invention that include 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, a high driving force achieves a surprisingly high level of bleaching efficacy and/or bleaching speed; while a low overall concentration or low level of bleaching agent delivered to the tooth surface may help reduce tooth sensitivity. For example, the ratio of the weight percent concentration of the oral care active present in the solid hydrophilic particles to the weight percent concentration of the oral care active present in the overall article may be from about 2 to about 50000, preferably from about 3 to about 10000, most preferably from about 5 to about 1000.

The oral care actives of the present invention may be stabilized against degradation by the shielding effect of the water insoluble delivery vehicle. Other stabilizers for oral care actives may be present in the articles as disclosed herein. Oral care actives such as bleaching agents may be further stabilized to prevent degradation of the article. Thus, stabilizers may be added to the articles of the present invention. Suitable stabilizers are, for example, orthophosphoric acid, phosphates such as sodium hydrogen phosphate, pyrophosphates, organic phosphonates, ethylenediamine tetraacetic 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. For example, a composition that exhibits additional oral care effects such asStabilizers for the anticalculus effect produced by the phosphates disclosed herein, preferably pyrophosphates, tripolyphosphates, hexametaphosphates, phytic acid, PO ₃ (PO2) _n Salts of PO3 (where n=2-30), phosphoric acid, gantrez, zinc salts (including zinc citrate, zinc lactate, zinc chloride, zinc phosphate, zinc oxide), enzymes such as dextranase, xylanase, protease, phosphonates such as bisphosphonates, chelators such as EDTA, sodium calcium EDTA, citrate, citric acid, oxalic acid, oxalates, polymers (such as those disclosed in U.S. patent application 16/216,329), PVP, polyacrylic acid (acrylic polymers), polyacrylates, stannous salts, tin salts. The stabilizer may be present in the articles 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% by weight of the articles. For example, the stabilizing agent may be present in the articles of the present invention in an amount of about 0.0001%, or 0.01% to about 0.01%, 0.1%, or about 1% by weight of the solid hydrophilic particles.

The stabilizer may also include a chelating agent. The chelating agent may be a copper, iron and/or manganese chelating agent, or mixtures thereof. Suitable chelating agents may be selected from: diethylene triamine pentaacetate, diethylene triamine penta (methylphosphonic acid), ethylenediamine-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' -disuccinic acid (EDDS), hydroxyethanediphosphate (HEDP) or mixtures thereof. The stabilizer may comprise ethylenediamine-N' -disuccinic acid or a salt thereof. ethylenediamine-N' -disuccinic acid may be in the form of the S, S enantiomer. The composition may comprise disodium 4, 5-dihydroxyisophthalenesulfonate, glutamic acid-N, N-diacetic acid (GLDA) and/or salts thereof, 2-hydroxypyridine-1-oxide, trilon P available from BASF (Ludwigshafen, germany) ^TM . Suitable chelating agents may also be calcium carbonate crystal growth inhibitors such as 1-hydroxyethane diphosphonic acid (HEDP); n, N-dicarboxymethyl-2-aminopentane-1, 5-diacid; 2-phosphonobutane-1, 2, 4-tricarboxylic acid; and salts thereof; and any combination thereof. The stabilizer may comprise a hydroxamic acid chelating agent, such as hydroxamic acid or the corresponding Salts, such as cocoa hydroxamic acid (Axis House RK 853).

The articles disclosed herein may comprise optional additional ingredients. For example, another optional ingredient may be present in the article that is intended to be released from the second side (e.g., distal) of the water-insoluble delivery vehicle. For example, cooling agents, desensitizing agents, tingling agents and/or taste and/or aesthetic modifiers such as flavoring agents may be used as optional ingredients in the articles of the present invention, for example, in amounts of from about 0.001% to about 10%, preferably from about 0.1% to about 1%, by weight of the article. Coolants, desensitizing agents and numbness agents can reduce potential negative sensations caused by active agents such as bleach, such as stinging, burning, and the like. A variety of materials may be used as the cooling agent including, but not limited to, carboxamides, menthol, ketals, diols, and mixtures thereof. The optional cooling agent in the compositions of the present invention may be a p-menthanecarbamoyl agent such as N-ethyl-p-menthane-3-carboxamide (referred to as "WS-3"), N,2, 3-trimethyl-2-isopropyl butanamide (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

) And mixtures thereof. As used herein, the term menthol and menthyl include the dextro-and levorotatory isomers of these compounds and their racemic mixtures. Desensitizing or analgesic agents may include, but are not limited to, strontium chloride, potassium nitrate, natural herbs such as nutgall, asarum, piper cubeba, galangal, scutellaria baicalensis, radix zanthoxyli, radix angelicae and the like. Suitable numbness agents include benzocaine, lidocaine, clove bud oil, and ethanol.

Suitable flavoring agents include wintergreen, peppermint, spearmint, clove bud, menthol, p-propenyl anisole, methyl salicylate, eucalyptol, 1-menthyl acetate, sage, eugenol, parsley oil, hydroxyphenyl butanone, α -ionone, oregano, lemon, orange, propenyl guaiacol, cinnamon, vanillin, thymol, linalool, cinnamaldehyde glycerol acetal (known as CGA), and mixtures thereof. If present, the flavoring agent is typically used in an amount of about 0.01% to about 10%, such as about 1% to about 5%, more preferably about 1.5% to about 2%, by weight of the article.

The articles of the present invention may optionally comprise sweeteners including sucralose, sucrose, glucose, saccharin, dextrose, levulose, lactose, mannitol, sorbitol, fructose, maltose, xylitol, sugar salts, thaumatin, aspartame, D-tryptophan, dihydrochalcones, acesulfame and cyclamates, particularly sodium cyclamate and sodium saccharin, and mixtures thereof. The article, if present, comprises from about 0.1% to about 10% of these agents, for example from about 0.1% to about 1%, by weight of the article.

Dyes, pigments, colorants, and mixtures thereof may optionally be included in the articles of the present invention to impart a colored appearance to the articles. The advantage of adding pigments and/or colorants to the articles herein is that: it will allow the user to see if the product covers their teeth uniformly and completely, as the coverage is easier to see with colored products. The colorant may provide a color similar to the color of the bleached tooth. The colorants useful in the present invention are stable with the active agent and are recognized as safe ones. The amount of dyes, pigments and colorants optionally used herein ranges from about 0.001% to about 15%, preferably from about 0.01% to about 10%, and more preferably from about 0.1% to about 5% by weight of the article.

In one aspect, it has surprisingly been found that two or more oral care active agents that are generally incompatible with each other can be separately combined in the same article of the present invention. Thus, solid water-insoluble delivery vehicles can maintain separation of such incompatible active agents. For example, the present invention may comprise a hydrophilic bleach as the active in combination with an additional oral care active that may further improve the bleaching efficacy of the article. Examples include combinations of bleaching agents with additional oral care actives that can provide a driving force to raise pH upon contact with water. Specifically, examples include solid hydrophilic peroxide-containing particles combined in a solid water insoluble delivery vehicle separately from sodium bicarbonate (baking soda). When contacted with each other, the peroxide and baking soda react with each other, and when added separately to the solid water insoluble delivery vehicle of the present invention, they can be kept separate from each other prior to use. Without wishing to be bound by theory, it is hypothesized that the particles of the two or more hydrophilic oral care active agents that are generally incompatible with each other remain substantially separated from each other in the water insoluble delivery vehicle-such separation can minimize or eliminate the incompatibility even on a microscopic scale. Further, it is also contemplated that when the particles of one of the hydrophilic oral care agents are contacted with moisture, such as when used in the oral cavity, the components of the particles may at least partially dissolve or swell and be in direct contact with the 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 article before that time. Thus, the articles of the present invention may comprise two or more oral care active agents that are generally incompatible with each other.

