JP2010081978A - Transdermal administration positioning device - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a transdermal administration positioning device appropriately disposing a transdermal administration system on an intended position on a skin. <P>SOLUTION: A sheet-like positioning device 400 consisting of substantially two layers is used. The first layer to be stuck to a skin has a hole where a patch 300 comes into contact with the skin, and the periphery of the hole has a mark (for example: a cross) indicating the center of pharmaceutical of the patch 300. The second layer on the first layer is a transparent sheet as a whole and the portion covering the hole is also transparent, so that the skin is visible therethrough. <P>COPYRIGHT: (C)2010,JPO&INPIT

Description

  The present invention relates to a drug administration positioning device for use in a transdermal drug administration system.

In general, oral administration and administration by injection are often used for drug administration. In the case of oral administration, although it is excellent in convenience and safety, it has a drawback that water-soluble drugs and polymer drugs are not sufficiently absorbed. In the case of injection, there is an advantage that it is fast-acting, but there is a drawback that it causes pain to the patient.
Currently, in addition to these conventional methods, development of a drug administration system through the skin (hereinafter referred to as a transdermal drug administration system) is in progress. There are several methods for transdermal drug delivery systems, such as using electrical energy, using ultrasound, and the like, using energy to pass through the epidermal barrier and deliver the drug into the skin. Among the methods using electric energy, iontophoresis is a method that has been studied for a long time and has been partially used.

Iontophoresis is charged in the stratum corneum layer by attaching positive and negative electrodes to two distant points of the skin, forming a flow of electricity across the stratum corneum of the skin and flowing through the skin to connect the two poles. This is a method in which a drug is moved and absorbed by the principle of electrophoresis. In principle, a charged drug is a target for promoting absorption, but it is reported that the flow of water is also caused by the flow of electricity, so that even a drug having no charge or a drug having a high molecular weight has an increased skin permeability.
A general iontophoretic transdermal drug administration system comprises a patch containing a drug (drug-containing unit) and a controller for supplying an electric current to the patch. Conventionally, a controller is generally supplied with power from a wall power supply. However, in recent years, it is operated by a coin battery (eg, diameter: 20 mm, thickness: 3.2 mm) so as not to limit patient behavior during administration. Portable controllers are also commercialized.

  In addition to downsizing the controller, a reusable compact controller that replaces only the patch when in use has also been studied, and a controller that has a controller that is approximately the same size as the patch attached to the skin is proposed. ing. (Patent Documents 1 and 2) FIG. 1 is an iontophoresis device (electrotransport device) described in Patent Document 2, and is configured so that it can be coupled to and decoupled from a drug-containing unit 70 (patch). The controller 52 is a plurality of medicine units 70 that are discarded when the contained medicine is completely transported or emptied. The controller 52 includes a printed circuit (PC) board 58, a battery power source 60 formed of a button-type battery, and the like. The drug unit 70 is configured to be detachably coupled to the controller 52, and is composed of a hydrogel or the like. It has the storage part 76 which contains a medicine (for example, chemical | medical agent), and the storage part 78 which is a counter electrode assembly.

On the other hand, in the transdermal drug administration system including iontophoresis, i) to reduce the size by battery drive so as not to limit the behavior of the patient, ii) to obtain a predetermined effect with as little drug as possible, Therefore, accurate positioning of the patch (drug-containing unit) with respect to the administration site is necessary.
This is explained in the case of iontophoresis.
A: Area of the site where the administration effect is given by the patch
I: current supplied from controller Δt: current density D
D = I / A
The amount of electricity (charge) Q consumed by the battery is
Q = I · Δt
Therefore, when trying to design a small controller that can be driven by a battery, the quantity of electricity (charge) Q that needs to be reduced is:
Q = I · Δt
= D ・ A ・ Δt
However, the current density D is restricted by the living body (the drug is not absorbed sufficiently if D is small, and if it is too large, the skin is damaged, so it is necessary to select an appropriate value). Since the administration time Δt is also determined by treatment restrictions (approximately 15 minutes or less), the area A is mainly reduced in order to reduce the electric quantity (charge) Q. is there. That is, in order to reduce the area A, it is necessary to accurately position the patch with respect to the administration site.

