Microneedle patch having detachable base layer

Abstract

Provided is a microneedle patch having a detachable base layer. The microneedle patch comprises: a needle part containing an active material; the base layer, which maintains mechanical support for the needle part when the needle part is inserted into the skin; and a connection part disposed between and connecting the needle part and the base layer. At least one of the connection part or the base layer is made of a material that is dissolved by a predetermined solvent, the needle part remains in the skin after being inserted into the skin, and at least one of the connection part or the base layer is dissolved by the predetermined solvent so that the base layer detaches from the needle part within a predetermined time.

Description

Microneedle patch with detachable basal layer

[0001] The present invention relates to a microneedle patch, and more particularly, but not exclusively, to a soluble microneedle patch.

[0002] The injection method of currently used drugs, especially the method of introducing active substances with pharmacological and cosmetic activities into the human body, is usually oral injection and local injection using a syringe, etc.

[0003] The most commonly used method for topical injection, or transdermal penetration, is using a syringe. This method can cause skin damage due to the needle's structure and diameter, making it impossible to administer concentrated treatments over a wide area.

[0004] As a structure and method to replace the above existing syringe, a microneedle patch with a size much smaller than the needle of the existing syringe is being developed and applied.

[0005] Such microneedle patches have a structure comprising a very small microneedle array on the basal layer, as shown in Fig. 1. These microneedle patches have the characteristic of enabling stable treatment with less side effects and uniformity over a wider treatment area compared to using a conventional syringe, in the process of delivering drugs for treatment or skin beautification by incorporating drugs into the microneedle array or coating drugs on the outside.

[0006] The aforementioned microneedle patch structure has microneedles attached to a specific basal layer. The basal layer used here can be a sheet of various polymer materials, and some may even have an adhesive surface for ease of use. However, it is clear that this basal layer must remain continuously attached to the skin surface after the microneedle injection, and the basal layer's attachment time must continue until drug delivery through the microneedles is complete.

[0007] An outline of the treatment process using the above microneedle patch is shown in Fig. 2. Referring to Fig. 2, a conventional microneedle patch inserts a microneedle array into the skin to inject a drug solution, and at this time, the basal layer of the microneedle patch is attached to the skin layer. First, in the case of a patch in which the microneedle array itself dissolves and delivers the drug subcutaneously, the microneedle array itself can be completely dissolved before the patch, and second, in the case of a patch in which the microneedle array itself does not dissolve, while the drug solution injection of the microneedle array is in progress, the entire microneedle patch including the basal layer and the microneedle array can be removed from the skin layer at the same time.

[0008] As a result, while existing microneedle patches offer the ability to reliably inject a specific drug across a wide area of ​​skin, they also suffer from the problem of requiring a significant amount of time to remove the underlying basal layer of the microneedle patch after the procedure. Furthermore, the adhesive material used to securely attach the basal layer can, over time, cause side effects such as hypersensitivity, allergic reactions, and skin inflammation on the skin surface.

[0009] In conventional microneedle patches, there was a problem of causing trouble to the skin attachment surface because the basal layer had to be continuously attached to the skin surface until drug delivery through the microneedle was completed after the microneedle patch was inserted.

[0010] One object of the present invention to solve the above-described problem is to provide a microneedle patch comprising a needle portion containing an active substance, a basal layer for maintaining mechanical support for the needle portion, and a connecting portion for connecting the needle portion and the basal layer, wherein after insertion of the needle portion into the skin, the needle portion remains in the skin and at least one of the connecting portion or the basal layer is dissolved by a predetermined solvent to separate the basal layer from the needle portion within a predetermined time.

[0011] However, the problem to be solved by the present invention is not limited thereto, and may be expanded in various ways without departing from the spirit and scope of the present invention.

[0012] According to one embodiment of the present invention for achieving the above-described object, a microneedle patch capable of separating a basal layer comprises: a needle part containing an active substance; a basal layer that maintains mechanical support for the needle part when the needle part is inserted into the skin; and a connecting part connecting the needle part and the basal layer between the needle part and the basal layer; wherein at least one of the connecting part or the basal layer is made of a material that is dissolved by a predetermined solvent, and after insertion of the needle part into the skin, the needle part remains in the skin, and at least one of the connecting part or the basal layer is dissolved by the predetermined solvent, so that the basal layer can be separated from the needle part within a predetermined time.

[0013] According to one aspect, a microneedle patch capable of separating a basal layer according to one embodiment of the present invention may further include a solvent supply pack containing the predetermined solvent and attached to the skin in addition to the basal layer to deliver the predetermined solvent to the basal layer.

[0014] According to one aspect, the content of the predetermined solvent contained in the solvent supply pack can be determined according to the length of time required to maintain the base layer.

[0015] According to one aspect, the length of time required to maintain the base layer can be determined based on at least one of the type or content of the active material.

[0016] According to one aspect, the solvent supply pack may be provided in a sealed package.

[0017] According to one aspect, the solvent supply pack can be removed together with the base layer after dissolving the base layer with the predetermined solvent and drying the predetermined solvent and the dissolved base layer together over a predetermined period of time.

[0018] According to one aspect, at least a portion of the needle portion, the connecting portion and the base layer are made flexible upon attachment of the solvent supply pack, so that the base layer can be separated from the needle portion upon removal of the solvent supply pack after a predetermined period of time.