If it is desired to incorporate an oral care active into the solid hydrophilic particles of the present invention, but the oral care active is typically provided in the form of solid particles having relatively low water solubility (e.g., less than about 20, preferably less than about 15 parts by weight of the solid particles dissolved in about 100 parts by weight of water), such oral care active may be dissolved in a suitable solvent (e.g., water, glycerin, etc.), then incorporated into solid hydrophilic particles (e.g., PVP solid hydrophilic particles), and then the resulting solid hydrophilic particles comprising the oral care active are incorporated into the oral care article of the present invention.

If it is desired to incorporate an oral care active into the solid hydrophilic particles of the present invention, but the oral care active is typically provided in the form of a liquid material, such oral care active may be incorporated into solid hydrophilic particles (e.g., PVP solid hydrophilic particles) and then the resulting solid hydrophilic particles comprising the oral care active are incorporated into the oral care articles of the present invention.

Identification mark

The oral care articles of the present invention may also include identifying indicia to assist the user of the article in applying the correct side of the article to the teeth of the user. The user preferably applies the first surface of the article (as described herein) to the user's teeth while the second surface is remote from the user's teeth. The identifying indicia may be in the form of text, logos, trademarks, trade names, etc., and are printed or embossed on the surface of the oral care article itself or on the packaging of the oral care article. The identifying indicia may also include coloring the first surface of the article to a different color than the second surface of the article. Thus, in one aspect, the oral care article further comprises an identifying indicia to distinguish (preferably visually distinguish) the first surface of the article from the second surface of the article.

Bleaching efficacy

If a bleaching agent is used as an oral care active, for example, the bleaching efficacy of the inventive article 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. Generally, a change in yellowness of at least 0.25 as measured according to the clinical protocols disclosed herein and calculated as- Δb is significant.

If a bleaching agent is used as an oral care active, for example, the present invention can achieve a surprisingly high ratio of bleaching efficacy as measured according to the clinical protocols disclosed herein and calculated as- Δb to the weight percent of bleaching agent present in the overall article. For example, for a preparation comprising 3% bleach by weight of the preparation, - Δb of 1.5 would achieve a ratio of bleaching efficacy of- Δb to the weight percent of bleach present in the whole preparation of 0.5 as measured according to the clinical protocol disclosed herein. If a bleaching agent is used as an oral care active, for example, the ratio of the bleaching efficacy of the present invention to the weight percent of bleaching agent present in the overall article, as measured and calculated as- Δb according to the clinical protocols disclosed herein, may be at least about 2.5, preferably at least about 5, more preferably at least about 10, even more preferably at least about 15.

If a bleaching agent is used as an oral care active, for example, the invention may achieve: 1) A surprisingly high ratio of bleaching efficacy as measured according to the clinical protocol disclosed herein and calculated as- Δb to the proportion of participants reporting oral irritation or observed to have oral irritation that can or can be attributed to the tested article; 2) A surprisingly high ratio of bleaching efficacy to the proportion of participants reporting tooth sensitivity that can or can be attributed to the article, as measured according to the clinical protocol disclosed herein and calculated as- Δb; or 3) a surprisingly high ratio of bleaching efficacy to reported tooth sensitivity and reported oral irritation or observed to have a participant ratio that can or can be attributed to oral irritation of the article as measured according to the clinical protocol disclosed herein and calculated as- Δb.

If a bleaching agent is used as an oral care active, for example, the ratio of bleaching efficacy of the present invention to reported tooth sensitivity, oral irritation, or both, or observed to have a tooth sensitivity, oral irritation, or both that may be or may be attributed to the present invention, as measured according to the clinical protocols disclosed herein, may be at least about 6, more preferably at least about 8, more preferably at least about 10, more preferably at least about 15, more preferably at least about 20, more preferably at least about 25, even more preferably at least about 50.

Clinical protocol

The bleaching efficacy of oral compositions comprising bleaching agents as active agents 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 oral composition had less than about 1% bleach, and 8 to 25 participants were recruited to complete the clinical study when the test oral composition had at least about 1% bleach. The recruiting participant must have four natural maxillary anterior teeth and all measurable facial sites. The mean baseline L of the participant group must be 71 to 76 and the mean baseline b of the participant group must be 13 to 18. In addition, malocclusions, severe or atypical intrinsic discoloration of the anterior maxillary teeth, such as the repair of the facial surfaces of the anterior maxillary teeth, crowns or facial surfaces caused by tetracycline, fluorosis or calcareousness, a self-recorded medical history of melanoma, current smoking or tobacco use, light-sensitive or skin pigment abnormalities, self-recorded tooth sensitivity, or previous tooth whitening using professional treatment, over-the-counter kits or research products, are excluded from the study. The home kit (both from Procter & Gamble, cincinnati, OH, USA) providing participants with Crest Cavity Protection toothpaste and Oral-B indicator soft manual toothbrush was used twice a day in a conventional manner.

The participants brushed their teeth with water for 30 seconds before being treated with the oral composition using a toothbrush (an "Anchor 41tuft whitening toothbrush" from Team Technologies, inc.Morristown, TN, USA). The anterior maxillary teeth of each participant were treated with the oral composition for 60 minutes once daily. If the oral composition to be evaluated is a semi-solid gel, 0.6g to 0.8g of the oral composition is applied to a transparent flexible polyethylene film having dimensions 66mm x 15mm and a thickness of about 0.01mm to about 0.02mm prior to application to the anterior maxillary tooth. If the oral composition to be evaluated is a solid product, the product is applied directly to the anterior maxillary tooth.

If the oral composition is used with electromagnetic radiation, then:

1) After 50 minutes of treatment with the oral composition, electromagnetic radiation was applied to the buccal surface of the anterior maxillary tooth for 10 minutes;

2) Electromagnetic radiation is directed through the oral composition toward the anterior maxillary teeth;

3) The water-insoluble delivery vehicle needs to allow at least about 90% of the electromagnetic radiation from 400nm to 500nm to pass through; and

4) Electromagnetic radiation is delivered via four fiber optic cables (model M71L01 from Thorlabs, newton, NJ, USA) connected to four high power LEDs (model M455F1 from Thorlabs, newton, NJ, USA) having peak intensity wavelengths of 455nm, as shown in FIG. 8. Four LEDs were each operated at 1000mA using an LED driver and HUB (model DC4104 and DC4100-HUB, available from Thorolabs, newton, NJ, USA). Outlet ends of four optical fiber cables Is mounted behind the transparent mouthpiece to facilitate reproducible positioning of the electromagnetic radiation against the outer surface of the water-insoluble delivery vehicle. The exit ends of the four fiber optic cables were approximately 7mm away from the exit surface of the mouthpiece through which the electromagnetic radiation passed. The articulator of the mouthpiece is offset such that the transparent window through which the electromagnetic radiation passes towards the anterior maxilla is 7.4mm high. In addition, the transparent window through which the electromagnetic radiation passes toward the anterior maxillary tooth is 40mm long, measured straight from end to end (excluding curves). The exit end of the fiber optic cable is positioned and angled such that the cone of electromagnetic radiation exiting the fiber optic cable is centrally located in the transparent window through which the electromagnetic radiation passes toward the anterior maxilla, as shown in fig. 8. In addition, the outlet ends of the four fiber optic cables are spaced apart such that the electromagnetic radiation cones are spaced apart throughout the length of the transparent window through which electromagnetic radiation passes toward the anterior maxilla, as shown in fig. 8. The intensity of electromagnetic radiation of 445nm to 465nm measured at the central axis of each cone of electromagnetic radiation exiting through the transparent window toward the exit face of the transparent window through which the maxillary anterior tooth passes needs to be about 175mW/cm ² To about 225mW/cm ² As measured by the methods disclosed herein.

Once the treatment with the oral composition is completed for 60 minutes, the polyethylene film is removed in the case of a semi-solid gel, or the article is removed in the case of a solid article. Treatments were performed once daily for a minimum of 7 days for oral compositions with less than about 1% bleach and for a minimum of 3 days for oral compositions with at least about 1% bleach.

