KR20040009547A - Patch attached hydrogel matrix for dental-whitening - Google Patents

Abstract

PURPOSE: Provided is a dental-whitening patch attached with multi-layered hydrogel matrix containing active ingredients which have dental whitening effect. It is minimized in oral cavity stimulation, and maintains whitening effect for a long time. CONSTITUTION: A dental-whitening patch attached with multi-layered hydrogel matrix is characterized by forming multi-layered hydrogel matrix between a protection layer of the exposed part and a protection layer of the attached part. The multi-layered hydrogel matrix contains 0.01-40.0 wt.% of a whitening component, 0.01-70.0 wt.% of water soluble adhesive, 0.01-10.0 wt.% of a neutralizing agent, 0.01-5.0 wt.% of a cross-linking agent, 0.1-5.0 wt.% of an emulsifier and 0.01-1.0 wt.% of a stabilizer.

Description

Patch attached hydrogel matrix for dental-whitening}

The present invention relates to a patch for tooth whitening with a hydrogel matrix having excellent tooth whitening effect. More specifically, the present invention comprises one or more hydrogel matrix layer containing the active ingredient that can provide a whitening effect on the teeth, tooth attachment site protective layer and exposed site protective layer, excellent tooth whitening effect The present invention relates to a patch for tooth whitening with a hydrogel matrix that can be continuously provided, manufactured in a thin sheet form, and has a low foreign body feeling during use, and minimizes oral irritation.

The causes of tooth discoloration are endogenous and exogenous factors. Tooth discoloration due to endogenous factors may be caused by food deposits, coffee, tea, etc. deposited on the dentin of the tooth, tartar or soft deposits on the tooth surface by pigment, or other pigmented bacteria or gingiva bleeding and excessive fluoride Occurred by coloration due to ingestion, mineral metal dust and chemicals from factories. In addition, tooth discoloration due to exogenous factors may occur when dental neuropathy is suffered, when silver amalgam, a prosthetic aid, is used, or when an overdose of a tetracycline antibiotic is used.

Recently, as interest in beauty has increased, interest in teeth whitening has increased. In response, various methods for treating tooth discoloration have been developed. Representative tooth discoloration treatment methods include temporary methods of applying a jacket crown to discolored teeth, and surgical methods such as scaling, which are cumbersome and expensive to treat.

Another method is brushing teeth using a bristle toothbrush or toothpaste with a simple addition of abrasive, which is not only satisfactory in whitening effect, but also susceptibility to swelling or pain caused by physical wear of the enamel or cervical area of the tooth surface. There is a problem with teeth.

Thus, research has been made on various types of whitening agents that directly contact teeth and increase the whitening effect.

U. S. Patent No. 5,326, 685 discloses that a tooth whitening agent in gel form is placed between a porous material such as a sponge and a water impermeable film and then directly attached to a tooth. In this case, the tooth whitening agent gradually acts on the tooth through the porous material while the tooth is in contact with the tooth, thereby exhibiting a whitening effect. However, since the thickness of the material attached to the tooth is too thick, the foreign matter is inconvenient to use, and the process of adhering the porous material and the non-permeable film is difficult to manufacture, and the whitening agent is manufactured in the form of a gel so that the stickiness is strong. There are disadvantages.

In addition, Korean Patent Publication No. 2001-13448 discloses a tooth whitening agent that provides a sticky adhesion between a tooth surface and a strip by coating a tooth enamel adhesion layer containing a tooth whitening agent on a thin and flexible strip, in which case a tooth The thinner the adhesive agent, the less foreign body feels. As the drug is less effective in releasing the drug and is applied directly to the teeth in a gel form, many residues remain on the teeth when used after desorption.

Accordingly, the present inventors have conducted research to solve the above problems, as a result, the present invention hydrogel comprising at least one hydrogel matrix layer formed between the exposed portion protective layer, the adhesion portion protective layer and the two layers. Tooth whitening patch with matrix contains whitening ingredients, water-soluble adhesives, crosslinking agents, emulsifiers and stabilizers in an effective amount in the hydrogel matrix layer, providing excellent adhesion to teeth and providing excellent tooth whitening effects. The present invention has been found to have an excellent effect of minimizing oral irritation.

