JP2018011712A - Percutaneous administration device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a percutaneous administration device that enables medicine to be easily administered to an administration target.SOLUTION: A microneedle includes a substrate 11 including a surface 11S, and projection part 12 that projects from the surface 11S. The projection part 12 includes a first projection 21 that projects from the surface 11S and includes a tip 21a that is in contact with the surface 11S and a tip 21b opposite to the tip 21a, and at least one second projection group 22G composed of a plurality of second projections 22 projecting from the outer peripheral surface 21S of the first projection 21. Each of the second projections 22 is located on a virtual line VL unique to the second projection group 22G to which the second projection 22 belongs, which extends linearly along the outer peripheral surface 21S from the tip 21b to the tip 21a.SELECTED DRAWING: Figure 2

Description

  The present invention relates to a transdermal administration device used for administration of a drug through the skin.

  The percutaneous absorption method, which is a method of administering a drug into the body through the skin, is known as a method capable of administering the drug without giving pain to the drug administration target. As one of such transdermal absorption methods, the skin is perforated using a transdermal administration device having a protrusion having a length of several tens to several hundreds of μm, and the drug is administered through the hole formed in the skin. A method has been proposed (see, for example, Patent Document 1).

Japanese Patent No. 4276691

By the way, in the method of administering a drug using a transdermal administration device, after applying the drug to the surface of the protrusion, a method of perforating the skin using the protrusion, or after perforating the skin using the protrusion, A method of applying a drug to the skin, a method of puncturing the skin with a transdermal administration device formed of the drug, and the like are known. Whatever method is used, there is a need for a transdermal administration device that can facilitate administration of a drug to an administration subject.
An object of the present invention is to provide a transdermal administration device that makes it easy to administer a drug to an administration subject.

  A transdermal administration device for solving the above problems includes a base including a surface and a protrusion protruding from the surface. The protrusion protrudes from the surface, and includes a first protrusion including a base end portion in contact with the surface and a tip end portion opposite to the base end portion, and a plurality of protrusions protruding from the outer peripheral surface of the first protrusion. And at least one second protrusion group composed of the second protrusions. Each of the second protrusions is on a virtual line unique to the second protrusion group to which the second protrusion belongs, and extends on a virtual line extending linearly from the distal end portion toward the base end portion along the outer peripheral surface. Located in.

  According to the above configuration, when the protrusion is punctured into the skin with the liquid medicine applied to the protrusion, the medicine is held between the outer peripheral surface of the first protrusion and the second protrusion. Compared with the structure without the second protrusion, the amount of the drug administered to the administration subject through the hole formed in the skin is increased. In addition, since the plurality of second protrusions are positioned on the imaginary line, the medicine can be held in the entire region where the second protrusions are arranged.

On the other hand, when the drug is applied to the perforated skin, and when the protrusion itself is formed by the drug administered to the administration target, the protrusion is provided on the skin by the amount provided with the second protrusion. The area of the surface that partitions the hole to be formed is increased. Therefore, it becomes easier to administer the drug to the administration subject through the hole formed in the skin. In addition, since the plurality of second protrusions are located on the imaginary line, the area of the surface defining the hole can be increased over the entire region where the second protrusions are arranged.
For these reasons, according to the transdermal administration device, the drug can be easily administered to the administration subject.

  In the transdermal administration device, the plurality of second protrusions belonging to the second protrusion group include a proximal-side protrusion and a distal-side protrusion located on the distal side of the proximal-end protrusion, and the outer peripheral surface. The amount of protrusion of the second protrusion may be the amount of protrusion, and the amount of protrusion of the tip side protrusion may be larger than the amount of protrusion of the base end protrusion.

  In the transdermal administration device, the plurality of second protrusions belonging to the second protrusion group include a proximal-side protrusion and a distal-side protrusion located on the distal side of the proximal-end protrusion, and the outer peripheral surface. In the region where the second protrusion is in contact, the width on the phantom line is the width of the second protrusion, and the width of the tip side protrusion is larger than the width of the base end protrusion. Good.

  According to each of the above configurations, since the surface area of the projection portion closer to the distal end portion can be made larger than that of the proximal end side projection in comparison with the configuration having no second projection, it is desired to allow the medicine to reach the skin. It becomes easier to administer the drug to the site.

  In the transdermal administration device, in the plurality of second protrusions constituting the second protrusion group, the protrusion amount may be larger as the second protrusion is closer to the distal end portion.

  In the transdermal administration device, the width of the plurality of second protrusions constituting the second protrusion group may be larger as the second protrusion is closer to the distal end portion.

  According to each said structure, the surface area of a projection part can be enlarged in the site | part which wants to make a chemical | medical agent reach | attain in the skin compared with the structure which does not have a 2nd protrusion. Thereby, in the protrusion, the medicine is more easily held toward the tip side, and in the hole formed by the protrusion, the area of the surface defining the hole becomes larger toward the bottom side of the hole. As a result, the drug is likely to be administered to the site of the skin where the drug is desired to reach.

  In the transdermal administration device, each of the second protrusions has a shape that tapers from a portion of the outer peripheral surface where the second protrusion is located toward the outside of the first protrusion of the surface. May be.

  According to the above configuration, the second projection is less likely to become a resistance when the first projection is punctured into the skin, compared to a configuration in which the direction in which the second projection projects is the same as the direction in which the first projection projects. Therefore, even if it is a protrusion part which has a 2nd protrusion, it is suppressed that a protrusion part becomes difficult to puncture skin.

  In the transdermal administration device, the transdermal administration device includes a plurality of the protrusions, and the virtual line group configured by the virtual lines of the protrusions is a single point in a plan view facing the surface. A plurality of the imaginary lines extending radially from may be included.

  According to the above configuration, in the region of the microneedle substrate in which the plurality of phantom lines extend radially, it is possible to suppress the occurrence of bias in the site where the drug is easily administered. Therefore, it is possible to suppress variation in the amount of medicine to be administered at a portion of the skin facing a region where a plurality of virtual lines on the base body extend radially.

  In the transdermal administration device, in a plan view facing the surface, a portion including the center of the surface is a first surface element, and a portion outside the first surface element is a second surface element, The first surface element includes a plurality of protrusions, the protrusion positioned on the first surface element is a first protrusion, and the second surface element includes a plurality of protrusions. The protrusion located on the second surface element is a second protrusion, the amount of protrusion of the second protrusion from the outer peripheral surface is a protrusion amount, and the second protrusions in all the first protrusions The average value of the protrusion amounts is the first average protrusion amount, the average value of the protrusion amounts of the second protrusions in all the second protrusions is the second average protrusion amount, and the first average The protrusion amount may be larger than the second average protrusion amount.

