JPH10226638A - Patch excellent in handling - Google Patents

Abstract

PROBLEM TO BE SOLVED: To obtain a patch which affords neither stimulation to skin not feeling of physical disorder and is excellent in handling. SOLUTION: The patch is equipped with an adhesive face-like substance which satisfies the below (1) to (4) at the same time on the rear face of support for patch of which bending resistance (45 deg.C cantilever method) is 10mm or less. (1) The bending resistance (45 deg. cantilever method) of the adhesive face-like substance is 20-220mm. (2) The thickness of the adhesive face-like substance is 40-650μm. (3) The 90 deg. peeling force between the rear face of support and the adhesive face-like substance is 2-45g/30mm. (4) The adhesive face-like substance is composed of two or more than three pieces and a part of this adhesive face-like substance consisting of two or more than three pieces is mutually piled up at the plate near the central part of patch.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

TECHNICAL FIELD The present invention relates to a patch to be applied to human skin. More specifically, the present invention provides a patch excellent in handleability by attaching a specific planar body to a patch having low rigidity, which is difficult to handle as it is.

[0002]

2. Description of the Related Art Patches, especially patches for percutaneously absorbing systemic drugs,
It is expected that it will continue to spread steadily in the future because of its excellent safety and stability of drug efficacy. However, serious drawbacks or side effects of patches include skin irritation at the patch site and discomfort at the patch site, which are more serious problems than patches that are used for a long time to treat or prevent chronic diseases. Has become. One solution to overcome such disadvantages is to increase the flexibility of the patch. In other words, it is intended to reduce physical irritation and reduce discomfort and irritation to the skin. Another solution is to reduce the adhesive strength by devising an adhesive or the like. In other words, it is intended to reduce chemical irritation, to reduce pain at the time of disinfecting by low adhesive strength, and to reduce irritation to the skin at the time of application. However, if the adhesive strength is reduced too much, a problem that the patch is likely to peel off tends to occur.To avoid this trouble, it is effective to make the patch as thin as possible and to make the patch flexible. is there. That is, if the patch is physically or chemically treated to reduce skin irritation, which is a drawback of the patch, the patch becomes thinner and more flexible as a result.

However, if the flexibility exceeds a certain value, there arises a problem of poor handling, that is, the handling is poor because the patch is too flexible. In particular, since patients with chronic illness, for example, where patches are frequently used, are often elderly people, the problem of poor handling has a large effect on patches as a medicine, and sometimes becomes a decisive problem. In order to improve the problem of poor handling properties, there has been proposed a method of using a handling sheet for improving handling properties on the back surface of a patch support. For example, the actual opening 62-14
No. 8526, and Japanese Utility Model Laid-Open No. 61-111419. In these methods, a film plane larger than the patch is used on the back of the patch. Then, the handling planar body is attached to the back surface of the support of the adhesive patch by a force such as static electricity. However, these methods can be easily applied when the film is easily adhered to the film surface by electrostatic force or the like, such as a polyurethane support, but is difficult to apply when the material of the support changes. It is also difficult to adjust the adhesive force between the support and the film-like body to a value that is preferable for use.

[0004] As another method, in the specification of WO91 / 16044, a planar body is pressure-bonded to the back surface of a support of a patch with an adhesive whose adhesive strength is adjusted. This method is preferable in that the adhesive force between the support and the sheet can be freely adjusted. However, even in the case of this method, when a wear test was actually performed, skin irritation became large because the sheet was used without removing the sheet, and the patch itself was peeled off when the sheet was removed. It turned out that a considerable number of people mishandled it, such as when the sheet was peeled off before being stuck and it could not be stuck easily. In the case of pharmaceuticals, especially for large numbers of unspecified patients, especially for life-threatening drugs, almost all patients need to be able to use the drug with certainty. Drugs that require a long preparation period or education to ensure certainty are not preferred. In addition, the cost is enormous and is not preferable from the viewpoint of cost. In order to overcome such a problem, the present inventors have repeatedly and intensively studied many trials and errors, and as a result, have reached the present invention.

[0005] That is, an object of the present invention is to provide a patch which is free from problems of skin irritation and discomfort and which is excellent in handleability.

