JP2009521396A - Dissolvable tooth whitening strip - Google Patents

Abstract

  The present invention provides a dissolvable strip for whitening teeth. Preferably, the strip is a single layer and has a whitening agent and a water soluble or water dispersible polymer system. Dissolution of the whitening composition is controlled by the interaction of the whitening composition saliva with the oral environment. The present invention further provides a method for producing a whitening strip in the form of a dry film and a method for whitening teeth.

Description

Background of the Invention FIELD OF THE INVENTION This invention relates to a dissolvable whitening strip for whitening teeth. More particularly, the present invention relates to dissolvable whitening having a whitening agent and a polymer system for controlled and complete dissolution of the whitening strip by interaction of the whitening strip with saliva in the oral cavity. It concerns the strip.

2. 2. Description of Related Art Several types of patches and other products for tooth whitening and drug delivery in individual film dosage forms are known in the art. Powder compositions for whitening teeth with fluoride-containing compounds, essential amino acids and polybasic acids are also known.

  Recently, commercially known whitening strips have been developed to whiten teeth. However, these commercial whitening strips are not supple or flexible enough to contact all desired surfaces of the teeth in the oral cavity. These strips have the disadvantage that they do not touch and therefore do not effectively whiten these areas, especially the interdental (gap). When the strips are pressed to cover these gaps, these strips may lift from some of the teeth, which may not result in a completely uniform whitening.

  Despite considerable interest in systems for whitening teeth, there is a need for consumer products and products that can improve the appearance of teeth by whitening all desired surfaces of the teeth in the dental care industry. is there. Preferably they also provide additional benefits to the consumer as well as convenience to the user. Preferably, such additional benefits include increased tooth opacity, promotion of tooth whitening that does not require prior mixing of reagents and active agents, prevention of tooth sensitivity, and the use of one or more active ingredients. Includes more precise control of diffusion rate and increased contact time with teeth.

  A whitening strip with controlled dissolution that dissolves completely while the strip is on the teeth and leaves virtually no unwanted residue is desired. The present invention provides such a whitening strip.

Summary of the Invention It is an object of the present invention to provide a dissolvable strip for whitening teeth.

  It is another object of the present invention to provide a dissolvable single layer whitening strip having a whitening agent and a water soluble or water dispersible polymer system.

  It is yet another object of the present invention to provide a whitening strip that dissolves in the mouth without substantially leaving undesired residues.

  It is a still further object of the present invention to provide a whitening strip having a controllable contact time.

  It is yet another object of the present invention to provide a whitening strip that can be targeted to deliver a whitening agent to a desired area at a desired delivery rate.

  It is a further object of the present invention to provide a dissolvable whitening strip that is initially a dry film but hydrates, thereby becoming gelatinous upon contact with saliva and initiating its stickiness. .

  It is a still further object of the present invention to provide a dissolvable whitening strip that is a dry film for ease of handling prior to use.

  Dissolvable whitening strip that begins to hydrate when exposed to saliva and therefore becomes very supple and follows the shape of the tooth, thereby enhancing contact with the desired surface of the tooth It is a still further object of the present invention to provide

  It is still a further object of the present invention to provide a dissolvable whitening strip that has increased flexibility and increased stickiness while continuously exposed to saliva in the oral cavity or hydrated. It is.

  It is a still further object of the present invention to provide a dissolvable whitening strip that does not require a support layer.

  It is a still further object of the present invention to provide a dissolvable whitening strip such that the dissolution rate is controlled by the composition of the strip substrate.

  It is also an object of the present invention to provide a multilayer whitening strip for whitening teeth, in which the overall dissolution of the strip is controlled by interaction with each layer of saliva.

  It is another object of the present invention to provide a multilayer whitening strip for whitening teeth, in which one or more regions are present in a layer of the strip having one or more different components.

  The present invention provides a dissolvable water soluble strip for whitening teeth. The strip has a whitening agent and a water soluble or water dispersible polymer system. The polymer system includes poly (vinyl pyrrolidone) or any derivative thereof and at least one other polymer. Preferably, the dissolution of the whitening strip is controlled exclusively by the interaction of the strip with the oral environment including saliva.

  The present invention also provides a method for whitening teeth, that is, a method for improving tooth whiteness. The method comprises the step of applying a whitening strip according to the invention on the tooth for a time sufficient to produce a known improvement in the art that is detectable in the course of treatment of tooth whiteness.

  These and other subjects and advantages of the present invention are achieved through the use of a whitening strip according to the present invention that dissolves substantially undesired residues.

DETAILED DESCRIPTION OF THE INVENTION The present invention provides a dissolvable whitening strip or film. As used herein, a whitening strip refers to a formed dry film. In the most preferred embodiment, the strip is a single layer, but in another embodiment shown below, the strip can be multilayered.

  The strip has a polymer system and whitening agent (s) to improve tooth whiteness. Whitening strips may have additional ingredients, and some of them may help to clean breath, maintain whitening, prevent dental calcification, prevent or treat dental sensitivity, and gum health It may be active to provide additional benefits including maintenance or treatment.

  In any embodiment, the strips of the present invention are soluble in saliva formed in the oral cavity or mouth. In another embodiment, after applying the strip on the teeth, a substantial coating that is not considered an undesired residue remains, extending the residence time of the whitening agent or any active ingredient.

