Oral patch with improved stability and usability

Abstract

The present invention provides an oral adhesive patch with improved stability and usability. The patch of the present invention is attached to teeth or oral mucosa and releases active ingredients to the attached site. The patch is characterized in that the patch includes a drug layer with an attachment surface attached to teeth or oral mucosa and a supporting layer stacked with the drug layer, and the drug layer includes at least one mesh body inside, and is divided into at least two drug layers with the mesh body as a boundary.

Description

Technical Field

[0001] The present invention relates to an oral adhesive patch, and more particularly, to a patch attached to teeth or oral mucosa. Background Art

[0002] When delivering active ingredients (teeth whitening, tooth decay prevention, anti-inflammatory, and tooth hypersensitivity prevention) to oral tissues (teeth, gums), the active ingredients are diluted or swallowed through saliva, which not only reduces the effect but also makes people feel uncomfortable when using it. In order to solve this problem, oral patch technology is currently used, which is a patch containing active ingredients attached to oral tissues to deliver drug effects for a long time.

[0003] Conventional patch products contain water-soluble polymers that have good adhesion to teeth and oral tissues. In particular, in the case of tooth whitening patches, water-soluble polymers that have good compatibility with whitening ingredients (e.g., hydrogen peroxide) are used. In addition, the drug layer of conventional whitening patches has strong adhesion when dissolved by water such as saliva.

[0004] However, due to the strong adhesive force in the oral cavity, there is a problem that the polymer remains in the oral tissue after use, and attempts have been made in the art to improve this problem.

[0005] In some products circulating in the market, in order to solve the problem of residues on the tooth surface and to somewhat weaken the adhesiveness of the PVP polymer used as a tooth adhesion polymer, an acrylate polymer is also used in combination. However, there is a problem that the manufacturing process becomes somewhat complicated, for example, a process of pre-mixing the PVP polymer and the acrylate polymer is required.

[0006] The present inventors have confirmed that the polymer formulated with hydrogen peroxide is excessively formulated to an amount greater than that required for adhesion to the oral cavity in order to ensure the stability of hydrogen peroxide, and therefore a considerable amount of the polymer remains on the tooth surface after use of the oral patch.

[0007] On the other hand, most of the oral patches circulating on the market are rapidly diluted by the wetting of saliva, so in order not to reduce the adhesion to the teeth, another supporting layer (Backing layer) is stacked on the drug layer and used, and PE film is mainly used. The PE film layer does not break during the manufacture of the oral patch due to its high tensile strength, and can be properly attached along the curvature of the teeth due to its high flexibility. However, when the patch using PE film is exposed to specific conditions (for example: high temperature, for a long time, etc.), the drug layer of the patch is separated (detached) from the PE film supporting layer, resulting in a decrease in commercial value. In addition, when the patch with a PE film layer is packaged in bulk, the detachment of the PE film may cause the patch products to stick together and be contaminated, resulting in a problem of reduced commercial value. Summary of the invention

[0008] Problems to be solved by the invention

[0009] Therefore, the problem to be solved by the present invention is to provide a patch that is adhered to teeth or oral mucosa and has excellent usability and commercial value. Specifically, a patch that has adhesion to teeth or oral mucosa and can be removed cleanly without leaving any residue when removed is provided.

[0010] Another problem to be solved by the present invention is to prevent the water-insoluble support layer and the drug layer from separating, thereby allowing the patch to be stably attached to the teeth or the oral mucosa.

[0011] Another problem to be solved by the present invention is to provide a patch of a new form that can prevent the support layer and the drug layer from being separated, preferably to provide a patch for teeth whitening.

[0012] In addition, another problem to be solved by the present invention is to provide a teeth whitening kit including the above-mentioned patch, and a teeth whitening method including the above-mentioned patch or kit.

[0013] Means for solving problems

[0014] One embodiment of the present invention provides a patch for attachment to teeth or oral mucosa, comprising: a drug layer having an attachment surface; and a support layer stacked with the drug layer, wherein the drug layer comprises at least one mesh body, and the at least one mesh body divides the drug layer into multiple sections.

[0015] The drug layer may include two parts, namely, a first drug layer and a second drug layer, wherein the first drug layer is located between the attachment surface and the mesh body, and the second drug layer is located between the first drug layer and the supporting layer, and the first drug layer has a thickness of 5% to 50% of the thickness of the entire drug layer.

[0016] The mesh body may include through holes and an embossed pattern, the embossed pattern may include protrusions and recesses, and the protrusions may be formed toward the attachment surface.

[0017] The mesh body may include: an embossed pattern located at a filament connection portion where at least two filaments meet or cross; and through holes formed between the filament connection portions for allowing the active ingredient to pass through.

[0018] The through holes may have an area of ​​10% to 60% of the total width of the mesh body parallel to the attachment surface of the drug layer.

[0019] The filament connecting portion may be formed of two filaments.

[0020] The filament connecting portion may be formed by three filaments.

[0021] The filaments forming the mesh body may be arranged at intervals of 30% to 500% of the thickness of the filaments.

[0022] Each of the mesh through holes formed in the mesh may have a diameter of at least 0.01 mm. 2 Up to 0.5mm 2 area.

[0023] It can be that each unit area of ​​the mesh surface, i.e. 1cm 2 The mesh body is provided with 100 to 800 through holes formed in the mesh body.

[0024] The patch may release active ingredients from the drug layer, the drug layer may contain a water-soluble or water-dispersible polymer and may be attached to the target site after being impregnated with water, wherein the patch is attached by impregnation of the first drug layer.

[0025] The polymer may include at least one selected from the group consisting of polyvinyl pyrrolidone, carbomer, pullulan, carrageenan, sodium alginate, acrylate polymers or copolymers, water-soluble cellulose polymers, xanthan gum, polyvinyl alcohol, and mixtures thereof.

[0026] The drug layer may further contain at least one plasticizer selected from the group consisting of polypropylene glycol, glycerin or polyethylene glycol, castor oil, PEG-60 hydrogenated castor oil, PEG-40 hydrogenated castor oil, and a mixture thereof.

[0027] Of the water-soluble or water-dispersible polymers in the entire drug layer, 40 wt % to 70 wt % of the polymer may be contained in the second drug layer.

[0028] The support layer may include a water-insoluble polymer, a thermoplastic, or a mixture thereof having a hydrophilic functional group such as a hydroxyl group or a carboxyl group.

[0029] The water-insoluble polymer may be selected from the group consisting of ethyl cellulose, cellulose acetate, polymethyl methacrylate copolymer, acetate-polyvinyl pyrrolidone copolymer, and a mixture thereof.

[0030] The thermoplastic may be selected from the group consisting of polyethylene, polyethylene terephthalate, polyvinyl chloride, polyvinylidene chloride, polystyrene, polypropylene and a mixture thereof.

[0031] The mesh may be formed of filaments of a polymer selected from the group consisting of acrylic acid ester, polyester, nylon, polypropylene, polyethylene, polybutylene terephthalate, ethylene vinyl acetate, and a mixture thereof.

[0032] The mesh body may include an embossed pattern formed of polyethylene filaments.

[0033] The above-mentioned active ingredient may include a teeth whitening ingredient.

[0034] One embodiment of the present invention provides a patch having a reticular structure. More specifically, one embodiment of the present invention provides a patch including a drug layer attached to teeth, a support layer stacked on the drug layer, and a reticular structure located inside the drug layer.

[0035] The support layer has a bonding force with the drug layer, and includes, for example, ethylcellulose.

[0036] The mesh may be polyethylene, which can prevent the support layer from breaking. In addition, the mesh can also reduce the amount of residue on the target site after the drug layer is applied with a polymer for adhesion to teeth or oral mucosa.

[0037] The inside of the drug layer of the above-mentioned patch includes at least one reticulate body, which can be divided into at least two drug layers with the above-mentioned reticulate body as a boundary. The above-mentioned drug layer includes the first drug layer between the attachment surface formed on one side of the drug layer and the reticulate body and the second drug layer between the first drug layer and the supporting layer. That is, the above-mentioned drug layer includes the first drug layer, the reticulate body and the second drug layer.

[0038] One embodiment of the present invention provides a patch that adheres to teeth or oral mucosa and releases active ingredients to the attached site. The first drug layer has adhesion to the oral mucosa or teeth, so it can be directly attached to the target site, or it can be attached to the oral mucosa or teeth as the first drug layer is hydrated by saliva. When the first drug layer is attached to the oral mucosa or teeth, the polymer of the first drug layer is hydrated and swelled, so that the saliva present in the oral mucosa or teeth is transferred to the second drug layer through the mesh. The saliva transferred to the second drug layer hydrates and swells the second drug layer, and the active ingredients present in the second drug layer are transferred to the oral mucosa or teeth through the mesh and the first drug layer. The mesh present between the first drug layer and the second drug layer has through holes to achieve the movement of saliva and active ingredients. The above-mentioned active ingredients can be contained in the first drug layer and the second drug layer respectively, or only exist in the second drug layer. Of course, the above-mentioned active ingredients can only exist in the first drug layer as needed.