Accordingly, an object of the present invention is to provide a hydrogel matrix-attached tooth whitening patch comprising an exposed site protective layer, an attachment site protective layer and at least one hydrogel matrix layer formed between the two layers. .

Another object of the present invention is that the hydrogel matrix layer is 0.01 to 40.0% by weight of a whitening component, 0.01 to 70.0% by weight of a water-soluble adhesive, 0.01 to 5.0% by weight of a crosslinking agent, 0.1 to 5.0% by weight relative to the total weight of the hydrogel matrix layer The present invention provides a patch for tooth whitening with a hydrogel matrix, comprising a% emulsifier and 0.01 to 1.0 wt% stabilizer.

Figure 1 shows the configuration of a hydrogel matrix attached whitening patch according to the present invention.

1. Protective layer of exposed area

2. Hydrogel Matrix Layer

3. Protective layer of attachment site

In order to achieve the above object, the hydrogel matrix-attached tooth whitening patch according to the present invention comprises an exposed site protective layer, an attachment site protective layer and at least one hydrogel matrix layer formed between the two layers, The hydrogel matrix layer is 0.01 to 40.0% by weight of a whitening component, 0.01 to 70.0% by weight of a water-soluble adhesive, 0.01 to 10.0% by weight of a neutralizing agent, 0.01 to 5.0% by weight of a crosslinking agent, 0.01 ~ to the total weight of the hydrogel matrix layer 5.0 weight% emulsifier and 0.01 to 1.0 weight% stabilizer.

Hereinafter, the present invention will be described in more detail.

Hydrogel matrix layer of the constituent layer of the hydrogel matrix with a tooth whitening patch according to the present invention is a layer that can be attached to the teeth containing the whitening component, a whitening component that is fixed to the teeth by the attachment site protective layer To pass. This hydrogel matrix layer contains a whitening component, a water-soluble adhesive, a crosslinking agent, an emulsifier and a stabilizer as components.

As a whitening component of the hydrogel matrix layer of the hydrogel matrix patch for tooth whitening according to the present invention, at least one selected from the group consisting of peroxide, metal chlorite, percarbonate, peroxide and mixtures thereof may be used. However, it is not limited thereto. This whitening component is preferably used in an amount of 0.01 to 40.0% by weight based on the total weight of the hydrogel matrix layer.

The water - soluble adhesive component of the hydrogel matrix layer of the hydrogel matrix-attached tooth whitening patch according to the present invention is for enhancing the adhesion of the hydrogel matrix layer to tooth enamel. Such adhesives include gelatin, polyacrylic acid, polyvinyl alcohol, polyvinyl alcohol, xanthan gum, galang gum, sodium alginate, polyvinylpyrrolidone, polyvinylformamide, carboxymethylcellulose and carboxypolymethylene. More than one species can be used, but not always limited thereto. Such a water-soluble adhesive is preferably used in an amount of 0.01 to 70.0% by weight based on the total weight of the hydrogel matrix layer.

Another component of the hydrogel matrix layer in the patch for tooth whitening with the hydrogel matrix according to the present invention is corrector Is to neutralize the water-soluble adhesive to obtain the appropriate viscosity and to improve the safety of the teeth and oral mucosa. The neutralizing agent may be one or more selected from the group consisting of sodium hydroxide, potassium hydroxide, triethanolamine, citric acid, sodium citrate, sodium phosphate, and the like, but is not limited thereto. Such neutralizing agent is preferably used in an amount of 0.01 to 10.0% by weight based on the total weight of the hydrogel matrix layer.