  The whitening strip is initially a film. However, once exposed to saliva in the oral cavity, the strip hydrates and becomes gelatinous immediately or substantially immediately. Hydration can cause swelling or expansion of the gelatinous material. This gelatinous structure will continue to hydrate and therefore become more flexible for some time in the oral cavity until it dissolves with a substantially undesired residue. Thus, the strip becomes increasingly flexible and supple and therefore continues to conform to the tooth profile or form to which it is applied. Continuous hydration also results in an increase in the adhesive properties of the strip, and thereby allows the strip to conform to and adhere to the tooth profile (including filling in cavities and interdental spaces or gaps), It is possible to perform its whitening action on all desired surfaces of the teeth. The ability to cover the tooth gaps of the strip and thus substantially whiten is a major advantage over prior art strips.

  Importantly, once exposed to saliva in the oral cavity, as the duration of exposure increases, stickiness increases and thus contact strength with the teeth increases. Increased tack improves the effectiveness of the strip.

  The solubility or dissolvability of the strip is controlled by the composition that allows dissolution of the strip or film beyond the desired predetermined time frame. The time frame for strip dissolution can be adjusted based on the desired end benefit. In order to adjust the time frame, the nature of the water-soluble or water-dispersible polymer system, the degree of crosslinking, if any, should be adjusted. Generally, the thickness of the strip is about 5 μm to about 2000 μm. Preferably, the thickness of the strip is from about 50 μm to about 500 μm.

  The present invention provides a desired delivery rate of whitening agent to a desired area, for example from about 1 minute to about 360 minutes, preferably from about 1 minute to about 30 minutes, and most preferably from about 5 minutes to about 20 minutes. To provide a whitening strip that can be targeted to whiten teeth.

  In another embodiment, the whitening agent or another desired agent is encapsulated in a water-soluble or water-dispersible shell and incorporated in or on the surface of the whitening strip, or in or on the layer of the whitening strip, Furthermore, the delivery rate can be controlled.

  Preferably, the whitening strip has no support or support layer. The support layer as defined in this application means the outermost layer that is dissolvable and is opposite to the layer that is in contact with the tooth surface that is a functional part of the multilayer whitening strip. Preferably, the support layer facilitates, for example, easily preventing unwanted adhesion to surfaces other than teeth while in the oral cavity. When a support layer is used in the whitening strip of the present invention, the support layer must be completely soluble or water dispersible.

  The whitening strip of the present invention has a polymer system comprising a first polymer, ie water-soluble or water-dispersible poly- (vinylpyrrolidone) (PVP) or any derivative thereof, and at least one second polymer. . The combination of the first and second polymers defines a water soluble and / or water swellable and / or water dispersible polymer system. The polymer system has adhesive properties so that the strip adheres to the teeth when it is carried to the teeth.

  The second polymer that can be used with the first polymer to produce a water-soluble or water-dispersible polymer system according to the present invention is one or more of: alkyl vinyl ether / maleic anhydride copolymer, alkyl vinyl ether / maleic acid copolymer Alkali metal or amine salts of alkyl vinyl ether / maleic acid copolymers, partially or fully cross-linked alkyl vinyl ether / maleic anhydride copolymers, vinyl acetate copolymers, polyacrylates, polyurethane interpolymers, chitosan, poly (acrylic acid) , Poly (vinyl alcohol), poly (vinyl alcohol-g-ethylene glycol) copolymer, cellulose derivatives, hydroxy-propyl-methylcellulose, hydroxyl-ethylcellulose, hydroxy Propylcellulose, poly (ethylene oxide), poly (propylene oxide), polyquaterium-11, polyquaterium-39, poloxamer, carbomer, gelatin, starch, alginic acid, salt of alginic acid, karaya gum, xanthan gum, guar gum, arabian Includes rubber, natural rubber such as tragacanth, or any combination thereof.

  Preferably, the first and second polymer combinations are one or more of the following: poly (vinyl pyrrolidone) -alkyl vinyl ether / maleic anhydride copolymer, poly (vinyl pyrrolidone) -alkyl vinyl ether / maleic acid copolymer, poly ( Alkali metal or amine salts of vinylpyrrolidone) -alkyl vinyl ether / maleic acid copolymer, poly (vinyl pyrrolidone) -partially or fully cross-linked alkyl vinyl ether / maleic anhydride copolymer, poly (vinyl pyrrolidone) -vinyl acetate copolymer, poly (Vinyl pyrrolidone) -polyurethane interpolymer, poly (vinyl pyrrolidone) -chitosan, poly (vinyl pyrrolidone) -polyacrylate, poly (vinyl pyrrolidone) -poly (acrylic acid), poly ( Nylpyrrolidone) -poly (vinyl alcohol), poly (vinyl pyrrolidone) -poly (vinyl alcohol-g-ethylene glycol) copolymer, poly (vinyl pyrrolidone) -cellulose derivative, poly (vinyl pyrrolidone) -hydroxy-propyl-methyl cellulose, poly (Vinyl pyrrolidone) -hydroxy-ethyl cellulose, poly (vinyl pyrrolidone) -hydroxypropyl cellulose, poly (vinyl pyrrolidone) -poly (ethylene oxide), poly (vinyl pyrrolidone) -poly (propylene oxide), poly (vinyl pyrrolidone) -polyqua Thallium-11, poly (vinylpyrrolidone) -polyquaterium-39, poly (vinylpyrrolidone) -poloxamer, poly (vinylpyrrolidone) -carbomer, poly (vinylpyrrolidone) -ze Tin, poly (vinyl pyrrolidone) -starch, poly (vinyl pyrrolidone) -alginic acid, poly (vinyl pyrrolidone) -salt of alginic acid, poly (vinyl pyrrolidone) -karaya gum, poly (vinyl pyrrolidone) -xanthan gum, poly (vinyl pyrrolidone)- Guar gum, poly (vinyl pyrrolidone) -arabic gum, poly (vinyl pyrrolidone) -tragacanth, or any combination thereof.