[0019] According to one aspect, a microneedle patch capable of separating a base layer according to one embodiment of the present invention further includes a bubble structure having a cavity at the connection portion between the needle portion and the base layer, and as the wall surface of the bubble structure is softened by the predetermined solvent, the cross-sectional area of ​​the cavity at the wall surface position of the bubble structure of the needle portion is reduced, so that the connection strength between the base layer and the needle portion can be reduced.

[0020] According to one aspect, the cross-sectional area of ​​the cavity at the wall surface position of the above bubble structure can be reduced by the resilient elasticity of the skin.

[0021] According to one aspect, a microneedle patch capable of separating a base layer according to one embodiment of the present invention further includes an adhesive patch attached to the base layer, wherein the adhesive patch may have a through hole at least partially formed therein through which the predetermined solvent passes to reach at least one of the connecting portion or the base layer.

[0022] According to one aspect, at least one of the connecting portion or the basal layer may be made of a soluble biocompatible material comprising at least one material selected from the group consisting of hyaluronic acid, starch, carboxymethyl cellulose, and polyvinyl alcohol.

[0023] According to one aspect, at least one of the connecting portion or the base layer may be formed of hyaluronic acid, and the predetermined solvent may be water.

[0024] According to one aspect, the active substance may comprise at least one of a pharmacologically active substance or a cosmetically active substance.

[0025] According to one aspect, the predetermined solvent may comprise at least one of a pharmacologically active substance or a cosmetically active substance.

[0026] According to one aspect, the predetermined solvent may contain an active substance different from the active substance contained in the needle portion.

[0027] The disclosed technology may have the following effects. However, this does not mean that a particular embodiment must include all or only the following effects, and therefore the scope of the disclosed technology should not be construed as being limited thereby.

[0028] According to the microneedle patch capable of separating the basal layer according to one embodiment of the present invention described above, since the basal layer of the microneedle is separated from the needle portion by a predetermined solvent, there is no need for the adhesive sheet of the polymer material to be continuously attached to the skin surface after the microneedle patch is administered, and thus the possibility of side effects such as hypersensitivity, allergic reaction, and skin inflammation occurring on the skin surface can be reduced.

[0029] In addition, the microneedle patch capable of separating the basal layer according to the above-described embodiment of the present invention enhances the convenience and safety of use of existing microneedle patch structure products, and through the basal layer separation method of this improved structure, the needle part of the microneedle patch and the basal layer can be separated in a short period of time, thereby shortening the treatment time using the microneedle patch, and since the timing of removing the basal layer of the microneedle patch can be adjusted according to the user's needs, daily life can be resumed within a short period of time after the treatment.

[0030] In a non-limiting but more specifically, according to one aspect, the microneedle patch capable of separating the basal layer according to one embodiment of the present invention described above can maintain the basal layer for different periods of time depending on the type or content of the active substance, and the solvent supply pack provided together contains an appropriate type and amount of solvent depending on the active substance contained in the needle portion, so that the user can separate the basal layer after a predetermined period of time by simply attaching the corresponding solvent supply pack without having to adjust the amount or time of the solvent.

[0031] Figure 1 is an example of a conventional microneedle patch structure.

[0032] Figure 2 is a schematic diagram of a treatment process using a conventional microneedle patch.

[0033] FIG. 3 is a schematic diagram of a process for forming a microneedle patch structure having an improved structure according to one embodiment of the present invention.

[0034] Figure 4 shows one embodiment of a microneedle patch capable of basal layer separation of the present invention.

[0035] FIG. 5 is a drawing showing the dissolution of the basal layer of a microneedle patch according to one embodiment of the present invention.

[0036] Figure 6 shows another embodiment of a microneedle patch capable of basal layer separation of the present invention.

[0037] Figure 7 shows another embodiment of a microneedle patch capable of basal layer separation of the present invention.

[0038] Figure 8 shows another embodiment of a microneedle patch capable of basal layer separation of the present invention.

[0039] Figure 9 shows another embodiment of a microneedle patch capable of basal layer separation of the present invention.

[0040] The present invention can be modified in various ways and has various embodiments, and specific embodiments are illustrated in the drawings and described in detail.

[0041] However, this is not intended to limit the present invention to a specific embodiment, but should be understood to include all modifications, equivalents, or substitutes included in the spirit and technical scope of the present invention.

[0042] While terms such as "first" and "second" may be used to describe various components, these components should not be limited by these terms. These terms are used solely to distinguish one component from another. For example, without departing from the scope of the present invention, a first component may be referred to as a "second component," and similarly, a second component may also be referred to as a "first component." The term "and / or" includes any combination of multiple related items described herein or any item among multiple related items described herein.

[0043] When a component is referred to as being "connected" or "connected" to another component, it should be understood that it may be directly connected or connected to that other component, but that there may be other components intervening. Conversely, when a component is referred to as being "directly connected" or "connected" to another component, it should be understood that there are no other components intervening.

[0044] The terminology used in this application is only used to describe specific embodiments and is not intended to limit the present invention. The singular expression includes the plural expression unless the context clearly indicates otherwise. In this application, it should be understood that the terms "comprise" or "have" indicate the presence of a feature, number, step, operation, component, part, or combination thereof described in the specification, but do not exclude in advance the possibility of the presence or addition of one or more other features, numbers, steps, operations, components, parts, or combinations thereof.

[0045] Unless otherwise defined, all terms used herein, including technical or scientific terms, have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. Terms defined in commonly used dictionaries should be interpreted as having a meaning consistent with their meaning in the context of the relevant technology, and will not be interpreted in an idealized or overly formal sense unless explicitly defined herein.