The tooth color change due to treatment with the oral composition was measured using the procedure described below, measured for the day after treatment 7 for oral compositions having less than about 1% bleaching agent, and measured for the day after treatment 3 for oral compositions having at least about 1% bleaching agent.

Tooth color was measured using a digital camera (camera model Canon EOS 70D from Canon inc., melville, NY, having an NIKON 55mm micro-NIKKOR lens with adapter) with a lens equipped with a polarizing filter. The lamp system is provided by a Dedo lamp (model DLH 2) equipped with a 150 watt, 24V bulb model (Xenophot model HL X64640), positioned about 30cm apart (measured from the center of the outer circular surface of one to the other of the glass lenses through which light exits), and aimed at a 45 degree angle such that the light paths intersect at a vertical plane of chin rest about 36cm in front of the focal plane of the camera. Each light had a polarizing filter (Lee 201 filter) and a decolorizing filter (Rosco 7 mil thermalshield filter, available from Rosco, stamford, CT, USA).

At the intersection of the light paths, a fixed chin rest is mounted for repositioning in the light field. The camera is placed between the two lights such that its focal plane is about 36cm from the vertical plane of the chin rest. Before starting to measure tooth color, the color standard is imaged to establish a calibration set point. The Munsell N8 gray scale was first imaged. The white balance of the camera was adjusted so that the RGB value of gray was 200. The color standard is imaged to obtain standard RGB values for the color chip. Color and gray standards are listed in fibers (available from Munsell Color, division of X-rite, grand rapid, mich., USA). Each color standard is labeled with Munsell nomenclature. To create a grid of color standards, they may be arranged in the following manner. This allows the multiple color standards to be contained in a single image of a grid of captured color standards.

Color standard grid 1

Color standard grid 2

5YR7.53.5	2.5Y64	10YR7.53.5	2.5R78	7.5R78	10YR7.52
						10YR7.52.5	N50	2.5R68	10YR72	5R74	10YR72.5
N6.50	7.5RP68	7.5R84	5Y81	7.5YR82	2.2YR6.474.1
						N50	2.5Y84	10YR73	N9.50	10RP74	2.5Y72

Color standard grid 3

5R610	N8.50	10YR6.53.5	10RP610	N80	7.5YR73
						2.5Y3.50	10YR73.5	5Y8.51	5YR82.5	5YR7.53	5R56
10YR7.53	5YR6.53.5	2.5YR54	2.5Y82	10YR82	2.5Y72
						2.5R66	5R76	10YR82.5	10R56	N6.50	7.5YR83

For the baseline tooth color, the participants brushed their teeth with water to remove debris from the teeth using a toothbrush (an "Anchor 41tuft white toothbrush from Team Technologies, inc.Morristown, TN, USA). Each participant then pulls back the cheek using a cheek retractor (available from Scientific Camera Company, sumner, WA, USA; cincinnati, OH, USA with a frosted matte surface treatment) and causes the facial surfaces of their teeth to be illuminated. Each participant is instructed to bite their teeth together such that the incisors of the maxillary incisors contact the incisors of the mandibular incisors. The participants were then positioned on the chin rest with the intersection of the light paths centered in the camera field of view and the dental image captured. After imaging all participants, the images were processed using image analysis software (Optimas manufactured by Silver Spring, media Cybernetics of MD). The middle four incisors were separated and the average RGB values of the teeth were extracted.

After the participant uses the whitening product, but before capturing the participant's tooth image, the system is set to a 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 location as the pre-processed image, including the orientation of the teeth. The image is processed using image analysis software to obtain the average RGB values of the middle four maxillary incisors. The RGB values of all images are 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. The values of L x a x b x of the color chips on the color standard were measured using Photo Research SpectraScan PR650 from Photo Research inc, LA using the same illumination conditions described for capturing digital images of facial dentition. PR650 is positioned at the same distance from the color standard as the camera. After calibration, L x a x b x for each chip was measured individually according to manufacturer's instructions. The RGB values are then converted to lx values using regression equations, such as:

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

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]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

r of L, a and b ² Should be>0.95. Each study should have its own formula.

These formulas are generally efficient transformations in the areas of tooth color (60 <L*<95，0<a*<14，6<b*<25). The data from each participant's image set was then used to calculate product whitening performance from the L, a, and b changes-standard method for assessing whitening benefit. When evaluating oral compositions having less than about 1% bleach: the change in L is defined as Δl=l # _{The day after 7 treatments} –L* _{Base line} Wherein a positive change indicates an improvement in brightness; the change in a (red-green balance) is defined as Δa=a =a _{The day after 7 treatments} –a* _{Base line} Wherein a negative change indicates less red teeth; the change in b (yellow blue balance) is defined as Δb=b-b the day after 7 treatments _{Base line} Wherein a negative change indicates that the tooth is becoming less yellow. When evaluating oral compositions having at least about 1% bleach: the change in L is defined as Δl=l # _{After 3 times of treatment} –L* _{Base line} Wherein a positive change indicates an improvement in brightness; the change in a (red-green balance) is defined as Δa=a-a after 3 treatments _{Base line} Wherein a negative change indicates less red teeth; the change in b (yellow blue balance) is defined as Δb=b-b after 3 treatments _{Base line} Wherein a negative change indicates that the tooth is becoming less yellow. Δb is used as the primary measure of bleaching efficacy. The overall color change is represented by the formula Δe= (Δl +) ² +Δa* ² +Δb* ² ) ^1/2 To calculate.

After using the whitening product, color variation of the CIE Lab color space can be calculated for each participant based on a given formula.

Preparation of the inventive article

The present invention also relates to a method of making an oral care article comprising the steps of: (i) Providing a solid water-insoluble delivery vehicle in the form of a strip having a length and a width forming a first surface and having a thickness extending from the first surface to a second surface, preferably wherein the average thickness is less than about 3mm; (ii) Applying solid hydrophilic particles comprising an oral care active agent to a first surface of a solid water insoluble delivery vehicle, the content of solid hydrophilic particles preferably being from about 0.01% to about 15% by total weight of solid water insoluble delivery vehicle and solid hydrophilic particles; and (iii) forcing the solid hydrophilic particles into the first surface of the solid water insoluble delivery vehicle, thereby preferably embedding the solid hydrophilic particles into the solid water insoluble delivery vehicle.

In one aspect, the particles are forced into the first surface of the solid water-insoluble delivery vehicle under a pressure of at least about 50 pounds Per Square Inch (PSI), preferably at least about 500PSI, preferably at least about 5000PSI, and most preferably at least about 50,000PSI.

In one aspect, the solid hydrophilic particles are applied only to the first surface of the solid water-insoluble delivery vehicle (i.e., the solid hydrophilic particles are not applied to the second surface of the solid water-insoluble delivery vehicle).

Commercially available materials, such as size 24 casting wax clear (reference number 114009, provided by Freeman Manufacturing Company, ohio, USA) may be used as the water insoluble delivery vehicle of the present invention.

The solid hydrophilic particles may be forced into or embedded in the water insoluble delivery vehicle by any suitable procedure, for example:

1. the solid hydrophilic particles may be sieved or deposited onto a water insoluble delivery vehicle and pressed under a specified pressure in a hydraulic press for a specified period of time, for example, for 60 seconds at 625PSI, such that the solid hydrophilic particles are embedded in the water insoluble delivery vehicle. The material may then be cut into suitable shapes, such as strips.

2. The solid hydrophilic particles may be sieved or deposited onto a water insoluble delivery vehicle and pressed by a press roll at a specified pressure or nip such that the solid hydrophilic particles are embedded in the water insoluble delivery vehicle.

3. A photosensitive drum (e.g., in combination with corona wires and lasers) can be used to obtain a selective surface charge that attracts solid hydrophilic particles in a desired amount. The solid hydrophilic particles can then be deposited onto a water insoluble delivery vehicle using a photosensitive drum, and then passed between press rolls to embed the solid hydrophilic particles in the water insoluble delivery vehicle.

