Adhesive patch for oral mucosa and manufacturing method thereof

Abstract

The present invention provides an adhesive patch for oral mucosa, the adhesive patch comprising a substrate and a hollow structure disposed on the substrate so as to protrude. The hollow structure is a cup structure including a support part disposed on the substrate and an adhesive part extending downward from the support part and having an empty interior. The adhesive part has a hollow shape such that same can expand in volume in a wet state.

Description

Adhesive patch for oral mucosa and method for manufacturing the same

[0001] This invention claims the benefit of Korean Patent Application No. 10-2023-0134976 filed with the Korean Intellectual Property Office on October 11, 2023, the entire contents of which are incorporated herein by reference.

[0002] The present invention relates to an adhesive patch for oral mucosa and a method for manufacturing the same.

[0003]

[0004] Unlike the skin, which has a thick inner and outer layer, the oral mucosa has well-developed blood vessels and provides a favorable environment for drug delivery due to the high permeability of the mucosa.

[0005] However, the oral mucosa is wet with saliva, making it difficult to deliver the drug in the form of a patch according to the movement of the oral cavity, and there is a problem in that it is difficult to maintain the adhesiveness of the patch.

[0006] Professor Langer's group at MIT developed a platform technology for delivering drugs into the oral cavity using microneedles, publishing a paper in Science Advances in 2021. The paper demonstrated rapid drug absorption through oral drug delivery, addressing the issue of delivering small amounts of drug, a weakness of microneedles.

[0007] Sichuan University in China developed a patch using mussel proteins that adheres to the oral mucosa and delivers drugs. However, this study focused on the chemical bonding of mussel proteins, and did not investigate their desorption.

[0008] The Korea Atomic Energy Research Institute has developed a technology for manufacturing oral mucosal adhesive drug delivery systems that combine drugs with biocompatible polymers, control the crosslinking rate using an electron beam, and create a vacuum between the patch and the mucosa by swelling the area with a low crosslinking rate.

[0009] However, existing technologies have problems such as difficulty in quantitatively delivering drugs or difficulty in detaching them after bonding.

[0010] Meanwhile, it is necessary to develop a patch that is not affected by chemical reactions with microorganisms or saliva when attached to the oral mucosa, and a patch with strong adhesive ability against moisture is required to attach the patch to the oral mucosa that is wet with saliva.

[0011] However, although the above problem can be solved in the case of a chemical wet patch using the biomimetic mussel protein described above, the problem of difficulty in detaching the wet patch after drug delivery still exists.

[0012] Therefore, there is a need to develop a patch technology that allows sufficient drug delivery and easy removal after wet adhesion is achieved.

[0013] ※ Prior art document: Korean Patent Publication No. 10-1833821

[0014]

[0015] The present invention relates to an adhesive patch for oral mucosa and a method for manufacturing the same.

[0016]

[0017] In order to solve the above-mentioned conventional problem, according to one embodiment of the present invention, an adhesive patch for oral mucosa is provided, which includes a substrate and a hollow structure protrudingly arranged on the substrate, wherein the hollow structure is a cup structure including a support portion arranged on the upper portion of the substrate and an adhesive portion extending downward from the support portion and having an empty interior, and wherein the adhesive portion has a hollow shape that is capable of expanding in volume in a wet state.

[0018] The hollow structure is characterized in that it is filled with a drug or functional substance.

[0019] The above drug or functional material may be further filled with a biodegradable material.

[0020] The above hollow structure can be separated from the substrate within the oral cavity.

[0021] The above adhesive portion may have an expansion ratio of 150% to 400% at the other end compared to the one end in contact with the support portion.

[0022] The above adhesive portion is divided into a first region having a certain height from the support portion and a second region extending from the first region to the lower end, and the thickness of the first region may be greater than the thickness of the second region.

[0023] The hollow structure may include a swellable polymer or a biodegradable polymer.

[0024] The above description may be in the form of multiple layers laminated together.

[0025] In the substrate in which the plurality of layers are laminated, the first layer in contact with the hollow structure may include the same material as the material included in the structure.

[0026] In the substrate in which the above multiple layers are laminated, the first layer in contact with the hollow structure may be a water-soluble film.

[0027] The above-described material may be a water-soluble film.

[0028] Another embodiment of the present invention provides a method for manufacturing an adhesive patch for oral mucosa, comprising the steps of: providing a substrate; forming a thin film on the substrate; forming a pattern on the thin film by an imprinting method to form a structure having a shape corresponding to the pattern; and curing the structure.

[0029] The step of forming a pattern by imprinting the above thin film can be performed by a process using a stamp on which a pattern has been formed or by an exposure process.

[0030] The step of curing the above structure can be performed by thermal curing or UV curing.

[0031]

[0032] According to one embodiment of the present invention, a hollow structure of an adhesive patch for oral mucosa is positioned to protrude from the substrate, has an internally empty cup structure fixed to the substrate, and has a hollow shape that can expand in volume in a wet state, so that when the structure is adhered to the oral mucosa, adhesion to the oral mucosa can be achieved.