  According to the above configuration, in the first surface element, more medicine is more easily retained than in the second surface element, and in the hole formed by the first surface element, compared to the hole formed by the second surface element. The area of the surface that divides the holes tends to be large. Therefore, a part of the skin that is in contact with the first surface element of the substrate is more easily administered with a drug than a part of the skin that is in contact with the second surface element. Here, the transdermal administration device is usually pressed against the skin so that the center of the substrate is located in the vicinity of the portion of the skin where the drug is to be administered. Therefore, according to the above-described transdermal administration device, the drug is more easily administered in the vicinity of the part where the drug is to be administered than the other parts.

  In the transdermal administration device, in a plan view facing the surface, a portion including the center of the surface is a first surface element, and a portion outside the first surface element is a second surface element, The first surface element includes a plurality of protrusions, the protrusion positioned on the first surface element is a first protrusion, and the second surface element includes a plurality of protrusions. The protrusion located on the second surface element is a second protrusion, and in each protrusion, the second protrusion closest to the base end is a base end protrusion, and in each protrusion, The distance between the base end projection and the tip is the tip distance, the average value of the tip distances in all the first projections is the first average distance, and all the second projections Is the second average distance, and the first average distance is the first average distance. It may be larger than the second average distance.

  According to the above configuration, in the first surface element, the region where the medicine is held is larger than in the second surface element, and in the hole formed by the first surface element, compared to the hole formed by the second surface element. The part where the area of the surface that divides the hole becomes larger spreads. Therefore, in the part of the skin that comes into contact with the first surface element, more drug is more easily administered than the part that comes into contact with the second surface element. Here, the transdermal administration device is usually pressed against the skin so that the center of the substrate is located in the vicinity of the portion of the skin where the drug is to be administered. Therefore, according to the transdermal administration device described above, a larger amount of drug is more likely to be administered in the vicinity of the part to which the drug is to be administered than in other parts.

  According to the present invention, it is possible to facilitate administration of a drug to an administration subject.

The perspective view which shows the perspective structure in one Embodiment which actualized the transdermal administration device as a macroneedle. The expansion perspective view which expands and shows the perspective structure of the projection part in one Embodiment. Sectional drawing which shows the cross-section of the projection part along the surface which passes along the virtual line in one Embodiment. The top view which shows the planar structure in the planar view facing the surface of the base | substrate in one Embodiment. The top view which shows the planar structure of the 1st surface element and 2nd surface element in planar view which opposes the surface of the base | substrate in one Embodiment. Sectional drawing which shows the cross-sectional structure of the 2nd protrusion part in one Embodiment with the cross-sectional structure of a 1st protrusion part. Sectional drawing which shows the cross-section of the 1st protrusion along the II line | wire of FIG.

  An embodiment in which a transdermal administration device is embodied as a microneedle will be described with reference to FIGS. 1 to 7. Below, the structure of a microneedle, the formation material of a microneedle, the manufacturing method of a microneedle, the use of a microneedle, and an Example are demonstrated in order.

[Configuration of microneedle]
The configuration of the microneedle will be described with reference to FIGS.
As shown in FIG. 1, the microneedle 10 includes a base body 11 including a surface 11S and a plurality of protrusions 12 protruding from the surface 11S. The plurality of protrusions 12 are arranged in a square lattice pattern on the surface 11S. That is, a virtual square lattice is set on the surface 11S, and the plurality of protrusions 12 are located one by one on lattice points of the square lattice.

  The plurality of protrusions 12 may be arranged along the closest packing structure on the surface 11S, may be arranged concentrically, or may be arranged randomly. Further, the microneedle 10 may include only one protrusion 12.

  It is preferable that the base body 11 is flexible enough to follow the deformation of the skin in the puncture target. If the base body 11 is flexible, even if the skin to be punctured is deformed, the protrusion 12 is likely to be punctured into the skin. The base 11 may have a rigidity that does not follow the deformation of the skin in the puncture target.

  As shown in FIG. 2, the protrusion 12 includes a first protrusion 21 and one second protrusion group 22G. The first protrusion 21 protrudes from the surface 11S of the base 11, and includes a base end portion 21a in contact with the surface 11S and a front end portion 21b opposite to the base end portion 21a.

  The second protrusion group 22 </ b> G includes a plurality of second protrusions 22 protruding from the outer peripheral surface 21 </ b> S of the first protrusion 21. Each second protrusion 22 is on a virtual line VL unique to the second protrusion group 22G to which each second protrusion 22 belongs, and linearly extends from the distal end portion 21b toward the proximal end portion 21a along the outer peripheral surface 21S. It is located on the extending virtual line VL.

  When the protrusion 12 is punctured into the skin with the liquid drug applied to the protrusion 12, the drug is held between the outer peripheral surface 21S of the first protrusion 21 and the second protrusion 22, Compared to the configuration without the second protrusion 22, the amount of drug administered to the administration subject through the hole formed in the skin is increased. In addition, since the plurality of second protrusions 22 are positioned on the virtual line VL, the medicine can be held in the entire region where the second protrusions 22 are arranged.

On the other hand, when the drug is applied to the perforated skin, and when the protrusion 12 itself is formed by the drug administered to the administration target, the protrusion 12 includes the second protrusion 22. The area of the surface that divides the holes formed in the skin increases. Therefore, it becomes easier to administer the drug to the administration subject through the hole formed in the skin. In addition, since the plurality of second protrusions 22 are located on the virtual line VL, the area of the surface defining the hole can be increased over the entire region where the second protrusions 22 are arranged.
For these reasons, according to the microneedle 10, it is possible to easily administer the drug to the administration target.

  In the case where the protrusion 12 is formed of a drug, the protrusion 12 is compared to the case where the drug applied to the protrusion 12 is administered or the drug is applied to the hole formed in the protrusion 12. It is necessary to keep the state punctured in the skin for a long time. In the protrusion 12 including the second protrusion 22, the surface of the protrusion 12 is an uneven surface, and therefore, the protrusion 12 is maintained in a state of being punctured into the skin as compared to the protrusion including only the first protrusion. It becomes easy. Also in this point, according to the microneedle 10, it becomes easy to administer the medicine to the administration subject.

  The first protrusion 21 has a needle shape, that is, a shape extending along a direction orthogonal to the surface 11S of the base body 11. The first protrusion 21 has a shape that tapers from the proximal end portion 21a toward the distal end portion 21b. Each first protrusion 21 has the same shape as all the other first protrusions 21, but the plurality of first protrusions 21 may include first protrusions 21 having different shapes. Good.

  The outer peripheral surface 21S of the first protrusion 21 is a conical surface, in other words, the first protrusion 21 has a conical shape. The first protrusion 21 has a shape defined by an outer peripheral surface including a curved surface, a shape defined by an outer peripheral surface constituted by a flat surface, and a shape having substantially the same thickness from the base end portion 21a to the distal end portion 21b. And so on. Specifically, the first protrusion 21 may have, for example, a cylindrical shape, a pyramid shape, a prism shape, and the like.