Another component of the hydrogel matrix layer in the patch for tooth whitening with the hydrogel matrix according to the present invention is Crosslinking agent Is to crosslink the glass reactor of the water-soluble adhesive to enhance the physical strength of the hydrogel matrix layer. Such crosslinkers include glyoxal; Zinc salts such as zinc oxide and zinc chloride; Aluminum salts such as aluminum glycinate and aluminum sulfate; Calcium salts such as calcium chloride and calcium oxide; And it may be used one or more selected from the group consisting of magnesium salts such as magnesium chloride, magnesium oxide, but is not limited thereto. Such a crosslinking agent is preferably used in an amount of 0.01 to 5.0% by weight based on the total weight of the hydrogel matrix layer.

The emulsifier which is another component of the hydrogel matrix layer of the hydrogel matrix-attached tooth whitening patch according to the present invention is for uniformly emulsifying the components of the matrix layer. Such emulsifiers may be, but are not limited to, one or more selected from the group consisting of polyoxyethylene sorbitan fatty acid esters, sorbitan fatty acid esters, polyglyceryl fatty acids, and fatty acid sugar esters. Such emulsifier is preferably used in an amount of 0.01 to 5.0% by weight based on the total weight of the hydrogel matrix layer.

Another component of the stabilizing agent in the hydrogel matrix layer of the patch for the hydrogel matrix attachment tooth whitening according to the present invention is effective to stabilize the whitening ingredient. The stabilizer may be one or more selected from the group consisting of sodium stearate, sodium pyrophosphate, phenacetin, zirconium oxychloride, and laponite, but is not limited thereto. Such stabilizer is preferably used in an amount of 0.01 to 1.0% by weight based on the total weight of the hydrogel matrix layer.

Hydrogel matrix layer of the tooth whitening patch with a hydrogel matrix according to the present invention may further contain a fragrance in an amount of 0.001 ~ 1.0% by weight in addition to the essential components as described above.

The hydrogel matrix layer of the hydrogel matrix-attached tooth whitening patch according to the present invention may contain active ingredients effective for oral diseases in addition to the above components. These medicinal ingredients include sodium fluoride, sodium monofluorophosphate, tin fluoride, and gum disease prevention components such as sodium chloride, tocopherol acetate, pyridoxine hydrochloride, allantoin, allantoin chlorohydroxyaluminum, tranexamic acid and aminocaproic acid. Sodium pyrophosphate as the prevention component of tartar deposition, triclosan, cetylpyridinium chloride, chlorhexidine gluconate, etc. may be used as an antimicrobial component, but is not limited thereto.

In order to maintain the tooth whitening patch of the present invention with the hydrogel matrix attached to the teeth in a circular shape for a long time in the oral cavity, an exposed area protective layer is required to prevent the whitening agent from penetrating into the oral cavity. In the present invention, a conventional film used in a general transdermal patch may be used as an exposed portion protective layer without particular limitation. As the film that can be used for the exposed portion protective layer, a polymer film or a nonwoven fabric may be used. In particular, a scratched or embossed film or a non-woven thin laminate film may be used for firm bonding with the hydrogel matrix layer. It is preferable. However, it is not limited to this.

In order to attach the hydrogel matrix-attached tooth whitening patch according to the present invention to the tooth surface, an attachment site protective layer is required. In the present invention, as a protective layer for the attachment site, a conventional one used in the general transdermal patch application field can be used without particular limitation. The adhesion site protective layer may be a polypropylene film, a polyethylene terephthalate film or a polyvinyl chloride film treated with fluorine or silicon, but is not limited thereto.

Method for producing a tooth whitening patch with a hydrogel matrix according to the present invention is as follows,

(1) adding a water-soluble pressure-sensitive adhesive to the solvent, heating and stirring to dissolve uniformly, and then adding and mixing a neutralizing agent, an emulsifier, and a stabilizer to the solution;

(2) adding a whitening component and a crosslinking agent dispersed in purified water to the mixed solution and stirring to stop the stirring when the mixed solution is in a uniform state and to cool after degassing in vacuum;

(3) applying the solution to the protective layer on the film-like attachment site with a uniform thickness of about 10 ~ 1000㎛, and then drying at room temperature by passing through a tunnel equipped with a blowing facility; And

And (4) laminating an exposed portion protective layer to the layer. However, it is not limited to this method.