4. The surface of the water-insoluble delivery vehicle may be at least partially melted (e.g., by a stream of hot air), and the solid hydrophilic particles may then be sieved or deposited onto the partially melted surface. The water-insoluble delivery vehicle may then be cooled (e.g., by exposure to ambient air) such that the melted water-insoluble delivery vehicle resolidifies around at least a portion of the solid hydrophilic particles, thereby embedding them in the water-insoluble delivery vehicle.

The present invention also relates to methods of making oral care articles wherein solid hydrophilic particles can be disposed in a water insoluble delivery vehicle by any suitable procedure, such as:

1. the material of the water-insoluble delivery vehicle may also be at least partially melted or softened and the solid hydrophilic particles may be incorporated into the partially melted or softened material by mixing or kneading. The material may then be cooled or solidified and formed into a suitable form, such as a tape.

2. The solid hydrophilic particles may also be incorporated into the material of the water insoluble delivery vehicle by repeatedly folding the water insoluble delivery vehicle over the solid hydrophilic particles and recompressing it into a sheet in a hydraulic press. The material may then be formed into a suitable form, such as a strip.

3. The material of the water-insoluble delivery vehicle may be softened by heating until it becomes plastic, for example at about 50 ℃. It may be mixed with the solid hydrophilic particles at the plastic temperature, for example in a single screw extruder, twin screw extruder, z-blade mixer or similar equipment suitable for processing viscous materials. The mixture of plastic water insoluble delivery vehicle and solid hydrophilic particles can then be formed into a suitable form, such as a tape or tray, by conventional forming techniques such as extrusion, injection molding, thermoforming, and the like.

4. The material of the water-insoluble delivery vehicle may be melted, for example, at 80 ℃, and then mixed with the solid hydrophilic particles using conventional mixing equipment. The molten mixture may then be formed into a suitable form, such as a tape or tray, by conventional forming techniques such as casting or injection molding.

The oral care articles of the present invention may be unit dose articles and/or removable articles. Suitable examples of "unit dose articles" and/or "removable articles" include gauge 24 cast wax transparency sheet (reference number 114009, provided by Freeman Manufacturing Company, ohio, USA) in combination with solid hydrophilic particles comprising at least one oral care active agent, such as bleach, and a) cut into strips about 0.51mm thick, about 22mm wide and about 62mm long, or b) preformed into dental trays. Examples of products that are not "unit dose products" or "removable products" include stick products (e.g., lip balm or lipstick) -since these are typically not single use products, nor are they typically removed from the oral cavity.

Referring now to the drawings, fig. 1A illustrates an oral care article 10 for delivering an active agent provided by solid hydrophilic particles 20 in a solid water insoluble delivery vehicle 12 as disclosed herein to teeth and oral cavity. The water-insoluble delivery vehicle 12 is in the form of a strip comprising a surface having a width W of about 50mm to about 80mm and a length L of about 15mm to 25 mm. The body of the water-insoluble delivery vehicle 12 has an average thickness T of about 0.15mm to about 1.0 mm. The water insoluble delivery vehicle 12 in fig. 1A is shaped in the form of a strip that is substantially flat and may have rounded corners. A suitable strip may be a gauge 24 cast wax transparency cut into strips of about 0.51mm thick, about 22mm wide and about 62mm long (reference number 114009, supplied by Freeman Manufacturing Company, ohio, USA). The solid hydrophilic particles 20 are contained in the water-insoluble delivery vehicle 12 by the melting process, and some of the particles are near the surface and/or some of them may be in direct contact with the environment.

Fig. 1B illustrates another embodiment of an article 10 for delivering an active agent provided by solid hydrophilic particles 20 in a water insoluble delivery vehicle 12 as disclosed herein to teeth and oral cavity. The water insoluble delivery vehicle 12 in fig. 1B is in the form of a strip with rounded corners. The strip includes a first surface 14 having a width W of about 50mm to about 80mm and a length L of about 15mm to 25mm and a second surface 16 on opposite sides of the water insoluble delivery vehicle 12. The first surface 14 and the second surface 16 are separated by a body of the water-insoluble delivery vehicle 12 having an average thickness T of about 0.15mm to about 1.0 mm. A suitable strip may be a gauge 24 cast wax transparency cut into strips of about 0.51mm thick, about 22mm wide and about 62mm long (reference number 114009, supplied by Freeman Manufacturing Company, ohio, USA). The solid hydrophilic particles 20 are embedded in the water-insoluble delivery vehicle 12 of fig. 1B such that at least some of the solid hydrophilic particles 20 are proximate to the first surface 14 and/or some of them may be in direct contact with the environment and/or may protrude slightly from the first surface 14. The second surface 16 exhibits less or no solid hydrophilic particles 20 as compared to the first surface 14.

The solid hydrophilic particles 20 used in the article 10 shown in fig. 1A and 1B may comprise a bleaching agent or be an oral care active agent itself, the bleaching agent being capable of affecting or effecting a desired change in appearance or structure of the surface with which it is in contact. As previously discussed, exemplary oral care actives include: hydrogen peroxide, carbamide peroxide, sodium fluoride, sodium monofluorophosphate, pyrophosphate, chlorhexidine, polyphosphate, triclosan, enzymes, and mixtures thereof. Examples of changes in appearance and structure include, but are not limited to, stain bleaching, stain removal, remineralization to form fluorapatite, plaque removal, and tartar removal.

Fig. 2A shows a cross-sectional view taken along section line 2-2 of the water-insoluble delivery vehicle 12 shown in fig. 1A. From this figure, it can be seen that the solid hydrophilic particles 20 are irregularly distributed within the bulk of the water-insoluble delivery vehicle 12. The solid hydrophilic particles 20 may also be located near the surface of the water insoluble delivery vehicle 12 or may be in contact with the environment.

Fig. 2B shows a cross-sectional view taken along section line 2-2 of the water-insoluble delivery vehicle 12 shown in fig. 1B. From this figure, it can be seen that the concentration of solid hydrophilic particles 20 at the first surface 14 of the water-insoluble delivery vehicle 12 produced by the intercalation process is greater than the concentration of solid hydrophilic particles 20 at the second surface 16. In the article shown in fig. 2B, the second surface 16 is almost free of solid hydrophilic particles 20.

Fig. 3 and 4 illustrate an article 10 of the present invention applied to the tooth surfaces of a plurality of adjacent teeth 22. The article 10 may be applied to the tooth surface after or before molding (fig. 3). For example, the article 10 may be applied to the teeth with sufficient force to shape the water-insoluble delivery vehicle 12 such that it at least partially conforms to the shape of the teeth 22, such as shown in fig. 3. Embedded in adjacent soft tissue 24 are a plurality of adjacent teeth 22 (fig. 4). Adjacent soft tissue 24 is defined herein as a soft tissue surface surrounding a tooth structure, which includes: gingival papillae, marginal gingiva, gingival sulcus, interproximal gingiva, and mucosal-gingival junctions (including those) on the upper jaw from gingival structures on the lingual and buccal surfaces. In both fig. 3 and 4, the article 10 is preferably in the form of a strip. The material of the water-insoluble delivery vehicle 12 of the article 10 may have a thickness and a flexural rigidity of at least 50g/cm such that it may conform to the surface contours of the teeth 22 and adjacent soft tissue 24. Thus, the water-insoluble delivery vehicle 12 may have sufficient flexibility to shape into the contours of the oral surface, which is a plurality of adjacent teeth 22, wherein the article 10 may be applied without significant pressure. A suitable material for the water-insoluble delivery vehicle 12 of the article 10 may be a casting wax (reference number 114009, provided by Freeman Manufacturing Company, ohio, USA).

The water-insoluble delivery vehicle 12 serves as a protective barrier for the oral care active provided by the solid hydrophilic particles 20. It prevents leaching or corroding of the active agent by the wearer's tongue, lips and saliva. This allows the solid hydrophilic particles 20 to act on the tooth surface 22 of the oral cavity for a desired period of time, for example, a few minutes to a few hours.