  Further, the first protrusion 21 may have a shape in which a part of the conical shape is cut out by a plane passing through the conical tip portion and two arbitrary points at the base end portion. Alternatively, the first protrusion 21 may have a shape in which at least one surface is formed of a curved surface among a plurality of side surfaces of the pyramid.

  Alternatively, the first protrusion 21 may have a shape obtained by combining two or more shapes arranged along the direction in which the first protrusion 21 extends. For example, the first protrusion 21 includes a proximal end element including a proximal end portion 21a and a distal end element including a distal end portion 21b. The proximal end element has a column shape, and the distal end element has a cone shape. Also good.

  In the direction in which the first protrusion 21 protrudes, the distance between the base end portion 21a and the distal end portion 21b is a first protrusion amount P1 that is the amount of protrusion of the first protrusion 21, and the first protrusion amount P1 is, for example, 10 μm. It is 1000 μm or less.

  A plurality of second protrusions 22 belonging to one second protrusion group 22G are arranged at intervals along one virtual line VL unique to the second protrusion group 22G. Of the plurality of second protrusions 22 constituting the second protrusion group 22G, the second protrusion 22 that is closest to the distal end portion 21b of the first protrusion 21 is located at the distal end portion 21b, but is more basic than the distal end portion 21b. You may be located near the edge part 21a.

  On the other hand, among the plurality of second protrusions 22 constituting the second protrusion group 22G, the second protrusion 22 closest to the base end part 21a of the first protrusion 21 is located at the base end part 21a. Further, it may be positioned closer to the distal end portion 21b than the proximal end portion 21a.

  The amount of the second protrusion 22 protruding from the outer peripheral surface 21S of the first protrusion 21 is the second protrusion amount, and the second protrusion amount is, for example, 0.1 μm or more and 10 μm or less. In the virtual line VL, the distance between the adjacent second protrusions 22 is, for example, not less than 0.1 μm and not more than 10 μm.

FIG. 3 shows a cross-sectional structure of one protrusion 12, and shows a cross-sectional structure of the protrusion 12 along a plane including the tip 21 b of the first protrusion 21 and the virtual line VL.
As shown in FIG. 3, in the plurality of second protrusions 22 constituting the second protrusion group 22G, the second protrusion 22 is closer to the second protrusion 22 closer to the tip portion 21b. In the second protrusion 22, an end portion that contacts the outer peripheral surface 21 </ b> S of the first protrusion 21 is a second base end portion 22 a, and an end opposite to the second base end portion 22 a is a second tip end portion 22 b. In the direction in which the second protrusion 22 protrudes, the distance between the second base end portion 22 a and the second tip end portion 22 b is a second protrusion amount P <b> 2 that is the protrusion amount of the second protrusion 22.

  Further, the width on the virtual line VL is the width of the second protrusion 22 in the region where the second protrusion 22 is in contact with the outer peripheral surface 21 </ b> S of the first protrusion 21. Among the plurality of second protrusions 22 constituting the second protrusion group 22G, the width of the second protrusion 22 closer to the distal end portion 21b is larger.

  In the cross section of the projection 12 passing through the tip 21b and including the virtual line VL, the width on the virtual line VL, in other words, the width where the second projection 22 is in contact with the outer peripheral surface 21S is the width of the second projection 22. The second width W2 is the width.

  According to such a microneedle 10, the surface area of the protruding portion 12 can be increased in a portion of the skin where the drug is desired to reach, compared to a configuration without the second protrusion. Thereby, in the projection part 12, it becomes easy to hold | maintain a chemical | medical agent as the front-end | tip part 21b side, and in the hole formed of the projection part 12, the area of the surface which divides | segments a hole becomes large toward the bottom part side of a hole. As a result, the drug is likely to be administered to the site of the skin where the drug is desired to reach.

  Further, while the surface area of the first protrusion 21 is smaller as it is closer to the tip portion 21b, the surface area of the second protrusion 22 belonging to the second protrusion group 22G is larger as it is closer to the tip portion 21b of the first protrusion 21. The small surface area of the protrusion 21 can be compensated by the surface area of the second protrusion group 22G. Therefore, compared with the structure which does not have a 2nd process, it becomes easy to administer a chemical | medical agent to an administration subject.

  As described above, in the plurality of second protrusions 22 constituting one second protrusion group 22G, both the second protrusion amount P2 and the second width W2 are larger as the second protrusion 22 is closer to the distal end portion 21b. In the microneedle 10, the second protrusion 22 closer to the tip 21b tends to have a larger second protrusion amount P2, and the second protrusion 22 closer to the tip 21b in the plurality of second protrusions 22 has the second width. If it has at least one of the tendency with large W2, the effect mentioned above can be acquired.

  Each of the second protrusions 22 has a shape that tapers from the portion of the outer peripheral surface 21S of the first protrusion 21 toward the outside of the first protrusion 21 in the surface 11S of the base 11 from the portion where the second protrusion 22 is located. doing. In each second protrusion 22, the second distal end portion 22 b is located closer to the base end portion 21 a than the center of the second width W <b> 2 in the protruding direction of the first protrusion 21.

  Therefore, the second protrusion 22 is less likely to become a resistance when the first protrusion 21 is punctured into the skin, compared to a configuration in which the direction in which the second protrusion protrudes is the same as the direction in which the first protrusion protrudes. Therefore, even if it is the projection part 12 which has the 2nd protrusion 22, it is suppressed that the projection part 12 becomes difficult to puncture skin.

  Each of the second protrusions 22 has a substantially conical shape that tapers toward the outside of the first protrusion 21 in the surface 11S of the base body 11 from the portion where the second protrusion 22 is located. You may have either the shape of a substantially pyramid shape and a substantially prismatic shape. In the plurality of second protrusions 22 constituting one second protrusion group 22G, each second protrusion 22 has a shape substantially similar to all of the other second protrusions 22, but the plurality of second protrusions 22G. The protrusions 22 may include second protrusions 22 having shapes that are not substantially similar to each other.

  FIG. 4 shows a planar structure of the microneedle 10 in a plan view facing the surface 11S. In FIG. 4, for convenience of illustration, the imaginary line VL in each protrusion 12 is indicated by a solid line.

  As shown in FIG. 4, in a plan view facing the surface 11 </ b> S of the base body 11, the virtual line group including the virtual lines VL of the protrusion 12 includes a plurality of virtual lines VL extending radially from one point. Yes.

  On the surface 11S of the base body 11, the plurality of protrusions 12 are arranged at equal intervals along the X direction which is one direction, and are arranged at equal intervals along the Y direction which is a direction orthogonal to the X direction. It is out. The distance between the two protrusions 12 in the X direction is equal to the distance between the two protrusions 12 in the Y direction. The direction perpendicular to the X direction and the Y direction, and the direction in which the protrusion 12 protrudes from the surface 11S of the base body 11, is the Z direction.