[0046] Hereinafter, with reference to the attached drawings, preferred embodiments of the present invention will be described in more detail. In order to facilitate an overall understanding in describing the present invention, identical reference numerals will be used for identical components in the drawings, and redundant descriptions of identical components will be omitted.

[0047]

[0048] As previously discussed, conventional microneedle patches require that the adhesive sheet made of polymer material remain continuously attached to the skin surface after the procedure, so it takes a very long time to remove the basal layer of the microneedle patch, making it difficult to remove the basal layer, which causes skin trouble, from the microneedle patch in a short period of time.

[0049] A microneedle patch capable of separating the basal layer according to one embodiment of the present invention is intended to solve the above-mentioned problem, and by separating the basal layer of the microneedle patch from the needle portion using a predetermined solvent, the basal layer can be removed within a short period of time after the microneedle patch is administered, thereby reducing the risk of hypersensitivity, allergic reaction, and skin inflammation on the skin surface, and not only shortening the administration time, but also varying the time for which the basal layer is maintained depending on the type or content of the active substance.

[0050] Below, a microneedle capable of separating a base layer according to one embodiment of the present invention will be described in more detail with reference to the drawings.

[0051]

[0052] Hereinafter, the term "solvent supply pack" in this description may refer to various solvent supply packs, such as packs used on the skin for skin care, nutrition supply, etc., in the form of sheets made of various materials containing a predetermined solvent, such as toner, that are attached to the skin and then removed after a certain period of time, or in the form of packs that are applied to the skin and then washed or wiped off. However, it should be understood that the solvent supply pack is not limited to this general definition, and may take any form that can deliver a predetermined solvent to the skin surface.

[0053] In addition, the term 'bubble structure' in this description should be understood as a general term for a structure in which the inside of the bubble is empty, and the shape of the bubble structure is not limited to a certain shape such as a circle or a sphere, but can be any shape that can be formed during manufacturing.

[0054]

[0055] FIG. 3 is a schematic diagram of a process for forming a microneedle patch structure having an improved structure according to one embodiment of the present invention.

[0056] First, referring to (f) of FIG. 3 to explain the microneedle patch (10) structure according to one embodiment of the present invention, the microneedle patch (10) structure according to one embodiment of the present invention may include a needle portion (11) and a base layer (12) supporting the needle portion (11). Referring to the enlarged view shown in (f) of FIG. 3, the needle portion (11) and the base layer (12) are connected by a connecting portion (13). The connecting portion (13) is illustrated as being a part of the base layer (12) connected to the needle portion (11), but the connecting portion (13) may be a part of the needle portion (11) connected to the base layer (12), or may be an area of ​​the microneedle patch (10) including a part of the base layer (12) connected to the needle portion (11) and a part of the needle portion (11) connected to the base layer (12). Hereinafter, for clarity of the drawings, the connecting portion (13) is omitted in FIGS. 4 to 9, and for the illustration of the connecting portion (13), refer to (f) of FIG. 3.

[0057] Referring to (a) and (b) of FIG. 3 to explain the process of forming a microneedle patch (10) structure according to one embodiment of the present invention, first, the needle portion (11) can be manufactured by injecting an active material (20) forming a microneedle array into a mold (1). Thereafter, a material for forming a connecting portion (13) can be injected onto the needle portion (11) into which the active material (20) has been injected, and this material can be injected into a groove of the mold (1) forming the needle portion (11) so as to be placed on the upper portion of the needle portion (11) depending on the required conditions, can be injected onto the mold surface on the upper portion of the needle portion (11) so as to be placed under the base layer (12), or can be injected onto both sides (not shown).

[0058] The active material (20) that can be used to form the needle portion (11) may include, but is not limited to, at least one of a pharmacologically active material or a cosmetically active material, and for example, various materials including hyaluronic acid may be applied. The active material is described in detail below. The material that can be used to form the connecting portion (13) may be a soluble biocompatible material (21) that is dissolved by a predetermined solvent, and for example, various materials including hyaluronic acid may be applied, but is not limited to.

[0059] After the needle portion (11) and the connecting portion (13) of the microneedle patch (10) are formed through the above mold manufacturing process, a base layer (12) forming material can be applied to the surface of the mold (1) with an even thickness to form the base layer (12). The material that can be used to form the base layer (12) can be a soluble biocompatible material (21) that is dissolved by a predetermined solvent, similar to the connecting portion (13), or can be another biocompatible material that is not soluble. At least one of the connecting portion (13) or the base layer (12) is made of a material that is dissolved by a predetermined solvent. At this time, spin coating can be used to form a base layer (12) surface of uniform thickness, or a doctor blade method using a blade (2) for application as schematically illustrated in (c) of Fig. 3 can be used to obtain a base layer (12) of desired thickness and quality (see (c) and (d) of Fig. 3).

[0060] The evenly applied base layer is then dried and cured (see (e) of Fig. 3). At this time, the base layer can be formed by natural drying and curing under conditions of a temperature of 20°C to 35°C and a humidity of 30% to 70%. If the temperature condition is lower than 20°C or the humidity condition is higher than 70%, the drying process will be prolonged, which may cause defects such as wrinkles on the surface of the base layer, and may cause the material to be re-dissolved in the needle structure under the microneedle patch, which may cause defects in the microneedle patch structure. In addition, such an increase in drying time reduces the productivity of the microneedle patch, so it is necessary to perform the application and curing under the appropriate conditions as described above.

