JP2020069270A - Method for manufacturing film for patch support, laminate, patch and laminate - Google Patents

Abstract

To provide a film for patch support having a shape-forming stability which can suppress extension and winding wrinkles during production, the support having an excellent medical agent barrier property and extensibility during use.SOLUTION: A film for patch support includes a support layer 2 on which a patch layer can be provided on one surface side thereof. The support layer 2 has a thickness of 5 μm or more to 150 μm or less, and the whole layer is formed in a waved shape in a thickness direction such that a waved structure 4 in which a recessed part and a projected part are repeated along the surface. In the waved structure 4, a vertical difference H between the recessed part and the projected part is larger than a thickness of the support layer 2, and a protective layer 3 is laminated in a peelable manner on the other surface which is opposite to the one surface of the support layer 2. A peeling strength between the support layer 2 and the protective layer 3 is 0.5 N/15 mm or less in a 180° peeling test.SELECTED DRAWING: Figure 1

Description

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

  Generally, a plastic film has properties such as being lightweight, chemically stable, easy to process, flexible and strong, and capable of mass production. Therefore, the plastic film is used for various purposes. Examples of applications of the plastic film include packaging materials for packaging foods and medicines, drip packs, shopping bags, posters, tapes, optical films used for LCD TVs, protective films, windows to be attached to windows, etc. A wide variety of products such as films, greenhouses, and building materials. For such applications, appropriate plastic materials are selected according to the applications. Further, a plurality of types of plastic films are stacked to form a laminated body. There is also a method in which a plurality of plastic materials are mixed in one layer so as to make up for the drawbacks of a single material. In many cases, an appropriate film material is selected due to its heat resistance, mechanical strength, transparency, etc.

  Generally, the mechanical properties and barrier properties of a plastic film are determined by the material and layer structure. For example, a plastic film tends to have low extensibility in a material that emphasizes strength, and a film material that has high strength and can ensure sufficient extensibility is desired. In addition, when barrier properties are required, it is necessary to limit the use of materials with good barrier properties or to laminate the barrier layers in a separate process, which causes labor and cost during manufacturing. May come.

  By the way, a patch represented by a ship to be applied to the skin is one in which a drug is put in an adhesive constituting the surface to be applied to the skin and the drug is absorbed from the skin into the body. The support constituting the outer surface of the patch is composed of a film or a nonwoven fabric laminate. The function required for the support of this patch is, for example, that it has a barrier property (drug barrier property) against a drug and that it has extensibility. The drug barrier property is a property that the support does not absorb the drug or hardly absorbs the drug so that the drug is efficiently absorbed from the skin. Elongation is an important factor such as suppressing the feeling of stiffness after applying the patch to the skin and preventing the applied patch from coming off during operation.

However, at present, it is difficult to achieve both the drug barrier property and the extensibility. In particular, the material of the plastic film having a drug barrier property is limited to some materials such as biaxially oriented PET (PolyEthylene Terephthalate), ethylene-vinyl alcohol copolymer, and cycloolefin copolymer, These materials have the drawback of low elongation due to their high strength.
For example, in Patent Document 1, materials such as PET and ethylene-vinyl alcohol copolymer are used as a support for the adhesive patch, but these materials have low extensibility, and a stiff feeling when used as an adhesive patch or a severe feeling. It has a drawback that it is easily peeled off during operation. As described above, conventionally, a film for patch support has been required to have both drug barrier properties and extensibility.

  In addition, a film made of a stretchable material (a material having a large ductility) is difficult to handle, and if tension is applied during the manufacturing process or during use, the film may stretch and a desired film required as a product may not be obtained. In addition, as in the case of a normal film, it is also necessary to prevent scratches and stains from adhering to the patch support film.

Japanese Patent No. 6176846

  The present invention has been made paying attention to the above points, and has a molding stability capable of suppressing elongation at the time of production, winding wrinkles, etc., and at the same time, a support having good drug barrier properties and extensibility. An object is to provide a film for a patch support as a body, a laminate using the film, and a patch.

  In order to solve the problem, a first aspect of the present invention is a patch support film having a support layer capable of disposing an adhesive layer on one surface side, wherein the support layer has a thickness of 5 μm. It has a concavo-convex structure in which the concave portion and the convex portion are repeated along the surface by configuring the entire layer to have a shape undulating in the thickness direction, and the concavo-convex structure includes the concave portion and the convex portion. The difference in height is greater than the thickness of the support layer, and a protective layer is releasably laminated on the one surface of the support layer or the other surface opposite to the one surface, and the support is formed. The gist is that the peel strength between the layer and the protective layer is 0.5 N / 15 mm or less in the 180 ° peel test.

According to the film for patch support of the aspect of the present invention, it has molding stability capable of suppressing elongation during production, and has a simple structure and good elongation during use.
Further, according to the aspect of the present invention, by providing the peelable protective layer, it is also possible to prevent the support layer from being scratched or soiled.

It is a cross-sectional schematic diagram which shows an example in the film for patches support of this embodiment. It is a cross-sectional schematic diagram which shows the example of the contact | adherence state between a support layer and a protective layer in the film for patches support of this embodiment. It is a cross-sectional schematic diagram showing the state which has peeled the support layer and the protective layer in the film for patches support of this embodiment. It is a cross-sectional schematic diagram explaining the film thickness, the height difference of uneven | corrugated structure, and the space | interval of uneven | corrugated structure in the film for patches support of this embodiment. It is a cross-sectional schematic diagram explaining the film thickness, the height difference of uneven | corrugated structure, and the space | interval of uneven | corrugated structure in the film for patch support of another embodiment which concerns on this invention. It is a cross-sectional schematic diagram which shows an example which changed the cross-sectional shape in the film for patches support of this embodiment. It is a cross-sectional schematic diagram which shows an example which changed the cross-sectional shape in the film for patches support of this embodiment. It is a cross-sectional schematic diagram which shows an example which changed the cross-sectional shape in the film for patches support of this embodiment. It is a cross-sectional schematic diagram which shows an example which changed the cross-sectional shape in the film for patches support of this embodiment. It is a cross-sectional schematic diagram which shows an example which changed the cross-sectional shape in the film for patches support of this embodiment. It is a cross-sectional schematic diagram which shows an example which changed the cross-sectional shape in the film for patches support of this embodiment. It is a cross-sectional schematic diagram which shows an example which changed the cross-sectional shape in the film for patches support of this embodiment. It is a bird's-eye view schematic diagram which showed the extension direction example of the concavo-convex structure in one division in the film for patches support of this embodiment. It is a bird's-eye view schematic diagram which showed another example of the extending direction of the concavo-convex structure in one division in the film for patches support of this embodiment. It is a bird's-eye view schematic diagram which showed another example of the extending direction of the concavo-convex structure in one division in the film for patches support of this embodiment. It is a bird's-eye view schematic diagram which showed another example of the extending direction of the concavo-convex structure in one division in the film for patches support of this embodiment. It is a bird's-eye view schematic diagram which showed another example of the extending direction of the concavo-convex structure in one division in the film for patches support of this embodiment. It is a graph which shows the extension behavior of the example and conventional support film concerning the present invention. It is a graph which showed the relation between the whole film elongation and the maximum value of local distortion, when changing the section shape of the film for patches support. It is sectional drawing which changes and shows the cross-sectional shape of the film for patches support. It is a cross-sectional schematic diagram which shows the example of the laminated body which laminated | stacked another thermoplastic resin of this embodiment. It is a cross-sectional schematic diagram which shows an example of the patch using the conventional film for patches support. It is a cross-sectional schematic diagram which shows the example of the patch using the laminated body of this embodiment. It is a bird's-eye view schematic diagram which showed the extension direction example of the uneven | corrugated structure at the time of combining several divisions in the film for adhesive patch supports of this embodiment. It is a bird's-eye view schematic diagram which showed another extension direction example of the uneven | corrugated structure at the time of combining several divisions in the film for adhesive patch supports of this embodiment.

