Microneedle protective material

Abstract

To provide a microneedle that exhibits a high protectability during a period from storage to puncturing, since there is a risk of a user touching the microneedle when it is taken out from a protective material.SOLUTION: A microneedle includes: a first protective member that locally protects a puncture projection; and a second protective member that protects the entire microneedle. This makes it possible to enhance the protectability of the microneedle during a period from storage to puncturing. The first protective member is made of a biocompatible material and may be laminated to provide appropriate strength and resistance, and the second protective member is a relatively thick tray and may be made of a material that is highly moisture resistant and deformable.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to microneedles used for drug administration. In particular, it relates to the protection of microneedles that store drugs and microneedles integrally. Material Related.

Background Art

[0002] As a method for administering drugs such as vaccines into the body, a method using microneedles is known (for example, see Patent Documents 1 to 6). The microneedle is pressed against the skin, the skin is perforated with the puncture protrusions, and the drug is sent into the skin. Since the puncture protrusions are fine and do not reach nerve cells, administration using microneedles can reduce the pain when the skin is perforated compared to administration using conventional injection needles.

[0003] Administration using microneedles can administer drugs intradermally where there are many antigen-presenting cells. Therefore, the drug can efficiently contact antigen-presenting cells, and there is a possibility that the dosage of the drug can be reduced compared to conventional subcutaneous injections. Reducing the dosage of the drug can achieve more significant effects when the supply of the drug is insufficient. Administration using conventional injection needles requires a technique of appropriately pinching the skin with one hand and operating the syringe of the syringe with the other hand, whereas administration using microneedles does not require any special technique and can be self-administered.

[0004] Initial microneedles were made of metal or silicon, which were easy to mold and difficult to deform. However, in order to eliminate the concern of remaining broken in the body, they were later transferred to highly biocompatible materials. For example, microneedles using biodegradable plastics or polysaccharides derived from living organisms such as hyaluronic acid as a base material and having a drug previously applied to the surface thereof are known. In addition, microneedles containing a drug in a base material of a polysaccharide derived from a living organism such as biodegradable plastic or hyaluronic acid are known (for example, see Patent Document 7).

[0005] Patent document 8 describes a microneedle unit. It has a configuration in which a liquid-holding part (container lid) is separated from the puncture projection of the microneedle by a gap, and it is used by puncturing through the liquid-holding part. By using a microneedle unit and preventing the drug and microneedle from coming into contact until immediately before administration, the deterioration of both can be suppressed.

[0006] Furthermore, Patent Document 9 is known as a microneedle container. The microneedles are an array of multiple needles bundled together and have a common base portion. The container lid has a stepped structure that incorporates the relative sizes of the base portion and the puncture projection in the extending and inward directions. When the container is shaken during transport, the stepped portion becomes the point of contact, preventing the puncture projection from coming into contact with the container, thus suppressing physical damage to the puncture projection.

[0007] Incidentally, it is known that humidity affects the shelf life of pharmaceuticals. When drugs such as vaccines are freeze-dried and then stored in ampoules or other containers, it is known that if the drugs absorb moisture, the period during which they can maintain their efficacy is significantly shortened (see, for example, Non-Patent Document 1).

[0008] Furthermore, it is known that humidity affects the shelf life of the substrate. It is also known that when removing microneedles from the protective material, one should not have wet hands or touch the puncture points. [Prior art documents] [Patent Documents]

[0009] [Patent Document 1] International Publication Number 2008 / 020632 [Patent Document 2] Patent No. 4913030 [Patent Document 3] Patent No. 4265696 [Patent Document 4] Patent No. 4987916 [Patent Document 5] Japanese Patent Publication No. 2006-345983 [Patent Document 6] Japanese Patent Publication No. 2006-341089 [Patent Document 7] Japanese Patent Publication No. 2013-52202 [Patent Document 8] International Publication Number 2015 / 005143 [Patent Document 9] International Publication Number 2015 / 129894 [Non-patent literature]

[0010] [Non-Patent Document 1] Tetsuji Sawada et al., Journal of the Freezing and Drying Research Society, Vol. 17 [Overview of the project] [Problems that the invention aims to solve]

[0011] Unlike conventional injection needles, microneedles are often stored together with the medication. During storage, the microneedle is covered with protective material to protect it from deformation and contamination of the puncture point, as well as from moisture absorption of the medication and substrate. Immediately before puncture, the user removes the microneedle from the protective material, but at this time, the user's fingers sometimes come into contact with the microneedle.

[0012] This invention was made in view of these circumstances, and aims to enhance the protectiveness of microneedles from storage to puncture. [Means for solving the problem]

[0013] A protective material for microneedles coated with or containing a drug, comprising a first protective material that locally protects the puncture projection of the microneedle and a second protective material that protects the entire microneedle, wherein the first protective material is made of a material that is highly biocompatible and easily deformable, and the second protective material is made of a material that is highly moisture resistant and difficult to deform.

[0014] A protective material for micro needles coated with or containing a drug, comprising a first protective material for locally protecting the puncture protrusions of the micro needles and a second protective material for protecting the entire micro needles, wherein the first protective material is composed of a film and a framework.

[0015] A puncture method using a micro needle coated with or containing a drug, wherein the micro needle is removed from a second protective material for protecting the entire micro needle, and the first protective material for locally protecting the puncture protrusions of the micro needle is attached to the micro needle and punctured.