In the case of other methods other than iontophoresis, the energy density (energy per unit area) is determined by constraints from the living body, and the administration time is also determined by treatment constraints, so design a power-saving controller. Then,
Since total energy = energy density × area × dosing time needs to be reduced, it is necessary to reduce the area, and as a result, accurate positioning of the patch relative to the site of administration is required.

  In iontophoresis in which the controller and patch are separated and connected by a cord that supplies power, a product that has been positioned by the user by placing a cross mark on the patch has been commercialized. Yes. In addition, in a tape-type drug administration device without energy supply, an auxiliary kit for directly marking the skin has been proposed (see Patent Document 3). However, as described above, this method cannot be used in a system in which a controller is arranged on a patch to improve portability in order to quickly administer a drug using energy and further reduce the size. was there.

This is because the controller is placed on top of the patch.
1) First, connect the patch to the controller. 2) Next, take the procedure of applying the patch integrated with the controller to the target administration site. That is, in this method / procedure, the mark on the patch is not visible by the controller, and even if the controller is marked, the mark is separated from the administration site, so accurate positioning cannot be performed.
FIGS. 1 and 3 of FIG. 3 of Patent Document 1 and FIGS. 1 and 3 of Patent Document 2 each have two drug units serving as electrode ends for obtaining electricity between the skin, and drug administration is performed among the two drug units. Therefore, the position where the drug solution is administered becomes a position deviated from the center of the entire device placed on the skin, making accurate positioning difficult.
US Pat. No. 5,320,597 Japanese National Patent Publication No. 10-512474 Japanese Patent Laid-Open No. 11-158059

  An object of the present invention is to provide a positioning device for an administration site that can be suitably used for an iontophoresis device in which a controller that solves the above problems and a patch containing a chemical solution are integrated.

In order to solve the above problems, the present invention uses a positioning device that is generally sheet-shaped and generally consists of two layers. Here, the first layer applied to the skin has a hole in a portion where the patch contacts the skin, and a mark (eg, a cross) indicating the center of the drug portion of the patch is attached around the hole. In addition, the second layer above is a transparent sheet as a whole, and the portion covering the hole is also transparent so that the skin can be seen. However, the mark covering the hole is marked with a mark (for example, a cross) indicating the center of the drug part of the patch. That is, the transparent sheet is marked. Furthermore, it is preferable that the mark indicating the center position of the drug is on the side surface and the upper surface in a state where the controller is also connected to the patch.
The center position of the drug does not necessarily mean the geometric center position of the drug administration portion of the patch, and the drug administration when the patch is placed on the skin and used in a state of being connected to the controller. This is the position where drug release from the part is best performed. Usually it is the geometric center of the drug administration part.
The present invention can be achieved by the following configurations (1) to (6).

(1) A drug administration positioning device for a transdermal drug administration system for administering a drug through the skin, the first surface having a first adhesive layer that adheres to the skin, the second surface opposite to the first surface, A first layer having a space through which a skin contact portion including a medication portion from which a drug of the skin drug administration system is released can pass; and covering the space of the first layer and overlapping the first layer. A second layer having a possible size, a third surface that peelably adheres to the second surface of the first layer, and a fourth surface opposite to the third surface. Means for determining a relative position with respect to the active drug delivery system, wherein the second layer is substantially transparent and the transdermal drug administration at a position defined by the means for determining the relative position on the skin When the means is placed, the dosing part is in the most preferred position on the skin. To be placed in the drug administration positioning apparatus characterized by having an optimum position display mark indicating the position of the optimal sites on the skin should be administered the drug.

(2) The drug administration positioning device according to (1), wherein the means for determining the relative position is a shape of the space having a shape approximate to a contour shape of the skin contact portion.

(3) In the state where the transdermal drug administration system is disposed on the skin, the transdermal drug administration system has a position mark at a visible position, and the means for determining the relative position is the position The drug administration positioning device according to (1) or (2), which is an alignment mark that is visible at the same time as the mark and is displayed on the second surface corresponding to the position mark.

