KR100471919B1 - Flexible patches for teeth whitening - Google Patents

Abstract

The present invention relates to a tooth whitening patch containing a peroxide as a tooth whitening agent. In particular, the upper part of the patch is relatively thin, the middle and lower parts are thicker, more flexible, and the peroxide content in the gum contact area is more safe. In some cases, when the patch is to be attached to the back of the tooth, the upper part is equally thin, the middle part is relatively thick, and the lower part is thin and easy to fold. In both cases, the center part is relatively thick, so it is comfortable to wear.

Description

Flexible tooth whitening patch {FLEXIBLE PATCHES FOR TEETH WHITENING}

The present invention relates to a tooth whitening patch that removes stains of teeth and makes teeth white by just attaching them to the teeth. More specifically, the thickness of the patch varies depending on the part, and in particular, the middle part is relatively thick, which is more flexible and convenient to wear, and it is safe because the amount of the whitening agent is relatively small in contact with the gum. It is a thinner patch for teeth whitening that is thin and easy to use.

Recently, many new patents have been filed for non-tray type of tooth adhesives that can be used in a short period of time and are easy to use in terms of cost and convenience. In particular, Procter & Gamble uses US Pat. A tooth whitening delivery system is proposed that pre-coates a conventional whitening gel or similar formulation or is applied directly to a tooth or strip prior to use and then attached. The ease of use is improved by not using a mouse tray, and it is a big advantage that it is transparent and thin when worn, so that it does not interfere with daily life, but as shown in the examples, a high viscosity using a large amount of carbopol as the main gelling agent is shown. The gel is pre-coated in a thin, uniform thickness to a flexible polyethylene strip, and it is inconvenient, large foreign matter, and irritating gums in the process of folding and fixing the back of the teeth.

WO 00/54699 has filed a patent for a better form of strip for better contact of the strip with the whitening agent to the teeth. The biggest feature is that the tooth has four incisors and two fangs, the strips of which do not cover the ends of the lateral fangs. If the strip covers the end of the canine, it is difficult for the user to easily attach the strip to the tooth as it bends, and the strip does not stick to the tooth for a sufficient time. However, in the case of the lower teeth, as in this patent, if the strip is made into a trapezoidal shape and folds to the back of the tooth, the tongue can be easily touched and a large amount of foreign body may be worn. In terms of use, rather than securing the adhesion time by the shape like this, by adjusting the thickness according to the part of the formulation or adding sufficient adhesion and flexibility to the formulation, even if you do not make the shape so that the end of the trapezoid or the canine is not covered It is thought that it is more preferable to be able to attach easily.

The present invention has sufficient flexibility by adjusting the thickness of each part of the tooth whitening patch to improve the feeling of use, and in particular, by relatively thinning the thickness of the upper part that can reach the gum to prevent the gum from contacting with a high concentration of peroxide, and sufficient adhesive strength. There is no problem of desorption even if the patch is grounded, but if the size does not fit with your teeth and you need to fold it on the back of the tooth, the bottom is relatively thin, which makes it easier to fold and reduce the feeling of foreign body. To provide.

The present invention is to improve the feeling of use while improving the whitening effect by adjusting the thickness of the patch for each part in the patch for tooth whitening containing peroxide as a tooth whitening agent, high efficiency. In more detail, unlike the formulation of the same thickness of the top, middle, and bottom, the upper part is particularly thin and relatively flexible, so it is more flexible and adheres well to the curved teeth, and the area touching the gum is relatively thin. It is characterized by more safety and less foreign object.

The product of the present invention can be dry or wet type, but dry type is more preferable in terms of usability and peroxide stabilization. The dry type uses a hydrophilic glass polymer on the adhesive layer so that it doesn't get wet before it is hydrated, so when the size of the product doesn't match your own, you can easily adjust it to a size that fits with a hygienic knife or scissors. For ease of use anywhere, as long as the patch has sufficient adhesive force, it can be folded into the back of the tooth even if it is a little small and not too big. At this time, however, if the patch is inflexible or thick, the foreign material may be large. Therefore, the present invention is not limited only to the relatively thin thickness of the upper portion, and if necessary, the bottom portion of the patch may be easily folded by applying a thin thickness as the upper portion.

Only the upper part of the patch is thick and the middle and the lower part of the patch is the thickness of the upper part is 1 ~ 300㎛, preferably 5 ~ 100㎛ in accordance with the object of the present invention, the middle and the lower part is 30 ~ 500㎛ thickness Preferably, it is 50-200 micrometers according to the objective of this invention.

