JP2021161031A - Patch support film, laminate and patch - Google Patents

Abstract

To provide a patch support film as a support comprising a preferable medicine barrier property, extension property and slipperiness, and a laminate and a patch comprising the same.SOLUTION: There is provided a patch support film on which, an adhesive agent layer can be arranged on one plane thereof, and is formed of a medicine barrier property material whose thickness is 10 μm or greater and 75 μm or smaller, the patch support film has an irregular structure in which recesses and salients are repeatedly arranged along a plane, by being formed into a wavy shape in a thickness direction, in a whole layer, the recesses and the salients extend respectively, in a linear state. The irregular structure includes at least two or more kinds of the salients having a different height, and a height difference of the recess and salient is 20 μm or greater and 150 μm or smaller, and 10% or greater and 70% or less of the salients comprise a structure with a maximum height.SELECTED DRAWING: Figure 1

Description

The present invention relates to a patch support film, a laminate, and a patch.

In general, plastic films have properties such as light weight, chemical stability, easy processing, flexibility and strength, and mass production. For this reason, plastic films are used for various purposes. Applications of plastic films include, for example, packaging materials for wrapping foods and pharmaceuticals, optical films used for drip packs, shopping bags, posters, tapes, liquid crystal televisions, protective films, windows to be attached to windows, etc. A wide variety of films, plastic greenhouses, building materials, etc. For such applications, it is important to select an appropriate plastic material according to the application. Further, a plurality of types of plastic films are laminated to form a laminated body. There is also a usage in which a plurality of plastic materials are mixed in one layer to make up for the shortcomings of a single material. In many cases, an appropriate film material is selected from the viewpoints of heat resistance, mechanical strength, transparency, and the like.

In general, the mechanical properties and barrier properties of a plastic film are determined by the material and layer composition. For example, a plastic film tends to have low extensibility in a material that emphasizes strength, and a film material that can secure sufficient extensibility while having high strength is eagerly desired. When barrier properties are required, it is necessary to limit the use of materials having good barrier properties or to laminate the barrier layer in another step. For this reason, labor and cost at the time of manufacturing may become a problem.

By the way, a patch typified by a ship to be attached to the skin is one in which a drug is put into an adhesive constituting a surface to be attached to the skin and the drug is absorbed from the skin into the body. The support constituting the outer surface of the patch is usually composed of a laminated body of a film or a non-woven fabric. The functions required of the support of this patch are that it has a barrier property (drug barrier property) to the drug, that it has elasticity and flexibility, that it has an appropriate slipperiness with clothes, etc., and that it is a commercial product. It has printability (visibility) and the like. The drug barrier property is a performance in which the support does not absorb the drug or hardly absorbs the drug so that the drug is efficiently absorbed through the skin. Stretchability and flexibility are important factors such as suppressing the feeling of stiffness after applying the patch to the skin and making it difficult for the applied patch to come off during operation. Here, the extensibility is an index of the degree of elongation when the support is pulled. Flexibility is an index of extensibility and is an index showing the degree of elongation at low stress.

However, at present, it is difficult to combine drug barrier properties with extensibility and flexibility. In particular, the material of the plastic film having a drug barrier property has been limited to some materials such as biaxially stretched PET (PolyEthylene terephthalate), ethylene-vinyl alcohol copolymer, cycloolefin copolymer and the like. The material has a drawback of low extensibility and flexibility due to its high strength.

Further, in terms of slipperiness with clothes and the like, if the slipperiness is poor, the patch will be caught on the clothes and the patch will be peeled off in the middle, resulting in poor drug efficiency. As a method for solving these problems, slipperiness can be improved by attaching a mat structure to the surface to reduce contact points. However, with a simple mat structure, it is difficult to put ink on the top of the mat structure, resulting in a product with poor visibility.

As described above, although the film for a patch support has been conventionally required to have functions such as drug barrier property, extensibility, and slipperiness, the actual situation is that it has not been achieved easily. For example, in Patent Document 1, a concave-convex structure is formed on the front and back surfaces of a film for a patch support, and a convex portion (or concave portion) on the front surface and a concave portion (or convex portion) on the back surface are aligned to form a bellows-like structure. Is formed, and even though it is a material that does not stretch originally, it can be stretched, improving flexibility. However, there is no mention of slipperiness during use, which is an important element of the patch support, and no reference is made to the specific uneven shape design corresponding to them.

JP-A-2019-88765

The present invention has been made by paying attention to the above points, and is a film for a patch support as a support having good drug barrier property, extensibility and slipperiness, and a laminate or a patch using the film. The purpose is to provide the agent.

In order to solve the problem, the first aspect of the present invention is a film for a patch support made of a drug barrier material having a thickness of 10 μm or more and 75 μm or less, in which a pressure-sensitive adhesive layer can be arranged on one surface side. The film for the patch support has a concavo-convex structure in which the entire layer is formed in a undulating shape in the thickness direction to repeat concave and convex portions along the surface, and the concave and convex portions are formed. Each of them extends linearly, and the uneven structure is composed of at least two kinds of convex portions having different heights, and the height difference between the concave portion and the convex portion is 20 μm or more and 150 μm or less. The gist is that the structure having the maximum height is 10% or more and 70% or less.

According to the film for a patch support, which is an aspect of the present invention, the drug barrier property and the extensibility are good, and the slipperiness is also good. Therefore, according to the film for a patch support, which is an aspect of the present invention, when used as a patch, it has good followability to body movements and also has good slipperiness with clothes, so that it can be peeled off. It has the effect of being difficult.

