JP5572301B2 - Microneedle holding container - Google Patents

Description

  The present invention relates to a microneedle holding container suitable for storing and transporting microneedles.

  In recent years, as a method of administering a physiologically active substance into a living body, a method of transdermal administration using a microneedle has attracted attention. By perforating the stratum corneum having a high barrier property using microneedles to form a passage route for the physiologically active substance, it is possible to obtain a higher physiologically active substance penetration efficiency compared to general transdermal administration. At this time, by designing the microneedle so as not to penetrate the stratum corneum and reach the capillaries and nerves, it is possible to prevent bleeding or pain during use.

  When a microneedle is used for the purpose of transdermal administration, the microneedle is thin enough to pierce the skin, penetrates the tip corner, the stratum corneum that is the outermost layer of the skin, and does not reach the nerve layer Specifically, the diameter of the microneedle is preferably several μm to 100 μm, the tip of the microneedle is sharp, the angle is 30 degrees or less, and the length of the microneedle is several It is desirable that the thickness is about 10 μm to several hundred μm.

  When a substance is administered to the stratum corneum, it is desirable that the microneedles have a length that stays in the stratum corneum, specifically 100 μm or less.

  The material constituting the microneedle is desirably a material that does not adversely affect the human body even if damaged microneedles remain in the body. Examples of the material include medical silicone resin, maltose, polylactic acid, and dextran. Biocompatible materials such as chitin and chitosan are considered promising (see Patent Document 1).

  In addition, as a method of manufacturing the above-described microneedle, a manufacturing method has been proposed in which a microneedle original plate is manufactured by X-ray lithography, a replica plate is formed from the original plate, and transfer processing is performed (see Patent Document 2).

On the other hand, a gel polymer having self-adhesiveness is known (see Patent Document 3).
Japanese Patent Laid-Open No. 2005-21677 JP 2005-246595 A JP 2007-85461 A

  As described above, the microneedle has a shape in which a large number of fine protrusions are formed, and there is a demand for a microneedle holding container that can be stored and transported without damaging the fine protrusions.

  Further, it is desirable that the microneedle holding container is excellent in handling the microneedles when the microneedles are attached to and detached from the microneedle holding container.

  Therefore, the present invention has been made to solve the above-described problems, and an object of the present invention is to provide a microneedle holding container in which a microneedle can be suitably attached or detached.

The present invention according to claim 1 is a microneedle holding container in which a microneedle having a fine protrusion on one surface of a pedestal is held inside the outer container, the outer container and the outer container. And a microneedle in which the surface of the pedestal opposite to the surface provided with the fine protrusion is held in the adhesive holding portion, and the adhesive holding portion has a protrusion. The microneedle holding container is characterized in that the surface of the pedestal opposite to the microneedles is not in contact with the adhesive holding site over the outer periphery .

  The present invention according to claim 2 is the microneedle holding container according to claim 1, wherein the microneedle holding container has a plurality of protrusions.

  The third aspect of the present invention is the microneedle holding container according to any one of the first or second aspects, wherein the adhesive holding portion is made of a gel polymer.

  In the microneedle holding container of the present invention, the adhesive holding portion for holding the microneedle has a shape having a protrusion, and the microneedle is held on the protrusion. At this time, the end of the microneedle is held without contacting the bottom surface of the outer container. For this reason, when attaching and detaching the microneedle from the microneedle holding container, the end of the microneedle can be grasped, and the microneedle can be suitably moved from the microneedle holding container.

  Hereinafter, the microneedle holding container of the present invention will be described.

  The outer container may be any material and shape having a strength that is not easily deformed and broken during storage and transportation, and may be appropriately designed according to the specifications of the stored microneedles. For example, the material of the outer container may be selected from resins conventionally used for medical and food containers. Specifically, for example, chemically synthesized resins represented by polycarbonate resin, styrene resin, polypropylene resin, and the like can be given.

  The adhesion holding portion may be formed from a material having adhesiveness enough to hold the stored microneedles, and may be appropriately designed according to the specifications of the stored microneedles. For example, a resin having a viscoelasticity or an adhesive may be used.