[0061] Through the above process, a microneedle patch (10) structure can be manufactured, which includes a needle portion (11) containing an active material according to the present invention, a base layer (12), and a connection portion (13), and at least one of the base layer (12) or the connection portion (13) can be manufactured from a material that is soluble in a predetermined solvent (see (f) of FIG. 3).

[0062]

[0063] Fig. 4 illustrates one embodiment of a microneedle patch capable of separating the basal layer of the present invention. Referring to Fig. 4, one embodiment of a microneedle patch capable of separating the basal layer of the present invention will be described in more detail without limitation.

[0064] A microneedle patch (10) capable of separating the basal layer according to an embodiment of the present invention illustrated in FIG. 4 comprises a needle portion (11) containing an active substance, a basal layer (12), and a connecting portion (13) through the process of FIG. 3 described above, and at least one of the basal layer (12) or the connecting portion (13) is made of a substance that is soluble in a predetermined solvent and is attached to the skin (see (a) to (c) of FIG. 4). The needle portion (11) of the attached microneedle patch (10) is inserted subcutaneously to inject an active substance (20) into the body as illustrated by a dotted arrow in FIG. 4 (c), and the basal layer (12) is attached to the skin and maintained.

[0065] Thereafter, when a predetermined solvent (30) capable of dissolving at least one of the base layer (12) or the connecting portion (13) is supplied onto the base layer (12) (see (d) of FIG. 4), dissolution of at least one of the base layer (12) or the connecting portion (13) occurs. Referring to (e) of FIG. 4, dissolution of the base layer (12) is illustrated for clarity of the drawing, but only the connecting portion (13) and not the base layer (12) may be dissolved, or both the base layer (12) and the connecting portion (13) may be dissolved.

[0066] In addition, although FIG. 4 of the present invention illustrates spraying a small amount of solvent to supply a predetermined solvent (30), the method of supplying the solvent (30) is not limited to spraying, and various methods capable of supplying the solvent (30) may be used. When the base layer (12) is dissolved, the dissolved base layer (12a) can be separated from the needle portion (11) by drying for a predetermined time, or can be immediately separated from the needle portion (11) by wiping or washing (see (f) of FIG. 4). When only the connecting portion (13) is dissolved, the base layer (12) can be separated from the needle portion (11) by removing the base layer (12) within a predetermined time (not shown). This process of dissolving and separating the connecting portion (13) or the base layer (12) can be equally applied to other embodiments of the present invention to be described later.

[0067] Hereinafter, the active substance (20), the soluble biocompatible material (21), and the predetermined solvent described above with reference to FIGS. 3 and 4 will be described in detail. The active substance (20) forming the needle portion (11) of the microneedle patch (10) of the present invention may include at least one of a pharmacologically active substance or a cosmetically active substance, and may include various active substances for, for example, supplying therapeutic drugs, supplying energy, enhancing immunity, acting as an antioxidant, improving skin, etc. Such active substances (20) may include, but are not limited to, various active substances such as, for example, specific disease treatment drugs with proven efficacy and safety, vitamins, minerals, amino acids, plant extracts, probiotics, prebiotics, hyaluronic acid, collagen, etc.

[0068] In addition, the soluble biocompatible material (21), which is a substance that is dissolved by a predetermined solvent, may include various materials with high biocompatibility and proven safety. The soluble biocompatible material (21) that can form at least one of the base layer (12) or the connecting portion (13) of the present invention may be selected as a material having solubility among the above-described active materials that form the needle portion (11). For example, hyaluronic acid, which may be one of the soluble biocompatible materials (21) that forms the base layer (12) of the present invention, may be a material that can be used to form all of the needle portion (11), the base layer (12), and the connecting portion (13) of the microneedle patch (10) of the present invention as one of the hydrophilic biocompatible materials.

[0069] This hyaluronic acid is a polysaccharide that exists in the human body, and is a biodegradable polymer compound composed of N-acetylglucosamine and glucuronic acid, and has strong water solubility. Therefore, when a small amount of water is sprayed as a solvent after forming the microneedle patch (10) of FIGS. 3 and 4, at least one of the basal layer (12) or the connecting portion (13) is dissolved in a very short time and becomes liquid. When the liquefied hyaluronic acid is wiped off at this time, only the needle portion (11) of the microneedle patch (10) remains inside the skin, and the basal layer (12) is removed. Even when the basal layer (12) is removed, the active substance (20) can be continuously delivered in the subcutaneous layer before the needle portion (11) is completely dissolved.

[0070] As a result, one embodiment of the microneedle patch (10) capable of separating the basal layer (12) of the present invention can remove the basal layer (12) of the microneedle patch (10) within a desired time, unlike the existing polymer basal layer, and even when the basal layer (12) is removed in this way, the needle portion (11) continuously injects the active substance (20) in the subcutaneous layer, so that the basal layer (12) can be removed within a short time after the procedure, enabling daily life while maintaining the effect of the active substance (20).

[0071] The dissolution time of the separable base layer (12) as described above can be determined by the amount of solvent (30), for example, water in the case of hyaluronic acid, supplied (e.g., sprayed) to at least one of the base layer (12) or the connecting portion (13). This can satisfy the time required for medical and cosmetic reasons to maintain the base layer (12) after the procedure, and can satisfy various removal times required from several tens of seconds to several minutes, and no specific means other than the amount of water supplied may be required as a method for controlling this.

[0072] In addition, as an advantage of using the basal layer (12) or connecting portion (13) made of the above-described hyaluronic acid, it can be mentioned that the contact characteristics according to the curvature of the skin are excellent. The skin that requires actual treatment has many curvatures such as wrinkles, and accordingly, the treatment process of the microneedle patch (10) must be carried out carefully. However, the basal layer (12) using hyaluronic acid has the advantage of being able to be treated along the curvature of the skin because it has very high flexibility.

