JP6398293B2 - Acicular device - Google Patents

Description

  The present invention relates to an acicular device.

  The percutaneous absorption method in which a delivery product such as a drug is permeated through the skin to administer the delivery product into the body is known as a method capable of simply administering the delivery product without causing pain to the human body. Patent Document 1 discloses a method of puncturing the skin using a needle-like body having a micron (μm) order needle and administering a drug or the like into the skin in the field of transdermal administration. Patent Document 2 discloses a method for manufacturing a needle-like body. In this method, an original plate is produced by machining, a transfer plate is formed from the original plate, and transfer processing molding is performed using the transfer plate to produce a needle-like body.

  Patent Document 3 discloses another method for manufacturing a needle-like body. In this method, an original plate is produced by using an etching method, a transfer plate is formed from the original plate, and transfer processing molding is performed using the transfer plate to produce a needle-like body. Patent Document 4 discloses a method in which a drug is contained in a needle-like body that dissolves in the skin, and the drug is gradually released into the skin by dissolving the needle-like body in the skin. . Further, a needle-like body having a structure in which the base portion of the needle has a lower tensile strength than the tip portion is disclosed.

  On the other hand, the material constituting the needle-like body is desirably a material that does not adversely affect the human body even if the damaged needle-like body remains in the body. Patent Document 5 discloses a method using chitin, chitosan and derivatives thereof. Patent Document 6 discloses a method using a cellulose derivative. Patent Document 7 discloses a two-layered needle-like body in which the base of the needle has a sufficiently higher dissolution rate than the tip of the needle in order to shorten the time for applying the needle-like substrate to the skin. Patent Document 8 discloses a pressure-sensitive adhesive sheet that includes a water-containing layer and is thin enough to supply moisture only to the root portion of the needle-like body, and a method for manufacturing the same.

JP-A-48-93192 International Publication No. 2008/013282 International Publication No. 2008/004597 JP 2003-238347 A International Publication No. 2008/020632 International Publication No. 2013/199125 JP 2008-149288 A JP 2005-318887 A

As a technique for administering an active ingredient via the skin, a drug delivery technique using needles is required. One means for delivering a drug by an acicular body uses an acicular body in which an active ingredient is mixed with a base material that dissolves after puncturing the skin. In drug delivery using needles, it may be required to administer the drug in a sustained manner. When the needle-like body is punctured into the skin under a condition of high sustained release, if the needle portion of the needle-like body and the substrate are integrated, the needle-like body substrate is dissolved until the needle portion of the needle-like body is dissolved. Need to continue to be applied to the skin. In addition, a base material having a high sustained release of active ingredients is often a relatively hard material, and it may be uncomfortable to apply for a long time.
In order to avoid this phenomenon, there is a demand for a technique for quickly removing the substrate from the needle portion after the needle-like body is punctured into the skin and leaving only the needle portion in the skin.

In the needle-like body described in Patent Document 4, the tip of the needle is quickly detached from the substrate by using a base material having a higher dissolution rate than the tip of the needle at the base of the needle, To remain. In the needle-shaped body described in Patent Document 7, the needle portion is broken from the root by a slight movement of the substrate and left in the skin by making the mechanical strength of the base portion of the needle portion weaker than the tip portion. ing.
However, in any of the needle-like bodies, when the speed at which the needle portion remaining in the skin is dissolved is low, the needle portion may be pushed out from the skin due to the elasticity of the skin. As a method of preventing the needle portion from being pushed out from within the skin, there is a method of applying a patch. However, when there is a symptom such as skin hypersensitivity, it may be inappropriate to apply the patch for a long time.
The present invention has been made in view of such circumstances, and only the needle portion of the needle-like body easily remains in the skin, and the remaining needle portion is not easily detached from the skin. A needle device is provided.

  In order to solve the above-described problem, a needle-like device according to one embodiment of the present invention includes a needle-like body including a substrate, a needle portion protruding from one surface of the substrate, and one surface of the substrate. The film includes a solvent capable of dissolving the needle portion, and the thickness of the film is smaller than the height from the one surface of the needle portion. To do.