[0039] In a patch of one embodiment of the present invention, the first drug layer does not contain any active ingredient related to teeth whitening, but contains a hydrogen peroxide activator, and the second drug layer contains a teeth whitening active ingredient but does not contain a hydrogen peroxide activating ingredient. When used, the hydrogen peroxide activator in the first drug layer can activate the whitening active ingredient in the second drug layer.

[0040] When the patch is used up, the supporting layer and the mesh are removed from the target site together, and the second drug layer between the supporting layer and the mesh can be removed together. For ease of removal, the supporting layer and the mesh can be attached to each other at the two ends of the patch. Thus, the supporting layer and the mesh are not separated and are separated from the oral cavity or teeth at one time. In addition, the amount of the second drug layer on the two ends of the patch can be less than the amount of the second drug layer in the center. When the patch is removed after use, the first drug layer is dissolved in whole or in part by saliva, thereby reducing the amount remaining in the oral cavity, and thus the removal amount of the drug layer remaining in the teeth or oral cavity after the patch is used can be minimized.

[0041] Based on the longitudinal section of the patch, the thickness of the first drug layer between the mesh and the attachment surface of the patch is 5% to 50%, preferably 10% to 40%, of the thickness of the entire drug layer including the mesh.

[0042] The mesh body has an embossed pattern.

[0043] The mesh body has an embossed pattern at a filament connection portion where at least two filaments forming the mesh body meet or cross each other, and through holes are formed between the crossed filaments to allow the effective ingredient to pass through. The mesh body may have a plurality of through holes.

[0044] The through holes of the mesh body have an area of ​​10% to 60% of the total width of one surface of the mesh body parallel to the surface to which the drug layer is attached.

[0045] The filament connection portion may be formed by two filaments meeting or crossing each other, or may be formed by three filaments meeting or crossing each other.

[0046] The filaments forming the mesh may be spaced apart by 30% to 500% of the filament thickness, preferably by 50% to 400%, more preferably by 60% to 300%, and even more preferably by 70% to 250%.

[0047] Each of the mesh through holes formed in the mesh may have a diameter of at least 0.01 mm. 2 Up to 0.5mm 2 area.

[0048] Each unit area of ​​the mesh surface is 1cm 2 The mesh body includes 100 to 800 through holes formed in the mesh body.

[0049] Furthermore, the mesh body may be an injection-molded product of a thermoplastic resin.

[0050] The above-mentioned mesh body can be a mesh.

[0051] The mesh body has a concave-convex shape with a concave surface and a convex surface based on the tooth or oral attachment surface, which can be located inside the drug layer. That is, the concave surface is a position with a long length drawn vertically to the mesh body relative to the attachment surface, and the convex surface is a surface with a short length drawn vertically to the mesh body relative to the attachment surface. At the position of the convex surface, when the amount of the polymer present in the first drug layer does not exist or is small, the adhesion to the teeth or oral mucosa can be further weakened. That is, based on the surface of the attachment surface, a strong surface and a weak surface of the patch's adhesion to the teeth or oral mucosa are formed, so that the patch can be easily removed after use.

[0052] The drug layer is impregnated with water to adhere to the target site, and the active ingredient is released from the drug layer. The drug layer contains a water-soluble or water-dispersible polymer.

[0053] The polymer includes any one or more selected from the group consisting of polyvinyl pyrrolidone, carbomer, pullulan, carrageenan, sodium alginate, acrylate polymers or copolymers, water-soluble cellulose polymers, xanthan gum and polyvinyl alcohol. Preferably, the polymer may be a glassy polymer. In this specification, a glassy polymer refers to a polymer whose adhesive force increases by 50% or more when hydrated compared to a dry state.

[0054] The drug layer may contain, in addition to the polymer, at least one plasticizer selected from the group consisting of polypropylene glycol, glycerin, polyethylene glycol, castor oil, PEG-60 hydrogenated castor oil, and PEG-40 hydrogenated castor oil.

[0055] The patch further comprises a support layer, and the support layer may be located on the opposite side of the attachment surface of the drug layer.

[0056] The support layer comprises or consists of a water-insoluble polymer, a thermoplastic, or a mixture thereof having a hydrophilic functional group such as a hydroxyl group or a carboxyl group.

[0057] The water-insoluble polymer having a hydrophilic functional group of a hydroxyl group or a carboxyl group may include at least one selected from the group consisting of ethyl cellulose, cellulose acetate, polymethyl methacrylate copolymer, and acetate-polyvinylpyrrolidone copolymer.

[0058] The thermoplastic plastic includes one or more selected from the group consisting of polyethylene, polyethylene terephthalate, polyvinyl chloride, polyvinylidene chloride, polystyrene, and polypropylene.

[0059] The mesh may include at least one polymer filament selected from the group consisting of polyester, nylon, polypropylene, polyethylene, polybutylene terephthalate, and ethylene vinyl acetate. The mesh may include polyethylene filaments, and the mesh may include an embossed pattern.

[0060] In the present specification, "filament" means a thin thread in a fiber or fiber-like form. Examples of such filaments include natural fibers and thermoplastic fibers. It is preferred that the filaments can be fused to each other by heat.

[0061] The above-mentioned active ingredient may include a tooth whitening ingredient, and the above-mentioned patch may be a tooth whitening patch.

[0062] One embodiment of the present invention provides a kit for teeth whitening.

[0063] The tooth whitening kit may include a patch that releases a tooth whitening component and instructions for use of the patch. The patch has a mesh body inside and may include a drug layer having an attachment surface that is attached to the teeth, the drug layer includes a mesh body inside, and a portion of the drug layer may be present between the mesh body and the attachment surface.

[0064] The patch may further include a support layer, and may have a configuration in which the support layer is laminated on the opposite side of the surface formed on which the drug layer is attached.

[0065] The mesh body has an embossed pattern and through holes.

[0066] The mesh body has an embossed pattern at the filament connection portion where at least two or more filaments forming the mesh body meet or cross each other, and through holes are formed between the crossed filaments to allow the effective ingredients to pass through.

[0067] The tooth whitening component may include at least one peroxide selected from the group consisting of hydrogen peroxide, carbamide peroxide, calcium peroxide, sodium percarbonate, sodium perborate, tetrasodium pyrophosphate peroxidate, and mixtures thereof.

[0068] The instructions for use may include instructions for removing the patch after leaving it on for 30 minutes to a day, preferably for 3 minutes to 12 hours, more preferably for 5 minutes to 3 hours, and even more preferably for 10 minutes to 90 minutes.

[0069] In one implementation example, a teeth whitening kit comprising a patch described in any one of the above-mentioned technical solutions, a kit for alleviating, preventing or preventing hypersensitive teeth comprising a patch including ingredients for alleviating, preventing or preventing hypersensitive teeth, and a kit for alleviating, preventing or preventing bad breath comprising a patch including ingredients for removing, alleviating or preventing bad breath is provided.

[0070] Another embodiment of the present invention provides a method for whitening teeth.

[0071] Regarding the above-mentioned teeth whitening method, a teeth whitening method using the patch or the above-mentioned kit according to the content of the present disclosure is provided. In an implementation example, the above-mentioned teeth whitening method provides a teeth whitening method having a teeth whitening kit including the patch described in any of the above-mentioned technical solutions.

[0072] One embodiment of the present invention provides a teeth whitening method, which includes the following steps: preparing a patch according to the content of the present disclosure; attaching the above patch to tissue including teeth; and after a certain period of time, removing the above patch from the tissue including teeth.

[0073] The patch can be removed 10 to 90 minutes after attachment.

[0074] According to the above method, the teeth whitening component contained in the drug layer is moved to the tooth surface through the through holes formed in the mesh body, thereby whitening the teeth.

[0075] An implementation example of the present invention provides a method for manufacturing a patch including a mesh body.

[0076] The above method comprises the following steps:

[0077] (S1) preparing a drug layer manufacturing solution containing a water-soluble or water-dispersible polymer and an active ingredient;

[0078] (S2) drying a certain amount of the drug layer manufacturing solution into a film form to form a first drug layer;

[0079] (S3) coating the first drug layer with a mesh body, and coating a certain amount of drug layer manufacturing liquid and drying to form a second drug layer; and

[0080] (S4) A support layer is provided on the second drug layer.

[0081] If necessary, the above steps may be followed by a step of further drying the patch.

[0082] The above drying may be performed at a temperature of 40 to 60°C.