In the case where the upper and lower portions of the patch are thin and the middle portion is thick, the upper and lower portions do not necessarily have to have the same thickness, but the upper and lower portions have a thickness of 1 to 200 µm, preferably 5 to 100 µm. In accordance with the object of the present invention, the middle part has a thickness of 30 to 400 μm, preferably 50 to 200 μm.

As in the present invention, when the dry type is used, the stability of the peroxide used as the tooth whitening agent becomes a problem. In the present invention, the peroxide stabilizer is used in the formulation containing the peroxide together with the adhesive force to the adhesive layer in the matrix type having a double layer. This problem was solved by the addition, and in order to have high time stability at high temperature, the hydrophilic glass polymer which can give adhesion to the matrix type adhesive layer having a triple layer is contained without the addition of peroxide, and the drug below This problem was solved by adding peroxide alone or peroxide stabilizer together in the layer.

On the other hand, in terms of whitening effect, high concentrations cannot be used unconditionally due to irritation when only peroxide is used as a whitening agent, and natural whitening products for professional whitening products using trays or strip products attached to teeth when proper concentrations are used. Is known to have a whitening effect even in a relatively short period of two weeks, but it is known that the effect caused by staining or smoking formed by the drug is effective when used for about six months. In the present invention, in order to enhance the whitening effect than when only peroxide is used, condensed phosphate (polyphosphates) may be added together with the peroxide as a tooth whitening agent. However, when addition of condensation phosphate alone does not provide the desired level of fast whitening reaction, it contains only a peroxide activator in multiple layers, or in some cases condensation phosphate, which is incompatible with peroxide alone or with a peroxide activator, More preferred is a tooth whitening patch, which comprises a protective layer in and then contains a peroxide in the drug layer together with a peroxide activator and, in some cases, a relatively suitable condensation phosphate with the peroxide.

In the case of a patch, the wet type and the dry type can be largely classified. The former corresponds to the application or impregnation of a gel or a solution in a hydrogel formulation or an adhesion layer, and a water or humectant in the formulation. The initial state of the formulation is characterized by a high content of) and the latter is characterized by a dry state of the formulation because of the low content of water or humectant in the formulation. A wet type with high flexibility and high moisture content is preferable for moisturizing or delivering other medicinal ingredients to dry skin.However, wet type generally lacks adhesion and is sticky from the initial state. Can be buried In addition, depending on the prescription there is a problem that the gel containing the drug or whitening agent in the opposite direction through the support layer may be released. In particular, when a high concentration of peroxide is applied with a gel containing a large amount of wetting agent, it can be adjusted according to the size and curvature of the tooth, and it can cause irritation by burying in unwanted areas such as hands, lips, and gums when attached. In addition, a large amount of humectant is buried in the tongue has no taste, you will feel a lot of foreign body use. However, this wet type problem could also be improved by varying the thickness of the patch. In other words, the area in contact with the gum is made as thin as possible, reducing the degree of gum irritation, and the lower part, which is the area that is folded in the back of the tooth, can be more convenient and less foreign body when folded.

More preferably, the dry type was selected, which also solved the disadvantage of the wet type. Dry type patch of the present invention has a sufficient adhesive strength in a wet oral cavity, when wearing dry, do not get whitening agent on the hands or many other, and do not even on the gums or tongue can be a big advantage when using less.

In order to make this dry type patch, a polymer that is weak in adhesive strength or weak in dry condition but is hydrated by a small amount of water at the point where the whitening agent is desired to be formed or becomes strong and releases a desired component is essential. need. In the present invention, it was found that the hydrophilic glassy polymer (glassy polymer) has these properties, the hydrophilic glassy polymer (glassy polymer) was used as the main polymer in the adhesive layer (Adhesive) to the patch of the matrix form.

Backing is a sheet using water-insoluble and water-impermeable polymer as film former. It prevents the patch from being deformed or detached by saliva without sticking to gums or tongue when attached to teeth.

As mentioned above, the whitening patch of teeth can control the whitening effect by adjusting the overall thickness or drug as well as the effect of improving the feeling by adjusting the thickness of each part of the patch, and can observe the oxygen drop of peroxide when worn. Therefore, the user can perceive the whitening effect emotionally. In addition, because the ticket does not appear while wearing it may not interfere with daily life.

