WO2023120858A1 - Procédé de préparation de micro-aiguilles - Google Patents

Procédé de préparation de micro-aiguilles Download PDF

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Publication number
WO2023120858A1
WO2023120858A1 PCT/KR2022/011828 KR2022011828W WO2023120858A1 WO 2023120858 A1 WO2023120858 A1 WO 2023120858A1 KR 2022011828 W KR2022011828 W KR 2022011828W WO 2023120858 A1 WO2023120858 A1 WO 2023120858A1
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WO
WIPO (PCT)
Prior art keywords
layer
outer skin
microneedle
skin layer
manufacturing
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Application number
PCT/KR2022/011828
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English (en)
Korean (ko)
Inventor
이재준
배태근
Original Assignee
주식회사 페로카
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Publication of WO2023120858A1 publication Critical patent/WO2023120858A1/fr

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    • 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
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • 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
    • 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
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0023—Drug applicators using microneedles
    • 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
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0046—Solid microneedles
    • 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
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0053—Methods for producing microneedles
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0244—Micromachined materials, e.g. made from silicon wafers, microelectromechanical systems [MEMS] or comprising nanotechnology
    • 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
    • A61M2207/00—Methods of manufacture, assembly or production

Definitions

  • the present invention relates to a method for manufacturing a microneedle.
  • Drug injection into the human body has traditionally been performed by needle injection, but needle injection causes great pain. Therefore, a non-invasive drug injection method has also been developed, but there is a problem in that the amount of drug required is too large compared to the amount of injection.
  • DDS drug delivery system
  • microneedles can be characterized by painless skin penetration and no trauma.
  • a certain degree of physical hardness may be required because the microneedle must penetrate the stratum corneum of the skin.
  • an appropriate length may be required in order for the physiologically active material to reach the epidermal layer or the dermal layer of the skin.
  • the skin permeability of the "micro" needles must be high and maintained for a certain period of time until they are dissolved after being inserted into the skin.
  • microneedles capable of delivering drugs in precise amounts and accurately setting target positions
  • interest and research on manufacturing methods for manufacturing a large amount of microneedles are also increasing.
  • the present invention can provide a method for manufacturing a microneedle that can easily set and mount the location of an effective substance accommodated inside the microneedle and can effectively deliver a drug to a target location when penetrating into a user's body.
  • One embodiment of the present invention the step of applying a base material to the mold portion in which the mold groove portion is formed; drying the base material to form an outer skin layer; Injecting an effective material onto the outer skin layer; and connecting a cover layer to the outer skin layer while covering the outer skin layer and the active material disposed on the outer skin layer.
  • an accommodation groove having a predetermined depth may be formed in a region corresponding to the mold groove in the skin layer.
  • the active material may be injected into a hollow accommodation space formed inside the accommodation groove.
  • a protrusion insertable into the mold groove may protrude from one surface of the cover layer facing the mold groove.
  • one surface of the mold part facing the cover layer includes a first region in which the mold groove part is formed;
  • the method may further include removing an outer skin layer formed of a second region excluding the first region and located on the second region.
  • forming a bonding layer on the outer skin layer may further include.
  • forming a bonding layer on one surface of the cover layer facing the active material may further include.
  • the active substance may be a fat-soluble substance.
  • the mold groove portion may be formed with a relatively reduced cross-sectional area along the central axis in the longitudinal direction.
  • a partition wall having a predetermined height may protrude along an outer circumferential surface of the mold unit.
  • the outer skin layer and the cover layer are independently manufactured, and the solid-state outer skin layer and the separately manufactured solid-state cover layer are connected to rapidly manufacture the microneedle. There is an effect that can manufacture a needle.
  • a bonding layer is formed on the outer skin layer, and the bonding layer dissolves a predetermined area of the outer skin layer and the cover layer so that the outer skin layer and the cover layer can be connected to improve the airtightness of the inner space surrounded by the outer skin layer and the cover layer.
  • FIG. 1 is a flowchart illustrating a method of manufacturing a microneedle according to embodiments.
  • FIG. 2 is a view showing a state in which an outer skin layer is formed by injecting a base material into a mold part.
  • FIG. 3 is a view showing a state in which an effective material is injected onto an outer skin layer disposed in a mold unit.