It is a further object of the present invention to provide a patch which is free from problems of misuse by patients, problems in production or economics, has no problems of skin irritation or discomfort, and is excellent in handleability. is there.

[0007]

That is, the present invention relates to the following 1) to 4) 1) the use of an adhesive sheet on the back surface of a patch having a stiffness (45 ° Cantilever method) of 10 mm or less. Hardness (45 ° cantilever method) is 2
0 to 220 mm. 2) The thickness of the adhesive sheet is 40 to 650 μm. 3) The 90 ° peeling force between the support surface and the adhesive sheet is 2 to 4
5 g / 30 mm. 4) The adhesive sheet is composed of two or more sheets, and a part of the two or more sheets is overlapped with each other near the center of the patch. , Which simultaneously satisfies the above conditions, and has excellent handleability with a pressure-sensitive adhesive sheet comprising a pressure-sensitive adhesive and a sheet.

The patch of the present invention has a bending resistance (45 ° cantilever method) of 10 mm or less. Such a softness is 1
The patch having a thickness of 0 mm or less corresponds to a patch comprising a support and a drug-containing pressure-sensitive adhesive layer which is particularly soft or thin to prevent skin irritation and peeling from the skin. Can be prepared by using an ultra-thin polyester film of 0.5 to 5 μm or a film of another material as a support, and forming a 5-150 μm-thick adhesive layer containing a drug on one surface of the support. Such patches are also
The thickness of the film is 5 to 100 μm, but a film such as polyurethane having high flexibility or a film which has become flexible due to porosity is used as a support, and an adhesive having a thickness of 5 to 150 μm containing a drug on one surface thereof It can also be made by forming layers. Such a patch has a basis weight of 3 to
A thin woven or knitted fabric or nonwoven fabric of 20 g / m ² may be used alone or in combination with these films to form a pressure-sensitive adhesive layer containing a drug on one surface thereof. Even if it is generally called a flexible patch, its bristles are 10 mm
In the case of exceeding the value, it was possible to use as a patch as it was in the test of the present inventors even without a sheet for handling. In such a case, that is, when there is no medical merit of making it more flexible, it is considered that it is preferable to use without a handling sheet in view of the cost of the patch. Here, the rigidity (45 ° cantilever method) refers to JIS L101.
8 refers to the measurement value obtained by measuring according to the 6.22.1A method. At this time, remove the plaster coating material consisting of a film-like material such as polyester, which covers the surface of the patch containing the drug-containing adhesive layer that contacts the human skin, and pay attention to the bending of the patch due to static electricity. It shall be measured while measuring.

In the patch of the present invention, a specific adhesive sheet is used as the sheet for handling. By using such a specific adhesive sheet, even if the bristles of the patches are 10 mm or less, the handling of the patches can be improved without inducing a patient's operation error. . In the pressure-sensitive adhesive sheet according to the present invention, the pressure-sensitive adhesive is applied to the sheet by pressure bonding, impregnation, or surface coating. In the pressure-sensitive adhesive sheet according to the present invention, the bending resistance is important, and the bending resistance of the pressure-sensitive adhesive sheet alone or the pressure-sensitive adhesive sheet after application of the adhesive is important. The softness must be in the range of 20-220 mm (45 ° cantilever method). Flexibility is 10mm or more and 20mm
Although it is possible to handle patches in the range below, it is difficult for more patients, including the elderly, to reliably and easily handle them. The lower limit of the numerical value range of the stiffness of the pressure-sensitive adhesive sheet according to the present invention is 20 mm or more, preferably 40 mm or more. On the other hand, the greater the degree of softness, the harder the patch becomes, which may cause problems such as cutting your finger near the end face of the patch, or make it difficult to apply the patch in accordance with the unevenness of the sticking site on the human body. is there. Therefore, the upper limit of the numerical range of the bending resistance of the adhesive sheet body of the present invention is 22
It was important that the thickness be 0 mm or less, preferably 160 mm or less, particularly preferably 130 mm or less. That is, the rigidity (45 ° cantilever method) of the pressure-sensitive adhesive sheet according to the present invention is preferably in a numerical range of 40 mm to 160 mm, particularly preferably 40 mm to 130 mm.