Embodiments of the present invention will be described below with reference to the drawings.
It should be noted that each drawing is a schematic view, and the size and shape of each portion are exaggerated as appropriate for easy understanding. Further, for simplification of description, the same reference numerals are given to corresponding parts in each drawing.

(Structure of film for patch support)
As shown in FIG. 1, the patch support film of the present embodiment has a surface 2b side (the side opposite to the one surface 2a side of the support layer 2 constituting the main body of the patch support film 1). 1 has a peelable protective layer 3 on the lower surface side.
The support layer 2 is a layer on which the adhesive layer 6 containing a drug can be arranged on one surface 2a side (upper surface side in FIG. 1). The support layer 2 is made of a material having a drug barrier property against the drug contained in the adhesive layer 6. The material of the support layer 2 may be appropriately selected from publicly known plastic materials having a drug barrier property against a drug supposed to be used in a patch.

Here, in the following description of the embodiment, as shown in FIG. 1, the adhesive layer 6 containing a drug can be arranged mainly on one surface 2a side (upper surface side in FIG. 1) of the support layer 2. The description will be given by taking as an example the case where it is a different surface.
However, the present invention is not limited to the case where the surface opposite to the side on which the protective layer 3 is laminated, as shown in FIG. 1, is the surface on which the adhesive layer 6 can be arranged. The present invention also includes the case where the peeling surface side (lower surface side in FIG. 1) of the support layer 2 after peeling the protective layer 3 in FIG. 1 is the surface on which the adhesive layer 6 can be arranged.

  Examples of the material of the support layer 2 include polyethylene terephthalate, cycloolefin copolymer, cycloolefin polymer, polyacrylonitrile, ethylene-vinyl alcohol copolymer, and modified polymers thereof. When the patch is attached to the body, the medicinal component contained in the adhesive layer 6 is permeated into the skin, and the systemic action is performed through blood. It is important that the patch support film 1 used for such a patch is a barrier to the medicinal component and does not or does not easily adsorb. The above-mentioned material has a good barrier property (non-adhesiveness) to the medicinal component, and functions as a support without reducing the medicinal component of the patch. When the support layer 2 is formed of such a material, it has a drug barrier property against drugs such as rivastigmine and tulobuterol.

As shown in FIG. 1, the support layer 2 of the present embodiment is configured such that the entire layer has a undulating shape in the thickness direction (a meandering shape when viewed from the side), so that a concave portion 2A is formed along the surface. It has a concavo-convex structure 4 in which the convex portions 2B are repeated. The concavo-convex structure 4 is formed such that the height difference H between the concave portion 2A and the convex portion 2B is larger than the thickness of the support layer 2. The concavo-convex structure 4 can be provided, for example, by processing the entire layer into a meandering shape along the surface direction.
Here, the support layer 2 may be composed of a plurality of layers. When the support layer 2 is composed of a plurality of layers, each layer may be composed of the same material or may be composed of different materials.

The protective layer 3 is laminated on the other surface of the support layer 2, which is the surface (lower surface in FIG. 1) opposite to the surface on which the pressure-sensitive adhesive layer 6 is arranged.
The protective layer 3 may be made of any material, and may be designed in consideration of the peel strength between the support layer 2 and the protective layer 3 and the dimensional stability in the manufacturing process. As the material for the protective layer 3, it is more preferable to use an inexpensive material such as low density polyethylene, linear low density polyethylene, medium density polyethylene, high density polyethylene, or polypropylene.
In the protective layer 3 of the present embodiment, the back surface 3a (the lower surface in FIG. 1), which is the surface facing the side opposite to the support layer 2, is flat. Flatness refers to having flatness having printability. The flatness of the protective layer 3 is, for example, preferably such that the arithmetic average roughness (Ra) at 200 times observation with a laser microscope is 0.3 μm or less. Since the back surface is flat, wrinkles are less likely to occur during winding.

Further, in the present embodiment, the surface 3 b of the protective layer 3 on the support layer 2 side has a shape along the surface shape of the uneven structure 4 on the protective layer 3 side. That is, the interface of the support layer 2 with air (the upper surface in FIG. 1) and the interface with the protective layer 3 are provided with an uneven shape, and the positions of the concave portions 2A and the convex portions 2B on the two surfaces are the same. There is.
Although FIG. 1 illustrates the case where the upper surface 3b of the protective layer 3 is formed so as to be in close contact with the lower surface 2b of the support layer 2 having the uneven structure 4, between the support layer 2 and the protective layer 3, Voids may be formed. For example, the protective layer 3 may be formed into a flat plate shape, and the upper surface 3b of the protective layer 3 may be in close contact with only the lower surface of the convex portion 2B of the concave-convex structure 4 of the support layer 2.

That is, in the patch support film 1 of the present embodiment, as shown in FIG. 1, the protective layer 3 may penetrate deep into the convex portions of the support layer 2, and FIG. 2 (a) (b) ( A void 11 may be partially present between the convex portion of the support layer 2 and the protective layer 3 as in c). It is preferable that the protective layer 3 is deeply embedded in the convex portion of the support layer 2, and such a configuration is effective for suppressing elongation when tension is applied during the manufacturing process. is there.
The peel strength between the support layer 2 and the protective layer 3 in a 180 ° peel test is 0.5 N / 15 mm or less. The lower limit of the peel strength between the support layer 2 and the protective layer 3 in the 180 ° peel test is 0.01 N / 15 mm.

  In the film 1 for patch support of the present embodiment, the protective layer 3 is peeled off from the support layer 2 as shown in FIG. Only one support layer 2 is taken out, and then another layer such as a functional layer is laminated on the support layer 2. In such a demand, it is desirable that the interfacial peel strength between the support layer 2 and the protective layer 3 in the 180 ° peel test is 0.5 N / 15 mm or less. With such peel strength, the support layer 2 and the protective layer 3 can be peeled relatively easily. When it is desired to reduce the peeling strength, it is preferable that a void 11 is partially present between the convex portion of the support layer 2 and the protective layer 3 as shown in FIG. With such a state, the contact area between the support layer 2 and the protective layer 3 can be reduced, and the peel strength can be reduced.

