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WO2025037862A1 - Timbre à micro-aiguilles ayant une couche de base détachable - Google Patents

Timbre à micro-aiguilles ayant une couche de base détachable Download PDF

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Publication number
WO2025037862A1
WO2025037862A1 PCT/KR2024/011888 KR2024011888W WO2025037862A1 WO 2025037862 A1 WO2025037862 A1 WO 2025037862A1 KR 2024011888 W KR2024011888 W KR 2024011888W WO 2025037862 A1 WO2025037862 A1 WO 2025037862A1
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WO
WIPO (PCT)
Prior art keywords
base layer
basal layer
microneedle patch
solvent
needle portion
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/KR2024/011888
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English (en)
Korean (ko)
Inventor
임덕규
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sntel Co ltd
Original Assignee
Sntel Co ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from KR1020240006156A external-priority patent/KR20250024462A/ko
Application filed by Sntel Co ltd filed Critical Sntel Co ltd
Publication of WO2025037862A1 publication Critical patent/WO2025037862A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin

Definitions

  • the present invention relates to a microneedle patch, and more specifically, but not exclusively, to a soluble microneedle patch.
  • the injection methods of currently used drugs are usually oral injection and local injection using syringes, etc.
  • the most commonly used technical means for local injection targeting the skin that is, percutaneous penetration, is the local injection method using a syringe.
  • skin damage occurs due to the structure and diameter of the needle of the syringe, and it has the characteristic of being impossible to perform intensive treatment on a wide area.
  • a microneedle patch having a size much smaller than the needle of an existing syringe is being developed and applied.
  • microneedle patches have a structure having a very small-sized microneedle array on the basal layer, as shown in Fig. 1.
  • Such microneedle patches have the characteristics of enabling stable treatment with less side effects and uniform treatment over a wider treatment area than using a conventional syringe, in the process of delivering drugs for treatment or skin beauty by incorporating drugs, etc. into the microneedle array or coating the outside of the microneedle array with drugs, etc.
  • the structure of the microneedle patch described above has a shape in which microneedles are attached to a specific base layer.
  • the base layer used at this time uses a sheet of various polymer materials, and includes a case in which the surface has adhesiveness for convenience of use. However, it is obvious that this base layer must be continuously attached to the skin surface after the microneedle procedure, and the attachment time of the base layer must continue until the drug delivery through the microneedle is completed.
  • 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.
  • the entire microneedle patch including the basal layer and the microneedle array can be removed from the skin layer at the same time.
  • microneedle patches have the characteristic of stably injecting a certain drug to a wide area of the skin, they have the problem that it takes a very long time until the point of removal of the basal layer of the microneedle patch that remains after the procedure.
  • the adhesive material for stably attaching the basal layer can cause side effects such as hypersensitivity, allergic reactions, and skin inflammation on the skin surface over time.
  • One object of the present invention to solve the above-described problems is to provide a microneedle patch, which comprises a needle portion containing an active substance, a basal layer maintaining mechanical support for the needle portion, and a connecting portion connecting the needle portion and the basal layer, such that 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 so that the basal layer is separated from the needle portion within a predetermined time.
  • a microneedle patch capable of separating a basal layer comprises: a needle portion containing an active material; a basal layer for maintaining 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 basal layer between the needle portion and the basal layer; wherein at least one of the connecting portion or the basal layer is made of a material that is dissolved by 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 can be separated from the needle portion within a predetermined time.
  • a microneedle patch capable of separating a basal layer 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.
  • 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.
  • 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.
  • the solvent supply pack may be provided in a sealed package.
  • 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.
  • 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, such that the base layer can be separated from the needle portion upon removal of the solvent supply pack after a predetermined period of time.
  • a microneedle patch capable of separating a base layer further includes a bubble structure having a cavity provided in the connecting 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 decreases, so that the connecting strength between the base layer and the needle portion can be reduced.
  • the cross-sectional area of the cavity at the wall surface location of the bubble structure can be reduced by the skin's resilience.
  • a microneedle patch capable of separating a base layer further includes an adhesive patch attached on the base layer, wherein the adhesive patch may have a through hole at least partially formed through which the predetermined solvent passes to reach at least one of the connecting portion or the base layer.
  • At least one of the connecting portion or the basal layer can 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.
  • At least one of the connecting portion or the base layer may be formed of hyaluronic acid, and the predetermined solvent may be water.
  • the active substance may comprise at least one of a pharmacologically active substance or a cosmetically active substance.
  • the predetermined solvent may comprise at least one of a pharmacologically active substance or a cosmetically active substance.
  • the predetermined solvent may contain an active substance different from the active substance contained in the needle portion.
  • the disclosed technology may have the following effects. However, this does not mean that a specific embodiment must include all or only the following effects, and thus the scope of the disclosed technology should not be construed as being limited thereby.
  • 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, so the possibility of occurrence of side effects such as hypersensitivity, allergic reaction, and skin inflammation on the skin surface can be reduced.
  • the microneedle patch capable of separating the basal layer according to one embodiment of the present invention described above 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 portion 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 the basal layer removal of the microneedle patch can be adjusted according to the user's needs, daily life can be resumed quickly after the treatment.