The thickness of the pressure-sensitive adhesive sheet of the present invention is from 40 to
It is 650 μm, preferably 65 μm to 400 μm. A particularly preferred range is from 100 μm to 350 μm. If the thickness is less than 40 μm, even if the patient attempts to remove the sheet after application, it is difficult to grasp the end that should serve as the removal port, and as a result, the skin is likely to be damaged by nails or the like. Met. When the thickness exceeds 650 μm, the bulk becomes too bulky, so that when the patch is cut, only the sheet-like body is shifted laterally and the cutting itself tends to be difficult. Furthermore, when handling the patch before application, only the sticky sheet tends to peel off from the adhesive. Examples of such a sheet material of the sticky sheet of the present invention include polyethylene, polypropylene,
Polystyrene, polyester, nylon, polyvinyl chloride, polyurethane, polyvinyl acetate, or a copolymer or mixture thereof can be used. Especially,
In the present invention, such a planar body is not used directly on human skin, but is removed immediately after pasting on humans, and has a wider range of choices than materials used directly on human skin. Become. Such a material can be used by molding it into a single or composite film, a porous film, a woven or knitted fabric, a nonwoven fabric, or the like. Among them, particularly when used as a fabric such as a woven or knitted fabric or a nonwoven fabric, it gives a feeling that the patient easily adapts to the skin when touched, and further, there are few troubles such as cuts and the like caused by the planar body. In particular, a woven or knitted fabric that is appropriately thin and has sufficient rigidity and softness is preferable. Among these fabrics,
Fabrics having a basis weight of 20 to 250 g / m ² and satisfying the other requirements of the present invention are particularly preferable, and examples thereof include polyester hard twill fabrics.

The relationship between the thickness (y μm) and the degree of softness (xmm) of the pressure-sensitive adhesive sheet according to the present invention is sufficient even though y / x is in the range of 1.2 to 10 although it is thin. There is also a softness and softness, and without cutting your finger at the end face, thickness, softness,
It is preferable in terms of ease of handling. When y / x is 1.0 or less, the sheet is a hard material, and particularly when y / x is 0.5.
Those having a y of 60 μm or less nearby were hard and tended to cut human fingers when the fingers were displaced obliquely at the end faces of such planar bodies. When y / x is 20 or more, this material is thick and has little flexibility. y
Specific examples of the film having a thickness of 50 μm include a polyester film having a thickness of 50 μm and a thickness of 80 μm.
m polypropylene film, good quality paper, etc.
As those having x close to 1.2 to 3.5, there are dense polyester and cotton woven fabrics (hard twill) with a textured or stitched pattern,
Loose knits include those with y / x near 20.

On one surface of the adhesive sheet according to the present invention, an adhesive for adhering the sheet to the back of the support has a 90 ° peeling force of 2 ° between the back of the support and the adhesive sheet. ~ 45g / 30m
m. Particularly preferably, the 90 ° peeling force is 3 to 30 g / 30 mm. As a method of measuring the peeling force, when the support and the adhesive sheet are peeled in a 90 ° direction at a pulling speed of 300 mm / min using a 30-mm-wide strip-shaped sample (the official standard is 12 m in width).
In many cases, a sample of m or 20 mm is used, but in the case of the present invention, the adhesive strength is originally low, so it is better to measure with a width of 30 mm), and the peeling force is measured. If the 90 ° peeling force is less than 2 g / 30 mm, it tends to cause troubles such as detachment of the adhesive from the adhesive sheet during production or handling of the adhesive. The 90 ° peeling force is 45g.
If it exceeds / 30 mm, even if the handling sheet is peeled off after applying the patch to human skin, not only the sheet but also the patch tends to peel off at the same time or float off the skin. Further, a problem that the support film thinned in order to reduce skin irritation, which is an object of the present invention, tends to be broken.