  Examples of preferred commercial products of such first polymers are polyalkyl vinyl ether-maleic acid copolymers (PVM / MA copolymers), poly (vinyl alcohol) such as Gantrez AN 119, AN 139, S-97 and MS-955; Poloxamer 407 (Pluronic); poly (vinyl-pyrrolidone-co-vinyl acetate) copolymers (PVP / VA copolymers) such as Luviskol VA and Plasdone S630 PVP / VA; poly (vinyl pyrrolidone) (PVP, K-15 to about K-120); Polyquaterium-11 (Gafquat 755N); Polyquaterium-39 (Merquat plus 3330); Carbopol; Hydroxypropyl Hydroxyl-ethylcellulose; hydroxypropyl-cellulose; gelatin; and alginates such as sodium alginate. Examples of preferred polyurethanes include poly (vinyl pyrrolidone-polyurethane) interpolymers such as polycarbamyl polyglycol esters, and poly (vinyl pyrrolidone / polycarbamyl) polyglycol ester interpolymers.

  The first and second polymer combination is a combination of PVP and polymer. The polymers can interact preferably or form a complex to effectively increase the molecular weight of the polymer mixture. Binders can also be incorporated to facilitate interaction between the polymers. An effective increase in molecular weight results in a reduction in the dissolution rate of the strip. Without being bound by any theory or mechanism, the interaction between PVP and the polymers described in the Examples, including polymers such as Gantrez, Aquamere, Chitosan and Pecogel, is achieved via hydrogen bonding Conceivable. Such interaction allows the polymer composite to bind onto the teeth, thereby providing effective whitening of the teeth.

  Preferably, the water soluble or water dispersible polymer system is present up to about 99.9% by weight of the total weight of the whitening strip. More preferably, the polymer system is about 60% to about 98% by weight of the total weight of the whitening strip.

  Also, the amount of the first polymer is from about 1% to about 99% by weight, preferably from about 25% to about 75% by weight of the total weight of the whitening strip. The amount of the second polymer is about 1% to about 80%, preferably about 5% to about 50% by weight of the total weight of the whitening strip.

  The whitening agent, which is the active agent in the strip, can contact the saliva in the oral cavity and release the active agent onto the teeth. Alternatively, the active agent can penetrate through the film and be released to the surface to which it is applied, including surfaces such as enamel, gingival tissue and tongue.

  Whitening agents that can be used in the present invention include hydrogen peroxide; carbamide peroxide; peroxycarbamate; persulfate such as persulfate salt or percarbonate; perborate; perborate; PVP- Hydrogen peroxide complex; calcium peroxide; metal chlorite (eg, calcium chlorite, barium chlorite, magnesium chlorite, lithium chlorite, sodium chlorite, and potassium chlorite), hydro Peroxy acids; organic peroxides (eg benzoyl peroxide) chlorine dioxide; hydrogen peroxide addition compounds of persulfuric carbodiimide; peroxide-generating compounds (eg azobisisobutyronitrile), phosphates, polyphosphorus Acid salt, alkali metal phosphate, alkali metal polyphosphate, sodium tripolyphosphate, or Including any combination of et al.

  The whitening agent is present up to about 99% by weight of the total weight of the whitening strip. Preferably, the whitening agent is about 0.5% to about 99% by weight of the total weight of the whitening strip. More preferably, the whitening agent is about 2% to about 75% by weight of the total weight of the whitening strip.

  In one preferred embodiment, the whitening agent is an alkali metal polyphosphate such as sodium tripolyphosphate and is present in an amount from about 7.5% to about 25% by weight of the total weight of the whitening strip.

  The whitening strip can also have ingredients that further enhance the benefits to the oral cavity and teeth. Such ingredients include antibacterial agents, calcifying compounds, anti-coloring compounds, desensitizing compounds, anticalculus agents, perfume additives, anti-inflammatory agents, antioxidants, volatile sulfur scavengers, odorant neutralizing agents, and / or Contains vitamins. The whitening strip may also have penetration enhancers, plasticizers, preservatives, surfactants or wetting agents, anesthetics, antiallergic agents, pharmaceuticals, or any combination thereof. Preferably, however, the whitening strip does not contain unwanted surfactants in the oral cavity.