Fig. 5A is a photographic image of a gauge 24 cast wax transparency (reference number 114009, supplied by Freeman Manufacturing Company, ohio, USA) cut into strips about 22mm wide and about 62mm long. The strip may be used directly as a water insoluble delivery vehicle 12 or the water insoluble delivery vehicle 12 may be shaped into a tray (fig. 5B and 5C). During use, the first surface 14 of the water-insoluble delivery vehicle 12 will be positioned inside the tray of the tooth-facing surface. The second surface 16 will be on the outside of the tray, facing the soft tissue and tongue during use. The water-insoluble delivery vehicle 12 may be shaped in the form of a tray with (fig. 5C) or without (fig. 5B) notches 18.

Fig. 6 is Sup>A photographic image (example IV-Sup>A) of Sup>A cast wax sheet (reference number 114009, provided by Freeman Manufacturing Company, ohio, USA) that may be used as the water insoluble delivery vehicle 12 comprising embedded solid hydrophilic particles 20. FIG. 7 shows Sup>A photomicrograph (4 times magnification) of the same example (IV-A).

Methods of using oral care articles

The invention also relates to methods of using the oral care articles of the invention. The oral care articles may be applied to the teeth of a consumer by a dental professional in a dental office, or may be used by the consumer at home. Typically, the recommended treatment period is a period of time sufficient to achieve the desired effect of the oral care active, e.g., to achieve a desired level of bleaching.

In practicing the present invention, a user applies the present article comprising an oral care active to one or more teeth to achieve a desired effect, such as whitening. The article may be applied with any suitable auxiliary device or even with the fingers. The articles herein are preferably hardly noticeable when applied to teeth. After a desired period of time, the residual product can be easily removed from the tooth surface. Generally, no preparation of the teeth prior to application of the inventive article is required. For example, a user may choose to brush or rinse the teeth prior to applying the article of the present invention, but the oral surfaces need neither be cleaned nor be excessively wetted with saliva or water prior to application.

The above-described articles and delivery systems may be combined in a kit comprising: 1. the product of the invention and 2. Instructions for use; or it comprises: 1. the product of the invention, and 2. Instructions for use. If the teeth are to be irradiated with electromagnetic radiation, the kit may also include a source of electromagnetic radiation of a suitable wavelength and instructions for use so that the kit may be used in a convenient manner by the consumer.

Optional electromagnetic radiation treatment

Articles disclosed herein, such as those comprising a bleaching agent as an oral care active, can be used to whiten/bleach teeth and/or remove stains from tooth surfaces. Whitening efficacy may be further enhanced by directing electromagnetic radiation of a suitable wavelength to at least one tooth. A device suitable for providing such electromagnetic radiation is shown in fig. 8. If the effectiveness of the active agent provided by the solid hydrophilic particles 20 can be increased by electromagnetic radiation, electromagnetic radiation is applied to the article 10 disclosed herein. For example, if the active agent is a bleach or a whitening agent, such as a peroxide, electromagnetic radiation having a peak intensity wavelength of about 455nm may enhance bleaching efficacy.

Suitable wavelengths may be any wavelength corresponding to the maximum absorption band of the tooth and/or tooth stain to be bleached. For example, the article may be irradiated with electromagnetic radiation having one or more wavelengths in the range of about 200nm to about 1200 nm. Electromagnetic radiation may be directed to at least one tooth. For example, more than one tooth may be illuminated. For example, the electromagnetic radiation may have a peak intensity at a wavelength in the range of about 400nm to about 500nm, preferably about 425nm to about 475nm, and most preferably about 445nm to about 465nm, or wherein the peak intensity wavelength of the electromagnetic radiation is similar to the wavelength of the stain absorption maximum electromagnetic radiation. Electromagnetic radiation may be directed to at least one tooth during part or all of the wear time of the article; or after the article has been removed from the tooth. The electromagnetic radiation may be applied for a period of time at least sufficient for whitening or for a period of time sufficient to achieve the desired effect of the active, for example at least about 1 minute, for example at least about 5 minutes, for example at least about 10 minutes. Electromagnetic radiation may be applied using the procedure disclosed in US 2013/0295125. Preferably, the articles disclosed herein are applied to at least one tooth and remain on the at least one tooth for a first period of time; after a first period of time, directing electromagnetic radiation to at least one tooth for a second period of time, wherein the first period of time has a duration of greater than 50%, preferably 80%, of the total duration of the first and second periods of time; and finally, removing the article from the at least one tooth.

Suitable sources of electromagnetic radiation include those described herein in the section entitled "clinical protocols".

The articles disclosed herein may be transparent or translucent to electromagnetic radiation having a wavelength of about 400nm to about 500 nm. For example, the articles disclosed herein, when applied at an average thickness of about 0.05mm to about 2mm, preferably about 0.1mm to about 1.0mm, more preferably about 0.25mm to about 0.75mm, allow about 10%, 20% or 30% to about 40%, 50%, 60%, 70%, 80%, 90% or 100% of electromagnetic radiation from about 400nm to about 500nm to pass through as measured by a spectrophotometer.

The electromagnetic radiation having a wavelength in the range of about 400nm to about 500nm impinging on the tooth surface or the outer surface of the water insoluble delivery vehicle may have an intensity in the range of about 5mW/cm2 to about 500mW/cm2, preferably about 10mW/cm2 to about 300mW/cm2, most preferably about 175mW/cm2 to about 250mW/cm2, as measured according to the procedures specified herein.

Procedure for measuring intensity of electromagnetic radiation

The intensity of electromagnetic radiation can be measured using an optical photometer (USB 2000 < + >) connected to a UV-VIS 200 micro fiber cable with a cosine corrector at its tip (OP 200-2-UV-VIS from Ocean Optics). The photometer was connected to a computer running photometer software (oceanoview 1.3.4 from Ocean Optics). The tip of the fiber optic cable is held pointed at the light source at the location where the light intensity is to be measured. Photons collected at the detector surface are directed through a fiber optic cable to an electrically coupled device in a photometer (CCD). The CCD calculates photons that reach the CCD during a predetermined period of time at each wavelength of 200nm to 1100nm and converts these photon counts into spectral irradiance (mW/cm) using a software algorithm ² /nm). Integrating the spectral irradiance from 200nm to 1100nm by software to produce absolute irradiance (mW/cm ² ) Which is the intensity of electromagnetic radiation from 200nm to 1100 nm. Integrating the spectral irradiance from 400nm to 500nm by software to produce absolute irradiance (mW/cm ² ) It is 400nm to 50Intensity of electromagnetic radiation at 0 nm.

For the convenience of the consumer, the articles disclosed herein may be provided as kits comprising the articles disclosed herein, an optional electromagnetic radiation source that emits electromagnetic radiation of a suitable wavelength, and instructions for use.

The articles of the invention may be used in human and other animal (e.g., pet, zoo, or livestock) applications.

Examples

Preferred articles within the scope of the present invention are further described in the following non-limiting examples I-A, II-A, II-B, II-C, II-D, II-E, III-A, III-B, III-C, IV-A, V-A, VI-A and VI-B. Many variations of these embodiments are possible without departing from the scope of the invention. All examples were performed at Room Temperature (RT) and atmospheric pressure unless otherwise indicated.

These examples (and comparative examples II-A) were prepared by the following steps: 1) weighing the cast wax sheet, 2) sieving solid hydrophilic particles (a complex of hydrogen peroxide and polyvinylpyrrolidone, carbamide peroxide or sodium percarbonate) onto the cast wax sheet through a U.S. standard test sieve No. 40 with 425 micron openings, 3) sandwiching the wax sheet and particles between two papers and a non-stick release liner, 4) placing the sandwich in a hydraulic press and applying 625psi pressure for 60 seconds, 5) taking out the wax sheet now embedded with particles and weighing to calculate the weight of the embedded particles. The sheets may be cut to a shape and size suitable for use in the oral cavity, for example about 22mm wide and about 62mm long.