The adhesive to be adhered to the adhesive sheet according to the present invention includes, for example, an acrylic adhesive, a vinyl acetate adhesive, a silicone adhesive, a rubber adhesive, a urethane adhesive, a polyvinyl alcohol, Or polyvinylpyrrolidone or the like is used, among these acrylic acrylic, vinyl acetate-based adhesive, silicone-based adhesive is safe,
It is preferable in terms of stability and cost. In the present invention, it is necessary to adjust the adhesive force of the adhesive so that the back surface of the support and the adhesive sheet have a specific peeling force. In general, the smaller the amount of adhesive, the lower the adhesive strength,
In adjusting to the peeling force of the present invention, it is necessary to consider not only the type and the amount of the adhesive but also other requirements. That is, the pressure-sensitive adhesive sheet of the present invention is to remove the patch immediately after it is applied to human skin, and it is necessary to satisfy the condition of this peeling force on safety and stability. Accordingly, the material of the support of the patch and the state of its surface, for example, whether or not a release agent has been applied, or the material of the sheet and its configuration, for example, a film,
The peeling force is also affected by whether the fabric is knitted or woven, for example, the basis weight of a woven or knitted fabric, and so these requirements are taken into consideration. In general, applying a release agent to the surface of the support is not preferable in terms of safety and cost of the patch.

In the case where the peeling force of the present invention is adjusted by the kind of the pressure-sensitive adhesive, the acrylic pressure-sensitive adhesive, the vinyl acetate pressure-sensitive adhesive, and the silicon-based pressure-sensitive adhesive include a carboxyl group contained as a monomer component in the pressure-sensitive adhesive. And / or cross-linking with a chemically equivalent divalent or trivalent polyvalent metal or polyfunctional molecule such as aluminum, magnesium, calcium, etc. necessary to crosslink 5 to 80% of the crosslinkable functional groups such as hydroxy groups. By doing so, it is easy to adjust to the numerical value range of the peeling force of the present invention, which is preferable. Alternatively, copolymerization of a necessary amount of a monomer component having a divalent or trivalent functional group in one molecule such as a compound having epoxy groups at both ends is also preferable as a means for adjusting the peeling force. The peeling force can also be adjusted by adding a third component such as isopropyl myristate, ethyl oleate, or polyethylene glycol to the entire solid content of the adhesive in an amount of 5 to 50% by weight. Furthermore, it is possible to adjust the release force by the amount of the adhesive used for adhesive planar body, in that case, it is preferable that the planar object 1 m ² per adhesive 3～60G. In the present invention, the adhesive sheet used for one patch is 2 or 3
And the two or more sticky sheets overlap each other near the center of the patch. When a sticking test is performed on a human using a placebo preparation having an adhesive sheet which satisfies the above conditions 1) to 3), when one adhesive sheet is used, unspecified handling of a patch is not specified. It was difficult to prevent many human manipulation errors. In addition, when the area of the adhesive sheet is larger than that of the patch with one sheet, it often causes troubles in production, especially in the cutting step. When the patch and the adhesive sheet have the same area, it is particularly difficult to remove the sheet only by taking the end of the sheet, and there is a high probability that the patch is peeled off together. It was easy to end up. On the other hand, in the case where two or three or more sticky sheet bodies are used so that a part of these sticky sheet bodies overlap each other near the center of the patch, operation errors are prevented, and It was easy to peel off the adhesive sheet from the vicinity of the center, and it was also possible to solve a problem in manufacturing.

Further, as another effect that enables the film to be peeled off from the vicinity of the center, the following effects are significant. That is, the 90 ° peeling force between the back surface of the support and the adhesive sheet body of the present invention is:
Even when the adhesive sheet is removed, the patch main body has a weak adhesive force as in the case of being adhered to the skin, and is 2 to 45 g /
Although it is adjusted to 30 mm, sometimes, when a person peels off the strongly sticky sheet, the patch frequently peels off from the human skin. Especially,
This tendency tends to increase when the adhesive strength of the patch of the present invention to human skin is reduced to reduce skin irritation. However, when the adhesive sheet was peeled from near the center, this problem could be completely solved, and a patch with no practical problem could be provided.

