JP2017164191A - Percutaneous administration device - Google Patents

Abstract

A transdermal administration device that can be easily fixed to the skin. A transdermal administration device 10 includes a microneedle 20 which is an example of an administration unit, an adhesive sheet 30, and a first protective sheet 40 attached to a first region R1 of an adhesive surface 30S of the adhesive sheet 30. And a second protective sheet 50 attached to the second region R2 of the adhesive surface 30S. The first protective sheet 40 is included in a portion of the first protective sheet 40 that is peeled from the pressure-sensitive adhesive sheet 30 in a region included in the non-facing surface 40S when the first protective sheet 40 is peeled from the pressure-sensitive adhesive sheet 30. The first protective sheet 40 can be folded until the region to be touched and the region included in the portion of the first protective sheet 40 attached to the adhesive sheet 30 are in contact with each other. [Selection] Figure 1

Description

  The present invention relates to a transdermal administration device used for drug administration.

  The transdermal administration device includes an administration unit for administering a drug from the skin to the administration target. A microneedle, which is an example of an administration unit, includes a plurality of protrusions having a needle shape and a plate-like substrate. Each of the plurality of protrusions holds the drug on the surface or inside thereof, and is aligned with the surface of the base. Furthermore, the transdermal administration device includes an adhesive sheet for fixing the microneedle to the skin, and a protective sheet for protecting the adhesive surface of the adhesive sheet, in addition to such microneedles. The pressure-sensitive adhesive sheet is attached to the back surface of the base so that a part of the pressure-sensitive adhesive surface protrudes outside the base, and the protective sheet covers a portion of the pressure-sensitive adhesive surface that protrudes outside the base ( Patent Document 1).

  The user of the transdermal administration device first peels off the protective sheet from the adhesive sheet when administering the drug. Subsequently, the user presses the substrate of the microneedle against the skin at the administration site of the drug and attaches an adhesive sheet protruding around the substrate to the skin. As a result, the protruding portion perforates the skin, and the medicine held by the protruding portion is sent into the body of the administration target through the hole formed by the protruding portion. And while the chemical | medical agent is sent in, the microneedle is being fixed to skin with the adhesive sheet. Since the protrusions are very small, the method of administering a drug using microneedles can suppress the occurrence of pain when the skin is perforated.

JP 2012-213586 A

  By the way, in order to accurately administer the drug, it is preferable that each of the plurality of protrusions sufficiently pierce the skin and the above-mentioned hole is formed to a desired depth suitable for the drug administration. For this purpose, it is required that the microneedles are fixed along the surface of the skin, and the fixation is maintained for a predetermined period. Therefore, the base body and the pressure-sensitive adhesive sheet are configured to have such flexibility that the shape can be changed according to the shape of the skin surface.

  However, when the adhesive sheet is highly flexible, it is difficult to handle the transdermal administration device after the protective sheet is peeled off, and when the microneedles are fixed to the skin, the adhesive surfaces adhere to each other and wrinkles are formed on the adhesive sheet. Cheap. As a result, a gap is created between the pressure-sensitive adhesive sheet and the skin in the vicinity of the microneedle, and a situation in which the microneedle is fixed to the skin without being in close contact with the skin is likely to occur.

  An object of this invention is to provide the transdermal administration device which can be easily fixed to skin.

  A transdermal administration device that solves the above-mentioned problem is an administration comprising a substrate having a first surface and a second surface that is the surface opposite to the first surface, and a protrusion protruding from the first surface. And an adhesive sheet having an adhesive surface to which the second surface is attached, wherein the adhesive sheet has a part of the adhesive surface that protrudes outside the substrate when viewed from the direction facing the first surface. And a first protective sheet that is affixed to the entire first region that is a part of the region that protrudes from the base in the adhesive surface, and one of the regions that protrude from the base in the adhesive surface. And a second protective sheet that is affixed to the entirety of a second region that is a region different from the first region, and the first protective sheet is opposed to the adhesive surface. A surface and a non-facing surface that is a surface opposite to the facing surface And when the first protective sheet is peeled from the pressure-sensitive adhesive sheet, among the areas included in the non-facing surface, the area included in the portion peeled from the pressure-sensitive adhesive sheet in the first protective sheet; The first protective sheet is configured to be able to bend until the region included in the portion of the first protective sheet attached to the adhesive sheet comes into contact.

  According to the above configuration, with the second protective sheet peeled from the second region of the pressure-sensitive adhesive surface of the pressure-sensitive adhesive sheet, the percutaneous administration device is picked and supported by the portion of the first region where the first protective sheet is attached. However, the second region can be attached to the skin. Further, the first protective sheet is folded so that the areas included in the non-facing surfaces are in contact with each other, and the first area is gradually removed from the first area so as to be pulled out from between the adhesive sheet and the skin. Can be pasted on. At this time, since the first protective sheet is bent until the regions included in the non-facing surfaces come into contact with each other, the first region is positioned near the skin and sequentially from the peeled portion of the first protective sheet, Can be applied to the skin. Therefore, it is easy to fix the transdermal administration device to the skin, and it is also easy to fix the administration part in close contact with the skin while suppressing the formation of wrinkles on the adhesive sheet.

  In the transdermal administration device, when the first protective sheet is peeled from the pressure-sensitive adhesive sheet, the first protective sheet includes a portion peeled from the pressure-sensitive adhesive sheet and a portion attached to the pressure-sensitive adhesive sheet. It is preferable that the first protective sheet can be folded at the boundary.

  According to the above configuration, the first protective sheet is gradually peeled from the first region while changing the bending position while maintaining the state where the first region is positioned in the immediate vicinity of the skin, 1 The protective sheet can be applied to the skin sequentially from the peeled portion. Therefore, it becomes easier to fix the administration portion in close contact with the skin.

  In the transdermal administration device, the first protective sheet has a rigidity capable of bending the first protective sheet until the areas included in the non-facing surfaces come into contact with each other, and the second protective sheet is It is preferable that the first protective sheet has rigidity higher than that of the first protective sheet.