  Preferably, the following antibacterial agents may be used in the whitening strips of the present invention: polyphenol (eg, triclosan) zinc salt, tin fluoride, chlorhexidine, hexetidine, sanguinarine, benzalkonium chloride, salicylanilide, domifene bromide, Cetylpyridinium chloride, tetradecylpyridinium chloride (TPC), N-tetradecyl-4-ethylpyridinium chloride (TDEPC), octenidine, delmopinol, octapinol, and other piperidine derivatives, niacin preparations, zinc / tin ion agents, augmentin Antibiotics such as amoxicillin, tetracycline, doxycycline, minocycline, and metronidazole, and analogs and salts of the above, including: Essential oils thymol, menthol, eugenol, geraniol, carvacrol, citral, hinokitiol, eucalyptol, catechol, methyl salicylate, hydrogen peroxide, metal salts of chlorite, or any and all combinations those described above.

  The following calcified compounds are preferred for use in the whitening strips of the present invention: sodium monofluorophosphate, potassium monofluorophosphate, magnesium monofluorophosphate, acidic fluorophosphate, amine fluoride, fluoride. Water-soluble salts of, for example, sodium fluoride, potassium fluoride, calcium fluoride, tin fluoride, sodium silicofluoride, bis-salicylate-bis-fluorotitanium (IV), ammonium silicofluoride, calcium salt, phosphate , Calcium salt / phosphate, calcium salt / ion fluoride source, zinc salt / phosphate, or any combination thereof.

  Preferably, the following desensitizing compounds may be used in the whitening strips of the present invention: water-soluble potassium salts including potassium nitrate, potassium citrate, potassium chloride, potassium bicarbonate, potassium oxalate, and root canal stenosis compounds (eg, , Ferric oxalate), or any combination thereof.

  Preferably, the following anticalculus agents may be used in the whitening strips of the present invention: phosphates, pyrophosphates, polyphosphates, phosphonates (eg ethane-1-hydroxy-1,1-diphosphonate, 1-azacycloheptane-1,1-diphosphonate), polyphosphonates, polyacrylates and other polycarboxylates, ethylenediaminetetraacetic acid and other calcium chelators, carboxylic acids and their salts, zinc salts ( For example, sodium zinc citrate), PVM / MA copolymers or other polymers that interfere with crystal nucleation or growth, or any combination thereof. It should be understood that when a phosphate anticalculus agent is used with a phosphate whitening agent, the phosphate anticalculus agent used is typically different from the phosphate whitening agent used.

  Preferably, the following perfume additives may be used in the whitening strips of the present invention: aromatic oils such as spearmint oil, peppermint, wintergreen, sassafras, cloves, sage, eucalyptus, marjoram, cinnamon, lemon, menthol, anethole , Thymol, parsley oil, oxanone and orange, α-irisone, cassia, marjoram, their oils, propenyl guaetol, and methyl salicylate. Sweeteners include, but are not limited to, sucrose, lactose, maltose, sorbitol, xylitol, sodium cyclamate, sucralose, acesulfame-K, aspartame, and sodium saccharin. Any combination of the aforementioned fragrance additives is also suitable for use in the whitening strip.

  Preferably, the following anti-inflammatory agents may be used in the whitening strips of the present invention: non-steroidal anti-inflammatory agents such as ketorolac, flurbiprofen, ibuprofen, naproxen, indomethacin, aspirin, ketoprofen, piroxicam, meclofenamic acid, Or any combination thereof. Steroidal and non-steroidal anti-inflammatory agents and plant extracts that exhibit anti-inflammatory activity may also be used.

  Preferably, the following antioxidants may be used in the whitening strips of the present invention: vitamin E, ascorbic acid, uric acid, kojic acid, coenzyme compounds (eg, coenzyme Q-10), carotenoids, vitamin A, flavonoids and polyphenols, Herbal antioxidant, melatonin, aminoindole, lipoic acid, or any combination thereof.

  Other suitable antioxidants are rosemary extract, tocopherol, tocotriene, carotene, tocopherol derivatives including carotenoids, phenolic antioxidants including phenolic acids, bioflavonoids, plant extracts, curcumin, tetrahydrocurcumin, camphorol (Camphorol), quercetin, epigenin, or any mixture thereof.

  Preferably, the following vitamins may be used in the whitening strip of the present invention: vitamin K, retinol (vitamin A), tocopherol, or any combination thereof.

  The whitening strip can be produced by solution deposition, film casting, die casting or extrusion.

  In operation, in contact with the teeth and moisture, the strip hydrates and fills any space due to the polymer system in a manner that matches the tooth contours and gaps. As a result, the interaction of the whitening composition with the tooth surfaces and the gaps between teeth becomes tighter and stronger over time. Surprisingly, after the first application of the strip, the inventor continued to improve the adhesive properties of the strip, thereby leading to good, intimate contact with the strip tooth form and to the strip tooth form. It has been found that this results in adhesion.

  Note that unlike the strips described in the prior art, the whitening strip of the present invention does not require a support layer. In fact, the whitening strip according to the invention preferably does not have a support layer.

  Preferably, after introducing the whitening strip into contact with the teeth, the whitening action of the strip is accomplished in less than about 60 minutes. Typically, however, when used towards a whitening treatment plan, contacting the teeth with the whitening strip for about 1 to about 25 minutes is sufficient to whiten the teeth.

  The present invention further provides a method for producing a whitening strip in the form of a dry film. The method mixes a whitening agent, a water soluble or water dispersible polymer system that provides a plasticized substrate for the whitening agent, and a volatile solvent to form a mixture; applying the mixture to a surface; A film of the mixture is formed on the surface; then the volatile solvent is removed to produce a whitening strip in the form of a dry film.