[0083] The above-mentioned support layer may be formed by coating a support layer manufacturing liquid mixed with a water-insoluble polymer or may include a water-insoluble film.

[0084] Based on the longitudinal section of the patch, the thickness of the first drug layer accounts for 5% to 50% of the thickness of the entire drug layer.

[0085] Below, a more specific description is given.

[0086] Patch 1

[0087] The term "patch" mentioned in this specification refers to a general meaning of all structures that can release active ingredients by attaching the attachment surface to the target site. Other terms such as "drug delivery system", "strip", "membrane", "belt" and the like may also be used instead, and the content of this disclosure does not exclude the above-mentioned terms.

[0088] The patch can be attached to the target site of the teeth or oral mucosa. The "target site" can be understood as the site where the active ingredient is expected to act. In the case of teeth, it can be understood as the target site where the active ingredient acting on the teeth is expected to act. In the case of gums, it can be understood as the target site where the active ingredient acting on the gums is expected to act. The term "oral mucosa" mentioned in this specification can be understood as the mucosa covering the inner surface of the oral cavity, which can include mucosal tissues located at "gums", "lips", "tongue" and the like. Figure 1 1 is a three-dimensional diagram showing an example of a patch of an implementation example of the present disclosure. A patch 1 of an implementation example may include a drug layer 20 and a support layer 30 located on or laminated on one side of the drug layer. The support layer 30 may be located on or laminated on the opposite side of the attachment surface 21. The drug layer 20 may include a mesh body 10 inside, and a portion of the drug layer exists between the mesh body 10 and the attachment surface 21. This is referred to as the first drug layer 20a. Referring to the above Figure 1 The saliva or water absorbed by the attachment surface 21 can be transferred through the through holes 112 of the mesh body 10 to the area of ​​the drug layer between the support layer and the mesh body. In the process of the water or saliva being transferred through the drug layer, the active ingredient can be released from the swollen polymer. Figure 1 The mesh structure is enlarged in the picture, the mesh 10 is formed by winding filaments 113 that can provide the mesh shape, and a part of the filament area may include embossing 111. The mesh structure is not limited to the above examples, and the mesh can be made by weaving thermoplastic spun fibers or entanglement in the form of non-woven fabrics, or can be provided in the form of an injection molded object with through holes.

[0089] Drug layer 20

[0090] The patch according to the content of the present disclosure has a drug layer including a mesh body 10. The above-mentioned drug layer 20 includes at least one mesh body inside, and is divided into at least two drug layers with the above-mentioned mesh body as a boundary. According to an implementation example, the drug layer 20 includes a first drug layer 20a and a second drug layer 20b or is composed of these drug layers. The above-mentioned first drug layer 20a has an attachment surface 21 that makes the drug layer of the patch contact with the target site, and the attachment surface 21 and the mesh body 10 are shown. The second drug layer 20b is shown between the first drug layer 20a and the supporting layer 30. The mesh body 10 is located in the above-mentioned second drug layer 20b. The above-mentioned first drug layer 20a and the second drug layer 20b can contain the same ingredients, or different ingredients, but preferably contain the same ingredients. The above-mentioned first drug layer has adhesion to the oral cavity or teeth and can be directly attached to the target site, or the first drug layer can be hydrated by saliva and attached to the oral cavity. When the first drug layer is attached to the oral cavity or teeth, the polymer of the first drug layer is hydrated and swelled, so that the saliva present in the teeth is transferred to the second drug layer. The saliva transferred to the second drug layer hydrates and swells the second drug layer, and the active ingredient present in the second drug layer is transferred to the target site through the first drug layer.

[0091] In order to achieve sufficient adhesiveness only by the first drug layer, the first drug layer has a thickness of 1 cm per unit area of ​​the adhesion surface. 2 The above contains about 5 mg to 50 mg, about 7 mg to 40 mg of the substrate polymer.

[0092] The thickness of the first drug layer in the drug layer can reduce the residue remaining on the tooth surface, and the convenience of use for the user can be improved when removing the drug layer after use.

[0093] Based on the longitudinal section of the patch, the thickness of the first drug layer between the mesh and the attachment surface of the patch is equivalent to 5% to 50% of the thickness of the entire drug layer including the mesh, preferably 40% to 10%. For example, it can be 49%, 48%, 47%, 46%, 45%, 44%, 43%, 42%, 41%, 40%, 39%, 38%, 37%, 36%, 35%, 34%, 33%, 32%, 31%, 30%, 29%, 28%, 27%, 26%, 25%, 24%, 23%, 22%, 21%, 20%, 19%, 18%, 17%, 16%, 15%, 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6% and below.

[0094] The thickness h1 of the first drug layer can be measured by the distance from the attachment surface 21 to the surface where the first drug layer and the second drug layer are in contact with each other in the through hole. The above distance can be defined by the following length: the average length of a line drawn perpendicularly to the attachment surface from any point of the line formed by connecting two points (P' and P") that are connected to the end points of the filaments at the through hole portion of the mesh body. As another method, when a vertical line is drawn from the attachment surface 21 in the direction of the supporting layer 30, the intersection point of the vertical line and the mesh body is called P, and the above h1 represents the value obtained by dividing the volume of the drug layer between the surface formed by connecting the above P and the tooth attachment surface by the entire width of the tooth attachment surface.

[0095] In an implementation example, when the mesh body is an embossed pattern, the thickness of the first drug layer can be defined by the same method.

[0096] In one implementation example, in the longitudinal section of the patch 1 ( Figure 1 When the surface cut by the A-A' line of the first drug layer 20a is taken as the reference, the thickness of the first drug layer 20a ( Figure 2 h1) is the thickness of the entire drug layer ( Figure 2 The amount of H) is 50% or less, preferably 40% or less. When the above range is met, the amount of adhesive polymer remaining after removal can be reduced while achieving the target release amount of the active ingredient.

[0097] The drug layer of the present disclosure comprises an active ingredient and a substrate polymer, and the active ingredient is stored inside and / or outside the matrix formed by the substrate polymer. The drug layer can be provided in a dry matrix type, which provides adhesion and begins to release the active ingredient when in contact with the target site containing water. The dry matrix type has almost no or very low adhesion before being exposed to water, and exhibits adhesion when the drug layer begins to be hydrated when exposed to water. The above-mentioned "active ingredient" is a component provided as a patch for the content of the present disclosure to achieve the desired effect, for example, the tooth whitening component in the tooth whitening patch is an active ingredient, and the hypersensitive tooth relief component in the hypersensitive tooth relief patch is an active ingredient. Regarding the above-mentioned active ingredient, for example, it can include a tooth whitening component, a component for preventing or improving hypersensitive teeth, a component for preventing or improving periodontitis, and a component for preventing or improving gingivitis. As the above-mentioned tooth whitening component, peroxide, polyphosphate, enzyme, chlorine bleach can be cited. The peroxide can be selected from the group consisting of hydrogen peroxide, carbamide peroxide, calcium peroxide, sodium percarbonate, sodium perborate, tetrasodium pyrophosphate peroxidate and mixtures thereof. Phosphates and enzymes effectively remove major stains contained in the enamel deposit layer. As polyphosphates, for example, one or more of tetrasodium pyrophosphate (TSPP), sodium acid pyrophosphate (SAPP), sodium hexametaphosphate (SHMP), sodium tripolyphosphate (STP), sodium potassium tripolyphosphate (SKTP), tetrapotassium pyrophosphate (TKPP), acidic sodium meta-polyphosphate and acidic sodium polyphosphate as superphosphates can be used. In general, polyphosphates are used as tartar control agents in toothpaste and can effectively inhibit tartar formation or remove tartar.In addition, these good chelating agents for metals can effectively remove food in the stain of teeth or the stain of teeth generated by metals such as iron, calcium, and magnesium in the working environment, thereby improving the whitening effect to some extent. As chlorine bleaching agents, sodium chlorite, sodium hypochlorite, etc. can be used. In addition, papain, vitamin E, and sodium bicarbonate, etc. can also be used as whitening agents. In another embodiment, strontium chloride, calcium carbonate, sodium citrate, sodium fluoride, silicon dioxide, hydroxyapatite, potassium nitrate, potassium phosphate, etc. can be used as components for preventing or improving hypersensitive teeth or preventing tooth decay. In another embodiment, the active ingredient can include periodontal disease prevention ingredients, and periodontal disease clinically refers to the loss of teeth caused by periodontitis, gingival inflammation and bleeding, the formation of periodontal pockets, and the destruction of alveolar bone. In order to prevent the occurrence of periodontal diseases, the drug layer contains bamboo salt, corn unsaponifiable quantitative extract, polyphenol sulfonate, tetracycline, chlorhexidine gluconate, cetylpyridium chloride, sanguinarine and triclosan, and can also contain herbal extracts such as magnolia bark, centella asiatica, chamomile, latani root, myrrh, mulberry bark, cimicifuga, green tea, licorice, scutellaria baicalensis, dandelion, honeysuckle and the like.