  • FIG. 4 is a view showing a state in which an effective material in a preset area on the outer skin layer is removed.
  • FIG. 5 is a view showing a state in which a bonding layer is disposed on the skin layer and the effective material in FIG. 4 .
  • FIG. 6 is a view showing a state in which a cover layer is connected to an outer skin layer according to an embodiment of the present invention.
  • FIG. 7 is a perspective view illustrating a microneedle according to an embodiment of the present invention.
  • FIG. 8 is a flowchart illustrating steps of forming an outer skin layer according to another embodiment of the present invention.
  • FIG. 9 is a view showing a state in which a removal material is applied on the outer skin layer.
  • FIG. 10 is a view showing a state in which the skin layer in a preset area on the mold unit is removed.
  • FIG. 11 is a view showing a state in which an effective material is injected into a mold part.
  • FIG. 12 is a view showing a state in which a bonding layer is disposed on an outer skin layer and an active material.
  • FIG. 13 is a view showing a state in which a cover layer is connected to an outer skin layer according to another embodiment of the present invention.
  • FIG. 14 is a view showing the creation of a bonding layer on a cover layer according to another embodiment of the present invention.
  • 15 is a view showing a state in which a cover layer is connected to an outer skin layer according to another embodiment of the present invention.
  • FIG. 1 is a flowchart illustrating a method of manufacturing a microneedle according to embodiments.
  • 2 is a view showing a state in which an outer skin layer is formed by injecting a base material into a mold part.
  • 3 is a view showing a state in which an effective material is injected onto an outer skin layer disposed in a mold unit.
  • 4 is a view showing a state in which an effective material in a preset area on the outer skin layer is removed.
  • FIG. 5 is a view showing a state in which a bonding layer is disposed on the skin layer and the effective material in FIG. 4 .
  • 6 is a view showing a state in which a cover layer is connected to an outer skin layer according to an embodiment of the present invention.
  • 7 is a perspective view illustrating a microneedle according to an embodiment of the present invention.
  • the microneedle 1 may include an outer skin layer 10, an active material 20, and a cover layer 40.
  • the outer skin layer 10 forms the outer skin of the microneedle 1, and as the base material applied to the mold unit 100 dries, the microneedle It forms the appearance of (1), and may be formed extending along the longitudinal direction (up and down directions based on FIG. 7).
  • the microneedle 1 shown in FIG. 7 shows the state of the outer layer 10 after the base material is dried, and the outer layer 10 is manufactured by the microneedle manufacturing method according to an embodiment of the present invention. The appearance of the microneedle 1 is formed.
  • the inside of the outer layer 10 forming the outer shell of the microneedle 1 according to an embodiment of the present invention is formed hollow, and an active material 20 to be described later is inside the outer layer 10. ) can be accommodated, and a cover layer 40 to be described later can be coupled to one end (lower end in reference to FIG. 7) of the outer skin layer 10.
  • the outer skin layer 10 may have a shape corresponding to the mold groove 103 formed in the mold part 100, and may have a shape corresponding to the mold groove 103 in the longitudinal direction (refer to FIG. 7). It may be formed such that the cross-sectional area relative to the central axis in the longitudinal direction decreases toward one side (upper side in FIG. 7 ) along the vertical direction).
  • a sharpened tip may be formed at one end of the microneedle 1, specifically, the outer skin layer 10.
  • the base material forming the outer skin layer 10 of the microneedle 1 manufactured by the microneedle manufacturing method may be formed of hyaluronic acid.
  • Hyaluronic acid is used to include not only hyaluronic acid but also hyaluronic acid salts (eg, sodium hyaluronate, potassium hyaluronate, magnesium hyaluronate and calcium hyaluronate) and mixtures thereof.
  • Hyaluronic acid is used as a meaning including cross-linked hyaluronic acid and/or non-cross-linked hyaluronic acid.
  • the hyaluronic acid of the present invention has a molecular weight of 2 kDa to 5000 kDa.
  • the hyaluronic acid has a molecular weight of 100-4500, 150-3500, 200-2500 kDa, 220-1500 kDa, 240-1000 kDa or 240-490 kDa.
