JP2023545297A - Oral care article comprising a water-insoluble delivery carrier and solid hydrophilic particles comprising a bleaching agent - Google Patents

Abstract

Article (10) in the form of a strip for intraoral use. The article comprises a water-insoluble delivery carrier (12) comprising solid hydrophilic particles (20) comprising at least one bleaching agent, wherein (i) at least about 20 parts by weight of the solid hydrophilic particles (20) are about 100 parts by weight; and/or (ii) the solid hydrophilic particles (20) increase in volume and/or weight by at least about 50% in the water, and the particles (20) are embedded in the carrier (12). ing.

Description

The present invention relates to oral care articles suitable for use in the oral cavity that include a water-insoluble delivery carrier and solid hydrophilic particles containing an oral care bleaching agent.

Currently, there are dental products on the market that deliver a variety of cosmetic and/or therapeutic actives to the teeth and oral cavity. Examples of such products include brushing aids, mouthwashes containing breath fresheners or antimicrobial actives, such as dentifrice products for delivering oral care actives such as polyphosphates or fluoride; Includes whitening strips for delivering bleaching actives to the teeth. As a convenient and inexpensive method of providing cosmetic and therapeutic effects to the teeth and mucosal surfaces of the oral cavity, for example, the whitening composition may be applied in a strip and then applied to the teeth to provide a permanent bond between the teeth and the whitening article. It has been recognized that dental whitening strips can be used to achieve effective contact.

Despite the above-mentioned known approaches for the treatment or amelioration of oral conditions, in particular for teeth whitening or fluoride application, there is no need for improved performance, e.g. increased whitening speed, increased bleaching effectiveness, increased antimicrobial action, There remains a need to provide products with reduced tooth sensitivity and/or reduced oral soft tissue irritation. Attempts have been made in the past to solve these problems, such as increasing the concentration of active agent in the article. However, problems can arise with this approach. Users may experience increased sensitivity and/or irritation sensitivity that may accompany the use of increased amounts of active agent.

Therefore, despite the above-mentioned well-known approaches for treating oral conditions, particularly for whitening teeth, there is no improvement in bleaching effectiveness, increase in whitening rate, decrease in tooth sensitivity, and/or oral soft tissues. There remains a need to provide products with reduced irritation.

The present invention
a) in the form of a strip having a length and a width forming a first surface and a thickness extending from the first surface to the second surface, preferably having an average thickness of less than about 3 mm; a solid water-insoluble delivery carrier;
b) solid hydrophilic particles comprising a bleaching agent, wherein 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 are in contact with the water. the solid hydrophilic particles increasing in volume and/or weight by at least about 50%;
The solid hydrophilic particles are disposed and embedded in the solid water-insoluble delivery carrier, the solid hydrophilic particles being i) at least partially below the first surface, and ii) of the solid water-insoluble delivery carrier. disposed on or on at least a portion of a surface of 1;
Oral care articles wherein the total concentration of bleaching agents is from about 0.01% to about 15% by weight of the article.

The article may be used or used in a manner to provide a health, therapeutic or cosmetic benefit to the oral cavity by applying bleaching agents directly to the teeth and/or oral cavity. Preferably, the articles of the invention reduce and/or remove caries, plaque, tartar and stains, promote gum health, prevent and treat dental caries, improve bad breath, promote bleaching, provide antimicrobial benefits, and / or a combination thereof.

The invention further provides a cosmetic method for whitening teeth using an article or kit disclosed herein, comprising:
a) applying the article to at least one tooth surface such that the first surface of the water-insoluble delivery carrier contacts the at least one tooth surface;
b) allowing the article to remain on the surface of at least one tooth for a suitable period of time, such as at least 1 minute;
c) optionally applying electromagnetic radiation for a suitable period of time, such as at least one minute.

The article may be provided as a kit with equipment for increasing the effectiveness of the bleaching agent, such as, for example, a source of electromagnetic radiation.

The article may further be provided with instructions for using the article.

The present invention further provides a method for manufacturing the oral care articles disclosed herein, comprising:
a) a solid body 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, the average thickness being, for example, less than about 3 mm; providing a water-insoluble delivery carrier;
b) applying solid hydrophilic particles comprising an amount of bleaching agent disclosed herein to a first surface of a solid water-insoluble delivery carrier;
Solid hydrophilic particles are forced into a first surface of the solid water-insoluble delivery carrier such that the solid hydrophilic particles are i) at least partially below the first surface, and ii) of the solid water-insoluble delivery carrier. disposed on or on at least a portion of a surface of the object.

The article is attached directly to the teeth or oral cavity. That is, the adhesive function or attachment mechanism can be provided directly by the article, eg, the water-insoluble delivery carrier itself. For example, the article can optionally be of sufficient size so that when applied, the article overlaps the oral soft tissues, making more of the tooth surface available for the effect achieved with the bleaching agent. The article may be attached to the oral cavity by physical interference or mechanical interlock between the article and the oral cavity surfaces, including the teeth.

1 is a perspective view of an article 10 in the form of a strip with rounded corners containing solid hydrophilic particles 20 capable of contacting the environment; FIG. The article 10 is shown having a greater number of particles 20 on the first surface 14 . 1A is a cross-sectional view of article 10 of FIG. 1A taken along section line 2-2. FIG. 1B is a cross-sectional view of article 10 of FIG. 1B along section line 2-2. FIG. 2 is a cross-sectional plan view showing article 10 attached to tooth 22. FIG. 4 is a cross-sectional elevational view of the tooth taken along section line 4-4 of FIG. 3 showing article 10 attached to tooth 22. FIG. A is a photographic image of an article 10 in strip form formed into a dental tray (B) including a notch 18 (C). 2 is a photographic image of a sheet of wax that can be used as a water-insoluble delivery carrier 12 containing embedded solid hydrophilic particles 20 (Example IV-A). 2 is a microscopic image of a sheet of wax usable as a water-insoluble delivery carrier 12 containing embedded solid hydrophilic particles 20 (Example IV-A). 1 illustrates a device for delivering electromagnetic radiation toward a tooth surface.

The bleaching agent, when provided as solid hydrophilic particles and combined with a water-insoluble delivery carrier to form an oral care article as disclosed herein, is present at a relatively low concentration relative to the weight of the oral care article. It has been found that it can be effective. The oral care articles of the present invention comprise from about 0.01% to about 50%, preferably from about 0.1% to about 30%, preferably from about 0.1% to about 25%, by weight of the article. Preferably from about 0.1% to about 15% by weight, or preferably from about 0.3% to about 10% by weight of a bleaching agent, solid hydrophilic particles are soluble in water and are soluble in water. It may include solid hydrophilic particles that swell on contact and/or release bleaching agents on contact with water or water-containing liquids.

Solid hydrophilic particles are embedded in, ie, disposed on and in, a water-insoluble delivery carrier to form the oral care articles of the present invention. The solid hydrophilic particles contain at least one oral care bleaching agent, and because the solid hydrophilic particles are embedded, the concentration of bleaching agent on the first surface of the water-insoluble delivery carrier is equal to the bleaching agent on the second surface. It may be higher than the concentration of the agent. Examples of at least one bleaching agent include sources of peroxide radicals, metal chlorides, perborates, percarbonates, peroxy acids, persulfates, compounds that form in situ the aforementioned compounds, and A complex of hydrogen peroxide with polyvinylpyrrolidone (PVP) polymer (also known as Peroxydone) and/or urea peroxide is preferred. Without wishing to be bound by theory, it is believed that when the article contacts a tooth surface, preferably a first surface, the solid hydrophilic particles embedded in the water-insoluble delivery carrier absorb the hydrophilic biomolecules on the tooth surface. It is believed to deliver bleach to the film. This reduces the total bleaching agent concentration and can increase the effectiveness of activities such as tooth whitening, antibacterial and/or anti-caries effects.

As used herein, the term "delivery carrier" includes materials in the form of strips that are used to deliver active agents from solid hydrophilic particles to a surface, such as a tooth surface. The delivery carriers used herein may be flat or preformed into a three-dimensional shape, such as the shape of a dental arch. The "delivery carrier" material must be compatible with the oral cavity, comfortable for the user, and water-insoluble. Exemplary materials for water-insoluble delivery carriers include waxes, polymers, and combinations thereof.

The terms "hydrophobic" and "hydrophilic" are used herein in accordance with common knowledge. The term "hydrophilic" is used for objects, articles, molecules, compounds, entities that are attracted to water and other polar substances. Accordingly, the term "hydrophobic" is used for objects, articles, molecules, compounds, entities that are not attracted to and/or are not repelled by water and other polar substances.

The term "strip" as used herein includes a material that 1) has a length in its longest dimension that is generally greater than its width, and 2) has a width that is generally greater than its thickness. The strips may be rectangular, arched, curved, semicircular and may have rounded corners to avoid irritation of the soft tissues of the oral cavity. As used in the present invention, "rounded corners" means the absence of acute angles or sharp points, eg, one or more angles of 135° or less. In addition, the strips can be bent or formed into three-dimensional shapes, such as dental arches, or combinations thereof. The strip can be solid, textured, rigid, moldable, deformable, permanently deformable, or a combination thereof. Strips useful in the present invention can be suitably shaped to fit within the oral cavity.

As used herein, the term "oral care article" refers to an article of manufacture for use within the oral cavity, preferably on the teeth within the oral cavity. The oral care article preferably comprises a solid water-insoluble delivery carrier in combination with solid hydrophilic particles comprising at least one bleaching 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" means an article that is removed from the oral cavity after use.

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

As used herein, the term "moldable" means that the material of the water-insoluble delivery carrier and/or article conforms to the general shape of the dental arch when applied by the user. . An example of a water-insoluble delivery carrier that is "mouldable" is a cast wax transparent sheet 24 gauge (Freeman Manufacturing Company, Ohio) cut into strips about 0.51 mm thick, about 22 mm wide, and about 62 mm long. Reference number 114009) supplied by the USA.

The term "wax" as used herein refers to organic compounds that are hydrophobic and solid at room temperature, such as higher alkanes. The wax preferably has a temperature of about 60°C to about 120°C, preferably about 70°C to about 110°C, more preferably about 80°C to about 100°C, more preferably about 90°C, as measured by ASTM method D127-08. Droplet melting point of ~100°C and/or needle penetrations 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 It may have a consistency value and/or a cone penetration consistency value of less than 10, preferably from 1 to 9, more preferably less than about 5, as measured by ASTM method D937-07.

As used herein, the term "needle penetration consistency value" means the depth, in tenths of a millimeter, that a standard needle would penetrate a sample under fixed conditions of mass, time, and temperature. do. Needle penetration consistency values are measured according to ASTM method D1321-16a.

As used herein, the term "cone penetration consistency value" means the depth, in one-tenth of a millimeter, that a standard cone would penetrate a sample under fixed conditions of mass, time, and temperature. do. Cone penetration consistency values are measured according to ASTM method D937-07.

As used herein, the term "particle" is a discrete solid material. Solid particles have dimensions larger than individual atoms or molecules, and typically their largest dimension is submicron to about 5 millimeters. The particles may be aggregated into aggregates of discrete particles.

As used herein, the term "solid hydrophilic particles" refers to particles that are soluble in water and/or swell (increase in volume and/or weight) on contact with water and/or bleach on contact with water. solid particles that release the agent. Additionally, solid hydrophilic particles are insoluble in water-insoluble delivery carriers. The solid hydrophilic particles contain a bleaching agent that is released from the solid hydrophilic particles upon contact with water. For example, the solid hydrophilic particles may contain bleaching agents, antibacterial agents and/or anti-caries agents as bleaching agents. If bleach is released, it can be a gas, a liquid, or a solid dissolved in a liquid. Solid hydrophilic particles can be used in water-soluble solvents such as, for example, water, water-soluble solvents, alcohols, carbopol, polyalkylene glycols, wetting agents, glycerin, sorbitol, xylitol, butylene glycol, polyethylene glycol, and propylene glycol, and mixtures thereof. The composition may further include components that are water-miscible, water-miscible, or a combination thereof. If these components are added to or present in the solid hydrophilic particles, the proportion of solid hydrophilic particles in the article is calculated by excluding these components. If water-insoluble or water-immiscible fillers are added to the solid hydrophilic particles, the proportion 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 "soluble" is the maximum number of parts by weight of a substance that can be dissolved in 100 parts by weight of a second substance.

As used herein, the term "embedded" or "embedded particle" means that the solid particle is i) at least partially below the surface, and ii) on the surface of a solid water-insoluble delivery carrier. means disposed at least partially on or on the surface of or on. Examples of embedded particles include solid hydrophilic particles pressed onto the surface of a wax sheet, such as a cast wax transparent sheet 24 gauge (reference number 114009 supplied by Freeman Manufacturing Company, Ohio, USA), for example at 625 PSI for 60 seconds. Examples include sexual particles.

The term "active agent" as used herein is a component present in a solid hydrophilic particle that produces an effect. For example, the activator may include a bleaching agent.

As used herein, the term "bleaching agent" is an ingredient present in solid hydrophilic particles that provides a bleaching or whitening effect. For example, when urea peroxide (also known as urea-hydrogen peroxide adduct) is used as the solid hydrophilic particle, the hydrogen peroxide component of the urea peroxide is a bleaching agent. Similarly, when a complex of hydrogen peroxide and polyvinylpyrrolidone (PVP) polymer is used as a solid hydrophilic particle, the hydrogen peroxide component of the complex of hydrogen peroxide and polyvinylpyrrolidone (PVP) polymer is It is a drug.

As used herein, a "safe and effective amount" means, within the scope of sound medical/dental judgment, that significantly (for the better) alters the condition being treated or produces the desired effect. refers to an amount of a component that is sufficiently high to be effective, but low enough to avoid serious side effects (with a reasonable benefit/risk ratio). Safe and effective amounts of the components will depend on the particular condition being treated, the age and physical condition of the patient being treated, the severity of the symptoms, the duration of treatment, the nature of the combination therapy, the particular form used, and the components. It may vary depending on the particular solvent applied.

As used herein, "sufficient time to achieve the desired effect of bleach" means that an article containing bleach may be used or worn by a participant, or that a participant means that the article can be instructed to be used or worn for about 10 seconds to about 24 hours, preferably about 1 minute to about 2 hours, and most preferably about 5 minutes to about 1 hour per application. . Treatment may be applied from about once a day to about 10 times a day, preferably from about once a day to about 5 times a day, most preferably from about once a day to about 3 times a day. Treatment may be applied for about 1 day to about 8 weeks, preferably about 1 day to about 4 weeks, most preferably about 1 day to about 1 week. Additionally, the length of the treatment to achieve the desired effect, e.g. tooth bleaching, can last for a specified period of time, e.g. from about 1 day to about 6 months or continuously, repeated as necessary. You can. The optimal duration and frequency of application depends on the desired effect, the severity of any condition being treated, the health and age of the user, and similar considerations.

The term "equal dimensions" of a particle, as used herein, refers to the dimensions of a sphere having the same volume as the particle.

All proportions and proportions used herein are by weight of the article (wt%) unless otherwise indicated. Percentages, ratios, and levels of ingredients referred to herein are, unless otherwise indicated, based on the actual amounts of the ingredients and include any solvents, fillers, or levels that may be combined with the ingredients as a commercial product. Contains no other substances.

Unless otherwise specified, all measurements referred to herein are performed at approximately 23° C. (ie, room temperature).

"Active substances and other ingredients" useful herein may be classified or described herein by their cosmetic and/or therapeutic effects, or their desired mode of action or function. However, the active substances and other ingredients useful herein may in some cases provide more than one cosmetic and/or therapeutic benefit or function or act in more than one mode of action. It should be understood that Accordingly, the classification herein is implemented for convenience and is not intended to limit the components to the specifically defined functions or actions listed.

The term "orally acceptable" includes one or more compatible solid or liquid excipients or diluents suitable for use in the oral cavity. The term "compatible" as used herein means that the components can be mixed without interacting in a manner that substantially reduces the stability and/or effectiveness of the article. do.

Oral Care Articles The oral care articles disclosed herein include a solid water-insoluble delivery carrier in combination with solid hydrophilic particles comprising at least one bleaching agent, the solid hydrophilic particles comprising a water-insoluble delivery carrier. placed in or on, i.e., embedded. The solid hydrophilic particles have (i) relatively high solubility such that 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) the solid hydrophilic particles (20) has a relatively high swelling property of at least about 50% swelling in water. The components and properties of the solid hydrophilic particles and the water-insoluble delivery carrier are selected to facilitate optimal release of the bleaching agent from the article.