[0098] In addition to the above-mentioned active ingredients, the above-mentioned drug layer may contain ingredients generally applicable to a patch to be attached to teeth or oral mucosa, such as a wetting agent, a thickening agent, a foaming agent, and an abrasive.

[0099] The above-mentioned drug layer can be impregnated from the attachment surface by moisture such as saliva. The "impregnable" used in this specification means that the morphology is destroyed compared to before exposure to moisture. It can be impregnated by hydration due to water or saliva where the polymer matrix chains are untied. In order to exert the efficacy of the active ingredient or to increase the efficacy by improving the stability of the active ingredient, a sufficient amount of the base polymer constituting the drug layer is used. However, in the case of a patch that needs to be removed after use, when the polymer constituting the drug layer is excessively hydrated, the base polymer will remain on the tooth when the patch is removed after use on the tooth surface, and it is necessary to remove it separately, so inconvenience occurs. Through an implementation example of the present invention, the following drug layer can be provided: a part of the area of ​​the above-mentioned drug layer is separated by a mesh body, thereby preventing excessive hydration or impregnation of the drug layer, and smoothly moving or flowing the loaded active ingredient.

[0100] The patch of the present invention may include a matrix type patch. The above-mentioned patch is included in a dry type patch that does not have adhesive force or is weak in strength in a dry state, and is hydrated by a small amount of water at the target site, thereby generating adhesive force or starting to release a whitening agent when hydration begins. The active ingredient contained in the above-mentioned drug layer does not release the active ingredient during storage or circulation or when touched by hand, and generates adhesive force and releases the active ingredient when it begins to be hydrated by the moisture on the tooth surface. As the base polymer forming the above-mentioned drug layer, a polymer that is hydrated or impregnated by water or saliva can be used, preferably comprising a water-soluble or water-dispersible polymer. The above-mentioned water-soluble or water-dispersible polymer can be used without restriction in the polymer approved in the patch manufacturing industry, but when considering the characteristics of the target part (for example, wet environment, surface inhomogeneity, etc.), it can be included in the group consisting of polyvinyl pyrrolidone, carbomer, pullulan, carrageenan, sodium alginate, acrylate polymer or copolymer, water-soluble cellulose polymer, xanthan gum and polyvinyl alcohol to release the active ingredient when the target part produces stronger adhesive force during hydration in the moist oral cavity, and most preferably includes polyvinyl pyrrolidone (PVP). In particular, the adhesion between the above-mentioned polyvinyl pyrrolidone and the teeth is excellent, and it is preferably used in order to keep the stability of the whitening component such as hydrogen peroxide. Relative to the weight of all the patches after drying, the above-mentioned polymer of 20 weight % to 50 weight % is included, preferably the above-mentioned polymer of 30 weight % to 45 weight % is included, and more preferably the above-mentioned polymer of 35% to 40% is included. In the above-mentioned content range, it is conducive to achieving the purpose of the present invention. As these solvents, water, ethanol or their mixture can be used. In order to provide sufficient flexibility, the drug layer further comprises one or more plasticizers selected from the group consisting of polypropylene glycol, glycerol or polyethylene glycol, castor oil, PEG-60 hydrogenated castor oil, and PEG-40 hydrogenated castor oil. In addition, when the drug layer comprises a tooth whitening component, a tooth whitening component stabilizer may be further included in order to improve the temporal stability of the peroxide, for example, a chelating agent such as EDTA or sodium citrate may be added. The active ingredient may be included in both the first drug layer 20a and the second drug layer 20b, or may be present only in the second drug layer.

[0101] The attachment surface of the drug layer is selectively protected by release paper. The release paper can be removed before using the patch. For example, as the release paper, paper, non-woven fabric, water-insoluble film (especially PET) etc. can be used, but it is not limited thereto.

[0102] Mesh 10

[0103] In one embodiment, the patch 1 comprises a mesh body 10, which is preferably located inside the drug layer. The drug layer 20 is divided into at least two layers by the mesh body 10.

[0104] The "mesh body" according to the present disclosure means a form of cross-weaving like a net, and may be used instead of "net", "net", "mesh" or the like.

[0105] In one embodiment, the mesh 10 includes a drug layer 20 inside, and a first drug layer 20a exists between the mesh 10 and the attachment surface 21. In one implementation example, the first drug layer 20a shows adhesiveness, and the mesh can prevent the adhesiveness of the second drug layer 20b, so even if the patch is removed after use, almost no sticky drug layer residue will remain on the teeth. The adhesiveness of the patch 1 is achieved by the above-mentioned first drug layer 20a. In one implementation example, the characteristics of the first drug layer 20a provide important significance for achieving the purpose of the present invention.

[0106] An implementation example of the present invention provides a patch 1 including a mesh body 10, wherein the mesh body 10 may have embossed patterns 111a, 111b and through holes 112. The method for manufacturing the mesh body of the present disclosure is not particularly limited, and the mesh body may be obtained by weaving with one or more filaments, or may be obtained by molding into an injection molded object using a pre-processed frame. In the case of weaving a mesh body using two or more filaments, the two or more filaments cross each other and become thicker than the thickness of a single filament itself, and the embossing effect may be performed by itself, so additional embossing processing may not be performed.

[0107] The term "embossing" used in this specification is a common term in the art, and refers to the fact that the thickness of the mesh body is uneven and is formed into thicknesses different from each other based on the cross section (A-A') of the patch, and may include multiple embossings to form an embossed pattern. In one embodiment, the embossing is formed in a partial area of ​​the filaments, and preferably may be included in the filament connecting portion. May be included in the filament connecting portion means that, in the characteristics of the filament connecting portion of more than two filaments stacked, the filament connecting portion itself becomes thicker and has a protruding structure to form the embossing, or the upper end of the filament connecting portion is subjected to additional treatment to form a protruding structure, and the process for manufacturing the embossing is not particularly limited. Due to the protruding surface 111a of the embossing, the first drug layer 20a becomes thinner, or due to the concave surface 111b, the first drug layer 20a becomes thicker. The concave surface 111b is a position where the length drawn perpendicularly to the mesh body 10 is long relative to the attachment surface 21, and the convex surface 111a is a surface where the length drawn perpendicularly to the mesh body 10 is short relative to the attachment surface 21. At the position of the convex surface, the amount of the polymer present in the first drug layer disappears or decreases, so the adhesion to the teeth or the oral cavity can be additionally weakened. That is, based on the surface of the attachment surface, the surface with strong adhesion to the teeth or the oral cavity and the surface with weak adhesion are formed, so that the patch can be easily removed after use.

[0108] The adhesive force between the patch and the teeth is adjusted by the embossed pattern, and when the patch is removed, the adhesive force is varied according to the position of the drug layer, and the patch can be easily removed. Easy removal means that the patch can be cleanly removed without leaving excessive residue of the drug layer on the teeth.

[0109] The mesh body 10 includes through holes 112 that allow the effective ingredients, saliva, etc. to move but restrict the movement of the polymer. The first drug layer can be connected to the second drug layer through the through holes. The through holes are each 0.01 mm thick. 2 Up to 0.5mm 2 Size, 0.015mm 2 Up to 0.4mm 2 Size, 0.018mm 2 Up to 0.38mm 2 Size, 0.02mm 2 Up to 0.35mm 2 When the size range is as described above, the effective ingredients and water in the drug layer can be smoothly transferred, and the polymer of the second drug layer can be prevented from passing through.

[0110] The total area of ​​the through holes 112 is 10% to 60%, 12% to 55%, or 13% to 50% of the total area of ​​one side of the mesh 10 when the mesh 10 and the attachment surface 21 are arranged horizontally. When the area of ​​the through holes 112 is less than 10% of the total area, it is too fine and the first drug layer 20a and the second drug layer 20b are difficult to contact. When it is more than 60%, it is difficult to achieve sufficient tensile strength during use. The number of through holes 112 is 1 cm per unit area on the surface of the mesh. 2 There are 100 to 800, 110 to 700, 120 to 600, 130 to 500, 140 to 400, 145 to 350 in the drug layer. When the above range is provided, the movement of the active ingredient and water in the drug layer can be smoothly performed, and the movement of the polymer of the second drug layer can be prevented. By having the through holes in the above range, the movement of hydrogen peroxide can be smoothly performed, and the active ingredient distributed in the second drug layer 20b is also released to the target site while preventing the excessive hydration of the first drug layer 20a and the movement of the polymer. Because the first drug layer 20a (preferably a polymer) shows adhesiveness, a large amount of polymer will not be used in the attachment of the patch, and when the patch is removed after use, almost no foreign matter will remain on the teeth. In order to adjust the adhesive force and the smooth movement of hydrogen peroxide, the position of the above-mentioned mesh body or the size of the through holes of the above-mentioned mesh body or the area occupied by the through holes are considered.