¹ Cast wax flakes 26-gauge, reference 114010, average thickness about 0.39mm, about 10cm x about 10cm square, provided by FreemanManufacturing Company, ohio, USA

² Cast wax flakes 24-gauge, reference 114009, average thickness about 0.51mm, about 10cm x about 10cm square, by Freeman Manufacturing Company, ohio, USAFeed device

³ Peroxydone K-30, available from Ashland Global Specialty Chemicals Inc., covington, KY. Solubility of>40 parts per 100 parts of water (estimated from the information provided in the product data sheet for polyvinylpyrrolidone polymer K-30 from the supplier). Sieving was performed through a U.S. standard test sieve No. 40 having 425 micron openings. According to the information from the suppliers, about 17% to 20% (median 18.5%) of H2O2 is contained.

² Cast wax flakes 24-gauge, reference 114009, average thickness about 0.51mm, about 10cm x about 10cm square, provided by Freeman Manufacturing Company, ohio, USA

³ Peroxydone K-30, available from Ashland Global Specialty Chemicals Inc., covington, KY. Solubility of >40 parts per 100 parts of water (estimated from the information provided in the product data sheet for polyvinylpyrrolidone polymer K-30 from the supplier). Sieving was performed through a U.S. standard test sieve No. 40 having 425 micron openings. According to the information from the suppliers, about 17% to 20% (median 18.5%) of H2O2 is contained.

	VI-A	VI-B
			Casting wax sheet24-gauge ¹ (g)	4.9286	5.0906
Carbamide peroxide ² (g)	0.4733	0.4848
			H2O2％	3.10	3.08
% hydrophilic particles	8.76	8.69

¹ Cast wax flakes 24-gauge, reference 114009, average thickness about 0.51mm, about 10cm x about 10cm square, provided by FreemanManufacturing Company, ohio, USA

² Urea hydrogen peroxide adduct, catalog No. L13940, available from Alfa Aesar, ward Hill, MA. The solubility in water at 20℃was 800 g/l (80 parts per 100 parts of water) according to the safety data sheet provided by the supplier. Sieving was performed through a U.S. standard test sieve No. 40 having 425 micron openings. The wikipedia according to 9/22 of 2020 contains about 35.4% H2O2.

Comparative example

Comparative example II-A
		Casting wax sheet 24-specification ¹ (g)	5.0586
Sodium percarbonate ² (g)	0.5058
		H2O2％	2.95
% hydrophilic particles	9.09

² Sodium percarbonate, catalog number a16045, available from Alfa Aesar, ward Hill, MA. Solubility in water was 150 grams/liter (15 parts per 100 parts water) -information from wikipedia published on day 21, 5, 2018. Calculated to contain about 32.5% H2O2. Sieving was performed through a U.S. standard test sieve No. 40 having 425 micron openings.

Bleaching efficacy

The results of bleaching efficacy of examples I-A (using electromagnetic radiation) and comparative examples I-A (using electromagnetic radiation) measured according to the in vitro procedure specified herein are set forth in Table 1.

TABLE 1 bleaching efficacy

Table 1 shows that even though example I-A has less% bleach (2.77% vs. 9.5%), example I-A provides a similar level of yellowness reduction (- Δb. Times. 2.9 vs. 2.8) as comparative example I-A. These results clearly demonstrate that example I-A (PVP-peroxide particles embedded in wax delivery vehicle) and comparative example I-A (H2O 2 dissolved in aqueous polymer gel) have surprisingly similar levels of efficacy, even though the% bleach of example I-A is less than 1/3 of comparative example I-A. These results clearly demonstrate that solid hydrophilic particles comprising bleach as an oral care active embedded in a wax delivery vehicle have a surprisingly large impact on efficacy.

The bleaching efficacy of examples III-A, III-B and III-C (samples taken from all three batches) and comparative examples I-A (using electromagnetic radiation) measured according to the in vitro procedure specified herein are listed in Table 2.

TABLE 2 bleaching efficacy

Table 2 shows that even though examples III-A, III-B and III-C had less% bleach (about 0.1% vs. 9.5%), examples III-A, III-B and III-C provided only slightly less yellow reduction (- Δb) after three treatments than comparative examples I-A (2.19 vs. 2.8). In particular, these results demonstrate that, surprisingly, examples III-A, III-B and III-C provide a reduction in yellowness of about 78% after one treatment of example I-A, even more surprisingly, because examples III-A, III-B and III-C have only about 1% bleach of comparative example I-A. These results clearly demonstrate that examples III-A, III-B and III-C (PVP-peroxide particles embedded in wax delivery vehicle) provide surprisingly high efficacy even at very low levels of% bleach-this may be particularly useful for people with sensitive teeth, or in areas with very severe limits on% peroxide. These results clearly demonstrate that solid hydrophilic particles comprising bleach as active agent embedded in a wax delivery vehicle have a surprisingly large impact on efficacy.

The bleaching efficacy of examples II-E (using electromagnetic radiation) and comparative examples II-A (using electromagnetic radiation) as measured according to the in vitro procedure specified herein are set forth in Table 3.

TABLE 3 bleaching efficacy

Table 3 shows that examples II-E provide a 58% greater reduction in yellowness (- Δb) than comparative examples II-A (3.8 vs. 2.4), although both products have the same level of% bleach (about 3%). In particular, these results clearly demonstrate that the articles prepared with solid hydrophilic particles (PVP-peroxide) having a solubility of 40 parts by weight in 100 parts by weight of water (examples II-E) have surprisingly high efficacy, even though both compositions have the same level of H2O2 (about 3%), compared to the articles prepared with solid hydrophilic particles (sodium percarbonate) having a solubility of only 15 parts by weight in 100 parts by weight of water (comparative example II-a). These results clearly demonstrate that the solubility of the solid hydrophilic particles has a surprisingly large impact on bleaching efficacy.

The bleaching efficacy of examples II-E (using electromagnetic radiation) and examples I-A (using electromagnetic radiation) as measured according to the in vitro procedure specified herein are listed in Table 4.

TABLE 4 bleaching efficacy

Table 4 shows that examples II-E provide a 31% greater reduction in yellowness (- Δb) than example I-A (3.8 vs. 2.9), although both products have the same level of% bleach (about 3%). In particular, these results clearly demonstrate that articles made with water-insoluble delivery vehicles having an average thickness of 0.51mm (examples II-E) have surprisingly high efficacy, even though both compositions have the same level of H2O2 (about 3%) compared to articles made with water-insoluble delivery vehicles having an average thickness of only 0.39mm (examples I-a). These results clearly demonstrate that the average thickness of the water-insoluble delivery vehicle has a surprisingly large impact on bleaching efficacy.

Bleach concentration at surface

Bleach concentrations at the first and second surfaces of examples II-A, II-B, II-C and II-D (samples taken from all four batches) measured according to the procedure specified herein are listed in table 5.

TABLE 5 bleaching agent concentration at surface

Table 5 shows that the bleach concentration at the first surface is greater than the bleach concentration at the second surface (1304 micrograms/cm 2 versus 82 micrograms/cm 2). These results also show that the ratio of bleach concentration at the first surface divided by bleach concentration at the second surface is about 16, which is greater than ratio 1. These results clearly demonstrate the surprising ability of the present invention to deliver more oral care active or bleach to the surface where they are most needed.

Bleach concentrations at the first and second surfaces of examples VI-a and VI-B (samples taken from two batches) measured according to the procedure specified herein are listed in table 6.

TABLE 6 bleaching agent concentration at surface

Table 6 shows that the bleach concentration at the first surface is greater than the bleach concentration at the second surface (1457 micrograms/cm 2 versus 43 micrograms/cm 2). These results also show that the ratio of bleach concentration at the first surface divided by bleach concentration at the second surface is about 34, which is greater than ratio 1. These results clearly demonstrate the surprising ability of the present invention to deliver more oral care active or bleach to the surface where they are most needed.