  According to the present invention, there is provided a needle-like device capable of easily leaving only the needle portion of the needle-like body in the skin and preventing the remaining needle portion from easily detaching from the skin. Can do.

It is a figure which shows the structural example of the acicular body device 1 which concerns on embodiment of this invention. It is a figure which shows the manufacturing method of the acicular device. It is a figure which shows the manufacturing method of the acicular device. It is a figure which shows the manufacturing method of a film. It is a figure which shows the 1st modification of embodiment. It is a figure which shows the 2nd modification of embodiment. It is a figure for demonstrating an Example. It is a figure for demonstrating an Example.

DESCRIPTION OF EMBODIMENTS Hereinafter, modes for carrying out the present invention (hereinafter referred to as embodiments) will be described with reference to the drawings. Note that, in each drawing described below, parts having the same configuration are denoted by the same reference numerals, and repeated description thereof is omitted.
(Constitution)
As shown in FIG. 1A, the needle-like device 1 includes a needle-like body 3 and a film 5. The acicular body 3 includes a substrate 11 and a needle portion 13 protruding from one surface 11 a of the substrate 11. The film 5 contains a solvent that can dissolve the needle portion 13. For example, this solvent is moisture, and the film 5 is a water-containing film containing moisture. Further, the thickness of the film 5 is smaller than the height H of the needle portion 13. The thickness of the film 5 is preferably 5% or more and 50% or less of the height H of the needle part 13. The height H of the needle portion 13 is a distance from one surface 11 a of the substrate 11 to the tip of the needle portion 13.

The needle part 13 should just be a shape suitable for puncturing skin. The needle part 13 has shapes, such as a cone, a pyramid, a cylinder, a prism, and a pencil shape (a trunk | drum is a pillar shape and a front-end | tip part is a cone shape), for example. Further, the needle portion 13 may be in a form in which only one needle 11 exists on one surface 11a of the substrate 11, or a plurality of needle portions 13 exist on the one surface 11a of the substrate 11 so as to be separated from each other (that is, stand up). Form may be sufficient.
When there are a plurality of needle portions 13 on one surface 11a of the substrate 11, the needle portions 13 are preferably arranged in an array. Here, “array shape” means a state in which the needle portions 13 are arranged in a predetermined manner, and includes, for example, a lattice arrangement, a close-packed arrangement, a concentric arrangement, a random arrangement, and the like.
Note that the needle-like body 3 according to the embodiment may have a hole in the needle portion 13. This hole may be a hole that is drilled from the tip or side surface of the needle portion 13 and penetrates to the back surface of the substrate 11, or may be a non-through hole that is drilled at one or more locations in the needle portion 13. Further, the needle-like body 3 according to the embodiment may be provided with holes in the substrate 11. This hole may be a hole penetrating the substrate 11, a non-through hole drilled from the surface of the substrate 11, or a non-through hole drilled from the back surface.

In the needle-like body 3, it is preferable that the size of the needle portion 13 has a thickness and a length suitable for forming a puncture hole in the skin 7. Specifically, the height H of the needle portion 13 shown in FIG. 1B is preferably in the range of 10 μm or more and 1000 μm or less. The height H of the needle portion 13 is a distance from one surface 11 a of the substrate 11 to the tip of the needle portion 13.
The height H of the needle portion 13 is preferably determined in consideration of how deep the puncture hole formed when the needle-like body 3 is punctured into the skin within this range is formed. In particular, when the puncture hole formed when the needle-like body 3 is punctured into the skin is held in “in the stratum corneum”, the height H of the needle portion 13 is, for example, 10 μm or more and 300 μm or less, more preferably 30 μm or more and 200 μm or less, It is desirable to be within the range.

Further, when the puncture hole formed when the needle-like body 3 is punctured into the skin is kept at “a length that penetrates the stratum corneum and does not reach the nerve layer”, the height H of the needle portion 13 is 200 μm or more and 700 μm. In the following, it is more preferable that the thickness be in the range of 200 μm to 500 μm, more preferably 200 μm to 300 μm.
Further, when the puncture hole formed when the needle-like body 3 is punctured into the skin is “the length that the puncture hole reaches the dermis”, the height H of the needle portion 13 is in the range of 200 μm or more and 500 μm or less. It is preferable to do. When the puncture hole formed when the needle-like body 3 is punctured into the skin is “the length that the puncture hole reaches the epidermis”, the height H of the needle portion 13 is in the range of 200 μm to 300 μm. It is preferable.