[0111] The shape of the through hole is not limited thereto. Saliva, active ingredients, etc. can smoothly move through the through hole, and the shape is not particularly limited as long as the flow of the polymer can be prevented.

[0112] Various implementation examples of the mesh body are exemplified as follows.

[0113] In an exemplary implementation, Figure 3 As shown in the figure, a mesh body 11 having a plurality of intersections and a plurality of through holes 112 is provided by using each warp 1131 and weft 1132. The same type of filaments or different types of filaments may be used for the warp 1131 and weft 1132. In another embodiment, a mesh body 12 is provided in which filaments are not arranged at a constant interval. Figure 4 As shown in the figure, a mesh body 12 having non-standard through holes 112 can be provided. For example, one or more embossings 111 are included in an unspecified area of ​​the filaments. Figure 5 As shown in the figure, the mesh body 13 is made in a form in which the filaments 113 are connected or meet. For example, the mesh body can also be provided by making a frame formed into a desired shape. Figures 3 to 5In the figure, the part connected by the filaments 113 of the mesh body illustrated as an implementation example is also called the filament connection part. As the part where the filaments are connected, meet or cross each other, in order to achieve the purpose of the present disclosure, the embossing with the protruding surface 111a is included in the part connecting the above filaments. The above filament connection part is formed by at least two or more filaments connected, met or crossed with each other, or by two or three or more filaments meeting or crossing each other. For example, Figure 6 The diagram illustrates the weaving of two or more filaments constituting a mesh body, and illustrates in an exemplary manner how a filament connection portion formed by overlapping two or more filaments 113 forms an embossed pattern 111 .

[0114] The material of the mesh body includes any one or more polymer filaments selected from the group consisting of acrylic acid ester, polyester fiber, nylon, polypropylene, polyethylene, polybutylene terephthalate and ethylene vinyl acetate. Any water-insoluble material can be used, and preferably includes polyethylene filaments. The mesh body made of polyethylene (PE) provides an appropriate tensile strength that can prevent the support layer (especially the ethyl cellulose support layer) from breaking, and does not melt in the saliva in the oral cavity, so it is conducive to maintaining the shape.

[0115] The term "filament" used to describe the above-mentioned mesh body means that a plurality of thin linear synthetic plastics are connected to form a line-like structure or a honeycomb, quadrilateral, triangle or other shape, and can also mean one side constituting the shape.

[0116] The mesh body has a concave-convex surface 111a and a concave surface 111b. Thus, the thickness of the first drug layer 20a is uneven, forming relatively thin and thick layers. In the first drug layer 20a, the thin layer contains less adhesive polymer than the thick layer, thus providing weaker adhesive force, so that less tooth residue remains after the patch is used.

[0117] In one embodiment, the mesh body has a thickness of 50 to 300 μm, preferably 60 to 250 μm, and preferably 80 to 200 μm. When the thickness is within the above range, the mesh body can be stably located in the drug layer and can be cleanly removed together with the support layer when the patch is removed.

[0118] Support layer 30

[0119] The patch 1 according to the present disclosure may further include a support layer 30 on the back side of the attachment surface 21 of the drug layer 20. The "support layer" used in this specification refers to a layer that prevents the drug layer from contacting other parts of the oral cavity other than the teeth or the target part. Preferably, the support layer has water-impermeable or water-insoluble properties.

[0120] In another embodiment of the present invention, it is found that in the case of a patch with a drug layer impregnated by water or saliva, the problem of separation of the drug layer from the supporting layer occurs, and thus a patch that can improve this problem is desired to be provided. The inventor of the present invention has confirmed that there is no interactive binding force between the supporting layer and the drug layer, and thus the problem of separation of the drug layer from the supporting layer may occur. The supporting layer of the present invention may include one or more of a water-insoluble polymer, a thermoplastic or a mixture thereof selected from a hydrophilic functional group having a hydroxyl or carboxyl group. The water-insoluble polymer having the hydrophilic functional group of the above-mentioned hydroxyl or carboxyl group includes one or more of the group consisting of a copolymer of ethyl cellulose, cellulose acetate, polymethyl methacrylate copolymer and acetate / ester-polyvinyl pyrrolidone, preferably including ethyl cellulose. Using the above-mentioned ethyl cellulose as a supporting layer of a substrate polymer reduces or prevents separation from the drug layer, and can improve the binding force between the drug layer. The thermoplastic comprises at least one selected from the group consisting of polyethylene, polyethylene terephthalate, polyvinyl chloride, polyvinylidene chloride, polystyrene and polypropylene, and preferably the thermoplastic comprises polyethylene. In particular, when the thermoplastic, particularly preferably polyethylene, comprises a mesh having an embossed pattern, it has an excellent effect of preventing separation of the drug layer from the support layer.

[0121] In one implementation example, considering the prevention of detachment of the support layer and the drug layer and / or the tensile strength of the support layer, based on the dry patch, the support layer of the patch of the present invention contains 60 wt % to 90 wt % of the above-mentioned polymer relative to the total weight of the support layer, and preferably contains 65 wt % to 80 wt % of the above-mentioned polymer.

[0122] Preferably, ethyl cellulose may be included as a water-insoluble polymer. Since the above-mentioned ethyl cellulose has weak tensile strength, when the drug layer is hydrated and has adhesive force, the problem of breaking or tearing may occur when it is removed after use. However, when used in the drug layer with a mesh body of the present invention, the tensile strength of the supporting layer can be supplemented, and the problem of the patch being torn or broken can be prevented. Considering the adhesive force between the tooth and the first drug layer, the patch, supporting layer, and mesh body of the present invention preferably have a tensile strength of about 300gf to 2000gf, about 400gf to 1500gf. When having the above range, the phenomenon of being broken or separating between the mesh body and the supporting layer when removing the tooth patch can be prevented.

[0123] Preferably, in addition to the above-mentioned water-insoluble polymer, the above-mentioned supporting layer may also include a surfactant, a plasticizer, a wetting agent, etc., as long as it is a component used in the industry of manufacturing tooth attachment veneer when manufacturing the supporting layer, it can be used. Specifically, the surfactant can be selected from any one or more of the group consisting of SPAN20, SPAN40, SPAN60 and SPAN80, preferably including SPAN80 for the purpose of the present invention. Regarding the content of the above-mentioned surfactant, 5% to 20% by weight is included relative to the total dry weight of the supporting layer. For the purpose of the present invention, castor oil is included as a plasticizer. Regarding the content of the above-mentioned plasticizer, 5% to 20% by weight is included relative to the total dry weight of the supporting layer. The above-mentioned supporting layer can also include a plasticizer in the same manner as the drug layer. As a solvent, water, ethanol or a mixture thereof is mainly used, and other organic solvents, such as ethyl acetate, dichloromethane, isopropanol, acetonitrile or a mixture thereof, can be adjusted and used.

[0124] The tooth-attaching patch of the present invention may be provided with an additional layer (layer) selectively provided on the outer periphery of the supporting layer between the drug layer and the supporting layer in addition to the drug layer and the supporting layer according to the purpose.

[0125] Teeth whitening kit

[0126] One embodiment of the present invention provides a kit including the patch of the present invention, for example, a teeth whitening kit having a patch containing the teeth whitening ingredients of the present invention, a kit for alleviating, preventing or preventing hypersensitive teeth having a patch containing the ingredients for alleviating, preventing or preventing hypersensitive teeth, and a kit for alleviating, preventing or preventing bad breath having a patch containing the ingredients for removing, alleviating or preventing bad breath can be provided.

[0127] The above-mentioned kit may include instructions for use, guides, instructions, etc. that can provide instructions for the applicability, use, coating, attachment, etc. of the patch disclosed herein. Additionally, the kit includes attachment tools (e.g., clips, tweezers) that can attach the above-mentioned patch, tools (e.g., tissue paper, gauze, etc.) that can remove moisture from the surface of teeth or mucosa before use, etc. The above-mentioned instructions for use, guides, instructions, etc. include the method for use of this patch. As a method in the method for use of the above-mentioned patch, information about the time to be removed after the patch is attached is included. For example, after the patch is attached to the target site, the supporting layer is grasped and the patch is removed after 3 minutes to 12 hours, more preferably 5 minutes to 3 hours, and more preferably 10 minutes to 90 minutes. In addition, the kit preferably includes a tooth whitening kit, including information (e.g., charts, etc.) that is conducive to evaluating the whitening effect achieved by the method disclosed herein and the patch.