  • the base material forming the outer skin layer 10 is dissolved after passing through the user's skin in a solid state and entering the user's body, and the active substance 20 accommodated inside the outer skin layer 10 Modifications such as being formed of various water-soluble materials are possible within the technical concept of being absorbed into the user's body.
  • a base material according to an embodiment of the present invention may be injected and applied onto the mold part 100 where the mold groove part 103 is formed.
  • a base material according to an embodiment of the present invention may be injected into the mold part 100, and specifically, one surface of the mold part 100 where the mold groove part 103 is formed (Fig. 2 reference top surface).
  • the base material may be injected into the mold part 100 through an external device in a fluid state, and the base material injected into the mold part 100 may form the skin layer 10 while being dried.
  • the mold groove part 103 is formed in the shape of a groove part in a region set in advance on the one surface of the mold part 100, and the tip tip ST is formed. It is possible to determine the shape of one end (top end of FIG. 7) of the microneedle 1 to be.
  • the mold groove portion 103 may be formed with a relatively reduced cross-sectional area along the central axis in the longitudinal direction. That is, the cross-sectional area may decrease toward one side (lower side in FIG. 2 ).
  • the shape of the outer circumferential surface of the outer skin layer 10 formed after a base material is applied and dried on one surface of the mold part 100 where the mold groove part 103 is formed (the upper surface in reference to FIG. 2 ) is the mold groove part 103 ) is formed to correspond to the shape of the inner circumferential surface, and the tip tip ST can be formed at one end of the outer skin layer 10 (top end in FIG. 7).
  • an accommodating groove 11 is formed in an area on the outer layer 10 corresponding to the mold groove 103, and as the base material dries, the outer layer 10 has a predetermined thickness on the accommodating groove 11. This may be formed, and the outer skin layer 10 may form the outer skin of the microneedle 1.
  • an accommodating groove 11 is formed in an area on the outer skin layer 10 corresponding to the mold groove 103 according to an embodiment of the present invention, and an accommodation space formed inside the accommodating groove 11
  • the active substance 20 may be accommodated in (AS).
  • the active material 20 is a material accommodated inside the microneedle 1, and can be accommodated inside the space surrounded by the outer skin layer 10 and the cover layer 40 to be described later. there is.
  • the first material may be accommodated in the accommodating space AS formed inside the accommodating groove 11 of the outer skin layer 10 formed close to the tip ST formed in the microneedle 1.
  • the active substance 20 according to an embodiment of the present invention can be absorbed into the user's body and can be formed of a fat-soluble substance.
  • the tip (ST) formed at one end of the microneedle (1) passes through the user's skin and is injected into the user's body, and when the outer skin layer (10) formed of the base material is dissolved, the outer skin layer (10) Allows the active substance 20 accommodated inside to be absorbed into the user's body.
  • the effective material 20 can be variously modified, such as being formed of a mixture of a fat-soluble material and a water-soluble material.
  • the active material 20 is formed of a single material, but is not limited thereto, and may be formed of different materials and formed in a multi-layered structure.
  • an active material 20 is injected into one surface of the mold part 100 where the mold groove part 103 is formed (upper surface in reference to FIG. 3 ), and the active material 20 is different from two or more materials.
  • each material can be sequentially injected and injected at different heights in the inner region of the receiving groove 11 formed in the outer skin layer 10, and the microneedle 1 can be injected into the user's body. After being injected, as the outer skin layer 10 dissolves, it can be absorbed into the user's body by changing its location.
  • the receiving groove 11 formed in the outer skin layer 10 may be concavely formed in an outward direction (upward direction based on FIG. 2 ).
  • the accommodating groove 11 may be formed with a curved section having a predetermined curvature.
  • the active substance 20 accommodated in the receiving groove 11 can be disposed close to the tip tip ST formed at one end of the outer skin layer 10 (lower end in reference to FIG. 3), and the microneedle 1 After being injected into the body of the user, the effective substance 20 can be precisely delivered and absorbed to the target location.
  • the cover layer 40 is provided at the other end opposite to one end (lower end based on FIG. 6) where the tip tip ST is formed. can be placed.
  • the cover layer 40 is connectable to the outer skin layer 10, and the other end opposite to one end (lower end based on FIG. 6) of the outer skin layer 10 on which the tip tip ST is formed ( It may be connected to the upper part of FIG. 6).