  The volatile solvent can be any commonly used volatile solvent. However, as shown in the examples below, the preferred volatile solvent is either water or ethanol.

  As shown in the examples below, wetting agents such as Pluronic F-68 may be used. And it can remain in the final whitening strip and the diffusion and film forming ability can be improved.

  The present invention also provides a method for tooth whitening. The method includes applying a whitening strip over the tooth for a time sufficient to produce a detectable improvement in tooth whiteness. Because the strip dissolves in the mouth, the method of the present invention does not require strip removal.

  The following examples illustrate the invention. They should not be construed as limiting in any way.

Ａｑｕａｍｅｒｅはポリウレタンエステルである。

Aquamere is a polyurethane ester.

  Pluronic F-68 was added to reduce surface tension and improve diffusion and film formation. Depending on the substrate on which the film is formed, it can be removed.

  Plasdone K-90 was dissolved in a solution of water, carbamide peroxide, glycerin, pluronic F-68, EDTA and citric acid. The film was dried at room temperature overnight and then at 37 ° C. for about 30 minutes.

  Plasdone K-90 was added as a 20% w / w solution in 0.1M NaOH, chitosan was added as a 2% w / w solution in 0.1M NaOH, and the film was dried at room temperature overnight.

^＊製造中の損失がないと仮定した理論値に基づく

^* Based on theoretical values assuming no loss during production

In another embodiment of the present invention, polymer dissolvable films containing different concentrations of sodium tripolyphosphate (STP) were produced and tested for their in vitro whitening ability. Example 8 above illustrates such a film. Films were cast from ethanol solutions of poly (vinyl pyrrolidone) (PVP), hydroxypropyl cellulose (HPC) and glycerin. The phosphate content was determined by ion chromatography. Whitening ability was evaluated using an in vitro model utilizing bovine teeth stained with tea. The film was applied to the teeth (n = 7) for 30 minutes in the presence of a PBS substantivity challenge. After baseline, 2, 4 and 6 treatments, tooth color was measured using a Labscan colorimeter. The change in color is expressed as ΔL ^* .

Formulated films containing different concentrations of STP were highly bioadhesive and showed good mechanical properties. The mean ± standard deviation values of ΔL ^* after 6 treatments are 1.84 ± 1.24, 1 for films containing 0, 2.4, 4.9 and 7.4% w / w STP, respectively. .67 ± 0.95, 1.95 ± 0.57, and 2.85 ± 1.23. There was no statistically significant difference between the whitening ability of films with 0, 2.4 or 4.9% w / w STP. Surprisingly, however, it was found that the ΔL ^* value of the film with about 7.4% w / w STP was statistically significantly higher than at rest after 6 treatments. The phosphate content remained unchanged after 4 weeks storage at 40 ° C./75% RH, but a small fraction of STP was converted to pyrophosphate as expected.

  Surprisingly, significant in vitro whitening was obtained in the absence of peroxide by using a substantially dissolvable strip containing STP. Low concentrations of STP (ie 2.4 and 4.9% w / w) did not show any whitening benefits compared to those of placebo. However, about 7.5% w / w STP film showed significant in vitro whitening. Thus, it appears that an STP in an amount of about 7.5% w / w to about 25% w / w of the weight of the whitening strip will achieve the desired and unexpected tooth whitening effect.

  The present invention also provides a multilayer stack for whitening teeth, ie a multilayer whitening strip. A stack is disposed on the first controlled water soluble or water dispersible whitening layer or film having a first whitening agent and a first water soluble polymer system; and It has a second controlled soluble water-soluble or water-dispersible whitening layer or film having a second agent (eg, reaction accelerator) and a second water-soluble or water-dispersible polymer system. The first and second films are combined to form a stack. An adhesive may or may not be necessary to bond the two layers. The overall dissolution of the strip in the oral cavity is controlled by the composition of each individual layer.

  Multilayer stacks can be formed from cast or extruded films, or any combination of cast or extruded films. Other means of carefully accumulating layers or domains (eg, spray dry material accumulation) may be used. The layers can be combined in a stack in any manner or in any form that has the same or different composition and includes random and / or regular arrangements and repeating units.

  Each individual layer in the strip can be generated from the same component, or the components in each layer can be varied to provide enhanced and / or multiple benefits.

  An example of an advantage provided by a multilayer strip is the ability to provide a stable delivery system for incompatible ingredients. Incompatible components can be carefully separated into domains until the strip is hydrated during use.

  The multilayer whitening strip may also have one or more units of one or more layers of the first and / or second controlled soluble water soluble or water dispersible whitening film.

  Further, each layer of the first and / or second controlled solubility water soluble or water dispersible whitening film may have a different formulation and result in different dissolution rates. The multilayer strip can be designed to provide directed diffusion of the whitening agent from the multilayer strip to the teeth by selecting layers with different dissolution rates.

  Still further, each layer may have one or more regions. A region is a range in the layer. In this example embodiment, the strip may have a region containing a desensitizer, preferably approximately around the strip.

  In addition, the multilayer strip has a film divided into specific layers and a bleach accelerator-containing peroxide, which does not require prior mixing of the whitening agent and accelerator upon dissolution of the strip. Whitening can be promoted. This layer system provides a stable environment for bleach and accelerators in the same strip.