[0128] The tooth whitening kit of one embodiment of the present invention, in addition to the whitening patch, also includes a whitening activation composition for activating the hydrogen peroxide contained in the whitening patch. The tooth whitening patch includes a substrate polymer for stabilizing hydrogen peroxide, so time is required for activating hydrogen peroxide when used. In this regard, the above-mentioned whitening activation composition includes metal ions for activating the hydrogen peroxide component, such as ferric chloride components, etc. The above-mentioned hydrogen peroxide activation component is well known in the art. In addition, hydrogen peroxide is activated in alkalinity, so the pH of the whitening activation composition is alkaline. The above-mentioned whitening activation composition can stimulate irritation of the gums or the oral cavity due to excessive hydrogen peroxide activation, so the tooth whitening kit includes an irritation relief agent in one of the patches or the whitening activation composition, or can additionally include an irritation relief agent as another composition. As the above-mentioned irritation relief agent component, components well known in the art can be included.

[0129] How to use the patch

[0130] By the process of removing the patch of the present invention after it is attached to the teeth according to an embodiment of the present disclosure, the active ingredient is released to the target site to obtain the desired effect. The desired effect can be understood as the effect that the active ingredient wants to achieve. For example, a tooth whitening method using the above-mentioned patch or a kit including the above-mentioned patch is provided. In one embodiment, the step of preparing the patch of the present disclosure, the step of attaching the above-mentioned patch to the tissue including the teeth, and the step of removing the above-mentioned patch from the target site after a certain period of time. For example, after the patch is attached to the target site, the supporting layer is grasped and the above-mentioned patch is removed after 3 minutes to 12 hours, more preferably 5 minutes to 3 hours, and further preferably 10 minutes to 90 minutes. In the tooth whitening method disclosed in the present disclosure, the tooth whitening components evenly distributed throughout the drug layer move to the tooth surface through the through holes, thereby whitening the teeth. Specifically, when the first drug layer 20a divided into regions by the mesh is hydrated by saliva, the saliva or water is swollen and transferred to the second drug layer 20b through the through holes 112 of the mesh, and the active ingredient (preferably hydrogen peroxide) flows into the tooth surface through the swollen polymers, so that the active ingredient is transferred between the teeth. However, the present teeth whitening method is not limited to such a theory, and any teeth whitening method using the patch disclosed herein is included in the scope of the present invention. The teeth whitening method disclosed herein has an excellent teeth whitening effect, and when the patch is peeled off after use, no foreign matter will remain on the teeth, and it can be removed cleanly.

[0131] Manufacturing method of patch

[0132] An implementation example provides a method for manufacturing a patch including a mesh body inside a drug layer, wherein the mesh body divides the inside of the drug layer into a first drug layer and a second drug layer.

[0133] An implementation example may include the following steps:

[0134] (S1) preparing a drug layer manufacturing solution containing a water-soluble or water-dispersible polymer and an active ingredient,

[0135] (S2) drying a certain amount of the drug layer manufacturing solution into a film form to form a first drug layer,

[0136] (S3) forming a second drug layer by laminating or coating a mesh body on the first drug layer and coating a certain amount of drug layer manufacturing liquid and drying the same; and

[0137] (S4) A support layer is provided on the second drug layer.

[0138] If necessary, the above steps may include a step of further drying the patch.

[0139] The drug layer preparation liquid may be composed of a viscous gel. After the drug layer preparation liquid is applied to the film substrate, it is dried. The surface in contact with the film substrate may become the attachment surface of the drug layer.

[0140] The drying is performed at a temperature of 40°C to 60°C, 45°C to 55°C.

[0141] In the dried patch, the degree of drying is defined by the content of the solvent (preferably water) of the dried patch, and the water content in the patch can be measured by the well-known Karl-Fischer method. The water content in the drug layer of the patch is set to 5% to 50%, preferably 15% to 45%, and more preferably 25% to 42% at room temperature and dried.

[0142] The mesh body can divide the first drug layer and the second drug layer inside the drug layer, and the thickness of the first drug layer is about 5% to 50% of the thickness of the entire drug layer based on the longitudinal section of the dry patch.

[0143] The supporting layer is provided by coating a supporting layer manufacturing liquid with a water-insoluble polymer and then drying it. As another example, the supporting layer can be formed by attaching a separately formed water-insoluble film.

[0144] In another embodiment, the cross-sectional area of ​​the mesh and the support layer of the patch is larger than the cross-sectional area of ​​the drug layer. The support layer and the mesh are connected at the left and right ends of the patch, and the drug layer may not exist at the left and right ends of the patch. The mesh and the support layer are connected to each other, and when the patch is removed after use, it is prevented that only the support layer falls off and the mesh remains on the teeth.

[0145] Effects of the Invention

[0146] The present invention provides a patch that is attached to teeth or oral mucosa and has excellent usability and commercial value. The patch of the present invention has adhesion to teeth or oral mucosa, and the hydration degree of the drug layer near the attachment surface of the patch and near the supporting layer is different, and almost no residue remains when removed, and it can be removed cleanly. The patch of the present invention does not fall off in the product and has appropriate tensile strength, so it has the characteristic of not being broken when peeled off. BRIEF DESCRIPTION OF THE DRAWINGS

[0147] The following drawings attached to this specification illustrate preferred embodiments of the present invention and are helpful for understanding the above-mentioned content of the invention and the technical concept of the present invention. Therefore, the present invention is not limited to the matters shown in such drawings.

[0148] Figure 1 is a perspective view showing an example of a patch of an implementation example of the present disclosure. Figure 1 In FIG. 1 , a portion of the mesh body 10 existing inside the drug layer 20 is enlarged and illustrated as an example.

[0149] Figure 2 : is a diagram illustratively showing a cross section of a patch of an implementation example of the present disclosure. The thickness occupied by the first drug layer is shown as h1, and the thickness of the entire drug layer is shown as H. P' and P" respectively represent the end points of the filaments connected to the through holes.

[0150] Figures 3 to 5 FIG. 1 is a top view showing a mesh body by way of example.

[0151] Figure 6 The diagram shows, by way of example, how two or more filaments constituting the mesh body are knitted.

[0152] Figure 7 These are comparative photographs to confirm the phenomenon that the supporting layer is separated from the patch over time at high temperature. A on the left is the result of placing the patch with the composition of Table 1 in an oven at 60°C for 24 hours, and B on the right is the result of placing the patch with the composition of Table 2 in an oven at 60°C for 24 hours.

[0153] Figure 8 Shows the tensile strength measurement method.

[0154] Fig. 9 It is the tensile strength evaluation result.

[0155] Fig.10 Shown is the patch removal experimental method.

[0156] Fig.11 It is the result of confirmation of the drug layer residue.

[0157] Fig.12 This is a SEM photograph showing a cross section of a patch according to an example of the present invention.

[0158] Fig.13 These are photographs showing the entire appearance of a patch (or mesh body) produced according to the present disclosure and photographs showing a portion of the mesh body in an enlarged manner.

[0159] Fig.14 It is the confirmation result of the residual amount of the drug layer.

[0160] Fig.15 It is the confirmation result of the amount of hydrogen peroxide released.

[0161] Fig.16 The results of SEM photographs of cross sections of the patches of Examples 6 to 8 and Comparative Example 1 are shown.

[0162] Description of Reference Numerals

[0163] 1: Patch

[0164] 10: Mesh

[0165] 11-13: Examples of manufacturing various mesh bodies

[0166] 111: Embossing

[0167] 111a: Embossed raised surface

[0168] 111b: Embossed concave surface

[0169] 112: Through hole of mesh body

[0170] 113: Filament

[0171] 1131: Warp

[0172] 1132: Weft

[0173] 20: Drug layer

[0174] 20a: 1st drug layer

[0175] 20b: Second drug layer

[0176] 21: Attachment surface

[0177] 30: Support layer

[0178] H: the total thickness of the drug layer in the patch

[0179] h1: Thickness of the first drug layer DETAILED DESCRIPTION

[0180] Below, in order to help understand the present invention, the present invention is described in detail by citing embodiments and the like. However, the embodiments of the present invention can be deformed in various forms, and the scope of the present invention is not limited to the following embodiments. The embodiments of the present invention are provided to fully explain the present invention to those skilled in the art.

[0181] The term "about" as used in this specification should be understood to mean a range enlarged to ±10 of the numerical value described. For example, about 10% may include 9% to 11%, and may also include decimals within the above range. In addition, for example, about 1 cm may include 0.9 to 1.1 cm, and may also include decimals within the above range.

[0182] [Production of a patch with a mesh body]

[0183] A tooth whitening patch including a drug layer and a support layer having the composition shown in Table 1 below was prepared.