It is a perspective view which shows an example in the film for a patch support of this embodiment. It is sectional drawing which shows an example in the film for a patch support of this embodiment. It is sectional drawing which shows another example in the film for a patch support of this embodiment. It is sectional drawing which shows another example in the film for a patch support of this embodiment. It is sectional drawing which shows another example in the film for a patch support of this embodiment. It is sectional drawing which shows an example which changed the cross-sectional shape in the film for a patch support of this embodiment. It is sectional drawing which shows another example which changed the cross-sectional shape in the film for a patch support of this embodiment. It is sectional drawing which explains the radius of curvature of the corner part of the convex part in the film for a patch support of this embodiment. It is a bird's-eye view schematic view which showed the example of the extending direction of the concavo-convex structure in one section in the film for a patch support of this embodiment. It is a bird's-eye view schematic view which showed the example of another extension direction of the concavo-convex structure in one section in the film for a patch support of this embodiment. It is sectional drawing which explains the film thickness, the height difference of the concavo-convex structure, and the interval of the concavo-convex structure in the film for the patch support of the embodiment according to the present invention. It is a graph which shows the Example which concerns on this invention, and the stretch behavior example of the conventional support film. It is a graph which showed the relationship between the total elongation of a film and the maximum value of a local strain when the cross-sectional shape of a film for a patch support is changed. It is sectional drawing which shows by changing the cross-sectional shape of the film for a patch support. It is sectional drawing which shows the example of the laminated body which laminated the functional layer of this embodiment. It is sectional drawing which shows an example of the patch using the conventional film for a patch support. It is sectional drawing which shows an example of the patch using the film for the patch support of this embodiment. It is sectional drawing which shows an example of the patch using the laminated body of this embodiment. It is a bird's-eye view schematic view which showed the example of the extending direction of the concavo-convex structure when a plurality of sections are combined in the film for a patch support of this embodiment. It is a bird's-eye view schematic view which showed the example of another extending direction of the concavo-convex structure when a plurality of sections are combined in the film for a patch support of this embodiment.

Hereinafter, embodiments of the present invention will be described with reference to the drawings.

It should be noted that each figure is a diagram schematically shown, and the size and shape of each part are exaggerated as appropriate for easy understanding. Further, for simplification of explanation, the same reference numerals are given to the corresponding parts in each figure.

(Structure of film for patch support)
As shown in FIG. 1, the patch film 1 of the present embodiment has a shape in which the entire layer undulates in the thickness direction (a shape meandering when viewed from the side) along the surface. It has a concave-convex structure 2 that repeats the concave portion 2b and the convex portion 2a. In the concave-convex structure 2, the concave portion 2b and the convex portion 2a extend linearly in the depth direction of FIG. The linear shape includes a case where it meanders in the width direction and extends in a predetermined straight line direction.

The uneven structure 2 is preferably formed so that the height difference between the concave portion 2b and the convex portion 2a is larger than the thickness of the patch support film 1. The uneven structure 2 can be provided, for example, by processing the entire layer into a meandering shape along the surface direction.
Here, the film 1 for the patch support may be composed of a plurality of layers. When the patch 1 for a patch support is composed of a plurality of layers, each layer may be composed of the same material or may be composed of different materials.

In the film 1 for the patch support, an adhesive layer containing a drug can be arranged on the surface of the recess 2b. The patch support film 1 is made of a material having a drug barrier property against the drug contained in the pressure-sensitive adhesive layer. The material of the film 1 for the patch support may be appropriately selected from known plastic materials having a drug barrier property against the drug expected to be used for the patch.

As the material of the film 1 for the patch support, for example, polyethylene terephthalate, cycloolefin copolymer, cycloolefin polymer, polyacrylonitrile, ethylene-vinyl alcohol copolymer, and modified polymers thereof can be preferably used. ..

When applied to the body, the patch is used to allow the medicinal ingredients contained in the adhesive layer to penetrate the skin and act on the whole body through blood. It is important that the patch support film 1 used for such a patch has a barrier property that barriers the medicinal component thereof and does not adsorb or is difficult to adsorb. The above-mentioned material has a good barrier property (non-adsorptive property) to the medicinal ingredient, and functions as a support without reducing the medicinal ingredient of the patch. The patch support film 1 made of such a material has a drug barrier property against drugs such as rivastigmine, tulobuterol, and lidocaine.

(About uneven structure 2)
Regarding the concave-convex structure 2, the distance D1 between the adjacent convex portions 2a and the distance D2 between the adjacent concave portions 2b (see FIG. 11) may be arranged with periodicity such as equal intervals, or may be different. Is also good. The intervals D1 and D2 can be appropriately set according to the desired stretching state required for the patch, but it is preferable that the intervals D1 and D2 have periodicity at equal intervals to exhibit the intended performance on the entire surface of the patch. It is easy to do and there is no unevenness in performance.

Here, the distance D1 between the adjacent convex portions 2a corresponds to the distance P of one pitch of the concave-convex structure. The 1-pitch spacing P of the concave-convex structure may be determined by the spacing D2 between adjacent recesses 2b.

Further, as shown in FIGS. 2 to 4, the shape of the concave-convex structure 2 along the arrangement direction of the convex portion and the concave portion is such that the convex portion 2a has a trapezoidal shape, an aspherical lens shape, or a triangular shape and is adjacent to each other. The convex portions 2a are connected by the concave portions 2b. The shape of the convex portion 2a can be any shape such as a semicircular shape or a polygonal shape. Further, as shown in FIG. 5, the corner portion which is the connecting portion between the top portion 2aa and the wall portion 2ab may be rounded, and the surfaces of the top portion 2aa and the wall portion 2ab may have roughness. Further, the cross-sectional shape of the recess may be V-shaped, or the bottom surface may be curved. Further, the same pattern may be used on the entire surface of the patch support film of the present embodiment, or different patterns may be combined.

As described above, the patch film 1 of the present embodiment has a trapezoidal shape in which the convex portion 2a can have an arbitrary shape, but more preferably the top portion has a flat cross-sectional shape. Since the top portion 2aa is flat, visibility is improved when the printing layers, which are functional layers, are laminated. Further, the concave portion 2b preferably has a flat shape because it is easy to secure adhesion when the concave portion 2b is attached to an adhesive or the like. Flatness means having a flatness having printability. The flatness of the patch support film 1 is preferably, for example, an arithmetic mean roughness (Ra) of 0.3 μm or less when observed at 200 times with a laser microscope.

Further, the concave-convex structure 2 is formed of a concave-convex pattern in which the concave portion 2b and the convex portion 2a extend linearly, respectively, as shown in FIGS. 9 and 10. The extending direction of the uneven structure is shown by a solid line. The concave portion 2b and the convex portion 2a may be configured to have the same width or may be configured to have different widths.

In FIG. 9, the region 10 forming the concave-convex structure 2 has a rectangular shape with the short side 10a and the long side 10b as boundaries, and the extending directions of the concave portion 2b and the convex portion 2a are set so as to be parallel to the short side 10a. This is an example of setting. That is, it is an example in which the concave-convex structure 2 is formed so that the concave portion 2b and the convex portion 2a are lined up in the long side 10b direction of the region 10 along the surface direction.