  According to the said structure, the rigidity of a transdermal administration device before these protective sheets peel will become high compared with the structure in which a 2nd protective sheet has comparable rigidity as a 1st protective sheet. Therefore, even if it is the structure provided with the 1st protective sheet which is easy to bend | fold, a transdermal administration device becomes easy to handle at the time of storage, transportation, etc.

  In the transdermal administration device, in a state where each of the first protective sheet and the second protective sheet is not peeled from the pressure-sensitive adhesive sheet, the second protective sheet is formed on the non-facing surface of the first protective sheet. It is preferable to cover at least a part.

  According to the said structure, before the 1st protective sheet and the 2nd protective sheet are peeled, the part covered with a 2nd protective sheet can be ensured large in a transdermal administration device. In other words, since a portion supported by the second protective sheet, which is a relatively rigid protective sheet, can be largely secured in the transdermal administration device, the temperature before the first protective sheet and the second protective sheet are peeled off. The rigidity of the skin administration device is increased. Therefore, the transdermal administration device becomes easier to handle during storage or transportation.

  In the transdermal administration device, in a state where the first protective sheet is not peeled from the pressure-sensitive adhesive sheet, the first protective sheet is attached to the first region and a portion attached to the first region. It is preferable to have a portion that extends from the attached portion and is not attached to the adhesive surface.

  According to the said structure, a 1st protective sheet can be peeled from a 1st area | region from the vicinity of this part by pulling the part which is not affixed on the adhesive surface in a 1st protective sheet. Therefore, the first protective sheet can be easily peeled off.

In the transdermal administration device, the area of the first region may be larger than the area of the second region.
According to the said structure, the area | region gradually stuck on skin with peeling of a 1st protective sheet can be ensured large in an adhesive surface. Therefore, since the adhesive sheet can be more gently affixed to the skin, the user of the transdermal administration device can more carefully fix the transdermal administration device to the skin.

In the transdermal administration device, the area of the first region may be smaller than the area of the second region.
According to the said structure, the area | region fixed to skin prior to peeling of a 1st protective sheet can be ensured large in an adhesive surface. Therefore, the first protective sheet can be peeled off while the position of the transdermal administration device with respect to the skin is stable.

  According to the present invention, the transdermal administration device can be easily fixed to the skin.

Sectional drawing which shows the cross-section of a transdermal administration device about one Embodiment of a transdermal administration device, and expands that part. The top view which shows the planar structure of the transdermal administration device of one Embodiment. The top view which shows the other example of the planar structure of the transdermal administration device of one Embodiment. The figure which shows the usage method of the transdermal administration device of one Embodiment, Comprising: The figure which shows the transdermal administration device of the state from which the 2nd protective sheet was peeled. The figure which shows the usage method of the transdermal administration device of one Embodiment, Comprising: The figure which shows the transdermal administration device of the state in the middle of the 1st protection sheet peeling. The figure which shows the usage method of the transdermal administration device of one Embodiment, Comprising: The figure which shows the transdermal administration device fixed to skin. The top view which shows the planar structure of the transdermal administration device of a 1st modification. The top view which shows the other example of the planar structure of the transdermal administration device of a 1st modification. The top view which shows the planar structure of the transdermal administration device of a 2nd modification. The top view which shows the planar structure of the transdermal administration device of a 3rd modification.

With reference to FIGS. 1-6, one Embodiment of a transdermal administration device is described.
[Configuration of transdermal administration device]
As shown in FIG. 1, the transdermal administration device 10 includes a microneedle 20 that is an example of an administration unit, an adhesive sheet 30, a first protective sheet 40, and a second protective sheet 50.

  The microneedle 20 includes a base 21 having a plate shape and a protrusion 22 protruding from the base 21. The base 21 has a first surface 21S that is a surface on which the protrusions 22 are arranged, and a second surface 21T that is a surface opposite to the first surface 21S, and the first surface 21S is the surface of the protrusions 22. Supports the proximal end. That is, the protrusion 22 protrudes from the first surface 21 </ b> S of the base 21. The outer shape of the base body 21 as viewed from the facing direction that is the direction facing the first surface 21S is not particularly limited, and the outer shape of the base body 21 may be circular or elliptical, or may be rectangular.

  The shape of the protrusion 22 may be a pyramid shape or a conical shape. Further, the protruding portion 22 may have a shape with a sharp tip, such as a cylindrical shape or a prismatic shape. Further, the protruding portion 22 may have a shape in which two or more solids are combined, such as a shape in which cones are stacked on a cylinder. In short, the protrusion 22 may have any shape that can pierce the skin. Further, a constriction or a step may be formed on the side wall of the protrusion 22, or a groove or a hole may be formed.

  The number of the protrusions 22 is not particularly limited as long as it is 1 or more. When the microneedle 20 has a plurality of protrusions 22, the plurality of protrusions 22 may be regularly arranged on the first surface 21S of the base 21 or may be irregularly arranged. For example, the plurality of protrusions 22 are arranged in a lattice shape or a concentric shape.

  The length H of the protrusion 22 is the length from the first surface 21S to the tip of the protrusion 22 in the thickness direction of the base 21, that is, in the direction orthogonal to the first surface 21S of the base 21. The length H of the protruding portion 22 is preferably 10 μm or more and 1000 μm or less, and the length H of the protruding portion 22 is a depth necessary for a hole formed in the object to be drilled by the protruding portion 22 within this range. It is decided accordingly. When the target of perforation is human skin and the bottom of the hole is set in the stratum corneum, the length H is preferably 10 μm or more and 300 μm or less, and more preferably 30 μm or more and 200 μm or less. When the bottom of the hole is set to a depth that penetrates the stratum corneum and does not reach the nerve layer, the length H is preferably 200 μm or more and 700 μm or less, more preferably 200 μm or more and 500 μm or less, More preferably, it is 200 μm or more and 300 μm or less. When the depth of the hole reaches the dermis, the length H is preferably 200 μm or more and 500 μm or less. When the depth of the hole reaches the epidermis, the length H is preferably 200 μm or more and 300 μm or less.