[0073] The substance dissolved by the predetermined solvent used to form at least one of the above-mentioned base layer (12) or connecting portion (13) may be various soluble substances such as starch, carboxymethyl cellulose, polyvinyl alcohol, etc., which are water-soluble biopolymers, in addition to hyaluronic acid. However, even in the case of such soluble biocompatible materials, it is necessary to prove their harmlessness to the human body before using them, and among the various soluble biocompatible materials currently, the one showing the best characteristics may be the hyaluronic acid mentioned in the above-mentioned embodiment, but is not limited thereto.

[0074] In the above-described embodiment of the present invention, hyaluronic acid, presented as a soluble biocompatible material (21), is water-soluble, and thus water can be used as a predetermined solvent (30) to remove it; however, the solvent is not limited thereto. It is self-evident that the above-described principle can be expanded to apply to various solvents and substances having solubility therein, and it should be understood that there may be various equivalents and modified examples that can replace it at the time of this application.

[0075] Specifically, the predetermined solvent (30) may include at least one of a pharmacologically active substance or a cosmetically active substance used to form the needle portion (11), the basal layer (12), or the connecting portion (13). In addition, the predetermined solvent (30) may include an active substance different from the active substance (20) contained in the needle portion (11). In this regard, for example, an active substance (20) for alleviating skin irritation resulting from application of the microneedle patch (10), such as a serum, may be included in the predetermined solvent (30), but is not limited thereto. For example, the serum may have the effect of actively alleviating skin irritation resulting from attachment of the microneedle patch (10) while simultaneously performing the role of a solvent for separation of the basal layer (12).

[0076]

[0077] FIG. 5 is a drawing showing the dissolution of a microneedle patch according to one embodiment of the present invention. Specifically, the microneedle patch (10) illustrated in FIG. 5 is partially impregnated in a solvent tray (31) containing a solvent (30), and the microneedle patch (10) of the impregnated portion has at least one of the base layer (12) or the connecting portion (13) dissolved by the solvent (30). At least one of the base layer (12) or the connecting portion (13) may be formed of hyaluronic acid, and in this case, the solvent (30) may be water.

[0078]

[0079] Meanwhile, Fig. 6 shows another embodiment of the microneedle patch capable of separating the basal layer of the present invention. The microneedle patch (10) capable of separating the basal layer illustrated in Fig. 6 includes a needle portion (11) containing an active substance, a basal layer (12), and a connecting portion (13) through the process of Fig. 3 described above, and at least one of the basal layer (12) or the connecting portion (13) is manufactured from a substance that is soluble in a predetermined solvent and is attached to the skin (see (a) to (c) of Fig. 6). The needle portion (11) of the attached microneedle patch is inserted subcutaneously to inject the active substance into the body, and the basal layer (12) is attached and maintained on the skin layer (see (c) of Fig. 6).

[0080] Thereafter, a solvent supply pack (40) containing a predetermined solvent and attached to the skin in addition to the basal layer (12) to deliver the predetermined solvent to at least one of the connection portion (13) or the basal layer (12) is provided on the basal layer (12) (see (d) of FIG. 6). When the solvent supply pack (40) is attached, dissolution of at least one of the connection portion (13) or the basal layer (12) of the microneedle patch (10) occurs. Referring to (e) of FIG. 6, dissolution of the basal layer (12) is illustrated for clarity of the drawing, but only the connection portion (13) and not the basal layer (12) may be dissolved, or both the basal layer (12) and the connection portion (13) may be dissolved and then separated from the needle portion (11). As shown in (e) of FIG. 6, when the base layer (12) is dissolved, the dissolved base layer (12a) can be separated from the needle portion (11) within a predetermined time. More specifically, the dissolved base layer (12a) can be separated from the needle portion (11) by being removed together with the solvent supply pack (40) that delivers a predetermined solvent after being dried together with the solvent supply pack (40) that delivers a predetermined solvent over a predetermined time (see (f) of FIG. 6). When only the connecting portion (13) is dissolved, the base layer (12) can be separated from the needle portion (11) by removing the base layer (12) together with the solvent supply pack (40) within a predetermined time.

[0081] This solvent supply pack (40) can apply the solvent more evenly than the spraying method. While spraying may damage the needle portion (11) of the microneedle patch (10) and the skin due to the impact caused by the spraying pressure, the solvent supply pack (40) does not cause damage to the microneedle patch (10) and the skin.

[0082] In addition, the solvent supply pack (40) can deliver the solvent to the skin and dry quickly, and this drying effect can be greater especially when the solvent supply pack (40) is made of a material that does not retain the solvent, has a large surface area, and when the base layer (12) is dissolved. That is, by utilizing the solvent supply pack (40), the dissolved base layer (12a) can be dried again after the solvent is quickly delivered to at least one of the base layer (12) and the connecting portion (13) of the microneedle patch (10). In other words, the microneedle patch (10) that has been dried and hardened during manufacture can be quickly hydrated (or softened) by the solvent of the solvent supply pack (40), and at the same time, the dissolved base layer (12a) can be quickly dried again together with the drying of the solvent supply pack (40). In addition, by this drying, a bonding force can be generated between the solvent supply pack (40) and the dissolved base layer (12a) of the microneedle patch (10), in which case the dissolved base layer (12a) of the microneedle patch (10) can be more easily separated from the needle portion (11) together with the solvent supply pack (40).