On the other hand, when the peeling strength is less than 0.01 N / 15 mm, the adhesion between the support layer 2 and the protective layer 3 is too poor, so that interlayer peeling may occur in the manufacturing process depending on the manufacturing conditions, and wrinkles and supporting may occur. A problem may occur in the dimensional stability of the layer 2.
In addition, in the film 1 for patch support of the present embodiment, it is preferable that the support layer 2 and the protective layer 3 are directly and releasably adhered to each other without an adhesive or a pressure-sensitive adhesive. Since no adhesive or pressure-sensitive adhesive is present, after the protective layer 3 is peeled from the support layer 2, no residue (adhesive residue) of other components is left on the peeled surface of the support layer 2. As a result, even after peeling, the support layer 2 can be used without impairing its function.

(About uneven structure 4)
Regarding the concavo-convex structure 4, the interval D1 between the adjacent convex portions 2B and the interval D2 between the adjacent concave portions 2A (see FIGS. 2 and 3) may be arranged at regular intervals such as equal intervals, It can be different. The intervals D1 and D2 can be appropriately set according to the desired stretched state required for the patch.
In addition, as shown in FIGS. 1 to 12, the shape of the concavo-convex structure 4 is a shape in which various straight lines and curved lines are combined in a cross-sectional view in the thickness direction, and the entire surface of the film for patch support of the present embodiment. The same pattern may be used, or different patterns may be combined. The shape patterns in FIGS. 1 to 12 are reference examples, and the shapes are not limited to these shapes.
In the concavo-convex structure 4, at least one of the top 2Ba of at least one protrusion 2B of the plurality of protrusions 2B and the bottom 2Aa of at least one recess 2A of the plurality of recesses 2A may have a flat cross section.

FIG. 1 and FIG. 9 exemplify a case where the top portion 2Ba of the convex portion 2B and the bottom portion 2Aa of the concave portion 2A are both flat in cross section.
6 and 10 exemplify a case where the top portion 2Ba of the convex portion 2B has a flat cross section and the bottom portion 2Aa of the concave portion 2A has a V-shaped cross section.
7 and 11 exemplify a case where the top portion 2Ba of the convex portion 2B has a sharp V-shaped cross section and the bottom portion 2Aa of the concave portion 2A has a flat cross section.
Further, in the concavo-convex structure 4, as shown in FIGS. 8 and 12, the top portion 2Ba of the convex portion 2B and the bottom portion 2Aa of the concave portion 2A each have a V-shaped cross-section in the layer thickness direction. The concavo-convex structure 4 may be formed in a saw-tooth shape in cross section.

9 to 12 are examples in which the corners of a ridge line portion (excluding a portion having a V-shaped cross section) which is a boundary where the direction of the surface is changed in the cross section are rounded.
Further, in the concave-convex structure 4, the concave portions 2A and the convex portions 2B are linear as shown in FIGS. 13 and 14 when viewed from the surface side (the upper surface 2a side in FIG. 1) on which the pressure-sensitive adhesive layer 6 is formed. You may comprise by the uneven | corrugated pattern which extends. The concave portions 2A and the convex portions 2B may have the same width or different widths.
FIG. 13 shows an example in which the region 10 forming the concavo-convex structure 4 has a rectangular shape with the sides 10a and 10b as boundaries, and the extending directions of the concave portions 2A and the convex portions 2B are set so as to be parallel to the short sides 10b. is there. That is, this is an example in which the concavo-convex structure 4 is formed such that the concave portions 2A and the convex portions 2B are arranged in the direction of the long side 10a of the region 10 along the surface direction.

FIG. 14 is an example in which the region 10 forming the concavo-convex structure 4 has a rectangular shape, and the extending directions of the concave portions 2A and the convex portions 2B are set to be inclined from both the short sides 10b and the long sides 10a.
Further, in the concavo-convex structure 4, the concave portions 2A and the convex portions 2B are, as viewed from the surface side (the upper surface side in FIG. 1) where the adhesive layer 6 is formed, as shown in FIGS. It may be configured by an uneven pattern in which at least a part of the extending direction of 2B is formed by a curved line. The concave portions 2A and the convex portions 2B may have the same width or different widths.
FIG. 15 is an example in which the region 10 forming the concavo-convex structure 4 has a rectangular shape and the extending directions of the concave portions 2A and the convex portions 2B are set to be concentric.

FIG. 16 is an example in which the region 10 forming the concavo-convex structure 4 has a rectangular shape, and the extending directions of the concave portions 2A and the convex portions 2B are set to be concentric and elliptical (similar ellipse).
In FIG. 17, the region 10 forming the concavo-convex structure 4 has a rectangular shape, and the extending directions of the concave portions 2A and the convex portions 2B are set to be parallel to the short sides, and meandering meanders along the extending direction. It is an example of setting to a state.
Note that the above concavo-convex pattern is an example, and the present invention is not limited to these shapes.
For example, in one region 10, the basic extending directions of the concave portions 2A and the convex portions 2B are linear shapes, and a portion extending along a curved line is provided in part, or the pattern of FIG. 13 and the pattern of FIG. You may set it to the pattern shape which mixed.

Moreover, although the rectangular shape is also illustrated as the area 10 in which the uneven structure 4 is formed, the shape of the area 10 is not limited to the rectangular shape. The contour of the region 10 may be circular or the like.
Further, it is not necessary to form the entire surface of the support layer 2 as the region 10 where the uneven structure 4 is provided. For example, there may be a portion where the concavo-convex structure 4 is not formed, such as the edge portions on both the left and right sides in FIG. In the case of FIG. 13, since the extensibility is increased in the left-right direction, there is no problem even if there is a portion where the uneven structure 4 is partially present in the support layer 2 at a position where the extension is not restrained. ..

(Thickness of film 1 for patch support and height of irregularities, etc.)
The total thickness T of the patch support film 1 at the position of the convex portion 2B is preferably, for example, 10 μm or more and 450 μm or less, and more preferably 10 μm or more and 300 μm or less.
The thickness of the support layer 2 of the patch support film 1 does not necessarily have to be uniform. In the film after the processing of the uneven shape, the thickness of the support layer 2 in the vicinity of the ridgeline (in the vicinity of the connecting portion of the two portions having different directions) may be different from the thickness of the support layer 2 in other portions.
The thickness of the support layer 2 is preferably 5 μm or more and 150 μm, more preferably 10 μm or more and 100 μm.

  The thickness of the protective layer 3 (thickness t3 in the recess 2A of the concavo-convex structure 4; see FIGS. 4 and 5) is arbitrary, but the thickness t2 of the portion of the support layer 2 that is in close contact with the recess 2A is 5 μm to 150 μm. Is preferable, and more preferably 10 μm to 100 μm. If the thickness of the protective layer 3 is too thin, the effect of suppressing elongation and winding wrinkles in the manufacturing process may be insufficient, and further, when the support layer 2 and the protective layer 3 are peeled off, There is a case where peeling cannot be performed well due to lack of stiffness. Further, if the thickness of the protective layer 3 is too thick, there is a problem that the manufacturing cost becomes high.