The width D of the needle portion 13 is preferably in the range of 1 μm to 300 μm. The width D of the needle portion 13 is preferably determined in consideration of, for example, how deep the puncture hole formed when the needle-like body 3 is punctured into the skin within this range is formed.
The width D of the needle portion 13 is the same as that of the substrate 11 at the root portion 13a located on the side closer to the substrate 11 of the needle portion 13 in a side view (that is, viewed from a direction parallel to the one surface 11a of the substrate 11). The maximum value of the length of the line connecting the two points on the surface in contact with. For example, when the needle part 13 is conical, the diameter of the circle of the surface in contact with the substrate 11 of the root part 13a becomes the width D. When the needle portion 13 is a regular quadrangular pyramid, the square diagonal line of the surface in contact with the substrate 11 of the root portion 13a is the width D. Moreover, when the needle part 13 is a cylinder, the diameter of the circle | round | yen in contact with the board | substrate 11 of the base part 13a becomes the width | variety D. FIG. When the needle portion 13 is a regular quadrangular prism, a square diagonal line of the surface in contact with the substrate 11 of the root portion 13a is the width D.
The aspect ratio is preferably in the range of 1 to 10. The aspect ratio is a value defined by A = H / D using the length H and the width D of the needle portion 13 where the aspect ratio is A.

In the needle-like body 3, when the needle part 13 has a tip angle like a cone shape and penetrates the stratum corneum, the tip angle θ of the needle part 13 is 5 ° or more and 30 ° or less, more preferably 10 ° or more and 20 It is desirable to be within the range of ° or less. The tip angle θ is cut off by a line passing the width of the needle portion 13 and a surface passing through the tip of the needle portion 13 in a side view (that is, viewed from a direction parallel to the one surface 11a of the substrate 11). In a triangle, the angle of the angle centering on the front-end | tip of the needle part 13 is pointed out. The distal end portion 13b is a portion located on the side farther from the one surface 11a of the substrate 11 than the root portion 13a.
In the needle-like body 3, the substrate 11 is preferably made of the same material as the needle portion 13. By forming the substrate 11 and the needle portion 13 from the same material, the substrate 11 and the needle portion 13 can be formed integrally. Further, the substrate 11 may have a multilayer structure in which a material different from the needle portion 13 is laminated on the lower layer. By laminating a plurality of types of materials, it is possible to obtain a substrate that takes advantage of the physical properties of the plurality of materials as described below.

For example, the substrate 11 in which the upper layer on the side close to the needle portion 13 is formed of the same material as the needle portion 13 and the lower layer on the side far from the needle portion 13 is formed of a flexible material is formed by rolling the substrate 11 into a roll shape. Can be bent. Moreover, the board | substrate 11 which formed the upper layer with the material with a malleability larger than a lower layer can be bent in roll shape. In addition, the substrate 11 in which the upper layer is formed of a material having smaller shrinkage than the lower layer can also be bent into a roll shape. Moreover, even if the needle-like body 3 provided with the substrate 11 in which the lowermost layer farthest from the needle portion 13 is formed of a flexible material is stored in a state where a plurality of needle-like bodies 3 are stacked, Is in contact with the lowermost layer (that is, a material having flexibility), and can be prevented from being damaged.
Moreover, the base part 13a and the front-end | tip part 13b of the needle part 13 may be comprised with a different material. If a material that dissolves quickly in water is used for the root portion 13a and a material that slowly dissolves in the tip portion 13b is used, the root portion 13a is melted away by contact with the film 5, and only the tip portion 13b remains in the skin. Can do. Moreover, it is not necessary to interpose a protective layer between the film 5 and the substrate 11 by using a water-soluble material for the needle portion 13 and using only a material insoluble in water for the substrate 11 (that is, the film 5 is removed). It can be in direct contact with the substrate 11).