  • the cover layer 40 may be produced separately from the outer skin layer 10, and may be formed as a solid after a separate drying process. As the cover layer 40 and the outer layer 10 are connected, the inner area surrounded by the cover layer 40 and the outer layer 10 can be sealed, and the active material 20 can be accommodated in the inner area.
  • the cover layer 40 covers the outer skin layer 10 and can be dissolved after entering the user's body in a state connected to the outer skin layer 10.
  • the cover layer 40 may be formed of the same material as the base material forming the outer skin layer 10 .
  • the cover layer 40 may be formed of hyaluronic acid.
  • the hyaluronic acid forming the cover layer 40 includes not only hyaluronic acid but also hyaluronic acid salts (eg, sodium hyaluronate, potassium hyaluronate, magnesium hyaluronate and calcium hyaluronate) and It is used in the sense of including all mixtures thereof.
  • Hyaluronic acid is used as a meaning including cross-linked hyaluronic acid and/or non-cross-linked hyaluronic acid.
  • the hyaluronic acid of the present invention has a molecular weight of 2 kDa to 5000 kDa.
  • the hyaluronic acid has a molecular weight of 100-4500, 150-3500, 200-2500 kDa, 220-1500 kDa, 240-1000 kDa or 240-490 kDa.
  • the material forming the cover layer 40 passes through the user's skin in a solid state and is dissolved after entering the user's body, and the active substance 20 accommodated inside the outer skin layer 10 Modifications such as being formed of various materials are possible within the technical concept of being absorbed into the user's body.
  • the cover layer 40 may be formed of a water-soluble material similar to the base material constituting the outer skin layer 10.
  • a bonding layer 30 may be formed on the outer skin layer 10 according to an embodiment of the present invention, and the outer skin layer 10 and the cover layer are formed through the bonding layer 30 (40) can be combined.
  • the bonding layer 30 may be formed of a material capable of dissolving the outer skin layer 10 and the cover layer 40 .
  • the material forming the bonding layer 30 may be formed of a water-soluble material.
  • the material forming the bonding layer 30 may be formed of water (H2O).
  • a material forming the bonding layer 30 according to an embodiment of the present invention is applied on the outer skin layer 10, and the upper region of the outer skin layer 10 may be partially dissolved.
  • a cover layer 40 is disposed on the bonding layer 30 that partially dissolves the skin layer 10, and the bonding layer 30 partially dissolves the lower region of the cover layer 40, thereby The skin layer 10 and the cover layer 40 may be bonded.
  • the microneedle 1 according to an embodiment of the present invention is applied on the outer layer 10 after the outer layer 10 and the cover layer 40 are independently dried, and the outer layer 10 and the cover layer 40 are respectively dried. It can be connected to each other through the bonding layer 30 formed while partially dissolving.
  • the base material which is a fluid
  • the active material 20 is injected, and then the outer layer 10 and the active material 20 are similarly formed.
  • the outer layer 10 and the cover layer 40 are independently manufactured, and then the outer layer 10 is formed through the bonding layer 30 Since the microneedle 1 can be manufactured by connecting the microneedle 1 and the cover layer 40, the manufacturing process is simplified and the microneedle 1 can be rapidly manufactured.
  • a protrusion 41 insertable into the mold groove 103 protrudes from one side of the cover layer 40 facing the mold groove 103 according to an embodiment of the present invention (the lower surface of FIG. 6). can be formed
  • the cover layer 40 disposed at the other end opposite to the end where the tip tip ST is formed in the microneedle 1 according to an embodiment of the present invention has a support (not shown) can be connected.
  • the support part supports the microneedle 1, and one surface of the support part connected to the microneedle 1 may contact the skin, and the other surface opposite to the support part may be exposed to the outside.
  • the support may be removed when the microneedle 1 is implanted into the skin.
  • the support may be removed from the skin by force applied by the user.
  • the support may dissolve relatively later than the microneedle 1 .
  • the support is formed of a dissolvable material, and can be removed from the skin by applying a material for dissolution by the user if necessary.
  • the support may include any one of the material included in the microneedle 1, the active material 20, the base material forming the outer layer 10, and the material forming the cover layer 40.