The height difference H between the concave portion 2A and the convex portion 2B of the uneven structure 4 is preferably in the range of 10 μm or more and 300 μm or less. When the height difference H between the concave portion 2A and the convex portion 2B is less than 10 μm, it is difficult to obtain the effect of adjusting the strain, and when it exceeds 300 μm, it may be difficult to form the uneven structure 4 in manufacturing. There is. It is more preferable that the height difference H is in the range of 10 μm or more and 200 μm or less. It is premised that the height difference H is thicker than the thickness of the protective layer 3.
The concavo-convex structure 4 is preferably a periodic structure in which concave portions 2A and convex portions 2B are regularly arranged. By not using the aperiodic structure, it is possible to easily obtain the intended stretchability and, at the same time, to simplify the design and manufacture of the uneven structure 4. However, it is optional to change the width of the aperiodic uneven structure 4 or the uneven structure 4 partially.

(Action and others)
The support layer 2, which is the main body of the patch support film, is provided with required extensibility due to the unique structure having the uneven structure 4. That is, since the support layer 2 alone has extensibility, the support layer 2 stretches more than necessary when a tension is applied to the support layer 2 in the manufacturing process, and it is used for a patch support during an operation such as winding. Problems such as wrinkling of the film and instability of the film for the patch support may occur.
On the other hand, in the film for patch support of the present embodiment, the protective layer 3 is laminated on the support layer 2. Therefore, the protective layer 3 plays the role of a so-called support during the manufacturing process, thereby suppressing the elongation of the support layer 2, contributing to the suppression of winding wrinkles and the dimensional stability.

In addition, the protective layer 3 protects the lower surface of the support layer 2 and also functions to prevent scratches and stains.
Here, when a film for patch support (also referred to as a comparative film) is composed of a flat plate-shaped support layer 2 not provided with the uneven structure 4 as in the present embodiment, the elongation behavior of the comparative film is represented by the symbols in FIG. As shown in FIG. 21, elastic deformation occurs only at a short distance after the film starts to stretch, and the yield point (hereinafter, the starting point where necking starts is called the yield point) is reached. 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 support layer 2 of the present embodiment is pulled in, for example, the left-right direction in FIG. 1, that is, the arrangement direction of the periodic concavo-convex structure 4, the shape is first deformed by elastic deformation, and then part of the shape is deformed. Plastic deformation occurs. If the tension is further continued, the height difference H of the concave-convex structure 4 becomes small due to the tensile stress, and the shape cannot be deformed because the height difference H approaches the flat. That is, the yield point is mainly passed through a stage in which the uneven structure collapses and expands (a region where it expands without applying too much force) and a stage in which the collapsed uneven structure is further expanded and becomes almost flat (a region where force expands). And finally necking occurs and breaks.

The support layer 2 of the present embodiment is subjected to such multi-step shape deformation, and as shown by reference numeral 21 in FIG. 18, until reaching a yield point as compared with the conventional patch support film. The amount of elongation increases and the stress required for elongation decreases. Therefore, the support layer 2 of the present embodiment contributes to the property of easily extending without necking.
Thus, even if the support layer 2 is made of a material that is generally considered to have low extensibility, it is possible to impart high extensibility to the support layer 2 by modifying the shape. .. That is, the film for a patch support (support layer 2) after peeling off the protective layer 3 can have both strength and stretchability.

At this time, by appropriately controlling the shape of the cross section of the support layer 2, it is possible to obtain an arbitrary extensibility. For example, when it is desired to greatly extend the film without breaking it, the height difference H of the ridges and valleys of the concavo-convex structure 4 is increased and the ridge top or the ridge valley is not rounded so much. Good.
The film for patch support after peeling off the protective layer 3 according to the present embodiment shows that the entire film for patch support is stretchable by the change in the shape of the support layer 2 in the initial stage of stretching. Can be improved. That is, the film is stretched by plastically deforming and stretching the material itself from the initial stage of pulling like a film for a patch support having a normal flat surface. In the film for patch support after peeling off the protective layer 3 according to the present embodiment, when the film is pulled in the direction in which the concavo-convex structure 4 is arranged, local strain is generated in the concavo-convex structure 4 of the support layer 2 at the beginning of the pulling. (Elongation and contraction) occur, and the shape changes due to the expansion and contraction, so that a large extensibility can be obtained with a weak stress. Therefore, by appropriately setting the shape of the concavo-convex structure 4, the elongation of the entire film can be adjusted freely.

(Relationship between the total elongation of the patch support film (support layer 2) after peeling off the protective layer 3 and the maximum value of local strain)
FIG. 19 shows the total elongation and the maximum value of the local strain when the shape of the uneven structure 4 of the support layer 2, which is the film 1 for patch support after peeling off the protective layer 3, is changed. It shows the relationship. The vertical axis represents the maximum value of local strain, and the horizontal axis represents the elongation of the entire film. A flat support layer 2 having no uneven structure 4 shown by a dotted line is used as a comparative example.
Further, FIG. 20 shows a cross-sectional shape of the support layer 2 having a high extensibility used for the evaluation shown in FIG. The shape A shown in FIG. 20A has a relatively large height difference H between the concave portion 2A and the convex portion 2B of the concave-convex structure 4, and the shape B shown in FIG. 20B shows the concave portion 2A and the convex portion of the concave-convex structure 4. The height difference H of 2B is relatively small (however, it is made larger than the thickness of the support layer 2 to make the layer thickness equal). Further, it can be seen that in the support layer 2 having high extensibility according to the present embodiment, the relationship between the overall elongation and the maximum value of local strain greatly changes due to the difference in the uneven structure 4.

  For example, by making the height difference H between the concave portions 2A and the convex portions 2B of the concave-convex structure 4 relatively large like the shape A of FIG. 20 (a), as shown in FIG. The elongation can be made smaller than the local strain. In the patch support film 1 having the shape A, cracks such as breakage are unlikely to occur in the film itself. In addition, for example, even if a hard functional layer is laminated on the surface (for example, vapor deposition or a hard coat) and pulled, the hard functional layer is less likely to be cracked. This is because the hard functional layer is loaded by the above-mentioned local strain. That is, the support layer 2 adopting the shape A can be applied to, for example, a laminated body in which functional layers are laminated, so that the support layer 2 can have elongation while suppressing breakage of the hard functional layer.

In the shape B of FIG. 20B, the height difference H between the concave portions 2A and the convex portions 2B of the concave-convex structure 4 is relatively small, but in this case, as shown in FIG. The local distortion may be larger than the local distortion. However, the elongation of the whole film is large and exhibits high extensibility as compared with the film having no shape. These uneven structures 4 may be optimized in consideration of the desired extensibility and strength of the support layer 2 or the material and form of the functionalized layer to be laminated. For example, by optimizing using a general-purpose non-linear finite element analysis solution Marc (registered trademark), it becomes possible to obtain the intended practical patch support film 1.
Further, in order to enhance the extensibility, the height difference H of the concavo-convex structure 4 is determined by the thickness of the support layer 2 (the average value of the thickness t1 of the top 2Ba of the convex portion 2B and the thickness t2 of the bottom 2Aa of the concave portion 2A, It is better to be larger than (see FIGS. 4 and 5). By doing so, the cross section of the support layer 2 is unlikely to be flat, and a strain adjusting effect can be effectively obtained.