(Production method)
Next, a method for manufacturing the needle-like device 1 shown in FIGS. 1A and 1B will be described.
(1) Intaglio Plate Preparation Step First, an original plate for determining the shape of the needle-like body 3 is prepared. Next, as shown in FIG. 2A, an intaglio plate 21 is produced from the original plate by reversing the shape of the desired needle-like body 3. The original plate for determining the shape of the needle-like body 3 can be manufactured by a known method according to the shape of the needle-like body 3. The original plate may be formed using a fine processing technique. Examples of the fine processing technique include a lithography method, a wet etching method, a dry etching method, a sand blasting method, a laser processing method, and a precision machining method. In order to form the intaglio 21 from the original plate, a known shape transfer method can be used. For example, formation of Ni intaglio 21 by Ni electroforming, transfer molding using a molten resin, or the like can be mentioned.

(2) Preparation process of liquid needle-shaped body material A biocompatible substance, for example, a cellulose derivative, a chitosan derivative, a mucopolysaccharide derivative or the like is dissolved in water to prepare a base aqueous solution. A pharmaceutical component aqueous solution is prepared separately from the base aqueous solution and mixed with the base aqueous solution to prepare a liquid needle-shaped body material 23. The liquid needle-shaped body material 23 preferably has a fluidity that can flow into the intaglio 21 and may be in the form of a gel.
(3) Filling Step with Liquid Needle Body Material As shown in FIG. 2 (b), the intaglio plate 21 is filled with a liquid needle body material 23. As a filling method, a publicly known method can be appropriately selected according to the shape and size of the intaglio 21. For example, a spin coating method, a method using a dispenser, a casting method, or the like can be used. Moreover, when filling, the environment around the intaglio 21 may be reduced or reduced in vacuum.

(4) Solidifying process of liquid needle-shaped body material As shown in FIG. 3A, the liquid needle-shaped body material filled in the intaglio 21 is dried and solidified. Thereby, the solidified product 26 of the needle-shaped body material is obtained. Solidification is completed even when drying at room temperature, but it is preferable to shorten the production time by heat drying. The heating temperature is preferably set to a temperature at which the aqueous solution does not boil in order to avoid bubbles remaining in the needle-like body. For this reason, it is preferable to make heating temperature into the range of 40 to 90 degreeC. The heating may be any known heating means, for example, a hot plate on which the intaglio 21 filled with a liquid needle-shaped body material is placed can be used.

(5) Desorption step of solidified material of needle-shaped body material As shown in FIG. 3B, the solidified material 26 of the needle-shaped body material is desorbed from the intaglio 21. The detached solidified product 26 has the shape of the needle-like body 3. As the detachment method, for example, a method of physically peeling the solidified material of the needle-shaped body material from the intaglio plate 21 or a method of chemically dissolving only the intaglio plate 21 using an appropriate chemical can be used.
(6) Film formation process The film 5 shown to Fig.1 (a) shall contain the component (henceforth a dissolution acceleration | stimulation component) which accelerates | stimulates the melt | dissolution of the solidified material of needle-shaped body material. This component may be a substance that promotes transdermal absorption of the drug component. The material of the film 5 containing the dissolution promoting component is not particularly limited as long as it is used by being spread in a sheet shape. As the material of the film 5, for example, a material obtained by crosslinking various water-soluble polymers such as polyacrylic acid or a salt thereof, polyvinyl alcohol, and polyvinylpyrrolidone with polyvalent metal salts can be used.

  Although the manufacturing method of the film 5 is not specifically limited, For example, the aqueous solution 33 containing a dissolution acceleration | stimulation component as shown by Fig.4 (a) is produced, and this is apply | coated on the support | carrier 31. FIG. Next, the aqueous solution of the polyvalent metal salt is sprayed onto the carrier 31 from the nozzle 35 and crosslinked to make it insoluble in water. And in order to prevent drying, it can manufacture by the method of sticking the film of a suitable material and thickness on a surface as a protective layer. When spraying the polyvalent metal salt aqueous solution from the nozzle 35, it is desirable to arrange one or more nozzles so that the aqueous solution 33 is sprayed uniformly on the carrier 31 in order to insolubilize uniformly.