The bleach concentrations at the surface of examples II-A, II-B, II-C and II-D (samples taken from all four batches) and at the surface of comparative example I-A, measured according to the procedure specified herein, are set forth in Table 7.

TABLE 7 bleaching agent concentration at surface

Table 7 shows that examples II-A, II-B, II-C and II-D have higher bleach concentrations at the surface (1304 micrograms/cm 2 versus 670 micrograms/cm 2) than comparative example I-A, even though examples II-A, II-B, II-C and II-D have less% bleach (about 3% versus about 9.5%). In particular, these results show that examples II-A, II-B, II-C and II-D have a bleach concentration at the surface of about 2 times that of comparative examples I-A even though examples II-A, II-B, II-C and II-D have a% bleach of less than 1/3 of comparative examples I-A. These results clearly demonstrate the surprising ability of the present invention to deliver more oral care active or bleach to the surfaces where they are most needed.

Number of solid particles at the surface

The number of solid particles at the first and second surfaces of example V-Sup>A counted according to the procedure specified herein is listed in table 8.

TABLE 8 number of particles at the surface

Table 8 shows that the number of solid particles per cm2 at the first surface is greater than the number of solid particles per cm2 at the second surface for example V-A (24.6/cm 2 vs. 1/cm 2). These datSup>A show that the ratio of the number of particles per cm2 at the first surface divided by the number of particles per cm2 at the second surface for example V-A is about 24.6, which is greater than ratio 1.

In vitro procedure for measuring bleaching efficacy

1. A disc (7.2 mm to 7.8mm diameter. Times.1.2 mm to 1.3mm thickness) was cut from the anterior surface of the human incisors. Leaving the buccal surface intact and flattening the lingual surface that has been cut from the teeth. The dental trays were stored in 15ml to 20ml water meeting USP specifications in glass vials for at least eighteen hours. The procedure was repeated for a total of 12 teeth.

2. The baseline L and B of the buccal surface of each fluted disc placed individually on a standard white background (white reference card for digital & film photography, e.g., DGK-XL X000B1R417 from DGK Color Tools) was measured using a handheld spectrophotometer Konica Minolta 700 d. Using a Konica Minolta 700d spectrophotometer with an aperture of about 6.3mm, the observer angle was set to 2 degrees, the light source was set to daylight color temperature 5003K, and specular reflection was excluded. To control the moisture content in the toothed disc during these measurements, discs of about 19mm diameter were cut from a transparent flexible polyethylene film of about 0.01mm to about 0.02mm thickness and placed on the toothed disc once it was removed from the water, and the values of L and b were measured by the polyethylene disc. A set of three measurements were taken daily on three different days. After each set of three measurements, the dental trays were stored in glass vials in 15ml to 20ml of water meeting USP specifications for at least eighteen hours. Calculate the average baseline L and b for each tray over all three days.

3. Each toothed disc was treated individually with the composition to be evaluated. If the composition is a solid product, a) the tray is removed from the water and the product is placed on the buccal surface of the tray while it is still wet, and b) pressure is briefly applied to the product to simulate positioning the product on teeth. If the composition is a semi-solid gel, a) the tray is removed from the water and about 0.04 to about 0.05 grams of gel is sandwiched between the tray and a polyethylene tray (cut from a transparent flexible polyethylene film about 0.01mm to about 0.02mm thick, about 19mm in diameter), and b) pressure is briefly applied to the polyethylene tray to simulate application of the gel to teeth. The tray + article or tray + gel + polyethylene tray sandwich was placed in an oven at about 34 c (to simulate conditions of the buccal surface of the anterior maxillary tooth) for about 60 minutes.

4. If the composition is used with electromagnetic radiation:

after 50 minutes of treatment with the composition, electromagnetic radiation was applied to the buccal surface of the dental tray for 10 minutes.

Electromagnetic radiation is directed towards the buccal surface of the dental tray through the article or through the gel + polyethylene tray.

Electromagnetic radiation is delivered via a fiber optic cable (model M71L01 from Thorlabs, newton, NJ, USA) connected to a high power LED (model M455F1 from Thorlabs, newton, NJ, USA) with a peak intensity wavelength of 455 nm. LEDs were operated at 1000mA using LED drivers (model DC2100, or DC4104 paired with DC4100-HUB, available from Thorlabs, newton, NJ, USA). The outlet end of the fiber optic cable is mounted to facilitate reproducible positioning of electromagnetic radiation against the outer surface of the ribbon. The outlet end of the fiber optic cable was about 7mm from the tooth surface. The intensity of the electromagnetic radiation of 400nm to 500nm measured at the distance at the central axis of the cone of electromagnetic radiation needs to be about 175mW/cm ² To about 225mW/cm ² As measured by the methods disclosed herein.

The radiation was applied to each dental tray for about 10 minutes.

5. Once the 60 minute treatment with the composition was completed, the residual composition on the tray was removed with paper towels and water.

6. After each treatment, the dental trays were stored in glass vials in 15ml to 20ml water meeting USP specifications for at least eighteen hours.

7. Eighteen (or more) hours after final treatment, post-treatment b for each toothed disc was measured separately using the previously specified procedure for the toothed disc. This was done for the next three days, and the average was taken for all three days for each toothed disc.

8. For each toothed disc, the change in b (yellow-blue balance) is calculated as Δb=b = _{After treatment} -b* _{Base line} Wherein a negative change indicates that the toothed disc is becoming less yellow. Δb is used as the primary measure of bleaching efficacy.

The average reduction in yellowness (- Δb) of all toothed plates was calculated.

Measuring the concentration of an oral care active at the surface of a water insoluble delivery vehicle (i.e., article) containing the active Sequence of steps

The concentration of the oral care active at the surface of the water insoluble delivery vehicle (i.e., article) containing the oral care active was measured according to the following procedure.

1. Discs of about 19mm diameter were cut from the article and their weights were recorded.

2. 0.425g +/-0.003g of water was weighed and placed into a small plastic weigh boat.

3. The disc was placed on water with a pair of tweezers and the surface to be tested was in contact with the water. Ensuring that water reaches the periphery of the disk but does not flow to the top of the disk.

After 4.2 minutes, the disc was removed and held upright to allow water to drop back into the weigh boat for 5 seconds.

5. The oral care active% of water was determined.

6. Calculate the total micrograms of oral care active agent in the water based on the initial amount of water added (0.425 g); divided by the surface area of the disc in contact with water (cm 2). This value (in micrograms/cm 2) is the oral care active concentration at the surface of the disc being tested.

7. Steps 1 to 6 were performed on a total of 24 discs and the average of all 24 values was taken. The average value (in micrograms/cm 2) is the concentration of oral care active on the tested surface of the article.

To verify the procedure described above, the hydrogen peroxide concentration at the first surface (gel surface) of comparative example I-A had to be measured and demonstrated to be 550 micrograms/cm 2 to 800 micrograms/cm 2.

For containing oral cavity protectionThe number of particles at the surface of the water-insoluble delivery vehicle (i.e., article) of the physiologically active agent Counting procedure

The number of particles at the surface of a water insoluble delivery vehicle (i.e., article) containing an oral care active was measured according to the following procedure.

1. 24 squares of 1cm were cut from the article

2. The number of particles at each square surface was counted using a microscope.

3. The number of particles counted at all 24 square surfaces was averaged. This is the number of particles at the surface per cm2.

The dimensions and values disclosed herein are not to be understood as being strictly limited to the exact numerical values recited. Rather, unless otherwise indicated, each such dimension is intended to mean both the recited value and a functionally equivalent range surrounding that value. For example, a dimension disclosed as "40mm" is intended to mean "about 40mm".