  In the microneedle 10, since all the protrusions 12 include the first protrusions 21 and the second protrusions 22, virtual lines VL can be set for all the protrusions 12. Note that the microneedle 10 may include a protrusion configured only by the first protrusion 21 in addition to the protrusion 12 including the first protrusion 21 and the second protrusion 22. In this case, it is preferable that 60% or more of the protrusions 12 include the second protrusions 22 in all of the protrusions 12 including the second protrusions 22 and the protrusions not including the second protrusions 22.

  Of the surface 11S of the base 11, the point where the plurality of virtual lines VL extend radially is the reference point RP, and the reference point RP is the center of the surface 11S, for example. The reference point RP may be a point other than the center on the surface 11S. On the surface 11S, it is possible to set a plurality of virtual radiations VR that overlap with at least one virtual line VL and extend radially from the reference point RP. In FIG. 4, for convenience of illustration, the virtual radiation VR is shown only in a quarter region of the surface 11S of the base body 11.

  In each protrusion 12, the first protrusion 21 has a central axis passing through the tip 21b, and the direction in which the virtual line VL extends in the circumferential direction of the central axis is the direction in which the virtual line VL faces. The virtual line VL faces the side opposite to the reference point RP on the virtual radiation VR. In other words, the direction in which the virtual line VL faces differs from the direction from the central axis toward the reference point RP by 180 ° in the circumferential direction of the central axis. In other words, the virtual line VL extends along the virtual radiation VR and in a plan view facing the surface 11S, and extends from the tip portion 21b toward the outer edge of the surface 11S.

  In the base 11 of the microneedle 10, in a region where the plurality of virtual lines VL extend radially, it is possible to suppress the occurrence of bias in the portion where the drug administration efficiency is increased. Therefore, it is possible to suppress variation in the amount of the drug to be administered in a portion of the skin facing the region where the plurality of virtual lines VL extend radially.

  As shown in FIG. 5, in a plan view facing the surface 11S, the portion including the reference point RP that is an example of the center of the surface 11S is the first surface element 11S1, and the portion outside the first surface element 11S1 is This is the second surface element 11S2. A plurality of protrusions 12 are positioned on the first surface element 11S1, and the protrusions 12 positioned on the first surface element 11S1 are first protrusions 12a. A plurality of protrusions 12 are located on the second surface element 11S2, and the protrusions 12 located on the second surface element 11S2 are second protrusions 12b.

  The average value of the second protrusion amounts P2 of the second protrusions 22 in all the first protrusion portions 12a is the first average protrusion amount, and the second protrusion amount P2 of the second protrusion 22 in all the second protrusion portions 12b. The average value is the second average protrusion amount. The first average protrusion amount is larger than the second average protrusion amount.

  The first average protrusion amount can be calculated by dividing the sum of the second protrusion amounts P2 of the plurality of second protrusions 22 included in each first protrusion 12a by the total number of second protrusions 22. Further, the second average protrusion amount can be calculated by dividing the sum of the second protrusion amounts P2 of the plurality of second protrusions 22 included in each second protrusion 12b by the total number of second protrusions 22.

  According to the microneedle 10, it becomes easier for the first surface element 11S1 to hold more medicine than the second surface element 11S2, and the second surface element 11S2 is formed in the hole formed by the first surface element 11S1. The area of the surface that divides the hole is likely to be larger than that of the hole. Therefore, a drug is more easily administered to a portion of the skin that contacts the first surface element 11S1 of the base body 11 than a portion that contacts the second surface element 11S2. Here, the microneedle 10 is normally pressed against the skin so that the center of the substrate 11 is positioned in the vicinity of the portion of the skin where the drug is to be administered. Therefore, according to the microneedle 10, the drug is more easily administered in the vicinity of the portion where the drug is to be administered than the other portions.

  Moreover, in each projection part 12, the 2nd protrusion 22 nearest to the base end part 21a is a base end part projection, and the distance between the base end part projection and the tip part is the tip in the protruding direction of each projection part 12. Distance. The average value of the tip distances in all the first protrusions 12a is the first average distance, and the average value of the tip distances in all the second protrusions 12b is the second average distance. The first average distance is greater than the second average distance.

  The first average distance can be calculated by dividing the sum of the tip distances of the first protrusions 12a by the total number of the first protrusions 12a. The second average distance is calculated by dividing the second protrusions 12a by the total number of the first protrusions 12a. It can be calculated by dividing the sum of the tip distances in the portion 12b by the total number of the second protrusions 12b.

  FIG. 6 is a cross-sectional structure of the second protrusion 12b, and shows a cross-sectional structure along the plane including the tip 21b of the first protrusion 21 and the virtual line VL, along with the cross-sectional structure of the first protrusion 12a. Yes. In FIG. 6, in order to clarify the distinction between the first protrusion 12a and the second protrusion 12b, the second protrusion 12b is indicated by a solid line, while the first protrusion 12a is indicated by a two-dot chain line. ing.

  As shown in FIG. 6, the second protrusion 12 b includes a first protrusion 21 and a plurality of second protrusions 22, and the first protrusion 12 a includes a first protrusion 21 and a plurality of second protrusions 22. ing. The first protrusion 21 included in the first protrusion 12a and the first protrusion 21 included in the second protrusion 12b have the same shape.

  As described above, in each of the first protrusion 12a and the second protrusion 12b, the second protrusion closest to the base end 21a is the base end protrusion 22c. In each of the first protrusion 12a and the second protrusion 12b, the distance between the base end protrusion 22c and the tip 21b is the tip distance D.

  According to the microneedle 10, in the first surface element 11S1, the region where the medicine is held is larger than that in the second surface element 11S2, and the second surface element 11S2 is formed in the hole formed in the first surface element 11S1. Compared with the hole, the part where the area of the surface which divides a hole becomes large spreads. Therefore, a drug is more easily administered to a portion of the skin that contacts the first surface element 11S1 of the base body 11 than a portion that contacts the second surface element 11S2. Therefore, according to the microneedle 10, the drug is more easily administered in the vicinity of the portion where the drug is to be administered than the other portions.

  The microneedle 10 has only one of the tendency that the first average protrusion amount is larger than the second average protrusion amount and the tendency that the first average distance is larger than the second average distance. May be.

  FIG. 7 shows a cross-sectional structure of the protrusion 12 along the line II in FIG. In FIG. 7, for convenience of illustration and description, only the first protrusion 21 in each protrusion 12 is shown, and the second protrusion 22 is not shown.

  As shown in FIG. 7, it is preferable that the first protrusion 21 of each protrusion 12 in the microneedle 10 has a thickness and length suitable for puncturing the skin to form a hole. The first protrusion amount P1 of the first protrusion 21 is preferably set according to the position where the bottom of the puncture hole formed when the first protrusion 21 is punctured into the skin reaches in the thickness direction of the skin. As described above, the first protrusion amount P1 is preferably 10 μm or more and 1000 μm or less.