The articles disclosed herein include a solid hydrophobic or solid water-insoluble delivery carrier in combination with solid hydrophilic particles that include at least one bleaching agent embedded in the water-insoluble delivery carrier.

The articles disclosed herein may preferably include a solid thermoplastic delivery carrier in combination with solid hydrophilic particles comprising at least one bleaching agent embedded in a water-insoluble delivery carrier. Without wishing to be bound by theory, it is believed that upon contact of the article with the tooth surface, the solid hydrophilic particles in contact with the external environment deliver the bleaching agent to the hydrophilic biofilm on the surface. . A possible net effect is that the tooth treatment effect is initiated only after contact with the tooth surface to be treated. This means that the hydrophilic bleaching agent can be protected from environmental influences and thereby stabilized by the article's water-insoluble delivery carrier up to and during use. Thus, the effect may be applied to the tooth surface and the hydrophilic bleaching agent may be potentially protected against the oral environment during use. Therefore, the effectiveness of bleaching agents may be increased and/or accelerated.

While not wishing to be bound by theory, the partially hydrophobic (delivery carrier) and partially hydrophilic (embedded solid particles) nature of the article allows the present invention to be applied to oral cavity surfaces such as tooth or gum surfaces. Delivery of hydrophilic bleach to surfaces can be improved. Because of the driving force resulting from improved delivery, the bleaching agent can be propelled toward the tooth surface. Thus, increased bleach rates and/or increased effectiveness can be achieved even though surprisingly low total amounts of bleach are used. Accordingly, the present invention provides a method for achieving a given total concentration, e.g., less than about 15% by weight, less than about 10% by weight, less than about 5% by weight, less than about 3% by weight, less than about 1% by weight, about 0.1% by weight. can yield surprisingly high levels of therapeutic efficacy with less than, or even less, bleaching agent and therefore may require fewer applications to obtain the same degree of effectiveness compared to prior art applications. or may require lower concentrations to obtain the same degree of effectiveness. Without wishing to be bound by theory, some of the reasons for the increased effectiveness provided by the articles of the present invention may be due to physical interference or mechanical interference between the water-insoluble delivery carrier and the oral surfaces, including the teeth. It is believed that the interlock allows the article to be attached to the oral cavity or that the article is self-adhesive or self-sustaining to the teeth and is resistant to being washed away in saliva or other fluids. There is. This allows the bleaching agent to remain in contact with or within the oral cavity, such as tooth surfaces, for an extended period of time, thus resulting in high effectiveness. It is worth noting that since surfaces within the oral cavity are moist, materials that are adhesive or persistent to the oral cavity are generally hydrophilic. It should also be noted that some product forms, particularly stick-type products, may require added persistence agents to adhere the article to surfaces within the oral cavity. However, the articles of the invention and/or the water-insoluble delivery carriers of the invention can be attached to the oral cavity by physical interference or mechanical interlock between the water-insoluble delivery carrier and the oral cavity surfaces, including the teeth, or by adhesive self-adhesive or adhesive to surfaces in the oral cavity, such as tooth surfaces, without the addition of agents (e.g., hydrophilic particles or hydrophilic liquids that become sticky when activated by moisture) or direct persistence agents. It has been found to be self-sustaining. Achieving adhesion or persistence without the use of added hydrophilic adhesives or hydrophilic persistence agents may help create articles that are less likely to be washed away in saliva or other liquids, i.e. , is particularly useful because it has higher effectiveness. This increases the concentration of hydrophobic components (which are less likely to be washed away) by achieving adhesion or persistence without the use of added hydrophilic adhesives or added hydrophilic persistence agents. , and/or it may be possible to reduce the concentration of hydrophilic components (which are easily washed away). Counter-intuitively, this may help increase the longevity of the article, as high concentrations of bleach are in contact with oral surfaces, such as tooth surfaces or the inside of the mouth, for longer periods of time, which results in higher effectiveness. Connected to sex. Thus, preferably, articles of the invention and/or water-insoluble delivery carriers of the invention may be substantially free of added adhesives, and preferably are substantially free of added hydrophilic adhesives (e.g., water-insoluble delivery carriers). (hydrophilic particles that become sticky when activated by) or added hydrophilicity sustaining agents, more preferably added hydrophilic liquid adhesives (e.g. glycerin). It does not have to contain substantially no. Preferably, the articles of the invention and/or the water-insoluble delivery carriers of the invention can be attached to the oral cavity by physical interference or mechanical interlock between the water-insoluble delivery carrier and oral surfaces, including the teeth, or It is self-adhesive or self-sustaining to the oral cavity, such as the surface of teeth.

Also, some product forms, especially stick-type products, are equipped with an additional active substance-releasing agent or an additional peroxide-releasing agent to improve the release of the active substance or peroxide entrapped in the stick-type product. It is also worth noting that it may require Generally, the active agent or peroxide releasing agent may provide hydration channels in the article that allow water to penetrate the article and allow the active agent or peroxide to leach out. A hydrophilic water-soluble or water-swellable polymer or a hydrophilic liquid. Additional peroxide releasing agents may help to disrupt the hydrophobic matrix as a result of microbubbles that may be generated upon contact with water, and this disruption enhances the release of whitening agents or active agents such as hydrogen peroxide. can do. However, the articles of the invention are preferably self-releasing (eg, release the active agent or peroxide without the addition of an active agent or peroxide releasing agent).

Retention of the article on the tooth surface may be improved when the water-insoluble delivery carrier is not susceptible to dilution by saliva and salivary enzymes that can degrade peroxides such as bleaching agents. . Still further, water-insoluble delivery carriers do not dehydrate the teeth and generate outward flow of water produced by many hydrophilic articles containing hydrophilic adhesives such as polycarboxylic acids. Because water-insoluble delivery carriers do not dehydrate teeth, they can deliver surprisingly high concentrations of active efficacy, such as bleaching efficacy, yet result in surprisingly low concentrations of tooth sensitivity.

Water-insoluble delivery carriers may provide additional advantages. For example, a water-insoluble delivery carrier can represent a stable matrix for components that are soluble in the water-insoluble delivery carrier. For example, many perfume ingredients commonly used in oral care articles are soluble in water-insoluble delivery carriers. This means that perfume ingredients can be protected from the effects of hydrophilic bleaching agents in oral care articles. During use of the article on a tooth surface, at least a portion of the water-insoluble delivery carrier is positioned toward the soft tissues of the oral cavity, such as the mucous membranes, thereby driving ingredients, such as flavoring compounds, present in the water-insoluble delivery carrier into the oral cavity. can be presented. For example, the perfume ingredient is preferably located on a second surface of the water-insoluble delivery carrier such that the solid hydrophilic particles and any perfume ingredients are located on opposite sides of the water-insoluble delivery carrier and can be independently released into the oral cavity. can do. A water-insoluble delivery carrier can protect the bleach against any effects from the oral cavity, such as dilution by saliva. The protective effect may also be applied to the tooth surface itself, with the water-insoluble delivery carrier providing stronger hydration to the tooth surface.

It should be noted that stick-type products can be unhygienic due to potential contamination or biofilm build-up due to repeated use in the oral cavity. Saliva or moisture can penetrate stick products when used intraorally, and this can degrade bleaching agents such as peroxide during storage between uses, and this degradation is present in saliva. It can be further facilitated by enzymes. Furthermore, this deterioration may be most pronounced at the tip of the stick product, which is in direct contact with saliva or moisture in the oral cavity, and may result in reduced effectiveness the next time the stick product is used. This "contact-degradation-contact" cycle may be repeated each time the stick product is used, resulting in a decrease in effectiveness in most if not always applications after the first application.

It is worth noting that the articles of the invention may be provided in unit dosage forms that are used once and then discarded. This unit dose form offers several advantages over other product forms, including stick products, such as: 1) a higher level of hygienic protection as it is disposed of once used; 2) the unit dose The format provides a pre-measured dose of bleach with each use, so guessing how much product to use (which can be confusing or even pressuring for consumers unfamiliar with the product) 3) the solid hydrophilic particles can be distributed throughout the article, minimizing over- or under-treated spots; and 4) the bleach does not need to be removed until the time of use. The bleaching agent can maintain its effectiveness for a longer period of time, as it is not exposed to the environment or oral cavity, and so on.

In another embodiment, the articles of the invention can be removed from the oral cavity after use. This, in contrast to stick-type products, allows the user to remove and discard any remaining bleach after the treatment period is complete. Additionally, water-insoluble delivery carriers can be monolayered.

Water-Insoluble Delivery Carrier The articles disclosed herein include a solid water-insoluble delivery carrier having embedded solid hydrophilic particles that include at least one bleaching agent. The water-insoluble delivery carrier or article can be attached to the oral cavity by physical interference or mechanical interlock between the water-insoluble delivery carrier and the surfaces of the oral cavity, including the teeth. For example, the water-insoluble delivery carrier or article can be of sufficient size that, when applied, the water-insoluble delivery carrier overlaps the oral soft tissues, making more tooth surface available for treatment. The basic form of a water-insoluble delivery carrier or article is a strip having a length and a width forming first and second surfaces separated from each other by a thickness. Additionally, the basic form of the water-insoluble delivery carrier or article can also be formed into any shape or size suitable for contacting the desired oral cavity surfaces, such as in the form of a dental arch.

The morphology of the first surface may be substantially flat or may have irregularities due to embedded solid hydrophilic particles that may be embedded therein, such as the formation of a dental arch or tooth. It may be formed into a three-dimensional shape, such as a three-dimensional shape, or a combination thereof. Generally, the first and second surfaces of the water-insoluble delivery carrier or article are similar in size and shape and are adjacent or nested with each other, preferably separated by an average distance of no more than about 3 mm. ing. For example, the average distance between the first and second surfaces of the water-insoluble delivery carrier or article is about 0.01 mm to about 3 mm, preferably about 0.1 mm to about 2 mm, or more preferably about 0. It can be from .15 mm to about 1 mm.

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

Without wishing to be bound by theory, the average thickness of a water-insoluble delivery carrier or article is such that the article is 1) comfortable during use, and/or 2) has an effective amount per cm during use. may be a factor to ensure that the bleach is released. Specifically, for a given percent bleach, if the average thickness of the water-insoluble delivery carrier or article is too small, the bleach will spread over a large area of the first surface, resulting in less bleach per cm2. may result in lower delivery levels and reduced efficacy. In contrast, if the average thickness of the water-insoluble delivery carrier or article is too large, the article may be too bulky to be comfortable during use. The average thickness of the water-insoluble delivery carrier or article is from 0.01 mm to about 3 mm, preferably from about 0.1 mm to about 2 mm, more preferably from about 0.15 mm to about 1 mm, and most preferably from about 0.25 mm to about 0. It can be in the range of .75mm. Additionally, water-insoluble delivery carriers can be monolayered.

Water-insoluble delivery carriers can be transparent or translucent to electromagnetic radiation having a wavelength of about 200 nm to about 1700 nm.

Without wishing to be bound by theory, the droplet melting point of a water-insoluble delivery carrier ensures that the article 1) does not melt or become sticky during storage, and/or 2) is effective during use. This can be a factor in ensuring that a large amount of bleach is released. Specifically, if the droplet melting point of the water-insoluble delivery carrier is too low, the article may melt or become sticky during storage. In contrast, if the droplet melting point of the water-insoluble delivery carrier is too high, the article may not release an effective amount of bleach during use. For example, the droplet melting point of suitable water-insoluble delivery carriers is about 60°C to about 120°C, preferably about 70°C to about 110°C, more preferably about 80°C to about 100°C, and most preferably about 90°C. to about 100°C.

Without wishing to be bound by theory, needle penetration consistency values for water-insoluble delivery carriers are such that the article 1) does not become tacky during storage, and/or 2) has an effective amount of bleaching during use. can be a factor in ensuring that the agent is released. Specifically, if the needle penetration consistency value of the water-insoluble delivery carrier is too high, the article can become sticky during storage. In contrast, if the needle penetration consistency value of the water-insoluble delivery carrier is too low, the article may not release an effective amount of bleach during use. Needle penetration values for water-insoluble delivery carriers can range from about 0.1 to about 100, preferably from about 0.5 to about 50, and most preferably from about 1 to about 10.

While not wishing to be bound by theory, cone penetration consistency values for water-insoluble delivery carriers are such that the article 1) does not become tacky during storage, and/or 2) has an effective amount of bleaching during use. can be a factor in ensuring that the agent is released. Specifically, if the cone penetration consistency value of the water-insoluble delivery carrier is too high, the article can become sticky during storage. In contrast, if the cone penetration consistency value of the water-insoluble delivery carrier is too low, the article may not release an effective amount of bleach during use. The water-insoluble delivery carrier can 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.

Water-insoluble delivery carriers or articles of the invention may be moldable. Moldability may allow the water-insoluble delivery carrier to be molded to the shape of a dental arch or tooth surface contour. Optimal adaptation to the tooth surface allows 1) effective release of the bleaching agent and/or 2) feeling of comfort during use. Preferably, permanent deformation occurs under minimal normal force applied by the wearer, and preferably the water-insoluble delivery carrier or article conforms to the shape of the tooth through permanent deformation under a pressure of less than about 250,000 Pascals. Substantially compatible.

Water-insoluble delivery carriers of the invention can be rigid. The stiffness of a water-insoluble delivery carrier or article can be a factor to ensure that 1) it is easy to handle and accurately position during application, and/or 2) that it maintains a given shape during use. obtain. Bending stiffness is a material property that is a function of a combination of strip thickness, width, and material modulus of material. The test described below is a method for measuring the stiffness of strips and sheets. This method determines the bending resistance of the sample by using strain gauges attached to the ends of horizontal beams. The opposite end of the beam presses down against the strip of sample when the sample is resting, forcing a portion of the strip into a vertical groove in the horizontal platform. A microamp meter wired to the strain gauge is calibrated in terms of deflection force. The stiffness of the sample is read directly from the microamp meter and is expressed as grams per centimeter of sample strip width. Specifically, if the water-insoluble delivery carrier or article has too high a bending stiffness, it may not be moldable and may break during molding on the tooth surface. In contrast, if the bending stiffness of a water-insoluble delivery carrier or article is too low, it may not be easy to handle and accurately position during application. The bending stiffness of the water-insoluble delivery carrier may be greater than 50 g/cm, preferably the bending stiffness of the water-insoluble delivery carrier is greater than 60 g/cm, more preferably about 75 g/cm, as measured by ASTM D2923-95. /cm to about 1000 g/cm, more preferably about 100 g/cm to about 750 g/cm, more preferably about 200 g/cm to about 500 g/cm.

Delivery carriers of the invention can be hydrophobic. Delivery carriers of the invention are water insoluble. Water-insoluble delivery carriers of the present invention may preferably include waxes, polymers, or combinations thereof. Waxes can be thermoplastic. Suitable waxes that can be used in water-insoluble delivery carriers may include microcrystalline waxes or combinations of waxes and polymers. Examples of microcrystalline waxes include the Multiwax series from Sonneborn (Parsippany, NJ), Crompton (Witco), including Multiwax 835, Multiwax 440, Multiwax 180, and mixtures thereof. Suitable polymers that can be combined to form water-insoluble delivery carriers can be, for example, polyethylene. Examples of polyethylene include Honeywell 25 Corp., which has permeability values of about 98.5 and about 90.0, respectively, under ASTM D-1321. (Morristown, NJ), the polyethylene Performalene series from Baker Hughes Inc. (Morristown, NJ); (Houston, TX), polyethylene Performalene 400. For example, the ratio of weight percent polymer divided by weight percent wax can 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 water-insoluble delivery carriers of the present invention are waxes, most preferably foundry waxes supplied by Freeman Manufacturing Company, Ohio, USA, such as those listed in the table below, or combinations thereof. be.

これらのワックスシートは成形可能であり、手の圧力下で歯列弓又は歯の形状に容易に適合する。

These wax sheets are moldable and easily conform to the shape of the dental arch or teeth under hand pressure.

As used herein, the delivery system may include adhesive means, which allows the delivery system to adhere 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 independently of the articles herein (e.g., the adhesive means may be provided by the articles of the invention herein may be a separate phase from the article; the article may also have adhesive means). Water-insoluble delivery carriers may be easily removed from oral surfaces without the application of instruments, chemical solvents or drugs, or excessive friction.

