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WO2022108184A1 - Microstructure à faible irritation - Google Patents

Microstructure à faible irritation Download PDF

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Publication number
WO2022108184A1
WO2022108184A1 PCT/KR2021/015703 KR2021015703W WO2022108184A1 WO 2022108184 A1 WO2022108184 A1 WO 2022108184A1 KR 2021015703 W KR2021015703 W KR 2021015703W WO 2022108184 A1 WO2022108184 A1 WO 2022108184A1
Authority
WO
WIPO (PCT)
Prior art keywords
region
microstructure
needle body
support wing
support
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.)
Ceased
Application number
PCT/KR2021/015703
Other languages
English (en)
Korean (ko)
Inventor
김용희
라히지샤얀 파크레이
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.)
Industry University Cooperation Foundation IUCF HYU
Original Assignee
Industry University Cooperation Foundation IUCF HYU
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 KR1020210102891A external-priority patent/KR102685381B1/ko
Application filed by Industry University Cooperation Foundation IUCF HYU filed Critical Industry University Cooperation Foundation IUCF HYU
Publication of WO2022108184A1 publication Critical patent/WO2022108184A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • 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
    • 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

Definitions

  • the present invention relates to a microstructure, and more particularly, to a hypoallergenic microstructure capable of minimizing irritation during skin penetration.
  • Administration routes for delivering drugs to the body include oral, injection, transdermal, and the like.
  • Oral administration is a convenient administration that can increase patient compliance, and the active ingredient is delivered to the body in the form of capsules, tablets, or syrups.
  • active ingredients may be inactivated due to first-pass metabolism in the liver, and in fact, the absorption rate of biopharmaceuticals is relatively low. Therefore, in order to express the precise and rapid efficacy of drugs and therapeutic agents, they are administered to the human body by piercing the skin barrier in the form of injections.
  • When delivered in the form of injection there is an advantage in that the activity of the active ingredient is maintained, but there are disadvantages such as the risk of infection, incorrect dose administration, phobia, and pain.
  • microstructures are mainly manufactured in the form of biodegradable/dissolving, solid, coating, and hollow.
  • the biodegradable microstructure is a transdermal delivery that can deliver drugs without pain by formulating various substances including polymers and active ingredients (API/cosmetics or pharmaceuticals) in the form of fine needles, and by dissolving the loaded substances by body fluids after skin insertion it is a system
  • the existing microstructure is composed of a base film and a microneedle, and the microneedle is mainly provided in the form of a cone or polygonal pyramid.
  • microneedles gradually increase in width as they are adjacent to the base film, they cause great irritation when penetrating the skin.
  • the microneedle is broken or cannot be accurately inserted into the skin depending on the direction and magnitude of the force.
  • the present invention provides a hypoallergenic microstructure that minimizes skin irritation and enables quantitative drug delivery.
  • the microstructure according to the present invention includes a base film; and a plurality of microneedles formed on one surface of the base film, wherein the microneedles have a columnar first area protruding from one surface of the base film to a predetermined height, and extending from the first area and the end thereof It includes a needle body having a second area that gradually decreases in width toward the .
  • the width of the first region may be 10 ⁇ m to 750 ⁇ m, and a tip having an angle between 10 degrees and 60 degrees may be formed at the end of the second region.
  • microneedle may further include support wings arranged in plurality around the needle body, connecting the outer surface of the needle body and the base film, and having a thickness thinner than that of the first region.
  • an upper end of the support wing may be positioned lower than an upper end of the first region.
  • the upper end of the support wing may be located at the same height as the upper end of the first region.
  • the upper end of the support wing may be located at the same height as the end of the second region.
  • the support wing may gradually decrease in thickness as it moves away from the center of the needle body.
  • the outer edge of the support wing may include a first corner region extending from the upper end at a first angle, and a second corner region extending from the first corner region at a second angle different from the first angle.
  • the support wing is a first support wing located on one side of the needle body; and a second support wing positioned on the opposite side of the first support wing with respect to the needle body, wherein the first support wing and the second support wing may have different thicknesses.