  • 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 amount of the active substance, and a solvent supply pack provided together contains an appropriate type and amount of solvent according to 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.
  • Figure 1 is an example of a conventional microneedle patch structure.
  • Figure 2 is a schematic diagram of a treatment process using a conventional microneedle patch.
  • 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.
  • Figure 4 shows one embodiment of a microneedle patch capable of basal layer separation of the present invention.
  • FIG. 5 is a drawing showing basal layer dissolution of a microneedle patch according to one embodiment of the present invention.
  • Figure 6 shows another embodiment of a microneedle patch capable of basal layer separation of the present invention.
  • Figure 7 shows another embodiment of a microneedle patch capable of basal layer separation of the present invention.
  • Figure 8 shows another embodiment of a microneedle patch capable of basal layer separation of the present invention.
  • Figure 9 shows another embodiment of a microneedle patch capable of basal layer separation of the present invention.
  • first, second, etc. may be used to describe various components, but the components should not be limited by the terms. The terms are only used to distinguish one component from another.
  • the first component may be referred to as the second component, and similarly, the second component may also be referred to as the first component.
  • the term and/or includes any combination of a plurality of related described items or any item among a plurality of related described items.
  • microneedle patches require that the adhesive sheet made of polymer material be continuously attached to the skin surface after the procedure, 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.
  • a microneedle patch capable of separating the basal layer according to one embodiment of the present disclosure is intended to solve the above-described problem, 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 an active substance.
  • 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, being 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.
  • a predetermined solvent such as toner
  • 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.
  • 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.
  • 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 a portion of the basal layer (12) connected to the needle portion (11), but the connecting portion (13) may be a portion of the needle portion (11) connected to the basal layer (12), or may be an area of the microneedle patch (10) including a portion of the basal layer (12) connected to the needle portion (11) and a portion of the needle portion (11) connected to the basal layer (12).
  • the illustration of 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.
  • the needle portion (11) can be manufactured by injecting an active material (20) forming a microneedle array into a mold (1).
  • 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 arranged 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 arranged on the lower portion of the base layer (12), or can be injected onto both sides (not shown).
  • the active material (20) that can be used to form the needle portion (11) may include at least one of a pharmacologically active material or a cosmetically active material, but is not limited thereto, and for example, application of various materials including hyaluronic acid may be possible.
  • the active material will be 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, application of various materials including hyaluronic acid may be possible, but is not limited thereto.
  • 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.
  • spin coating can be used to form a base layer (12) surface of uniform thickness, or a doctor blade method using a coating blade (2) 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).
  • the base layer is then dried and cured (see (e) of Fig. 3).
  • 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 at the bottom of the microneedle patch, which may induce defects in the microneedle patch structure. In addition, since such an increase in drying time reduces the productivity of the microneedle patch, it is necessary to perform application and curing under the appropriate conditions as described above.
  • a microneedle patch (10) structure 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 can be dissolved by a predetermined solvent (see (f) of FIG. 3).
  • FIG. 4 illustrates one embodiment of a microneedle patch capable of separating the basal layer of the present invention.
  • a microneedle patch capable of separating the basal layer of the present invention will be described in more detail without limitation.
  • a microneedle patch (10) capable of separating the basal layer according to one 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 manufactured from a substance that is dissolved by 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 the dotted arrow in FIG. 4 (c), and the basal layer (12) is attached to the skin and maintained.
  • FIG. 4 of the present invention illustrates spraying a small amount of solvent to supply a predetermined solvent (30)
  • the method for supplying the solvent (30) is not limited to spraying, and various methods capable of supplying the solvent (30) may be used.
  • the base layer (12) 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).
  • the base layer (12) can be separated from the needle portion (11) by removing the base layer (12) within a predetermined time (not illustrated). 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.
  • 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, having an antioxidant effect, improving skin, etc.
  • Such active substances (20) may include, but are not limited to, various active substances such as, for example, specific disease-treating drugs with proven efficacy and safety, vitamins, minerals, amino acids, plant extracts, probiotics, prebiotics, hyaluronic acid, collagen, etc.
  • the soluble biocompatible material (21) which is a substance dissolved by a predetermined solvent, may include various materials having 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 substance having solubility among the above-described active substances forming the needle portion (11).
  • hyaluronic acid which may be one of the soluble biocompatible materials (21) forming 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.
  • 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 a 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.
  • 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, the needle portion (11) continuously injects the active substance (20) into the subcutaneous layer, so that the basal layer (12) can be removed within a short time after the procedure, thereby enabling daily life, while maintaining the effect of the active substance (20).
  • the dissolution time of the separable base layer (12) as described above can be determined by the amount of the solvent (30), for example, water in the case of hyaluronic acid, supplied (for example, sprayed) to at least one of the base layer (12) or the connecting portion (13).
  • the solvent (30) for example, water in the case of hyaluronic acid
  • This can satisfy the time required for medical and cosmetic aspects in which the base layer (12) must be maintained 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.