  Alternatively, as shown in FIG. 4 (b), an aqueous polyvalent metal salt solution can be applied using a brush or impregnated sheet 37. The impregnated sheet 37 is a sheet impregnated with an aqueous polyvalent metal salt solution. When the polyvalent metal salt aqueous solution is applied using a brush, plastic or animal-derived hair can be used. Moreover, when apply | coating using the impregnation sheet | seat 37, the material will not be restrict | limited especially if it can impregnate polyvalent metal salt aqueous solution, such as a foaming body, a nonwoven fabric, a woven fabric, a knitted fabric, leather, a porous body. Alternatively, as shown in FIG. 4C, the carrier 31 coated with the aqueous solution 33 containing the dissolution promoting component may be immersed in the liquid tank 39 filled with the aqueous metal salt solution to be insolubilized.

The film 5 may be provided with pores for penetrating the needle portion 13 of the needle-like body 3 in advance. The diameter of the pores is such that all the side surfaces of the needle portion 13 are in contact with each other. Further, the strength of the film 5 may be determined so that the needle portion 13 can penetrate instead of providing the film 5 with pores. The film 5 may have a multilayer structure in which a layer containing a dissolution promoting component and a layer made of a material different from this layer are stacked. By laminating a plurality of types of materials, it is possible to obtain a film that takes advantage of the physical properties of the plurality of materials as described in (a) and (b) below.
(A) The upper layer of the film 5 (that is, the layer facing the skin) is formed of a material that does not transmit the dissolution promoting component. In the film 5 thus formed, when the needle part 13 penetrates the film 5, the root part 13 a comes into contact with the lower layer of the film 5. Thereby, even when the tip portion 13b, the root portion 13a, and the substrate 11 of the needle portion 13 are all formed of the same material, only the root portion 13a can be dissolved. As a result, only the needle portion 13 remains in the skin, and the substrate 11 can be removed from the skin.
(B) The film 5 is formed by laminating materials having different concentrations or types of dissolution promoting components. In the film 5 thus formed, dissolution of the needle-shaped body 3 proceeds from a layer having higher solubility. For this reason, by making the lower layer of the film 5 a layer having a high dissolution promoting effect, the neck portion 13a of the needle portion 13 can be constricted, and it becomes easier to remove the substrate.

(Handling and usage)
The acicular device 1 is shipped after the acicular body 3 and the film 5 are cut into a predetermined size at the time of marketing. In order to protect the needle portion 13 from dirt and dust adhesion and dissolution due to moisture, the inside is deeper than the height H of the needle portion 13 and is in the same size and shape as the cut needle-like body 3. The body 3 is fixed and sealed in a dry state. The material of the container which fixes the needle-shaped body 3 is not specifically limited, For example, polyethylene, a polypropylene, a polyethylene terephthalate etc. can be used.

When the acicular device 1 is used, the acicular device 1 is taken out from the container. And the film 5 shown to Fig.1 (a) is affixed on the skin 7, and the acicular body 3 is affixed from it. Next, the needle-like body 3 is pressed against the skin 7 using a finger or a dedicated instrument (applicator), and the needle portion 13 is punctured into the skin 7. Then, after elapse of a certain time, the needle-like body 3 together with the film 5 is quickly removed from the skin 7.
The applicator is an auxiliary instrument for fixing the puncture position of the needle-like body 3 and the angle with respect to the skin, and is produced according to the shape of the needle-like body device. By using the applicator, the user of the needle device can easily identify the puncture. In addition, by using the applicator, when the user punctures the needle-like body device into the skin, the needle portion of the needle-like body to be punctured can be easily punctured from the direction perpendicular to the skin. .