  The width D of the protrusion 22 is the maximum value of the length of the protrusion 22 in the direction along the first surface 21S of the base body 21, that is, in the direction parallel to the first surface 21S. For example, when the protrusion 22 has a regular quadrangular pyramid shape or a regular quadrangular prism shape, the length of the diagonal line in the square defined by the bottom of the protrusion 22 on the first surface 21S of the base 21 is the width D of the protrusion 22. It is. For example, when the protrusion 22 has a conical shape or a cylindrical shape, the diameter of a circle defined by the bottom of the protrusion 22 is the width D of the protrusion 22. The width D of the protrusion 22 is preferably 1 μm or more and 300 μm or less.

The aspect ratio A (A = H / D), which is the ratio of the length H to the width D of the protrusion 22, is preferably 1 or more and 10 or less.
When the protrusion 22 is formed to have a sharp tip and a hole having a depth penetrating the stratum corneum is formed by the protrusion 22, the tip angle θ of the protrusion 22 is preferably 5 ° or more and 30 ° or less. More preferably, the angle is 10 ° or more and 20 ° or less. The tip angle θ is the maximum value of the angle formed by the tip of the protrusion 22 in the cross section along the thickness direction of the base 21. For example, when the protrusion 22 has a regular quadrangular pyramid shape, the tip angle θ of the protrusion 22 is the apex angle of a triangle having a square diagonal line defined by the bottom of the protrusion 22 as a base and a vertex of the regular pyramid as a vertex. is there.

  The width D, the aspect ratio A, and the tip angle θ of the protrusion 22 are determined according to the volume required for the hole formed by the protrusion 22. If the length H, the width D, the aspect ratio A, and the tip angle θ are within the above ranges, the shape of the protrusion 22 is a shape suitable for forming a hole in the skin.

  The pressure-sensitive adhesive sheet 30 includes a base material sheet 31 and a pressure-sensitive adhesive layer 32 that covers one of the two surfaces of the base material sheet 31. The surface of the adhesive layer 32 opposite to the surface in contact with the base material sheet 31 is the adhesive surface 30S of the adhesive sheet 30, and the surface of the base material sheet 31 opposite to the surface in contact with the adhesive layer 32 is the adhesive sheet. 30 non-adhesive surfaces 30T. That is, in the adhesive sheet 30, the non-adhesive surface 30T is a surface opposite to the adhesive surface 30S. The second surface 21T of the base 21 is affixed to the adhesive surface 30S, whereby the base 21 of the microneedle 20 is affixed to the adhesive sheet 30.

  When viewed from the opposing direction, the outer shape of the pressure-sensitive adhesive sheet 30 is larger than that of the base 21, and a part of the pressure-sensitive adhesive surface 30 </ b> S of the pressure-sensitive adhesive sheet 30 protrudes outside the base 21. Moreover, the adhesive sheet 30 has the softness | flexibility which can deform | transform along the shape of the skin of administration object.

  The first protective sheet 40 covers the first region R <b> 1 that is a part of the region protruding outside the base 21 in the adhesive surface 30 </ b> S of the adhesive sheet 30. The second protective sheet 50 covers the second region R2 which is a part of the region protruding outside the base 21 and is different from the first region R1 in the adhesive surface 30S of the adhesive sheet 30. Yes.

  Each of the protective sheets 40, 50 is a pressure-sensitive adhesive sheet that is applied to the protective sheet 40, 50 by a force that is generated when the user of the transdermal administration device 10 picks and pulls each of the protective sheets 40, 50 with a finger. The adhesive sheet 30 is attached to the adhesive surface 30 </ b> S so that the adhesive sheet 30 can be peeled off.

  Of the two surfaces of the first protective sheet 40, the surface attached to the first region R1 of the adhesive surface 30S is the facing surface 40T, and the surface opposite to the facing surface 40T is the non-facing surface 40S. is there. Of the two surfaces of the second protective sheet 50, the surface attached to the second region R2 of the adhesive surface 30S is the facing surface 50T, and the surface opposite to the facing surface 50T is the non-facing surface 50S. is there.

  The first protective sheet 40 has a rigidity that allows the first protective sheet 40 to be bent until regions included in the non-facing surface 40S come into contact with each other. In other words, when viewed from the direction along the first surface 21S of the base body 21, the first protective sheet 40 has a position of the sheet before being bent and a position of the sheet after being bent by being moved from that position. It has rigidity that can be bent to a position where the angle between them is 180 degrees. Further, the rigidity of the first protective sheet 40 is such that the force required to bend the first protective sheet 40 is smaller than the force required to peel the first protective sheet 40 from the adhesive surface 30S of the adhesive sheet 30. It is a size that satisfies that.

  The second protective sheet 50 has a rigidity higher than that of the first protective sheet 40. Specifically, it is preferable that the second protective sheet 50 has such a rigidity that it is difficult to bend the second protective sheet 50 until regions included in the non-facing surface 50S come into contact with each other.

  As shown in FIG. 2, when viewed from the opposite direction, the adhesive sheet 30 protrudes from the base 21 over the entire outer periphery of the base 21 so as to surround the outer periphery of the base 21. The shape of the pressure-sensitive adhesive sheet 30 viewed from the facing direction is not particularly limited, and the pressure-sensitive adhesive sheet 30 may be circular or elliptical, may be rectangular, or has a shape different from these shapes. You may have.

  A region of the adhesive surface 30S that protrudes from the base 21 includes a first region R1 and a second region R2, and the area of the first region R1 is equal to the area of the second region R2. For example, when viewed from the opposite direction, the adhesive sheet 30 has a shape extending in one direction such as an ellipse or a rectangle, the base 21 is disposed in the center of the adhesive surface 30S, and the first region R1 and the second region The region R2 is virtually divided by a straight line passing through the center of gravity of the adhesive sheet 30 and a straight line passing through the center of gravity of the first surface 21S of the base 21.

  The first protective sheet 40 is attached to the entire first region R1, that is, the region where the first protective sheet 40 is attached is the first region R1. Moreover, the 2nd protection sheet 50 is affixed on the whole 2nd area | region R2, ie, the area | region where the 2nd protection sheet 50 is affixed is 2nd area | region R2.