FIG. 10 shows an example in which the region 10 forming the concave-convex structure 2 has a rectangular shape, and the extending directions of the concave portion 2b and the convex portion 2a are set so as to be inclined from both the short side 10a and the long side 10b.

Further, the concave-convex structure 2 may be formed of a concave-convex pattern such that at least a part of the concave portion 2b and the convex portion 2a in the extending direction is formed by a curved line. The concave portion 2b and the convex portion 2a may be configured to have the same width or may be configured to have different widths.

The above uneven pattern is an example, and is not limited to these shapes.

For example, in one region 10, the basic extending direction of the concave portion 2b and the convex portion 2a may be a linear shape, and a portion extending along a curved line may be provided in a part thereof.

Further, although the rectangular shape is exemplified for the region 10 forming the concave-convex structure 2, the shape of the region 10 is not limited to the rectangular shape. The contour of the region 10 may have a circular shape or the like.

Further, it is not necessary that the entire surface of the patch support film 1 is the region 10 where the uneven structure 2 is provided. For example, there may be a portion where the concave-convex structure 2 is not formed, such as the left and right edge portions in FIG. 9 and the central portion in the extending direction of the unevenness. In the case of FIG. 9, since the extensibility increases in the left-right direction, the film 1 for the patch support partially has a portion without the uneven structure 2 as long as the elongation is not restricted. There is no problem.

(Thickness of film 1 for patch support, height of uneven portion, etc.)
The thickness of the patch support film 1 is preferably 10 μm or more and 75 μm or less, more preferably 10 μm or more and 60 μm or less, and further preferably 10 μm or more and 50 μm or less. If the thickness is less than 10 μm, the strength and handleability of the patch will be impaired, resulting in impracticality. On the other hand, if the thickness exceeds 75 μm, not only the skin becomes stiff and uncomfortable when applied to the skin as a patch, but also the flexibility as a patch is impaired.

The thickness of the patch support film 1 does not necessarily have to be uniform. In the film after the uneven shape processing, the thickness t1 at the convex portion 2a position and the thickness t2 at the concave portion 2b position do not have to be the same. The thickness of the film 1 for the patch support of the present embodiment is represented by an average value obtained by measuring the thickness at 5 points of the thickness t1 at the convex portion 2a position and the thickness t2 at the concave portion 2b position. (See FIG. 11).

The concave-convex structure 2 is composed of at least two or more types of convex portions 2a having different heights. FIG. 2 shows an embodiment in which convex portions having different heights are alternately arranged. In the embodiment of FIG. 6, the convex portions (height Hmax) having a high height are arranged at a ratio of 1 to 4 convex portions. Further, in the embodiment of FIG. 7, it is formed from three types of convex portions having different heights. The arrangement of these maximum convex portions is arbitrary, but a regular arrangement is preferable because unevenness does not easily occur in the performance of the patch.

The ratio of the maximum convex portion may be 10% or more and 70% or less. If this ratio is less than 10%, the distance between the maximum convex portions becomes too wide, and when the object bends due to a load or the like, it becomes easy for the maximum convex portions to come into contact with each other. If it exceeds, the slipperiness does not change significantly. More preferably, it is in the range of 25% or more and 50% or less.

The height difference H between the concave portion 2b and the convex portion 2a is 20 μm or more and 150 μm or less. If the height difference H between the concave portion 2b and the convex portion 2a is less than 20 μm, it is difficult to obtain the strain adjustment effect, and if it exceeds 150 μm, it may be difficult to attach the concave-convex structure 2 in manufacturing. There is. More preferably, the height difference H is in the range of 30 μm or more and 120 μm or less. Further, the height difference H is preferably thicker than the thickness of the patch support film 1.

The height difference ΔH (see FIG. 11) between the height Hmax of the maximum convex portion and the height H of the non-maximum convex portion is preferably 3 μm or more and 10 μm or less. When this height difference ΔH is less than 3 μm, the object may be deformed when a strong load is applied to the object, and the object may not be sufficiently slippery due to contact with the convex portion. On the other hand, if it exceeds 10 μm, the ink may not be applied in normal printing, and the visibility in printing may be insufficient.

Further, it is preferable that the corner portion of the convex portion has a curved shape as shown in FIG. Since the corners are curved, it is possible to avoid a situation in which the corners are caught when the object to be slipped is a cloth-like substance. This curve preferably has a radius R in the range of 10 μm or more and 100 μm or less. If the radius of curvature is less than 10 μm, the effect of preventing catching on the corners is not sufficient, and if it exceeds 100 μm, the curvature is too large and it becomes difficult to obtain the desired shape.

The concave-convex structure 2 preferably has a periodic structure in which the concave portion 2b and the convex portion 2a are regularly arranged. By not having an aperiodic structure, it is easy to obtain the intended extensibility, and at the same time, the design and manufacture of the concave-convex structure 2 can be simplified. However, it is optional to change the width of the aperiodic uneven structure 2 or the uneven structure 2 partially.

(Action and others)
The patch film 1 of the present embodiment is provided with the required extensibility by a unique structure having an uneven structure 2. Here, when a flat plate-shaped patch support film (also referred to as a comparative film) without the uneven structure 2 as in the present embodiment is configured, the elongation behavior of the comparative film is shown by reference numeral 21 in FIG. As described above, elastic deformation occurs only a short distance after the film starts to stretch, and the yield point (hereinafter, the starting point at which necking starts is referred to as the yield point) is reached immediately. After the yield point, plastic deformation accompanied by necking occurs, and when the break point is reached, the film breaks.

On the other hand, when the film 1 for the patch support of the present embodiment is pulled in the left-right direction of FIG. 1, that is, in the direction orthogonal to the extending direction of the concave-convex structure 2, the shape is first deformed by elastic deformation, and then the shape is deformed. Plastic deformation occurs as part of the shape deformation. If the tension is further continued, the height difference H of the concave-convex structure 2 becomes smaller due to the tensile stress, and the shape becomes unable to be deformed as it approaches flat. That is, the yield point mainly goes through a stage where the uneven structure is crushed and spreads (a region where it is stretched without applying too much force) and a stage where the crushed uneven structure is further stretched and becomes almost flat (a region where a force is applied and stretches). Finally, necking occurs and breaks as in the case of the comparative film. The strength at break is determined by the Young's modulus and thickness of the material.