  • the support may include a biodegradable material like the microneedle 1 .
  • the microneedle 1 may have various shapes.
  • the microneedle 1 may have a cone shape.
  • the upper end of the microneedle 1 at which the tip ST is formed is formed in a quadrangular pyramid shape, but is not limited thereto and may have a polygonal shape such as a cone shape, a triangular pyramid shape, or a quadrangular pyramid shape.
  • the method for manufacturing a microneedle includes applying a base material to a mold part (S10), forming an outer skin layer (S20), and an active material on the outer layer. It may include injecting (S30), forming a bonding layer (S30), and connecting the cover layer (S50).
  • the base material in the step of applying the base material to the mold part (S10), may be applied by injecting the base material into the inner space of the mold part 100 through an external device.
  • a base material may be injected into one surface of the mold part 100 where the mold groove part 103 is formed (upper surface in FIG. 2 ), and the space into which the base material is injected is formed along the outer circumference of the mold part 100 . It means a space formed inside the partition wall portion 101 to be.
  • one side (upper side based on FIG. 2 ) is open, and a partition wall part 101 is formed at a predetermined height along the outer circumference, and the partition wall part 101 )
  • the base material may be injected into the inner space surrounded by.
  • a mold groove 103 is formed on one surface of the mold part 100 (upper surface with reference to FIG. 2 ).
  • a base material having a thickness may be applied, and the skin layer 10 constituting the exterior of the microneedle 1 may be formed by drying the base material.
  • the base material injected in a fluid state into the mold unit 100 may be dried while being solidified after a predetermined time, and the outer layer 10 may be formed.
  • An accommodation groove 11 may be formed with a predetermined depth.
  • an inner space of the accommodating groove 11 may be hollow, and an accommodating space AS may be formed.
  • An active substance 20 may be injected into the receiving space AS, and when the microneedle 1 is manufactured, the active substance 20 is positioned inside the microneedle 1, specifically, the outer skin layer 10. do.
  • the receiving groove 11 formed in the outer skin layer 10 may be formed such that its cross-sectional area decreases in the depth direction (from the top to the bottom in FIG. 2), and the inner circumferential surface of the receiving groove 11 is It may be concavely formed toward the direction (upward direction based on FIG. 2 ).
  • the inner circumferential surface of the receiving groove 11 is formed in a curved shape with a predetermined radius of curvature toward the outside, but is not limited thereto, and the tip formed on the outer skin layer 10 Various modifications are possible, such as being formed flat within the technical concept of decreasing the cross-sectional area in a direction approaching the tip ST.
  • the active material 20 is applied onto the outer skin layer 10 formed in a solid state by drying the base material. This is the injection stage.
  • the active material 20 is injected into the mold unit 100 and may be applied on the outer skin layer 10 disposed inside the mold unit 100 .
  • the receiving groove 11 which is an area on the outer skin layer 10 corresponding to the mold groove 103 formed in the mold unit 100
  • the active material 20 may also be applied to the area on the outer skin layer 10 corresponding to the remaining area except for.
  • the outer layer 10 corresponding to the remaining area except for the receiving groove 11 A step of removing the active material 20 applied to the upper region may be included.
  • the active material 20 applied to the area on the outer skin layer 10 excluding the area where the receiving groove 11 is formed may be removed by scratching or washing through an external device.
  • the area on the outer skin layer 10 may include a first area where the accommodating groove 11 is formed and a second area excluding the first area.
  • the active material 20 may be injected into the first area where the accommodating groove 11 is formed, and the active material 20 located on the second area of the outer skin layer 10 may be removed.
  • the active substance 20 is one in which the outer skin layer 10 is dissolved and absorbed into the user's body after the microneedle 1 is injected into the user's body, and may be formed of a fat-soluble material.
  • the active material 20 can be accommodated in the accommodation space AS formed inside and surrounded by the outer skin layer 10 and the cover layer 40, There is an effect of effectively sealing the accommodating space (AS).
  • forming a bonding layer according to an embodiment of the present invention is a step of forming a bonding layer 30 on the outer layer 10, and A bonding layer 30 may be formed in the region.
  • the bonding layer 30 may be made of a fluid, and the fluid may be injected and applied onto the outer skin layer 10 .