  • the microneedle can minimize the width of the needle body by providing the support wings, the occurrence of irritation during skin insertion can be minimized. And since the microstructure can maintain a state in close contact with the skin, the microstructure can be dissolved and penetrate the skin within a short time, enabling quantitative drug delivery. In addition, since the support wings connect the needle body and the base film, breakage of the microneedle can be prevented in the process of being separated from the mold or penetrating the skin.
  • FIG. 1 is a perspective view showing a microstructure according to an embodiment of the present invention.
  • FIG. 2 is an enlarged view of the microneedle shown in FIG. 1 .
  • 3 to 5 are views showing microneedles according to various embodiments of the present invention.
  • FIG. 6 and 7 are views showing a microneedle according to another embodiment of the present invention.
  • FIG. 8 is a view showing a needle body according to another embodiment of the present invention.
  • FIG. 9 is a view showing a cross-section of a support wing according to various embodiments of the present disclosure.
  • FIG. 10 is a view showing a cross-section of a support wing according to various embodiments of the present invention.
  • FIG. 11 is a cross-sectional view illustrating an arrangement of support wings according to various embodiments of the present disclosure.
  • FIG. 12 is an image showing a microstructure and a microneedle manufactured according to an embodiment of the present invention.
  • FIG. 13 is a view showing a process of penetrating the microstructure into the skin according to an embodiment of the present invention.
  • FIG. 14 is a view showing a process of penetrating the microstructure according to a comparative example into the skin.
  • the microstructure according to the present invention includes a base film; and a plurality of microneedles formed on one surface of the base film, wherein the microneedles have a columnar first area protruding from one surface of the base film to a predetermined height, and extending from the first area and the end thereof It includes a needle body having a second area that gradually decreases in width toward the .
  • first, second, third, etc. are used to describe various components, but these components should not be limited by these terms. These terms are only used to distinguish one component from another. Accordingly, what is referred to as a first component in one embodiment may be referred to as a second component in another embodiment.
  • a first component in one embodiment may be referred to as a second component in another embodiment.
  • Each embodiment described and illustrated herein also includes a complementary embodiment thereof.
  • 'and/or' is used in the sense of including at least one of the components listed before and after.
  • connection is used in a sense including both indirectly connecting a plurality of components and directly connecting a plurality of components.
  • microstructure according to various embodiments of the present invention may be loaded with a drug to deliver the drug through the skin of the body.
  • a drug means a broad concept, and includes energy, nano-components, cosmetic ingredients (eg, wrinkle improvement agents, skin aging inhibitors and skin whitening agents), cell culture solutions, as well as therapeutic agents for therapeutic purposes in a narrow sense.
  • cosmetic ingredients eg, wrinkle improvement agents, skin aging inhibitors and skin whitening agents
  • cell culture solutions as well as therapeutic agents for therapeutic purposes in a narrow sense.
  • the therapeutic agent includes chemical drugs, protein/peptide drugs, peptide drugs, nucleic acid molecules for gene therapy, and the like.
  • protein/peptide drugs include hormones, hormone analogs, enzymes, enzyme inhibitors, signal transduction proteins or parts thereof, antibodies or parts thereof, single-chain antibodies, binding proteins or binding domains thereof, antigens, adhesion proteins, structural proteins, regulatory proteins, Toxin proteins, cytokines, transcriptional regulatory factors, blood coagulation factors and vaccines may be included.
  • the protein / peptide drug is insulin, IGF-1 (insulin-like growth factor 1), growth hormone, erythropoietin, G-CSFs (granulocyte-colony stimulating factors), GM-CSFs (granulocytes) /macrophagecolony stimulating factors), interferon alpha, interferon beta, interferon gamma, interleukin-1 alpha and beta, interleukin-3, interleukin-4, interleukin-6, interleukin-2, EGFs (epidermal growth factors), calcitonin, ACTH (adrenocorticotropic hormone), TNF (tumor necrosis factor), atobisban, buserelin, cetrorelix, deslorelin, desmopressin, dynorphin A (1-13), elcatonin, eleidosin, eptifibatide, growth hormone releasing hormone-II (GHRHII), gonadorelin , gose
  • microstructure according to the present invention may be made of a biocompatible or biodegradable material.