The water-insoluble delivery carrier may be held in place on the oral surfaces by adhesive means and/or attachment provided by the water-insoluble delivery carrier itself. For example, a water-insoluble delivery carrier can be stretched, attached, and adhered to the soft tissues of the oral cavity. Additionally, an adhesive may be applied to the portion of the water-insoluble delivery carrier that allows the article to be attached to the soft tissue of the oral cavity. The water-insoluble delivery carrier may also be attached to the oral cavity by physical interference or mechanical interlock between the water-insoluble delivery carrier and the surfaces of the oral cavity, including the teeth. Additionally, the water-insoluble delivery carrier may be held in place by adhesive means independent of the articles of the invention herein, as disclosed in WO 03/015656.

Suitable adhesive means are well known to those skilled in the art. If adhesive means are present, this is provided by an adhesive, which may be any adhesive used to adhere material to a tooth surface or some surface of an oral cavity. Suitable adhesives include, but are not limited to, skin, gingival and mucoadhesive adhesives, which are also sensitive to moisture, chemicals in the oral environment in order for the oral care bleach to be effective. , and enzymes for a long time, but then must be water-soluble and/or biodegradable. Suitable adhesives include, for example, water-soluble polymers, hydrophobic and/or water-insoluble polymers, pressure-sensitive and moisture-sensitive adhesives, for example under the influence of oral moisture, chemicals or enzymes, etc. It may contain a drying adhesive that becomes tacky upon contact with. Suitable adhesives include natural gums, synthetic resins, natural or synthetic rubbers, the gums and polymers listed above under "thickeners", and various other adhesives of the type used in known adhesive tapes. These are well known from US Pat. No. 2,835,628.

Solid Hydrophilic Particles The article contains a safe and effective amount of solid hydrophilic particles. The solid hydrophilic particles include the bleaching agents disclosed herein. For example, the amount of solid hydrophilic particles in the article ranges from about 0.01% to about 50%, preferably from about 0.1% to about 30%, most preferably about 0.2% by weight of the article. to about 25% by weight.

Solid hydrophilic particles are insoluble in the water-insoluble delivery carriers of the present invention. However, surprisingly, the solubility of solid hydrophilic particles in water, their ability to swell upon contact with water, and/or their ability to release bleach upon contact with water influence the effectiveness of the article. It has been found that For example, at least about 20, about 25, about 30, about 40, about 50, about 60, about 70, or about 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 may be dissolved in about 100 parts by weight of water, more preferably 50 parts by weight of the solid hydrophilic particles, more preferably 70 parts by weight of the solid hydrophilic particles. parts, even more preferably 80 parts by weight of solid hydrophilic particles, may be dissolved in about 100 parts by weight of water. While not wishing to be bound by theory, the more soluble the solid hydrophilic particles, the higher their effectiveness may be. Particles with higher solubility can be more effectively delivered to the tooth surface from a water-insoluble delivery carrier, thereby increasing the intended effectiveness, eg, bleaching. Another parameter of solid hydrophilic particles that influences the effectiveness of the article can be swellability. For example, solid hydrophilic particles may swell upon contact with water, i.e. increase in volume and/or weight by at least about 50%, 55%, 60%, 65%, 70%, 75% or 80%. Preferably, the solid hydrophilic particles are capable of swelling by at least about 60%, more preferably at least about 70%, and more preferably at least about 80% upon contact with water. Without wishing to be bound by theory, the ability to release bleach from solid hydrophilic particles upon contact with water may depend on the swellability and/or solubility of the solid hydrophilic particles in water. it is conceivable that. In order to hydrate the solid hydrophilic particles and release the bleaching components, the amount of water available on the anterior surface of the upper anterior teeth is small compared to the rest of the oral cavity. This can be especially important for bleaching because the front surfaces of the upper front teeth are the most visible teeth when smiling. Therefore, the solubility of a solid hydrophilic particle in water, its ability to swell upon contact with water, and/or its ability to release bleaching agents upon contact with water is important for the "teeth when smiling" (the front surface of the maxillary anterior teeth). may unduly affect the effectiveness of the article.

The size of the individual solid hydrophilic particles can be a factor in reducing oral/local irritation or increasing the intended effect, such as bleaching effectiveness when bleaching agents are used. Without being limited by theory, if the size of the solid hydrophilic particles is too large, it may result in large spots on oral surfaces/topical surfaces/tooth surfaces that are exposed to high concentrations of bleaching agents, resulting in may result in oral/local sensitivity and/or tooth sensitivity. For example, the solid hydrophilic particles have a number average equivalent diameter or a volume average equivalent diameter of about 0.001 micrometer to about 5000 micrometers, preferably about 0.01 micrometer to about 2000 micrometers, and most preferably 1 micrometer. ~1000 micrometers. The number average equivalent diameter or volume average equivalent diameter of solid hydrophilic particles is determined by Malvern Panalytical Ltd. (e.g. Malvern Mastersizer 3000 particle size analyzer) or Horiba Ltd. It can be measured according to methods and equipment known in the art, such as those from laser-based particle size analyzers (e.g., laser-based particle size analyzers).

Articles of the invention include solid hydrophilic particles embedded in a solid water-insoluble delivery carrier. When solid hydrophilic particles are included in a water-insoluble delivery carrier by embedding, the solid hydrophilic particles may be flattened during the process of embedding into the water-insoluble delivery carrier. In one aspect, the particles may be pressed into irregular disc-like shapes during the embedding process. Thereby, 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 carrier) can be increased, and more bleaching agent is released; Potentially more effective. This positive effect can be negatively impacted if the thickness of the water-insoluble delivery carrier is too large. In one aspect, surprisingly, the ratio of the average thickness of the water-insoluble delivery carrier and/or article divided by the number-average equivalent diameter or volume-average equivalent diameter of the solid hydrophilic particles increases the effectiveness of bleaching agents. It was found that it can be useful. For example, the ratio of the average thickness of the water-insoluble delivery carrier and/or article to the number average equivalent diameter or volume average equivalent diameter of the solid hydrophilic particles is from about 0.001 to about 1000, from about 0.01 to about 100, or about 0.1 to about 10.

In articles in which solid hydrophilic particles are embedded in a water-insoluble delivery carrier, the configuration (e.g., shape or location) of the embedded particles is such that: 1) the embedded particles are embedded in the water-insoluble delivery carrier during storage, transportation, or handling; and/or 2) that the embedded particles release an effective amount of bleach during use. Specifically, in articles in which solid hydrophilic particles are embedded in a water-insoluble delivery carrier, the embedded particles are embedded such that a majority (e.g., greater than about 50%) of the embedded particles are on the surface of the water-insoluble delivery carrier. If the particles are comprised of particles, the embedded particles may become separated from the water-insoluble delivery carrier during storage, transportation or handling. Additionally, if a large portion of the embedded particles protrude above the surface of the water-insoluble delivery carrier, it increases the surface roughness (e.g., resembles sandpaper in appearance or texture) and makes it difficult for consumers to use it. Even before application, they can create an unpleasant impression on sensitive oral tissues, or even pierce sensitive oral tissues during application or use, causing discomfort. In this regard, 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 are disposed on the surface of the water-insoluble delivery carrier. It is preferable that

Additionally, if the embedded particles are configured such that a majority (e.g., greater than 50%) of the embedded particles are below the surface of the water-insoluble delivery carrier and are not directly exposed to the external environment, an effective amount of bleaching agent may not be released. In one aspect, surprisingly, in an article in which solid hydrophilic particles are embedded in a water-insoluble delivery carrier, the embedded particles 1) have a majority of the embedded particles below the surface of the water-insoluble delivery carrier; and 2) can be configured such that a large portion of the surface of the embedded particle is directly exposed to the external environment. This counterintuitive configuration can 1) inhibit the separation of the embedded particles from the water-insoluble delivery carrier and 2) release an effective amount of bleach from the embedded particles. For example, dispersing the particles on the surface of a water-insoluble delivery carrier and pressing the particles into the water-insoluble delivery carrier at high pressure (e.g., in a hydraulic press, between two rollers, or between a roller and a hard surface). When particles are embedded in a water-insoluble delivery carrier, the water-insoluble delivery carrier has 1) a large portion of the particles located below the surface, and 2) a planarization of the particles themselves at least partially at or near the surface. potential, resulting in a large portion of the particle's surface being directly exposed to the external environment, resulting in the release of an effective amount of bleach.

Thus, the solid hydrophilic particles preferably have 1) greater than about 50%, preferably greater than about 75%, preferably greater than about 95%, and most preferably 100% of the volume of the embedded particles in the water-insoluble delivery carrier. and/or 2) more than about 10%, preferably more than about 20%, preferably more than about 30% of the surface area of the embedded particles is on the surface of the water-insoluble delivery carrier. embedded in the water-insoluble delivery carrier so as to be placed in the water-insoluble delivery carrier, thereby being directly exposed to the external environment surrounding the water-insoluble delivery carrier.

The size of the solid hydrophilic particles, the thickness of the solid water-insoluble delivery carrier, or the applied pressure can influence the configuration (eg, shape or position) of the embedded particles. The solid hydrophilic particles disperse the particles on the surface of the water-insoluble delivery carrier at least about 50 pounds per square inch (PSI), preferably at least about 500 PSI, preferably at least about 5000 PSI, most preferably at least about 50,000 PSI, Alternatively, the particles can be embedded in a water-insoluble delivery carrier by pressing the particles into the water-insoluble delivery carrier at a pressure of about 50 PSI to about 50,000 PSI, preferably about 50 PSI to about 5000 PSI, most preferably about 500 PSI to about 5000 PSI.

The bleaching agent per solid hydrophilic particle is about 1% to about 95%, preferably about 10% to about 50%, most preferably about 15% to about 40% by weight of the solid hydrophilic particles. %.

Surprisingly, the concentration of bleach required to achieve the effect contemplated in this invention is surprisingly low relative to the weight of the article, e.g. the bleach commonly used in previous commercial products. It was found that the concentration was lower than that of For example, the concentration of bleach may be from about 0.01% to about 15%, preferably from about 0.01% to about 10%, more preferably from about 0.01% to about 3%, and most preferably less than 3%. could be. For example, the concentration of bleach may be from about 0.01% to 0.1% by weight of the article, preferably from about 0.01% to about 0.09%, preferably less than 0.1% by weight of the article. could be.

Bleaching Agents Articles of the present invention may contain a number of different bleaching agents as disclosed herein. The concentration of some bleaching agents may be regulated and/or limited due to regulatory requirements. For example, when bleach is used as a bleaching agent, the appropriate concentration of bleach must not only be calculated according to the intended effect, but also meet regulatory requirements. For example, suitable total concentrations of bleach as a bleaching agent include about 0.01% to about 0.1%, less than about 0.1%, about 0.01% to about 0.099995%, about 0.01% % to about 0.095%, about 0.05% to about 0.09%. Bleaching agents provided by solid hydrophilic particles can be effective even when used at very low concentrations in the articles disclosed herein. If higher concentrations of bleach are used, e.g. up to about 3% by weight of the article, the total concentration of bleach as a bleaching agent is less than about 3% by weight of the article, preferably about 0.1% by weight of the article. It may be from about 3% by weight, most preferably from about 0.5% to about 3% by weight of the article.

In one aspect, without wishing to be bound by theory, the surprisingly high effectiveness afforded by very low concentrations of bleach is achieved by delivering the bleach directly to the surface requiring treatment. It is thought that it will be obtained. Thus, the concentration of bleach at the first surface, which is generally the surface of the article intended to come into contact with the surface of the oral cavity to be treated, can be measured. For example, the concentration of at least one bleaching agent on the first surface is about 1 microgram/cm2 to about 10,000 micrograms/cm2, preferably about 10 micrograms/cm2, as measured according to the methods specified herein. It may range from about 5000 micrograms/cm2 to about 5000 micrograms/cm2, most preferably from about 50 micrograms/cm2 to about 3000 micrograms/cm2.

When the solid hydrophilic particles are introduced into the water-insoluble delivery carrier by embedding, the concentration of bleach on the second surface of the article, generally opposite the first surface, is significantly lower than the concentration on the first surface. There is a possibility that it will happen. For example, the concentration of at least one bleaching agent on the second surface is about 0.001 micrograms/cm2 to about 500 micrograms/cm2, preferably about 0. It can be from .01 micrograms/cm2 to about 200 micrograms/cm2, most preferably from about 0.1 micrograms/cm2 to about 100 micrograms/cm2.

When solid hydrophilic particles are introduced into a water-insoluble delivery carrier by embedding, the concentration of bleach on the first surface is the concentration of bleach on the second surface, measured according to the procedures set forth herein. The divided ratio may be greater than 1, preferably from about 2 to about 10,000, preferably from about 2 to about 1,000, and preferably from about 2 to about 100. In one aspect, it is surprising that the solid hydrophilic particles are unevenly located in the water-insoluble delivery carrier, e.g., more on the surface of the article intended to contact the oral cavity surface to be treated. It has been found that even better efficacy results can be achieved if there are a number of strands and a smaller number on the opposite surface. Therefore, the number of solid hydrophilic particles per cm2 may be a factor to reduce oral/local irritation, reduce tooth sensitivity, and/or increase effectiveness during use. Without wishing to be bound by theory, non-uniform distribution concentrates the bleach at the intended site of action, thereby reducing the amount of bleach and unintended, sometimes negative side effects. Therefore, if the size or number of solid hydrophilic particles is too large, it may result in large spots on oral/topical/tooth surfaces exposed to high concentrations of bleaching agents, resulting in oral/local irritation and/or Tooth sensitivity may occur, and if the size or number of solid hydrophilic particles is too small, effectiveness may be too low. The number of solid hydrophilic particles per cm2 on the first surface may be at least 5, preferably from about 5 to about 10,000, preferably from about 10 to about 1,000, or from about 10 to about 100. If solid hydrophilic particles are introduced into the water-insoluble delivery carrier by embedding, the number of solid hydrophilic particles on the second surface may be less than the number on the first surface. For example, the average number of solid hydrophilic particles per cm2 on the second surface can be up to 200, preferably from about 0.01 to about 100, most preferably from 1 to about 10.

Bleach Agents The articles of the present invention include a safe and effective amount of at least one bleaching agent. Suitable bleaching agents deliver hydrogen peroxide as an adduct or complex of hydrogen peroxide, or a precursor of hydrogen peroxide. Examples of hydrophilic bleach particles include agents that provide a tooth color change or whitening effect, a bleaching effect, a stain bleaching effect, a stain removal effect, a stain color changing effect, or any other effect. Can be mentioned. For example, hydrophilic bleach particles include a source of peroxide radicals. Hydrophilic bleach particles may include peroxides, metal chlorides, peroxy acids, persulfates, compounds that form the aforementioned compounds in situ, and combinations thereof. Examples of peroxide compounds include urea peroxide (also known as carbamide peroxide or urea hydrogen peroxide adduct), and mixtures thereof. Examples of metal chlorides include calcium chloride, barium chlorite, magnesium chloride, lithium chlorite, sodium chlorite, potassium chlorite, and mixtures thereof. Examples of hydrophilic bleach particles include hypochlorites (such as metal hypochlorites). Examples of persulfates may include salts of peroxymonosulfate, peroxydisulfates, and mixtures thereof. Examples of persulfates and hypochlorites include the corresponding salts of sodium, calcium, potassium, and other metals. Examples of preferred solid hydrophilic bleach particles include complexes of hydrogen peroxide and polyvinylpyrrolidone (PVP) polymer (also known as peroxidone), urea peroxide, and mixtures thereof. Most preferred are, but not limited to, complexes of hydrogen peroxide and polyvinylpyrrolidone (PVP) polymers.