(4) The position marks are a plurality of marks arranged radially on the visible surface of the transdermal drug administration system in a state where the transdermal drug administration system is arranged on the skin, The drug administration positioning device according to (3), including a plurality of the alignment marks corresponding to the position marks.

(5) The drug administration positioning device according to (3) or (4), wherein the position mark has a shape portion similar to the optimum position display mark in plan view.

The present invention is generally a sheet-like positioning device generally consisting of two layers, and the first layer applied to the skin has a hole in a portion where the patch contacts the skin, and the patch is formed around the hole. The mark indicating the center of the drug part (eg, cross) is attached. In addition, the second layer above is a transparent sheet as a whole, and the portion covering the hole is also transparent so that the skin can be seen. However, a mark covering the center of the drug portion of the patch (eg, a cross) is attached to the portion covering the hole. That is, the transparent sheet is marked. Since it has such a structure, a drug can be efficiently administered to a desired location on the skin. Therefore, it becomes easy to downsize the controller and integrate it with the patch.
Furthermore, since the mark indicating the center position of the drug is on the side surface and the upper surface in a state where the controller is also connected to the patch, the relative position between the patch and the controller can be easily determined.

  The present invention also provides a drug administration positioning device for a transdermal drug administration system for administering a drug through the skin, the first surface having a first adhesive layer that adheres to the skin, and the second surface opposite to the first surface. A first layer having a space through which a skin contact part including a dosage part from which a drug of the transdermal drug administration system is released can pass; and covering the space of the first layer; and the first layer; A second layer having a size that can be overlapped, a third surface having a second adhesive layer that peelably adheres to the second surface of the first layer, and a fourth surface on the opposite side. The first layer has means for defining a relative position with the transdermal drug delivery system, and the second layer is substantially transparent and is defined by means for determining the relative position on the skin. When the transdermal drug administration means is disposed at a different position. The second adhesive layer is affixed to the second surface so as to be disposed at the most preferable position on the skin, and has an optimal position display mark indicating the position of the optimal site on the skin where the drug is to be administered. Therefore, the drug can be efficiently administered to a desired site on the skin. Therefore, it becomes easy to downsize the controller and integrate it with the patch.

  Further, according to the present invention, since the means for determining the relative position is the shape of the space having a shape approximate to the contour shape of the skin contact portion, it can be accurately positioned without depending on vision. .

  Further, the present invention has a position mark on a visible portion of the transdermal drug administration system in a state where the transdermal drug administration system is placed on the skin, and the means for determining the relative position Since the alignment mark is visible at the same time as the position mark and displayed on the second surface corresponding to the position mark, the positioning mark can be easily positioned.

  Further, according to the present invention, the position marks are a plurality of marks radially arranged on a visible surface of the transdermal drug administration system in a state where the transdermal drug administration system is arranged on the skin. Since the plurality of alignment marks corresponding to the plurality of position marks are provided, an accurate position can be confirmed from any direction.

Further, according to the present invention, since the position mark has the same shape as that of the optimum position display mark in plan view, the images when the drug administration positioning device is applied and the arrangement of the transdermal drug administration system are overlapped and positioned. Becomes easy. Here, the plan view means how the percutaneous drug administration system or solution administration positioning device is seen from above the skin when it is placed on the skin. Including how it looks. The same applies hereinafter.

The chemical liquid administration positioning apparatus of the present invention will be described here by taking as an example a case where it is used in an iontophoresis system as a transdermal drug administration system.
Prior to the description of the medicinal solution administration positioning apparatus of the present invention, first, an iontophoresis system used in the present invention will be described. FIG. 2 is a perspective view of an iontophoresis system 100 comprising a controller 200 coupled with a patch 300, and the basic configuration is similar to the electrotransport device of FIG. The controller 200 has a structure similar to the controller 52 of FIG. 1, but has a substantially rectangular outline in plan view, and includes a switch 201 and an LED 202 for starting energization of the patch 300. Here, for example, the LED 202 blinks in green during normal energization, and blinks in red when an abnormality occurs. FIG. 3 shows only the controller, FIG. 3 (a) is a perspective view, and FIG. 3 (b) is a bottom view. The controller 200 has connection recesses 203 and 204 for connection with the patch 300. The connection recesses 203 and 204 serve not only for obtaining a mechanical connection with the patch 300 but also as an electrical connection terminal between the electric circuit of the controller 200 and the patch 300.