  Moreover, it is preferable that especially an adhesion holding site | part consists of a gel polymer. Gel polymers are highly tacky, and can be easily applied and removed. Moreover, when washed with purified water, pure water, ethyl alcohol, etc., the adhesive performance can be restored and can be used repeatedly. Specific examples of the gel polymer include silicone gel and urethane gel.

Examples of the gel polymer cleaning liquid include purified water, pure water, and ethyl alcohol, which are used alone or as a mixed liquid. When holding microneedles used for medical purposes, washing with purified water, ethyl alcohol or the like that can ensure sterility is preferable.
Examples of the cleaning method include spray cleaning, dip ultrasonic cleaning, and the like.

The microneedles stored in the microneedle holding container of the present invention are made into individual pieces.
FIG. 1 shows an example of a microneedle 100 that is divided into individual pieces. FIG. 1A is a top perspective view, and FIG. 1B is a cross-sectional view. A microneedle 100 shown in FIG. 1 includes a fine protrusion 1 and a base 2. At this time, the shape of the pedestal 2 may be appropriately designed according to the application and specifications. Specifically, for example, a circular shape, a rectangular shape, a square shape, a hexagonal shape, or the like may be used.

Moreover, in the microneedle holding container of the present invention, the adhesive holding portion has a protrusion. By forming the adhesive holding site for holding the microneedles into a shape having a protrusion, and holding the microneedle on the protrusion, the end of the microneedle is held without contacting the bottom surface of the outer container. For this reason, when attaching and detaching the microneedle from the microneedle holding container, the end of the microneedle can be grasped, and the microneedle can be suitably moved from the microneedle holding container.
Since the end of the microneedle is gripped, when the microneedle is taken out from the microneedle holding container of the present invention, there is no possibility that the tip of tweezers or the like touches the finely processed portion and makes a good product defective. Further, when the microneedle is handled, it is possible to prevent the tip of tweezers or the like from scratching the outer container and scratching the microneedle holding container itself.

  The shape of the protrusion is a matter of design and may be set freely as appropriate. For example, a cylinder, a truncated cone, a prism, or a truncated pyramid may be used.

The tip of the protrusion may be designed as appropriate according to the pedestal shape of the microneedle to be held. Since the pedestal bottom surface of a general microneedle is a flat surface, the shape of the tip portion is preferably a flat surface.
Moreover, you may design suitably the upper surface shape of the plane in the front-end | tip part of a projection part according to the base shape of the microneedle to hold | maintain. For example, specifically, a circular shape, a square shape (such as a square or a rectangle), or a star shape may be used.

It is preferable that the area of the flat surface at the tip of the protrusion is appropriately determined according to the specifications of the microneedle to be held.
If the flat surface at the tip is too narrow, the adhesive force between the protrusion and the microneedle is small, the fixed state of the microneedle placed on the protrusion is unstable, and there is a risk of falling off during transport. In addition, when the flat surface at the tip is too wide, the adhesive force between the protrusion and the microneedle is large, the contact between the protrusion and the microneedle is too strong, and the microneedle may be broken when peeled off.
For example, specifically, when a microneedle satisfying the specification range shown below is held by an adhesive holding part having a protrusion made of silicone gel, the width of one side of the flat surface (square shape) at the tip is 1 mm or more and 9 mm. Hereinafter, it is more preferably about 2 mm or more and 7 mm or less.
<Specification example of microneedle>
Base shape: square (length of one side: 0.5 cm to 2.0 cm) or circular (diameter 0.5 cm to 2.0 cm)
Pedestal thickness: 0.1 cm to 1.5 cm
Fine protrusion height: 100 μm to 1000 μm

Moreover, it is preferable that the height of the protrusion is appropriately determined according to the specification of the microneedle to be held.
When the height of the protrusion is too low, the tip of tweezers or the like that handles the microneedles comes into contact with the bottom surface of the outer container, making it difficult to handle. Moreover, when the height of the protrusion is too high, it is necessary to increase the volume of the outer container, which is not preferable.
For example, specifically, when a microneedle satisfying the specification range shown below is held by an adhesive holding part having a protrusion made of silicone gel, the height of the protrusion is preferably about 1 mm to 5 mm. .
<Specification example of microneedle>
Base shape: square (length of one side: 0.5 cm to 2.0 cm) or circular (diameter 0.5 cm to 2.0 cm)
Pedestal thickness: 0.1 cm to 1.5 cm
Fine protrusion height: 100 μm to 1000 μm

Further, a plurality of protrusions may be provided at the adhesive holding site. By providing a plurality of protrusions, microneedles corresponding to the number of protrusions can be held in one microneedle holding container.
FIG. 2 shows an example in which the microneedle 100 is held in the adhesive holding portion 3 having a plurality of protrusions 6 as an example.