(Characteristics of Film 1 for patch support)
In addition, the patch support film (support layer 2) after peeling off the protective layer 3 having high extensibility according to the present embodiment has an effect of expanding when stress is applied, and therefore has high impact resistance and unevenness. It also has a property that the structure 4 has a high shock absorption property due to being crushed.
Further, when the uneven structure 4 is a one-dimensional structure as shown in FIG. 1, there is also a property that the bending rigidity is strong in the extending direction of the unevenness (the paper surface direction in FIG. 1). Flexural rigidity is determined by the integral of the product of the moment of inertia of area and Young's modulus. Since the film 1 for patch support having high extensibility of the present embodiment has a larger second moment of area than the film 1 for normal patch support having the same amount of resin, the bending rigidity is increased.
On the other hand, in the case where the concavo-convex structure 4 is a one-dimensional structure as shown in FIG. 1, even if the concavo-convex structure 4 is provided, the bending rigidity of the support layer 2 is not improved in the arrangement direction of the concavities and convexities, but by providing the protective layer 3, The bending rigidity is improved accordingly. That is, since rigidity and strength are improved in the manufacturing process before the protective layer is peeled off, it contributes to prevention of elongation and improvement of handling property in the manufacturing process.

(Method for producing film for patch support)
As a method for producing the patch support film 1 of the present embodiment, for example, a method by hot pressing or a method by extrusion molding can be used.
The hot pressing method can be performed by passing the formed multilayer film between heating rolls having a concavo-convex shape on one surface or through a heated flat press machine. At this time, by adjusting the press depth and the press pressure, the interface between the support layer 2 and the air and the interface between the support layer 2 and the protective layer 3 are provided with irregularities, and the interface between the protective layer 3 and the air is substantially flat. Faces are retained.
Alternatively, the film of the support layer 2 can be produced by passing the formed single-layer film through a press machine that is provided with concave and convex shapes on the front and back sides of the press and precisely aligned, and further heats and press-bonds the protective layer 3 in a later step. It is also possible.

  Further, in the method by extrusion molding, a plurality of extruders are used and a plurality of different resins are co-extruded by a feed block method or a multi-manifold method to obtain a film having a multilayer structure of two or more layers. it can. In the cooling step for forming a film, the concavo-convex structure 4 can be provided by cooling while applying a nip pressure using a cooling roll having irregularities corresponding to the concavo-convex structure 4 provided on the surface. At this time, when the height difference H of the peaks and valleys of the uneven structure 4 is large with respect to the film thickness t of the supporting layer 2 in contact with the cooling roll, the uneven structure 4 is similarly added to the interface between the supporting layer 2 and the protective layer 3. Therefore, it is possible to obtain a film in which the interface between the support layer 2 and the air and the interface between the protective layer 3 are provided with unevenness after cooling, and the interface between the protective layer 3 and the air is substantially flat.

In another method by extrusion molding, it can be produced using a tandem machine. That is, in the cooling process for extruding a single layer from one extruder in the first half and forming a film, a pair of cooling rolls provided with unevenness corresponding to the unevenness structure 4 on the surface is used for nip pressure. By adding and cooling, the single-layer support layer 2 having the concavo-convex structure 4 can be obtained. Next, in the latter half, a protective layer extruded from another extruder is laminated on the single-layered support layer 2 to obtain a patch-supporting film 1 with a protective layer. At this time, the voids between the support layer 2 and the protective layer 3 can be appropriately adjusted depending on the process conditions, whereby the interfacial peel strength can be adjusted.
In addition, any method of adding the concavo-convex structure 4 such as injection molding can be selected, and the method is not particularly limited.

(Laminate)
The film for a patch support having a high stretchability of the support layer 2 is a printed layer on the outermost surface of the support layer 2 in a later step or on the release surface of the support layer 2 after the protective layer 3 is removed from the support layer 2. It is also possible to form a laminate in which functional layers such as a vapor deposition layer, a hard coat layer, and an antireflection layer are laminated. Alternatively, a laminated body in which another thermoplastic resin 31 or the like is laminated on the peeling surface of the support layer 2 after peeling the protective layer 3 from the support layer 2 can be used (see FIG. 21). The other thermoplastic resin 31 constitutes, for example, the functional layer as described above. In FIG. 21, the case where the pressure-sensitive adhesive layer 6 is formed on another laminated thermoplastic resin 31 is illustrated. Instead of another thermoplastic resin 31, the pressure-sensitive adhesive layer 6 may be directly provided.

FIG. 22 is a schematic sectional view of a general patch. In this general example, a pressure-sensitive adhesive layer 6 containing a drug is provided on one surface of a patch support film 8 and a release liner 7 is provided on the surface of the pressure-sensitive adhesive layer 6. When sticking to the skin, the release liner is peeled off and the adhesive layer 6 is stuck to the skin for use. Then, the drug contained in the adhesive layer 6 is absorbed from the skin and acts.
Such a general film 8 for a patch support lacks in extensibility. Due to the feeling of stiffness after applying the patch to the skin and lack of extensibility, the end part of the patch during operation is There is a problem that such things may come off.

On the other hand, by using the patch support film 1 or the laminate of the present embodiment, it becomes possible to impart extensibility, and the above-mentioned rough feeling and peeling are eliminated.
As an example, FIG. 23 shows a sectional view of the patch 9 when the film 1 for patch support of the present embodiment is used. In the present embodiment, by using a material having a high drug barrier property, there is an effect that the drug is efficiently absorbed into the skin, and even if the material itself of the patch support film 1 is a material that is hard and difficult to stretch, Shows high extensibility.
Here, in the patch support film 1 of the present embodiment, the support layer 2 after the protective layer 3 is peeled off is used as a component of the patch. In consideration of this, FIGS. 21 and 23A exemplify a case where another thermoplastic resin 31 is arranged in the support layer 2.

(Another Embodiment of Film 1 for Patch Support)
As shown in FIGS. 24 and 25, the support layer 2 that constitutes the patch support film 1 has a plurality of regions 10, and each of the regions 10 has the concavo-convex structure 4 formed in an individual concavo-convex pattern. You can
24 and 25, a plurality of regions 10 (FIGS. 24 and 25 are examples of being divided into four regions 10) are set by dividing the film 1 for a patch adhesive support into a plurality of sections. This is the case, and the extending direction of the concavo-convex structure 4 is indicated by a solid line. Reference numeral 10c indicates the boundary between the adjacent boundary lines 10.

  In FIG. 24, the extending direction of the concavo-convex structure 4 is parallel to the edge of each section, and the arrangement is orthogonal to the extending direction of the concavo-convex structure 4 in the adjacent section. A film with good extensibility has a problem that the film is stretched during processing and stable film formation is difficult. However, by arranging as shown in Fig. 24, more stable film formation is possible during molding and In the product, it is possible to provide the patch 1 film for a patch support that extends in a desired direction by cutting or punching for each section. There may not be a clear boundary between the adjacent sections, and the number of sections and the section size existing on the series of films 1 for patch support can be arbitrarily set. Further, there may be a region 10 having no concavo-convex structure 4 between each region 10.