  Multi-layer strips or films can also promote calcification, which can help prevent dental hypersensitivity. Calcification in this way can increase the opacity of the teeth and then whiten the teeth in appearance.

  Multi-layer strips that allow active dispersion of components at different rates can facilitate active unidirectional delivery to the desired site. For example, if such means is applied to the tooth and facilitates direct delivery to the tooth, less active ingredient will be lost in the oral cavity.

  The advantage of a multilayer strip is the ability to combine normally incompatible components in layers or films, thereby providing such incompatible components in a single delivery system.

  In one embodiment, peroxide activation can be achieved using, for example, bilayer films, peroxide-containing monolayers, and other layers containing active agents such as pH modifiers.

  In another embodiment, the different components may be located in separate film domains until they are combined by hydration in the oral cavity.

  In yet another embodiment, films or layers with different dissolution rates can be used to deliver the agent to the adherent surface (eg, peroxide in enamel) or in the oral cavity, eg, perfume delivery system. It can be developed to enhance the directionality of the agent to release slowly.

  Another possible advantage of multilayer films is that they can contain materials such as polymer systems that can be easily dissolved in the layers to which they belong. However, the solubility of these materials can be reduced with the components of separate layers, which can facilitate the formation of the desired residue on the surface. This can result in long-term benefits, such as long-lasting perfume persistence or long-lasting hypersensitivity treatment.

  The usefulness of films or layers according to the present invention is generally described in terms of oral care and treatment, while such films or layers can be used for denture care products, smoking cessation products, dermatological treatments, and buccal surfaces in the oral cavity. It can be used in a general drug delivery system.

  A whitening strip, whether a single layer strip or a multilayer strip, can have more than one region or domain on the surface of the layer of the strip. The region is the area on the whitening strip layer where the components (either compatible or incompatible components) can be separated from each other until the components are combined during dissolution of the whitening strip. Thus, each region can result in a region on the whitening strip having a particular component that can provide a particular benefit, such as, for example, an anti-irritant or anti-hypersensitive component along the gingival margin.

  It should be understood that the foregoing description is only illustrative of the invention. Various variations and modifications can be made by those skilled in the art without departing from the invention. Accordingly, the present invention is intended to embrace all such selections, modifications and variations that fall within the scope of the appended claims.

Claims (61)