  When the depth of the puncture hole is retained in the stratum corneum, the first protrusion amount P1 of the first protrusion 21 is preferably, for example, not less than 10 μm and not more than 300 μm, and more preferably not less than 30 μm and not more than 200 μm. When the depth of the puncture hole is kept at a depth that penetrates the stratum corneum and does not reach the nerve layer, the first protrusion amount P1 of the first protrusion 21 is preferably 200 μm or more and 700 μm or less, More preferably, it is 200 μm or more and 500 μm or less.

  When the depth of the puncture hole is set to a depth that reaches the dermis, the first protrusion amount P1 of the first protrusion 21 is preferably 200 μm or more and 500 μm or less. When the depth of the puncture hole is the depth that reaches the epidermis, the first protrusion amount P1 of the first protrusion 21 is preferably 200 μm or more and 300 μm or less.

  The first width W1 of the first protrusion 21 is preferably 1 μm or more and 300 μm or less. The first width W1 of the first protrusion 21 is preferably set according to the position where the bottom of the puncture hole reaches in the thickness direction of the skin. The first width W <b> 1 of the first protrusion 21 is the maximum value of the length of the surface 11 </ b> S of the base 11 in the region where the base end portion 21 a of the first protrusion 21 is in contact.

  For example, when the first protrusion 21 has a conical shape or when the first protrusion 21 has a cylindrical shape, the diameter of the region having a circular shape that the first protrusion 21 contacts on the surface 11S of the base 11 is the first. One width W1. When the first protrusion 21 has a regular quadrangular pyramid shape, or when the first protrusion 21 has a regular quadrangular prism shape, the diagonal line of the area having a square shape with which the first protrusion 21 is in contact with the first protrusion 21 is the first width W1. It is.

In the first protrusion 21, the ratio of the first protrusion amount P1 to the first width W1, that is, a value calculated using the following formula (1) is the aspect ratio A. The aspect ratio A is preferably 1 or more and 10 or less.
Aspect ratio A = first protrusion amount P1 / first width W1 (1)

  When a puncture hole having a pointed shape at the tip 21b of the first projection 21 and having a depth penetrating the stratum corneum is formed by the first projection 21, the tip angle θ of the first projection 21 Is preferably 5 ° or more and 30 ° or less, and more preferably 10 ° or more and 20 ° or less. The tip angle θ is the maximum value of the angle of the tip portion 21 b of the first protrusion 21 in the cross section along the thickness direction of the base body 11. For example, when the first protrusion 21 has a regular quadrangular pyramid shape, the tip angle θ of the first protrusion 21 has a square diagonal line defined by the base end portion 21a of the first protrusion 21 as a base and the apex of the regular quadrangular pyramid as a vertex. Is the apex angle of the triangle.

[Microneedle forming material]
The forming material of the microneedle 10 is preferably a thermoplastic resin, for example, polyethylene, polypropylene, polycarbonate, polyacetal, polystyrene, polymethyl methacrylate, cellulose acetate, polyethylene terephthalate, polyurethane, Teflon (registered trademark), polyvinyl chloride, polyvinyl chloride. It is preferably any one of vinylidene and ethylene / vinyl acetate copolymer.

  The material for forming the microneedle 10 is preferably a thermoplastic resin and a biodegradable resin, such as polylactic acid, polybutylene succinate, poly ε-caprolactone, and poly β-hydroxybutyric acid. It is preferable that it is either.

  Further, the material for forming the microneedle 10 may be a mixture of these thermoplastic resins. By using a biodegradable resin as the forming material of the microneedles 10 among the thermoplastic resins described above, the protruding portion 12 is punctured into the skin as compared with the case where other forming materials are used. Even if 12 is broken in the skin, the influence on the puncture target can be suppressed.

  The material for forming the microneedles 10 may be a material that dissolves with moisture of the skin, that is, a water-soluble material. As the water-soluble material, water-soluble polymers and polysaccharides can be used. Examples of water-soluble polymers include carboxymethylcellulose (CMC), methylcellulose (MC), hydroxypropylcellulose (HPC), hydroxypropylmethylcellulose (HPMC), polyvinyl alcohol (PVA), polyacrylic acid polymer, polyacrylamide (PAM), Examples include polyethylene oxide (PEO), pullulan, alginate, pectin, chitosan, chitosan succinamide, and oligochitosan. Among these water-soluble polymers, chitosan, chitosan succinamide, carboxymethylcellulose (CMC), hydroxypropylcellulose (HPC), and hydroxypropylmethylcellulose (HPMC) are preferable because of their high biological safety. . Examples of polysaccharides include trehalose and maltose. The protrusion 12 formed from a water-soluble material dissolves within the skin after being stabbed into the skin.

[Manufacturing method of microneedle]
As an example of the manufacturing method of microneedle, the manufacturing method in case the formation material of microneedle is a thermoplastic resin is demonstrated.
When the microneedle 10 is manufactured, first, an original plate including a protrusion having a shape equivalent to the protrusion 12 included in the microneedle 10, that is, a protrusion corresponding to the first protrusion and a protrusion corresponding to the second protrusion group. Form. The original plate can be formed using, for example, a fine processing technique. The fine processing technique may be any one of, for example, a lithography method, a wet etching method, a dry etching method, a sand blasting method, a laser processing method, and a precision machining method.

  Next, an intaglio is formed using the original plate. When forming the intaglio, it is preferable that the intaglio forming material is silicone resin and the intaglio is formed by transferring the original. Any silicone resin can be used as the silicone resin as long as it is suitable for the formation of the intaglio. When forming the intaglio, first, a silicone resin before curing is placed on the original, and the silicone resin is cured on the original. And the intaglio in which the shape of the original was transferred can be obtained by peeling the silicone resin hardened | cured on the original from the original.

  And a microneedle is formed using an intaglio. When forming the microneedles, first, after placing a thermoplastic resin on the intaglio, the intaglio and the thermoplastic resin are heated at a temperature equal to or higher than the melting point of the thermoplastic resin to melt the thermoplastic resin. Then, the thermoplastic resin is pressed from the opposite side of the intaglio plate with respect to the thermoplastic resin, and the thermoplastic resin is cooled and cured. The pressure when pressing the thermoplastic resin needs to be a pressure at which the intaglio is not damaged, and is preferably 1 MPa or less. Cooling of the thermoplastic resin may be performed in a state in which the thermoplastic resin is pressed, or may be performed after finishing the pressing of the thermoplastic resin. Cooling of a thermoplastic resin can be performed by arbitrary systems, such as a contact system and a non-contact system. By separating the cured thermoplastic resin from the intaglio, microneedles formed from the thermoplastic resin can be obtained.