[0033] In particular, by forming a structure in the shape of a hollow cone-shaped body with an expanded volume, an adhesive patch can be provided that can deliver a drug while maintaining adhesiveness even in a moist oral mucosa by utilizing the fact that the hollow cone-shaped body with an expanded volume spreads and adheres to the oral mucosa.

[0034] In addition, according to one embodiment of the present invention, when the oral mucosa and the hollow structure with an expanded volume come into contact, the adhesive force is maintained and the adhesive force can increase due to the pressure difference between the inside and outside of the hollow structure. In this way, the adhesive patch for the oral mucosa has strong adhesive force even in moisture or water, so it can adhere even when saliva is present in the oral cavity, and the adhesive force can be maintained and not detached even when the oral cavity moves.

[0035] In addition, in the present invention, an adhesive material or drug can be injected into a structure having an empty interior, and the amount of drug injected into the structure can be controlled, so that a fixed amount of drug can be delivered when the adhesive patch is attached to the oral mucosa.

[0036] In addition, in the present invention, the substrate and hollow structure can be manufactured from biodegradable materials, so that they can be detached and decomposed after drug delivery.

[0037] In addition, the present invention relates to a painless drug delivery patch, which allows for quantitative control of drugs compared to microneedles, and can provide an adhesive patch for oral mucosa that allows easy drug administration according to the demand for drug delivery such as vaccines.

[0038]

[0039] FIG. 1 is a schematic diagram and a cross-sectional view showing an oral mucosal adhesive patch having a structure according to a first embodiment of the present invention (a) before expansion, and (b) a schematic diagram and a cross-sectional view after expansion.

[0040] FIG. 2 is a schematic diagram and a cross-sectional view showing an oral mucosal adhesive patch having a structure according to a second embodiment of the present invention (a) before expansion, and (b) a schematic diagram and a cross-sectional view after expansion.

[0041] FIG. 3 is a schematic diagram and a cross-sectional view showing an oral mucosal adhesive patch having a structure according to a third embodiment of the present invention (a) before expansion, and (b) a schematic diagram and a cross-sectional view after expansion.

[0042] FIG. 4 is a schematic diagram showing the bonding process when an adhesive material is injected into the hollow structure of an oral mucosal adhesive patch having a structure according to the first embodiment of the present invention.

[0043] FIG. 5 is a schematic diagram showing a drug delivery process when a drug is injected into a hollow structure of an oral mucosal adhesive patch having a structure according to a second embodiment of the present invention.

[0044] Figure 6 is a schematic diagram showing a drug delivery process when a drug is injected into the hollow structure of an adhesive patch for oral mucosa according to the fourth embodiment of the present invention.

[0045] Figure 7 is a schematic diagram showing a drug delivery process when a drug and a biodegradable material on the drug are injected into the hollow structure of an adhesive patch for oral mucosa according to the fifth embodiment of the present invention.

[0046] ※ Explanation of symbols

[0047] 1: Adhesive patch for oral mucosa 10: Substrate

[0048] 10a: 1st floor 10b: 2nd floor

[0049] 20: Structure 20a: Support

[0050] 20b: Adhesive 20b': First area

[0051] 20b'': Area 2 30: Drugs or functional substances

[0052] 30a: Adhesive 30b: Drug

[0053] 40: Oral mucosa 50: Biodegradable material

[0054]

[0055] In this specification, when a part is said to "include" a certain component, this does not mean that it excludes other components, but rather that it may include other components, unless otherwise specifically stated.

[0056] In this specification, when it is said that a member is located “on” another member, this includes not only cases where the member is in contact with the other member, but also cases where another member exists between the two members.

[0057] In this specification, the terms “step of” and “step of” do not mean “step for”.

[0058]

[0059] The specific details for implementing the present invention will be described in detail with reference to the attached drawings below.

[0060] FIG. 1 is a schematic diagram and a cross-sectional view showing an oral mucosal adhesive patch having a structure according to a first embodiment of the present invention (a) before expansion, and (b) a schematic diagram and a cross-sectional view after expansion.

[0061] Referring to FIG. 1, according to a first embodiment of the present invention, an oral mucosal adhesive patch (1) is provided, which includes a substrate (10) and a hollow structure (20) protrudingly arranged on the substrate (10), wherein the hollow structure (20) has a cup structure including a support portion (20a) arranged on the upper portion of the substrate (10) and an adhesive portion (20b) extending downward from the support portion (20a) and having an interior that is hollow, and wherein the adhesive portion (20b) has a hollow shape that is expandable in a wet state.

[0062] The above-mentioned substrate (10) is not particularly limited and may be, for example, a substrate or a film. Specifically, the substrate or film may include a biodegradable material or a water-soluble material. When the substrate or film includes a biodegradable material, the biodegradable material may be cellulose, chitin, PHA, PCL, PGA, PLLA, PBS, PHB, or protein.