  The patch 300 has a structure similar to that of the drug visceral unit 70 of FIG. 1 and is detachable from the controller 200. 4 shows only the patch 300, FIG. 4 (a) is a perspective view, and FIG. 4 (b) is a bottom view. The patch 300 includes a patch body 301 having a substantially rectangular thin plate shape in plan view, two connection terminals 304 and 305 projecting to one surface side of the patch body, and a surface opposite to the projecting surface of the connection terminals 304 and 305. A chemical reservoir 303 and a return reservoir 302 having a substantially rectangular open surface provided in a recess in which the patch body is cut out. As a structure of the connection terminals 304 and 305 and the connection recesses 203 and 204, a metal button hook type connection structure makes it easy to attach and detach the patch 300, and an electrical connection can be obtained. However, even if the mechanical connection and the electrical connection are established by different mechanisms, the present invention is not affected at all.

  The patch 300 has positive and negative electrodes, and one of the two electrodes serves as a chemical solution reservoir 303 and is made of a gel containing a predetermined drug, and the other electrode is made a return reservoir 302 and made of a gel containing physiological saline. . The chemical reservoir 303 and the connection terminal 305, and the return reservoir 302 and the connection terminal 304 are electrically connected to each other. The connection terminals 304 and 305 also serve as electrical connection terminals, and when connected to the connection recesses 203 and 204 of the controller 200, the electrical circuit of the controller 200 and the reservoirs 303 and 304 are electrically connected. The The gels of the chemical solution reservoir 303 and the return reservoir 302 are open to the lower surface side in FIG. 4, and the lower surface side of the patch 300 is affixed to the skin and supplied with power from the controller 200, thereby Is formed, and the drug contained in the drug reservoir is delivered into the skin. The chemical reservoir 303 and the return reservoir 302 are not limited to gels such as hydrogel, but may be sponges that can hold liquid, porous bodies such as porous membranes, and the like.

  Although not shown, the patch 300 is usually sealed until just before use with a film or the like that restricts the passage of gas or liquid on the lower surface side where the chemical reservoir 303 and the return reservoir 302 are open. Yes.

  The iontophoresis system 100 of the present invention includes a controller 200 having a contour shape substantially the same as the contour shape of the patch 300 in a plan view, and is a very miniaturized system without wiring for connection. It is easy to handle and limits the behavior of the patient as much as possible. However, since the drug is administered only to the skin where the drug reservoir contacts, the drug reservoir and the return reservoir need to be in contact with the skin as described above. Must be in contact with the skin in a larger area than the area to which it is administered. Therefore, attention must be paid to positioning when the location on the skin where a drug is to be administered (for example, a site to be injected or a blood vessel puncture site) is limited.

  On the upper surface of the controller 200, an outline 510 of a portion corresponding to the portion where the chemical liquid reservoir 303 is in contact with the skin in a plan view is displayed. On the top surface of the controller 200, two straight lines passing through a portion 530 corresponding to the rotational symmetry center of the drug solution reservoir 303 that is rectangular in plan view are displayed as position marks 501 and 502. Further, on the side surface of the controller 200, position marks 503 and 504 are displayed by vertically extending the extension of the position marks 501 and 502 with respect to the skin. In FIG. 3 (a), even on the hidden side surface, a position mark is displayed by vertically dropping the position marks 501 and 502 on the skin.