The film 1 for the patch support of the present embodiment has a yield point higher than that of the conventional film for the patch support, as shown by reference numeral 22 in FIG. 12, by performing such a multi-step shape deformation. The amount of elongation before reaching is increased, and the stress required for elongation is reduced. The amount of elongation is determined by the ratio of the length along the unevenness to one pitch (straight line length) in one pitch of the concave-convex structure. Therefore, the film 1 for the patch support of the present embodiment contributes to the property of easily stretching without necking.

As described above, even with the patch support film 1 made of a material generally considered to have low extensibility, high extensibility can be imparted to the comparative film by devising the shape. , The stress required for elongation can be reduced. That is, the film for the patch support of the present embodiment can have a drug barrier property, high extensibility, and low stress (flexibility) required for elongation.

At this time, arbitrary extensibility can be obtained by appropriately controlling the shape of the cross section of the film 1 for the patch support. For example, when it is desired to stretch the film significantly without breaking it, or to obtain a low stress required for stretching, the height difference H of the concave-convex structure 2 is increased, and the angle of the bent portion of the convex portion 2a is reduced. It is advisable to make adjustments such as making the top of the ridgeline or the valley of the ridgeline less rounded.

(Relationship between the overall elongation of the patch support film 1 and the maximum value of local strain)
FIG. 13 shows the relationship between the overall elongation and the maximum value of local strain when the shape of the concave-convex structure 2 of the patch support film 1 according to the present embodiment is changed. The vertical axis is the maximum value of local distortion, and the horizontal axis is the elongation of the entire film. A flat plate-shaped patch support film that does not have the uneven structure 2 shown by the dotted line is used as a comparative example. Here, the elongation of the entire film on the horizontal axis represents the elongation ratio of the dimension of the entire film after the film is pulled with respect to the dimension before the film is pulled in the left-right direction in FIG. The local distortion on the vertical axis represents the maximum value of the elongation rate of the microscopic portion when the film is divided into microscopic portions. For example, a typical example of a portion where the local strain is large is the periphery of the bent portion of the apex angle portion in the triangular cross section of FIG.

Further, FIG. 14 shows the cross-sectional shape of the patch support film 1 having high extensibility used for the evaluation shown in FIG. FIG. 14 has a triangular cross section, but the principle is the same for the trapezoidal cross section. The shape A shown in FIG. 14A has a relatively large height difference H between the concave portion 2b of the concave-convex structure 2 and the convex portion 2a, and the shape B shown in FIG. 14B has the concave portion 2b and the convex portion of the concave-convex structure 2. The height difference H of 2a is relatively small (however, the thickness is made larger than the thickness of the film 1 for the patch support to make the layer thickness equal). Then, it can be seen that the relationship between the overall elongation and the maximum value of the local strain of the film 1 for the patch support of the present embodiment changes greatly due to the difference in the uneven structure 2.

For example, as shown in FIG. 13, the elongation of the entire film can be increased by relatively increasing the height difference H between the concave portion 2b and the convex portion 2a of the concave-convex structure 2 as shown in the shape A of FIG. 14A. can. Further, the local strain can be reduced as compared with the elongation of the entire film 1 for the patch support. In the film 1 for a patch support that adopts the shape A, the film itself is unlikely to have cracks such as breakage. In addition, for example, even if a hard functional layer is laminated on the surface (for example, vapor deposition, hard coating, etc.) and pulled, the hard functional layer can be prevented from cracking. This is because the hard functional layer is loaded by the amount of the above-mentioned local strain. That is, the patch 1 for the patch support adopting the shape A can be applied to, for example, a laminated body in which functional layers are laminated, so that the film 1 can be stretched while suppressing the destruction of the hard functional layer.

In the shape B of FIG. 14B, the height difference H between the concave portion 2b and the convex portion 2a of the concave-convex structure 2 is relatively small. In this case, as shown in FIG. 13, the film for the patch support is formed. In some cases, the local strain may be greater than the overall elongation of 1. However, the elongation of the entire film is larger and higher than that of the film without a shape. These uneven structures 2 may be optimized in consideration of the desired stretchability and strength of the patch support film, the material and form of the functionalized layer to be laminated, and the like. For example, by optimizing using the general-purpose nonlinear finite element analysis solution Marc (registered trademark), it becomes possible to obtain the target practical film 1 for a patch support.

Similarly, it can be seen that by reducing the apex angle of the convex portion, the entire film can be stretched with less distortion.

Further, in order to increase the extensibility, the height difference H of the uneven structure 2 is preferably larger than the thickness of the film 1 for the patch support. By doing so, the cross section of the patch support film 1 is less likely to be flat, and the effect of adjusting strain can be effectively obtained.

(Surface slipperiness of film 1 for patch support)
In the patch support film 1 of the present embodiment, the ratio of the maximum convex portion in the plurality of convex portions is preferably 10% or more and 70% or less. If the ratio of the maximum convex parts is less than 10%, the distance between the maximum convex parts becomes too wide, and when the object bends due to a load or the like, it becomes easy for the objects to come into contact with each other and slip. The property becomes difficult to stabilize, and if it exceeds 70%, the slipperiness does not change significantly. Since the slipperiness largely depends on the contact area between the film 1 for the patch support of the present embodiment and the object, it is important to set an appropriate range. In particular, when the convex portion is a flat surface such as a trapezoidal shape, the tendency is remarkable.

It is generally assumed that the patch is applied to the skin such as the chest, upper arm, and back, and then comes into contact with clothing. Since the coefficient of friction of such a fabric (object) is relatively large, if the surface of the patch is not slippery, the clothing and the patch will be caught and the patch will be peeled off from the end, resulting in the result. Since the drug contained in the adhesive does not penetrate into the skin, the drug efficiency is lowered.