  The first protective sheet 40 has a portion that is affixed to the first region R1, and a knob 41 that is a portion protruding outward from this portion and not affixed to the first region R1. . The knob 41 is located in the vicinity of the boundary between the first protective sheet 40 and the second protective sheet 50, that is, in the vicinity of the boundary between the first region R1 and the second region R2 when viewed from the facing direction. The knob 41 protrudes outward from the adhesive sheet 30 when viewed from the facing direction, and the outer edge of the first protective sheet 40 swells at the knob 41.

  The entire second protective sheet 50 is attached to the second region R2, and the first protective sheet 40 and the second protective sheet 50 do not overlap. When viewed from the facing direction, the outer edge of the pressure-sensitive adhesive sheet 30 coincides with the outer edge of the first protective sheet 40 at a portion other than the knob 41 and also coincides with the outer edge of the second protective sheet 50.

  In addition, the knob | pick part which the 1st protective sheet 40 has is a part extended from the part affixed on 1st area | region R1, and should just be a part which is not affixed on 1st area | region R1. That is, like the knob portion 42 shown in FIG. 3, the knob portion may be a portion extending from a portion attached to the first region R <b> 1 to a region overlapping with the adhesive sheet 30. The knob 42 is overlapped with the second protective sheet 50 attached to the second region R2 and the second region R2 when viewed from the facing direction.

[Material for transdermal administration device]
The material of each part constituting the transdermal administration device 10 will be described.
Examples of the material constituting the microneedle 20 include metals such as silicon, stainless steel, titanium, and manganese, and thermoplastic resins such as medical silicone, polylactic acid, polyglycolic acid, polycarbonate, and cyclic olefin copolymer, Examples include water-soluble materials. The microneedle 20 is preferably formed from a biocompatible material.

  Among these materials, the material constituting the microneedle 20 is preferably a water-soluble material, that is, a material that is dissolved by moisture of the skin. 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 the above materials, chitosan, chitosan succinamide, carboxymethylcellulose (CMC), hydroxypropylcellulose (HPC), and hydroxypropylmethylcellulose (HPMC) are preferably used because they are biologically safe. it can. Examples of polysaccharides include trehalose and maltose. The protrusion 22 formed from a water-soluble material dissolves within the skin after being stabbed into the skin.

  When the microneedle 20 includes a protrusion 22 made of a water-soluble material, and when the drug is fed into the skin to be administered together with the dissolution of the protrusion 22, the microneedle 20 is used for accurate administration of the drug. It is required that the fixing be maintained until the protrusion 22 is dissolved in the skin. That is, since a transdermal administration device that can be fixed in a state where the microneedle 20 and the skin are in close contact with each other is particularly required, the effect of applying the configuration of the transdermal administration device 10 of this embodiment is great.

In addition, the base | substrate 21 and the projection part 22 may be formed from the mutually same material, and may be formed from a mutually different material.
The drug administered by the microneedle 20 is applied to the surface of the protrusion 22 and may be sent into the skin together with the formation of a hole by the protrusion 22, or the protrusion 22 is soluble as described above. In the case where the protrusion 22 is formed, it may be included in the protrusion 22 and fed into the skin together with the dissolution of the protrusion 22. Or when the groove | channel and the hole are formed in the projection part 22, a chemical | medical agent may be filled into a groove | channel and a hole, and a chemical | medical agent may be sent into skin with the formation of the hole to the skin by the projection part 22. FIG. In addition, before or after the protrusion 22 is pierced by the skin, a liquid medicine may be applied to the skin, and the medicine may be sent into the skin from the hole formed by the protrusion 22. Furthermore, the drug may be administered in a form in which these methods are combined. In addition, when the projection part 22 is formed from the material which has solubility, the water-soluble material which comprises the projection part 22 may function as a chemical | medical agent.

  The type of drug is not particularly limited as long as it is a substance that functions by being administered intradermally. Examples of the drug include pharmacologically active substances and cosmetic compositions, and are selected according to the purpose.

  Examples of the pharmacologically active substance include vaccines such as influenza, analgesics for cancer patients, insulin, biologics, gene therapy drugs, injections, oral preparations, and preparations for skin application. In transdermal administration using the microneedle 20, a drug is administered to a hole formed in the skin. Therefore, transdermal administration using the microneedle 20 can be used for administration of pharmacologically active substances that require subcutaneous injection in addition to the pharmacologically active substances used for conventional transdermal administration. In particular, transdermal administration using the microneedle 20 is suitable for administration of injections such as vaccines to children because it does not give pain to the patient during administration. Moreover, since transdermal administration using the microneedle 20 does not require the patient to take a drug at the time of administration, it is suitable for administration of an oral preparation for children who are difficult to take oral preparations.

  A cosmetic composition is a composition used as a cosmetic or a cosmetic. Examples of the cosmetic composition include a moisturizer, a colorant, a fragrance, or a physiologically active substance that exhibits a beauty effect such as an improvement effect on wrinkles, acne, pregnancy lines, and an improvement effect on hair loss. When a fragrant material is used as the cosmetic composition, it is possible to impart an odor to the microneedles 20, so that the transdermal administration device 10 suitable for cosmetics can be obtained.

  Although the material of the adhesive sheet 30 is not particularly limited, examples of the base sheet 31 include polyolefin resins such as polyethylene and polypropylene, polyester resins such as nylon and polyethylene terephthalate, polyvinyl chloride, polyvinylidene chloride, or A resin sheet made of polyvinyl alcohol or the like is used. The adhesive layer 32 is formed of, for example, a silicone-based adhesive, a rubber-based adhesive, an epoxy-based adhesive, an acrylic-based adhesive, or the like.

  The material of the first protective sheet 40 is particularly limited as long as the first protective sheet 40 has a function of protecting the adhesive surface 30S of the adhesive sheet 30 and can be formed so as to satisfy the above-described rigidity condition. Not. That is, the material of the first protective sheet 40 is capable of peeling the first protective sheet 40 from the adhesive surface 30S of the adhesive sheet 30 and until the regions included in the non-facing surface 40S come into contact with each other. Any material that can be formed so as to have rigidity that can be bent may be used.