Whitening teeth in the oral cavity comprising a phosphate whitening agent; and a water-soluble or water-dispersible polymer system having either poly (vinylpyrrolidone) or any derivative or copolymer thereof and at least one other polymer A dissolvable strip for dissolving by saliva in the oral environment.   The whitening strip of claim 1 wherein the phosphate whitening agent is selected from the group consisting of alkali metal phosphates, polyphosphates, alkali metal polyphosphates, and any combination thereof.   The whitening strip of claim 1 wherein the phosphate whitening agent is sodium tripolyphosphate.   The whitening strip of claim 1, wherein the whitening agent is about 2 wt% to about 75 wt% of the total weight of the whitening strip.   The whitening strip of claim 3, wherein the sodium tripolyphosphate is about 7.5% to about 25% by weight of the whitening strip.   The whitening strip of claim 1, wherein the whitening agent is encapsulated in a water soluble or water dispersible shell.   The whitening strip of claim 6, wherein the water-soluble or water-dispersible shell controls dissolution of the whitening composition by interaction with the saliva of the shell.   The water-soluble or water-dispersible polymer system is a poly (vinyl pyrrolidone) -alkyl vinyl ether / maleic anhydride copolymer, poly (vinyl pyrrolidone) -alkyl vinyl ether / maleic acid copolymer, poly (vinyl pyrrolidone) -alkyl vinyl ether / maleic acid copolymer Alkali metal or amine salts, poly (vinyl pyrrolidone) -partially or fully cross-linked alkyl vinyl ether / maleic anhydride copolymer, poly (vinyl pyrrolidone) -vinyl acetate copolymer, poly (vinyl pyrrolidone) -polyurethane interpolymer, poly (Vinyl pyrrolidone) -chitosan, poly (vinyl pyrrolidone) -poly (acrylic acid), poly (vinyl pyrrolidone) -poly (vinyl alcohol), poly (vinyl pyrrolidone) -poly ( Nyl alcohol-g-ethylene glycol) copolymer, poly (vinyl pyrrolidone) -cellulose derivatives, poly (vinyl pyrrolidone) -hydroxy-propyl-methyl cellulose, poly (vinyl pyrrolidone) -hydroxy-ethyl cellulose, poly (vinyl pyrrolidone) -hydroxy-propyl Cellulose, poly (vinyl pyrrolidone) -poly (ethylene oxide), poly (vinyl pyrrolidone) -poly (propylene oxide), poly (vinyl pyrrolidone) -polyquaterium-11, poly (vinyl pyrrolidone) -polyquaterium- 39, poly (vinyl pyrrolidone) -poloxamer, poly (vinyl pyrrolidone) -carbomer, poly (vinyl pyrrolidone) -gelatin, poly (vinyl pyrrolidone) -starch, (Vinyl pyrrolidone) -alginic acid, poly (vinyl pyrrolidone) -alginic acid salt, poly (vinyl pyrrolidone) -karaya gum, poly (vinyl pyrrolidone) -xanthan gum, poly (vinyl pyrrolidone) -guar gum, poly (vinyl pyrrolidone) -arabic gum, The whitening strip of claim 1 selected from the group consisting of poly (vinyl pyrrolidone) -tragacanth, poly (vinyl pyrrolidone) -polyvinyl pyrrolidone derivatives or copolymers, and any combination thereof.   The whitening strip of claim 8, wherein the poly (vinyl pyrrolidone) -polyurethane interpolymer is a poly (vinyl pyrrolidone) / polycarbamyl polyglycol ester interpolymer.   The at least one other water-soluble or water-dispersible polymer is an alkyl vinyl ether / maleic anhydride copolymer, an alkyl vinyl ether / maleic acid copolymer, an alkali metal or amine salt of an alkyl vinyl ether / maleic acid copolymer, partially or fully crosslinked Combined alkyl vinyl ether / maleic anhydride copolymer, vinyl acetate copolymer, polyacrylate, polyurethane interpolymer, chitosan, poly (acrylic acid), poly (vinyl alcohol), poly (vinyl alcohol-g-ethylene glycol) copolymer, cellulose Derivatives, hydroxypropylmethylcellulose, hydroxyl-ethylcellulose, hydroxypropylcellulose, poly (ethylene oxide) or copolymers thereof, poly ( Propylene oxide) or copolymers thereof, polyquaterium-11, polyquaterium-39, poloxamer, carbomer, gelatin, starch, alginic acid, salts of alginic acid, karaya gum, xanthan gum, guar gum, gum arabic tragacanth, and any of them 2. A whitening strip according to claim 1 selected from the group consisting of combinations.   The whitening strip of claim 1, wherein the water soluble or water dispersible polymer system is present up to about 99.9% by weight of the total weight of the whitening strip.   The whitening strip of claim 1, wherein the water soluble or water dispersible polymer system is about 60 wt% to about 95 wt% of the total weight of the whitening strip.   The whitening strip of claim 1, wherein the water soluble or water dispersible polymer system is also hydratable in contact with saliva.   The whitening strip of claim 13, wherein the whitening strip contacts the saliva in the oral cavity and conforms to the tooth shape.   The whitening strip of claim 1, wherein the whitening strip does not comprise a surfactant.   Further comprising an ingredient selected from the group consisting of antibacterial agents, calcifying compounds, desensitizing compounds, anticalculus agents, flavoring agents, anti-inflammatory agents, antioxidants, anti-coloring agents, and any combination thereof, The whitening strip of claim 1.   The antibacterial agent is triclosan, zinc salt, tin fluoride, chlorhexidine, hexidine, sanguinarine, benzalkonium chloride, salicylanilide, domifene bromide, cetylpyridinium chloride, tetradecylpyridinium chloride, N-tetradecyl-4-ethylpyridinium chloride 17. The method of claim 16, selected from the group consisting of: octenidine, delmopinol, octapinol, nicin preparation, zinc / tin ion agents, antibiotics, and analogs and salts thereof, essential oils, and any combination thereof. Whitening strip.   The calcified compound is sodium monofluorophosphate, potassium monofluorophosphate, amine fluoride, bis-salicylate-bis-fluorotitanium (IV), magnesium monofluorophosphate, acidic fluorophosphate, fluoride The whitening strip of claim 16, selected from the group consisting of sodium, potassium fluoride, calcium fluoride, tin fluoride, sodium silicofluoride, ammonium silicofluoride, calcium salts, phosphates, and any combination thereof. .   The desensitizing compound is a water soluble potassium salt selected from the group consisting of potassium nitrate, potassium citrate, potassium chloride, potassium bicarbonate, potassium oxalate, or root canal stenosis, and any combination thereof; The whitening strip of claim 16.   The carboxylic acid wherein the anticalculus agent comprises phosphate ester, pyrophosphate, polyphosphate, phosphonate, polyphosphonate, polyacrylate, polycarboxylate, carboxylic acid, sodium and / or zinc The whitening strip of claim 16, wherein the whitening strip is selected from the group consisting of a salt of   The whitening strip of claim 1 further comprising a plasticizer.   21. The phosphonate salt is selected from the group consisting of ethane-1-hydroxy-1,1-diphosphonate, 1-azacycloheptane-1,1-diphosphonate, and any combination thereof. Whitening strip.   The fragrance additive is spearmint, peppermint, winter green, sassafras, clove, sage, eucalyptus, marjoram, cinnamon, lemon, menthol, anethole, thymol, parsley oil, oxanone, orange, α-irisone, cassia, marjoram, those Selected from the group consisting of oil, propenyl guaetol, methyl salicylate, sucrose, lactose, maltose, sorbitol, xylitol, sodium cyclamate, sodium saccharin, aspartame, sucralose, acesulfame K, and any combination thereof, claim Item 15. A whitening strip according to item 16.   