[0184] A gel for manufacturing a drug layer and a gel for manufacturing a supporting layer having the composition of Table 1 below were prepared, and then the prepared gel for manufacturing a drug layer was spread on PET (release paper) with a thickness of 70 μm, and then dried at a temperature of 50° C. for 10 minutes. A mesh body was attached to the dried drug layer, and then a drug layer was coated again thereon in a manner to form a thickness of 180 μm including the thickness of the mesh body, and dried at a temperature of 50° C. for 20 minutes, and then a supporting layer was coated thereon again in a thickness of 20 μm, and dried at a temperature of 50° C. for 20 minutes. Thereafter, additional drying was performed at 105° C. for 10 minutes, thereby manufacturing a patch with a drying loss of 15%.

[0185] As for the mesh body of Example 1, a product named H526 purchased from SWM Corporation was used, and as for the mesh body of Comparative Example 2, a product named X540NAT purchased from SWM Corporation was used.

[0186] Table 1

[0187]

[0188] [Confirmation of support layer detachment phenomenon and tensile strength depending on the type of support layer]

[0189] For comparison with the patch having the ingredients in Table 1, a patch having the ingredients in Table 2 below was manufactured using a polyethylene film instead of ethylcellulose in the support layer. The thickness of the drug layer including the mesh was 180 μm, and the support layer thickness was 20 μm, thereby manufacturing a patch with a total thickness of 200 μm.

[0190] Table 2

[0191]

[0192] 1. Detachment of the support layer over time at high temperatures

[0193] Patch A with a PE support layer but no mesh and patch B with an EC support layer and a mesh inserted were made into a shape of 1 cm in width and 6 cm in length, and placed in an oven at 60°C for 24 hours to confirm whether the support layer was separated. Figure 7 As shown. Figure 7 It was confirmed that patch B had excellent stability at high temperatures and there was no separation between the drug layer and the support layer of the patch.

[0194] 2-1. Changes in tensile strength due to the presence or absence of a mesh body

[0195] Equipment used: TA / TX analyzer

[0196] Experimental method: The experimental method can be referred to Figure 8 The sample was cut into a certain size (1.0x5.0cm) and fixed at both ends of the jig by 1.0cm, leaving only 3.0cm exposed. The sample was pulled 60.0mm at a test speed of 1.0mm / s and stretched (twice the original length) to measure the tensile strength.

[0197] Evaluation results such as Fig. 9 shown.

[0198] The tensile strength of the mesh measured without the above-mentioned polyethylene supporting layer is more than 1000gf. The tooth adhesion of the drug layer is about 350gf (the adhesion force measured when the patch is pressed against a hydroxyapatite disc (Hydroxyapatite disc) with a diameter of 1cm with 100gf for 10 seconds and then removed). In order to smoothly remove the patch in the teeth, the tensile strength of the patch should be the adhesion between the patch and the teeth, that is, more than 350gf. The mesh is included in the drug layer. When the supporting layer contains ethylcellulose, the tensile strength is more than 2 times relative to the tooth adhesion, thereby confirming that it can be removed smoothly. In addition, when the drug layer has a mesh, it has a tensile strength stronger than the tensile strength of the PE supporting layer.

[0199] Therefore, the patch including the drug layer having the EC support layer and the mesh body does not have a separation phenomenon between the support layer and the drug layer and has excellent tensile strength, so that when the patch is peeled off from the tooth, there is no problem of tearing or breaking.

[0200] 2-2. Patch breakage due to differences in adhesive force and tensile strength of the patch (EC backing & mesh-free)

[0201] Equipment used: TA / TX analyzer

[0202] Experimental method: Fig.10 The apparatus used for the experiment is shown in the figure. The experiment was conducted using a patch having the ingredients shown in Table 1. A HAP tablet with a diameter of 1.0 cm was attached to the end of a jig. After the patch was fixed to the bottom upside down, 20 μl of water was dripped in a circular shape with a diameter of 1.0 cm. After the patch was wetted, it was pressed with a force of 100 gf for 10 seconds, and the force when peeled off was measured.

[0203] Experimental results: The force of attaching the adhesive surface of the patch to the HAP tablet was 341.7±18.0gf, which was more than twice as strong as the tensile strength of 133.2±2.34gf, causing the problem of breakage during removal. However, when the mesh was inserted into the drug layer, the tensile strength of the patch increased to 1152.7±95.12gf, and the patch did not break during removal, which had the effect of improving the feel of use during removal.

[0204] 3. Stability of each formulation under high temperature conditions (50°C) (PE detachment)

[0205] Under high temperature conditions, whether the support layer detached was confirmed according to the prescription of the drug layer. The prescription of the drug layer was composed of compositions 1 to 5. A PE mesh was used in the following drug layer. However, the confirmation result showed that the PE support layer detached regardless of the following prescription, but the ethyl cellulose support layer did not detach.

[0206] Examples 1, 2, 3, 4, and 5 are patches using an EC backing layer, and Examples 1-2, 2-2, 3-2, 4-2, and 5-2 are patches using a PE backing layer. The patch manufacturing method is the same as the above case.

[0207] Table 3

[0208] Composition 1 Composition 2 Composition 3 Composition 4 Composition 5 Hydrogen Peroxide 10.0 10.0 10.0 10.0 10.0 glycerin 10.0 PEG300 10.0 10.0 HCO40 10.0 SPAN80 10.0 Povidone 20.0 20.0 21.0 21.0 16.0 Carbomer 1.0 1.0 Pullulan 5.0 Saccharin Sodium 0.1 0.1 0.1 0.1 0.1 spices 1.0 1.0 1.0 1.0 1.0 Phosphoric acid 0.1 0.1 0.1 0.1 0.1 Trisodium phosphate 0.1 0.1 0.1 0.1 0.1 Purified water Up to 100 Up to 100 Up to 100 Up to 100 Up to 100

[0209] Table 4

[0210]

[0211]

[0212] X indicates a state where separation can be observed immediately.

[0213] △ indicates that the patch was separated when it was grasped or separated from the PET for use (when a physical external force was applied).

[0214] O indicates that no separation of the support layer and the drug layer was observed.

[0215] As can be seen from Table 4, whether the support layer and the drug layer will separate or not is determined by the material used for the support layer.

[0216] 4. Cost reduction effect through bulk packaging

[0217] When using a PE film backing layer for bulk packaging, the PE film may detach, causing sticking and contamination between patch products. However, when using an EC backing layer, there is no detachment problem, and bulk packaging is possible, which improves commercial viability.

[0218] 5. Residue evaluation

[0219] Experimental method: Press each patch on a HAP disk (1.0 cm in diameter) with a 200g weight for 10 seconds and leave it for 1 hour before removing the patch. Then dye with KI and measure the amount of patch remaining on the HAP disk. (Reaction formula: H2O2+2KI→I2(brown)+2KOH)

[0220] Experimental samples: a patch with the mesh removed from the recipe of Example 1 in Table 3 (conventional) and a patch with the recipe of Example 1 and a mesh (improved)

[0221] Experimental results: It was confirmed that by improving the structure, the drug layer was removed without remaining on the HAP disk. Fig.11 shown. Fig.11 This is the result of repeating the confirmation three times in Example 1. Fig.11 , the patch without mesh (conventional) confirmed a large amount of residue on the tooth surface due to excessive hydration of the drug layer. However, in the case of the patch including mesh (improvement), the degree of no residue on the tooth surface reached almost 100%, which shows that it was cleanly removed from the tooth surface. Regarding the degree of no residue, the ratio of the stained area per total area was calculated. The total area and the stained area were calculated and displayed in pixels using the image J program.

[0222] [Manufacturing of a patch having a polyethylene support layer + a drug layer including a mesh body]

[0223] Through the above-mentioned various processes, a patch including a mesh body inside the drug layer and ethylcellulose in the supporting layer was manufactured.

[0224] Fig.12 This is a SEM photograph showing a cross section of the patch of Example 1. The drug layer exists between the mesh body inside the drug layer and the supporting layer (EC), and the drug layer also exists between the attached surface of the drug layer and the mesh body.

[0225] In addition, it was confirmed that the thickness of the drug layer between the mesh and the attachment surface was different along the concave and convex surfaces of the mesh. It has the following form: a thicker drug layer is applied on the concave surface of the mesh, and a very thin drug layer is formed on the convex surface of the mesh to the extent that it almost sticks to the teeth, or there is almost no drug layer. As a result, the convex surface of the mesh provides a weaker adhesion force (thin drug layer) to the teeth, and the concave surface of the mesh has a relatively strong adhesion force (thicker drug layer) to the teeth, so that the patch can be easily removed when it is removed.