The present invention is characterized by supplying a whitening agent for a sufficient time by attaching to the enamel layer of the tooth rather than attaching it to the skin or mucous membrane with a matrix type patch. In the present invention, the patch is attached to the tooth, the principle that can release the whitening agent in the matrix on the surface of the tooth is as follows. In the field of drug delivery, there is an idea of using water emanating from the skin as an example of a transdermal formulation that is attached to one of the methods used for transdermal delivery with a time lag and then causes the drug to release over a period of time. In other words, the drug impermeable barrier (barrier) is installed between the skin adhesion surface and the drug reservoir, and after the drug is attached, the barrier is hydrated by moisture invading the skin, thereby increasing the permeability of the drug over time. will be. In this case, the barrier material is a hydrophilic glassy polymer. In the present invention, using a hydrophilic glass polymer on the adhesive layer of the patch of the Matrix Type using the technique, the whitening agent is not released when stored or when touched by hand for attachment to the teeth, but begins to hydrate by moisture on the surface of the tooth. While the adhesion and the release of the whitening agent is characterized in that it takes place. These glass polymers also have excellent adhesion to most hydrophilic tooth surfaces, so there is no need to fold the patch to the back of the tooth to ensure sufficient contact time. In addition, in the case of gums, even a small amount of whitening agent is used, even if it is not a big irritation is concerned, but if you attach the patch to touch only the teeth, the gum may not release the whitening agent is also a big feature. The first feature of the invention is therefore the use of hydrophilic glass polymers in the adhesive layer of the dry type patch.

Glass polymers mainly used in the adhesive layer of Matrix Type patches for this purpose are polyalkyl vinyl ether-maleic acid copolymers (PVM / MA copolymer, Gantrez AN 119, AN 139, S-97), polyvinyl alcohol, polyacrylic acid , Poloxamer 407 (Pluronic), polyvinyl pyrrolidone-vinyl acetate copolymer (PVP / VA copolymer; Luviskol VA, Plasdone S PVP / VA), polyvinyl pyrrolidone (PVP, K-15 to K-120), Polyquaternium-11 (Gafquat 755N), Polyquaternium-39 (Merquat plus 3330), Carbomer (Carbopol), hydroxy propyl methyl cellulose, hydroxy ethyl cellulose, hydroxy propyl cellulose, gelatin, sodium alginate alone Or mixtures thereof. As these solvents, water, ethanol and their mixing ratio may be controlled.

Tooth enamel patches should be flexible enough because they attach directly to the teeth and must be easily shaped as the teeth are bent. Some polymers lack this flexibility, so a suitable plasticizer has been added. Suitable plasticizers vary depending on the type of polymer and its formulation, but are commonly used polypropylene glycol, glycerin and polyethylene glycol.

The tooth whitening agent contained in the tooth enamel adhesion layer is hydrogen peroxide, carbamide peroxide, calcium peroxide, sodium percarbonate, sodium perborate, and fatigue peroxide. Sodium phosphate (tetrasodium pyrophosphate peroxidate) and mixtures thereof were selected and used. Sodium pyrophosphate (TSPP-H ₂ O ₂ ), an addition compound of sodium pyrophosphate and hydrogen peroxide, exhibits the properties of hydrogen peroxide in aqueous solution or crystalline state and at the same time exhibits the properties of sodium pyrophosphate itself. In normal cases sodium pyrophosphate stabilizes hydrogen peroxide without altering its original properties. It also prevents the drawbacks of using hydrogen peroxide alone. Hydrogen peroxide is accelerated by metal catalysis, ultraviolet rays, oxidase, heat treatment, etc., but sodium peroxide pyrophosphate is stable against all these and exhibits the original properties and properties of hydrogen peroxide. In fact, sodium peroxide pyrophosphate had better stability over time at 40 ° C than when only peroxides were used in liquids, gels, and pastes. However, the peroxide stability in the patch was not easily obtained even by using sodium peroxide pyrophosphate as the whitening agent.

Generally, peroxides are difficult to stabilize in products due to their excellent reactivity, but are not particularly compatible with polymers. The stabilization of peroxide in the product is related to the form and prescription of the product, and there are many patents related to the peroxide stabilization in general gel, paste, and solution phases. Although it is known that peroxide stabilization in thinly applied gels or patches is not a known technique, the results of the inventors of the present invention were not a problem that can be easily solved with generally known peroxide stabilizers.

The inventors found a stabilizer that can be used for the basic properties of the patch or the range of use of the present invention while screening the stabilizer of the peroxide in the patch, and can significantly improve the stability over time at high temperatures of the peroxide in the patch. It became. Thus, a second feature of the invention is the use of a peroxide, a tooth whitening agent, with a peroxide stabilizer.