(Characteristics of film 1 for patch support)
In the film 1 for the patch support of the present embodiment, the ratio of the 20% tensile load in the direction in which the concave and convex portions are aligned to the 20% tensile load in the direction orthogonal to the alignment direction of the concave and convex portions is 1/20 or more. , 1/3 or less is preferable. If the ratio of the 20% tensile load is smaller than 1/20, the force required to stretch the film in the alignment direction of the concave and convex portions is too weak with respect to the material strength, so that the alignment direction of the concave and convex portions is weak. The film may stretch and lose its handleability, making it difficult to handle during use or in the manufacturing process. In addition, if the ratio of 20% tensile load exceeds 1/3, it will stretch in two directions, making it difficult to adhere cleanly during use, and molding stability and dimensional stability will be impaired in the manufacturing process, making manufacturing difficult. May be.

The method for measuring a 20% tensile load in the present invention conforms to the test conditions of JIS K7127: 1999 plastic-test method for tensile properties-with a sample width of 15 mm, a distance between chucks of 50 mm, and a tensile speed of 100 mm / min. It can be measured by obtaining the tensile load when the film 1 for the patch support is stretched by 20% while applying a tensile force from this state until the film breaks.

Further, since the film 1 for the patch support of the present embodiment has the effect of stretching when a force is applied, it also has the characteristics of high impact resistance and high impact absorption due to the concavo-convex structure 2 being crushed. There is.

Further, when the uneven structure 2 has a one-dimensional structure as shown in FIG. 1, it also has a property that the bending rigidity is strong in the direction orthogonal to the uneven extending direction. Flexural rigidity is determined by the integral of the product of the moment of inertia of area and Young's modulus. The film 1 for a patch support having high extensibility of the present embodiment has a larger moment of inertia of area than a normal flat film for a patch support having the same amount of resin, so that the flexural rigidity is increased. ..

(Manufacturing method of film 1 for patch support)
As the method for producing the film 1 for the patch support of the present embodiment, for example, a method by hot pressing or a method by extrusion molding can be used.

In the hot press method, a multi-layer flat film in which the film 1 for the patch support is arranged on one side surface is formed between heating rolls having an uneven shape on the surface on the one side of the film 1 for the patch support, or in a heated flat plate shape. It is possible to impart the concave-convex structure 2 to the film 1 for the patch support by passing it through the press machine of the above. At this time, by adjusting the press depth and the press pressure, a desired concave-convex shape is imparted, and after cooling, the patch support film 1 to which the concave-convex structure 2 is imparted is peeled from the multilayer film to obtain the present embodiment. A film 1 for a patch support having an undulating shape can be obtained.

Alternatively, the film 1 for the patch support having a undulating shape can be obtained by passing the film 1 for the patch support, which is a single-layer and flat film, through a press machine in which the front and back surfaces of the press are provided with uneven shapes and precisely aligned. It is possible to obtain.

Further, in the extrusion molding method, a plurality of different resins are co-extruded by a feed block method or a multi-manifold method using a plurality of extruders, so that the film 1 for a patch support is arranged on one side surface. It is possible to obtain a film having a multilayer structure of two or more layers. In the cooling step for forming a film, the surface on which the film 1 for the patch support is arranged is cooled while applying nip pressure using a cooling roll provided with irregularities corresponding to the concave-convex structure 2 on the surface. Then, the uneven structure 2 can be attached. At this time, when the height difference H of the peaks and valleys of the concave-convex structure 2 is large with respect to the film thickness of the patch support film 1 in contact with the cooling roll, it is located at the interface opposite to the cooling roll of the patch support film 1. Similarly, since the concave-convex structure 2 is added to the film, the undulating shape of the patch support film of the present embodiment is obtained by peeling the patch support film 1 to which the concave-convex structure 2 is applied after cooling from the multilayer film. 1 can be obtained.

Further, in another method by extrusion molding, in a cooling step for extruding a single layer from one extruder and forming a film, a pair of cooling rolls having irregularities corresponding to the concave-convex structure 2 on the surface are used. Then, by cooling while applying the nip pressure, it is possible to obtain the undulating shape of the patch support film 1 to which the uneven structure 2 is applied.

In addition, any method of adding the concave-convex structure 2 such as injection molding can be selected, and the method is not particularly limited.

(Laminate and patch)
The film 1 for a patch support according to the present embodiment has a functional layer such as a printing layer, a vapor deposition layer, a hard coat layer, an antireflection layer, and an anchor coat layer for improving adhesion to an adhesive on the surface in a subsequent step. It is also possible to make a laminated body 20 in which 6 is laminated. Alternatively, it may be a laminated body 20 in which a functional layer 6 made of another thermoplastic resin or the like is laminated (see FIG. 15). Another thermoplastic resin may form, for example, a functional layer as described above, or may further form a functional enhancement layer such as strength.

FIG. 16 shows a schematic cross-sectional view of a general patch 5'. In this general example, the flat adhesive support film 1'has a pressure-sensitive adhesive layer 3 containing a drug on one side, and a release liner 4 is provided on the surface of the pressure-sensitive adhesive layer 3. When it is attached to the skin, the peeling liner 4 is peeled off, and the adhesive layer 3 is attached to the skin for use. Then, the drug contained in the pressure-sensitive adhesive layer 3 is absorbed through the skin and acts.

Such a general patch support film 1'is insufficient in low stress and extensibility required for elongation, and due to a feeling of stiffness after applying the patch to the skin and insufficient extensibility, There is a problem that the end of the patch may come off during operation.

On the other hand, by using the patch 1 or laminate of the present embodiment, it is possible to have low stress and extensibility required for elongation, and the above-mentioned stiff feeling and peeling can be eliminated.

As an example, FIG. 17 shows a cross-sectional view of the patch 5 when the film 1 for the patch support of the present embodiment is used. In the present embodiment, by using a material having a high drug barrier property, the drug has an effect of being efficiently absorbed by the skin, and the material itself of the film 1 for the patch support has a high Young's modulus and is difficult to stretch. However, it shows low stress and high extensibility required for elongation. Further, at the time of breaking, the strength is maintained by the hardness of the material itself.

FIG. 18 shows an example of the patch 5 in which the pressure-sensitive adhesive layer 3 is arranged on one surface of the film for the patch support of the laminated body 20 in which the functional layers 6 are laminated. Further, although FIG. 17 shows that there is a gap between the pressure-sensitive adhesive layer 3 and the film 1 for the patch support, the pressure-sensitive adhesive layer 3 may be filled to eliminate the gap. Similarly, in FIG. 18, although it is shown that there is a gap between the pressure-sensitive adhesive layer 3 and the film 1 for the patch support, the pressure-sensitive adhesive layer 3 may be filled to eliminate the gap.