The position to be cut can also be set arbitrarily. For example, in the arrangement shown in FIG. 24, by half-cutting each region 10 in the vertical or horizontal direction, it is easy to extend in two directions such as the vertical direction and the horizontal direction. It is possible to obtain the patch support film 1 for the compartments. In this case, it is effective in a case where half of the film is fixed and only the other half is desired to have stretchability. That is, the plurality of regions 10 may be designed to form one final product. In this case, when the patch is applied to the skin, it is possible to first stick the non-stretchable half of the film to the skin and fix it, and stretch and stick the other half.
In the film 1 for patch support shown in FIG. 25, the concavo-convex structure 4 angled from one side of each region 10 to the other side intersecting with the region 10 extends straight. The other configurations are the same as those of the patch support film 1 shown in FIG. The angle of the concavo-convex structure 4 with respect to the boundary line 10c that divides the region 12 is arbitrary, and the angle may be different for each region 10.

(Effect of this embodiment)
(1) The film 1 for patch support of the present embodiment is a film for patch support having a support layer 2 capable of disposing an adhesive layer on one surface side, and the support layer 2 has a film thickness. Is 5 μm or more and 150 μm or less, and the entire layer is formed in a wavy shape in the thickness direction to have a concavo-convex structure 4 in which concaves and convexes are repeated along the surface. Is larger than the thickness of the support layer 2 and the protective layer 3 is releasably laminated on the other surface, which is the surface opposite to the one surface of the support layer 2, to protect the support layer 2 from the surface. The peel strength with the layer 3 is 0.5 N / 15 mm or less in the 180 ° peel test.
According to this configuration, a film 1 for the patch support after peeling off the protective layer, which has molding stability capable of suppressing elongation during production, winding wrinkles, and the like, and also has good drug barrier properties and extensibility. Can be provided.

For example, in the film 1 for patch support of the present embodiment, even if the support layer 2 is formed from a film having a drug barrier property, the unevenness structure 4 can be provided to improve the extensibility of the support layer 2. .. At this time, by providing a peelable protective layer 3 on the support layer 2, while ensuring the above-mentioned extensibility during use, it is applied at the time of the manufacturing process of the film 1 for patch support and at the time of handling in the post process. A required strength can be imparted to the agent support film 1. That is, it becomes possible to impart molding stability capable of suppressing elongation to the patch support film 1 in a manufacturing process such as winding.
In addition, the provision of the peelable protective layer 3 also has an effect of preventing the support layer 2 from being scratched or soiled.

(2) In the film 1 for patch support of the present embodiment, the surface 3b of the protective layer 3 on the support layer 2 side has a shape along the surface shape of the concave-convex structure 4 on the protective layer 3 side.
According to this configuration, the strength imparting effect of the protective layer 3 can be more reliably performed while suppressing the peel strength between the protective layer 3 and the support layer 2.
(3) In the patch support film 1 of the present embodiment, the back surface 3a, which is the surface of the protective layer 3 facing the side opposite to the support layer 2, is flat.
According to this structure, since the back surface has flatness, wrinkles are less likely to occur during winding, as compared with the case of unevenness on both sides.

(4) In the patch support film 1 of the present embodiment, the support layer 2 and the protective layer 3 can be directly peeled off without an adhesive and a pressure-sensitive adhesive interposed between the support layer 2 and the protective layer 3. Is glued to.
According to this configuration, the remaining residue (adhesive residue) of other components does not occur on the release surface of the support layer 2 after the protection layer 3 is removed. As a result, even after peeling, the support layer 2 can be used without impairing its function.
(5) In the film 1 for patch support of the present embodiment, the material of the support layer 2 is polyethylene terephthalate, cycloolefin copolymer, cycloolefin polymer, polyacrylonitrile, ethylene-vinyl alcohol copolymer, and modified weight thereof. And a resin selected from the group consisting of
According to this structure, the support layer 2 can be provided with a drug barrier property.

(6) In the patch support film 1 of the present embodiment, one or more voids are formed between the support layer 2 and the protective layer 3.
According to this configuration, by providing the void, it becomes easy to set the peel strength between the support layer 2 and the protective layer 3 to be small.
(7) In the film 1 for patch support of the present embodiment, the concavo-convex structure 4 has a top 2Ba of at least one protrusion 2B of the plurality of protrusions 2B and a bottom of at least one recess 2A of the plurality of recesses 2A. At least one of 2Aa has a flat cross section.
According to this structure, the film 1 for a patch support of the present embodiment is easy to obtain an elongation amount up to the yield point, and is suitable for a patch support for which a larger elongation is desired. Further, the presence of the flat surface increases the contact area when laminating the drug-containing pressure-sensitive adhesive layer or the functional layer, thereby improving the adhesion strength.

(8) In the patch support film 1 of the present embodiment, in the concavo-convex structure 4, the top portion 2Ba of the convex portion 2B and the bottom portion 2Aa of the concave portion 2A each have a V-shaped cross section in the layer thickness direction.
According to this configuration, since the straightness of tearing is improved at the position of the V-shaped cross section, there is an advantage that it can be easily cut at the position of the V-shaped cross section when used by cutting it into a desired size. ..
(9) In the patch support film 1 of the present embodiment, the concave portions and the convex portions each extend linearly in a plan view.
According to this structure, it is possible to surely increase the extensibility in the direction in which the concavities and convexities are arranged, and it is possible to set a high bending rigidity in the direction in which the concavities and convexities extend.

(10) In the patch support film 1 of the present embodiment, at least a part of the extending direction of the concave portions and the convex portions 2B is formed by a curved line in a plan view.
According to this structure, it is possible to surely increase the extensibility in the direction in which the concavities and convexities are arranged, and it is possible to set a high bending rigidity in the direction in which the concavities and convexities extend.
In addition, by providing a curve in the extending direction in at least a part, for example, by forming a curve assuming the direction in which the body bends, it is possible to more follow the change in the body at the position where the body is attached. Has the advantage of increasing.

(11) In the film 1 for patch support of the present embodiment, the height difference H of the unevenness is 10 μm or more and 300 μm or less.
With this configuration, the extensibility can be reliably improved.
(12) In the film 1 for patch support of the present embodiment, the irregularities are periodically arranged at equal intervals.
According to this configuration, it is easy to set the extensibility.
(13) In the patch support film 1 of the present embodiment, the intervals of the irregularities are aperiodic.
According to this configuration, for example, by narrowing the pitch of the portion where the body bends more and widening the pitch of the portion where the body bends less, it is possible to control the extension of the patch in accordance with the movement of the body. For example, there is an advantage that the followability is improved in a portion where the feeling of unevenness of the body, such as the joint and the vicinity of the scapula, greatly changes.

(14) In the film 1 for patch support of the present embodiment, the support layer 2 has a plurality of regions 10, and the concavo-convex structure 4 is formed in each region 10 by an individual concavo-convex pattern.
In this configuration, when used as a raw material of the final product, the elongation of each region 10 cancels each other to some extent, and excessive elongation is suppressed, and when the film is managed in a roll shape or the like, the patch The handling of the support film 1 becomes easy.
In addition, when used as the film 1 for a patch support of the final product, it is easy to set two or more directions in which the film easily stretches.