  • 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 micro needle patch (10) must be carried out carefully.
  • the basal layer (12) using hyaluronic acid it has the advantage of being able to be treated along the curvature of the skin because it has very high flexibility.
  • 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.
  • various soluble substances such as starch, carboxymethyl cellulose, polyvinyl alcohol, etc., which are water-soluble biopolymers, in addition to hyaluronic acid.
  • the one showing the best characteristics may be the hyaluronic acid mentioned in the above-mentioned embodiment, but is not limited thereto.
  • the hyaluronic acid presented as the soluble biocompatible material (21) is water-soluble, so water can be used as a predetermined solvent (30) to remove it, but the solvent is not limited thereto. It is obvious that the above principle can be applied 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 the present application.
  • 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).
  • the predetermined solvent (30) may include an active substance different from the active substance (20) contained in the needle portion (11).
  • an active substance (20) for alleviating skin irritation due to application of the microneedle patch (10) such as a serum
  • the serum may have the effect of actively alleviating skin irritation due to attachment of the microneedle patch (10) while simultaneously performing the role of a solvent for separation of the basal layer (12).
  • FIG. 5 is a drawing showing the dissolution of a microneedle patch according to one embodiment of the present invention.
  • 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.
  • 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 dissolved by 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 an active substance into the body, and the basal layer (12) is attached and maintained on the skin layer (see (c) of FIG. 6).
  • 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).
  • 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).
  • 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 dried together with the solvent supply pack (40) that delivers a predetermined solvent over a predetermined time and then removed together with the solvent supply pack (40) (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.
  • 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.
  • 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).
  • 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).
  • a bonding force may be generated between the solvent supply pack (40) and the dissolved base layer (12a) of the microneedle patch (10) by such drying, and in this case, the dissolved base layer (12a) of the microneedle patch (10) may be more easily separated from the needle portion (11) together with the solvent supply pack (40).
  • 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 material (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 material (20).
  • the base layer (12) 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.
  • 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 desirable for the base layer (12) to be maintained for a certain period of time to support the needle portion (11), and if not, the base layer (12) may be separated in a short period of time.
  • 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). Therefore, 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).
  • 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 after a predetermined time has elapsed, the base layer (12) can be separated from the needle portion (11) along with removal of the solvent supply pack.
  • the needle portion (11), the base layer (12), and the connecting portion (13) can be manufactured from the same active material (20) that is soluble in a predetermined solvent, and when the soluble active material (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.
  • 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.
  • the separation of the base layer (12) can be made easier.
  • FIG. 7 shows another embodiment of a microneedle patch capable of basal layer separation of the present invention.
  • Fig. 7 (a) is an enlarged view of part A of the microneedle patch (10) of Fig. 4 (d).
  • a microneedle patch according to one embodiment of the present invention may include a bubble structure (B) having a cavity in a connecting portion (13) between a needle portion (11) and a basal layer (12), as shown in Fig. 7 (b).
  • the cross-sectional area of the cavity at the wall surface position of the bubble structure (B) of the needle portion (11) that has penetrated the skin is wide at the time of insertion as shown in (b) of FIG. 7, but the hardening is weakened due to hydration or softening by a solvent in the state of being inserted into the skin, so that 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.
  • 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).
  • 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).
  • FIG. 8 shows another embodiment of a microneedle patch capable of basal layer separation 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 a needle portion (11) and a 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.
  • a solvent supply pack (40) containing a predetermined solvent capable of dissolving at least one of the basal layer (12) or the connection portion (13) and attached to the skin in addition to the basal layer (12) and delivering the predetermined solvent to at least one of the basal layer (12) or the connection portion (13) is provided, dissolution of at least one of the basal layer (12) or the connection portion (13) occurs.
  • the basal layer (12) is illustrated as being dissolved 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.
  • the dissolved base layer (12a) can be separated from the needle portion (11) within a predetermined time period. 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) over a predetermined time period (see (d) of FIG. 8).
  • 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 period.
  • the description of the solvent supply pack (40) is the same as that described above with respect to FIG. 6.
  • 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.
  • the solvent supply pack (40) and the dissolved base layer (12a) are dried together as shown in (c) and (d) of FIG.
  • 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 Fig. 9 (a) to (c)).
  • 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) is maintained in a state of being attached on the skin layer. Thereafter, an adhesive patch (50) can be attached on the basal layer (12) (see (d) of FIG. 9).
  • Such adhesive patches (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 portions. This is to provide a function of treating and protecting wounds, etc. while dissolving at least one of the basal layer (12) or the connecting portion (13) by the predetermined solvent (30) provided later and preventing the adhesive patch (50) from being detached from the skin.
  • 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.
  • 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).
  • 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 off, or washed off.
  • the adhesive patch (50) may be, for example, an adhesive hydrocolloid patch.
  • the technical idea of the present invention is not limited to the material of the adhesive patch (50) being hydrocolloid.