(Another Embodiment of the film 1 for the patch support)
As shown in FIGS. 19 and 20, the patch support film 1 may have a plurality of regions 10 and the concave-convex structure 2 may be formed in an individual concave-convex pattern for each region 10.

In FIGS. 19 and 20, a plurality of regions 10 (FIGS. 16 and 17 are examples of being divided into four regions 10) are set by dividing the series of the patch support film 1 into a plurality of compartments. This is a case, and the extending direction of the concave-convex structure 2 is shown by a solid line. Reference numeral 10c indicates a boundary between adjacent regions 10.

In FIG. 19, the extending direction of the uneven structure 2 is parallel to any edge of each section, and is arranged orthogonal to the extending direction of the uneven structure 2 in the adjacent section. A film with good extensibility has a problem that the film stretches during processing and stable film formation is difficult. However, by arranging the film as shown in FIG. 19, stable film formation during molding processing becomes possible, and the final product has a problem. By cutting or punching each section, it is possible to provide a film 1 for a patch support that extends in a desired direction. It is not necessary to have a clear boundary between adjacent compartments, and the number of compartments and the compartment size existing on the series of patch support films 1 can be arbitrarily set. Further, there may be a region 10 having no concave-convex structure 2 between the regions 10.

The cutting position can also be arbitrarily set. For example, in the arrangement shown in FIG. 19, by halving the adjacent region 10 in the vertical or horizontal direction without separating it at the boundary line 10c, the vertical direction and the horizontal direction can be set. It is possible to obtain a film 1 for a patch support for two sections that easily stretches in two directions such as. In this case, it is effective when half of the film is fixed and only the other half is to be stretched. That is, it may be designed so that one final product is composed of a plurality of regions 10. In this case, when the patch is applied to the skin, it is possible to first apply the non-stretchable half of the film to the skin to fix it, and then extend the other half to apply it.

In the patch support film 1 shown in FIG. 20, the uneven structure 2 extends in a direction in which the film 1 is inclined at a predetermined angle with respect to the sides of each region 10. Other than that, the structure is the same as that of the patch support film 1 shown in FIG. The angle of the uneven structure 2 with respect to the boundary line 10c that divides the region 10 is arbitrary, and the angle may be different for each region 10.

(Effect of this embodiment)
(1) The patch support film 1 of the present embodiment is a patch support film made of a drug barrier material having a thickness of 10 μm or more and 75 μm or less so that the pressure-sensitive adhesive layer can be arranged on one side. Therefore, the film for the patch support has a concavo-convex structure in which the concave portion and the convex portion are repeated along the surface because the entire layer is formed in a undulating shape in the thickness direction, and the concave portion and the convex portion are formed. Each extends linearly, and the uneven structure is composed of at least two types of convex portions having different heights, and the height difference between the concave portion and the convex portion is 20 μm or more and 150 μm or less, and the convex portion. Of these, the structure having the maximum height is 10% or more and 70% or less.

According to this configuration, it is possible to provide a film 1 for a patch support having good drug barrier property, extensibility, and slipperiness.

For example, in the film 1 for a patch support of the present embodiment, even if a film having a hard drug barrier property having a large Young's modulus is formed, the concave-convex structure 2 is provided and the film has an undulating shape for the patch support. It is possible to impart extensibility and flexibility (low stress required for elongation) to the film 1. Further, by setting the height of the convex portion to at least two kinds of heights and adjusting the ratio occupied by the number of convex portions of the maximum height, it becomes possible to control the slipperiness, and the drug barrier property, the extensibility, and the slipperiness can be controlled. It is possible to provide a film for a patch support that also has the above.

(2) In the film 1 for the patch support of the present embodiment, the height difference of the uneven structure is larger than the thickness of the film for the patch support.

According to this configuration, the shape reproducibility of the undulating shape in the manufacturing process is good, and the target effects such as extensibility and flexibility (low stress required for elongation) can be more reliably performed.

(3) The material of the film 1 for the patch support of the present embodiment is any one of polyethylene terephthalate, cycloolefin copolymer, cycloolefin polymer, polyacrylonitrile, ethylene-vinyl alcohol copolymer, and modified polymer thereof. It consists of a resin selected from.

According to this configuration, the film 1 for the patch support can be provided with a drug barrier property.

(4) In the film 1 for the patch support of the present embodiment, the height difference between the structure having the maximum height of the concave-convex structure and the structure having other heights is 3 μm or more and 10 μm or less.

As a result, it is expected that the slipperiness is improved by reducing the contact area and the visibility is improved because the ink is applied during printing.

(5) In the film 1 for a patch support of the present embodiment, the shape of the convex portion along the arrangement direction of the convex portion and the concave portion is a trapezoidal shape having a top and continuous wall portions on both sides of the top. ..

As a result, since the convex portion has a flat surface, the ink is placed on the flat portion at the time of printing, and the visibility can be improved.

(6) In the film 1 for the patch support of the present embodiment, the corners of the plurality of convex portions are curved, and the curves are arcuate with a radius of 10 μm or more and 100 μm or less.

As a result, when the patch is applied to the skin as a patch, rubbing against clothing or the like is reduced, and it is possible to prevent the fabric from being caught in the corners of the convex portion and the patch from peeling off.

(7) The ratio of the 20% tensile load in the direction orthogonal to the unevenness with respect to the unevenness extending direction of the film 1 for the patch support of the present embodiment is 1/20 or more and 1/3 or less.

As a result, the film 1 for the patch support can be easily handled when the film is managed in a roll shape or the like in the manufacturing process or when the film is used because it does not stretch with a force that is too small and stretches in one direction.

(8) The patch film 1 of the present embodiment has a plurality of regions 10, and the concave-convex structure 2 is formed by an individual uneven pattern for each region 10.

In this configuration, when used as the raw material of the final product, the elongation of each region 10 cancels out to some extent, and the excessive elongation is suppressed, and when the film is managed in a roll shape or the like, a patch is applied. The support film 1 can be easily handled.

Further, when it is used as the film 1 for the patch support of the final product, it becomes easy to set the stretchable direction to two or more directions.

(9) The functional layer 6 may be laminated on one side of the patch support film 1 of the present embodiment.