  Further, in FIG. 3, as an example of the microneedle holding container of the present invention, the outer container is composed of a part of the outer container (vessel) 4 and the outer container (lid) 5 and the adhesive holding part 3 having the protrusions 6 is the outer part. The microneedle holding container 200 formed on the bottom surface of the container (vessel) 4 is shown.

<Example>
Silicone gel KE1051 (manufactured by Shin-Etsu Chemical Co., Ltd.) A 1 mm thick adhesive sheet of 90 mm in length and 85 mm in length, with cylindrical projections 30 with a radius of 6 mm and a height of 5 mm arranged at equal intervals, from an equal mixture of liquid A and liquid B did. The produced adhesive sheet was affixed to a polystyrene square case 7 type (size 124 × 87 × 19 mm, including a lid).
Thirty plate-shaped medical device members having a substrate thickness of 1 mm formed by starch-based resin bioplus HSCP (manufactured by Zheanji Hisun Chemical) were fixed to each cylindrical protrusion of the adhesive sheet. The lid was closed and the lid was fixed with tape.

<Evaluation: Vibration test>
A vibration test was conducted to evaluate the transport resistance of the microneedle holding container to which the microneedle was fixed. For the vibration test, a vibration tester model G14-005 manufactured by Senken Co., Ltd. was used. In addition, the setting conditions of the testing machine were changed with the setting conditions 1 and 2 set. The setting conditions 1 and 2 are shown in Table 1 below.

  As a result of the vibration test, it was visually confirmed that the microneedle was not missing inside the microneedle holding container even under the setting condition 1 or setting condition 2. Thereby, it was confirmed that the microneedle holding container of the present invention can sufficiently hold the microneedle.

<Evaluation: Peel test>
A peel test was conducted to evaluate the detachability of the microneedle holding container to which the microneedles shown above were fixed. In the peeling test, the microneedles held inside the holding container were tweezered. It was performed by peeling with ID-475 (FIG. 4).

  When the installation and peeling were repeated 50 times, the microneedle was not damaged during the handling of the microneedle. Further, the tweezers did not come into contact with the outer container and were not damaged. Thereby, it was confirmed that the microneedle holding container of the present invention can suitably move the microneedle from the microneedle holding container.

It is a schematic diagram which shows an example of the microneedle hold | maintained at the microneedle holding | maintenance container of this invention. It is the schematic diagram which showed what fixes a microneedle to the adhesion holding | maintenance site | part which has a projection part in the microneedle holding container of this invention. It is a schematic diagram which shows one Embodiment of the microneedle holding | maintenance container of this invention. It is a schematic diagram explaining the peeling test done in the Example.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 ... Fine protrusion part 2 ... Base 3 ... Adhesion holding | maintenance part 4 ... Exterior container (vessel)
5 ... Exterior container (lid)
6 ... Projection 7 ... Tweezers 100 ... Microneedle 200 ... Microneedle holding container

Claims (3)

A microneedle holding container that holds microneedles provided with fine protrusions on one surface of a pedestal inside the outer container,
An outer container,
An adhesive holding part provided on the inner bottom surface of the outer container;
A microneedle in which the surface of the pedestal opposite to the surface provided with the fine protrusions is held in the adhesive holding portion,
With
The adhesive holding part is an adhesive holding part having a protrusion, and
The microneedle holding container, wherein the surface of the base on the opposite side of the microneedle is not in contact with the adhesive holding site over the outer periphery . The microneedle holding container according to claim 1,
A microneedle holding container having a plurality of protrusions. The microneedle holding container according to any one of claims 1 and 2,
The microneedle holding container, wherein the adhesive holding portion is made of a gel polymer.

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