Stabilizers compatible with peroxides include alkyl aryl sulfonates, alkyl sulfonate salts, alkyl carboxylate salts, alkyl diphenyl oxide disulfonates, span 60; Sorbitan Stearate, Span 80; Sorbitan Oleate, Span 85; Sorbitan Trioleate) and mixtures thereof were used. In more detail,

In the present invention, peroxide was used as the main tooth whitening agent in the patch. However, even when stored at 40 ℃ when a patch made of only the whitening agent in the patch within the peroxide content decreases over time, it was confirmed that a lot less than the first in vitro whitening effect. In the case of gel form, the formulation containing peroxide same as Adhesive had a very small peroxide loss without using a stabilizer even when the polymer was used as a film-forming agent, and a formulation lacking peroxide stability was known as a general peroxide stabilizer. By adding small amounts of chelating agents such as EDTA or sodium citrate, the desired level of prescription was obtained. However, in the case of the sheet-type patch obtained by evaporating the solvent of the gel as in the present invention, the stability of the peroxide was lower than that of the solution even when the same formulation was used. When the chelating agent was added, as in the solution, the stability of peroxide in the patch was lower than before the addition. Also, when the dequest phosphonates known to have excellent peroxide stabilizing effects were added to the patch, peroxide stabilizing effects could not be obtained.

There are various reasons why the peroxide over time stability in the prescription depends on whether the same composition is gel or liquid or sheet phase, but according to US Pat. No. 4,320,102, the amount of peroxide is very small due to the catalytic reaction by metal. It is said that even the only metal is very sensitive to decomposition. In other words, hydrogen peroxide decomposes even if only 0.1 mg of iron, 0.2 mg of copper, 0.1 mg of magnesium, and 0.02 mg of chromium per liter. Based on these data, sheet-shaped patches made by evaporation of solvent in solution or gel state contain relatively high amounts of metals in a thin thickness and are more responsive because their surface area increases. It is thought that stability with time of peroxide will become inadequate. In the present invention, the materials used as peroxide stabilizers in the patch are mainly surfactants or emulsifiers, and they are considered to have a positive effect on peroxide stabilization by forming micelles on the sheets. Indeed, the gels in the container had excellent stability over time at relatively high temperatures, while the same gel formulation was applied thinly to the strip to increase the surface area. . However, the present inventors have found that some of the hydrophilic glassy polymers are excellent in compatibility with the peroxide and can be sufficiently stable by appropriately adjusting the proportion of the solvent without adding a peroxide stabilizer. Therefore, the present invention is not limited to the use of a peroxide and a peroxide stabilizer together. In more detail,

Polyvinyl pyrrolidone (PVP, K-15,-K-120), Polyquaternium-11, Polyquaternium-39, polyvinyl pyrrolidone-vinyl acetate copolymer (PVP / VA copolymer) among hydrophilic glassy polymers ) Is not only soluble in both water and ethanol, but also has excellent compatibility with peroxides, so that the stability of peroxide in patches is excellent when the water and ethanol ratio is adjusted to 9: 1 to 0:10 without adding peroxide stabilizer. Seemed. This good compatibility of the peroxide and polyvinyl pyrrolidone is thought to be stabilized by forming a complex by hydrogen defect of polyvinyl pyrrolidone and peroxide. In addition, it was confirmed that the peroxide and the polymer having a quaternary ammonium structure such as Polyquaternium have good compatibility. The solvent used as a mixed solvent of water and ethanol is that glass polymers compatible with these peroxides are very hydrophilic and are not uniformly applied to the release liner or other sheets. This problem is solved and a uniform sheet phase can be obtained. Therefore, the third feature of the present invention is to control the ratio of water and ethanol solvent in the adhesive layer composition during manufacturing, using peroxide as a tooth whitening agent and adding a separate peroxide stabilizer when using a glass polymer having high compatibility with the peroxide. By doing so, a patch having excellent peroxide stability at high temperature can be produced. In addition, as in the case of the patch containing the peroxide stabilizer, a suitable plasticizer may be added depending on the polymer in order to give sufficient flexibility to the patch. Suitable plasticizers vary depending on the type of polymer and its formulation, but are commonly used polypropylene glycol, glycerin and polyethylene glycol.

In addition, in the present invention, although the peroxide is used as the main whitening agent, condensed phosphate is used together with the peroxide as the whitening agent to improve the whitening effect.