(Effect of embodiment)
According to the present embodiment, the acicular device 1 includes the film 5 disposed on the one surface 11 a side of the substrate 11. The film 5 contains a solvent that can dissolve the needle portion 13, and the thickness of the film 5 is smaller than the height H of the needle portion 13. Thereby, when the needle part 13 of the needle-like body 3 is punctured into the skin 7 through the film 5, the root part 13 a which is a part located inside the film 5 in the needle part 13 is dissolved with the solvent of the film 5. be able to. As a result, the substrate 11 and the needle portion 13 can be separated (that is, the substrate 11 is removed), and the tip portion 13b of the needle portion 13 can remain in the skin 7.
Further, the distal end portion 13 b remaining on the skin 7 is covered with the film 5 and the substrate 11 after the root portion 13 a is dissolved away. Then, until the film 5 is peeled off from the skin 7 until the distal end portion 13b is stably held in the skin, the distal end portion 13b can be kept pressed in the film 5 to be fixed in the skin. Thereby, it can prevent that the front-end | tip part 13b of the needle part 13 does not detach | leave easily from skin.

(First modification)
FIG. 5 is a diagram illustrating a first modification of the needle-like body device 1. As shown in FIG. 5 (a), in this embodiment, the needle-like device 1 has an upper surface (that is, a needle) of the film 5 in order to prevent the dissolution promoting component in the film 5 from evaporating and adhering dust and dust. You may provide the protective film 15 which covers the part 13 surface.
As shown to Fig.5 (a), in the 1st modification, after sticking the film 5 to the skin 7, the protective film 15 is peeled off from the film 5, and after that, as shown to FIG.5 (b) and (c). Further, the needle-like body 3 is stuck on the film 5 (or after the protective film 15 is peeled off from the film 5, the film 5 is stuck on the skin 7, and the needle-like body 3 may be stuck thereon. .) Then, the needle part 13 is punctured by pressing against the skin 7 using a finger or a dedicated instrument (applicator). Then, after elapse of a certain time (that is, after dissolving the root portion 13a with the solvent of the film 5), the substrate 11 is quickly removed together with the film 5. When the root portion 13a is dissolved, the tip portion 13b of the needle portion 13 and the substrate 11 are separated, so that the film 5 and the substrate 11 can be removed from the skin 7 while the tip portion 13b remains in the skin 7. Is possible.

The material of the protective film 15 is not specifically limited, For example, polyethylene, a polypropylene, polyester etc. can be used. In addition, the protective film 15 may have an adhesive layer on the surface in contact with the film 5. Furthermore, this adhesive layer may be weakly adhesive so that the protective film 15 can be easily removed from the film 5 when the needle-like body 3 is used (that is, when the needle portion 13 is punctured into the skin). . Further, in order to reliably puncture the needle portion 13 of the needle-like body 3 into the skin 7 and to reliably dissolve and remove the root portion 13a of the needle portion 13, a recess corresponding to the needle portion 13 is formed on the upper surface of the film 5. It may be provided.
In the first modification, the combination of the film 5 and the protective film 15 corresponds to the “film” of the present invention. The first modification also has the effect of the above-described embodiment.

(Second modification)
FIG. 6 is a diagram illustrating a second modification of the needle-like body device 1.
As shown in FIG. 6 (a), the protective film 15 includes a perforated layer 15a that has been previously perforated to prevent the needle portion 13 from being damaged by the protective film 15 when the needle-shaped body 3 is used. A two-layer structure of a weakly-adhesive protective layer 15b that protects the porous layer 15a may be used.
Further, in order to easily puncture the needle portion 13 in the skin, a pore for allowing the needle portion 13 to pass through the film 5 may be provided. In this case, in order to prevent transpiration of the dissolution promoting component from the pores and adhesion of dust and dust, a protective film (see FIG. 5) is applied to the lower surface of the film 5 (that is, the surface facing the skin) as well as the upper surface of the film 5. (Not shown) may be attached. The material of the protective film stretched on the lower surface and the upper surface of the film 5 is not particularly limited, and for example, polyethylene, polypropylene, polyester, or the like can be used.