Further Additional Active Agents and Optional Active Agents The articles of the invention can further comprise a safe and effective amount of at least one additional active agent, e.g., the solid hydrophilic particles are and/or one or more additional active agents can be added to the water-insoluble delivery carrier separately from the solid hydrophilic particles. Suitable additional active agents include any material that is generally considered safe for use in the oral cavity and that produces a change in the overall appearance and/or health of the oral cavity. For example, suitable additional oral care actives include one or more healing agent(s), antilithic agent(s), fluoride ion source, antimicrobial agent(s), remineralizing agent(s). ), dentin desensitizer(s), anesthetic agent(s), antifungal active substance(s), cooling agent(s), anti-inflammatory agent(s), selective H-2 antagonist(s) , anti-caries agent(s), nutritional(s), erythritol, probiotics, resolvins containing eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), and docosapentaenoic acid (DPA) clupanodonic acid, resolvins D's 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's: RvE1 (5S, 12R, 18R-trihydroxy-EPA). ), 18S-Rv1 (5S,12R,18S-trihydroxy-EPA), RvE2 (5S,18R-dihydroxy-EPA), and RvE3 (17R,18R/S-dihydroxy-EPA), tranexamic acid, glycine, retinol, Amino acids such as histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, valine, alanine, asparagine, aspartic acid, glutamic acid, arginine, cysteine, glutamine, tyrosine, glycine, ornithine, proline, and serine, peptides, Mention may be made of calcium salts of amino acids, as well as peptides, niacinamide, human growth factors, and mixtures and/or combinations thereof. The solid hydrophilic particles may contain at least one additional active agent in a concentration that, when used directly, promotes the intended effect without damaging the oral surfaces to which it is applied. Examples of oral conditions that these active substances address include changes in the appearance and structure of the teeth, e.g. caries, reduction and/or removal of plaque, tartar and stains, providing an antibacterial effect, prevention and treatment of cavities, gums. Treatment of inflammation and/or bleeding of mucous membranes, wounds, lesions, ulcers, aphthous ulcers, herpes simplex, tooth abscesses, as well as the removal of bad breath and breath odor resulting from the above conditions and other causes such as bacterial growth. Improvements include, but are not limited to:

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

Additional oral care actives can be one or more anti-inflammatory agents, examples of which include acetylsalicylic acid, ketorolac, flurbiprofen, ibuprofen, naproxen, indomethacin, acetaminophen, acetylsalicylic acid, steroids , non-steroidal anti-inflammatory agents such as ketorolac, naproxen, ketoprofen, piroxicam and meclofenamic acid, COX-2 inhibitors such as valdecoxib, celecoxib and rofecoxib, and mixtures thereof. When present, the anti-inflammatory agent generally comprises from about 0.001% to about 5% by weight of the article.

Additional oral care actives include Lactobacillus reuteri ATCC 55730, Lactobacillus salivarius strain TI12711 (LS 1), Lactobacillus paracasei ADP-1, Streptococcus saliv arius K12, Bifidobacterium DN-173 010, L. filtrate of S. paracasei strain (pro-t-action™), S. paracasei strain (pro-t-action(TM)); Oralis KJ3,S. rattus JH145,S. uberis KJ2, Lactobacillus reuteri Prodentis, Lactobacillus salivarius LS1, Lactobacillus paracasei, Lactobacillus paracasei A DP1, Streptococcus salivarius M18, K12, or BLIS K12 and BLIS M18, Bacillus Amyloliquefaciens, Bacillus Clausii, Bacillus Coagulans, Ba cillus subtilis, Bacillus subtilis: E-300 , Bifidobacterium Animalis, Bifidobacterium B6, Bifidobacterium Bifidum, Bifidobacterium Breve (Bb-03), Bifidobacterium DN-173 010, Bifidobacterium GBI30 6068, Bifidobacterium infantis, Bifidobacterium Lactis, Bifidobacterium lactis Bb-12, Bifidobacterium Longum, Bifidobacterium thermophilum, Enterococcus Faecalis, Enterococcus Faecium, Enterococcus Faecium NCIMB10415, Enterococcus LAB SF 68, Lactobacilli reuteri ATCC55730 and ATCC PTA5289, Lactobacilli r Euteri ATCC55730 and ATCC PTA5289 (10:1), Lactobacillus acidophilus, Lactobacillus acidophilus ATCC4356 and Bifidobacterium bifidum AT CC29521, Lactobacillus acidophilus, Bifidobacterium longum, Bifidobacterium bifidum, Bifidobacterium lactis, Lactobacillus Brevis, Lactobacillus Casei (subspecies, Casi), Lactobacillus casei Shirota, Lactobacillus Confus us, Lactobacillus crispatus YIT12319, Lactobacillus Curvatus, Lactobacillus Delbrueckii Ssp. Bulgaricus PXN39, Lactobacillus Fermentum, Lactobacillus fermentum YIT12320, Lactobacillus Gasseri, Lactobacillus gasseri YIT 12321, Lactobacillus Helveticus, Lactobacillus Johnsonii, Lactobacillus Kimchii, Lactobacillus Lactis L1A, Lactobacillus Paracas ei (Lpc37), Lactobacillus paracasei GMNL-33, Lactobacillus Pentosus, Lactobacillus plantarum, Lactobacillus plantarum , Lactobacillus Protectus, Lactobacillus Reuteri, Lactobacillus reuteri ATCC55730, Lactobacillus reuteri SD2112 (ATCC55730), La ctobacillus Rhamnosus (GG), Lactobacillus rhamnosus GG, Lactobacillus rhamnosus GG, L. rhamnosus LC705, Propionibacterium freudenreichii ssp, shermanii JS, Lactobacillus rhamnosus L8020, Lactobacillus rhamnosus L B21, Lactobacillus Salivarius, Lactobacillus salivarius WB21, Lactobacillus Sporogenes, Lactococcus Lactis Ssp Diacetylactis, La ctococcus Lactis Ssp. Lactis, Pediococcus acidilactici, Pediococcus Pentosaceus, Saccharomyces Boulardii, Saccharomyces Cerevisiae, Strep. uberis KJ2sm, Strep. oralis KJ3sm, trep. rattus JH145, Streptococcus mitis YIT12322, Streptococcus Oralis KJ3, Streptococcus Rattus JH145, Streptococcus Salivarius (BL IS K12, or BLIS M18), Streptococcus salivarius K12, Streptococcus thermophilus, Streptococcus Uberis KJ2, Thermus thermophiles, Wei Weissella cibaria CMS2, Weissella cibaria CMS3, and Weissella cibaria CMU.

The use of probiotics in articles of the invention promotes positive oral hygiene effects, such as reducing caries and plaque, promoting gum health, improving hygiene, and promoting whitening. I can do it. The effectiveness of probiotics in an article may be determined by, for example, one or more of the following: reducing levels of Streptococcus mutans in saliva, reducing gingival crevicular fluid, reducing periodontal disease caused by subgingival plaque (C. rectus, and P. gingivitis), yeast counts, oral candida prevalence, oral volatile sulfur compound (VSC) levels, and TNF-α and IL-8 production. , can be determined by measuring . Without being limited by theory, one or more of the positive oral health effects described above may be achieved through the production of bacterial toxins that eliminate or reduce certain types of bacteria in the oral cavity. It is further believed that one or more of the positive oral health effects described above may include one or more enzymes that inhibit the formation or dissolution/loosening of biofilms or sticky deposits that can lead to hygiene problems. may be achieved through bacterial production of.

For example, at least one anti-calculus agent can be used in the articles disclosed herein. Antilithic agents also include polyphosphates and their salts, polyaminopropanesulfonic acid (AMPS) and their salts, polyolefin sulfonates and their salts, polyvinylphosphonates and their salts, polyolefin phosphonates and their salts, diphosphonic acids and their salts, phosphonoalkanes. Can be selected from the group consisting of carboxylic acids and salts thereof, polyphosphonates and salts thereof, polyvinylphosphonates and salts thereof, polyolefin phosphonates and salts thereof, polypeptides, and mixtures thereof, and the aforementioned salts are typically It's salt. Anti-calculus agents such as, for example, pyrophosphates, polyphosphates, polyphosphonates and mixtures thereof may also exhibit a stabilizing effect on solid hydrophilic bleaching agents.

The anti-calculus agent can be, for example, a polyphosphate. Polyphosphates are generally understood to contain two or more phosphate molecules arranged in a predominantly linear configuration, although some cyclic derivatives may also be present. The linear polyphosphate corresponds to (X PO ₃ ) _n , where n is about 2 to about 125, preferably n is greater than 4, and X is, for example, sodium, potassium, etc. . Regarding (X PO ₃ ) _n , when n is at least 3, the polyphosphate has vitreous properties. Counterions for these phosphates may be alkali metals, alkaline earth metals, ammonium, C ₂ -C ₆ alkanolammonium and salt mixtures thereof. Polyphosphates are generally used as wholly or partially neutralized water-soluble alkali metal salts, such as potassium, sodium, ammonium salts, and mixtures thereof. Inorganic polyphosphate salts include alkali metal (e.g. sodium) tripolyphosphate, tetrapolyphosphate, dialkyl metal diacid (e.g. disodium), trialkyl metal monoate (e.g. trisodium), potassium hydrogen phosphate, phosphorus. and alkali metal (eg, sodium) hexametaphosphates, and mixtures thereof. Polyphosphates larger than tetrapolyphosphate are typically manufactured by FMC Corporation, commercially known as Sodaphos (n≈6), Hexaphos (n≈13), Glass H (n≈21), and mixtures thereof. It occurs as an amorphous glassy material, such as The concentration of polyphosphate in articles of the invention is preferably from about 1.5% to about 10%, such as from about 2% to about 10%, more preferably from about 6% to about 10%, by weight of the article. % by weight.

Pyrophosphates that may be useful in this article include alkali metal pyrophosphates, di-, tri-, and mono-potassium or sodium pyrophosphates, dialkali metal pyrophosphates, tetraalkali metal pyrophosphates, and the like. A mixture of the following may be mentioned. For example, pyrophosphates include trisodium pyrophosphate, disodium dihydrogen pyrophosphate (Na ₂ H ₂ P ₂ O ₇ ), dipotassium pyrophosphate, tetrasodium pyrophosphate (Na ₄ P ₂ O ₇ ), and tetrasodium pyrophosphate. It may be selected from the group consisting of potassium (K ₄ P ₂ O ₇ ), and mixtures thereof, with tetrasodium pyrophosphate being preferred. Tetrasodium pyrophosphate may be in anhydrous salt form or decahydrate form, or any other species that is stable in solid form in the articles of the invention. The salt is in solid particle form, which means that the particle size of the salt is preferably small enough to be aesthetically acceptable and rapidly soluble during use in the crystalline and/or amorphous state. It may be a state. The concentration of pyrophosphate in articles of the invention ranges from about 1.5% to about 10%, such as from about 2% to about 10%, more preferably from about 3% to about 8%, by weight of the article. It can be. Sources of phosphates, including but not limited to polyphosphates and pyrophosphates, are found in Kirk & Othmer, Encyclopedia of Chemical Technology, Fourth Edition, Volume 18, Wiley-Interscience Publications. Hers (1996) pp. 685-707.

Polyolefin phosphonates include those in which the olefin group contains two or more carbon atoms. Polyvinylphosphonates include polyvinylphosphonic acid. Diphosphonates and their salts include azocycloalkane-2,2-diphosphonic acid and its salts, azocycloalkane-2,2-diphosphonic acid and its salt ions (where the alkane moiety is 5, 6, or 7 azacyclohexane-2,2-diphosphonic acid, azacyclopentane-2,2 -diphosphonic acid, N-methyl-azacyclopentane-2,3-diphosphonic acid, EHDP (hydroxyethane-1,1,-diphosphonic acid), AHP (azacycloheptane-2,2-diphosphonic acid, a.k. a.1-azacycloheptylidene-2,2-diphosphonic acid), ethane-1-amino-1,1-diphosphonate, dichloromethane diphosphonate, and the like. Phosphonoalkanecarboxylic acids or alkali metal salts thereof include PPTA (phosphonopropanetricarboxylic acid) and PBTA (phosphonobutane-1,2,4-tricarboxylic acid), each of which is an acid or an alkali metal salt. .

Antibacterial antiplaque agents can be used as suitable additional active agents in the present invention, such agents include triclosan, humulone, adhumulone, cohumulone, posthumulone, prehumulon, and the like. or hop acids from hops extracts, such as hop alpha acids containing combinations of or hop beta acids containing lupulone, adlupulone, colupulone, and combinations thereof, U.S. Patent No. 3,506,720 and European Patent Application No. 0, 251,591 The Merck Index, 11th ed. (1989), pp. 5-chloro-2-(2,4-dichlorophenoxy)-phenol described in No. 1529 (entry no. 9573), chlorhexidine (Merck Index, No. 2090), alexidine (Merck Index, No. 222), hexetidine (Merck Index, No. 222), 4624), sanguinarine (Merck Index, No. 8320), benzalkonium chloride (Merck Index, No. 1066), salicylanilide (Merck Index, No. 8299), domiphene bromide (Merck Index, No. 3411), cetylpyridinium chloride ( cetylpyridinium chloride (CPC) (Merck Index, No. 2024), tetradecylpyridinium chloride (TPC), N-tetradecyl-4-ethylpyridinium chloride (TDEPC) , octenidine, delmopinol , octapinol, and other piperidino derivatives; cocomidylpropyl betaine, sodium cocomidyl glutamate, sodium lauryl sarcosinate, GTF inhibitors, povidone iodine delmopinol, propolis, phthalic acid and its salts, monoparsalic acid and its salts and esters, stearic acid May include, but are not limited to, ascorbyl, oleylpsychosine, alkyl sulfates. The article contains antimicrobial effective amounts of essential oils, herbal extracts, and combinations thereof, such as citral, geranial, rosemary extract, tea extract, magnolia extract, eucalyptol geraniol, carvacrol, citral, hinokitiol, catechol. , methyl salicylate, epigallocatechin gallate, epigallocatechin, gallic acid, miswak extract, sea buckthorn extract, and combinations of menthol, eucalyptol, thymol, and methyl salicylate; antibacterial metals and their salts; e.g. such as those that provide zinc ions, tin ions, copper ions, and/or mixtures thereof; bisbiguanides, or antibiotics such as phenols, augmentin, amoxicillin, tetracycline, doxycycline, minocycline, and metronidazole; and the antibacterial antibiotics listed above. Plaque agents and/or analogs of antifungal agents and salts thereof, such as those for the treatment of Candida thrush, may be included. When present, these additional active agents are generally present in safe and effective amounts, such as from about 0.1% to about 5% by weight of the article of the invention.

In another aspect, anti-caries agents may be additional active agents suitable for articles of the invention. Anti-caries agents include fluoride, sodium fluoride, potassium fluoride, titanium fluoride, hydrofluoric acid, amine fluoride, sodium monofluorophosphate, ammonium fluoride, stannous fluoride, stannous chloride, and glucone. Stannous acids, copper salts, copper chloride, copper glycinate, zinc chloride, zinc lactate, zinc citrate, zinc phosphate, sodium iodide, potassium iodide, calcium chloride, calcium lactate, calcium phosphate, hydroxy Apatite, fluoroapatite, amorphous calcium phosphate, crystalline calcium phosphate, sodium bicarbonate, sodium carbonate, calcium carbonate, oxalic acid, dipotassium oxalate, monosodium monopotassium oxalate, casein phosphopeptide, casein phosphopeptide-coated hydroxyapatite, one or more of _SiO2 , _CaO , _Na2O , _P2O5 , _CaF2 , _B2O3 , _{K2O ,} MgO, such as those disclosed in U.S. Pat. No. 5,735,942; can be selected from the group consisting of bioglass containing. When present, the article provides about 50 ppm to 10,000 ppm, preferably about 100 to 3000 ppm of fluoride ions in the articles disclosed herein.

Nutrients such as minerals have the potential to improve teeth and tooth surfaces and therefore can be used as suitable additional active agents with the articles disclosed herein. Suitable minerals are, for example, calcium, phosphorus, fluoride, zinc, manganese, potassium, and mixtures thereof. These minerals are described, for example, in Drug Facts and Comparisons (loose leaf drug information service), Wolters Kluer Company (St. Louis, Mo.), Copyright 1997, pp 10-17. has been disclosed.

Accordingly, the articles disclosed herein provide a high ratio of the weight percent concentration of a bleaching agent, such as hydrogen peroxide, present in the solid hydrophilic particles to the weight percent concentration of bleaching agent present throughout the article. . This results from the combination of the high weight percent concentration of bleach in the solid hydrophilic particles and the relatively low weight percent concentration of bleach in the entire molded article. Without wishing to be bound by theory, in embodiments of the invention involving hydrogen peroxide, the surprising combination of seemingly contradictory parameters may affect the overall concentration or amount of hydrogen peroxide delivered to the tooth surface. Deliver hydrogen peroxide to the tooth surface with high propulsive force even when the pressure is low. As a result, high propulsion forces deliver surprisingly high levels of bleaching effectiveness and/or bleaching rates, while lower total concentrations or amounts of bleach delivered to the tooth surface result in less tooth sensitivity. can help reduce For example, the ratio of the weight percent concentration of bleach present in the solid hydrophilic particles to the weight percent concentration of bleach present in the entire article is from about 2 to about 50,000, preferably from about 3 to about 10,000, most preferably can be from about 5 to about 1000.