Condensed phosphates used are, for example, sodium pyrophosphate (TSPP), sodium pyrophosphate (SAPP), sodium hexametaphosphate (SHMP), sodium tripolyphosphate (STP), 1 type among sodium potassium tripolyphosphate (SKTP), potassium pyrophosphate (TKPP), acidic sodium meta-polyphosphate (Sporix) and multiphos (acidic sodium polyphosphate, Multiphos) Or more was used with peroxide. In general, condensed phosphates are known to be effective as tartar control agents in toothpaste to inhibit tartar formation or to remove tartar. In addition, they are known to contribute to the improvement of the whitening effect by effectively removing tooth stains produced by metals such as iron, calcium, and magnesium in food or working environment as a good chelating agent of metals. . Therefore, when the polyphosphate is used in combination with the peroxide in the present invention, it is expected to be effective in inhibiting tartar formation or removing tartar by prolonging contact time between teeth and polyphosphate as well as improving whitening effect. In fact, when the patch containing these were attached, the tooth surface or between the teeth was cleared.

Polymers usable in the backing layer of the matrix patch in the present invention are polyvinyl acetate, ethyl cellulose, poly methyl methacrylate, methacrylic acid copolymers such as methacryloyl ethyl betaine / methacrylate copolymer (Yukaformer Mitsubishi, Metacryloyl Ethyl Betain / Metacylate Copolymer, Metaacrylic Acid Copolymers (Eurdragit L 100, Eudragit L 12,5, Eudragit L 100-55, Eudragit L 30D-55) Aminoalkyl methacrylate copolymers (Eudragit E 100, Eudragit E 12,5, Eudragit RL 100, Eudragit RL 30D), cellulose acetate phthalate alone or mixtures thereof. In addition, as an enteric coating material, any polymer that is insoluble in oral conditions between pH 6 and 8 can be used.

The backing layer can also be used with the addition of several plasticizers for the same reasons as the adhesive layer. In addition to the plasticizers mentioned above, propylene glycol, glycerin, polyethylene glycol and more can be used depending on the solvent used, and caster oil and hydrogenated caster oil can also be used.

Also, when the patch of the present invention is attached to the teeth, white pigments such as titanium dioxide, talc, which are white pigments in the backing layer, can be seen visually white as well as whitening by chemical and physical action. Hydroxyapatite, zinc oxide, or the like may be used in combination, and when these pigments are not compatible with the whitening agent of the adhesive layer, surface-treated titanium dioxide may be used. In addition to the white pigments, pearls or pigments of various colors may be applied depending on the individuality.

Formulations used in the present invention may be used alone or in combination with enzymes, particularly dextranase, glucose oxidase, etc., which were difficult to apply due to stability over time when applied to toothpaste, and also added papain that is effective in whitening teeth. can do. Therapeutic medicinal products for oral disease include triclosan, chlorohexidin, vitamin E or derivatives thereof, including vitamin E acetate or oxidants, chlorophyll or derivatives thereof, and spices, which are effective for removing bad breath. It is possible.

Hereinafter, a preferred embodiment of the present invention. However, the following examples are merely to help the understanding of the present invention is not limited to the following examples.

Examples 1 to 10, Comparative Examples 1 to 4

Tooth whitening patches of Examples 1 to 10 and Comparative Examples 1 to 4 were prepared with the composition as described below.

Example 1

Post-Production Thickness: Top 50μm, Center 115μm, Bottom 50μm

Adhesive Manufacturing Solution

Hydroxypropyl Cellulose 12%, Ethanol to 100

Drug layer preparation solution

Polyalkyl vinyl ether-maleic acid copolymer (Gantrez S 97) 12%, hydrogen peroxide 3%, ethanol to 100

Backing Preparation Solution

Ethyl cellulose 10%, caster oil 6%, ethanol to 100

Example 2

Post-production thickness: 35 μm at the top, 130 μm at the rest

Adhesive Manufacturing Solution

Contact Adhesive (1 ^st layer) Preparation Solution

Polyalkyl vinyl ether-maleic acid copolymer (Gantrez S 97) 12%, glycerin 3%, TKPP 2%, sodium bicarbonate 5%, water to 100

The protective layer (Barrier, 2 ^nd layer) prepared solution

Polyvinyl alcohol 10%, water to 100

Drug storage layer (Drug Reservoir, 3 ^rd layer) prepared solution of 15% polyvinylpyrrolidone, 1.5% hydrogen peroxide, glycerol 3%, 2% span 80, water to 100

Backing Preparation Solution

Ethyl cellulose 8%, Eudragit 5%, caster oil 4%, ethanol to 100

Example 3

Post-Production Thickness: Top 80μm, Middle 215μm, Bottom 115μm

Adhesive Manufacturing Solution

Polyquaternium-39 10%, urea peroxide 10%, propylene glycol 50% water to 100

Backing Preparation Solution

Cellulose aceteart phthalate 30%, caster oil 4%, acetone: ethanol = 4: 1 mixed solution to 100

Example 4

Post-production thickness: 15 µm at the top, 160 µm at the center, 15 µm at the bottom