  • the bonding layer 30 is formed on the skin layer 10 formed by drying the base material, and the material forming the bonding layer 30 may be water (H2O).
  • the material forming the bonding layer 30 may be formed of the same material as the base material forming the outer skin layer 10 .
  • the material forming the bonding layer 30 may be formed of hyaluronic acid.
  • the step of connecting the cover layer (S50) covers the outer layer 10 and the active material 20 disposed on the outer layer 10 and connects the cover layer 40 to the outer layer 10.
  • it may be manufactured separately from the outer skin layer 10 and formed in an already dried solid state.
  • the cover layer 40 in a solid state enters the inside of the mold part 100 through one side opened on the mold part 100 (upper side in FIG. 6 ), and the bonding layer 30 Covering the formed outer skin layer 10 may be connected.
  • one side of the cover layer 40 facing the outer skin layer 10 may come into contact with the bonding layer 30 formed on the outer layer 10 .
  • cover layer 40 may be formed of the same material as the base material forming the outer skin layer 10 .
  • cover layer 40 may be formed of a water-soluble material.
  • the cover layer 40 may be formed of hyaluronic acid.
  • one surface of the cover layer 40 in contact with the bonding layer 30 is dissolved by the bonding layer 30 and can be connected to the outer layer 10 accommodating the active material 20 .
  • the bonding layer 30 is disposed between the outer skin layer 10 and the cover layer 40, this is expressed for ease of understanding, and the bonding layer 30 is placed on both sides (top and bottom based on FIG. 6). side), there is an effect that the outer layer 10 and the cover layer 40 can be combined by dissolving each side of the outer layer 10 and the cover layer 40.
  • the microneedle 1 can be manufactured by connecting the cover layer 40 to the outer skin layer 10 in which the active material 20 is accommodated and drying the mold unit 100 .
  • the bonding layer 30 connects the outer skin layer 10 and the cover layer 40
  • the accommodation space AS which is the inner space of the area surrounded by the outer skin layer 10 and the cover layer 40, remains sealed, It can accommodate the active substance 20, and after the microneedle 1 is injected into the body, the outer skin layer 10 and the cover layer 40 are dissolved, and then the active substance 20 can be effectively delivered to the user's body. there is.
  • the active material 20 accommodated inside the microneedle 1 is formed of a fat-soluble material, but is not limited thereto, and may be formed of a mixture of a fat-soluble material and a water-soluble material, and various modifications are carried out. is possible
  • the active material 20 may be accommodated in the accommodating space AS, which is an inner space of the accommodating groove 11 formed in the outer skin layer 10 in a multi-layer structure in which two different materials form a layer.
  • the microneedle 1 can be manufactured, and the cover layer 40 and The microneedle 1 that can be injected into the user's body can be manufactured by adjusting the area where the outer skin layer 10 forms the laminated structure.
  • the outer skin layer 10 and the cover layer 40 are independently manufactured, and the solid-state cover layer 40 manufactured separately from the solid-state outer skin layer 10 There is an effect that can quickly manufacture the microneedle (1) by connecting the microneedle (1).
  • a bonding layer 30 is formed on the outer layer 10, and the bonding layer 30 dissolves a predetermined area of the outer layer 10 and the cover layer 40 so that the outer layer 10 and the cover layer 40 are formed. There is an effect of improving the airtightness of the inner space surrounded by the outer skin layer 10 and the cover layer 40 by enabling the connection.
  • FIG. 8 is a flowchart illustrating steps of forming the skin layer 10 according to another embodiment of the present invention.
  • 9 is a view showing a state in which a removal material is applied on the outer skin layer 10.
  • FIG. 10 is a view showing a state in which the outer skin layer 10 in a preset area on the mold unit 100 is removed.
  • FIG. 11 is a view showing a state in which the active material 20 is injected into the mold part 100 .
  • 12 is a view showing a state in which the bonding layer 30 is disposed on the outer skin layer 10 and the active material 20.
  • 13 is a view showing a state in which the cover layer 40 is connected to the outer skin layer 10 according to another embodiment of the present invention.