The bleaching agents of the present invention may be stabilized against degradation by the protective effect of the water-insoluble delivery carrier. Additional stabilizers for bleaching agents may be present in the articles disclosed herein. The bleach can be further stabilized against degradation by the article. Accordingly, stabilizers may be added to articles of the invention. Suitable stabilizers are, for example, ortho-phosphoric acid, phosphates such as sodium hydrogen phosphate, pyrophosphates, organophosphonates, ethylenediaminetetraacetic acid, ethylenediamine-N,N'-diacetic acid, ethylenediamine-N,N'-diacetic acid, etc. Succinic acid, potassium stannate, sodium stannate, stannous salts, zinc salts, salicylic acid, 1-hydroxyethylidene-1,1-diphosphonic acid, and combinations thereof. For example, phosphates as disclosed herein, preferably pyrophosphates, tripolyphosphates, hexametaphosphates, phytic acid, PO ₃ (PO2) _n PO3 (wherein n=2-30) salts of phosphoric acid, zinc salts including gantrez, zinc citrate, zinc lactate, zinc chloride, zinc phosphate, zinc oxide, enzymes such as dextransess, xylanase, protease, phosphonates such as bisphosphonates , EDTA, calcium sodium EDTA, citrate, citric acid, oxalic acid, chelating agents such as oxalate, polymers (such as those disclosed in U.S. patent application Ser. No. 16/216,329), PVP, polyacrylics. Stabilizers that exhibit additional oral care benefits may be used, such as the anti-tartar effect produced by acids (Carbopol), polyacrylates, stannous salts, stannic salts. The stabilizer is in an amount from about 0.0000001%, 0.000001%, or 0.00001% to about 0.00001%, 0.0001%, or 0.01% by weight of the article; may be present in the articles of the invention. For example, the stabilizer may be present in an amount of about 0.0001%, or from 0.01% to about 0.01%, 0.1%, or about 1% by weight of the solid hydrophilic particles. may be present in the article.

Stabilizing agents may also include chelating agents. The chelating agent may be a copper, iron and/or manganese chelating agent, or a mixture thereof. Suitable chelating agents include diethylenetriaminepentaacetic acid, diethylenetriaminepenta(methylphosphonic acid), ethylenediamine-N'N'-disuccinic acid, ethylenediaminetetraacetic acid, ethylenediaminetetra(methylenephosphonic acid), hydroxyethanedi(methylenephosphonic acid), and Any combination thereof may be selected. Suitable chelating agents are ethylene diamine-N'N'-disuccinic acid (EDDS) and/or hydroxyethane diphosphonic acid (HEDP), or mixtures thereof. can be selected from. The stabilizer may include ethylenediamine-N'N'-disuccinic acid, or a salt thereof. Ethylenediamine-N'N'-disuccinic acid can be in the S,S enantiomeric form. The stabilizer is 4,5-dihydroxy-m-benzenedisulfonic acid disodium salt, glutamic acid-N,N-diacetic acid (GLDA) and/or its salt, 2- Hydroxypyridine-1-oxide, Trilon P™ (available from BASF, Ludwigshafen, Germany) may be included. Suitable chelating agents include 1-hydroxyethanediphosphonic acid (HEDP), N,N-dicarboxymethyl-2-aminopentane-1,5-dioic acid, 2-phosphonobutane-1,2,4-tricarboxylic acid , and salts thereof, and any combinations thereof. Stabilizers may include hydroxamate chelators such as hydroxamic acid or a corresponding salt, eg cocohydroxamic acid (Axis House RK 853).

Articles disclosed herein may include optional additional ingredients. For example, additional optional ingredients may be present in the article that are intended to be released from a second side, such as the other side, of the water-insoluble delivery carrier. For example, coolants, desensitizers, anesthetics and/or taste improvers and/or aesthetic improvers, such as perfumes, etc., may be optional ingredients in articles of the invention, for example from about 0.001% to about 10% by weight of the article. It can be used at a concentration of % by weight, preferably from about 0.1% to about 1% by weight. Coolants, desensitizers, and anesthetics can reduce potential negative sensations, such as stinging, burning pain, etc. caused by bleach. A wide variety of materials can be used as coolants, including, but not limited to, carboxamides, menthol, ketals, diols, and mixtures thereof. Optional coolants in articles of the invention include N-ethyl-p-menthane-3-carboxamide (known as "WS-3"), N,2,3-trimethyl-2-isopropylbutanamide ( Menthol, 3-1-menthoxypropane-1,2-diol (known as "TK-10"), Menthone glycerol acetal (known as MGA) ), menthyl lactate (known as Frescolate®), and mixtures thereof. As used herein, the terms menthol and menthyl include the dextro and levorotatory isomers of these compounds, as well as racemic mixtures thereof. Desensitizers or analgesics may include, but are not limited to, strontium chloride, potassium nitrate, and natural herbs such as gallnut, asarum, cubebin, galanga root, huangxiang, liang mianzheng, and baishi. . Suitable anesthetics include benzocaine, lidocaine, clove bud oil, and ethanol.

Suitable flavoring agents include wintergreen oil, peppermint oil, spearmint oil, clove bud oil, menthol, anethole, methyl salicylate, eucalyptol, 1-menthyl acetate, sage, eugenol, parsley oil, oxanone, alpha - irisone, marjoram, lemon, orange, propenylguetol, cinnamon, vanillin, thymol, linalool, cinnamaldehyde glycerol acetal (known as CGA), and mixtures thereof. Flavoring agents, if present, generally at a concentration 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. used in

The article of the present invention optionally contains sucralose, sucrose, glucose, saccharin, dextrose, lebulose, lactose, mannitol, sorbitol, fructose, maltose, xylitol, saccharin salts, thaumatin, aspartame, D-tryptophan, dihydrochalcones, acesulfame salts. and cyclamate salts, particularly sodium cyclamate and sodium saccharin, and mixtures thereof. When present, the article contains from about 0.1% to about 10%, such as from about 0.1% to about 1%, by weight of the article.

Articles of the invention may optionally include dyes, pigments, colorants, and mixtures thereof to give the article a colored appearance. An advantage of adding pigments and/or colorants to the articles herein is that the colored article makes it easier to see the coverage, thereby ensuring even and complete coverage of the user's teeth. This means that the user can confirm it. The colorant may provide a color similar to that of bleached teeth. The colorants useful herein are stable with bleach, and they are recognized as safe. The concentration of dyes, pigments, and colorants optionally used herein ranges from about 0.001% to about 15%, such as about 0.01% to about 10%, more preferably about It ranges from 0.1% to about 5% by weight.

In one aspect, two or more oral care actives that are normally mutually exclusive can be combined separately in the same article of the invention. Thus, a solid water-insoluble delivery carrier can maintain separation of such incompatible active agents. For example, the invention may include a hydrophilic bleaching agent in combination with additional oral care actives that further improve the bleaching effectiveness of the article. Examples include bleaching agents in combination with additional oral care actives that can provide the driving force to increase pH when contacted with water. Specifically, examples include solid hydrophilic particles comprising peroxide separately combined with sodium bicarbonate (baking soda) in a solid water-insoluble delivery carrier. When in contact, peroxide and baking soda are reactive toward each other, and when added separately to the solid water-insoluble delivery carrier of the present invention, can be maintained separate from each other until use. Without wishing to be bound by theory, it is believed that particles of two or more hydrophilic oral care active agents, typically incompatible with each other, are kept substantially separated from each other in a water-insoluble delivery carrier; It is assumed that separation can minimize or eliminate incompatibilities even on a microscopic scale. Additionally, when one particle of a hydrophilic oral care agent comes into contact with moisture, for example during oral use, the components of the particle will at least partially dissolve or swell, and the particles of the other oral care agent will dissolve or swell. It is assumed that direct contact is possible. However, this may occur primarily during intraoral use, with minimal or no occurrence occurring in the article prior to use. Accordingly, articles of the invention may include two or more oral care actives that are normally incompatible with each other.

Although it is desirable for oral care actives to be incorporated into the solid hydrophilic particles of the present invention, oral care actives typically have relatively low water solubility (e.g., less than about 20 parts by weight, preferably about 15 parts by weight). such oral care actives are solubilized in a suitable solvent (e.g., water, glycerin, etc.) and then , into solid hydrophilic particles (eg, PVP solid hydrophilic particles), and the resulting solid hydrophilic particles containing the oral care active agent can then be incorporated into the oral care articles of the present invention.

Although it is desirable for oral care actives to be incorporated into the solid hydrophilic particles of the present invention, oral care actives are typically provided as liquid materials and such oral care actives are incorporated into solid hydrophilic particles (e.g. PVP solid hydrophilic particles) and the resulting solid hydrophilic particles containing oral care active agents can then be incorporated into oral care articles of the present invention.

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

Bleaching Efficacy The bleaching effectiveness of articles of the invention, measured according to the clinical protocols disclosed herein and calculated as -Δb ^* , is 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, measured according to the clinical protocols disclosed herein and calculated as -Δb ^* , is noteworthy.

The present invention can result in a significantly higher ratio of bleaching effectiveness, measured according to the clinical protocols disclosed herein and calculated as -Δb ^* relative to the weight percent of bleach present in the entire article. . For example, a -Δb ^* of 1.5 with an article containing 3% bleach by weight of the article is measured according to a clinical protocol as disclosed herein, and in the entire article of 0.5 It has been found that one can yield a ratio of bleach effectiveness calculated as -Δb ^* relative to the weight percent of bleach present. When a bleaching agent is used as a bleaching agent, for example, the bleaching effectiveness of the present invention relative to the weight percent of bleaching agent present in the total article (measured according to the clinical protocol disclosed herein, as −Δb ^* ) The ratio of (calculated) may be at least about 2.5, preferably at least about 5, more preferably at least about 10, and even more preferably at least about 15.

For example, the present invention provides that: 1) the bleaching efficacy of the present invention on the fraction of participants who reported or were observed to have oral irritation that could have been or was probably caused by the product; 2) a surprisingly ^high ratio of or 3) result in a significantly higher proportion of bleaching effectiveness, calculated as -Δb ^* , relative to the fraction of participants who reported potentially or possibly attributable tooth sensitivity; or 3) as herein described. Participants who reported tooth sensitivity, or who reported oral irritation, or where such oral irritation was observed, as measured in accordance with the disclosed clinical protocol, and that may or may have been caused by the Product. This results in a significantly higher ratio of bleaching effectiveness, calculated as −Δb ^* to fraction.

For example, tooth hypersensitivity, possibly or possibly attributable to the present invention, of the bleaching effectiveness of the present invention measured according to the clinical protocols disclosed herein and calculated as -Δb ^* ; The ratio to the proportion of participants reporting oral irritation, or both, or observed to have tooth sensitivity, oral irritation, or both, is at least at least about 6, more preferably at least about 8, and more. Preferably it will be at least about 10, more preferably at least about 15, more preferably at least about 20, more preferably at least about 25, and even more preferably at least about 50.

Clinical Protocol The following clinical protocol is used to measure the bleaching effectiveness of oral compositions containing bleaching agents. When testing oral compositions with less than about 1% bleaching agent, 17 to 25 participants per treatment group are required to complete the clinical trial, and having at least about 1% bleaching agent. When testing oral compositions, 8-25 participants are required. The required participant must have four natural maxillary segmental teeth with all measurable facets. The average baseline L ^* of the group of participants must be between 71 and 76, and the average baseline b ^* of the group of participants must be between 13 and 18. In addition, participants with malocclusion of the maxillary anterior teeth, severe or atypical endogenous staining caused by tetracycline, fluoride, or hypomineralization, crowns or restorations on the facial surfaces of the maxillary anterior teeth, melanoma Participants with self-reported medical history, current smoking or tobacco use, mild irritation sensitivity or pigmented skin disease, participants with self-reported tooth sensitivity Participants will be excluded from the study if they are whitening their teeth or have previously had their teeth whitened using a professional procedure with an over-the-counter kit or investigational product. Participants were provided with Crest Cavity Protection toothpaste and Oral-B Indicator soft manual toothbrushes (both from Proctor & Gamble (Cincinnati, OH, USA)) and completed their daily routine in a customary manner. Use twice.

Participants used a toothbrush ("Anchor 41 Bunch White Toothbrush" from Team Technologies, Ind. (Morristown, TN, USA)) to inject 30 minutes using water before being treated with the oral composition. Brush your teeth for seconds. Each participant's upper anterior teeth are treated with the oral composition once a day for 60 minutes. If the oral composition being evaluated is a semi-solid gel, 0.6 g to 0.8 g of the oral composition is applied to a 66 mm x 15 mm size and about 0.01 mm to about Apply over a .02 mm thick film of clear flexible polyethylene. If the oral composition being evaluated is a solid article, the article is applied directly to the upper anterior teeth.

When oral compositions are used with electromagnetic radiation,
1) 50 minutes after treatment with the oral composition, electromagnetic radiation is applied for 10 minutes towards the anterior surface of the maxillary anterior teeth;
2) directing electromagnetic radiation through the oral composition to the upper anterior teeth;
3) The water-insoluble delivery carrier must be capable of transmitting at least about 90% of electromagnetic radiation between 400 nm and 500 nm, and 4) As shown in FIG. Electromagnetic radiation was transmitted through four fiber optic cables (model number M71L01, from Thorlabs (Newton, NJ, USA)) connected to high-power LEDs (model number M455F1, from Thorlabs (Newton, NJ, USA)). Deliver. The four LEDs are operated at 1000 mA and each uses an LED driver and hub (model numbers DC4104 and DC4100-hub from Thorlabs (Newton, NJ, USA)). The exit ends of the four fiber optic cables are attached to the rear of the transparent mouthpiece and serve to reproducibly position the electromagnetic radiation against the outer surface of the water-insoluble delivery carrier. The exit ends of the four fiber optic cables are approximately 7 mm away from the exit surface of the mouthpiece, allowing electromagnetic radiation to pass through the transparent mouthpiece. The occlusal shelf of the mouthpiece is offset such that the transparent window through which electromagnetic radiation passes toward the upper anterior teeth is 7.4 mm high. Also, the transparent window through which electromagnetic radiation passes towards the upper anterior teeth is 40 mm long, measured linearly from end to end (not including curvature). The exit end of the fiber optic cable is positioned and positioned such that the cone of electromagnetic radiation emanating from the fiber optic cable is centered within a transparent window through which the electromagnetic radiation passes toward the upper anterior teeth, as shown in FIG. angled. Additionally, the exit ends of the four fiber optic cables are such that the cones of electromagnetic radiation are spaced apart relative to the length of the transparent window through which the electromagnetic radiation passes toward the upper anterior teeth, as shown in FIG. They are spaced apart so that The intensity of electromagnetic radiation between 445 nm and 465 nm, measured at the central axis of each cone of electromagnetic radiation exiting at the exit surface of the transparent window through which the electromagnetic radiation passes towards the maxillary anterior teeth, is disclosed herein. It should be between about 175 mW/cm ² and about 225 mW/cm ² as measured by the method.

Upon completion of the 60 minute treatment with the oral composition, the polyethylene film is removed for semi-solid gels and the article is removed for solid articles. This treatment is applied once a day for a minimum of 7 days for oral compositions having less than 1% bleaching agent, and for a minimum of 3 days for oral compositions having at least about 1% bleaching agent.

the day after the seventh treatment for oral compositions containing less than about 1% bleaching agent, and the day after the third treatment for oral compositions containing at least about 1% or more bleaching agent. The change in tooth color after treatment with the substance is measured using the following procedure.

Tooth color is measured using a digital camera (camera model number CANON EOS 70D from Canon Inc., Melville, NY) equipped with a NIKON 55mm micro NIKKOR lens with adapter. The light system consists of a 150 watt, 24V bulb model number (Xenophot model number HL) placed approximately 30 cm apart (measured from the center of the outer circular surface of one of the glass lenses through which the light exits). X64640) and aimed at 45 degrees, the light path intersects in the vertical plane of the chin rest, in front of the focal plane of the camera, approximately 36 cm. . Each light has a polarizing filter (Lee 201 filter) and a blocking filter (Rosco 7 mil, Thermashield filter from Rosco (Stamford, CT, USA)).