(15) It may be a laminate in which a functional layer is laminated on the surface of the film for patch support 1 of the present embodiment on the support layer 2 side.
According to this structure, it is possible to provide a laminate having good stretchability.
(16) The patch of the present embodiment has the pressure-sensitive adhesive layer 6 laminated on one surface side of the support layer 2 in the patch support film 1 or the laminate, and peeled off on the pressure-sensitive adhesive layer 6. The liner is formed.
According to this structure, it is possible to provide a patch having good drug barrier properties and good extensibility while maintaining the strength as a support with a simple structure while suppressing the labor and cost during manufacturing.
Although the embodiment of the present invention has been illustrated above, it goes without saying that the present invention is not limited to the above embodiment. Further, it is optional to use the above embodiments in combination.

Hereinafter, examples created by the present inventors will be described in detail, but the present invention is not limited to the following examples.
(Example 1)
As the material for the film 1 for patch support, a cyclic olefin copolymer (COC) TOPAS 8007 (trade name) manufactured by Polyplastics Co., Ltd. was used as the support layer 2. As the protective layer 3, polystyrene (PS) HF77 (trade name) manufactured by PS Japan Co., Ltd. was used. Then, the film 1 for patch support is extruded to form a two-layer structure by nipping the support layer 2 side with an uneven roll and the protective layer 3 side with a mirror surface roll having a substantially flat surface. To obtain the sample of Example 1.
The support layer 2 had a thickness of 12 μm, the protective layer 3 had a thickness of 30 μm, and the concavo-convex structure 4 had a shape in which trapezoidal cross-sectional shapes were periodically arranged. The height difference H of the trapezoidal uneven structure 4 was 31 μm, the pitch was 140 μm, the upper side length was 61 μm, and the lower side length was 68 μm.

(Example 2)
A sample of Example 2 was produced in the same manner as in Example 1 except that the wave-shaped cross-section was changed to have a height difference H of 25 μm and a pitch of 50 μm.
(Example 3)
As the support layer 2, an ethylene-vinyl alcohol copolymer (EVOH) Soanol D2908 (trade name) manufactured by Nippon Synthetic Chemical Industry Co., Ltd. was used. As the protective layer 3, a low density polyethylene (LDPE) Novatec LD LC701 (trade name) manufactured by Nippon Polyethylene Corporation was used. The support layer 2 had a thickness of 30 μm, the protective layer 3 had a thickness of 45 μm, and the concavo-convex structure 4 had a shape in which trapezoidal cross-sectional shapes were periodically arranged. The height difference H of the trapezoidal uneven structure 4 was 60 μm, the pitch was 255 μm, the upper side length was 205 μm, and the lower side length was 224 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 support layer 2 was 50 μm, the thickness of the protective layer 3 was 50 μm, and the uneven structure 4 was changed to a wavy cross-sectional shape with a height difference H of 100 μm and a pitch of 200 μm. 4 samples were prepared.
(Example 5)
The thickness of the support layer 2 was 125 μm, the thickness of the protective layer 3 was 50 μm, and the uneven structure 4 was changed to a wavy cross-sectional shape with a height difference H of 250 μm and a pitch of 500 μm. 5 samples were prepared.

(Example 6)
The support layer 2 has a thickness of 6 μm, the protective layer 3 has a thickness of 12 μm, and the concavo-convex structure 4 has a trapezoidal cross-sectional shape with a height difference H of 31 μm, a pitch of 140 μm, an upper side length of 61 μm, and a lower side length of 68 μm. A sample of Example 6 was prepared in the same manner as in Example 3 except for the above.
(Example 7)
Example 3 is the same as Example 3 except that the support layer 2 has a thickness of 6 μm, the protective layer 3 has a thickness of 12 μm, and the concavo-convex structure 4 has a wavy cross-sectional shape with a height of 25 μm and a pitch of 50 μm. A sample of Example 7 was prepared by the method described in 1.

(Comparative Example 1)
A sample having no irregularities on the front and back sides was prepared by using a roll having a mirror surface with no irregularities on the support layer 2 side at the time of extrusion molding. A sample of Comparative Example 1 was prepared in the same manner as in Example 1 except for the above.
(Comparative example 2)
The sample of Comparative Example 2 was prepared in the same manner as in Example 1 except that the linear low-density polyethylene (LLDPE) Evolution SP2040 (trade name) manufactured by Prime Polymer Co., Ltd. was used as the protective layer 3. Was produced.

(Comparative example 3)
A sample having no irregularities on the front and back sides was prepared by using a roll having a mirror surface with no irregularities on the support layer 2 side at the time of extrusion molding. A sample of Comparative Example 3 was prepared in the same manner as in Example 3 except for the above.
(Comparative example 4)
The support layer 2 has a thickness of 3 μm, the protective layer 3 has a thickness of 30 μm, and the uneven structure 4 has a trapezoidal sectional shape with a height difference H of 31 μm, a pitch of 140 μm, an upper side length of 61 μm, and a lower side length of 68 μm. A sample of Comparative Example 4 was prepared in the same manner as in Example 3 except that the sample was changed.

(Comparative example 5)
A sample was prepared by using the support layer 2 alone without using the resin of the protective layer 3 to perform single layer extrusion and nipping with a pair of rolls having irregularities. The thickness of the support layer 2 was 12 μm, and the uneven structure 4 was changed to Example 3 except that the height difference H was 31 μm, the pitch was 140 μm, the upper side length was 61 μm, and the lower side length was 68 μm. A sample of Comparative Example 5 was prepared by the same method.
(Comparative example 6)
The thickness of the support layer 2 was 30 μm, the uneven structure 4 was changed to Comparative Example 5 except that the height difference H was 60 μm, the pitch was 255 μm, the upper side length was 205 μm, and the lower side length was 224 μm. A sample of Comparative Example 6 was prepared by the same method.

(Comparative Example 7)
The support layer 2 has a thickness of 50 μm, the protective layer 3 has a thickness of 30 μm, and the concavo-convex structure 4 has a trapezoidal sectional shape with a height of 31 μm, a pitch of 140 μm, an upper side length of 61 μm, and a lower side length of 68 μm. A sample of Comparative Example 7 was prepared in the same manner as in Example 3 except that the sample was changed.
The resulting sample did not have a trapezoidal shape at the interface between the support layer 2 and the protective layer 3.
(Comparative Example 8)
As the support layer 2, polylactic acid (PLA) Ingeo 3052D (trade name) manufactured by Nature Works was used. As the protective layer 3, low density polyethylene (LDPE) Novatec LD LC600A (trade name) manufactured by Nippon Polyethylene Corporation was used. The support layer 2 had a thickness of 6 μm, the protective layer 3 had a thickness of 12 μm, and the concavo-convex structure 4 had a shape in which trapezoidal cross-sectional shapes were periodically arranged. The height difference H of the trapezoidal uneven structure 4 was 31 μm, the pitch was 140 μm, the upper side length was 61 μm, and the lower side length was 68 μm.
A sample of Comparative Example 8 was prepared in the same manner as in Example 1 except for the above.