[0083] According to one aspect, the content of a predetermined solvent contained in such a solvent supply pack (40) can be determined according to the length of time required to maintain the base layer (12), and since the length of time required to maintain the base layer (12) can be determined based on at least one of the type or content of the active substance (20), the solvent supply pack (40) can be provided in a sealed package so as to contain an appropriate solvent according to the type or content of such active substance (20).

[0084] For example, if the active substance (20) is a slow-release type, it may be advantageous for the base layer (12) to be maintained for a certain period of time until the active substance (20) is released, and if the active substance (20) is a rapid-release type, the base layer (12) may be separated in a short period of time. In addition, for example, if the amount of the active substance (20) contained in the needle portion (11) is large, the rigidity of the needle portion (11) may be somewhat weak, so it may be advantageous for the base layer (12) to be maintained for a certain period of time to support the needle portion (11), and otherwise, the base layer (12) may be separated in a short period of time.

[0085] In this way, the time for which the base layer (12) of the microneedle patch (10) of the present invention is maintained may vary depending on the type and content of the active substance (20). The solvent supply pack (40) provided with the microneedle patch (10) of the present invention contains an appropriate solvent depending on the type and content of the active substance (20) contained in the needle portion (11), so that the user can separate the base layer (12) by simply attaching the corresponding solvent supply pack (40) without having to adjust the supply amount and supply time of the solvent in order to separate the needle portion (11) and the base layer (12) of the microneedle patch (10).

[0086] In addition, according to one aspect, at least a part of the needle portion (11), the base layer (12), and the connecting portion (13) of the microneedle patch (10) of the present invention is made flexible by attachment of the solvent supply pack (40), so that the base layer (12) can be separated from the needle portion (11) along with removal of the solvent supply pack after a predetermined time has elapsed. More specifically, at least a portion of the needle portion (11), the base layer (12), and the connecting portion (13) can be manufactured from the same active substance (20) that is soluble in a predetermined solvent, and when the soluble active substance (20) is distributed throughout the microneedle patch (10) including the needle portion (11), the base layer (12), and the connecting portion (13) of the microneedle patch (10), when the solvent supply pack (40) is attached, the solvent can flexibilize not only the base layer (12) or the connecting portion (13), but also the entire microneedle patch (10) manufactured from the same component. That is, in terms of the usability of the microneedle patch (10), rather than waiting for the separation of the base layer (12), the base layer (12) of the microneedle patch (10) can be easily separated from the needle portion (11) by removing the solvent supply pack (40) from the microneedle patch (10) that has been made flexible by the solvent supply pack (40) after a predetermined period of time has elapsed. At this time, since a bonding force is generated between the solvent supply pack (40) and the base layer (12) by drying after the predetermined period of time has elapsed as described above, the separation of the base layer (12) can be made easier.

[0087]

[0088] Fig. 7 shows another embodiment of a microneedle patch capable of separating the basal layer of the present invention. Fig. 7 (a) is an enlarged view of part A of the microneedle patch (10) of Fig. 4 (d). The microneedle patch according to one embodiment of the present invention may include a bubble structure (B) having a cavity in the connecting portion (13) between the needle portion (11) and the basal layer (12), as shown in Fig. 7 (b).

[0089] When a microneedle patch (10) that has been dried and hardened during manufacturing is inserted into the skin with a certain mechanical strength, the cross-sectional area of ​​the cavity at the wall surface position of the bubble structure (B) of the needle portion (11) that has pierced the skin is wide at the time of insertion, as shown in (b) of FIG. 7, but when inserted into the skin, the hardening is weakened due to hydration or softening by a solvent, and the mechanical strength of the microneedle patch (10) is lowered, and accordingly, the cross-sectional area of ​​the cavity at the wall surface position of the bubble structure (B) can be reduced as shown in part C in (c) of FIG. 7 due to the resilience of the skin at the part where the needle portion (11) is inserted. As the cross-sectional area of ​​the cavity at the wall surface location of the bubble structure (B) decreases, the connection strength between the needle portion (11) and the base layer (12) or the connecting portion (13) also decreases, and accordingly, even if at least one of the base layer (12) or the connecting portion (13) is completely dissolved or not separated from the needle portion (11), the base layer (12) can be easily separated from the needle portion (11) due to the low tension of the cross-sectional area of ​​the cavity at the wall surface location of the bubble structure (B).

[0090] As shown in (c) of Fig. 7, when the inserted needle portion (11) injects the active substance (20) subcutaneously and the basal layer (12) is attached to the skin layer, when a solvent (30) capable of dissolving at least one of the basal layer (12) or the connecting portion (13) is supplied (e.g., sprayed) onto the basal layer (12), dissolution of at least one of the basal layer (12) or the connecting portion (13) occurs. In (c) of Fig. 7, the basal layer (12) is illustrated as being dissolved for clarity of the drawing, but only the connecting portion (13) and not the basal layer (12) may be dissolved, or both the basal layer (12) and the connecting portion (13) may be dissolved. The dissolved base layer (12a) can be separated from the needle portion (11) by drying for a predetermined time, or can be immediately separated from the needle portion (11) by wiping or washing. If only the connecting portion (13) is dissolved, the base layer (12) can be separated from the needle portion (11) by removing the base layer (12) within a predetermined time (see (d) of FIG. 7).