[Use of microneedle]
The microneedle 10 can be provided with a drug for administration to an administration subject on the protrusion 12. For example, the microneedle 10 can be provided with a drug on the surface of the protrusion 12 by applying a liquid containing the drug to the surface of the protrusion 12 before the protrusion 12 is punctured into the administration target. . Further, for example, the first protrusion 21 of the protrusion 12 has a groove or a hole, and the microneedle 10 can include the drug in the protrusion 12 by filling the groove or hole with the drug. The drug provided in the microneedle 10 may be, for example, a pharmacologically active substance and a cosmetic composition.

  An appropriate substance can be selected as the pharmacologically active substance. Examples of the pharmacologically active substance include vaccines for infectious diseases such as influenza, pain relieving drugs for cancer patients, insulin, biologics, gene therapy drugs, injections, oral preparations, and preparations for skin application. Since the microneedles 10 are punctured into the skin, as the pharmacologically active substance, in addition to the pharmacologically active substance used for conventional transdermal administration, a pharmacologically active substance that requires subcutaneous injection can also be used.

  When administering an injection such as a vaccine, administration using the microneedle 10 is not painful during administration compared to administration using a syringe. Therefore, administration of a pharmacologically active substance using the microneedle 10 is suitable for administration of a pharmacologically active substance to children.

  In addition, when a conventional oral preparation is orally administered, it may be difficult for a child to take an oral preparation, but the administration using the microneedle 10 does not require a pharmacologically active substance to be taken. Therefore, administration of a pharmacologically active substance using the microneedle 10 is suitable for administration of a pharmacologically active substance to children.

  The cosmetic composition is a composition used as a cosmetic product and a cosmetic product. Examples of the cosmetic composition include a moisturizer, a colorant, a fragrance, and a physiologically active substance exhibiting a cosmetic effect. The beauty effect includes, for example, an improvement effect on wrinkles, acne, and pregnancy lines, an improvement effect on hair loss, and the like. A cosmetic composition containing a fragrance is preferable as a cosmetic because it can impart an odor to the cosmetic composition.

  When the depth of the puncture hole is retained in the stratum corneum, the cosmetic composition can be retained in the stratum corneum. Since the stratum corneum is constantly generated by metabolism, the cosmetic composition in the stratum corneum is discharged out of the body over time. Therefore, the cosmetic composition can be excluded from the administration subject by washing the skin or peeling the skin.

  On the other hand, when the depth of the puncture hole is kept at a depth that penetrates the stratum corneum and does not reach the nerve layer, the cosmetic composition is administered deeper than the stratum corneum in the skin. can do. Since the puncture hole formed in the stratum corneum is closed over time, the cosmetic composition administered at a position deeper than the stratum corneum is retained in the administration subject while being protected from the outside by the stratum corneum. Therefore, it is possible to prevent the cosmetic composition from being peeled off from the administration target by washing the skin, such as metabolism of the stratum corneum and skin care, and as a result, the cosmetic composition is more effective than the case where the cosmetic composition is administered into the stratum corneum. It is held in the administration subject for a long time.

  Thus, when the cosmetic composition is administered at a position deeper than the stratum corneum, the subject to be administered is maintained in a makeup state for a longer period of time than when the cosmetic composition is administered into the stratum corneum. The Therefore, when a cosmetic composition containing a colorant is administered deeper than the stratum corneum, it is necessary to maintain the color for a long period of time, such as the eyebrows, around the eyes, and around the lips. It is preferable to administer the chemical composition. In addition, it is preferable to administer the cosmetic composition at a position deeper than the stratum corneum as a prescription for skin abnormalities having a cause in a site below the stratum corneum, such as spot-like spots, for example, makeup or treatment.

  In addition, after puncturing the microneedle 10 to form a hole in the skin, or before forming a hole in the skin, each of the above-described drugs may be applied to the skin. Thereby, a chemical | medical agent can be administered to an administration subject through the hole formed in skin.

  Moreover, when the forming material of the microneedle 10 is the material having the above-described solubility, the drug is contained in the protrusion 12, and the protrusion 12 can be dissolved to be administered to the administration target. Good. In this case, the material for forming the microneedle 10 may function as a medicine.

  The drug may be administered to the administration subject by a method in which two or more methods are combined among the administration methods using the microneedle 10 described above.

  When the skin is punctured using the microneedle 10, the microneedle 10 has a surface 11S of the base 11 facing the skin, and the surface opposite to the surface 11S of the base 11 is directly applied by a user's finger or the like. It may be pressed against the skin. Alternatively, when the skin is punctured using the microneedle 10, an applicator for fixing a portion of the skin where the protrusion 12 of the microneedle 10 is inserted and a direction in which the protrusion 12 is inserted into the skin. May be used.

  When the base 11 has flexibility, the base 11 is formed into a cylindrical shape so that the surface 11S of the base 11 is located on the outer surface, thereby forming a roller having a plurality of protrusions 12 on the outer surface. be able to.

[Example]
[Example 1]
A silicon substrate was prepared, and a microneedle master having an area corresponding to the surface of the substrate having an area of 50 mm ² was formed from the silicon substrate by precision machining. In the original plate, 1600 protrusions were arranged in a 40 × 40 square lattice, and the interval between adjacent protrusions was set to 1 mm. In each protrusion, the shape of the first protrusion was conical, the diameter of the first protrusion was 40 μm, and the height was 120 μm.

  In each protrusion, ten second protrusions were formed so as to be positioned on one imaginary line extending linearly from the distal end portion to the base end portion of the first protrusion. The distance between the second protrusions adjacent to each other on the virtual line was 5 μm. Of the second protrusions, the protrusion of the second protrusion closest to the tip is 5 μm, the width is 5 μm, and the protrusion and width are 0.5 μm for each second protrusion from the tip to the base end. Only made small.

  Next, a mold release treatment was performed on the original plate by applying a fluorine-based coating agent to the surface of the original plate including the surface of the protrusion.

  A silicone resin (manufactured by Momentive Performance Materials, TSE3032) was dropped on the surface of the original plate subjected to the mold release treatment, and the silicone resin was cured by heating to 150 ° C. An intaglio was obtained by peeling the cured silicone resin from the original plate.

  Pellets of low density polyethylene (manufactured by Nippon Polyethylene Co., Ltd., LC600A) were placed on the intaglio, and the intaglio and low density polyethylene were heated to 180 ° C. to dissolve the low density polyethylene. And in the state which pressed the low density polyethylene with the force of about 0.4 N, room temperature air was sprayed on the low density polyethylene, it cooled, and the low density polyethylene was hardened. The microneedle was obtained by peeling the cured low density polyethylene from the intaglio.

[Comparative Example 1]
A microneedle was formed using the same method as in Example 1 except that an original plate having a protrusion portion composed of only the first protrusion was formed.

[Evaluation results]
The protrusions included in the microneedles of Example 1 and the protrusions included in the microneedles of Comparative Example 1 were immersed in water in which Evans Blue was dissolved. Then, when the state of the protrusions was observed using a microscope, in the microneedle of Example 1, the amount of liquid droplets attached to each protrusion was a liquid attached to each protrusion in the microneedle of Comparative Example 1. More than the amount of drops was observed.