[0063] When the above-mentioned material (10) includes a water-soluble material, the water-soluble material may be a polyvinyl alcohol (PVA)-based material, a polyvinyl pyrrolidone (PVP)-based material, a polyethylene oxide (PEO)-based material, or an ethylene vinyl alcohol (EVA)-based material.

[0064] The above-mentioned substrate (10) may be in the form of a plurality of layers (10a, 10b) being laminated, and the first layer (10a) in contact with the hollow structure (20) in the substrate (10) in which the plurality of layers are laminated may include the same material as the material included in the hollow structure (20).

[0065] Therefore, as described below, when the hollow structure (20) includes a swellable polymer hydrogel, the first layer (10a) in contact with the hollow structure (20) may include the swellable polymer hydrogel. In addition, when the hollow structure (20) includes a biodegradable polymer hydrogel, the first layer (10a) in contact with the hollow structure (20) may include the biodegradable polymer hydrogel. However, the present invention is not limited thereto, and the first layer (10a) in contact with the hollow structure (20) may be manufactured from a material different from the material of the hollow structure (20).

[0066] Meanwhile, according to one embodiment of the present invention, the first layer (10a) in contact with the hollow structure (20) may be a water-soluble film. When the first layer (10a) in contact with the hollow structure (20) of the substrate (10) is a water-soluble film, the first layer (10a) in contact with the hollow structure (20) of the substrate (10) may melt in the oral cavity, allowing the hollow structure (20) to be separated from the substrate (10).

[0067] In addition, the material of the second layer (10b) laminated on the first layer (10a) is not particularly limited, and may include, for example, a biodegradable material or a water-soluble material as described above. Alternatively, a commonly used film may be applied as the material of the second layer (10b).

[0068] In FIG. 1 and FIGS. 2 to 5 described below, the substrate (10) is illustrated as being composed of only the first layer and the second layer (10a, 10b), but it is not necessarily limited thereto, and may be composed of only one layer, or multiple layers of three or more layers may be laminated.

[0069] The hollow structure (20) protruding and arranged on the above-described substrate (10) may be a structure with an empty interior. In FIG. 1, a case in which there are two hollow structures (20) is illustrated, but this is not necessarily limited to the case in which there are one, or three or more. Similarly, in the case of FIGS. 2 to 7 below, the hollow structure may be one, or three or more.

[0070] The above hollow structure (20) may include a swellable polymer or a biodegradable polymer.

[0071] As an example, the hollow structure (20) may include a swellable polymer hydrogel. Alternatively, the hollow structure (20) may include a biodegradable polymer hydrogel.

[0072] The above biodegradable polymer hydrogel can be used without limitation as long as it is commonly used, and may include, for example, one or more of polylactic acid (PLA), polyglutamic acid (PGA), and polylactic-coglycolic acid (PLGA).

[0073] According to one embodiment of the present invention, the substrate (10) and the hollow structure (20) can be manufactured from a biodegradable material, so that they can be detached and decomposed after drug delivery.

[0074] The above hollow structure (20) is a cup structure including a support portion (20a) arranged on the upper portion of the substrate (10) and an adhesive portion (20b) extending downward from the support portion (20a) and having an empty interior, and the adhesive portion (20b) has a hollow shape that can expand in volume in a wet state.

[0075] The above adhesive portion (20b) may be manufactured to have a hollow shape that expands in volume during manufacturing, but is not necessarily limited thereto, and may be manufactured to have a hollow shape that can expand in volume in a wet state.

[0076] When the above-mentioned adhesive portion (20b) expands in volume in a wet state or is already expanded in volume during manufacturing, the hollow shape is not particularly limited and may be, for example, any one of a truncated cone, an elliptical truncated cone, and a square truncated cone, and preferably a truncated cone.

[0077] In the present invention, the hollow structure (20) is a cup structure including a support portion (20a) disposed on the upper portion of the substrate (10) and an adhesive portion (20b) extending downward from the support portion (20a) and having an empty interior, and the adhesive portion (20b) has a hollow shape that can expand in a wet state, and when the hollow shape expands in a wet state, the hollow shape can have a hollow truncated cone shape in particular.

[0078] When the hollow truncated cone shape is expanded in the above wet state, the lower part of the hollow truncated cone is spread out, so when attached to a curved and moist surface such as the oral mucosa, the contact area increases and the adhesive strength with the oral mucosa can be excellent.

[0079] In particular, by forming a micro-sized hollow horn structure, an adhesive patch can be provided that can deliver a drug while maintaining adhesiveness even in moist oral mucosa by utilizing the fact that the hollow horn structure spreads and adheres to the oral mucosa.