  The material of the second protective sheet 50 is not particularly limited as long as the second protective sheet 50 has a function of protecting the adhesive surface 30S of the adhesive sheet 30 and can be formed so as to satisfy the above-described rigidity condition. Not. That is, the material of the second protective sheet 50 is difficult to bend until the second protective sheet 50 can be peeled off from the adhesive surface 30S and the regions included in the non-facing surface 50S come into contact with each other. It only needs to be formed so as to have a certain degree of rigidity.

  As the 1st protective sheet 40 and the 2nd protective sheet 50, a sheet | seat provided with the base material sheet and the peeling layer laminated | stacked on the base material sheet can be used, for example. The opposite surface of the release layer to the base sheet is the facing surfaces 40T and 50T, and the opposite face of the release sheet to the release layer is the non-facing surfaces 40S and 50S.

  Examples of the base sheet include paper, polyolefin sheets such as polyethylene, polyethylene terephthalate (PET) sheets, resin sheets such as nylon sheets and polyurethane sheets. The release layer is formed from, for example, a silicone resin, a fluorine resin, or the like. In addition, when the base sheet itself has releasability, that is, non-adhesiveness like a silicone sheet, the release layer can be omitted. In the present embodiment, the structure expressed as “sheet” includes a sheet-like structure and a film-like structure, and the thickness of the structure is not limited.

  In order to make the rigidity of the first protective sheet 40 different from the rigidity of the second protective sheet 50 so as to satisfy the above-described conditions, the material constituting the first protective sheet 40 and the material constituting the second protective sheet 50 are used. May be selected in consideration of the rigidity of the material itself. For example, the first protective sheet satisfying the rigidity condition by using different appropriate materials for the base sheet material used for the first protective sheet 40 and the base sheet material used for the second protective sheet 50. 40 and the second protective sheet 50 can be realized. In addition, when the material of the base sheet in the first protective sheet 40 and the material of the base sheet in the second protective sheet 50 are the same, in addition to the material of the release layer in the first protective sheet 40, Even if the material of the release layer in the second protective sheet 50 is the same, the thickness of the first protective sheet 40 and the thickness of the second protective sheet 50 are made different to make the rigidity of these sheets different. Can be made. Specifically, by making the thickness of the first protective sheet 40 smaller than the thickness of the second protective sheet 50, desired rigidity can be imparted to each of these sheets.

  In addition, as for each material of the protection sheets 40 and 50, when the protection sheets 40 and 50 are peeled from the adhesive surface 30S, the adhesive surface 30S indicates a state in which the adhesive sheet 30 is adhered to a drug administration target for a desired period. It is preferable that the non-biocompatible material is a material that retains the adhesive force that can be maintained over a wide range and that does not remain on the adhesive surface 30S.

[Action]
The operation of the transdermal administration device 10 of the present embodiment will be described with reference to FIGS.

  As shown in FIG. 4, the user of the transdermal administration device 10 first peels the second protective sheet 50 from the adhesive sheet 30. For example, the user may peel off the second protective sheet 50 from the adhesive surface 30 </ b> S of the adhesive sheet 30, starting from the boundary between the first protective sheet 40 and the second protective sheet 50. Thereby, the second region R2 of the adhesive surface 30S is exposed.

  Subsequently, the user presses the base 21 of the microneedle 20 against the skin where the drug is administered, and affixes the second region R2 of the adhesive surface 30S to the skin. At this time, since the first region R1 of the adhesive surface 30S is covered with the first protective sheet 40, the user grasps and supports the transdermal administration device 10 at the portion of the first region R1, while the second region R2 can be affixed to the skin. Therefore, the microneedle 20 and the adhesive sheet 30 together with the adhesive sheet 30 are compared with a configuration in which the adhesive surface 30S is attached to the skin from a state in which the adhesive surface 30S around the substrate 21 is exposed. It is easy to fix to the skin, that is, fix the transdermal administration device 10 to the skin.

  When 2nd area | region R2 is affixed on skin, the 1st protective sheet 40 will be in the state pinched | interposed between the adhesive sheet 30 and skin. Further, the user pulls the first protective sheet 40 from between the adhesive sheet 30 and the skin while peeling the first protective sheet 40 from the first region R1 by pinching the knob 41 of the first protective sheet 40. The first protective sheet 40 is pulled like this.

  As shown in FIG. 5, the first protective sheet 40 is folded so that the regions included in the non-facing surface 40S are in contact with each other, and the folding position is changed as the peeling from the pressure-sensitive adhesive sheet 30 progresses. It is pulled out between the sheet 30 and the skin Sk. And 1st area | region R1 is affixed on skin Sk gradually as progress of peeling of the 1st protective sheet 40 progresses. For example, the first region R1 is attached to the skin Sk so as to wrap around the outer periphery of the base body 21 of the microneedle 20 from a portion located in the vicinity of the knob portion 42 before the first protective sheet 40 is peeled off. It will be.

  At this time, the first protective sheet 40 is bent at the boundary between the portion peeled from the pressure-sensitive adhesive sheet 30 and the portion attached to the pressure-sensitive adhesive sheet 30, and peeled from the pressure-sensitive adhesive sheet 30 in the non-facing surface 40S. The region included in the portion that is made and the region included in the portion that is attached to the pressure-sensitive adhesive sheet 30 come into contact with each other. Therefore, the first region R1 can be positioned in the immediate vicinity of the skin Sk, and the first region R1 can be attached to the skin Sk sequentially from the peeled portion of the first protective sheet 40. Therefore, the transdermal administration device 10 can be easily fixed to the skin as compared with the configuration in which the first region R1 is attached to the skin Sk from the state in which the first region R1 is completely exposed.