  • a biocompatible or biodegradable material is substantially non-toxic to the human body, chemically inert, and non-immunogenic, and has the advantage of being dissolved after finally penetrating into the body.
  • the type of the biocompatible material is not particularly limited, and for example, hyaluronic acid, polyester, polyhydroxyalkanoate (PHAs), poly( ⁇ -hydroxyacid), poly( ⁇ -hydroxyacid) ), poly(3-hydroxybutyrate-co-valerate; PHBV), poly(3-hydroxypropionate; PHP), poly(3-hydroxyhexanoate; PHH), poly(4-hydro hydroxy acid), poly(4-hydroxybutyrate), poly(4-hydroxyvalerate), poly(4-hydroxyhexanoate), poly(esteramide), polycaprolactone, polylactide, poly Glycolide, poly(lactide-co-glycolide; PLGA), polydioxanone, polyorthoester, polyetherester, polyanhydride, poly(glycolic acid-co-trimethylene carbonate), polyphosphoester , polyphosphoester urethane, poly(amino acid), polycyanoacrylate, poly(trimethylene carbonate
  • a drug may be additionally loaded.
  • hypoallergenic microstructures according to various embodiments of the present invention will be described.
  • FIG. 1 is a perspective view illustrating a microstructure according to an embodiment of the present invention
  • FIG. 2 is an enlarged view of the microneedle shown in FIG. 1 .
  • the microstructure 10 includes a base film 100 and a microneedle 200 .
  • the base film 100 is a thin film and is provided with a predetermined width.
  • the base film 100 may be provided as a film having a circular or polygonal shape.
  • a plurality of microneedles 200 are formed on one surface of the base film 100, and are provided in a structure capable of penetrating into the skin and minimizing irritation when penetrating the skin.
  • the microneedle 200 includes a needle body 210 and a support wing 250 .
  • the needle body 210 protrudes from one surface of the base film 100 to a predetermined height.
  • the needle body 210 may have a total height of 100um to 2000um.
  • the needle body 210 has a first region 211 and a second region 212 .
  • the first region 211 has a pillar shape protruding from one surface of the base film 100 , and has a predetermined height h1 and a width w1 .
  • the first region 211 may have a height h1 of 50 ⁇ m to 1000 ⁇ m and a width w1 of 10 ⁇ m to 750 ⁇ m.
  • the lower region of the first region 211 may have a width of 10 ⁇ m to 750 ⁇ m, and the upper region may have a width of 10 ⁇ m to 500 ⁇ m.
  • the first region 211 may have a circular or polygonal cross-section.
  • the second region 212 extends from the upper end of the first region 211 and gradually decreases in width toward the end thereof. According to an embodiment, the second region 212 may have a height of 10 ⁇ m to 1000 ⁇ m. An end of the second region 212 forms a sharp tip. According to an embodiment, the tip of the second region 212 may have a tip angle of 10 degrees to 60 degrees.
  • the region where the first region 211 and the second region 212 are connected may have an outer circumferential surface at a predetermined angle or a curved surface. The curved surface can minimize skin irritation.
  • a plurality of support wings 250 are formed to have a thin thickness, and are disposed to be spaced apart from each other along the periphery of the needle body 210 .
  • Support wings 250 may be disposed at the same angle between the needle body 210 as a center.
  • the support wings 250 may be disposed symmetrically with each other around the needle body 210 .
  • three support blades 250 are formed, and it will be described for example that they are disposed at an angle of 120 degrees with respect to the central axis of the needle body 210 .
  • the number and arrangement of the support wings 250 are not limited thereto, and may be variously changed.
  • the support wing 250 has a triangular shape, and connects the outer surface of the needle body 210 and the base film 100 .
  • the support wing 250 gradually decreases in thickness as it goes away from the center of the needle body 210 , and gradually increases in thickness from the top to the bottom connected to the base film 100 . Accordingly, the support wing 250 may have a triangular cross section.
  • the upper end of the support wing 250 may be positioned lower than the upper end of the first region 211 .
  • a width w2 of the connection region where the lower end of the support wing 250 and the base film 110 are connected may be provided to be the same as the width w2 of the first region 211 .
  • the width w2 of the connection region where the lower end of the support wing 250 and the base film 100 are connected may be 10 ⁇ m to 750 ⁇ m.
  • 3 to 5 are views showing microneedles according to various embodiments of the present invention.
  • the upper end of the support wing 250 may be positioned lower than the upper end of the first region 211 . According to the embodiment, the upper end of the support wing 250 may be located at 1/3 of the first area 211 .
  • the upper end of the support wing 250 may be positioned at the same height as the upper end of the first region 211 .
  • the upper end of the support wing 250 may be positioned at the same height as the tip of the second region 212 .