[0080] Furthermore, according to one embodiment of the present invention, when the oral mucosa and the hollow structure come into contact, adhesive strength is maintained and increased due to the pressure difference between the inside and outside of the structure. Thus, because the adhesive strength is strong even in moisture or water, adhesion is possible even when saliva is present in the oral cavity, and the adhesive strength is maintained and does not detach even when the oral cavity moves.

[0081] The above oral mucosa adhesive patch (1) may have an empty interior of the hollow structure (20), or the oral mucosa adhesive patch (1) may have a drug or functional substance filled inside the hollow structure (20).

[0082] Among the above hollow structures (20), the expansion ratio of the other end of the adhesive portion (20b) in contact with the support portion (20a) may be 150% to 400%.

[0083] The expansion ratio of the other end of the adhesive portion (20b) to the other end in contact with the support portion (20a) is defined as a value calculated as a percentage of the diameter of the structure by adding the horizontal increase distance expanded from the one end in contact with the support portion (20a) to the other end, assuming that the diameter of the hollow structure is 100%, to 100% of the diameter of the structure.

[0084] That is, the expansion ratio of the other end of the adhesive portion (20b) of the hollow structure (20) compared to the one end in contact with the support portion (20a) is 150% to 400%, which means that the other end of the expanded adhesive portion (20b) has expanded to a point where it has increased by 50% to 300% in the horizontal direction from the one end in contact with the support portion (20a).

[0085] When the expansion ratio of one end of the adhesive portion (20b) in contact with the support portion (20a) to the other end of the adhesive portion (20b) satisfies the above numerical range, the structure can be spread out and adhered to the oral mucosa when adhered to the oral mucosa.

[0086] In particular, by forming a micro-sized hollow cone-shaped structure, an adhesive patch can be provided that can deliver a drug while maintaining adhesiveness even in moist oral mucosa by utilizing the fact that the hollow cone-shaped structure spreads and adheres to the oral mucosa.

[0087] If the expansion ratio of the other end of the adhesive portion (20b) in contact with the support portion (20a) is less than 150% or more than 400%, the adhesive patch for oral mucosa may not adhere well to the oral mucosa.

[0088]

[0089] FIG. 2 is a schematic diagram and a cross-sectional view showing an oral mucosal adhesive patch having a structure according to a second embodiment of the present invention (a) before expansion, and (b) a schematic diagram and a cross-sectional view after expansion.

[0090] Referring to FIG. 2, in an oral mucosal adhesive patch (1) having a structure according to the second embodiment of the present invention, a drug or functional material (30) can be injected into the hollow structure (20). That is, the hollow structure (20) can be filled with a drug or functional material. The functional material is not particularly limited and may include, for example, an adhesive material.

[0091] The method of injecting the drug or functional substance (30) into the interior of the hollow structure (20) may be performed after the hollow structure (20) has expanded in volume in a wet state, or the hollow structure (20) may be expanded in volume after the drug or functional substance (30) is injected into the interior of the hollow structure (20) while the hollow structure (20) is in a cup-like structure with an empty interior.

[0092] When the drug or functional material (30) is injected into the interior of the hollow structure (20) in a cup-like structure with the interior empty, the adhesive portion (20b) region that is empty downward from the region filled with the drug or functional material (30) can expand in volume in a wet state.

[0093] When an adhesive material is injected into the interior of the hollow structure (20) while the interior of the hollow structure (20) is empty and solidified, the shape of the hollow structure (20) can be adjusted by fixing the portion.

[0094] In particular, when a drug is injected into the hollow structure (20), the amount of the drug injected into the hollow structure (20) can be controlled, so that a fixed amount of the drug can be delivered when attached to the oral mucosa.

[0095] That is, existing technologies had problems such as difficulty in delivering drugs quantitatively or difficulty in detaching them after bonding.

[0096] However, the present invention relates to a painless drug delivery patch, which allows for quantitative control of drugs compared to microneedles, and can provide an adhesive patch (1) for oral mucosa that allows easy drug injection according to the demand for drug delivery such as vaccines.

[0097] According to another embodiment of the present invention, a biodegradable material may be further filled on the drug or functional material (30). That is, in the oral mucosal adhesive patch (1) having the structure according to the second embodiment of the present invention, a drug or functional material (30) may be filled inside the hollow structure (20), and a biodegradable material may be further filled on the drug or functional material (30).

[0098] As described above, when the hollow structure (20) is in a cup-like structure with an empty interior, and the drug or functional material (30) is injected into the interior of the hollow structure (20), and a biodegradable material is further filled on the drug or functional material, the adhesive portion (20b) region that is empty downward in the region where the biodegradable material is further filled can have a hollow shape that can expand in a wet state.

[0099] When the hollow structure (20) is filled with a drug or functional material (30), the biodegradable material is further filled on the drug or functional material (30), and the substrate is made of a water-soluble film, the substrate melts in the oral cavity and the hollow structure can be separated from the substrate.