At the intersection of the light paths, a fixed chin rest is attached for reproducible repositioning in the light field. The camera is positioned between the two lights so that its focal plane is approximately 36 cm from the vertical plane of the chin rest. Prior to initiating tooth color measurements, a color reference is photographed to establish a calibration set point. First, photograph the Munsell N8 gray standard. Adjust the white balance of the camera so that the RGB value of gray is 200. A color reference is photographed to obtain the standard RGB values of the color chip. Color standards and gray standards (from Munsell Color, a division of X-rite, Grand Rapids, MI, USA) are listed below. Each color standard was labeled using the Munsell nomenclature. To create a grid of color standards, they can be arranged in the following manner. This allows multiple color fiducials to be included in a single image captured by a grid of color fiducials.

For baseline tooth color, participants brushed their teeth with water using a toothbrush ("Anchor 41 Bristle White Toothbrush" from Team Technologies, Inc. (Morristown, TN, USA)); Remove food particles from your teeth. Each participant then had a cheek hook (from Washington Scientific Camera Company (Sumner, WA, USA) treated with an A&B Deburring Company (Cincinnati, OH, USA) brushed matte finish) The Unfold and illuminate the facial surface of the participant's teeth. Each participant is instructed to bite their teeth together so that the incisal edge of the maxillary sector tooth contacts the incisal edge of the mandibular sector tooth. The participant is then positioned on the chin rest at the intersection of the optical paths, in the center of the camera field of view, and images of the teeth are captured. After all participants have been imaged, images are processed using image analysis software (Optimas manufactured by Media Cybernetics, Inc. (Silver Spring, MD)). The four central incisors are isolated and the average RGB values of the teeth are extracted.

After the participant has used the whitening product, but prior to capturing images of the participant's teeth, the system is set to a baseline configuration and calibrated as described above. After calibration, each participant was previously imaged a second time using the same procedure as the preprocessed images, including tooth orientation, to ensure that participants were in the same physical location. be treated. Process the images using image analysis software to obtain the average RGB values of the central four maxillary incisions. The RGB values of all images are then mapped into the CIE L ^* a ^* b ^* color space using the RGB values and the L ^* a ^* b ^* values of the color chips in the color standard. The L ^* a ^* b ^* value of the color chip in the color standard is given by Photo Research Inc. Measurements are made using the same lighting conditions described for capturing digital images of the anterior dentition using a Photo Research SpectraScan PR650 from LA. The PR650 is positioned at the same distance from the color standard grid as the camera. Each tip is individually measured for L ^* a ^* b ^* after calibration according to the manufacturer's instructions. The RGB values are then converted to L ^* a ^* b ^* values using a regression equation as follows.

Ｌ^＊、ａ^＊、及びｂ^＊のためのＲ^２は、＞０．９５でなければならない。各研究は、その独自の方程式を有するべきである。

^R2 for L ^* , a ^* , and b ^* must be >0.95. Each study should have its own equation.

These equations are generally valid transformations in the tooth color region (60<L ^* <95, 0<a ^* <14, 6<b ^* <25). The data from each participant's image set is then used to evaluate the performance of the whitening product in terms of changes in the standard methods of L ^* , a ^* , and b ^* , -a ^* used to evaluate whitening effectiveness. used for. For evaluation of oral compositions with less than about 1% bleaching agent, the change in L ^* is defined as ΔL ^* = L ^* _{day after 7 treatments} - L ^* _baseline , and a positive change in brightness The change in a ^* (red-green balance) is defined as Δa ^* = a ^* _{day after 7 treatments} - a ^* _baseline , a negative change indicates a tooth with less redness. , b ^* (yellow-blue balance) is defined as Δb ^* = b ^* _{day after 7 treatments} - b ^* _baseline , a negative change indicates less yellow tinge in the teeth. show. For the evaluation of oral compositions having at least about 1% or more bleaching agent, the change in L ^* is defined as ΔL ^* = L ^* _{after 3 treatments} - L ^* _baseline , and a positive change is defined as brightness. The change in a ^* (red-green balance) is defined as Δa ^* = a ^* _{after 3 treatments} - ^a* _baseline , a negative change indicates a tooth with less redness. , b ^* (yellow-blue balance) is defined as Δb ^* = b ^* _{after 3 treatments} - b ^* _baseline , a negative change indicates that the teeth are less yellowish. show. -Δb ^* is used as the primary measure of bleaching effectiveness. The overall color change is calculated by the equation ΔE=(ΔL ^*2 +Δa ^*2 +Δb ^*2 ) ¹ /2.

After using the whitening product, the color change in CIE Lab color space can be calculated for each participant based on the given equation.

Method of Making an Oral Care Article The present invention further provides a method of making an oral care article, comprising: (i) having a length and a width forming a first surface and extending from the first surface to a second surface; (ii) providing a solid water-insoluble delivery carrier in the form of a strip having a thickness, preferably an average thickness of less than about 3 mm; and (ii) adding solid hydrophilic particles containing a bleaching agent to the solid water-insoluble delivery carrier. (iii) applying the solid hydrophilic particles to a first surface of the solid hydrophilic particles, preferably at a concentration of about 0.01% to about 15% based on the total weight of the solid water-insoluble delivery carrier and the solid hydrophilic particles; embedding the solid hydrophilic particles into the solid delivery carrier, preferably by forcing, into a first surface of the solid water-insoluble delivery carrier.

In one aspect, the particles are deposited in a solid water-insoluble delivery carrier under a pressure of at least about 50 pounds per square inch (PSI), preferably at least about 500 PSI, preferably at least about 5000 PSI, and most preferably at least about 50,000 PSI. pressed into the surface.

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

Commercially available materials such as cast wax transparent sheet 24 gauge (reference number 114009 supplied by Freeman Manufacturing Company, Ohio, USA) can be used as the water-insoluble delivery carrier of the present invention.

Solid hydrophilic particles can be forced or embedded into a water-insoluble delivery carrier by any suitable procedure, for example:
1. The solid hydrophilic particles are sieved or deposited onto a water-insoluble delivery carrier and pressed in a hydraulic press at a specific pressure for a specific time, e.g., 10,000 PSI for 60 seconds, to release the solid hydrophilic particles into water. Can be embedded in an insoluble delivery carrier. The material can then be cut into suitable shapes, for example strips.
2. The solid hydrophilic particles can be sieved or deposited onto the water-insoluble delivery carrier and pressed through nip rollers at a certain pressure or gap to embed the solid hydrophilic particles into the water-insoluble delivery carrier.
3. A photoreceptor drum (eg, in combination with a corona wire and a laser) can be used to obtain a selective surface charge that attracts solid hydrophilic particles in the desired amount. A photoreceptor drum can then be used to deposit the solid hydrophilic particles onto the water-insoluble delivery carrier and then passed between nip rollers to embed the solid hydrophilic particles into the water-insoluble delivery carrier.
4. The surface of the water-insoluble delivery carrier may be at least partially melted (e.g., via a stream of hot air), and solid hydrophilic particles may immediately be sieved onto the partially melted surface, or can be deposited. The water-insoluble delivery carrier is then cooled (e.g., by exposure to ambient air) to re-solidify the molten water-insoluble delivery carrier around at least a portion of the solid hydrophilic particles in the water-insoluble delivery carrier. It can be embedded in

The present invention further relates to a method of manufacturing an oral care article, in which solid hydrophilic particles can be placed within a water-insoluble delivery carrier by any suitable procedure, such as:
1. The material of the water-insoluble delivery carrier can also be at least partially melted or softened, and the solid hydrophilic particles can be incorporated into the partially melted or softened material by mixing or kneading. The material can then be cooled or solidified and formed into a suitable form, such as a strip.
2. Solid hydrophilic particles can also be incorporated into the material of the water-insoluble delivery carrier by repeatedly folding the water-insoluble delivery carrier over the solid hydrophilic particles and compressing it back into a sheet with a hydraulic press. The material can then be formed into a suitable form, for example a strip.
3. The material of the water-insoluble delivery carrier can be softened until it becomes plastic, eg, by heating at about 50°C. It can be mixed with the solid hydrophilic particles at 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 carrier and solid hydrophilic particles can then be formed into a suitable form, such as a strip or tray, by conventional shape forming techniques such as extrusion, injection molding, thermoforming, etc.
4. The water-insoluble delivery carrier material can be melted, for example at 80° C., and then mixed with the solid hydrophilic particles using conventional mixing equipment. The molten mixture can then be formed into a suitable form, such as a strip or tray, by conventional shape forming techniques such as casting or injection molding.

Oral care articles of the invention can be unit dose articles and/or removable articles. Suitable examples of unit dose articles and/or removable articles include cast wax transparent sheets 24 gauge (reference number supplied by Freeman Manufacturing Company, Ohio, USA) in combination with solid hydrophilic particles containing at least one bleaching agent. 114009) and are either a) cut into strips approximately 0.51 mm thick, approximately 22 mm wide and approximately 62 mm long, or b) preformed into dental trays. Examples of products that are not "unit dose articles" or "removable articles" include stick products (eg, lip balms and lipsticks). This is because stick-type products are generally not single-use products, nor are they generally products that are removed from the oral cavity.

Referring now to the drawings, FIG. 1A shows an oral care article 10 for delivering a bleaching agent to teeth and oral cavity provided by solid hydrophilic particles 20 in a solid water-insoluble delivery carrier 12 as disclosed herein. shows. Water-insoluble delivery carrier 12 is in the form of a strip and includes a surface having a width W of about 50 to about 80 mm and a length L of about 15 to 25 mm. The bulk of water-insoluble delivery carrier 12 has an average thickness T of about 0.15 to about 1.0 mm. The water-insoluble delivery carrier 12 of FIG. 1A is formed into a strip that may be substantially flat and have rounded corners. A suitable strip may be a cast wax transparent sheet 24 gauge (reference number 114009 supplied by Freeman Manufacturing Company, Ohio, USA). The solid hydrophilic particles 20 are included in the water-insoluble delivery carrier 12 by a melting process, some of which may be located near the surface, and/or some of which may be in direct contact with the environment.

FIG. 1B shows another embodiment of an article 10 for delivering a bleaching agent to teeth and oral cavity provided by solid hydrophilic particles 20 in a water-insoluble delivery carrier 12 as disclosed herein. The water-insoluble delivery carrier 12 of 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 50 to about 80 mm and a length L of about 15 to 25 mm, and a second surface 16 opposite the water-insoluble delivery carrier 12. First surface 14 and second surface 16 are spaced apart by the bulk of water-insoluble delivery carrier 12 having an average thickness T of about 0.15 to about 1.0 mm. A suitable strip is a cast wax transparent sheet 24 gauge (reference number 114009 supplied by Freeman Manufacturing Company, Ohio, USA) cut into strips about 0.51 mm thick, about 22 mm wide, and about 62 mm long. obtain. The solid hydrophilic particles 20 are arranged such that at least a portion of the solid hydrophilic particles 20 are located near the first surface 14 and/or such that a portion thereof is in direct contact with the environment; and/or embedded in the water-insoluble delivery carrier 12 of FIG. 1B such that it may slightly protrude from the first surface 14. In contrast to the first surface 14, the second surface 16 exhibits little or no solid hydrophilic particles 20.

The solid hydrophilic particles 20 used in the article 10 shown in FIGS. 1A and 1B contain a bleaching agent that can affect or bring about a desired change in the appearance or structure of the surface with which it comes into contact, or It can itself be a bleaching agent. As mentioned above, examples of bleaching agents include hydrogen peroxide, carbamide peroxide, and mixtures thereof. Examples of appearance and structural changes include, but are not limited to, stain bleaching, stain removal, plaque removal, and tartar removal.

FIG. 2A shows a cross-sectional view along section line 2-2 of the water-insoluble delivery carrier 12 shown in FIG. 1A. Thereby, it can be seen that the solid hydrophilic particles 20 are randomly distributed within the bulk of the water-insoluble delivery carrier 12. Solid hydrophilic particles 20 may also be located near the surface of water-insoluble delivery carrier 12 or contacted with the environment.

FIG. 2B shows a cross-sectional view of the water-insoluble delivery carrier 12 shown in FIG. 1B along section line 2-2. This shows that the concentration of solid hydrophilic particles 20 on the first surface 14 is higher than the concentration of solid hydrophilic particles 20 on the second surface 16 of the water-insoluble delivery carrier 12 produced by the embedding process. In the article shown in FIG. 2B, second surface 16 is substantially free of solid hydrophilic particles 20. In the article shown in FIG.

3 and 4 illustrate the article 10 of the present invention applied to the tooth surfaces of a plurality of adjacent teeth 22. FIG. Article 10 can be applied to the tooth surface after or before molding (Figure 3). For example, article 10 may be applied to a tooth with sufficient force to shape water-insoluble delivery carrier 12 to at least partially conform to the shape of tooth 22, as shown in FIG. A plurality of adjacent teeth 22 are embedded in adjacent soft tissue 24 (FIG. 4). Adjacent soft tissue 24 is defined herein as the soft tissue surrounding the tooth structure, including the papilla, marginal gingiva, gingival sulcus, intergingival, and up to and including the gingival-alveolar mucosal junction on the pallet. gingival structures on the lingual and buccal surfaces, including. In both Figures 3 and 4, article 10 is preferably in the form of a strip. The material of water-insoluble delivery carrier 12 of article 10 can have a thickness and bending stiffness of at least 50 g/cm so that it can conform to the contoured surface of tooth 22 and adjacent soft tissue 24. Thus, the water-insoluble delivery carrier 12 may have sufficient flexibility to contour the oral cavity surface, which is a plurality of adjacent teeth 22, and the article 10 may be applied without significant pressure. A suitable material for the water-insoluble delivery carrier 12 of article 10 may be casting wax (reference number 114009, supplied by Freeman Manufacturing Company, Ohio, USA).

Water-insoluble delivery carrier 12 functions as a protective barrier against bleaching agents provided by solid hydrophilic particles 20. This prevents leaching or erosion of the bleaching agent, such as due to consumption of the wearer's tongue, lips, and saliva. This allows the solid hydrophilic particles 20 to act on the dental surfaces 22 of the oral cavity for a desired period of time, for example from several minutes to several hours.

FIG. 5A is a photographic image of a cast wax transparent sheet 24 gauge (reference number 114009 supplied by Freeman Manufacturing Company, Ohio, USA) cut into strips about 22 mm wide and about 62 mm long. The strip can be used directly as a water-insoluble delivery carrier 12, or the water-insoluble delivery carrier 12 is formed into a dental tray (FIGS. 5B and 5C). The first surface 14 of the water-insoluble delivery carrier 12 is located on the inside of the dental tray facing the tooth surface during use. The second surface 16 is located on the outside of the dental tray, facing the soft tissue and tongue during use. The water-insoluble delivery carrier 12 can be formed into a dental tray configuration with (FIG. 5C) or without (FIG. 5B) a notch 18.

FIG. 6 shows (Example IV-A) a sheet of casting wax (reference number 114009 supplied by Freeman Manufacturing Company, Ohio, USA) that can be used as a water-insoluble delivery carrier 12 with embedded solid hydrophilic particles 20. ) is a photographic image. Figure 7 shows a microscopic image (4x magnification) of the same example (IV-A).

Methods of Using the Oral Care Articles The present invention further relates to methods of using the oral care articles of the present invention. The oral care article can be applied to the consumer's teeth in a dental office by a dental professional, or used by the consumer at home. Generally, the recommended treatment period is sufficient time to achieve the desired effect of the bleaching agent, such as sufficient time to achieve the desired degree of bleaching.

In the practice of the present invention, a user applies an article herein containing a bleaching agent to achieve a desired effect, such as whitening, to one or more teeth. The article can be applied by any suitable auxiliary means, even the fingers. Preferably, the articles herein are substantially unnoticeable when applied to teeth. After the desired time has elapsed, the residue can be easily removed from the tooth surface. Generally, there is no need to prepare the tooth before applying the article of the invention. For example, a user may choose to brush their teeth and rinse their mouth before applying an article of the invention, but do not clean or dry the oral surfaces before application, or smear them with saliva or water. There is no need to over-wet.

The articles and delivery systems described above include: 1. Article of the present invention, and 2. May be included in a kit containing instructions for use, or 1. Article of the present invention, and 2. Can be assembled into a kit including instructions for use. If the teeth can be irradiated with electromagnetic radiation, the kit may further include a source of electromagnetic radiation of an appropriate wavelength and instructions for use, so that the kit can be conveniently used by the consumer.