Next, the drug administration positioning apparatus of the present invention for accurately placing the iontophoresis system on the skin will be described.
FIG. 5 is a perspective view of a drug administration positioning device 300 suitable for the iontophoresis system 100. FIG. 6 is a cross-sectional view taken along the line dd ′ of FIG. The drug administration positioning device 300 includes a base 428 having a first surface 421 having a first adhesive layer 427 that adheres to the skin and a second surface 422 opposite to the first surface 421, and the drug solution reservoir 303 (the drug is released). A first layer 420 having a space 450 through which the skin contact portion 301 of the patch 300 including the administration portion can pass, and a size capable of covering the space 450 of the first layer 420 and overlapping the first layer 420. And a second layer having a third surface 411 that peelably adheres to the second surface 422 of the first layer 420 and a fourth surface 412 opposite to the third surface 411. The pressure-sensitive adhesive in the present invention includes an acrylic pressure-sensitive adhesive, a synthetic rubber-based pressure-sensitive adhesive, a composition of an acrylic pressure-sensitive adhesive and a synthetic rubber-based pressure-sensitive adhesive, and a composition containing a tackifier and a plasticizer. Yes, but not limited to this.

  The first layer 420 serves as a means for determining a relative position with the iontophoresis system 100. The first layer 420 substantially matches the contour shape of the skin contact portion 301 of the patch 300 and has a slightly larger space (hole, notch portion). ) 450, and alignment marks 423, 424, 425, 426 that coincide with the position marks 501, 502, 503, 504, and the like. The alignment marks 423, 424, 425, and 426 are characterized by having the shape of the space having an approximate shape, and are provided so as to be visible at the same time as the position marks provided on the controller 200. Examples of the material of the base material 428 of the first layer 420 include polyethylene, polypropylene, and polyester, but are not limited thereto.

The second layer 410 is substantially transparent, and when the transdermal drug administration means is disposed at a position determined by the means for determining the relative position on the skin, the dosing part is on the skin. Optimal position display marks 413 and 414 indicating the position of the optimal site on the skin where the drug is to be administered are provided so as to be arranged at the most preferable position. The optimum position display marks 413 and 414 have the same shape as the position marks 501 and 502 provided on the controller 200. In this embodiment, the drug reservoir has a rectangular shape in plan view, and its rotational symmetry center is shown as the intersection of the optimum position display marks 413 and 414 and is designed to coincide with the optimum portion. .
The optimal position display mark is preferably a plurality of radially arranged marks having the optimal position as an intersection. However, the optimal position display mark only needs to be able to indicate the optimal position, and may be a simple point or a plurality of marks centered on the optimal position. It is good also as a concentric circle. As the material of the second layer 410, the target site of the skin can be visually observed when pasted on the skin, and any material that is substantially transparent can be used, and examples thereof include polyethylene, polypropylene, and polyester. However, it is not limited to this.

  The first layer 420 and the second layer 410 overlap each other so that the second surface 422 of the first layer 420 and the third surface 411 of the second layer 410 can be peeled off. In the present embodiment, the second adhesive layer 417 is provided on the third surface 411 that does not contact the space 450, and is attached to the second surface 322 via the second adhesive layer 417. The second adhesive layer 417 may be provided on the first layer 420 side, that is, on the second surface 322.

  When the contour shape of the skin contact portion of the transdermal drug administration system does not have a rotationally symmetric center, as a means for determining the relative position of the present invention, By providing a space having a shape approximate to the contour shape in the skin patch member which is the first layer of the drug administration positioning device of the present invention, when the percutaneous drug administration system is to be placed on the skin, The drug administration reservoir can be placed in the most preferred location automatically and accurately. In this case, it is most preferable to form a space having a shape approximate to the overall contour shape of the skin contact portion. However, if the skin contact portion can pass, a characteristic of the skin contact portion is formed. You may design so that the space of the shape approximated with the outline shape of only a shape part may be formed.

  Further, as a means for determining the relative position of the present invention, when the transcutaneous drug administration system has a position mark at a visible part of the transdermal drug administration system in a state where the transdermal drug administration system is placed on the skin, When the skin drug administration system is pasted, the percutaneous drug can be visually recognized at the same time as the position mark, and an alignment mark is provided on the skin sticking member as the first layer corresponding to the position mark. When trying to place the dosing system on the skin, the drug dosing reservoir can be precisely placed in the most preferred location. Furthermore, by arranging the position mark so that it does not have a rotational symmetry axis with respect to the plane at the time of skin placement, the contour shape of the skin contact portion of the transdermal drug administration system has a rotational symmetry center. However, when trying to place the transdermal drug delivery system on the skin, the drug delivery reservoir can be placed in the most preferred position automatically and accurately.