Here, "near the center of the patch" means, for example, when the patch is an oval patch having a length of 35 mm and a width of 70 mm, strictly speaking, the center is 35 mm from the horizontal end face, and Is 17.5 mm from the end face. In the present invention, the center is not limited to the strict center, but in general, two or three or more sticky sheet bodies are overlapped with each other near the center of 35 mm from the lateral end face for good handling. The term "near the center" of the present invention is considered from the purpose of achieving the object that the position at which the planar body is peeled is apparent to the patient at first glance, and is easy to peel, and even when strongly peeled, the patch is hard to peel from the skin. hand,
Any peripheral area that can achieve the object may be used, and in the above specific example, it refers to an area of 10 mm to 60 mm from an end surface of 70 mm in width. In other words, even in the case of other normal sizes, the area 10 mm or more inside from both end faces means near this center. In the present invention, it is essential that two or three or more sticky sheet bodies overlap each other near the center. The degree of the overlap is preferably 3 to 40 mm in terms of the width of the overlap. If there is an overlap, the effect is not only obvious at first glance the removal of the planar body,
In the case where there is no overlap, in the case of a patch having a low rigidity as referred to in the present invention, bending occurs at the parting line of the sheet, or the support of the patch is broken at this portion during production. Also, when the patch is held in hand during use, the patch may be bent depending on how it is held. With overlap, the patch is very stable both during use and during manufacture.

Furthermore, since stress such as tearing and bending is not applied to the backing of the patch until it is applied to the human skin, the trouble that the support of the flexible thin patch of the present invention is broken is greatly reduced.

The effect of the present invention is particularly remarkable because when two or more sticky sheets are used, the color and / or pattern of one sheet and another sheet are changed. It is time. Even if the support of the patch has two or more sheets for handling, if it is the same color, for example, transparent or white, it is difficult to see the removal opening. It is also difficult to write explanations for handling. In such a case,
Some people in the majority always make operation mistakes. Color coding is effective to reduce it. In other words, the different colors make it clear at first glance how to remove, and the operator can also write a simpler and easier-to-understand manual. This further helps to reduce operation errors.

Here, it is preferable to use red, blue, yellow, green, and pink for one color and combine them with one or more other colors. For example, particularly preferred combinations of colors are white and red, and white and red. Blue, white and yellow, white and pink, or white and green.

The patch of the present invention uses two or three or more sticky sheets, and since the opening is clear by overlapping each other near the center, the size of the patch and the sticky sheet is clear. There is no problem even if they are completely overlapped with the same length, which means that if you create both long-lasting products, both adhesive and adhesive, at the time of production, and cut them all at once, you can cut the product at once. Will be obtained as a patch
As a result, the productivity is also favorable. Of course, a patch and an adhesive sheet having different sizes may be prepared.

However, in the present invention, in order to reduce skin irritation, an extremely thin and flexible patch was tested and completed. In the case of such a patch, for example, the patch and the sheet When the sizes are different, it is necessary to cut each with a cutter blade of different specifications (usually, such cutting is often called half cut in the industry), but as thin as the patch of the present invention. It is extremely difficult to continuously cut the patch, for example, only a patch with a thickness of 10 μm, which requires a significant reduction in product yield, strict quality checks, etc. Easy to cause. For this reason, it is more preferable that the patch and the planar body have the same size.

[0022]

The present invention will be described in more detail with reference to the following examples. All parts, percentages and ratios in the examples are on a weight basis. The acrylic pressure-sensitive adhesive solution and the polyvinyl acetate-based pressure-sensitive adhesive used in the examples are as follows. "(1) Preparation of Acrylic Adhesive (AP) Solution (A Dope)" 90 parts of 2-ethylhexyl acrylate, 7 parts of methacrylic acid, 3 parts of acrylic acid, benzoyl peroxide 1.
0 parts and 100 parts of ethyl acetate were charged into a reaction vessel having a reflux condenser and a stirrer, and the polymerization was continued for 10 hours while slowly stirring at 60 ° C. under a nitrogen atmosphere. The polymerization conversion was 99.9%. 500 parts of ethyl acetate was added to the obtained polymer solution to adjust the solid content concentration to about 20% to obtain a pressure-sensitive adhesive solution. The weight average molecular weight (in terms of polystyrene) of the obtained acrylic pressure-sensitive adhesive was 585,000.

"(2) Polyvinyl acetate-based pressure-sensitive adhesive solution (B
Preparation of Dope] In addition to using vinyl acetate (manufactured by Wako Pure Chemical Industries, Ltd.), a copolymer composed of 2-ethylhexyl acrylate and the like was used. This polymer was synthesized by the following method. That is, 70 parts of vinyl acetate, 27 parts of 2-ethylhexyl acrylate, 3 parts of acrylic acid, 1 part of benzoyl peroxide and 150 parts of ethyl acetate were charged into a reaction vessel having a reflux condenser and a stirrer at 60 ° C. under a nitrogen atmosphere.
The polymerization was continued for 12 hours while stirring slowly. The polymerization conversion was 99.9%. 250 parts of ethyl acetate was added to the obtained polymer solution to adjust the solid concentration to about 20% to obtain a polyvinyl acetate-based pressure-sensitive adhesive solution. The weight average molecular weight (Mw) of this vinyl acetate pressure-sensitive adhesive was 510,000, the number average molecular weight was 78,000, and the residual monomer was 1% or less.