Optional Electromagnetic Radiation Treatment The articles disclosed herein, such as those containing bleaching agents, may be used to whiten/bleach teeth and/or remove stains from tooth surfaces. Bleaching effectiveness may be further increased by directing electromagnetic radiation of a suitable wavelength towards the at least one tooth. An apparatus suitable for providing such electromagnetic radiation is shown in FIG. If the effectiveness of the bleaching agent provided by solid hydrophilic particles 20 can be increased by electromagnetic radiation, electromagnetic radiation is applied to article 10 as disclosed herein. For example, electromagnetic radiation having a peak intensity wavelength of about 455 nm can enhance the bleaching effectiveness of bleaching or whitening agents such as peroxides.

Suitable wavelengths may be any wavelength that corresponds to the maximum absorption band of the tooth and/or the stain of the tooth to be bleached. For example, the article may be irradiated with electromagnetic radiation with one or more wavelengths ranging from about 200 nm to about 1200 nm. Electromagnetic radiation may be directed at at least one tooth. For example, more than one tooth may be irradiated. For example, the electromagnetic radiation may have a peak intensity at a wavelength in the range of about 400 nm to about 500 nm, preferably about 425 nm to about 475 nm, most preferably about 445 nm to about 465 nm, or the peak intensity wavelength of the electromagnetic radiation. may be similar to the wavelength at which the stain absorbs the most electromagnetic radiation. The electromagnetic radiation may be directed to at least one tooth during part or the entire wear time of the article, or after the article is removed from the tooth. The electromagnetic radiation is applied for at least a period of time sufficient for whitening, or for a period sufficient to achieve the desired effect of the bleaching agent, such as at least about 1 minute, at least about 5 minutes, or at least about 10 minutes. Good too. Electromagnetic radiation may be applied using the procedures disclosed in US Patent Application Publication No. 2013/0295525. The articles disclosed herein are preferably applied to at least one tooth and maintained on the at least one tooth for a first period, and after the first period, the electromagnetic radiation is applied to at least a second tooth. the period may be oriented towards at least one tooth, the first period having a duration of more than 50%, preferably 80% of the total duration of the first and second period, and Generally, the article is removed from at least one tooth.

Suitable sources of electromagnetic radiation include those described herein under the heading "Clinical Protocols."

The articles described herein may be transparent or translucent to electromagnetic radiation with wavelengths of about 400 nm to about 500 nm. For example, the articles disclosed herein have an average diameter in the range of about 0.05 mm to about 2 mm, preferably in the range of about 0.1 mm to about 1.0 mm, more preferably in the range of about 0.25 mm to about 0.75 mm. When applied in thickness, about 10%, about 20%, or about 30% to about 40%, about 50%, about 60% of electromagnetic radiation from about 400 nm to about 500 nm, as measured by a spectrophotometer; Allow about 70%, about 80%, about 90%, or about 100% to pass through.

In the wavelength range of about 400 to about 500 nm, the electromagnetic radiation impinging on the tooth surface or the outer surface of the water-insoluble delivery carrier is about 5 mW/cm2 to about 500 mW/cm2, preferably about Intensities may range from 10 mW/cm2 to about 300 mW/cm2, most preferably from about 175 mW/cm2 to about 250 mW/cm2.

Procedure for measuring the intensity of electromagnetic radiation Spectrometer (USB2000+ from Ocean Optics) connected to a UV-VIS 200 micrometer fiber optic cable with a cosine corrector (OP 200-2-UV-VIS from Ocean Optics) at the tip ) can be used to measure the intensity of electromagnetic radiation. The spectrometer is connected to a computer running spectrometer software (Oceanview 1.3.4 from Ocean Optics). The tip of the fiber optic cable is held so as to point toward the light source at the location where the light intensity is to be measured. Photons collected at the detector surface are guided via a fiber optic cable to a charge-coupled device in the spectrometer (CCD). The CCD counts the number of photons that arrive at the CCD during a predetermined period of time at each wavelength from 200 nm to 1100 nm, and uses a software algorithm to calculate these photon numbers as spectral irradiance (mW/mW/ cm ² /nm). The spectral irradiance is integrated by the software from 200 nm to 1100 nm to obtain the absorbed irradiance (mW/cm ² ), which is the intensity of electromagnetic radiation from 200 nm to 1100 nm. The software integrates the spectral irradiance between 400 nm and 500 nm to obtain the absorbed irradiance (mW/cm ² ), which is the intensity of electromagnetic radiation between 400 nm and 500 nm.

For the convenience of consumers, the articles described herein include the article described herein, a source of electromagnetic radiation that emits any electromagnetic radiation at a suitable wavelength, and instructions for use. It may be provided as a kit containing.

The articles of the invention are useful in both human and other animal (eg, pets, animals, or livestock) applications.

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 further describe preferred articles within the scope of the invention. Various changes can be made to these embodiments without departing from the scope of the invention. All experiments were performed at room temperature (RT) and atmospheric pressure unless otherwise indicated.

These Examples (and Comparative Example II-A) were prepared by 1) weighing the cast wax sheet and 2) solid hydrophilic particles (complexes of hydrogen peroxide with polyvinylpyrrolidone, urea peroxide, or sodium percarbonate). Cast a USA Standard Testing Sieve No. 1000 with a 425 micrometer aperture onto a wax sheet. 3) sandwich the wax sheet and particles between two sheets of paper and a non-stick release liner; 4) place the sandwich in a hydraulic press and apply 625 psi pressure for 60 seconds; 5) It was made by taking a wax sheet with embedded particles and weighing it to calculate the weight of the embedded particles. These sheets can be cut into shapes and sizes suitable for intraoral use, eg, about 22 mm wide and about 62 mm long.

^１鋳造ワックスシート２６ゲージ、参照番号１１４０１０、平均厚さ約０．３９ｍｍ、約１０ｃｍ×約１０ｃｍ平方、Ｆｒｅｅｍａｎ Ｍａｎｕｆａｃｔｕｒｉｎｇ Ｃｏｍｐａｎｙ，Ｏｈｉｏ，ＵＳＡから供給
^２鋳造ワックスシート２４ゲージ、参照番号１１４００９、平均厚さ約０．５１ｍｍ、約１０ｃｍ×約１０ｃｍ平方、Ｆｒｅｅｍａｎ Ｍａｎｕｆａｃｔｕｒｉｎｇ Ｃｏｍｐａｎｙ，Ｏｈｉｏ，ＵＳＡから供給
^３Ｐｅｒｏｘｙｄｏｎｅ Ｋ－３０、Ａｓｈｌａｎｄ Ｇｌｏｂａｌ Ｓｐｅｃｉａｌｔｙ Ｃｈｅｍｉｃａｌｓ Ｉｎｃ．（Ｃｏｖｉｎｇｔｏｎ，ＫＹ）から。水１００部当たりの溶解度は４０部超（ポリビニルピロリドンポリマーＫ－３０上の供給元からの製品データシートに提供される情報から推定）。４２５マイクロメートルの開口部を有する米国標準試験ふるい（ＵＳＡ Ｓｔａｎｄａｒｄ Ｔｅｓｔｉｎｇ Ｓｉｅｖｅ）第４０号でふるいにかける。供給業者からの情報によると、約１７％～２０％（中央値１８．５％）のＨ２Ｏ２を含有する。

¹ Cast wax sheet 26 gauge, reference number 114010, average thickness approximately 0.39 mm, approximately 10 cm x approximately 10 cm square, supplied by Freeman Manufacturing Company, Ohio, USA
² Cast wax sheet 24 gauge, reference number 114009, average thickness approximately 0.51 mm, approximately 10 cm x approximately 10 cm square, supplied by Freeman Manufacturing Company, Ohio, USA
³ Peroxydone K-30, Ashland Global Specialty Chemicals Inc. (Covington, KY). Solubility greater than 40 parts per 100 parts of water (estimated from information provided in the product data sheet from the supplier on Polyvinylpyrrolidone Polymer K-30). Sieve with USA Standard Testing Sieve No. 40 with 425 micrometer openings. According to information from the supplier, it contains approximately 17% to 20% (median 18.5%) H2O2.

^１鋳造ワックスシート２６ゲージ、参照番号１１４０１０、平均厚さ約０．３９ｍｍ、約１０ｃｍ×約１０ｃｍ平方、Ｆｒｅｅｍａｎ Ｍａｎｕｆａｃｔｕｒｉｎｇ Ｃｏｍｐａｎｙ，Ｏｈｉｏ，ＵＳＡから供給
^２鋳造ワックスシート２４ゲージ、参照番号１１４００９、平均厚さ約０．５１ｍｍ、約１０ｃｍ×約１０ｃｍ平方、Ｆｒｅｅｍａｎ Ｍａｎｕｆａｃｔｕｒｉｎｇ Ｃｏｍｐａｎｙ，Ｏｈｉｏ，ＵＳＡから供給
^３Ｐｅｒｏｘｙｄｏｎｅ Ｋ－３０、Ａｓｈｌａｎｄ Ｇｌｏｂａｌ Ｓｐｅｃｉａｌｔｙ Ｃｈｅｍｉｃａｌｓ Ｉｎｃ．（Ｃｏｖｉｎｇｔｏｎ，ＫＹ）から。水１００部当たりの溶解度は４０部超（ポリビニルピロリドンポリマーＫ－３０上の供給元からの製品データシートに提供される情報から推定）。４２５マイクロメートルの開口部を有する米国標準試験ふるい（ＵＳＡ Ｓｔａｎｄａｒｄ Ｔｅｓｔｉｎｇ Ｓｉｅｖｅ）第４０号でふるいにかける。供給業者からの情報によると、約１７％～２０％（中央値１８．５％）のＨ２Ｏ２を含有する。

¹ Cast wax sheet 26 gauge, reference number 114010, average thickness approximately 0.39 mm, approximately 10 cm x approximately 10 cm square, supplied by Freeman Manufacturing Company, Ohio, USA
² Cast wax sheet 24 gauge, reference number 114009, average thickness approximately 0.51 mm, approximately 10 cm x approximately 10 cm square, supplied by Freeman Manufacturing Company, Ohio, USA
³ Peroxydone K-30, Ashland Global Specialty Chemicals Inc. (Covington, KY). Solubility greater than 40 parts per 100 parts of water (estimated from information provided in the product data sheet from the supplier on Polyvinylpyrrolidone Polymer K-30). Sieve with USA Standard Testing Sieve No. 40 with 425 micrometer openings. According to information from the supplier, it contains approximately 17% to 20% (median 18.5%) H2O2.

^１鋳造ワックスシート２４ゲージ、参照番号１１４００９、平均厚さ約０．５１ｍｍ、約１０ｃｍ×約１０ｃｍ平方、Ｆｒｅｅｍａｎ Ｍａｎｕｆａｃｔｕｒｉｎｇ Ｃｏｍｐａｎｙ，Ｏｈｉｏ，ＵＳＡから供給
^２過酸化尿素付加物、Ａｌｆａ Ａｅｓａｒ（Ｗａｒｄ Ｈｉｌｌ，ＭＡ）からの、カタログ番号Ｌ１３９４０。供給元からの安全データシート１リットル当たり２０℃で８００グラムの水への溶解度（水１００部当たり８０部）。４２５マイクロメートルの開口部を有する米国標準試験ふるい（ＵＳＡ Ｓｔａｎｄａｒｄ Ｔｅｓｔｉｎｇ Ｓｉｅｖｅ）第４０号でふるいにかける。２０２０年９月２２日付のウィキペディアによれば、約３５．４％のＨ２Ｏ２を含有する。

¹ Cast wax sheet 24 gauge, reference number 114009, average thickness approximately 0.51 mm, approximately 10 cm x approximately 10 cm square, supplied by Freeman Manufacturing Company, Ohio, USA
² Peroxide Urea Adduct, Catalog Number L13940 from Alfa Aesar (Ward Hill, Mass.). Safety data sheet from supplier Solubility in 800 grams of water per liter at 20°C (80 parts per 100 parts of water). Sieve with USA Standard Testing Sieve No. 40 with 425 micrometer openings. According to Wikipedia dated September 22, 2020, it contains approximately 35.4% H2O2.

Comparative example

^１鋳造ワックスシート２４ゲージ、参照番号１１４００９、平均厚さ約０．５１ｍｍ、約１０ｃｍ×約１０ｃｍ平方、Ｆｒｅｅｍａｎ Ｍａｎｕｆａｃｔｕｒｉｎｇ Ｃｏｍｐａｎｙ，Ｏｈｉｏ，ＵＳＡから供給
^２過炭酸ナトリウム、カタログ番号Ａ１６０４５、Ａｌｆａ Ａｅｓａｒ（Ｗａｒｄ Ｈｉｌｌ，ＭＡ）から。水への溶解度は１５０グラム／リットル（水１００重量部当たり１５重量部）（Ｗｉｋｉｐｅｄｉａからの情報、２０１８年５月２１日付）。約３２．５％のＨ２Ｏ２を含有すると計算される。４２５マイクロメートルの開口部を有する米国標準試験ふるい（ＵＳＡ Ｓｔａｎｄａｒｄ Ｔｅｓｔｉｎｇ Ｓｉｅｖｅ）第４０号でふるいにかける。

¹ Cast wax sheet 24 gauge, reference number 114009, average thickness approximately 0.51 mm, approximately 10 cm x approximately 10 cm square, supplied by Freeman Manufacturing Company, Ohio, USA
Sodium ² Percarbonate, catalog number A16045, from Alfa Aesar (Ward Hill, MA). Solubility in water is 150 g/liter (15 parts by weight per 100 parts by weight of water) (information from Wikipedia, dated May 21, 2018). It is calculated to contain approximately 32.5% H2O2. Sieve with USA Standard Testing Sieve No. 40 with 425 micrometer openings.

Bleach Efficacy Example IA (with electromagnetic radiation) versus Comparative Example IA (with electromagnetic radiation) bleaching efficacy, measured according to the ex-vivo procedure specified herein, is listed in Table 1.

Table 1 shows that Example I-A is comparable to Comparative Example I-A even though Example I-A has less bleach % (2.77% vs. 9.5%). ⁽ -Δb ^* of 2.9 vs. 2.8). These results demonstrate that Example I-A (PVP-peroxide particles embedded in a water-insoluble wax delivery carrier) compared to Comparative Example I-A (H2O2 dissolved in an aqueous polymer gel). -A clearly shows that it has surprisingly similar effectiveness despite having less than 1/3 of the bleach %. These results clearly demonstrate that solid hydrophilic particles containing bleach embedded in a water-insoluble wax delivery carrier have a surprisingly large impact on effectiveness.

Examples III-A, III-B, and III-C (samples taken from all three batches) (by electromagnetic radiation) and Comparative Example I- measured according to the ex-vivo procedure specified herein. The bleaching effectiveness of A (by electromagnetic radiation) is listed in Table 2.

Table 2 shows that Examples III-A, III-B, and III-C after three treatments compared to Comparative Example I-A (2.19 vs. 2.8) after one treatment. Even though Examples III-A, III-B, and III-C had less % bleach (approximately 0.1% vs. 9.5%), there was a slightly less decrease in yellowness (−Δb ^* ) indicates that only Specifically, these results show that Examples III-A, III-B, and III-C after three treatments surprisingly have a lower yellow color than Example I-A after one treatment. This shows that Examples III-A, III-B, and III-C had only about 1% bleach percentage of Comparative Example IA. This is even more surprising since it was not. These results demonstrate that Examples III-A, III-B, and III-C (PVP-peroxide particles embedded in a water-insoluble wax delivery carrier) contained very low concentrations of % bleach. has also clearly demonstrated that it has a surprisingly high effectiveness, which may be particularly suitable in people with sensitive teeth or in areas where there are very strict restrictions on peroxide %. These results clearly demonstrate that solid hydrophilic particles containing bleach embedded in a water-insoluble wax delivery carrier have a surprisingly large impact on effectiveness.

The bleaching efficacy of Example II-E (by electromagnetic radiation) and Example II-A (by electromagnetic radiation) measured according to the ex-vivo procedure specified herein is listed in Table 3.

Table 3 shows that Example II-E compared to Comparative Example II-A (3.8 vs. 2.4), with both articles having the same concentration of % bleach (approximately 3%). also showed that it resulted in a 58% greater reduction in yellowness (-Δb ^* ). Specifically, these results demonstrate that an article made with solid hydrophilic particles (PVP-peroxide) having a solubility of greater than 40 parts by weight in 100 parts by weight of water (Example II-E) , for an article made 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), both compositions at the same concentration of H2O2 (approximately 3%), it clearly demonstrates a surprisingly high effectiveness. These results clearly demonstrate that the solubility of solid hydrophilic particles has a surprisingly large effect on bleaching effectiveness.