  In other words, the first protective sheet 40 of the present embodiment is opposed when the facing surface 40T is peeled from the adhesive surface 30S from one end of the facing surface 40T to the other end of the facing surface 40T. The first protective sheet 40 is configured to bend at a boundary between a region peeled off from the adhesive surface 30S in the surface 40T and a region attached to the adhesive surface 30S in the opposing surface 40T. And when it bend | folds in this way, the 1st protective sheet 40 is in the area | region in the non-facing surface 40S located in the opposite side of the area | region peeled off from the adhesion surface 30S in the opposing surface 40T, and the opposing surface 40T. Thus, a region in the non-facing surface 40S located on the opposite side of the region attached to the adhesive surface 30S is configured to come into contact.

  Thus, in the process in which the adhesive surface 30S of the adhesive sheet 30 is affixed to the skin, the user presses the non-adhesive surface 30T of the adhesive sheet 30 and stretches the adhesive sheet 30 while the adhesive surface 30S is applied to the skin. As shown in FIG. 6, the transdermal administration device 10 can be fixed to the skin while suppressing the formation of wrinkles on the adhesive sheet 30. Therefore, it is possible to suppress the generation of a gap between the adhesive sheet 30 and the skin in the vicinity of the microneedle 20, and to fix the transdermal administration device 10 to the skin in a state where the microneedle 20 and the skin are in close contact with each other. it can.

Thereby, the protrusion 22 perforates the skin, and the drug is fed into the body of the administration target while the microneedle 20 is fixed to the skin from the hole formed by the protrusion 22.
As described above, according to the transdermal administration device 10 of the present embodiment, the following effects can be obtained.

  (1) The 1st protective sheet 40 and the 2nd protective sheet 50 are affixed on the adhesive surface 30S of the adhesive sheet 30, and the 1st protective sheet 40 peels from the adhesive sheet 30 in the 1st protective sheet 40. In this case, it can be bent until the areas included in the non-facing surface 40S come into contact with each other. Therefore, with the second protective sheet 50 peeled off from the second region R2 of the adhesive surface 30S, the percutaneous administration device 10 is picked and supported by the portion of the first region R1 where the first protective sheet 40 is adhered. Meanwhile, the second region R2 can be attached to the skin. Further, the first protective sheet 40 is folded so that the regions included in the non-facing surface 40S are in contact with each other and gradually peeled from the first region R1, and the first region R1 is positioned near the skin, The first protective sheet 40 can be applied to the skin sequentially from the peeled portion. Therefore, the transdermal administration device 10 can be easily fixed to the skin, and the formation of wrinkles on the pressure-sensitive adhesive sheet 30 can be suppressed, and the microneedle 20 can be easily fixed in close contact with the skin.

  (2) When the first protective sheet 40 is peeled from the pressure-sensitive adhesive sheet 30, the first protective sheet 40 is first at the boundary between the portion peeled from the pressure-sensitive adhesive sheet 30 and the portion attached to the pressure-sensitive adhesive sheet 30. The protective sheet 40 can be bent. According to such a configuration, the first protective sheet 40 is gradually peeled from the first region R1 while changing the bending position while maintaining the state where the first region R1 is positioned in the immediate vicinity of the skin, and the first region R1 can be applied to the skin sequentially from the peeled portion of the first protective sheet 40. Therefore, it becomes easier to fix the microneedles 20 in close contact with the skin.

  (3) The first protective sheet 40 has a rigidity that can be bent until the regions included in the non-facing surface 40S come into contact with each other, and the second protective sheet 50 has a rigidity higher than that of the first protective sheet. have. According to such a configuration, the rigidity of the transdermal administration device 10 before the protective sheets 40, 50 are peeled is higher than that of the configuration in which the second protective sheet 50 has the same degree of rigidity as the first protective sheet 40. Become. Therefore, even if it is the structure provided with the 1st protective sheet 40 which is easy to bend | fold, the transdermal administration device 10 becomes easy to handle at the time of storage, transportation, etc. In particular, such an effect is enhanced in a configuration in which the second protective sheet 50 has a rigidity that is difficult to bend until the regions included in the non-facing surface 50S come into contact with each other.

  (4) In a state before the first protective sheet 40 is peeled off from the adhesive sheet 30, the first protective sheet 40 extends from the portion attached to the first region R1 and is attached to the adhesive surface 30S. It has knobs 41 and 42, which are not provided. According to such a configuration, the first protective sheet 40 can be peeled from the first region R1 starting from the vicinity of the knobs 41 and 42 by pulling the knobs 41 and 42. Therefore, the first protective sheet 40 can be easily peeled off.

(Modification)
A modification of the transdermal administration device of the above embodiment will be described. In the following description, differences from the above embodiment will be mainly described, and the same components as those in the above embodiment will be denoted by the same reference numerals and description thereof will be omitted. The transdermal administration device may have a configuration in which the configurations of the modifications described below are combined.

[First Modification]
In the transdermal administration device of the first modification, the sizes of the first region R1 and the second region R2 are different.
In the transdermal administration device 11 shown in FIG. 7, the area of the first region R1 is larger than the area of the second region R2. For example, when viewed from the facing direction, the first region R1 and the second region R2 are straight lines passing outside the region where the protrusion 22 is disposed in the first surface 21S of the base 21 or the base 21 It is virtually divided by a straight line passing outside.

  In the configuration in which the area of the first region R1 is larger than the area of the second region R2, a large area in the adhesive surface 30S that is gradually attached to the skin as the first protective sheet 40 is peeled is secured. be able to. Accordingly, since the user can more gently attach the adhesive sheet 30 to the skin, the transdermal administration device 11 can be more carefully fixed to the skin.

  In the transdermal administration device 12 shown in FIG. 8, the area of the first region R1 is smaller than the area of the second region R2. A line passing through the boundary between the first region R1 and the second region R2 when viewed from the facing direction preferably overlaps the base 21. For example, the first region R1 and the second region R2 are the first of the base 21. In the surface 21S, it is virtually divided by a straight line passing outside the area where the protrusion 22 is disposed.

  In the configuration in which the area of the first region R1 is smaller than the area of the second region R2, it is possible to secure a large region in the adhesive surface 30S that is fixed to the skin prior to the peeling of the first protective sheet 40. Therefore, peeling of the first protective sheet 40 can be started in a state where the position of the transdermal administration device 12 with respect to the skin is stable.