Adhesive Manufacturing Solution

12% polyalkyl vinyl ether-maleic acid copolymer (Gantrez S 97), 6% sodium pyrophosphate peroxide, 2% Span 85, water to 100

Backing Preparation Solution

Ethyl cellulose 10%, caster oil 6%, ethanol to 100

Example 5

Post-Production Thickness: Top 60μm, Center 120μm, Bottom 60μm

Adhesive Manufacturing Solution

12% polyalkyl vinyl ether-maleic acid copolymer (Gantrez S 97), 6% sodium peroxide pyrophosphate, 10% alkyl aryl sulfonate (SLS), moderate NaOH (pH up to 7), 60% glycerin, water to 100

Backing Preparation Solution

Ethyl cellulose 10%, caster oil 6%, ethanol to 100

Example 6

Post-Production Thickness: Top 100μm, Middle 300μm, Bottom 100μm

Adhesive Manufacturing Solution

11% polyalkyl vinyl ether-maleic acid copolymer (Gantrez S 97), 3% polyvinyl pyrrolidone, 3% hydrogen peroxide, SAPP 4%, 2% alkyl sulfonate salts, pH appropriate to pH up to 7 100

Backing Preparation Solution

Polymethyl Methacrylate 8%, Acetone to 100

Example 7

Post-Production Thickness: Top 10μm, Middle 50μm, Bottom 10μm

Adhesive Manufacturing Solution

Polyquaternium-11 20%, PC 4%, TKPP 4%, Alkyl Diphenyl Oxide Disulfonate 2%, Water to 100

Backing Preparation Solution

Eudragit 15%, Propylene Glycol 5%, Ethanol to 100

Example 8

Post-production thickness: 50 μm at the top, 150 μm at the center, 50 μm at the bottom

Adhesive Manufacturing Solution

Polyvinyl pyrrolidone 10%, hydrogen peroxide 1.5%, SAPP 2%, alkyl diphenyl oxide disulfonate 1%, glycerin 5%, water to 100

Backing Preparation Solution

Ethyl cellulose 12%, caster oil 6%, ethanol to 100

Example 9

Post-Production Thickness: Top 20μm, Center 64μm, Bottom 40μm

Adhesive Manufacturing Solution

Polyvinyl Alcohol 12%, Hydrogen Peroxide 1.5%, TSPP 3.4%, Span 60 5%, Propylene Glycol 3%, Water to 100

Backing Preparation Solution

Ethyl cellulose 8%, cellulose acetate phthalate 2% ethanol: acetone = 1: 4 mixed solvent to 100

Example 10

Post-Production Thickness: Top 10μm, Middle 50μm, Bottom 10μm

Adhesive Manufacturing Solution

Polyvinyl Pyrrolidone 18%, Hydrogen Peroxide 1.5%, Ethanol to 100

Backing Preparation Solution

Ethyl cellulose 10%, Eudragit 2%, caster oil 7%, ethanol to 100

[Comparative Example 1]

Post Manufacture Thickness: 50μm overall

Adhesive Manufacturing Solution

Polyvinyl pyrrolidone 10%, hydrogen peroxide 1.5%, SAPP 2%, alkyl diphenyl oxide disulfonate 1%, glycerin 5%, water to 100

Backing Preparation Solution

Ethyl cellulose 10%, caster oil 6%, ethanol to 100

[Comparative Example 2]

Post Manufacture Thickness: 150μm overall

Adhesive Manufacturing Solution

Polyvinyl pyrrolidone 10%, hydrogen peroxide 1.5%, SAPP 2%, alkyl diphenyl oxide disulfonate 1%, glycerin 5%, water to 100

Backing Preparation Solution

Ethyl cellulose 10%, caster oil 6%, ethanol to 100

[Comparative Example 3]

Post Manufacture Thickness: 300㎛ overall

Adhesive Manufacturing Solution

11% polyalkyl vinyl ether-maleic acid copolymer (Gantrez S 97), 3% polyvinyl pyrrolidone, 3% hydrogen peroxide, SAPP 4%, 2% alkyl sulfonate salts, pH appropriate to pH up to 7 100

Backing Preparation Solution

Polymethyl Methacrylate 8%, Acetone to 100

[Comparative Example 4]

Overall thickness: 240㎛

Adhesive Manufacturing Solution

Carbopol 12%, Hydrogen Peroxide 4.5%, SAPP 0.48%, Glycerin 80%, Water to 100

Backing floor

Polyethylene strip

TKPP; tetrapotassium pyrophosphate, SAPP; sodium acid pyrophosphate, TSPP; tetrasodium pyrophosphate