In the above (1), purified water may be used as the solvent for dissolving the water-soluble adhesive, but is not limited thereto. In addition, fragrances may be further added together with emulsifiers and stabilizers.

In addition, in the method for producing a tooth whitening patch with a hydrogel matrix, each hydrogel matrix solution prepared by varying the type of the whitening component, the water-soluble adhesive, and the crosslinking agent is sequentially applied to the protective layer on the film-like attachment site, and then room temperature. It can be dried to manufacture a multi-layer structure, through which it is possible to control the tooth penetration rate of the components effective for whitening teeth.

The hydrogel matrix-attached tooth whitening patch prepared by the above method is aged at room temperature or 37 ° C. for 12 to 48 hours, and then cut into a shape that is easy to attach to a tooth and finally formulated.

Hydrogel matrix-attached tooth whitening patch according to the present invention is, firstly, excellent adhesion to the teeth; Second, due to the lamination of the protective layer of the exposed area, the circular shape is maintained in the oral cavity for a long time, so that the whitening agent is prevented from penetrating into the oral cavity and the oral irritation is minimized; Third, the use of a thin sheet form not only minimizes foreign matter; Fourth, there is a characteristic that can continuously release the whitening ingredients effective for teeth whitening.

Hereinafter, the present invention will be described in more detail with reference to Examples and Test Examples, but the scope of the present invention is not limited thereto, and modifications commonly known in the art may be performed, and such modifications may also be used in the present invention. It is included in the scope of rights.

EXAMPLES AND COMPARATIVE EXAMPLE Preparation of the patch for tooth whitening with a hydrogel matrix

Tooth whitening patch with a hydrogel matrix having a composition of Table 1 was prepared, respectively.

[Examples 1-3]

Ionized water in which sodium hydroxide was dissolved was added to an aqueous polyacrylic acid solution, followed by stirring while heating at about 60 to 70 ° C. To this was added a solution of polyoxyethylene (20) sorbitan stearate, tetrasodium pyrophosphate, sodium sterate and agar, and stirred for 20 minutes while maintaining the temperature at 60 ~ 70 ℃. 35% hydrogen peroxide and potassium aluminum sulfate were added to the mixture, followed by further stirring for 10 minutes, followed by vacuum degassing and cooling to 50 °.

The solution was applied to a PET film with a uniform thickness of about 300 μm using a coater, then dried at room temperature for 5 minutes, and the PE film was laminated to the layer. After that it was cut to a suitable size and prepared by crosslinking for 3 days at a temperature of 50 ~ 60 ??.

Comparative Example 1

Carboxypolyethylene was dispersed in glycerin, followed by stirring while keeping ionized water at 40 to 50 ° C. When the carboxypolyethylene was completely dissolved, ionized water in which sodium hydroxide was dissolved was added and stirring continued. Then, polyoxyethylene (20) sorbitan stearate, tetrasodium pyrophosphate, and sodium stearate were added and stirred at room temperature for 20 minutes. Hydrogen peroxide was added to the mixed solution, followed by further stirring for 10 minutes, followed by vacuum degassing.

The solution was applied to a PET film with a uniform thickness of about 300 μm using a coater, then dried at room temperature for 5 minutes, and the PE film was laminated to the layer. It was then cut to a suitable size to prepare.

Furtherance Example 1 Example 2 Example 3 Comparative Example 1 Polyacrylic acid aqueous solution 40.0 40.0 40.0 - Carboxy Polyethylene - - - 2.0 Sodium hydroxide 2.5 2.5 2.5 0.2 Potassium aluminum sulfate 0.20 0.20 0.20 - Agar 1.0 1.0 1.0 - Tetrasodium pyrophosphate 0.5 0.5 0.5 0.5 glycerin 5.0 5.0 5.0 25.0 Polyoxyethylene (20) sorbitan stearate 0.7 0.7 0.7 0.7 Sodium stearate 0.10 0.10 0.10 0.10 Hydrogen peroxide (35%) - 4.29 8.57 8.57 Ionized water to 100 to 100 to 100 to 100

<Test Example 1> Measurement of adhesive force of the patch for tooth whitening with the present invention hydrogel matrix

Instron tester (model 4201 / Instron Ltd.) was used to measure the adhesive force of the protective layer of the attachment site of the tooth whitening patch with the hydrogel matrix.