[0091]

[0092] Fig. 8 shows another embodiment of a microneedle patch capable of separating the basal layer of the present invention. Fig. 8 (a) is an enlarged view of part A of the microneedle patch (10) of Fig. 4 (d). The microneedle patch (10) according to one embodiment of the present invention may include a bubble structure (B) having a cavity in a connecting portion (13) between the needle portion (11) and the basal layer (12), as shown in Fig. 8 (b). The description of the bubble structure (B) is the same as that described above with respect to Fig. 7.

[0093] As shown in (c) of Fig. 8, when the inserted needle portion (11) injects the active substance (20) subcutaneously and the basal layer (12) is attached to the skin layer, a solvent supply pack (40) containing a predetermined solvent capable of dissolving at least one of the basal layer (12) or the connecting portion (13) and attached to the skin in addition to the basal layer (12) to deliver the predetermined solvent to at least one of the basal layer (12) or the connecting portion (13) is provided, dissolution of at least one of the basal layer (12) or the connecting portion (13) occurs. In (c) of Fig. 8, the basal layer (12) is illustrated as being dissolved for clarity of the drawing, but only the connecting portion (13) and not the basal layer (12) may be dissolved, or both the basal layer (12) and the connecting portion (13) may be dissolved. When the base layer (12) is dissolved, the dissolved base layer (12a) can be separated from the needle portion (11) within a predetermined time. More specifically, the dissolved base layer (12a) can be separated from the needle portion (11) by being removed together with the solvent supply pack (40) that delivers a predetermined solvent after being dried together with the solvent supply pack (40) that delivers a predetermined solvent over a predetermined time (see (d) of FIG. 8). When only the connecting portion (13) is dissolved, the base layer (12) can be separated from the needle portion (11) by removing the base layer (12) together with the solvent supply pack (40) within a predetermined time. The description of the solvent supply pack (40) is the same as that described above with respect to FIG. 6.

[0094] As shown in (d) of FIG. 7 and (d) of FIG. 8, the separation of the base layer (12) can be more easily achieved by tearing and pushing sideways as shown in F of FIGS. 6 to 9, rather than by separating the base layer (12) and the needle portion (11) up and down due to the low tension at the wall surface position of the bubble structure (B) where the cross-sectional area of ​​the cavity is reduced. At this time, if the solvent supply pack (40) and the dissolved base layer (12a) are dried together as shown in (c) and (d) of FIG. 8 and a bonding force is generated between the two, the state in which a breakage occurs more easily in the cavity where the cross-sectional area of ​​the wall surface position of the bubble structure (B) of the microneedle patch (10) is reduced will become easier, so that the separation of the base layer (12) can be facilitated.

[0095]

[0096] Fig. 9 shows another embodiment of a microneedle patch capable of separating the basal layer of the present invention. The microneedle patch (10) capable of separating the basal layer (12) illustrated in Fig. 9 includes a needle portion (11) containing an active substance, a basal layer (12), and a connecting portion (13) through the process of Fig. 3 described above, and at least one of the basal layer (12) or the connecting portion (13) is manufactured from a substance that is dissolved by a predetermined solvent and is attached to the skin (see (a) to (c) of Fig. 9).

[0097] Referring to (c) of Fig. 9, the needle portion (11) of the attached microneedle patch is inserted subcutaneously to inject an active substance (20) into the body, and the basal layer (12) remains attached on the skin layer. Thereafter, an adhesive patch (50) can be attached on the basal layer (12) (see (d) of Fig. 9).

[0098] Such an adhesive patch (50) may have at least partially formed through holes (51) that allow a predetermined solvent (30) to pass through and reach at least one of the basal layer (12) or the connecting portion (13). The through holes (51) may be distributed in a portion that comes into contact with the basal layer (12) when the adhesive patch (50) is attached, but may not be distributed in the remaining portion. This is to provide a function of treating and protecting a wound, etc. while separating the basal layer (12) by dissolving at least one of the basal layer (12) or the connecting portion (13) by a predetermined solvent (30) provided later and preventing the adhesive patch (50) from being detached from the skin.

[0099] Thereafter, when a solvent (30) capable of dissolving at least one of the base layer (12) or the connecting portion (13) is supplied (e.g., sprayed) onto the base layer (12), the solvent (30) flows through the through hole (51) of the adhesive patch (50) to supply the solvent to at least one of the base layer (12) or the connecting portion (13), so that separation of the base layer can occur.

[0100] Referring to (e) of FIG. 9, the dissolution of the basal layer (12) is illustrated for clarity of the drawing, but only the connection portion (13) may be dissolved, and not the basal layer (12), or both the basal layer (12) and the connection portion (13) may be dissolved. The adhesive patch (50) may be separated and removed from the needle portion (11) together with the basal layer (12) by being removed from the skin within a predetermined time period in which at least one of the basal layer (12) or the connection portion (13) is dissolved (see (f) of FIG. 9). When the basal layer (12) is dissolved, the adhesive patch (50) may be removed from the skin at the predetermined time period, and the dissolved basal layer (12a) may be dried, wiped, or washed away.

[0101] According to one aspect of the present disclosure, the adhesive patch (50) may be, for example, an adhesive hydrocolloid patch. However, it should be noted that the technical idea of ​​the present invention is not limited to the material of the adhesive patch (50) being hydrocolloid.

[0102]

[0103] Although the present invention has been described with reference to the drawings and embodiments, it does not mean that the scope of protection of the present invention is limited by the drawings or embodiments, and it will be understood that a person skilled in the art can variously modify and change the present invention within a scope that does not depart from the spirit and scope of the present invention as described in the following claims.