According to this configuration, it is possible to provide a laminate having good drug barrier property, extensibility, and slipperiness.

(10) In the patch 5 of the present embodiment, the adhesive layer 3 containing the drug is laminated on one surface side of the film 1 for the patch support or the laminate, and on the adhesive layer 3 thereof. A release liner 4 is formed.

According to this configuration, it is possible to provide a patch 5 having good drug barrier property, extensibility, and slipperiness, and having good followability to the skin.

Although the embodiments of the present invention have been illustrated above, it goes without saying that the present invention is not limited to the above embodiments. Further, it is optional to use the above embodiments in combination.

Hereinafter, the examples created by the present inventors will be described in detail, but the present invention is not limited to the following examples.

(Example 1)
Ethylene-vinyl alcohol copolymer (EVOH) Soanol D2908 (trade name) manufactured by Nippon Synthetic Chemical Industry Co., Ltd. was used as the material of the film 1 for the patch support. The patch 1 for the patch support was coextruded by niping the side of the film 1 for the patch support into a roll having irregularities to form a two-layer structure to impart the concave-convex structure 2. Then, the film 1 for the patch support was peeled off from the coextruded film to prepare a sample of Example 1. As the material for coextrusion, low density polyethylene (LDPE) Novatec LD LC600A (trade name) manufactured by Japan Polyethylene Corporation was used.

The thickness of the film 1 for the patch support is 20 μm, the maximum height difference of the trapezoidal concave-convex structure 2 is 60 μm, the pitch is 255 μm, the upper side length is 205 μm, the lower side length is 224 μm, and the trapezoidal apex angle is 99 °. bottom. The height of the unevenness was alternately high and low, the height difference between the high structure and the low structure was 5 μm, and the ratio of the high structure was 50%. The trapezoidal corners are not arcuate.

(Example 2)
As the material of the film 1 for the patch support, a cyclic olefin copolymer (COC) TOPAS 8007 (trade name) manufactured by Polyplastics Co., Ltd. was used, and the thickness of the film 1 for the patch support was 20 μm. A sample of Example 2 was prepared in the same manner as in Example 1 except for the above.

(Example 3)
Homo PET resin EFG70 (trade name) manufactured by Bell Polyester Products Co., Ltd. was used as the material of the film 1 for the patch support, and the thickness of the film 1 for the patch support was 20 μm. A sample of Example 3 was prepared in the same manner as in Example 1 except for the above.

(Example 4)
The thickness of the film 1 for the patch support was set to 12 μm. A sample of Example 4 was prepared in the same manner as in Example 1 except for the above.

(Example 5)
The thickness of the film 1 for the patch support was set to 75 μm. A sample of Example 5 was prepared in the same manner as in Example 1 except for the above.

(Example 6)
The ratio of the high structure of the trapezoidal uneven structure 2 was set to 10%. A sample of Example 6 was prepared in the same manner as in Example 1 except for the above.

(Example 7)
The ratio of the high structure of the trapezoidal uneven structure 2 was set to 70%. A sample of Example 7 was prepared in the same manner as in Example 1 except for the above.

(Example 8)
The height difference H of the trapezoidal concave-convex structure 2 was 100 μm, the pitch was 425 μm, the upper side length was 205 μm, the lower side length was 236 μm, and the apex angle of the trapezoid was 99 °. The height of the unevenness was alternately high and low, the height difference between the high structure and the low structure was 5 μm, and the ratio of the high structure was 50%. The trapezoidal corners are not arcuate. A sample of Example 8 was prepared in the same manner as in Example 1 except for the above.

(Example 9)
The height difference between the high structure and the low structure of the trapezoidal concave-convex structure 2 was set to 15 μm. A sample of Example 9 was prepared in the same manner as in Example 1 except for the above.

(Example 10)
The trapezoidal corners of the trapezoidal concave-convex structure 2 have an arc shape with a radius of curvature of 35 μm. A sample of Example 10 was prepared in the same manner as in Example 1 except for the above.

(Comparative Example 1)
At the time of extrusion molding, a flat sample having no uneven shape on the front and back was prepared by using a mirror-surfaced roll having no unevenness on the side of the film 1 for the patch support. A sample of Comparative Example 1 was prepared in the same manner as in Example 1 except for the above.

(Comparative Example 2)
As the material of the film 1 for the patch support, polylactic acid (PLA) Ingeo 3052D (trade name) manufactured by NatureWorks was used, and the thickness of the film 1 for the patch support was 20 μm. A sample of Comparative Example 2 was prepared in the same manner as in Example 1 except for the above.

(Comparative Example 3)
In the trapezoidal concavo-convex structure 2, the maximum height difference of the trapezoidal concavo-convex structure 2 was 60 μm, the pitch was 255 μm, the upper side length was 205 μm, the lower side length was 224 μm, and the apex angle of the trapezoid was 99 °. At this time, the height of the uneven structure was not changed, and the height was made uniform. A sample of Comparative Example 3 was prepared in the same manner as in Example 1 except for the above.

(Comparative Example 4)
The thickness of the film 1 for the patch support was set to 6 μm. A sample of Comparative Example 4 was prepared in the same manner as in Example 1 except for the above.

(Comparative Example 5)
The thickness of the patch support film 1 was 150 μm, and the trapezoidal concave-convex structure 2 used in Example 8 was used. A sample of Comparative Example 5 was prepared in the same manner as in Example 1 except for the above.

(Comparative Example 6)
The ratio of the high structure of the trapezoidal uneven structure 2 was set to 80%. A sample of Comparative Example 6 was prepared in the same manner as in Example 1 except for the above.

(Drug barrier property evaluation method)
In order to evaluate the drug barrier performance of the patch support film 1 in each Example and Comparative Example, an adsorptivity test evaluation was carried out.

After cutting the sample into 100 mm squares, a patch (Rivas Touch Patch 18 mg, manufactured by Ono Pharmaceutical Co., Ltd.) was attached to the center of the sample. The drug was sealed with aluminum foil so that it would not volatilize and diffuse, and stored in an environment of 40 ° C. and 75% for 6 months. Then, the patch was peeled off from the film, the drug adsorbed on the film was extracted with methanol at 55 ° C. for 3 hours or more, and the amount of the drug adsorbed was measured by an ultra-high performance liquid chromatography 1260 HPLC system manufactured by Agilent Technologies.