The anti-inflammatory agent is a non-steroidal anti-inflammatory agent selected from the group consisting of ketorolac, flurbiprofen, ibuprofen, naproxen, indomethacin, aspirin, ketoprofen, piroxicam, meclofenamic acid, and any combination thereof; The whitening strip of claim 16.   The antioxidant is vitamin E, ascorbic acid, uric acid, carotenoid, vitamin A, kojic acid, flavonoid, phenolic compound, polyphenol, coenzyme, herbal antioxidant, melatonin, aminoindole, lipoic acid, rosemary extract, tocopherol, 17. The whitening strip of claim 16, wherein the whitening strip is selected from the group consisting of tocotrienes, bioflavonoids, plant extracts, curcumin, tetrahydrocurcumin, camphorol, quercetin, epigenin, and any combination thereof.   The whitening strip of claim 1, wherein the whitening strip does not include a support.   The whitening strip of claim 1, wherein the strip is manufactured by a method selected from the group consisting of solution deposition, film casting, die casting and extrusion.   The whitening strip of claim 1, wherein the whitening strip is a single layer.   29. A whitening strip according to claim 28, wherein the layer has a surface comprising two or more regions.   30. The whitening strip of claim 29, wherein each one of the two or more regions has a different composition. A dissolvable whitening strip for whitening teeth in the oral cavity comprising a controlled soluble water soluble or water dispersible whitening film having a phosphate whitening agent and a water soluble or water dispersible polymer system The polymer system has either poly (vinyl pyrrolidone) or a copolymer or derivative thereof and at least one other polymer;
A whitening strip, wherein dissolution of the whitening strip is controlled in the oral cavity by interaction with the saliva of the whitening strip.   32. A whitening strip according to claim 31, wherein the whitening strip is a flexible thin film without support.   33. A whitening strip according to claim 32 which is a single layer.   32. The whitening strip of claim 31, wherein the whitening strip is from about 5 [mu] m to about 2000 [mu] m thick.   32. The whitening strip of claim 31, wherein the phosphate whitening agent is selected from the group consisting of alkali metal phosphates, polyphosphates, alkali metal polyphosphates, and any combination thereof.   32. The whitening strip of claim 31, wherein the phosphate whitening agent is sodium tripolyphosphate. A first controlled dissolvable film having a first whitening agent and a first water-soluble or water-dispersible polymer system; and a second whitening agent and a second disposed on the first film A dissolvable multilayer strip for whitening teeth in the oral environment, comprising a second controlled dissolvable film having a water soluble or water dispersible polymer system of:
The first and second films combine to form a stack;
A multilayer strip, wherein the dissolution of each of the first and second films is controlled by the interaction of the first and second films with saliva in the oral environment.   38. The multilayer strip of claim 37, wherein the first polymer system comprises either poly (vinyl pyrrolidone) or a copolymer or derivative thereof.   40. The multilayer strip of claim 38, wherein the first polymer system also has at least one other polymer.   38. The multilayer strip of claim 37, wherein the second polymer system comprises either poly (vinyl pyrrolidone) or a copolymer or derivative thereof.   40. The multilayer strip of claim 39, wherein the second polymer system also has at least one other polymer.   38. The multilayer strip of claim 37, wherein the first and second whitening agents are the same phosphate whitening agent.   The first film has a different whitening agent and / or water soluble or water dispersible polymer system than the second film, and the first film or the second film contains a phosphate whitening agent 38. The multilayer strip of claim 37.   38. The multilayer strip of claim 37, further comprising one or more units of one or more layers of the first and / or the second film.   45. The multilayer of claim 44, wherein each of the one or more layers of the first and / or second film has a whitening accelerator, resulting in rapid degradation of the bleach for enhanced whitening efficacy. strip.   45. The multilayer strip of claim 44, wherein each of the one or more layers of the first and / or the second film has a different structure or composition, resulting in different dissolution rates.   47. The multilayer strip of claim 46, wherein the structure or composition of each of the first and second films is selected to provide directional dissolution of the multilayer strip.   38. The multilayer strip of claim 37, further comprising a layer having a whitening agent on the surface of any layer.   49. The multilayer strip of claim 48, wherein the whitening agent is encapsulated.   38. The multilayer strip of claim 37, wherein the first film has two or more regions, each region having a different composition.   51. The multilayer strip of claim 50, wherein the second film has two or more regions, each region having a different composition.   52. The multilayer strip of claim 51, wherein two or more regions of the first film and two or more regions of the second film each have a different composition. A method for producing a whitening strip in the form of a dry film comprising:
Mixing a phosphate whitening agent, a water soluble or water dispersible polymer system for the whitening agent, and a volatile solvent to form a mixture;
Applying the mixture to a surface and forming a film of the mixture on the surface; then removing the volatile solvent to produce a whitening strip in the form of a dry film;
Including a method. Tooth whitening method,
Applying a whitening strip over the tooth as a directional treatment plan for use according to claim 1 for a time sufficient to produce a detectable improvement in tooth whiteness;
Including a method.   55. The method for whitening teeth according to claim 54, wherein the period is from about 1 minute to about 360 minutes.   55. The method for whitening teeth according to claim 54, wherein the period is from about 1 minute to about 30 minutes.   55. The method for whitening teeth according to claim 54, wherein the period is from about 5 minutes to about 20 minutes. Tooth whitening method,
Applying the multilayer whitening strip of claim 37 on the tooth for a time sufficient to produce a detectable improvement in tooth whiteness;
Including a method.   59. A method for whitening teeth according to claim 58, wherein the period is from about 1 minute to about 360 minutes.   59. A method for whitening teeth according to claim 58, wherein the period is from about 1 minute to about 30 minutes.   59. A method for whitening teeth according to claim 58, wherein the period is from about 5 minutes to about 20 minutes.