  • the support wing 250 may have various heights as compared to the needle body 210 .
  • the support wing 250 since the bonding strength of the needle body 210 and the base film 100 is improved, the width of the needle body 210 can be minimized. Minimizing the width of the needle body 210 facilitates skin penetration and minimizes skin irritation.
  • the support wing 250 allows the microstructure 10 to be stably separated without damage to the needle body 210 in the process in which the microstructure 100 is separated from the mold. And in the process of penetrating the needle body 210 into the skin by pressing the microstructure 10 with a finger, the support wing 250 prevents damage to the needle body 210 .
  • FIG. 6 and 7 are views showing a microneedle according to another embodiment of the present invention.
  • the support wings 250 may be provided with different inclination angles of outer corners according to their regions.
  • the first area 251 of the support wing 250 has an outer edge extending from the top at a first angle
  • the second area 252 has an outer edge at a second angle different from the first angle from the first area 251 . is extended
  • the outer edge of the second region 252 of the support wing 250 may have a smaller inclination angle than the outer edge of the first region 251 .
  • an outer edge of the second region 252 of the support wing 250 may extend perpendicularly to one surface of the base film 100 .
  • the shape of the support wing 250 may be selected according to the strength of the microstructure 10 and the degree of hardness of the skin layer into which the microstructure 10 is inserted.
  • FIG. 8 is a view showing a needle body according to another embodiment of the present invention.
  • a fillet 215 may be formed along the circumference of the needle body 210 in a region where the needle body 210 and the base film 100 are connected.
  • the fillet 215 may enhance the strength of the microneedle 200 together with the support wings 250 described above by reinforcing the connection region between the needle body 210 and the base film 100 .
  • FIG. 9 is a view showing a cross-section of a support wing according to various embodiments of the present disclosure.
  • the support wing 250 formed on one side of the support body 210 is referred to as a first support wing 250a
  • the support wing 250 formed on the other side of the support body 210 is referred to as a second support wing 250b.
  • the cross-sections of the first and second support wings 250a and 250b may have various shapes and sizes. According to an embodiment, the cross-sections of the first and second support wings 250a and 250b may have a triangular shape, a quadrangular shape, and a pentagonal shape. The shape and size of the first and second support wings 250a and 250b may be selected according to the insertion site of the skin, such as the thickness of the skin layer and the hardness of the skin layer.
  • FIG. 10 is a view showing a cross-section of a support wing according to various embodiments of the present invention.
  • the first and second support wings 250a and 250b may be provided in various thicknesses. As in (A) and (B), the thickness of the first and second support wings (250a, 250b) may be symmetrical with respect to the needle body (210).
  • the thickness of the first and second support wings (250a, 250b) may be asymmetrical with respect to the needle body (210). Specifically, the second support wing 250b may be thicker than the first support wing 250q. This is because one support wing 250b is thicker than the other support wing 250a depending on the direction of load applied to the needle body 210 in the process of the microstructure 10 being separated from the mold or inserted into the skin. It is possible to stably support the needle body 210 .
  • FIG. 11 is a cross-sectional view illustrating an arrangement of support wings according to various embodiments of the present disclosure.
  • At least two support wings 250 may be provided depending on the shape and size of the needle body 210 , and various numbers may be radially arranged around the needle body 210 .
  • FIG. 12 is an image showing a microstructure and a microneedle manufactured according to an embodiment of the present invention
  • FIG. 13 is a diagram showing a process of penetrating the microstructure according to an embodiment of the present invention into the skin
  • FIG. 14 is a comparative example It is a view showing the process of penetrating the microstructure according to the skin.
  • a conical microneedle 300 was used as the microstructure according to the comparative example.
  • the width of the needle body 210 can be minimized due to the support wing 250, so that the occurrence of irritation during skin penetration is minimized.
  • the microneedle 300 according to the comparative example gradually increases in width as it approaches the base film 100 , and thus a great stimulus may be generated during skin penetration.
  • microstructure according to the present invention can be used for medical and skin care.