  • a method for manufacturing a microneedle includes applying a base material to a mold part (S10), and drying the base material to form an outer skin layer. (S20), injecting the active material 20 onto the outer layer 10 (S30), forming a bonding layer (S40), and connecting the cover layer (S50).
  • the microneedle manufacturing method according to another embodiment of the present invention differs in the step of drying the base material to form the outer skin layer (S20). In this section, we will focus on this part.
  • the outer layer 10 is formed on the remaining area except for the predetermined area of the mold part 100, specifically, the area where the mold groove part 103 is formed.
  • a removing step (S21) may be included.
  • the base material is applied on one surface of the mold part 100 (top surface in reference to FIG. 9), and the area where the mold groove part 103 is formed
  • the first area A1 is referred to and the remaining area excluding the first area is referred to as a second area A2
  • the second area of the mold part 100 The outer skin layer 10 formed on it may be removed.
  • a removal material RM may be applied on the outer skin layer 10, and the outer layer 10 formed on the second area A2 of the mold part 100 by the removal material RM is dissolves and can be removed.
  • the removal material RM may be formed of water (H2O).
  • the removal material RM may be formed of the same material as the base material forming the outer skin layer 10 .
  • the base material applied on the mold groove 103 is dried, and the outer skin layer formed on the second region except for the outer skin layer 10 in which the receiving groove 11 is formed ( 10) may be removed from the mold part 100 through an external device.
  • an active material 20 may be injected into the mold unit 100 (S30).
  • the active substance 20 accommodated in the accommodating space AS which is the inner space of the accommodating groove 11 formed in the outer skin layer 10
  • the excluded active material 20 may be removed by an external device or the like.
  • a material for forming the bonding layer 30 may be applied on the mold unit 100 .
  • the material forming the bonding layer 30 may be water or a water-soluble material.
  • the bonding layer 30 can dissolve one side (upper side in FIG. 12) of the outer skin layer 10, and then, in the step of connecting the cover layer (S50), the cover layer 40, specifically the cover In the layer 40, one side of the protruding portion 41 protruding to be inserted into the mold groove portion 103 (lower side in FIG. 13) is dissolved, and the cover layer 40 and the outer layer 10 can be connected.
  • the outer skin layer 10, the bonding layer 30, and the cover layer 40 are shown as being sequentially stacked, but the bonding layer 30 is the top of the cover layer 40.
  • the boundary of the bonding layer 30 may not be clear, and due to the bonding layer 30, the cover layer 40 and the outer layer 10 This can be connected, there is an effect that the airtightness of the accommodating space (AS) that is surrounded by the cover layer 40 and the outer skin layer 10 and accommodates the active material 20 can be improved.
  • AS accommodating space
  • the step of drying the base material to form the outer layer 10 (S21) is the step of removing the outer layer 10 on the second region of the mold unit 100 (
  • 14 is a view showing the creation of the bonding layer 30 on the cover layer 40 according to another embodiment of the present invention.
  • 15 is a view showing a state in which the cover layer 40 is connected to the outer skin layer 10 according to another embodiment of the present invention.
  • a method for manufacturing a microneedle includes applying a base material to a mold part (S10), Forming the skin layer by drying (S20), injecting the active material 20 onto the skin layer 10 (S30), forming a bonding layer (S40), and connecting the cover layer (S50).
  • a base material to a mold part (S10)
  • injecting the active material 20 onto the skin layer 10 S30
  • forming a bonding layer S40
  • connecting the cover layer S50.
  • microneedle manufacturing method of the present invention has a difference in the step (S40) of forming the bonding layer compared to the microneedle manufacturing method according to an embodiment of the present invention, the following will focus on this part. let it do
  • forming a bonding layer according to another embodiment of the present invention is a step of forming a bonding layer 30 on one side of the cover layer 40, and the outer layer 10 through an external device.
  • the bonding layer 30 may be formed by spraying and coating a material constituting the bonding layer 30 on one surface of the cover layer 40 facing the ) (when referring to FIG. 14).
  • a predetermined area of the cover layer 40 that can be formed of a water-soluble material is a bonding layer ( 30) can be dissolved.
  • the bonding layer 30 is formed, and the cover in a state where a predetermined area on one side facing the outer skin layer 10 (lower side in FIG. 15) is dissolved.