[0100]

[0101] FIG. 3 is a schematic diagram and a cross-sectional view showing an oral mucosal adhesive patch having a structure according to a third embodiment of the present invention (a) before expansion, and (b) a schematic diagram and a cross-sectional view after expansion.

[0102] Referring to FIG. 3, in the adhesive patch (1) for oral mucosa having a structure according to the third embodiment of the present invention, the adhesive portion (20b) of the hollow structure (20) is divided into a first region (20b') having a certain height from the support portion (20a) and a second region (20b'') from the first region (20b') to the lower end, and the thickness of the first region (20b') may be greater than the thickness of the second region (20b''), and the second region (20b'') may expand in volume in a wet state.

[0103] According to the third embodiment of the present invention, since the thickness of the first region (20b') of the adhesive portion (20b) is structured to be greater than the thickness of the second region (20b''), in a wet state, the degree of expansion of the second region (20b'') may be greater than that of the first region (20b'). That is, the second region (20b'') having a thinner thickness may expand more in a wet state than the first region (20b') having a thicker thickness.

[0104] Accordingly, the second region (20b'') of the adhesive portion (20b) can have a hollow shape that is expanded in volume in a wet state.

[0105] According to the third embodiment of the present invention, the second region (20b'') of the adhesive portion (20b) can expand in volume in a wet state, so that when the second region (20b'') expands in volume, it can have a hollow cone-shaped structure.

[0106] In the oral mucosa adhesive patch (1) having a structure according to the third embodiment of the present invention, the thickness of the first region (20b') of the adhesive portion (20b) is greater than the thickness of the second region (20b''), so that the second region (20b'') having a thin thickness expands in a wet state to have a hollow horn structure.

[0107] The hollow cone structure expanded in volume in the above wet state is not particularly limited, and may be, for example, any one of a truncated cone, an elliptical truncated cone, and a square truncated cone, and preferably, a truncated cone.

[0108]

[0109] Another embodiment of the present invention provides a method for manufacturing an adhesive patch for oral mucosa, comprising the steps of: providing a substrate; forming a thin film on the substrate; forming a pattern on the thin film by an imprinting method to form a structure having a shape corresponding to the pattern; and curing the structure.

[0110] The step of forming a pattern by imprinting the above thin film can be performed by a process using a stamp on which a pattern has been formed or by an exposure process.

[0111] The step of curing the above structure can be performed by thermal curing or UV curing.

[0112]

[0113] The method for manufacturing an adhesive patch for oral mucosa first involves preparing a substrate and then forming a thin film on the substrate.

[0114] The above-described substrate is not particularly limited as described in the first embodiment of the present invention described above, and may be, for example, a substrate or a film. Specifically, the substrate or film may include a biodegradable material or a water-soluble material. When the substrate or film includes a biodegradable material, the biodegradable material may be cellulose, chitin, PHA, PCL, PGA, PLLA, PBS, PHB, or protein.

[0115] When the above-mentioned material includes a water-soluble material, the water-soluble material may be a polyvinyl alcohol (PVA)-based material, a polyvinyl pyrrolidone (PVP)-based material, a polyethylene oxide (PEO)-based material, or an ethylene vinyl alcohol (EVA)-based material.

[0116] The above description may be in the form of multiple layers laminated together.

[0117] Next, a step is performed to form a pattern on the thin film by an imprinting method to form a structure having a shape corresponding to the pattern.

[0118] The step of forming a pattern on the above thin film by an imprinting method and forming a structure having a shape corresponding to the pattern is not particularly limited and can be performed by a generally applicable nanoimprinting method.

[0119] The process of forming a pattern by imprinting the above thin film may be performed by a process using a stamp on which a pattern has been formed or an exposure process, but is not necessarily limited thereto.

[0120] Then, a step of hardening the above structure is performed.

[0121] The step of curing the above structure may be performed by thermal curing or UV curing, but is not necessarily limited thereto.

[0122] As described above, an adhesive patch for the oral mucosa can be manufactured by a method for manufacturing an adhesive patch for the oral mucosa according to another embodiment of the present invention.

[0123]

[0124] FIG. 4 is a schematic diagram showing the bonding process when an adhesive material is injected into the hollow structure of an oral mucosal adhesive patch having a structure according to the first embodiment of the present invention.

[0125] An adhesive patch (1) for oral mucosa having a structure according to the first embodiment of the present invention has a cup structure in which the hollow structure (20) includes a support portion (20a) arranged on the upper portion of the substrate (10) and an adhesive portion (20b) extending downward from the support portion (20a) and having an empty interior, and the adhesive portion (20b) has a hollow shape that is capable of expanding in a wet state.

[0126] The above-mentioned substrate (10) may be in a laminated form with a first layer (10a) in contact with the hollow structure (20) and a second layer (10b) disposed on top of the first layer (10a), but is not necessarily limited thereto.