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Abstract

L'invention concerne un timbre à micro-aiguilles ayant une couche de base détachable. Le timbre à micro-aiguilles comprend : une partie à aiguilles contenant un matériau actif; la couche de base, qui assure le support mécanique pour la partie à aiguilles lorsque la partie à aiguilles est insérée dans la peau; et une partie de liaison disposée entre la partie à aiguilles et la couche de base et reliant celles-ci. Au moins l'une de la partie de liaison ou de la couche de base est constituée d'un matériau qui est dissous par un solvant prédéterminé, la partie à aiguilles reste dans la peau après avoir été insérée dans la peau, et au moins l'une de la partie de liaison ou de la couche de base est dissoute par le solvant prédéterminé de telle sorte que la couche de base se détache de la partie à aiguilles en un laps de temps prédéterminé.
PCT/KR2024/011888 2023-08-11 2024-08-09 Timbre à micro-aiguilles ayant une couche de base détachable Pending WO2025037862A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
KR20230105254 2023-08-11
KR10-2023-0105254 2023-08-11
KR10-2024-0006156 2024-01-15
KR1020240006156A KR20250024462A (ko) 2023-08-11 2024-01-15 기저층의 분리가 가능한 마이크로 니들 패치

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WO2025037862A1 true WO2025037862A1 (fr) 2025-02-20

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20160124646A (ko) * 2015-04-20 2016-10-28 주식회사 엘지생활건강 유효 성분의 흡수속도가 개선된 용해성 마이크로니들 디바이스 및 이를 포함하는 키트
KR101692266B1 (ko) * 2016-08-01 2017-01-03 부산대학교 산학협력단 마이크로니들 패치 및 이의 제조 방법
KR101925678B1 (ko) * 2016-06-15 2018-12-05 가천대학교 산학협력단 마이크로 니들 및 이의 제조방법
KR102323528B1 (ko) * 2019-09-06 2021-11-05 연세대학교 산학협력단 마이크로 니들 패치 및 마이크로 니들 시스템
WO2023017907A1 (fr) * 2021-08-12 2023-02-16 주식회사 페로카 Timbre à micro-aiguilles

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20160124646A (ko) * 2015-04-20 2016-10-28 주식회사 엘지생활건강 유효 성분의 흡수속도가 개선된 용해성 마이크로니들 디바이스 및 이를 포함하는 키트
KR101925678B1 (ko) * 2016-06-15 2018-12-05 가천대학교 산학협력단 마이크로 니들 및 이의 제조방법
KR101692266B1 (ko) * 2016-08-01 2017-01-03 부산대학교 산학협력단 마이크로니들 패치 및 이의 제조 방법
KR102323528B1 (ko) * 2019-09-06 2021-11-05 연세대학교 산학협력단 마이크로 니들 패치 및 마이크로 니들 시스템
WO2023017907A1 (fr) * 2021-08-12 2023-02-16 주식회사 페로카 Timbre à micro-aiguilles

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