Next, an example of how to use the present invention will be described.
As shown in FIG. 5 (c), the drug administration positioning device of the present invention includes a first layer 420 that is a skin patch member and a second layer 410 that is a substantially transparent sheet material that is releasably attached thereto. It is prepared in the affixed state. In addition, a patch 300 is connected to the controller 200 for use. The usage method is as follows.
1) A positioning device is affixed on the skin so that the optimum position display mark overlaps the location where the medicinal effect on the skin is desired.
2) The transparent sheet 410 (second layer) with the optimum position display mark is peeled off. This exposes the skin.
3) The controller 200 to which the patch 300 is connected is brought into contact with the skin so that the position mark on the side surface and the upper surface thereof matches the positioning mark on the first layer, and the patch 300 is applied.

  FIG. 7 shows a state in which the iontophoresis system 100 is arranged on the skin of the human arm H using the drug administration positioning device of the present invention.

The above is an example of the case of iontophoresis, but the same positioning device can be applied to other transdermal drug administration.

FIG. 1 shows a known iontophoresis device. FIG. 2 is a perspective view of an iontophoresis system used in an embodiment of the present invention. 3 is a perspective view (FIG. 3A) and a bottom view (FIG. 3B) of the controller of the embodiment of FIG. 4 is a perspective view (FIG. 4A) and a bottom view (FIG. 4B) of the example patch of FIG. 2. FIG. 5 is a perspective view of a drug administration positioning device according to an embodiment of the present invention. FIG. 6 is a schematic cross-sectional view taken along the line dd ′ of FIG. FIG. 7 is an image diagram showing a use state of the embodiment of FIG.

Explanation of symbols

100 transdermal drug administration system 200 controller 201 switch 202 LED
203, 204 Connection recess 300 Patch 301 Patch body 302 Return reservoir 303 Drug solution reservoir 304, 305 Connection terminal 400 Drug administration positioning device 410 Second layer 411 Third surface 412 Fourth surface 413 414 Optimal position mark 416 Second layer transparent Film 417 Adhesive layer 420 First layer 421 First surface 422 Second surface 423, 424, 425, 526 Positioning mark 427 Adhesive layer 428 Base material 450 Space 501, 502 Position mark (upper surface, optimum position display)
503,504 Position mark (side)
510 Drug Reservoir Position Display Mark 530 Intersection

Claims (5)

A drug administration positioning device of a transdermal drug administration system for administering a drug through the skin,
A space through which a skin contact portion including a first surface having a first adhesive layer that adheres to the skin, a second surface opposite to the first surface, and a dosing portion from which the drug of the transdermal drug administration system is released can pass. A first layer having:
A size that covers the space of the first layer and can overlap the first layer, a third surface that peelably adheres to the second surface of the first layer, and a fourth surface opposite thereto And a second layer having
The first layer comprises means for defining a relative position with the transdermal drug delivery system;
The second layer is substantially transparent, and when the transdermal drug administration means is disposed at a position defined by the means for determining the relative position on the skin, the dosing part is on the skin. A drug administration positioning device comprising an optimum position display mark indicating the position of the optimum site on the skin where the drug is to be administered so as to be arranged at the most preferable position.
The drug administration positioning apparatus according to claim 1, wherein the means for determining the relative position is a shape of the space having a shape approximate to a contour shape of the skin contact portion.
The transcutaneous drug administration system has a position mark at a visible part of the transdermal drug administration system in a state where the transdermal drug administration system is placed on the skin, and the means for determining the relative position is simultaneously with the position mark. 3. The drug administration positioning apparatus according to claim 1, wherein the drug administration positioning apparatus is an alignment mark that is visible and displayed on the second surface in correspondence with the position mark.
The position marks are a plurality of marks arranged radially on a visible surface of the transdermal drug administration system in a state where the transdermal drug administration system is arranged on the skin, and a plurality of the position marks The drug administration positioning device according to claim 3, further comprising a plurality of the alignment marks corresponding to the same.
  The drug administration positioning apparatus according to claim 3 or 4, wherein the position mark has a shape portion similar to the optimum position display mark in plan view.

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