[0127] Referring to FIG. 4, the bonding process when an adhesive material (30a) is injected into the hollow structure (20) of an oral mucosal adhesive patch (1) having a structure according to the first embodiment of the present invention will be described.

[0128] The bonding process of the present invention involves injecting an adhesive material (30a) into the interior of a structure (20) having a hollow shape with an expanded volume of the adhesive portion (20b), and placing the hollow-shaped structure (20) of the oral mucosa adhesive patch (1) on the oral mucosa (40).

[0129] And, the hollow structure (20) is adhered to the oral mucosa (40) by being pressed until the empty area of ​​the hollow structure (20) becomes horizontal.

[0130] The above bonding process was performed by injecting an adhesive material (30a) into the hollow structure (20) of the oral mucosal adhesive patch (1) having a structure according to the first embodiment of the present invention, but is not necessarily limited thereto, and drug delivery may also be performed by injecting a drug into the hollow structure (20) of the oral mucosal adhesive patch (1) having a structure according to the first embodiment of the present invention.

[0131]

[0132] FIG. 5 is a schematic diagram showing a drug delivery process when a drug is injected into a hollow structure of an oral mucosal adhesive patch having a structure according to a second embodiment of the present invention.

[0133] Referring to FIG. 5, a drug delivery process when a drug (30b) is injected into the hollow structure (20) of an oral mucosal adhesive patch (1) having a structure according to the second embodiment of the present invention will be described.

[0134] The drug delivery process of the present invention involves injecting a drug (30b) into a hollow cup-shaped structure (20) having an empty interior protruding from the substrate (10) and fixed to the substrate, and adhering the oral mucosal adhesive patch (1) onto the oral mucosa (40). Specifically, the hollow structure (20) has a cup structure including a support portion (20a) arranged on the upper portion of the substrate (10) and an adhesive portion (20b) extending downward from the support portion (20a) and having an empty interior.

[0135] When a drug (30b) is injected into the interior of the hollow structure (20), the amount of the drug (30b) injected into the structure can be controlled, so that a fixed amount of the drug can be delivered when attached to the oral mucosa.

[0136] And, the drug (30b) injected into the interior of the hollow structure (20) adhered to the oral mucosa (40) is released and absorbed and delivered into the oral mucosa (40).

[0137]

[0138] Figure 6 is a schematic diagram showing a drug delivery process when a drug is injected into the hollow structure of an adhesive patch for oral mucosa according to the fourth embodiment of the present invention.

[0139] An adhesive patch (1) for oral mucosa according to a fourth embodiment of the present invention comprises a substrate (10) and a hollow structure (20) disposed on the substrate (10), wherein the hollow structure (20) has a cup structure including a support portion (20a) disposed on the upper portion of the substrate (10) and an adhesive portion (20b) extending downward from the support portion (20a) and having an empty interior, and the adhesive portion (20b) has a hollow shape capable of expanding in a wet state.

[0140] The above hollow structure (20) is a cup structure with an empty interior that is bonded to the substrate (10), and the bonding portion (20b) with an empty interior may be a cup structure having a hollow shape that can expand in volume in a wet state.

[0141] The hollow structure (20) having an empty cup structure is not particularly limited, but may be, for example, a micro cup.

[0142] Meanwhile, the substrate (10) may be a water-soluble film. The substrate (10) may be a water-soluble film, but is not necessarily limited thereto, and any material that can be dissolved and removed by moisture may be used.

[0143] When the above-mentioned substrate (10) is a water-soluble film, it may be a polyvinyl alcohol (PVA)-based film, a polyvinyl pyrrolidone (PVP)-based film, a polyethylene oxide (PEO)-based film, or an ethylene vinyl alcohol (EVA)-based film.

[0144] Meanwhile, a drug is filled inside the hollow structure (20), and an adhesive region that is empty downward from the region filled with the drug can have a hollow shape that can expand in a wet state.

[0145] When the hollow structure (20) is expanded in volume after the drug is injected into the hollow structure (20) in a cup structure with an empty interior, the adhesive region that is empty downward from the region filled with the drug can have a hollow shape with an expanded volume.

[0146] Referring to FIG. 6, the drug delivery process when a drug is injected into the hollow structure of an adhesive patch for oral mucosa according to the fourth embodiment of the present invention will be described.

[0147] The drug delivery process of the present invention involves injecting a drug (30b) into a hollow structure (20) having an empty cup structure attached to the substrate (10), and the hollow structure (20) of the oral mucosa adhesive patch (1) is attached to the oral mucosa (40).

[0148] When a drug (30b) is injected into the hollow structure (20), the amount of the drug (30b) injected into the hollow structure (20) can be controlled, so that a fixed amount of the drug can be delivered when attached to the oral mucosa.

[0149] In addition, the substrate (10) made of the water-soluble film is dissolved and removed by moisture. As a result, only the hollow structure (20) of the cup structure adheres to the oral mucosa (40).