Experimental Example 1

The patch is applied directly to the teeth and according to the degree of flexibility, the 5 points scale is the best when it is 5, the worst is 0, the stimulus is on the 5 points scale when it touches the gum, 5 points when the stimulus is severe, 0 points when no Table 1 shows the foreign materials sensed on a 5-point scale when the foreign materials are severe and 5 points if there is a heavy foreign material.

flexibility Gum irritation Foreign body when folded in the back Example 1 5 0 2 Example 2 5 2 3 Example 3 5 3 3 Example 4 5 One One Example 5 5 2 2 Example 7 5 0 0 Example 8 5 0 2 Example 9 5 One One  Example 10 5 0 0 Comparative Example 1 4 0 One Comparative Example 2 3 2 3 Comparative Example 3 3 3 5 Comparative Example 4 4 3 5

As can be seen from Table 1, the case where the thickness of the patch is different for each part is particularly excellent in flexibility than that of the comparative example in which the overall thickness is the same. When I fold it, there was less foreign object. Particularly, even when wet type, the difference in thickness was less when Examples 3 and 5 were folded than Comparative Example 4 of wet type having the same thickness.

Experimental Example 2

The whitening effect of the tooth whitening patch was measured by the following method.

(1) Preparation of Contaminated Hydroxyapatite (HAP) Tablet Specimen

Tablet made of hydroxyapatite powder by IR press, sintered at 1000 ° C, molded with epoxy resin to make resin, etched surface with strong acid, and then dissolved in tea, coffee, iron and mucin TSB (trypticase soybroth) solution The specimen was soaked and dried repeatedly, and the operation was contaminated for one week. After contamination, wash the specimen lightly with a toothbrush in running water to remove any contamination that is easily dissolved or removed by water, and then dried at room temperature.

(2) whitening effect evaluation method

The initial L value of the contaminated HAP tablet specimen (L indicates brightness, white at 100 and black at 0) was measured with a colorimeter, and the whitening patch prepared in Examples and Comparative Examples was wetted with water. In order to resemble the actual oral condition, leave it in a thermo-hygrostat set to 37 ° C and 95% humidity, remove the patch after a certain time, rub it gently with running water, and dry it at room temperature. L value was measured. ΔL, which is the difference between L values before and after patching, was calculated. The results are shown in Table 2 below.

△ L (1 hour) △ L (3 hours) Example 6 42.00 ± 1.03 48.85 ± 2.37 Example 8 32.38 ± 3.44 40.00 ± 3.88 Comparative Example 1 19.55 ± 1.71 36.00 ± 2.55 Comparative Example 2 31.99 ± 2.87 41.08 ± 2.99 Comparative Example 3 42.00 ± 1.03 48.85 ± 2.37 Comparative Example 4 14.55 ± 2.41 30.35 ± 3.24

It can be seen from the results of Table 2 that the whitening effect is different depending on the thickness of the portion in contact with the stain of the actual teeth in the case of the formulation containing the same weight ratio of the same whitening agent. As shown in the results of Table 1, the thickness of the middle part of the patch, that is, the area in contact with the stain of the actual tooth, has a relationship with the whitening effect. It seems most desirable to make the lower part of the or relatively thin and the middle part thicker.

As described above, the present invention has excellent tooth whitening effect and at the same time divides the thickness of the patch into the upper part and the remaining part or the upper, middle, and lower part and adjusts the thickness relatively, and when it comes in contact with the gum It is safer because of low peroxide content, comfortable to fold into the back of the tooth, and has less foreign body feeling.

1 illustrates a case in which an example of the present invention having a dry type triple layer structure has a thick center and a relatively thin upper and lower portions.

FIG. 2 illustrates a case in which the middle part and the lower part are thick and the upper part is relatively thin, according to an embodiment of the present invention having a dry type triple layer structure.

3 illustrates a case in which the middle part and the lower part are thick and the upper part is relatively thin in one embodiment of the present invention having a double layer structure of dry type.

FIG. 4 illustrates a case in which the middle is thick and the upper and lower parts are relatively thin in one embodiment of the present invention having a dry type double layer structure.

FIG. 5 illustrates a case in which a middle part and a lower part are thick and an upper part is relatively thin in an embodiment of the present invention having a multiple layer structure of a dry type.

FIG. 6 illustrates a case in which the center is thick and the upper and lower parts are relatively thin in one embodiment of the present invention having a dry type multiple layer structure.