[Second Modification]
The second modification differs from the above embodiment in the positional relationship between the first protective sheet and the second protective sheet.

  In the transdermal administration device 13 shown in FIG. 9, the second protective sheet 55 includes an affixing portion 56 that is a portion that is affixed to the second region R2 and an expansion that is a portion that is not affixed to the second region R2. Part 57. The extension part 57 extends from the sticking part 56 and overlaps the first protective sheet 40. The extension part 57 may overlap with the entire first protective sheet 40 or may overlap with a part thereof. In short, the second protective sheet 55 covers at least a part of the non-facing surface 40S of the first protective sheet 40 in a state where each of the first protective sheet 40 and the second protective sheet 55 is not peeled off from the adhesive sheet 30. Just cover it.

  According to such a configuration, a large portion of the transdermal administration device 13 covered with the second protective sheet 55 can be secured before the protective sheets 40 and 55 are peeled off. Therefore, since the part supported by the 2nd protective sheet 55 which is a comparatively highly rigid protective sheet compared with the said embodiment can be largely ensured in the transdermal administration device 13, the protective sheets 40 and 55 are provided. The rigidity of the transdermal administration device before peeling is increased. Therefore, the transdermal administration device becomes easier to handle during storage or transportation.

  In addition, the expansion part 57 may be affixed on the non-facing surface 40S of the 1st protective sheet 40 so that it can peel with the force of the grade which arises by picking and pulling the expansion part 57 with a finger | toe. According to such a configuration, the expansion part 57 can be suppressed from being lifted from the first protective sheet 40 during storage, transportation, and the like, so that the transdermal administration device 13 is easier to handle.

[Third Modification]
In the said embodiment, the 1st protection sheet 40 is comprised by the rigidity which 1st protection sheet 40 itself has so that it can be bent until the area | regions included in the non-facing surface 40S contact. On the other hand, in the 3rd modification, the 1st protection sheet can be bent by the processing given to the 1st protection sheet.

  In the transdermal administration device 14 shown in FIG. 10, the first protective sheet 45 has a fragile portion 46. Further, the first protective sheet 45 has such a rigidity that it is difficult to bend the first protective sheet 45 until the areas included in the non-facing surface 40S come into contact with each other.

  For example, the fragile portion 46 is a portion in which perforations are formed, and the strength of the first protective sheet 45 against bending is lower than the portion around the fragile portion 46. That is, the fragile portion 46 is a portion that is more easily bent by an external force than the portion other than the fragile portion 46 in the first protective sheet 45. The first protective sheet 45 is configured to be able to be bent at the fragile portion 46 until the areas included in the non-facing surface 40S come into contact with each other.

  In addition, as an example of the fragile portion 46 that replaces the portion where the perforation is formed, the fragile portion 46 may be a portion in which the thickness of the first protective sheet 45 is made smaller than that around the fragile portion 46. Further, the fragile portion 46 may be a portion in which a part of the first protective sheet 45 is cut in the thickness direction by half-cut processing or the like.

  In the example shown in FIG. 10, the fragile portions 46 are formed in a straight line shape, and the plurality of fragile portions 46 are arranged substantially evenly around the base 21 of the microneedle 20 when viewed from the facing direction. The number and positions of the fragile portions 46 may be set as appropriate according to the size and shape of the first protective sheet 45, and the fragile portions are located at positions where it is desired to bend the first protective sheet 45 when peeled from the adhesive sheet 30. 46 should just be arrange | positioned.

  When the first protective sheet 45 is peeled off, the first protective sheet 45 is folded at the fragile portion 46 so that the regions included in the non-facing surface 40S come into contact with each other as the peeling proceeds. It is pulled out from between the sheet 30 and the skin. That is, when folded at the fragile portion 46, the non-facing surface 40 </ b> S includes a region included in a portion of the first protective sheet 45 peeled from the pressure-sensitive adhesive sheet 30 and a pressure-sensitive adhesive sheet 30 in the first protective sheet 45. The area included in the pasted part comes into contact. And 1st area | region R1 is affixed on skin gradually as progress of peeling of the 1st protective sheet 40 progresses.

  Even in such a configuration, the first region R1 is close to the skin as compared with a configuration in which the first protective sheet cannot be folded until the regions included in the non-facing surfaces come into contact with each other in any part of the first protective sheet. The first region R1 can be attached to the skin from the peeled portion of the first protective sheet 45. Therefore, the effect according to the above (1) can be obtained.

  Moreover, since the rigidity of the 1st protective sheet 45 is high compared with the said embodiment, the rigidity of the transdermal administration device 14 before the protective sheets 45 and 50 are peeled becomes high. Therefore, the transdermal administration device 10 is easy to handle during storage or transportation.

  However, as in the above embodiment, the first protective sheet 40 is configured so that it can be bent at the boundary between the part peeled off from the adhesive sheet 30 and the part attached to the adhesive sheet 30. It is preferable in that the first protective sheet 40 can be peeled off and the first region R1 can be attached to the skin while maintaining the state where the first region R1 is positioned in the immediate vicinity of the skin. That is, in the said embodiment, since it is comprised so that the area | region included in the non-facing surface 40S may contact | fold the 1st protective sheet 40 in any location, the 1st protective sheet 40 is comprised. It can be gradually peeled from the first region R1 while changing its folding position.

[Other variations]
The above-described embodiment and each modification can be implemented with the following modifications.
The rigidity of the first protective sheet and the rigidity of the second protective sheet may be approximately the same, or the rigidity of the second protective sheet may be lower than the rigidity of the first protective sheet. Even if it is such a structure, the effect of said (1) is acquired.

  -The direction which affixes a microneedle and an adhesive sheet on the skin of an administration object may be induced | guided | derived by the position of a pick part. That is, the direction in which the first protective sheet is peeled can be defined by the position of the knob, and the user can easily pull the first protective sheet in the direction in which the first protective sheet is peeled off. The transdermal administration device is affixed to the skin in a direction, for example, a direction from the center of the face toward the outside. Accordingly, the position of the knob is set so that the microneedle and the adhesive sheet are in a desired direction when the direction in which the first protective sheet is to be peeled is the direction in which the first protective sheet is easily pulled. By this, the direction in which the microneedle and the adhesive sheet are attached to the skin can be induced.