The bleaching efficacy of Example II-E (by electromagnetic radiation) and Example IA (by electromagnetic radiation) measured according to the ex-vivo procedure specified herein is listed in Table 4.

Table 4 shows that Example II-E has the same concentration of bleach percent (approximately 3%) as compared to Example I-A (3.8 vs. 2.9). also resulted in a 31% greater reduction in yellowness (-Δb ^* ). Specifically, these results demonstrate that articles made with a water-insoluble delivery carrier (Example II-E) having an average thickness of 0.51 mm were found to Surprisingly high efficacy for articles made with insoluble delivery carriers (Example I-A) even though both compositions had the same concentration of H2O2 (approximately 3%) This is clearly demonstrated. These results clearly demonstrate that the average thickness of the water-insoluble delivery carrier has a surprisingly large effect on bleaching effectiveness.

Concentration of Bleach on 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. The concentrations of bleach for one surface to the second surface are listed in Table 5.

Table 5 shows that the concentration of bleach on the first surface is higher than the concentration of bleach on the second surface (1304 micrograms/cm2 vs. 82 micrograms/cm2). These results also indicate that the ratio of the concentration of bleach at the first surface divided by the concentration of bleach at the second surface is about 16, which is a ratio greater than 1. These results clearly demonstrate the surprising ability of the present invention to deliver more bleach to the surfaces where it is needed most.

Table 6 lists the bleach concentrations of the first surface to the second surface for Examples VI-A and VI-B (samples taken from both batches) measured according to the procedures specified herein. .

Table 6 shows that the concentration of bleach on the first surface is higher than the concentration of bleach on the second surface (1457 micrograms/cm2 vs. 43 micrograms/cm2). These results also indicate that the ratio of the concentration of bleach on the first surface divided by the concentration of bleach on the second surface is about 34, which is greater than 1. These results clearly demonstrate the surprising ability of the present invention to deliver more bleach to the surfaces where it is needed most.

The concentrations of bleach on the surfaces of Examples II-A, II-B, II-C, and II-D (samples taken from all four batches) and on the surface of Comparative Example IA are described herein. Measured according to the specified procedure and listed in Table 7.

Table 7 shows that Examples II-A, II-B, II-C, and II-D have less bleach percent (about 3% vs. about 9.5%) relative to Comparative Example IA. Despite having a higher concentration of bleach at the surface (1304 micrograms/cm2 vs. 670 micrograms/cm2). Specifically, these results demonstrate that even though Examples II-A, II-B, II-C, and II-D had less than 1/3 the percent bleach of Comparative Example I-A, However, it shows that the surface bleach concentration was approximately twice that of Comparative Example IA. These results clearly demonstrate the surprising ability of the present invention to deliver more bleach to the surfaces where it is needed most.

Number of Solid Particles on the Surfaces The number of solid particles on the first and second surfaces of Example VA, counted according to the procedures specified herein, are listed in Table 8.

Table 8 shows that the number of solid particles per cm on the first surface of Example V-A is greater than the number of solid particles per cm on the second surface (24.6 to 1 ). These data show that the ratio of the number of particles per cm on the first surface of Example V-A divided by the number of particles per cm on the second surface is approximately 24.6, which means that the ratio is less than 1. It shows that it is better than that.

Ex-vivo procedure for measuring bleaching effectiveness 1. A disc (7.2 to 7.8 mm in diameter x 1.2 to 1.3 mm in thickness) is cut from the front surface of a human incisor. Leave the front side intact and flatten the side of the tongue that was cut from the tooth. Store the discs in a glass bottle in 15-20 ml of water meeting USP standard requirements for at least 18 hours. Repeat this for a total of 12 teeth.
2. Using a handheld spectrophotometer Konica Minolta 700d, each sample was individually placed on a standard white background (white reference card used in digital and film photography, e.g. DGK-XL X000B1R417 from DGK Color Tools). Measure the baseline L ^* and b ^* of the front surface of the tooth disc. A Konica Minolta 700d spectrophotometer is used with an aperture of approximately 6.3 mm in diameter, the observer angle is set at 2 degrees, and the light source is set at a daylight color temperature of 5003 K to eliminate specular reflections. To control the water concentration in the tooth disk during these measurements, disks approximately 19 mm in diameter were cut from a transparent flexible polyethylene film with a thickness of approximately 0.01 mm to approximately 0.02 mm and removed from the water. Immediately place it on a gear disc and measure the L ^* value and b ^* value through this polyethylene disc. One set consists of three measurements per day, and the measurement is divided into three days. Place the discs in 15-20 mL of water meeting USP specifications in a glass vial and store for at least 18 hours between each of the three measurements. Calculate the average baseline L ^* and b ^* for each tooth plate over all three days.
3. Treat each disc individually with the composition being evaluated. If the composition is a solid article, a) remove the tooth disk from the water and place the article on the front surface of the tooth disk while still wet; b) apply pressure to the article for a short period of time so that the article rests on the tooth. Simulate being positioned at If the composition is a semi-solid gel, a) remove the disc from the water and add about 0.04 grams to about 0.05 grams of gel to the disc and the polyethylene disc (about 0.01 mm to about 0.0 mm thick); (approximately 19 mm in diameter) cut from 02 mm clear flexible polyethylene film; b) briefly applying pressure to the polyethylene disc to simulate the gel being applied to the tooth; This sandwich of disc + article or disc + gel + polyethylene disc is placed in an oven at about 34C (to simulate the condition of the anterior surface of the upper anterior teeth) for about 60 minutes.
4. When the composition is used with electromagnetic radiation,
- After 50 minutes of treatment with the composition, electromagnetic radiation is applied for 10 minutes towards the anterior surface of the tooth disc.
- Directing electromagnetic radiation through the article or through the gel + polyethylene disc to the front surface of the gear disc.
- Via a fiber optic cable (Model No. M71L01 from Thorlabs (Newton, NJ, USA)) connected to a high power LED (Model No. M455F1 from Thorlabs (Newton, NJ, USA)) with a peak intensity wavelength of 455 nm. to deliver electromagnetic radiation. The LEDs are operated at 1000 mA using an LED Driver (model number DC2100, or DC4104 paired with a DC4100-HUB, Thorlabs (Newton, NJ, USA)). The exit end of the fiber optic cable is attached to help reproducibly position the electromagnetic radiation relative to the outer surface of the strip. The exit end of the fiber optic cable is approximately 7 mm away from the tooth surface. The intensity of electromagnetic radiation between 400 nm and 500 nm, measured at the central axis of the cone of electromagnetic radiation at this distance, is between about 175 mW/cm ² and about 225 mW/cm ² when measured by the methods disclosed herein. There needs to be.
- This radiation is applied for approximately 10 minutes per tooth.
5. Once the 60 minute treatment with the composition is complete, residual composition is removed from the disc using paper towels and water.
6. After each treatment, the discs are stored for at least 18 hours in a glass bottle in 15-20 mL of water meeting USP standard requirements.
7. 18 hours (or more) after the last treatment, measure the post-treatment b ^* of each disc individually using the procedure defined above for the disc. This is then done for three days and averaged over all three days for each tooth.
8. For each tooth disc, the change in b ^* (yellow-blue balance) was calculated as Δb ^* = b ^* _{post-treatment} -b ^* _baseline , a negative change indicates less yellow tinge in the tooth disc. . -Δb ^* is used as the primary measure of bleaching effectiveness. Calculate the average decrease in yellowness (-Δb ^* ) over all discs.

Procedure for measuring the concentration of bleach at the surface of a water-insoluble delivery carrier (i.e., article) containing bleach The concentration of bleach at the surface of a water-insoluble delivery carrier (i.e., article) containing bleach is determined as follows: Measured according to procedure.
1. A disk approximately 19 mm in diameter is cut from the article and its weight is recorded.
2. Weigh 0.425g +/-0.003g of water into a small plastic weigh boat.
3. Using a pair of tweezers, place the disc over the water so that the surface to be tested is in contact with the water. Make sure that water reaches around the board and does not flow onto the board.
4. After 2 minutes, remove the disk, hold it vertically and drop it into the weighing boat for 5 seconds.
5. Assay the water for % bleach.
6. Calculate the total micrograms of bleach in the water based on the original amount of water added (0.425 g). Divide this by the surface area (cm2) of the board in contact with the water. This value (in micrograms/cm2) is the concentration of bleach at the surface of the board tested.
7. Steps 1 to 6 are performed on a total of 24 discs, and all 24 values are averaged. This average value (in micrograms/cm2) is the concentration of bleach in the article at the surface tested.

To verify the above procedure, the concentration of hydrogen peroxide on the first surface (gel surface) of Comparative Example IA is measured and demonstrated to be between 550 micrograms/cm2 and 800 micrograms/cm2. There is a need.

Procedure for counting the number of particles on the surface of a water-insoluble delivery carrier (i.e., an article) containing a bleaching agent The number of particles on the surface of a water-insoluble delivery carrier (i.e., an article) containing a bleaching agent is determined according to the following procedure. Ru.
1. Cut 24 squares, each 1 cm x 1 cm, from the article.
2. Count the number of particles on the surface using a microscope in each square.
3. Average the number of particles counted at the surface over all 24 squares. This is the number of particles/cm2 on its surface.

The dimensions and values disclosed herein are not to be understood as being strictly limited to the precise numerical values recited. Instead, unless indicated otherwise, 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 "40 mm" is intended to mean "about 40 mm."

All documents cited herein, including any cross-referenced or related patents or applications, and any patent applications or patents to which this application claims priority or benefit, are expressly excluded. or, unless otherwise limited, is incorporated herein by reference in its entirety. Citation of any document indicates that it is prior art with respect to any invention disclosed or claimed herein, or that it, alone or in combination with any other reference, constitutes prior art with respect to any invention disclosed or claimed herein. It does not constitute any teaching, suggestion or disclosure. Further, if 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 given to that term in this document shall control. shall be

While particular embodiments of the invention have been illustrated and described, it will be apparent 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, in the appended claims, to cover all such changes and modifications that fall within the scope of the invention.

Claims (18)

a) having a length (L) and a width (W) forming a first surface (14) and a thickness (T) extending from said first surface (14) to a second surface (16); a solid water-insoluble delivery carrier (12) in the form of a strip having an average thickness (T) of less than about 3 mm;
b) solid hydrophilic particles (20) comprising a bleaching agent, wherein (i) at least about 20 parts by weight of said solid hydrophilic particles (20) are dissolved in about 100 parts by weight of water; and/or (ii) ) solid hydrophilic particles (20), wherein said solid hydrophilic particles (20) increase in volume and/or weight by at least about 50% in water;
including;
said solid hydrophilic particles (20) are disposed and embedded in said solid water-insoluble delivery carrier (12), said solid hydrophilic particles (20) are of said solid water-insoluble delivery carrier (12); i) at least partially below said first surface (14), and ii) at least partially on or above said first surface (14);
An oral care article (10), wherein the total concentration of bleaching agents is from about 0.01% to about 15% by weight of the article (10). The solid hydrophilic particles (20) have a number average equivalent diameter or a volume average equivalent diameter of about 0.001 micrometer to about 5000 micrometer, preferably about 0.01 micrometer to about 2000 micrometer, most preferably 1 The oral care article (10) of claim 1, ranging from micrometers to about 1000 micrometers. Said average thickness (T) of said water-insoluble delivery carrier (12) or said article (10) is less than 3 mm, preferably in the range of about 0.01 mm to about 3 mm, more preferably in the range of about 0.1 mm to about 2.0 mm. An oral care article (10) according to claim 1 or 2, wherein the oral care article (10) is in the range of 0 mm, more preferably in the range of about 0.15 mm to about 1.0 mm. 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 volume average equivalent diameter of the solid hydrophilic particles (20); Oral care article (10) according to any one of claims 1 to 3, from about 0.001 to about 1000, preferably from about 0.01 to about 100, more preferably from about 0.1 to about 10. . At least about 30 parts by weight of the solid hydrophilic particles (20) are dissolved in about 100 parts by weight, 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. An oral care article (10) according to any preceding claim, wherein parts by weight of the solid hydrophilic particles are dissolved in about 100 parts by weight of water. 6, wherein the solid hydrophilic particles (20) increase in volume and/or weight by at least about 60%, preferably at least about 70%, more preferably at least about 80% when in contact with water. Oral care article (10) according to any one of the items. The bleaching agent is 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, Oral care article (10) according to any one of claims 1 to 6, selected from the group consisting of: and mixtures thereof, and preferably a complex of hydrogen peroxide and polyvinylpyrrolidone (PVP) polymer. The concentration of the at least one bleaching agent on the first surface (14) ranges from about 1 microgram/cm to about 10,000 micrograms/cm, preferably from about 10 micrograms/cm to about 5,000 micrograms/cm. Oral care article (10) according to any one of claims 1 to 7, more preferably in the range of about 50 micrograms/cm2 to about 3000 micrograms/cm2. The total concentration of said bleaching agent is from 0.1% to about 10% by weight of said article (10), preferably from 0.5% to 3% by weight, more preferably about 0.5% by weight of said article (10). Oral care article (10) according to any one of claims 1 to 8, wherein the oral care article (10) is from % to less than 3% by weight. The total concentration of bleaching agents is from about 0.01% to about 0.1%, preferably less than 0.1%, more preferably from about 0.01% to about 0.1%, by weight of the article (10). 99995% by weight, more preferably from about 0.01% to about 0.095%, more preferably from about 0.05% to about 0.09% by weight. Oral care article (10) as described. Said water-insoluble delivery carrier (12) (i) has a molecular weight 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 (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) ) from about 60°C to about 120°C, preferably from about 70°C to about 110°C, more preferably from about 80°C to about 100°C, more preferably from about 90°C to about 100°C, as measured by ASTM D127-08. and/or the flexural stiffness of said article (10) and/or said water-insoluble delivery carrier (12) is greater than 50 g/cm as measured by ASTM D2923-95; According to any one of claims 1 to 10, preferably from about 75 g/cm to about 1000 g/cm, preferably from about 100 g/cm to about 750 g/cm, more preferably from about 200 g/cm to about 500 g/cm. Oral care article (10) as described. Said water-insoluble delivery carrier (12) comprises a wax, a polymer, or a combination thereof, preferably said wax comprises a microcrystalline wax and/or said polymer comprises polyethylene, preferably said water-insoluble delivery carrier Oral care article (10) according to any one of the preceding claims, wherein the carrier (12) is a microcrystalline wax or a combination of wax and polymer. 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. Oral care article (10) according to any one of the preceding claims, wherein the water-insoluble delivery carrier (12) is monolayered and/or shaped in the form of a dental arch. More than about 50%, preferably more than about 75%, preferably more than about 95%, most preferably 100% of the volume of said solid hydrophilic particles (20) is comprised of said first portion of said water-insoluble delivery carrier (12). Oral care article (10) according to any one of claims 1 to 14, arranged under or on the surface (14). More than about 10%, preferably more than about 20%, preferably more than about 30% of the surface area of said solid hydrophilic particles (20) is located on said first surface (14) of said water-insoluble delivery carrier (12). An oral care article (10) according to any one of the preceding claims, wherein the oral care article (10) is exposed to an external environment surrounding the water-insoluble delivery carrier (12). An oral care article (10) according to any one of claims 1 to 16 and an electromagnetic device capable of directing electromagnetic radiation having one or more wavelengths in the range of about 200 nm to about 1700 nm to at least one tooth. a radiation source, preferably said electromagnetic radiation source emits electromagnetic radiation in the range of about 400 nm to about 500 nm, more preferably about 425 nm to about 475 nm, more preferably about 445 nm to about 465 nm, and preferably: The kit, wherein the electromagnetic radiation impinges on the outer surface of the water-insoluble delivery carrier (12) in a range of about 175 mW/cm2 to about 225 mW/cm2. A cosmetic method for whitening teeth,
a) applying an oral care article (10) according to any one of claims 1 to 16 to at least one tooth surface, such that the first surface (14) of the article (10) contacting the surface of one tooth;
b) allowing said article (10) to remain on said at least one tooth surface for a period of time, preferably at least 1 minute, more preferably at least 10 minutes, even more preferably at least 30 minutes, most preferably at least 60 minutes. and,
c) optionally applying electromagnetic radiation for a period of time, preferably at least 1 minute, more preferably at least 5 minutes, even more preferably at least 10 minutes.

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