Advantages of the Invention

[0016] According to the present invention, the protection of the micro needle can be enhanced from storage to puncture. In particular, a remarkable effect can be obtained when the drug and the micro needle are stored integrally.

Brief Description of the Drawings

[0017] [Figure 1] An explanatory diagram showing a cross-sectional structure of a micro needle and a protective material. [Figure 2] An explanatory diagram showing a planar structure of a micro needle and a protective material. [Figure 3] A perspective view of a micro needle and a protective material before puncture in one embodiment. [Figure 4] A perspective view of a micro needle and a protective material after puncture in one embodiment.

Embodiments for Carrying out the Invention

[0018] Referring to FIGS. 1 and 2, the configuration of the protective material for the micro needle will be described.

[0019] The microneedle 10 comprises a plate-shaped base 11 and puncture projections 12 protruding from the base 11. The base 11 is, for example, disc-shaped and has a surface on which the puncture projections 12 are formed and a flat surface on the other side. The puncture projections 12 protrude 500 μm perpendicular to the base 11. There are multiple puncture projections 12, for example 400, which are arranged, for example, in a grid pattern at equal intervals of 200 μm. The microneedle 10 is made of a highly biocompatible material, such as hyaluronic acid, pullulan, or chitosan.

[0020] The puncture projection 12 has a tip that is sharp enough to penetrate the skin and has an appropriate length for intradermal administration of the drug. The puncture projection 12 is preferably shaped such that its cross-sectional area decreases towards the tip, for example, by forming a conical or pyramidal shape. In a coating-type microneedle, a drug (not shown) is applied to the surface of the puncture projection. In a dissolving-type microneedle, a drug (not shown) is contained inside the puncture projection.

[0021] The puncture projection 12 is protected by a first protective material 20. The first protective material 20 consists of a membrane 21 and a framework 22. The membrane 21 is made of a highly biocompatible material, such as pullulan and chitosan, and is laminated for appropriate strength and resistance. The membrane 21 is thin, for example, 300 nm, but maintains moisture resistance. Because the membrane 21 is thin, for example, 300 nm, it deforms enough to adhere closely to the irregularities of the skin. The framework 22 is made of a highly biocompatible material, such as pullulan and chitosan. The framework 22 is deformed to the extent that it can maintain the gap between the puncture projection 12 and the membrane 21 during storage. The framework 22 does not deform enough during puncture to maintain the extension direction between the skin and the membrane 21 and the puncture projection 21.

[0022] The microneedle 10 is protected by a second protective material 30. The second protective material 30 is, for example, a relatively thick tray made of a general-purpose plastic that is highly moisture-resistant and resistant to deformation, such as polypropylene or polycarbonate. The second protective material 30 consists of a storage section 31 and a lid section 32.

[0023] The internal space 23 surrounded by the microneedle 10 and the first protective material 20 may be sealed, or it may be sealed and filled with an inert gas. An inert gas is a gas that has low reactivity with the drug. The internal space may also be kept free of moisture. A moisture-free state means, for example, that the humidity at 25°C is 10% or less. [Examples]

[0024] A puncture method using microneedles will be explained with reference to Figures 31 and 42.

[0025] During storage, the microneedle 10 is covered with a first protective material 20 and a second protective material 30 to protect the puncture projection 12 from deformation, contamination, and moisture absorption of drugs and substrates.

[0026] Immediately before puncture, the user removes the microneedle 10 from the second protective material 30. During puncture, the user places the membrane 21 against the skin and punctures the skin with the microneedle 10 along with the membrane 21. After puncture, leave it for several hours and then peel off the remaining membrane 21 and microneedle 10 from the skin.

[0027] Figure 3 shows a photograph of the microneedle and protective material taken from an oblique angle before puncture. For illustrative purposes, the image was taken with a portion of the cross-section exposed. Even immediately before puncture, the puncture projection 12 is protected by the first protective material 20 and is not visible.

[0028] Figure 4 shows a photograph of the microneedle and protective material taken from an oblique angle after puncture. The microneedle was manually punctured into simulated skin using a fingertip, and then withdrawn and photographed again for explanatory purposes. The puncture projection 12 protrudes from the second protective material and maintains a sharp tip.

[0029] The microneedle 10 is made of the same material for both the base 11 and the puncture projection 21. However, by leaving the membrane 21 after puncture, the base 11 is made less likely to dissolve selectively, making it easier to peel the microneedle 10 from the skin. [Industrial applicability]

[0030] This invention can be used in the medical and cosmetic fields. [Explanation of Symbols]

[0031] 10... Microneedles 11...Base 12...Puncture protrusion 20…First protective material 21...Membrane 22…Framework 30…Second protective layer 31...Storage section 32...Lid part

Claims

1. A protective material for microneedles coated with or containing a drug, It comprises a first protective material that locally protects the puncture projection of the microneedle and a second protective material that protects the entire microneedle. The first protective material consists of a material that is highly biocompatible and easily deformable. The second protective layer is made of a material that is highly moisture-resistant and resistant to deformation. A protective material characterized by the following features.

2. A protective material for microneedles coated with or containing a drug, It comprises a first protective material that locally protects the puncture projection of the microneedle and a second protective material that protects the entire microneedle. The protective material according to claim 1, characterized in that the first protective material is composed of a membrane and a framework.

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