As shown in FIGS. 6B and 6C, in this second modification, the film 5 is stuck on the skin 7 and the needle-like body 3 is stuck on the protective film 15. Next, the needle portion 13 is punctured into the skin 7 by pressing the needle portion 13 against the skin 7 using a finger or a dedicated instrument (applicator). After puncturing, the protective film 15 is peeled off from the upper surface of the film 5 together with the substrate 11. Further, after a predetermined time has elapsed, the film 5 is removed from the skin 7. Moreover, when the protective form is also affixed also to the lower surface of the film 5, puncture is implemented after removing this protective film.
In the second modification, the combination of the film 5 and the protective film 15 corresponds to the “film” of the present invention. The second modification also has the effect of the above-described embodiment. The perforated layer 15a also has an effect of preventing the needle part 13 from being detached from the skin.
Embodiments of the present invention will be described below with reference to the drawings. In addition, this invention is not limited to the acicular device produced in the following Example.

(First embodiment)
First, precision machining is performed on a silicon substrate to form needle portions in which 144 cones (height: 300 μm, bottom surface: diameter 180 μm) are arranged in a grid of 12 rows and 12 columns at intervals of 0.4 mm. Was made. Subsequently, a nickel film having a thickness of 500 μm was formed on the original made from the silicon substrate by plating. Thereafter, the original plate was dissolved and removed with a potassium hydroxide aqueous solution having a concentration of 30% by mass heated to 90 ° C. to prepare an intaglio plate 21 made of nickel.

Next, an aqueous hydroxypropylcellulose solution in which a bioactive substance was dispersed was prepared as the liquid needle-like material 23. Next, the intaglio 21 was filled with a liquid needle-like material 23 using a spin coating method (see FIG. 2). Subsequently, the intaglio 21 filled with the liquid acicular body material 23 was allowed to stand for 72 hours, and the acicular body material 23 was naturally dried and solidified to obtain a solidified product 26 of the acicular body material. Thereafter, the solidified material 26 of the acicular body material was peeled (detached) from the intaglio plate 21 and taken out (see FIG. 3).
Next, a sodium polyacrylate aqueous solution was prepared as an aqueous solution 33 containing a dissolution promoting component. And this aqueous solution 33 was apply | coated to the film-like support | carrier 31 which can be peeled, the aluminum hydroxide aqueous solution was sprayed from the nozzle 35, and it bridge | crosslinked and stabilized. Thereby, the water-containing film was produced as the film 5 (refer FIG. 4).

Next, as shown in FIG. 6 (a), a recess having a depth of 5 μm is provided in the center of the film to facilitate the designation of the position of the needle-like body 3, and the needle-like body 3 is further provided in the center of the film. A plurality of holes having a diameter of 200 μm centered on the apex of each needle portion 13 was formed to form a perforated layer 15a. Next, in order to prevent moisture from evaporating from the porous layer 15a, a protective layer 15b was attached to the upper surface of the porous layer 15a.
Next, the protective film was peeled off from the lower surface of the film 5 with the needle-like device 1 illustrated in FIG. Subsequently, the protective layer 15b was peeled off from the upper surface of the porous layer 15a. Then, as shown in FIG. 6 (b), each needle portion 13 of the needle-like body 3 was punctured into the skin 7 through the hole of the perforated layer 15 a and the film 5. After 5 minutes from the puncture, the perforated layer 15 a was peeled off from the film 5 together with the substrate 11. As shown in FIG. 6C, the root portion 13 a of the needle portion 13 was dissolved, and only the tip portion 13 b of the needle portion 13 remained on the skin 7.

(Second embodiment)
First, precision machining is performed on a silicon substrate to form needle portions in which 144 cones (height: 300 μm, bottom surface: diameter 180 μm) are arranged in a grid of 12 rows and 12 columns at intervals of 0.4 mm. Was made. Subsequently, a nickel film having a thickness of 500 μm was formed on the original made from the silicon substrate by plating. Thereafter, the original plate was dissolved and removed with a potassium hydroxide aqueous solution having a concentration of 30% by mass heated to 90 ° C. to prepare an intaglio plate 21 made of nickel.
Next, an aqueous hydroxypropylcellulose solution in which a bioactive substance was dispersed was prepared as the liquid needle-like material 23. Next, an aqueous chitosan succinamide aqueous solution was prepared as a liquid root portion material 24 for forming the root portion 13a of the needle portion 13.