The patch prepared in Examples 1 to 3 and Comparative Example 1 was left for 30 minutes in an incubator at 37 ° C., and then the exposed portion of the protective layer was removed. One end was quickly attached to a test plate made of stainless steel 25 mm long, 125 mm long, and 5 mm thick. This was then passed twice over a 850 g rubber roller at a speed of 350 mm / min. Leave this for 30 minutes in a 37 ° C thermostat, then tilt the other end attached to the test plate at an angle of 180 ° and use an Instron tester to clamp the other end of the patch to the upper part and clamp the test plate to the lower part and pull it out at 300mm / min. The load was measured. The magnitude of the force is expressed in g per 12 mm width. The results are shown in Table 2.

<Test Example 2> Measurement of the feeling of use of the patch for teeth whitening with the present invention hydrogel matrix

Patches of Examples 1 to 3 and Comparative Example 1 were attached to the teeth of 10 volunteers selected as samples, and after 30 minutes of removal, the usability was evaluated by the following 5-point evaluation method.

5: No residue on the teeth.

4: There is some residue in teeth, but there is no foreign matter.

3: There is a residue on the tooth, and there is a slight feeling of foreign body.

2: There is a lot of residue on the teeth, and there is a lot of foreign body feeling.

1: There is a lot of residue on teeth, and there is a lot of foreign body feeling.

The arithmetic mean of each volunteer's feeling of use was averaged. The results are shown in Table 2.

Adhesion (g per 12mm) Feeling Example 1 52 4.5 Example 2 51 4.3 Example 3 54 4.4 Comparative Example 1 45 1.6

As can be seen from the table, the patches of Examples 1 to 3 of the present invention were significantly superior in use compared to Comparative Example 1.

<Test Example 3> Measurement of the whitening effect on the teeth of the patch for teeth whitening with the present invention hydrogel matrix

In order to measure the tooth whitening effect of the tooth whitening patch with the hydrogel matrix of the present invention, 60 healthy male and female experimenters were selected as samples and tested.

The original tooth chromaticity of the subject was measured using SHADEEYE-EX (SHOFU Co.LTD., Japan). Place the SHADEEYE-EX tip 2 mm above the maxillary left central incisoral cervical cervical region and at a right angle so that light does not leak out to the tooth surface in the middle of the root, and then measure and collect the baseline data. Patches of Examples 1 to 3 and Comparative Example 1 were applied twice each day to the upper and lower mandibular buccal for 30 minutes. During the test, he was allowed to eat food according to his or her usual diet, but coffee, cola, and tobacco were prohibited before the color measurement on the day of chromaticity measurement. Chromaticity was measured (secondary measurement) 14 days after the patch was used.

The results are shown in Table 3 and Table 4, respectively.

Measurement result of change in tooth color after 2 weeks baseline mean Average after 2 weeks Example 1 7.92 7.89 Example 2 7.96 6.28 Example 3 7.98 5.92 Comparative Example 1 7.93 6.02

Tooth whitening effect measurement result two weeks later better same worse Example 1 2 (10%) 17 (85%) 1 (5%) Example 2 12 (60%) 7 (35%) 1 (5%) Example 3 16 (80%) 4 (20%) 0 (0%) Comparative Example 1 15 (75%) 5 (25%) 0 (0%)

From the above results, it can be seen that the patch for whitening teeth of the present invention is excellent in the whitening effect. In particular, the patch of Example 3 had the best whitening effect.