[0104] Although the present invention described above is described based on a series of functional blocks, it is not limited to the above-described embodiments and the attached drawings, and it will be apparent to those skilled in the art to which the present invention pertains that various substitutions, modifications, and changes are possible within a scope that does not depart from the technical spirit of the present invention.

[0105] The combination of the above-described embodiments is not limited to the above-described embodiments, and various combinations may be provided in addition to the above-described embodiments depending on implementation and / or needs.

[0106] In the above-described embodiments, the methods are described based on a flowchart as a series of steps or blocks. However, the present invention is not limited to the order of the steps, and some steps may occur in a different order or simultaneously with other steps described above. Furthermore, those skilled in the art will understand that the steps depicted in the flowchart are not exclusive, and that other steps may be included, or one or more steps in the flowchart may be deleted without affecting the scope of the present invention.

[0107] The above-described embodiments include examples of various aspects. While not all possible combinations can be described to illustrate the various aspects, those skilled in the art will recognize that other combinations are possible. Accordingly, the present invention is intended to encompass all other alterations, modifications, and variations within the scope of the following claims.

[0108]

[0109] [Explanation of symbols]

[0110] 1: Mold

[0111] 2: Blade for application

[0112] 10: Microneedle Patch

[0113] 11: Needle part

[0114] 12: Basal layer

[0115] 12a: Dissolved basal layer

[0116] 13: Connection

[0117] 20: Active substance

[0118] 21: Soluble biocompatible materials

[0119] 30: Solvent

[0120] 31: Solvent tray

[0121] 40: Solvent supply pack

[0122] 50: Adhesive patch

[0123] 51: Penetration hole

Claims

1. Needle portion containing an active substance; A basal layer that maintains mechanical support for the needle portion when the needle portion is inserted into the skin; and A connecting portion connecting the needle portion and the base layer between the needle portion and the base layer; At least one of the connecting portion or the basal layer is made of a material that is soluble in a predetermined solvent, and after insertion of the needle portion into the skin, the needle portion remains in the skin, and at least one of the connecting portion or the basal layer is dissolved by the predetermined solvent, so that the basal layer is separated from the needle portion within a predetermined time. Microneedle patch with detachable basal layer.

2. In paragraph 1, Further comprising a solvent supply pack containing the above-determined solvent and attached to the skin in addition to the above-determined base layer to deliver the above-determined solvent to at least one of the above-determined connecting portion or the above-determined base layer. Microneedle patch with detachable basal layer.

3. In paragraph 2, The content of the predetermined solvent contained in the above solvent supply pack is, Determined by the length of time required to maintain the above-mentioned base layer, Microneedle patch with detachable basal layer.

4. In paragraph 3, The length of time required to maintain the above-mentioned base layer is: Determined based on at least one of the types or contents of the above active substances, Microneedle patch with detachable basal layer.

5. In paragraph 2, The above solvent supply pack is, Supplied in sealed packaging, Microneedle patch with detachable basal layer.

6. In paragraph 2, The above solvent supply pack is, The base layer is dissolved by the above-determined solvent, and after the predetermined time has elapsed, the predetermined solvent and the dissolved base layer are dried together and then removed together with the base layer. Microneedle patch with detachable basal layer.

7. In paragraph 2, At least a portion of the needle portion, the connecting portion and the base layer, By attachment of the solvent supply pack, the base layer becomes flexible and is separated from the needle portion with removal of the solvent supply pack after a predetermined period of time. Microneedle patch with detachable basal layer.

8. In paragraph 1, It further includes a bubble structure having a cavity in the connecting portion between the needle portion and the base layer, As the wall surface of the bubble structure is made flexible by the above-determined solvent, the cross-sectional area of ​​the cavity at the wall surface position of the bubble structure of the needle portion is reduced, thereby reducing the connection strength between the base layer and the needle portion. Microneedle patch with detachable basal layer.

9. In paragraph 8, The cross-sectional area of ​​the cavity at the wall surface location of the above bubble structure is Reduced by the skin's elasticity recovery, Microneedle patch with detachable basal layer.

10. In paragraph 8, Further comprising a solvent supply pack containing the above-determined solvent and attached to the skin in addition to the above-determined base layer to deliver the above-determined solvent to at least one of the above-determined connecting portion or the above-determined base layer. Microneedle patch with detachable basal layer.

11. In paragraph 1, Further comprising an adhesive patch attached to the above-mentioned base layer, The above adhesive patch comprises: At least partially formed through holes through which the predetermined solvent passes to reach at least one of the connecting portion or the base layer, Microneedle patch with detachable basal layer.

12. In paragraph 1, At least one of the above connecting portion or the above base layer, A soluble biocompatible material made of at least one material selected from the group consisting of hyaluronic acid, starch, carboxymethyl cellulose, and polyvinyl alcohol. Microneedle patch with detachable basal layer.

13. In paragraph 12, At least one of the above connecting portion or the above basal layer is formed of hyaluronic acid, The above predetermined solvent is water, Microneedle patch with detachable basal layer.

14. In paragraph 1, The above active substances are, Containing at least one pharmacologically active substance or a cosmetically active substance, Microneedle patch with detachable basal layer.

15. In paragraph 1, The above predetermined solvent is, A microneedle patch capable of detaching the basal layer, comprising at least one pharmacologically active substance or a cosmetically active substance.

16. In paragraph 15, The above predetermined solvent is, Containing an active substance different from the active substance contained in the above needle portion, Microneedle patch with detachable basal layer.

Images