The amount of drug adsorbed was "○" if it was less than 10% of the drug amount of the original patch, and "x" if it was more than that.

(Yield elongation, 20% tensile load evaluation method)
A tensile test evaluation was carried out in order to evaluate the yield elongation and the 20% tensile load of the film 1 for the patch support in each Example and Comparative Example.

The tensile test evaluation was carried out using a Tensilon universal material tester (RTC-1250A) manufactured by A & D Co., Ltd. in accordance with the test conditions of JIS K7127: 1999 plastic-test method for tensile properties. When the sample width was 15 mm, the distance between chucks was 50 mm, and the tensile speed was 100 mm / min, a tensile force was applied from the zero state until the film broke, and the elongation rate to the yield point was defined as the yield elongation. Further, the tensile load when the film 1 for the patch support was stretched by 20% was determined.

The yield elongation of the film 1 for the patch support was 20% or more as “◯” and less than 20% as “x”.

The 20% tensile load of the patch support film 1 was “◯” for 4N / 15mm or less, “Δ” for 6N / 15mm or less, and “x” for more than that. When the 20% tensile load is 6 N / 15 mm or less, it can be practically used as the patch support in the present invention.

(Slipperiness evaluation method)
A friction test evaluation was carried out in order to evaluate the slipperiness of the film 1 for the patch support in each Example and Comparative Example.

The friction test evaluation was carried out using a friction tester (TR-2) manufactured by Toyo Seiki Seisakusho Co., Ltd. in accordance with the test conditions of the JIS K7125 plastic-film and sheet-friction coefficient test method. The objects to be covered were PET film (Toyobo Co., Ltd. E5100) and cotton cloth (Square cloth LUC6010-550), and the coefficient of static friction with the patch support film 1 was measured.

The coefficient of static friction of the patch support film 1 was "○" when it was 0.6 or less for both the PET film and the cotton fabric, and "x" when it exceeded even one of them.

Table 1 shows a list of conditions and evaluation results in each example. Table 2 shows a list of conditions and evaluation results in each comparative example. In the comprehensive judgment in Tables 1 and 2, the case where there is no "x" in the above evaluation result is regarded as "○", and the case where there is even one "x" in the evaluation result is regarded as "x".

(Evaluation results)
As can be seen from Table 1, in Examples 1 to 10, the drug barrier property, the yield point elongation, and the slipperiness are all good, and the 20% tensile load is also a practical level in the present invention. 1 was obtained.

On the other hand, in Comparative Example 1 in Table 2, since the patch 1 for the patch support is a flat film, the yield point elongation is low at the time of use, and the 20% tensile load does not significantly extend. In addition, the slipperiness was also a poor result.

In Comparative Example 2, since PLA was used as the material of the film 1 for the patch support, the drug barrier property was poor, and the result did not satisfy the requirements as the patch.

In Comparative Example 3, since the heights of the uneven structures of the patch support film 1 were all uniform, the slipperiness with the object was not good.

In Comparative Example 4, since the thickness of the patch support film 1 was too thin, it broke immediately, resulting in the result that the requirements as a patch were not satisfied.

In Comparative Example 5, since the thickness of the film 1 for the patch support is too thick, the shapes of the front and back surfaces of the film are not firmly formed, the yield elongation is low, and the 20% tensile strength of the film is too high, resulting in elongation. The result was lack of sex.

In Comparative Example 6, the ratio of the maximum height structure of the uneven structure of the patch support film 1 was too large, resulting in insufficient slipperiness.

The present invention can be used as a support for a patch. In particular, it is suitable as a support for a systemic patch that requires a long-lasting effect.

1 Film for patch support 2 Concavo-convex structure 2a Convex 2aa Top 2ab Wall 2b Recess 3 Adhesive layer 4 Peeling liner 5 Patch 6 Functional layer 10 Region 10c Edge (boundary)
20 Laminated body H Height difference t1 Convex thickness t2 Concave thickness

Claims (10)

A film for a patch support made of a drug barrier material having a thickness of 10 μm or more and 75 μm or less so that the pressure-sensitive adhesive layer can be arranged on one side.
The film for the patch support has a concavo-convex structure in which the entire layer is formed in a undulating shape in the thickness direction, so that the concave and convex portions are repeated along the surface.
The concave portion and the convex portion extend linearly, respectively.
The uneven structure includes two or more types of convex portions having different heights.
A film for a patch support, wherein the height difference between the concave portion and the convex portion is 20 μm or more and 150 μm or less, and the structure having the maximum height among the convex portions is 10% or more and 70% or less. The film for a patch support according to claim 1, wherein the height difference of the uneven structure is larger than the thickness of the film for the patch support. The drug barrier material is characterized by comprising a resin selected from any one of polyethylene terephthalate, cycloolefin copolymer, cycloolefin polymer, polyacrylonitrile, ethylene-vinyl alcohol copolymer, and modified polymer thereof. The film for a patch support according to claim 1 or 2. The present invention according to any one of claims 1 to 3, wherein the height difference between the convex portion having the maximum height and the convex portion having another height is 3 μm or more and 10 μm or less. The film for the patch support described. Claims 1 to 4, wherein the shape of the convex portion along the arrangement direction of the convex portion and the concave portion is a trapezoidal shape having a top and continuous wall portions on both sides of the top. The film for a patch support according to any one of the following items. The invention according to any one of claims 1 to 5, wherein the corners of the plurality of convex portions are curved, and the curves are arcuate with a radius of 10 μm or more and 100 μm or less. Film for patch support. The feature is that the ratio of the 20% tensile load in the alignment direction of the concave portion and the convex portion to the 20% tensile load in the direction orthogonal to the alignment direction of the concave portion and the convex portion is 1/20 or more and 1/3 or less. The film for a patch support according to any one of claims 1 to 6. The film for a patch support has a plurality of regions, and the concave-convex structure is formed by an individual concave-convex pattern for each region, according to any one of claims 1 to 7. The film for the patch support described in. A laminate in which a functional layer is laminated on one side of the film for a patch support according to any one of claims 1 to 8. A pressure-sensitive adhesive layer containing a drug and a release liner are formed on one surface of the film for a patch support according to any one of claims 1 to 8 or the laminate according to claim 9. A patch formed in this order.

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