[Example 1] (1) Acrylic pressure-sensitive adhesive (AP) solution (A-doped) 44
Then, 1.2 parts of buprenorphine hydrochloride (BN) is added thereto, and the mixture is sufficiently stirred. Then, the mixture is coated on a polyethylene terephthalate separator (drug base) so that the thickness after drying becomes 10 μm. After sufficiently drying, a 2.0 μ thick polyethylene terephthalate film (manufactured by Teijin Limited, F3 type) is pressure-bonded to the free surface as a support, and a patch raw material (hereinafter, patch raw material) is pressed. ) Got. When the raw patch was cut to a size of 22 cm ² , it contained 2.8 mg of BN. The pliability (45 ° cantilever method) of the patch comprising the support of the polyethylene terephthalate film and the drug-containing pressure-sensitive adhesive layer composed of the BN-containing acrylic pressure-sensitive adhesive was 5 mm or less. When this BN-containing patch was applied to an animal and tested for transdermal absorbability, it showed sufficiently high transdermal absorbability, but was poor in handleability.

(2) On the other hand, 300 parts of an acrylic pressure-sensitive adhesive solution (A dope) is mixed with 40 parts of isopropyl myristate, and 1.35 parts of aluminum acetylacetonate (Al-A) is further sufficiently added. And coated on a polyethylene terephthalate separator so that the thickness after drying is 10 μm (this adhesive layer is hereinafter referred to as
Sheet adhesive layer), using a polyethylene terephthalate of 150 denier / 35 filaments, a basis weight of 109 g /
m ² and ^two different kinds of hard twill fabrics of different colors, white and red, each woven to a thickness of 170 μm (this fabric is referred to as a planar substrate), and dried sufficiently. Two types of white and red sticky planar bodies (referred to as sticky planar bodies) were obtained. The rigidity (4
(5 ° cantilever method) was 85 mm.

Each of 50 white and red sticky sheets was used.
Slit to a width of mm, the red sticky sheet above the original patch, and the white sticky sheet overlaps this red sticky sheet with a width of 15 mm below the red sticky sheet. As described above, the pressure-sensitive adhesive sheet was pressure-bonded to the support film of the raw patch. Next, a laminate composed of a plaster coating material, a drug-containing adhesive layer, a support film (2.0 μ polyethylene terephthalate film), a red sticky sheet, and a white sticky sheet obtained from below in this manner. The product was cut into an oval having a size of 35 mm in a vertical direction and 70 mm in a horizontal direction to obtain a BN-containing patch having an area of 22 cm ² (FIGS. 1 and 2).
As a result, the two sticky sheets were near the center of the patch,
That is, the red and white adhesive planar bodies overlap each other (with the red adhesive planar body down) with an overlapping width of 15 mm from a position 30 mm from the lateral end face of one adhesive planar body. Was. The 90 ° peeling force between the adhesive sheet and the backing film of the patch was 12 g when measured.
/ 30 mm.

(3) In the above patch, a human PN-free placebo preparation prepared in the same manner as in (1) and (2) above except that it does not contain the drug BN, Even if it was handled with one hand in a rough manner, it did not bend or bend, and was extremely excellent in handleability. In addition, there was no operation error in the operation of removing the sheet-like body after sticking, and there was no trouble that the patch was peeled off when the adhesive sheet-like body was peeled off.

[Examples 2 to 3 and Comparative Examples 1 to 4] The same placebo patch as in Example 1 was prepared in the same manner as in Example 1 except that the sheet-like adhesive layer and the sheet-like base material were changed. Table 1 shows the results of measuring the force and comparing the handleability at the time of application and the like.