As described above, the hydrogel matrix-attached tooth whitening patch according to the present invention has excellent adhesion to teeth and maintains a circular shape in the oral cavity for a long time due to the lamination of the exposed area protective layer while the whitening agent penetrates into the oral cavity. In addition to minimizing oral irritation is prevented from being prevented, it is a very useful invention that has an excellent effect of continuously releasing whitening ingredients effective for whitening teeth.

Claims (12)

In a tooth whitening patch, a hydrogel matrix patch for tooth whitening comprising an exposed site protective layer, an attachment site protective layer and at least one hydrogel matrix layer formed between the two layers. According to claim 1, wherein the hydrogel matrix layer is 0.01 to 40.0% by weight of the whitening component, 0.01 to 70.0% by weight water-soluble adhesive, 0.01 to 10.0% by weight neutralizing agent, 0.01 to 5.0% by weight relative to the total weight of the hydrogel matrix layer A patch for tooth whitening with a hydrogel matrix, comprising a% crosslinking agent, 0.1 to 5.0 wt% emulsifier, and 0.01 to 1.0 wt% stabilizer. The tooth whitening patch of claim 2, wherein the whitening component is at least one selected from the group consisting of peroxides, metal chlorites, percarbonates, peroxides, and mixtures thereof. The method of claim 2, wherein the water-soluble adhesive is water-soluble polyacrylic acid, water-soluble polyacrylate, agar, gelatin, polyvinyl alcohol, xanthan gum, gellan gum, sodium alginate, polyvinylpyrrolidone, polyvinylformamide, silica and carbox Whitening patch for hydrogel matrix adhesion tooth, characterized in that at least one member selected from the group consisting of methyl methyl cellulose. The patch for tooth whitening with a hydrogel matrix according to claim 2, wherein the neutralizing agent is at least one selected from the group consisting of sodium hydroxide, potassium hydroxide, triethanolamine, citric acid, sodium citrate, and sodium phosphate. The patch for tooth whitening with a hydrogel matrix according to claim 2, wherein the crosslinking agent is at least one selected from the group consisting of glyoxal, zinc salt, aluminum salt, calcium salt and magnesium salt. The patch for tooth whitening with a hydrogel matrix according to claim 2, wherein the emulsifier is at least one selected from the group consisting of polyoxyethylene sorbitan fatty acid esters, sorbitan fatty acid esters, polyglyceryl fatty acids, and fatty acid sugar esters. . The patch of claim 2, wherein the stabilizing agent is at least one selected from the group consisting of sodium stearate, sodium pyrophosphate, phenacetin, zirconium oxychloride, and laponite. The tooth whitening patch of claim 1, wherein the exposed portion protective layer is a polymer film or a non-woven fabric thinly laminated. The patch of claim 1, wherein the adhesion layer protective layer is a polypropylene film, polyethylene terephthalate film, or polyvinyl chloride film treated with fluorine or silicon. As a method for producing a tooth whitening patch with a hydrogel matrix, (1) adding a water-soluble pressure-sensitive adhesive to the solvent, heating and stirring to dissolve uniformly, and then adding and mixing a neutralizing agent, an emulsifier, and a stabilizer to the solution; (2) adding a whitening component and a crosslinking agent dispersed in purified water to the mixed solution and stirring to stop the stirring when the mixed solution is in a uniform state and to cool after degassing in vacuum; (3) applying the solution to a protective layer on the film-like attachment site using a coating machine with a uniform thickness of about 10 to 1000 μm, and then drying at room temperature by passing through a tunnel equipped with a blowing facility; And (4) manufacturing a hydrogel matrix-attached tooth whitening patch comprising the step of laminating an exposed portion protective layer on the layer. In the method for producing a tooth whitening patch with a hydrogel matrix according to claim 11, each hydrogel matrix solution prepared by varying the type of the whitening component, the water-soluble adhesive, and the crosslinking agent is sequentially applied to the protective layer on the film. And drying at room temperature to produce a multilayer structure patch for tooth whitening with a hydrogel matrix.