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

Abstract

L'invention concerne une microstructure. Cette microstructure comprend un film de base et une pluralité de micro-aiguilles formées sur une surface du film de base, chaque micro-aiguille comprenant un corps d'aiguille ayant une première région en colonne faisant saillie, à une hauteur prédéterminée, d'une surface du film de base et une seconde région s'étendant à partir de la première région et ayant une largeur qui diminue progressivement vers l'extrémité de celle-ci.
PCT/KR2021/015703 2020-11-19 2021-11-02 Microstructure à faible irritation Ceased WO2022108184A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
KR20200155988 2020-11-19
KR10-2020-0155988 2020-11-19
KR1020210102891A KR102685381B1 (ko) 2020-11-19 2021-08-05 저자극 마이크로 구조체
KR10-2021-0102891 2021-08-05

Publications (1)

Publication Number Publication Date
WO2022108184A1 true WO2022108184A1 (fr) 2022-05-27

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ID=81709186

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR2021/015703 Ceased WO2022108184A1 (fr) 2020-11-19 2021-11-02 Microstructure à faible irritation

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WO (1) WO2022108184A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2823850A1 (fr) * 2012-03-06 2015-01-14 Technical Institute of Physics and Chemistry of the Chinese Academy of Sciences Puce polymère à réseau de micro-aiguilles, procédé de préparation et utilisation associés
KR102014592B1 (ko) * 2017-05-08 2019-08-29 주식회사 에스엔비아 마이크로니들
US20190358441A1 (en) * 2018-05-28 2019-11-28 Industrial Cosmetic Lab Microneedle patch for transdermal injections
CN111298280A (zh) * 2018-12-11 2020-06-19 尹忠 一种软背微针及其制作方法
CN107073210B (zh) * 2014-09-03 2020-11-10 新南创新私人有限公司 微流体装置和制造

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2823850A1 (fr) * 2012-03-06 2015-01-14 Technical Institute of Physics and Chemistry of the Chinese Academy of Sciences Puce polymère à réseau de micro-aiguilles, procédé de préparation et utilisation associés
CN107073210B (zh) * 2014-09-03 2020-11-10 新南创新私人有限公司 微流体装置和制造
KR102014592B1 (ko) * 2017-05-08 2019-08-29 주식회사 에스엔비아 마이크로니들
US20190358441A1 (en) * 2018-05-28 2019-11-28 Industrial Cosmetic Lab Microneedle patch for transdermal injections
CN111298280A (zh) * 2018-12-11 2020-06-19 尹忠 一种软背微针及其制作方法

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