[0029]

[Table 1]

[Comparative Example 5] The adhesive surface of the white adhesive sheet obtained in Example 1 was pressed on the back surface of the support of the original patch obtained in Example 1, and the resulting laminate was subjected to pressure bonding. A patch placebo was obtained in the same manner as in Example 1 by cutting into the same size and shape as in Example 1. The patch thus obtained was one in which one adhesive sheet was pressure-bonded to the back of the support of the patch.

The characteristics of this placebo patch were examined in the same manner as in Example 1. As a result, the 90 ° peeling force between the back surface of the support and the adhesive sheet was 12 g / 30 mm,
The bending resistance of the sticky sheet was 85 mm. There was no problem with this patch, including operability, until it was pasted.However, most people who participated in the test performed an operation to remove the adhesive sheet only leaving the patch itself after pasting. Said it was too difficult.

[Comparative Example 6] In Comparative Example 4, when a white pressure-sensitive adhesive sheet was pressure-bonded, a linear slit (cut line) was inserted into the white pressure-sensitive adhesive sheet and pressed, and a placebo was pressed. When the patches were cut into the same shape, the patch was cut so that the linear slit was located at the center on the support surface of the oval patch. As a result, the obtained placebo preparation was the same placebo patch as in Example 1 except that the sticky planar body did not overlap and was one color of only white instead of two colors of white and red. When the preparation was subjected to an adhesion test, when the preparation was peeled off and the coating was peeled off and held in hand, the preparation could be bent along the slit line of the adhesive sheet and was difficult to apply.
Further, when this bending was repeated several times, the film of the support of the patch was broken. Peeling off the sticky sheet after application was still better as compared with Comparative Example 5, but it was difficult to operate as compared with Example and there was a risk of damaging the film with a nail.

[Brief description of the drawings]

FIG. 1 is a plan view of the patch of Example 1. FIG. In the figure, 1 is a white sticky sheet, 2 is a red sticky sheet, and 3 and 4 are ends of a white sticky sheet and a red sticky sheet, respectively.

FIG. 2 shows a cross-sectional view of the patch of Example 1. In the figure, 1 is a white sticky sheet, 2 is a red sticky sheet, and 3 and 4 are a white sticky sheet and a red sheet which overlap near the center of the patch, respectively. End of adhesive sheet, 5 for support film, 6 for drug-containing adhesive layer, 7 for coating material (polyethylene terephthalate separator)
Is shown.

 ────────────────────────────────────────────────── ─── Continuing on the front page (72) Inventor Tosuke Oe 3-5-5 Midorigaoka, Hamura-shi, Tokyo Inside Teisan Pharmaceutical Co., Ltd.

Claims (5)

[Claims] 1. A rigidity (45 ° cantilever method) of 10 m
m) on the back side of the support of the patch having the following properties: 1) to 4) 1) The rigidity (45 ° cantilever method) of the adhesive sheet is 2
0 to 220 mm. 2) The thickness of the adhesive sheet is 40 to 650 μm. 3) The 90 ° peeling force between the back surface of the support and the adhesive sheet is 2 to 2.
45 g / 30 mm. 4) The adhesive sheet is composed of two or more sheets, and a part of the two or more sheets is overlapped with each other near the center of the patch. A patch with good handleability to which a pressure-sensitive adhesive sheet comprising a pressure-sensitive adhesive and a sheet-like body is simultaneously satisfied. 2. An adhesive sheet having a basis weight of 20 to 250 g /
^2. The patch according to claim 1, comprising a m2 fabric. 3. The adhesive patch according to claim 1, wherein the pressure-sensitive adhesive sheet comprises two or more pressure-sensitive adhesive sheets of different colors and / or colors. 4. One of the colors is red, blue, yellow, green,
4. The patch according to claim 3, which is pink. 5. The pressure-sensitive adhesive according to the following 1) to 3) 1) the pressure-sensitive adhesive is an acrylic pressure-sensitive adhesive, a vinyl acetate pressure-sensitive adhesive,
And one or more adhesives selected from silicone adhesives. 2) 5 to 80% of the crosslinkable functional groups in the pressure-sensitive adhesive are crosslinked with a polyvalent metal and / or a polyfunctional molecule. 3) The amount of the adhesive used is 3 to 60 g / m ² planar. The patch according to claim 1, which satisfies the following at the same time.