Claims (15)

Tooth whitening patch attached to teeth, which contains peroxide and peroxide stabilizer as a whitening agent, and when the tooth is attached, the upper part of the patch that comes into contact with the gum is relatively thin, and the middle part of the patch attached to the front of the tooth and the back of the tooth Tooth whitening patch, characterized in that the thickness of the lower portion of the patch can be folded into a relatively thick. The method of claim 1, wherein the peroxide is hydrogen peroxide, carbamide peroxide, calcium peroxide, sodium percarbonate, sodium perborate, sodium pyrophosphate, or tetrasodium pyrophosphate. peroxidate), or a mixture thereof. The peroxide stabilizer of claim 1 wherein the peroxide stabilizer is alkyl aryl sulfonate, alkyl sulfonate salt, alkyl carboxylate salt, alkyl diphenyl oxide disulfonate, Sorbitan Stearate, Sorbitan Oleate, Span 85 (Sorbitan Trioleate), or a tooth whitening patch, characterized in that a mixture thereof. The tooth whitening patch of claim 1, further comprising a condensed phosphate for enhancing the whitening effect. The method of claim 4, wherein the condensed phosphate is tetrasodium pyrophosphate (TSPP), sodium acid pyrophosphate (SAPP), sodium hexametaphosphate (SHMP), sodium tripolyphosphate (STP), sodium potassium tripolyphosphate (SKTP), tetrapotassium pyrophosphate (TKPP), acidic sodium metapolyphosphate (Sporix), or a patch for teeth whitening, characterized in that a mixture thereof. The method of claim 1, wherein the patch is a dry type double layer patch consisting of an adhesive layer and a backing layer containing peroxide, or an adhesive layer containing no peroxide, or containing peroxide. Multiple layers comprising a dry patch of a drug layer, and a triple layer of support layers, or an adhesion layer containing a peroxide activator, a protective layer, a drug storage layer containing a peroxide, and a support layer. Tooth whitening patch, characterized in that the dry patch. The tooth whitening patch according to any one of claims 1 to 6, wherein the thickness of the upper part of the patch is 1 to 300 µm, and the thickness of the middle part and the lower part of the patch is 30 to 500 µm, respectively. The patch for tooth whitening according to claim 7, wherein the thickness of the upper part of the patch is 5 to 100 m and the thickness of the middle part and the lower part of the patch is 50 to 200 m, respectively. A tooth whitening patch for attaching to a tooth, which contains a peroxide as a whitening agent and a main base is a polyvinyl pyrrolidone-vinyl acetate copolymer (PVP) as a hydrophilic glassy polymer having good compatibility with peroxides. / VA copolymer; Luviskol VA, Plasdone S PVP / VA), polyvinyl pyrrolidone (PVP, K-30-K-120), Polyquaternium-11 (Gafquat 755N), Polyquaternium-39 (Merquat plus 3330) or their The mixture is used and the ratio of water and ethanol is adjusted from 9: 1 to 0:10 to ensure the stability of the peroxide without the addition of a peroxide stabilizer. The thickness of the lower part of the patch can be relatively thin, tooth whitening patch, characterized in that the middle portion of the patch attached to the front of the tooth is relatively thick. 10. The method of claim 9, wherein the peroxide is hydrogen peroxide, carbamide peroxide, calcium peroxide, sodium percarbonate, sodium perborate, sodium pyrophosphate, or tetrasodium pyrophosphate. peroxidate), or a mixture thereof. 10. The tooth whitening patch of claim 9, further comprising condensed phosphate to enhance the whitening effect. The method of claim 11, wherein the condensed phosphate is tetrasodium pyrophosphate (TSPP), sodium acid pyrophosphate (SAPP), sodium hexametaphosphate (SHMP), sodium tripolyphosphate (STP), sodium potassium tripolyphosphate (SKTP), tetrapotassium pyrophosphate (TKPP), acidic sodium metapolyphosphate (Sporix), or a patch for teeth whitening, characterized in that a mixture thereof. 10. The method of claim 9, wherein the patch is a double layer dry type patch consisting of an adhesive layer and a backing layer containing peroxide, or an adhesive layer containing no peroxide, or containing peroxide. Multiple layers comprising a dry patch of a drug layer, and a triple layer of support layers, or an adhesion layer containing a peroxide activator, a protective layer, a drug storage layer containing a peroxide, and a support layer. Tooth whitening patch, characterized in that the dry patch. The tooth whitening patch according to any one of claims 9 to 13, wherein the thickness of the upper part and the lower part of the patch is 1 to 200 m and the thickness of the middle part of the patch is 30 to 400 m. The patch for tooth whitening according to claim 14, wherein the thickness of the upper and lower portions of the patch is 5 to 100 µm and the thickness of the central portion of the patch is 50 to 200 µm.