  • the layer 40 covers the outer skin layer 10 and can be connected to the outer layer 10, and due to the bonding layer 30, a predetermined area on one side of the outer skin layer 10 (upper side in FIG. 15) is dissolved, and the cover layer 40 There is an effect that can connect the outer skin layer (10).
  • the outer skin layer 10, the bonding layer 30, and the cover layer 40 are shown as being sequentially stacked, but the bonding layer 30 is the top of the cover layer 40.
  • the boundary of the bonding layer 30 may not be clear, and due to the bonding layer 30, the cover layer 40 and the outer layer 10 This can be connected, and there is an effect that the airtightness of the accommodation space (AS) that is surrounded by the cover layer 40 and the outer skin layer 10 and accommodates the active material 20 can be improved.
  • AS accommodation space
  • the bonding layer 30 is formed on one surface of the cover layer 40 (referring to FIG. 14) and a predetermined area is melted by the bonding layer 30.
  • a method for manufacturing a microneedle according to an embodiment of the present invention except that the cover layer 40 is connected to the outer layer 10, applying a base material to the mold part (S10), and drying the base material to the outer layer Since the configuration and effects of the step of forming (S20), the step of injecting the active material 20 onto the outer skin layer 10 (S30), and the step of connecting the cover layer (S50) are the same, detailed descriptions are provided to the extent that they overlap. is omitted.
  • a method for manufacturing a microneedle is provided.
  • the embodiments of the present invention can be applied to a method of manufacturing a microneedle that is attached to the skin for industrial use and delivers drugs.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Dermatology (AREA)
  • Medical Informatics (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

La présente invention concerne un procédé de préparation de micro-aiguilles comprenant les étapes consistant à : appliquer un matériau de base sur une partie moule présentant une partie rainure de moule ; former une couche de revêtement externe par séchage du matériau de base ; injecter un matériau actif sur la couche de revêtement externe ; et recouvrir la couche de revêtement externe et le matériau actif situé sur la couche de revêtement externe, et relier une couche de revêtement à la couche de revêtement externe.
PCT/KR2022/011828 2021-12-20 2022-08-09 Procédé de préparation de micro-aiguilles WO2023120858A1 (fr)

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KR10-2021-0182999 2021-12-20
KR1020210182999A KR20230093948A (ko) 2021-12-20 2021-12-20 마이크로니들의 제조방법

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101983970B1 (ko) * 2017-01-04 2019-05-30 (주) 지나인바이오사이언스 다단구조 마이크로니들 패치 및 이의 제조방법
CN110974891A (zh) * 2019-12-23 2020-04-10 广州新济薇娜生物科技有限公司 用于减肥的微针贴片及其制备方法
CN113750079A (zh) * 2021-09-01 2021-12-07 浙江大学 一种双层微针贴片及其制备方法

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Publication number Priority date Publication date Assignee Title
KR101983970B1 (ko) * 2017-01-04 2019-05-30 (주) 지나인바이오사이언스 다단구조 마이크로니들 패치 및 이의 제조방법
CN110974891A (zh) * 2019-12-23 2020-04-10 广州新济薇娜生物科技有限公司 用于减肥的微针贴片及其制备方法
CN113750079A (zh) * 2021-09-01 2021-12-07 浙江大学 一种双层微针贴片及其制备方法

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Title
JANG, DOSHI, NERAYO, CAPRIO, ALAIE, AUGE, MIN, MOSADEGH, DUNHAM: "Microneedle Patterning of 3D Nonplanar Surfaces on Implantable Medical Devices Using Soft Lithography", MICROMACHINES, vol. 10, no. 10, 1 January 2019 (2019-01-01), pages 1 - 12, XP093074556, DOI: 10.3390/mi10100705 *
SURIYAAMPORN PHUVAMIN, OPANASOPIT PRANEET, RANGSIMAWONG WORRANAN, NGAWHIRUNPAT TANASAIT: "Optimal Design of Novel Microemulsions-Based Two-Layered Dissolving Microneedles for Delivering Fluconazole in Treatment of Fungal Eye Infection", PHARMACEUTICS, vol. 14, no. 3, 1 January 2022 (2022-01-01), pages 1 - 24, XP093074559, DOI: 10.3390/pharmaceutics14030472 *

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