[0226] Fig.13 2 is a photograph showing a mesh body manufactured according to an embodiment, and the structure of the mesh body is enlarged and shown on the right. The mesh body has a plurality of through holes, and an embossed pattern with a convex surface is formed at the part where the filaments intersect each other. However, Fig.13 The photo is only an example of the mesh body disclosed in the present invention, and the photo does not limit the scope of rights.

[0227] Next, for the patch including the mesh body having the ethylcellulose supporting layer, the residual matter evaluation and the hydrogen peroxide release amount evaluation were performed according to the mesh body position.

[0228] 1. Evaluation of the residues based on the position of the mesh inside the drug layer

[0229] In this experiment, each patch was pressed on a HAP disk (1.0 cm in diameter) with a 200 g weight for 10 seconds and left for 1 hour before being removed. The remaining amount of the patch remaining on the HAP disk was measured by staining with KI. (Reaction formula: H2O2+2KI→I2(brown)+2KOH)

[0230] The experimental samples are shown in the following Table 5. The patch components of the following Examples and Comparative Examples are the same as those of Example 1.

[0231] Table 5

[0232]

[0233] The mesh body is arranged in the drug layer in such a way that the first drug layer has the above-mentioned thickness. The total thickness of the above-mentioned drug layer is about 270 μm. The total drying time of the drug layer is 40 minutes, and the drying time is appropriately allocated according to the coating thickness of the first drug layer and the coating thickness including the mesh body and the second drug layer. Regarding other matters related to manufacturing, the same as the above-mentioned situation.

[0234] The results are as follows Fig.14 As shown. Fig.14 It was confirmed that, based on the attachment surface, when the mesh body was arranged closer to the attachment surface than the position corresponding to 50% of the drug layer thickness, the surface residue on the tooth was significantly reduced.

[0235] Evaluation on the residue was performed in the same manner as the method described above.

[0236] 2. Evaluation of hydrogen peroxide release according to the position of the mesh and the size of the through-holes

[0237] In this experiment, the release amount of hydrogen peroxide was evaluated by changing the position of the mesh and the size of the through-holes in the patch of Example 1. Considering the unit area (per 1 cm 2 ) on the total through-hole area, a patch having a hole area approximately 1.9 times larger than that of Example 1 is used as Comparative Example 2.

[0238] The patch of Table 6 below was fixed on the bottom of a beaker with a double-sided tape in a manner such that the drug layer faced upward, and then 50 ml of pure water was poured into it and left for 30 minutes. Then, the pure water was poured into another beaker again and the content of the molten hydrogen peroxide was measured, thereby calculating the amount of hydrogen peroxide released relative to the initial value. The total thickness of the above drug layer was about 270 μm.

[0239] Table 6

[0240]

[0241] In the above Table 6 and Fig.15 It can be confirmed that even if the position of the mesh body is different, there is almost no difference in the release amount of hydrogen peroxide contained in the drug layer. Therefore, the present disclosure can provide a patch with a small amount of residue remaining on the tooth surface and excellent tooth whitening effect.

Claims

1. A patch for attachment to teeth or oral mucosa, characterized in that: The patch for attachment to teeth or oral mucosa comprises: a drug layer having an attachment surface; and a support layer stacked with the drug layer. The drug layer includes at least one mesh body inside, and the at least one mesh body divides the drug layer into a plurality of parts. The mesh body is used as a boundary to divide the drug layer into at least two drug layers.

2. The patch according to claim 1, characterized in that: The drug layer includes two parts, namely, a first drug layer and a second drug layer. Among them, the first drug layer is located between the attachment surface and the mesh body. The second drug layer is located between the first drug layer and the support layer. The first drug layer has a thickness of 5% to 50% of the thickness of the entire drug layer.

3. The patch according to claim 1, characterized in that: The mesh body includes through holes and embossed patterns. The embossed pattern has convex parts and concave parts. The protrusion is formed toward the attachment surface.

4. The patch according to claim 3, characterized in that: The mesh body has: An embossed pattern located at the filament junction where at least two filaments meet or cross; and Through holes are formed between the filament connecting parts to allow the active ingredient to pass through.

5. The patch according to claim 3, characterized in that: The through holes have an area of ​​10% to 60% of the total width of the mesh body parallel to the attachment surface of the drug layer.

6. The patch according to claim 4, characterized in that: The filament connecting portion is formed by two filaments.

7. The patch according to claim 4, characterized in that: The filament connecting portion is formed by three filaments.

8. The patch according to claim 4, characterized in that: The filaments forming the mesh body are arranged at intervals of 30% to 500% of the thickness of the filaments.

9. The patch according to claim 3, characterized in that: Each of the mesh through holes formed in the mesh has a diameter of at least 0.01 mm. 2 Up to 0.5mm 2 area.

10. The patch according to claim 3, characterized in that: Each unit area of ​​the mesh surface is 1cm 2 The mesh body is provided with 100 to 800 through holes formed in the mesh body.

11. The patch according to claim 1, characterized in that: Release the active ingredient from the drug layer, The drug layer contains a water-soluble or water-dispersible polymer and is attached to the target site after being impregnated with water, wherein the adhesion is achieved by the impregnation of the first drug layer.

12. The patch according to claim 11, characterized in that: The polymer includes at least one selected from the group consisting of polyvinyl pyrrolidone, carbomer, pullulan, carrageenan, sodium alginate, acrylate polymers or copolymers, water-soluble cellulose polymers, xanthan gum, polyvinyl alcohol, and mixtures thereof.

13. The patch according to claim 11, characterized in that: The drug layer further comprises at least one plasticizer selected from the group consisting of polypropylene glycol, glycerin or polyethylene glycol, castor oil, PEG-60 hydrogenated castor oil, PEG-40 hydrogenated castor oil, and a mixture thereof.

14. The patch according to claim 11, characterized in that: Of the water-soluble or water-dispersible polymer in the entire drug layer, 40 wt % to 70 wt % of the polymer is contained in the second drug layer.

15. The patch according to claim 1, characterized in that: The support layer includes a water-insoluble polymer, a thermoplastic, or a mixture thereof having a hydrophilic functional group such as a hydroxyl group or a carboxyl group.

16. The patch according to claim 15, characterized in that: The water-insoluble polymer is selected from the group consisting of ethyl cellulose, cellulose acetate, polymethyl methacrylate copolymer, acetate-polyvinyl pyrrolidone copolymer, and a mixture thereof.

17. The patch according to claim 15, characterized in that: The thermoplastic is selected from the group consisting of polyethylene, polyethylene terephthalate, polyvinyl chloride, polyvinylidene chloride, polystyrene, polypropylene and mixtures thereof.

18. The patch according to claim 1, characterized in that: The mesh body is formed of filaments of a polymer selected from the group consisting of acrylic acid ester, polyester fiber, nylon, polypropylene, polyethylene, polybutylene terephthalate, ethylene vinyl acetate, and a mixture thereof.

19. The patch according to claim 18, characterized in that: The mesh body includes an embossed pattern formed of polyethylene filaments.

20. The patch according to claim 11, characterized in that: The above-mentioned active ingredients include ingredients for teeth whitening.

21. A teeth whitening kit, characterized in that: It includes: The patch according to any one of claims 1 to 20; and Instructions for use of the above patch, The above-mentioned strips contain teeth whitening ingredients.

22. The teeth whitening kit according to claim 21, characterized in that: The tooth whitening component includes at least one peroxide selected from the group consisting of hydrogen peroxide, carbamide peroxide, calcium peroxide, sodium percarbonate, sodium perborate, tetrasodium pyrophosphate peroxidate, and mixtures thereof.

23. The teeth whitening kit according to claim 21, characterized in that: The instructions for use include instructions to leave the patch on for 10 to 90 minutes before removing it.

24. A method for manufacturing a patch including a mesh body inside a drug layer, characterized in that: The patch is a patch for attachment to teeth or oral mucosa, and the method comprises the following steps: (S1) preparing a drug layer manufacturing solution containing a water-soluble or water-dispersible polymer and an active ingredient; (S2) drying a certain amount of the drug layer manufacturing solution into a film form to form a first drug layer; (S3) laminating or coating a mesh body on the first drug layer, and coating a certain amount of drug layer manufacturing liquid and drying to form a second drug layer; and (S4) A support layer is provided on the second drug layer.

25. The method for manufacturing a patch according to claim 24, characterized in that: The drying in (S2) or (S3) is performed at a temperature of 40°C to 60°C.

26. The method for manufacturing a patch according to claim 24, characterized in that: The supporting layer is formed by coating a supporting layer manufacturing liquid mixed with a water-insoluble polymer, or the supporting layer is a water-insoluble film.

27. The method for manufacturing a patch according to claim 24, characterized in that: Based on the longitudinal cross-section of the patch, the thickness of the first drug layer accounts for 5% to 50% of the thickness of the entire drug layer.

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