As described above, according to one embodiment of the transdermal administration device, the effects listed below can be obtained.
(1) When the protrusion 12 is punctured into the skin with the liquid medicine applied to the protrusion 12, the medicine is held between the outer peripheral surface 21S of the first protrusion 21 and the second protrusion 22. Therefore, the amount of the drug administered to the administration target through the pore formed in the skin increases. In addition, since the plurality of second protrusions 22 are positioned on the virtual line VL, the medicine can be held in the entire region where the second protrusions 22 are arranged.

On the other hand, when the drug is applied to the perforated skin, and when the protrusion 12 itself is formed by the drug administered to the administration target, the protrusion 12 includes the second protrusion 22 only. The area of the surface defining the pores formed in the skin is increased. Therefore, it becomes easier to administer the drug to the administration subject through the hole formed in the skin. In addition, since the plurality of second protrusions 22 are located on the virtual line VL, the area of the surface defining the hole can be increased over the entire region where the second protrusions 22 are arranged.
For these reasons, according to the microneedle 10, it is possible to easily administer the drug to the administration target.

  (2) Compared with the configuration without the second protrusion, the surface area of the protrusion 12 can be increased in a portion of the skin where the drug is desired to reach. This makes it easier for the drug to be held at the distal end portion 21b of the protruding portion 12, and in the hole formed by the protruding portion 12, the area of the surface defining the hole at the bottom of the hole increases. As a result, the drug is likely to be administered to the site of the skin where the drug is desired to reach.

  (3) Since the second protrusion 22 is unlikely to be a resistance when the first protrusion 21 is punctured into the skin, even if the protrusion 12 has the second protrusion 22, the protrusion 12 is less likely to be punctured into the skin. It can be suppressed.

  (4) In the region of the base 11 where the plurality of virtual lines VL extend radially, it is possible to suppress the occurrence of bias in the portion where the medicine is easily administered. Variations in the amount of drug to be administered can be suppressed at a site facing the radially extending region.

  (5) In the first surface element 11S1, it becomes easier to hold more medicine than in the second surface element 11S2, and in the hole formed by the first surface element 11S1, compared to the hole formed by the second surface element 11S2. Thus, the area of the surface defining the hole tends to be large. Therefore, a drug is more easily administered to a portion of the skin that contacts the first surface element 11S1 than a portion that contacts the second surface element 11S2. Therefore, the drug is more easily administered in the vicinity of the portion where the drug is to be administered than in the other portions.

  (6) In 1st surface element 11S1, the area | region in which a chemical | medical agent is hold | maintained rather than 2nd surface element 11S2, and in the hole which 1st surface element 11S1 formed, compared with the hole which 2nd surface element 11S2 formed. As a result, the portion where the area of the surface defining the hole becomes larger spreads. Therefore, a drug is more easily administered to a portion of the skin that contacts the first surface element 11S1 than a portion that contacts the second surface element 11S2. Therefore, the drug is more easily administered in the vicinity of the portion where the drug is to be administered than in the other portions.

The embodiment described above can be implemented with appropriate modifications as follows.
The tip distance D may be substantially equal over the entire surface 11S, or the first average distance in the first surface element 11S1 may be smaller than the second average distance in the second surface element 11S2. In any configuration, if the protrusion 12 includes the first protrusion 21 and the second protrusion group 22G, it becomes easy to administer the drug to the administration target.

  The second protrusion amount P2 of the second protrusion 22 may be substantially equal over the entire surface 11S, and the first average protrusion amount in the first surface element 11S1 is the second average protrusion in the second surface element 11S2. It may be smaller than the amount. In any configuration, if the protrusion 12 includes the first protrusion 21 and the second protrusion group 22G, it becomes easy to administer the drug to the administration target.

  The second protrusion 22 is located on the outer side of the outer periphery 21S of the first protrusion 21 from the portion where the second protrusion 22 is located, outside the first protrusion 21 and opposite to the surface 11S of the base body 11. You may have the shape which tapers toward. In other words, the direction in which the second protrusion 22 protrudes may be the same as the direction in which the first protrusion 21 protrudes. Alternatively, the second protrusion 22 is a direction outside the first protrusion 21 and parallel to the surface 11 </ b> S of the base body 11 from the portion where the second protrusion 22 is located on the outer peripheral surface 21 </ b> S of the first protrusion 21. You may have the shape which tapers toward. In any configuration, if the protrusion 12 includes the first protrusion 21 and the second protrusion group 22G, it becomes easy to administer the drug to the administration target.

  In a plan view facing the surface 11S, a virtual line group composed of a plurality of virtual lines VL is a virtual line other than the plurality of virtual lines VL extending radially from one point, and the extending direction of the virtual line VL May include virtual lines that are not radial with respect to a point. Even in such a configuration, an effect equivalent to the above-described (5) can be obtained in a portion where a plurality of virtual lines extend radially from one point.

  In a plan view facing the surface 11S, the virtual line group including the plurality of virtual lines VL may not include the plurality of virtual lines VL arranged radially from one point. Even if it is such a structure, if the projection part 12 is the structure provided with the 1st protrusion 21 and the 2nd protrusion group 22G, it will become easy to administer a chemical | medical agent to an administration subject.

  The plurality of second protrusions 22 belonging to one second protrusion group 22G include a base end side protrusion and a front end side protrusion positioned on the front end side with respect to the base end side protrusion. The structure larger than the width | variety of an end side protrusion may be sufficient.

  That is, as long as the base end projection and the tip end projection satisfying the above-described relationship are included, the plurality of second projections 22 have other second projections having the same width as the base end projection more than the tip end projection. It may be included on the proximal end side, or another second protrusion having the same width as the distal end side protrusion may be included closer to the distal end side than the proximal end protrusion. Alternatively, the plurality of second protrusions 22 may include another second protrusion having the same width as that of the proximal end side protrusion on the distal end side relative to the distal end side protrusion, or another second protrusion having the same width as the distal end side protrusion. The protrusion may be included closer to the base end side than the base end side protrusion.

  The plurality of second protrusions 22 may include a second protrusion having a width larger than that of the distal end side protrusion on the distal end side of the proximal end side protrusion, or may be included on the proximal end side of the proximal end side protrusion. Alternatively, the plurality of second protrusions 22 may include a second protrusion having a width smaller than that of the proximal end side protrusion on the proximal end side of the distal end side protrusion, or may be included on the distal end side of the distal end side protrusion.

In any configuration, the following effects can be obtained.
(7) Compared to the configuration without the second protrusion, the surface area of the protrusion 12 closer to the distal end portion 21b than the protrusion on the proximal end side can be increased. It becomes easier for drugs to be administered.