Next, as shown in FIG. 7A, a portion corresponding to the tip of the intaglio 21 was filled with a liquid needle-like material 23 using a spin coating method. Subsequently, the intaglio 21 filled with the needle-shaped body material 23 was allowed to stand for 8 hours and was semi-dried.
Next, as shown in FIG. 7B, a liquid root portion material 24 was filled into a portion corresponding to the root portion of the intaglio 21 using a spin coating method. Subsequently, the intaglio 21 filled with the root material 24 was allowed to stand for 12 hours and was semi-dried. As shown in FIG. 8 (a), after semi-drying the root portion, a thin film made of a polylactic acid glycolic acid copolymer was pressed against the intaglio 21 as the substrate material 25. Each material laminated in the intaglio 21 was naturally dried and solidified to obtain a solidified material 26 of a needle-like material. Thereafter, the solidified product 26 was peeled off from the intaglio plate 21 as shown in FIG.

Next, a sodium polyacrylate aqueous solution was prepared as an aqueous solution 33 containing a dissolution promoting component. And this aqueous solution 33 was apply | coated to the film-like support | carrier 31 which can be peeled, the aluminum hydroxide aqueous solution was sprayed from the nozzle 35, and it bridge | crosslinked and stabilized. Thereby, the water-containing film was produced as the film 5 (refer FIG. 4).
The protective film on the lower surface of the film 5 was peeled off and stuck to the skin 7 with the needle-like body device 1 illustrated in FIG. Next, as shown in FIG. 5 (b), the protective film on the lower surface of the film 5 was peeled off, and the needle-like body 3 was punctured into the skin 7. After 5 minutes from the puncture, the film 5 was peeled off from the skin 7 together with the substrate 11. As shown in FIG. 5C, the root portion 13 a of the needle portion 13 was dissolved, and only the tip portion 13 b of the needle portion 13 remained on the skin 7.

(Other)
The present invention is not limited to the embodiment (including the first and second modifications) and the examples described above. Based on the knowledge of those skilled in the art, design changes or the like may be added to the embodiments and examples, and the embodiments and examples may be arbitrarily combined, and aspects in which such changes are added are also included in the present invention. Included in the range.

  The acicular body according to the embodiment of the present invention can be used in various fields that require drug delivery by sustained-release percutaneous absorption. For example, it can be expected to be applied as a needle-shaped body used for drug discovery, medical use, cosmetics, beauty use and the like.

DESCRIPTION OF SYMBOLS 1 Acicular body device 3 Acicular body 5 Film 7 Skin 11 Substrate 11a One surface 13 Needle part 13a Root part 13b Tip part 15 Protective film 15a Perforated layer (an example of an impregnated layer)
15 b Protective layer 21 Intaglio plate 23 Needle-like body material 24 Root material 25 Substrate material 26 Solidified material 31 Carrier 33 Solution 35 containing dissolution promoting component Nozzle 37 Impregnation sheet 39 Liquid tank

Claims (10)

A needle-like body having a substrate and a needle portion protruding from one surface of the substrate;
A film disposed on the needle side of the substrate,
The film contains a solvent capable of dissolving the needle, and
The needle-like device, wherein the film has a thickness smaller than a height from the one surface of the needle part. The needle part has a root part located on the side close to the one surface, and a tip part located on the side far from the one surface,
The acicular device according to claim 1, wherein the root portion has higher solubility in the solvent than the tip portion.   The acicular device according to claim 2, wherein the root portion and the tip portion include different components. The film, impregnation layer containing the solvent, any one of claims 1 to 3, characterized in that it comprises a said substrate opposite the protective layer arranged on the side of the free immersion layer The acicular device according to 1.   The needle device according to any one of claims 1 to 4, wherein the needle portion can penetrate the film.   The acicular device according to any one of claims 1 to 5, wherein a thickness of the film is 5% or more and 50% or less of the height of the needle portion.   The acicular device according to any one of claims 1 to 6, wherein the solvent is water.   The acicular device according to claim 2 or 3, wherein the needle part is separable from the substrate when the root part is dissolved.   The needle device according to claim 2 or 3, wherein when the root part is dissolved, the needle part can be separated from the film and the substrate.   The acicular device according to claim 4, wherein when the needle part is punctured into the skin, the impregnated layer prevents the needle part from being detached from the skin.

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