[0150] And, the drug (30b) injected into the interior of the hollow structure (20) adhered to the oral mucosa (40) is released and absorbed and delivered into the oral mucosa (40).

[0151] Next, the hollow structure (20) of the above cup structure can be detached and inserted into the stomach and finally discharged.

[0152]

[0153] Figure 7 is a schematic diagram showing a drug delivery process when a drug and a biodegradable material on the drug are injected into the hollow structure of an adhesive patch for oral mucosa according to the fifth embodiment of the present invention.

[0154] An adhesive patch (1) for oral mucosa according to a fifth embodiment of the present invention comprises a substrate (10) and a hollow structure (20) disposed on the substrate (10), wherein the hollow structure (20) has a cup structure including a support portion (20a) disposed on the substrate (10) and an adhesive portion (20b) extending downward from the support portion (20a) and having an empty interior, and the adhesive portion (20b) has a hollow shape that is expandable in a wet state. In addition, the hollow structure (20) is filled with a drug (30b), and the drug (30b) has a structure in which a biodegradable material (50) is further filled on the hollow structure.

[0155] The above hollow structure (20) is a cup structure with an empty interior that is bonded to the substrate (10), and the bonding portion (20b) with an empty interior may be a cup structure having a hollow shape that can expand in volume in a wet state.

[0156] The hollow structure (20) having an empty cup structure is not particularly limited, but may be, for example, a micro cup.

[0157] Meanwhile, the substrate (10) may be a water-soluble film. The substrate (10) may be a water-soluble film, but is not necessarily limited thereto, and any material that can be dissolved and removed by moisture may be used.

[0158] When the above-mentioned substrate (10) is a water-soluble film, it may be a polyvinyl alcohol (PVA)-based film, a polyvinyl pyrrolidone (PVP)-based film, a polyethylene oxide (PEO)-based film, or an ethylene vinyl alcohol (EVA)-based film.

[0159] According to the fifth embodiment of the present invention, a drug (30b) is injected into a hollow structure (20) having an empty interior and a cup structure attached to the substrate (10), and a biodegradable material (50) is additionally filled into the hollow structure (20) into which the drug (30b) is injected.

[0160] The method for additionally filling the biodegradable material (50) into the hollow structure (20) is not particularly limited, and can be performed by an inkjet printing method in the same manner as the method for filling the drug (30b) into the hollow structure (20).

[0161] When the biodegradable material (50) is coated inside the hollow structure (20) by an inkjet printing method, the biodegradable material (50) can function as an encapsulating agent (Encapsulant) that encapsulates the drug (30b) filled inside the hollow structure (20).

[0162] Referring to FIG. 7, a drug delivery process when a drug is injected into the hollow structure of an adhesive patch for oral mucosa according to a fifth embodiment of the present invention will be described. The fifth embodiment of the present invention is a form in which a biodegradable material is additionally filled into the drug phase filled into the hollow structure of the adhesive patch for oral mucosa according to the fourth embodiment of the present invention, and will be described based on the description of the fourth embodiment of the present invention.

[0163] According to the fifth embodiment of the present invention, when a drug (30b) is injected into a hollow structure (20) having an empty interior and a cup structure attached to the substrate (10) and is encapsulated with the biodegradable material (50), and the substrate (10) is used as a water-soluble film, the substrate (10) melts in the oral cavity, and the hollow structure (20) encapsulated with the biodegradable material (50) can be separated from the substrate (10).

[0164] In addition, when the hollow structure (20) is manufactured from a biodegradable material, delayed drug delivery is possible due to the difference in biodegradation time with the biodegradable material (50) used as an encapsulating agent. That is, an adhesive patch for the oral mucosa including the hollow structure (20) encapsulated with the biodegradable material (50) is capable of delivering drugs in a sustained-release form.

[0165] The drug delivery process of the present invention involves injecting a drug (30b) into a hollow structure (20) having an empty cup structure attached to the substrate (10), additionally filling the hollow structure (20) into which the drug (30b) has been inserted with a biodegradable material (50), and then the hollow structure (20) of the oral mucosa adhesive patch (1) is adhered to the oral mucosa (40).

[0166] When a drug (30b) is injected into the hollow structure (20), the amount of the drug (30b) injected into the hollow structure (20) can be controlled, so that a fixed amount of the drug can be delivered when attached to the oral mucosa.

[0167] In addition, the substrate (10) made of the water-soluble film is dissolved and removed by moisture. As a result, only the hollow structure (20) of the cup structure adheres to the oral mucosa (40).

[0168] And, the biodegradable material (50) injected into the hollow structure (20) adhered to the oral mucosa (40) gradually melts, and the injected drug (30b) is then released and absorbed and delivered into the oral mucosa (40).

[0169] According to the fifth embodiment of the present invention, unlike the fourth embodiment of the present invention, since the hollow structure (20) is further filled with a biodegradable material (50), delayed drug delivery is possible due to the biodegradation time of the biodegradable material (50). That is, the oral mucosal adhesive patch including the hollow structure (20) encapsulated with the biodegradable material (50) is capable of drug delivery in a sustained-release form.