  The plurality of second protrusions 22 belonging to one second protrusion group 22G include a base end side protrusion and a front end side protrusion positioned on the front end side of the base end side protrusion, and the second protrusion amount of the front end side protrusion P2 may be configured to be larger than the second protrusion amount P2 of the base end side protrusion.

  In other words, if the base end side protrusion and the front end side protrusion satisfying the above-described relationship are included, the plurality of second protrusions 22 are different from the front end side protrusion in the other second protrusions having the same protrusion amount as the base end side protrusion. May be included on the base end side, and another second protrusion having the same protrusion amount as the front end side protrusion may be included on the front end side of the base end side protrusion. Alternatively, the plurality of second protrusions 22 may include other second protrusions having the same protrusion amount as the proximal end protrusion on the distal end side than the distal end protrusion, or other second protrusions having the same protrusion amount as the distal end protrusion. The second protrusion may be included closer to the base end side than the base end side protrusion.

In addition, the plurality of second protrusions 22 may include a second protrusion having a larger protrusion amount than the distal end side protrusion on the distal end side relative to the proximal end side protrusion, or may include the second protrusion 22 closer to the proximal end side than the proximal end side protrusion. . Alternatively, the plurality of second protrusions 22 may include a second protrusion whose protrusion amount is smaller than that of the proximal end side protrusion on the proximal end side of the distal end side protrusion, or may be included on the distal end side of the distal end side protrusion. .
In any configuration, the same effect as the above (7) can be obtained.

  The plurality of protrusions 12 may include the protrusions 12 including two or more second protrusion groups 22G. Even in such a configuration, if each of the second protrusions 22 is positioned on the virtual line VL unique to the second protrusion group 22G to which the second protrusion 22 belongs, the same effect as the above-described (1) is obtained. I can. In addition, according to the projection part 12 provided with the several 2nd projection group 22G, since a liquid chemical | medical agent can be hold | maintained along each 2nd projection group 22G, a projection part provided with only the 2nd projection group 22G. More than 12 drugs can be retained. Moreover, according to the projection part 12 provided with the some 2nd projection group 22G, the area of the surface which divides a hole along each 2nd projection group 22G can be enlarged.

  The shape of the first protrusion 21 is not limited to a needle shape, that is, a shape extending along a direction orthogonal to the surface 11S of the base body 11. The shape of the first protrusion 21 is a blade shape, that is, the first protrusion 21 extends along one extending direction that is the direction along the surface 11S of the base body 11, and the tip of the first protrusion 21 is the tip of the base body 11. The shape formed in the direction different from the direction orthogonal to the surface 11S, for example, the linear form extended in the extension direction, may be sufficient. For example, the protruding portion has a triangular prism shape extending in the extending direction, and one of the three rectangular side surfaces of the triangular column is in contact with the base body 11, and the side that divides the other two side surfaces protrudes. You may have the shape which functions as a front-end | tip of a part.

  DESCRIPTION OF SYMBOLS 10 ... Microneedle, 11 ... Base | substrate, 11S ... Surface, 11S1 ... 1st surface element, 11S2 ... 2nd surface element, 12 ... Projection part, 12a ... 1st projection part, 12b ... 2nd projection part, 21 ... 1st Projection, 21a ... Base end, 21b ... Tip, 21S ... Outer peripheral surface, 22 ... Second projection, 22a ... Second base, 22b ... Second tip, 22c ... Base end, 22G ... Second Protrusion group.

Claims (9)

A substrate including a surface;
A protrusion protruding from the surface,
The protrusion is
A first protrusion that protrudes from the surface and includes a proximal end portion in contact with the surface and a distal end portion opposite to the proximal end portion;
And at least one second protrusion group composed of a plurality of second protrusions protruding from the outer peripheral surface of the first protrusion,
Each of the second protrusions is on a virtual line unique to the second protrusion group to which the second protrusion belongs, and extends on a virtual line extending linearly from the distal end portion toward the base end portion along the outer peripheral surface. Located in the transdermal administration device. The plurality of second protrusions belonging to the second protrusion group include a base end side protrusion and a front end side protrusion positioned on the front end side of the base end side protrusion,
The amount of protrusion of the second protrusion from the outer peripheral surface is the protrusion amount,
The transdermal administration device according to claim 1, wherein the protrusion amount of the distal protrusion is larger than the protrusion amount of the proximal protrusion. The transdermal administration device according to claim 2, wherein, in the plurality of second protrusions constituting the second protrusion group, the protrusion amount is larger as the second protrusion is closer to the distal end portion. The plurality of second protrusions belonging to the second protrusion group include a base end side protrusion and a front end side protrusion positioned on the front end side of the base end side protrusion,
Of the region where the second protrusion is in contact with the outer peripheral surface, the width on the imaginary line is the width of the second protrusion,
The transdermal administration device according to claim 1, wherein the width of the distal protrusion is larger than the width of the proximal protrusion. The transdermal administration device according to claim 4, wherein, in the plurality of second protrusions constituting the second protrusion group, the width of the second protrusion closer to the distal end portion is larger. Each said 2nd protrusion has a shape which tapers toward the outer side of the said 1st protrusion among the said surfaces from the site | part in which the said 2nd protrusion is located among the said outer peripheral surfaces. The transdermal administration device according to any one of the above. The transdermal administration device comprises a plurality of the protrusions,
7. The virtual line group configured by the virtual lines of the protrusions includes a plurality of the virtual lines extending radially from one point in a plan view opposite to the surface. The transdermal administration device described. In a plan view facing the surface, a portion including the center of the surface is a first surface element, and a portion outside the first surface element is a second surface element,
The first surface element has a plurality of protrusions, and the protrusions positioned on the first surface element are first protrusions,
A plurality of the protrusions are located on the second surface element, and the protrusions located on the second surface element are second protrusions,
The amount of protrusion of the second protrusion from the outer peripheral surface is the protrusion amount,
An average value of the protrusion amounts of the second protrusions in all the first protrusion portions is a first average protrusion amount,
An average value of the protrusion amounts of the second protrusions in all the second protrusion portions is a second average protrusion amount,
The transdermal administration device according to any one of claims 1 to 7, wherein the first average protrusion amount is larger than the second average protrusion amount. In a plan view facing the surface, a portion including the center of the surface is a first surface element, and a portion outside the first surface element is a second surface element,
The first surface element has a plurality of protrusions, and the protrusions positioned on the first surface element are first protrusions,
A plurality of the protrusions are located on the second surface element, and the protrusions located on the second surface element are second protrusions,
In each of the protrusions, the second protrusion closest to the base end is a base end protrusion,
In each projection, the distance between the base end projection and the tip is the tip distance,
The average value of the tip distances in all the first protrusions is the first average distance,
The average value of the tip distances in all the second protrusions is the second average distance,
The transdermal administration device according to any one of claims 1 to 7, wherein the first average distance is greater than the second average distance.