Each document cited herein, including any cross-referenced or related patent or patent application, and any patent application or patent for which this application claims priority or benefit from, is hereby incorporated by reference in its entirety unless expressly excluded or otherwise limited. The citation of any document is not an admission that it is prior art with respect to the present invention, or that it is not entitled to any disclosed or claimed herein, or that it is prior art with respect to itself or any combination of one or more of these references. Furthermore, to the extent that any meaning or definition of a term in this document conflicts with any meaning or definition of the same term in a document incorporated by reference, the meaning or definition assigned to that term in this document shall govern.

While particular embodiments of the present invention have been illustrated and described, it would be obvious to those skilled in the art that various other changes and modifications can be made without departing from the spirit and scope of the invention. It is therefore intended to cover in the appended claims all such changes and modifications that are within the scope of this invention.

Claims

1. An oral care article (10), the oral care article comprising:

a) A solid water-insoluble delivery vehicle (12) in the form of a strip having a length (L) and a width (W) forming a first surface (14) and having a thickness (T) extending from the first surface (14) to a second surface (16), wherein the average thickness (T) is less than about 3mm; and

b) Solid hydrophilic particles (20) comprising an oral care active agent, wherein the active agent comprises at least one of a bleach, a healing agent, an anticalculus agent, an anticaries agent, an antimicrobial agent, a dentinal desensitizing agent, an anesthetic agent, an antifungal agent, a cooling agent, an anti-inflammatory agent, a selective H-2 antagonist, a nutrient, erythritol, a probiotic, a fluoride ion source, a tooth whitening agent, or a combination thereof;

wherein at least about 20 parts by weight of the solid hydrophilic particles (20) are dissolved in about 100 parts by weight of water and/or the solid hydrophilic particles (20) increase in volume and/or weight by at least about 50% upon contact with water; and wherein the solid hydrophilic particles (20) release the active agent upon contact with water; and is also provided with

Wherein the solid hydrophilic particles (20) are arranged and embedded in the solid water insoluble delivery vehicle (12), wherein the solid hydrophilic particles (20) are arranged i) at least partially below the first surface (14), and ii) at least partially at or above the first surface (14) of the solid water insoluble delivery vehicle (12), wherein greater than about 10% of the surface area of the solid hydrophilic particles (20) is arranged at the first surface (14) of the water insoluble delivery vehicle (12) and exposed to the external environment surrounding the water insoluble delivery vehicle (12).

2. The oral care article (10) according to claim 1, wherein greater than about 20%, preferably greater than about 30% of the surface area of the solid hydrophilic particles (20) is disposed at the first surface (14) of the water-insoluble delivery vehicle (12) and exposed to the external environment surrounding the water-insoluble delivery vehicle (12).

3. The oral care article (10) according to any one of claims 1 or 2, wherein more than about 50%, preferably more than about 75%, preferably more than about 95%, most preferably 100% of the volume of the solid hydrophilic particles (20) is disposed below or at the first surface (14) of the water insoluble delivery vehicle (12).

4. The oral care article (10) according to any one of the preceding claims, wherein the concentration of the active agent at the first surface (14) is in the range of about 1 microgram/cm 2 to about 10000 microgram/cm 2, preferably in the range of about 10 microgram/cm 2 to about 5000 microgram/cm 2, more preferably in the range of about 50 microgram/cm 2 to about 3000 microgram/cm 2.

5. The oral care article (10) according to any one of the preceding claims, wherein the number average equivalent diameter or volume average equivalent diameter of the solid hydrophilic particles (20) is in the range of from about 0.001 microns to about 5000 microns, preferably from about 0.01 microns to about 2000 microns, and most preferably from 1 micron to about 1000 microns.

6. The oral care article (10) according to any one of the preceding claims, wherein the ratio of the average thickness (T) of the water-insoluble delivery carrier (12) and/or the article (10) divided by the number average equivalent diameter or the volume average equivalent diameter of the solid hydrophilic particles (20) is from about 0.001 to about 1000, preferably from about 0.01 to about 100, more preferably from about 0.1 to about 10.

7. The oral care article (10) according to any one of the preceding claims, wherein the average thickness (T) of the water-insoluble delivery carrier (12) or article (10) is less than 3mm, preferably in the range of about 0.01mm to 3mm, more preferably in the range of about 0.1mm to about 2.0mm, more preferably in the range of about 0.15mm to about 1.0 mm.

8. The oral care article (10) according to any one of the preceding claims, wherein the water-insoluble delivery carrier (12) is monolayer and/or shaped in a dental arch.

9. The oral care article (10) according to any one of the preceding claims, wherein the article (10) is a unit dose article and/or a removable article.

10. The oral care article (10) according to any one of the preceding claims, wherein the water-insoluble delivery carrier (12) comprises a material having the following characteristics: (i) A penetration consistency value of about 0.1 to about 100, preferably about 0.5 to about 50, more preferably about 1 to about 10, as measured by ASTM method D1321-16 a; and/or (ii) a cone penetration consistency value of less than about 10, preferably from about 1 to about 9, more preferably less than about 5, as measured by ASTM D937-07; and/or (iii) a drop melting point of about 60 ℃ to about 120 ℃, preferably about 70 ℃ to about 110 ℃, more preferably about 80 ℃ to about 100 ℃, more preferably about 90 ℃ to about 100 ℃, as measured by ASTM D127-08; and/or (iv) a flexural rigidity of greater than 50g/cm, preferably from about 75g/cm to about 1000g/cm, preferably from about 100g/cm to about 750g/cm, more preferably from about 200g/cm to about 500g/cm, as measured by ASTM D2923-95.

11. The oral care article (10) according to the preceding claim, wherein the water-insoluble delivery vehicle (12) comprises a wax, a polymer or a combination thereof, preferably wherein the wax comprises a microcrystalline wax and/or the polymer comprises polyethylene, preferably wherein the water-insoluble delivery vehicle (12) is a microcrystalline wax or a combination of a wax and a polymer.

12. The oral care article (10) according to any one of the preceding claims, wherein the solid hydrophilic particles (20) swell at least about 60%, preferably at least about 70%, more preferably at least about 80% upon contact with water.

13. The oral care article (10) according to any one of the preceding claims, wherein at least about 30 parts by weight of the solid hydrophilic particles (20) are dissolved in about 100 parts by weight of water; preferably at least about 50 parts by weight, more preferably at least about 70 parts by weight, even more preferably at least about 80 parts by weight of the solid hydrophilic particles are dissolved in about 100 parts by weight of water.

14. The oral care article (10) according to any one of the preceding claims, wherein the bleaching agent is selected from the group consisting of a complex of hydrogen peroxide and polyvinylpyrrolidone (PVP) polymer, urea peroxide and mixtures thereof, preferably a complex of hydrogen peroxide and polyvinylpyrrolidone (PVP) polymer, urea peroxide and mixtures thereof, and preferably a complex of hydrogen peroxide and polyvinylpyrrolidone (PVP) polymer.

15. The oral care article (10) according to any preceding claim, wherein the total concentration of active agent is from about 0.001% to about 25% by weight of the article (10), preferably from about 0.01% to about 15% by weight of the article (10), more preferably from about 0.01% to about 3%, more preferably from about 0.01% to about 0.09%, more preferably less than 0.1%.

16. The oral care article (10) according to any one of the preceding claims for delivering a health benefit to the oral cavity, preferably for reducing and/or removing dental caries, plaque, tartar and stains, promoting gum health, preventing and treating tooth decay, improving breath, promoting bleaching, providing an antibacterial effect and/or combinations thereof.

17. A kit comprising the oral care article (10) according to any one of the preceding claims and an electromagnetic radiation source capable of directing electromagnetic radiation having one or more wavelengths in the range of about 200nm to about 1700nm to at least one tooth, preferably wherein the electromagnetic radiation source emits electromagnetic radiation in the range of about 400nm to about 500nm, more preferably about 425nm to about 475nm, more preferably about 445nm to about 465nm, preferably wherein the electromagnetic radiation impinges on the outer surface of the water-insoluble delivery carrier (12) at an intensity in the range of about 175mW/cm2 to about 225mW/cm 2.