  -The 1st protection sheet may have a plurality of knobs. The second protective sheet may also have a knob portion similar to the knob portion of the first protective sheet. Or the 1st protection sheet does not need to have a knob part. If the first protective sheet does not have a knob, the first protective sheet can be peeled off from the adhesive surface starting from, for example, a portion located near the boundary between the first region R1 and the second region R2. Good.

  -Even if the weak part of a 3rd modification has the rigidity which can be bent until the area | region contained in a non-facing surface contacts the 1st protection sheet, even if it is provided in the 1st protection sheet Good. In this case, the first protective sheet is more easily bent by the fragile portion.

  -The 1st protective sheet should just be affixed on 1st area | region R1 of an adhesive surface, and the 1st protective sheet may spread to the outer side of the adhesive sheet seeing from the opposing direction. Moreover, the 2nd protective sheet should just be affixed on 2nd area | region R2 of an adhesive surface, and the 2nd protective sheet may spread to the outer side of the adhesive sheet seeing from the opposing direction. That is, when viewed from the facing direction, the outer edge of the adhesive sheet may not coincide with the outer edge of the first protective sheet, or may not coincide with the outer edge of the second protective sheet.

  -On at least one of the non-facing surface of the first protective sheet and the non-facing surface of the second protective sheet, a number indicating the order of peeling of the protective sheet, an explanation regarding how to use the transdermal administration device, A printed layer showing an illustration or the like related to the usage method may be provided. Such a printed layer allows the user to use the device for transdermal administration, that is, after peeling the second protective sheet from the adhesive sheet, a part of the adhesive surface is pressed against the skin, and then the first protective sheet is used. It is possible to easily guide the work of pulling out and peeling from the pressure-sensitive adhesive sheet and attaching the remaining part of the pressure-sensitive adhesive surface to the skin.

  The transdermal administration device may further include a protective sheet different from these protective sheets in addition to the first protective sheet and the second protective sheet. That is, the transdermal administration device may be provided with three or more protective sheets. In this case, in addition to 1st area | region R1 and 2nd area | region R2, an adhesive surface further includes the area | region different from these areas, The above-mentioned further protective sheet is affixed on this further area | region. .

  -The shape of the projection part 22 which an administration part has is not restricted to needle shape, ie, the shape extended along the direction orthogonal to the 1st surface 21S of the base | substrate 21. As shown in FIG. The shape of the protruding portion is a blade shape, that is, the protruding portion extends along one extending direction that is a direction along the first surface 21S of the base body 21, and the tip of the protruding portion is the first surface 21S of the base body 21. The shape may be a linear shape extending in a direction different from the direction orthogonal to the direction, for example, the extending direction. For example, the projecting portion has a triangular prism shape extending along the extending direction, one of three rectangular side surfaces of the triangular prism is in contact with the base body 21, and a side that divides the other two side surfaces projects. You may have the shape which functions as a front-end | tip of a part.

  DESCRIPTION OF SYMBOLS 10, 11, 12, 13, 14 ... Transdermal administration device, 20 ... Microneedle, 21 ... Base | substrate, 21S ... 1st surface, 21T ... 2nd surface, 22 ... Projection part, 30 ... Adhesive sheet, 30S ... Adhesive surface , 30T ... non-adhesive surface, 40, 45 ... first protective sheet, 40S ... non-opposing surface, 40T ... opposing surface, 41, 42 ... picking portion, 46 ... weak portion, 50, 55 ... second protective sheet, 50S ... Non-opposing surface, 50T ... opposing surface.

Claims (7)

A dosing unit comprising a base having a first surface and a second surface opposite to the first surface; and a protrusion protruding from the first surface;
The pressure-sensitive adhesive sheet having a pressure-sensitive adhesive surface to which the second surface is attached, wherein the pressure-sensitive adhesive sheet has a part of the pressure-sensitive adhesive surface protruding from the outside of the substrate as viewed from the direction facing the first surface;
A first protective sheet affixed to the entire first region which is a part of the region protruding from the base body in the adhesive surface;
A second protective sheet that is a part of a region that protrudes from the base in the adhesive surface and is attached to the entire second region that is different from the first region;
With
The first protective sheet has a facing surface attached to the pressure-sensitive adhesive surface and a non-facing surface that is a surface opposite to the facing surface, and the first protective sheet is peeled from the pressure-sensitive adhesive sheet. The region included in the non-facing surface, the region included in the portion of the first protective sheet peeled from the pressure-sensitive adhesive sheet, and the portion attached to the pressure-sensitive adhesive sheet in the first protective sheet A transdermal administration device configured to be able to bend the first protective sheet until it comes into contact with a region included in the device. When the first protective sheet is peeled from the pressure-sensitive adhesive sheet, the first protective sheet is a boundary between the portion peeled from the pressure-sensitive adhesive sheet and the portion attached to the pressure-sensitive adhesive sheet. The transdermal administration device according to claim 1, wherein the device can be bent. The first protective sheet has a rigidity capable of bending the first protective sheet until the areas included in the non-facing surfaces come into contact with each other.
The transdermal administration device according to claim 2, wherein the second protective sheet has rigidity higher than that of the first protective sheet. In a state where each of the first protective sheet and the second protective sheet is not peeled off from the adhesive sheet, the second protective sheet covers at least a part of the non-facing surface of the first protective sheet. The transdermal administration device according to claim 3. In a state where the first protective sheet is not peeled from the pressure-sensitive adhesive sheet, the first protective sheet extends from a portion attached to the first region and a portion attached to the first region. The transdermal administration device according to claim 1, further comprising: a portion that is not attached to the adhesive surface. The transdermal administration device according to any one of claims 1 to 5, wherein an area of the first region is larger than an area of the second region. The transdermal administration device according to any one of claims 1 to 5, wherein an area of the first region is smaller than an area of the second region.