[0170] Next, the hollow structure (20) of the cup structure can be detached and inserted into the stomach and finally discharged. Alternatively, if the hollow structure (20) of the cup structure is made of a biodegradable material, it can be biodegraded and disappear.

[0171]

[0172] The present invention proposes a concept of an adhesive patch that enables drug delivery while maintaining adhesiveness even within a moist oral mucosa.

[0173] According to one embodiment of the present invention, since the hollow structure included in the adhesive patch for oral mucosa has an internally empty structure fixed to a substrate and the adhesive portion has a hollow shape that can expand in volume in a wet state, when the hollow structure is spread out and adhered to the oral mucosa, adhesion to the oral mucosa can be achieved.

[0174] In particular, by forming a micro-sized hollow horn structure, an adhesive patch can be provided that can deliver a drug while maintaining adhesiveness even in moist oral mucosa by utilizing the fact that the hollow horn structure spreads and adheres to the oral mucosa.

[0175] Furthermore, according to one embodiment of the present invention, when the oral mucosa and the hollow structure are bonded, the adhesive strength is maintained and the adhesive strength can increase due to the pressure difference between the inside and outside of the hollow structure. In this way, the adhesive patch for the oral mucosa has strong adhesive strength even in moisture or water, so it can adhere even when saliva is present in the oral cavity, and the adhesive strength can be maintained and not detached even when the oral cavity is moved.

[0176] In addition, an adhesive patch for oral mucosa according to one embodiment of the present invention can inject a drug into a hollow structure, and can control the amount of drug injected into the hollow structure, so that a fixed amount of drug can be delivered when adhered to the oral mucosa.

[0177] In addition, in the present invention, the substrate and hollow structure can be manufactured from biodegradable materials, so that they can be detached and decomposed after drug delivery.

[0178] In addition, the present invention relates to a painless drug delivery patch, which allows for quantitative control of drugs compared to microneedles, and can provide an adhesive patch for oral mucosa that allows easy drug administration according to the demand for drug delivery such as vaccines.

[0179]

[0180] The present invention described above is not limited to the above-described embodiments, as various substitutions and changes can be made within the scope of the technical idea of ​​the present invention by a person having ordinary skill in the art to which the present invention pertains.

Claims

1. Description; and A hollow structure protruding and arranged on the above-mentioned substrate; The above hollow structure is, A support member arranged on the upper part of the above-mentioned device; and A cup structure including an adhesive portion that extends downward from the above support portion and has an empty interior; An adhesive patch for oral mucosa having a hollow shape capable of expanding in volume in a wet state, wherein the adhesive portion is:

2. In paragraph 1, An adhesive patch for oral mucosa, wherein a drug or functional substance is filled within the hollow structure.

3. In paragraph 2, An adhesive patch for oral mucosa further filled with a biodegradable material on the above drug or functional material.

4. In paragraph 1, The above hollow structure is an adhesive patch for the oral mucosa that is separated from the substrate within the oral cavity.

5. In paragraph 1, An adhesive patch for oral mucosa, wherein the adhesive portion has an expansion ratio of 150% to 400% at the other end compared to the one end in contact with the support portion.

6. In paragraph 1, An adhesive patch for oral mucosa, wherein the adhesive portion is divided into a first region having a certain height from the support portion and a second region extending from the first region to the lower end, and the thickness of the first region is greater than the thickness of the second region.

7. In paragraph 1, The above hollow structure is an adhesive patch for oral mucosa containing a swellable polymer or a biodegradable polymer.

8. In paragraph 1, The above description is an adhesive patch for oral mucosa in a form in which multiple layers are laminated.

9. In paragraph 8, An adhesive patch for oral mucosa, wherein the first layer in contact with the hollow structure in the substrate in which the plurality of layers are laminated comprises the same material as the material included in the hollow structure.

10. In paragraph 8, An adhesive patch for oral mucosa in which the first layer in contact with the hollow structure in the substrate in which the plurality of layers are laminated is a water-soluble film.

11. In paragraph 1, The above description is an adhesive patch for oral mucosa which is a water-soluble film.

12. Step of preparing the equipment; A step of forming a thin film on the above substrate; A step of forming a pattern on the above thin film by an imprinting method to form a structure having a shape corresponding to the pattern; and comprising a step of hardening the above structure; A method for manufacturing an adhesive patch for oral mucosa according to any one of claims 1 to 11.

13. In paragraph 12, A method for manufacturing an adhesive patch for oral mucosa, wherein the step of forming a pattern by imprinting the above thin film is performed by a process using a stamp on which a pattern has been formed or by an exposure process.

14. In paragraph 12, A method for manufacturing an adhesive patch for oral mucosa, wherein the step of curing the above structure is performed by heat curing or UV curing.

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