(Peeling strength evaluation method between the support layer 2 and the protective layer 3)
In order to evaluate the peel strength of the film 1 for patch support in each Example and Comparative Example, a tensile test evaluation was carried out.
The peel strength evaluation is based on JISK7127: 1999, using the Tensilon universal material testing machine (RTC-1250A) manufactured by A & D Co., Ltd., and peeling only the end portions between the support layer 2 and the protective layer 3 in advance. The sample was set on the upper and lower chucks separately, and the support layer 2 and the protective layer 3 were peeled from each other by 180 ° from the zero state, and the average value of the section in which the peel strength was stable was obtained.
Regarding the measurement conditions, the sample width was 15 mm, the chuck distance was 50 mm, and the pulling speed was 100 mm / min. When the peeling strength between the support layer 2 and the protective layer 3 is less than 0.3 N / 15 mm, it is “◯”, when 0.3 N / 15 mm or more and 0.5 N / 15 mm or less is “Δ”, and when it exceeds 0.5 N / 15 mm, it is “ X ".

(Molding processability evaluation method)
The evaluation of the moldability of the film 1 for patch support in each Example and Comparative Example was carried out.
Molding processability evaluation is mainly in the stage from film formation to winding, whether the film can be processed without defects and whether the film sample after winding has no defect in appearance. Paying attention to, the visual judgment evaluation was carried out.
When there was no defect in the molding processability, it was designated as "○", and when there was a defect, it was designated as "x".

(Elongation evaluation method)
In each of the examples and comparative examples, a tensile test evaluation was carried out in order to evaluate the elongation performance of the patch support film 1 after peeling off the protective layer.
The elongation evaluation is based on JISK7127: 1999, using the Tensilon universal material testing machine (RTC-1250A) manufactured by A & D Co., Ltd. It was carried out by obtaining the amount of elongation from the state until the yield point was reached (hereinafter referred to as yield point elongation).
Regarding the measurement conditions, the sample width was 15 mm, the chuck distance was 50 mm, and the pulling speed was 100 mm / min.
20% or more of the yield point extensibility was evaluated as “◯”, and less than that was evaluated as “x”.

(Drug adsorption evaluation method)
In order to evaluate the drug adsorption performance of the patch support film 1 in each of the Examples and Comparative Examples, an adsorption test evaluation was performed.
After the sample was cut into 100 mm square, a patch (Revas Touch patch 18 mg, manufactured by Ono Pharmaceutical Co., Ltd.) was stuck to the center of the sample. It was sealed with aluminum foil so that the chemicals would not volatilize and diffuse, and stored in an environment of 40 ° C and 75% for 6 months. After that, 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 adsorbed amount of the drug was measured by an ultra high performance liquid chromatography 1260 HPLC system manufactured by Agilent Technologies. The amount of adsorbed drug was "O" if it was less than 10% of the amount of drug in the original patch, and "X" if it was more than that.

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 table, the first layer means the support layer 2 and the second layer means the protective layer 3.

(Evaluation results)
As can be seen from Table 1, in Examples 1 to 7, in the film having a two-layer structure, the concavo-convex structures 4 were provided in parallel with each other at the interface between the support layer 2 and the air, and the protective layer 3. Since the interface between the protective layer 3 and the air is substantially flat, and the thickness of the support layer 2 is 5 to 150 μm, there is no problem during molding and peeling can be performed with appropriate peel strength during use. It can be seen that the support layer 2 after peeling has good yield point elongation and good drug adsorption.

On the other hand, in Comparative Examples 1 and 3 in Table 2, since both the support layer 2 and the protective layer 3 were flat films, they had small yield point elongation at the time of use and did not extend.
In Comparative Example 7, since the thickness of the support layer 2 is larger than the height difference H of the uneven structure 4, the interface between the support layer 2 and the protective layer 3 is flat, and as a result, similar to a flat film. When used, the yield point elongation was small and the film did not stretch.
Further, in Comparative Example 2, since the COC resin is used as the support layer 2 and the LLDPE resin is used as the protection layer 3, the adhesion between the support layer 2 and the protection layer 3 is good, and the peel strength becomes too large, resulting in peeling failure. It was

In Comparative Example 4, since the thickness of the support layer 2 was 3 μm, which was too thin, the rigidity of the film was small, and as a result, the peel strength between the support layer 2 and the protective layer 3 was too large, resulting in defective peeling. It was
In Comparative Examples 5 and 6, the concavo-convex structure 4 is provided on both the front and back sides of the film using only the support layer 2, and the winding is not successful during the molding process, and wrinkles are formed, and the pressure of the winding causes As a result, a part of the structure was crushed and a uniform film could not be produced. Further, in Comparative Example 8, since PLA was used as the material of the support layer 2, the drug barrier property was poor, and the result was that the requirements as a patch were not satisfied.

1 Film for Patch Support 2 Support Layer 2A Recess 2Aa Bottom 2B Convex 2Ba Top 3 Protective Layer 4 Concavo-convex Structure 6 Adhesive Layer 7 Release Liner 10 Region H Height Difference

Claims (18)

A film for patch support, which has a support layer capable of disposing an adhesive layer on one surface side,
The support layer has a film thickness of 5 μm or more and 150 μm or less, and has an uneven structure in which concaves and convexes are repeated along the surface by forming the entire layer in a wavy shape in the thickness direction,
The uneven structure has a height difference between the concave portion and the convex portion larger than the thickness of the support layer,
On the other surface, which is the surface opposite to the one surface or the one surface of the support layer, a protective layer is releasably laminated,
A film for patch support, wherein the peel strength between the support layer and the protective layer is 0.5 N / 15 mm or less in a 180 ° peel test.   The film for a patch support according to claim 1, wherein the surface of the protective layer on the support layer side has a shape along the surface shape of the uneven structure on the protective layer side.   The film for patch preparation support according to claim 1 or 2, wherein a back surface of the protective layer, which is a surface facing the side opposite to the support layer, is flat.   An adhesive and a pressure-sensitive adhesive are not interposed between the support layer and the protective layer, and the support layer and the protective layer are directly and releasably adhered to each other. The film for patch support according to any one of 3 above.   The material of the support layer is characterized by comprising a resin selected from polyethylene terephthalate, cycloolefin copolymer, cycloolefin polymer, polyacrylonitrile, ethylene-vinyl alcohol copolymer, and modified polymers thereof. The film for patch support according to any one of claims 1 to 4.   One or two or more voids are formed between the support layer and the protective layer, The film for patch support according to any one of claims 1 to 5, wherein:   The uneven structure is characterized in that at least one of a top of at least one projection of the plurality of projections and a bottom of at least one recess of the plurality of recesses has a flat cross section. A film for a patch support according to any one of claims 1 to 6.   The patch support according to any one of claims 1 to 7, characterized in that, in the concavo-convex structure, a top part of the convex part and a bottom part of the concave part are V-shaped in cross section, respectively. Film.   The patch support according to any one of claims 1 to 8, characterized in that, on the one surface side, the concave portion and the convex portion respectively extend linearly in a plan view. Film for body.   At least one part of the extending direction of the said recessed part and the said convex part is comprised by the curved line in planar view on the said one surface side, The any one of the Claims 1-8 characterized by the above-mentioned. The described film for patch support.   The height difference is 10 μm or more and 300 μm or less, The film for patch support according to any one of claims 1 to 10.   Arrangement of the said recessed part and the said convex part has a periodicity, The film for patch support bodies described in any one of Claims 1-11 characterized by the above-mentioned.   Arrangement of the said recessed part and the said convex part is aperiodic, The film for adhesive patch supports as described in any one of Claims 1-11 characterized by the above-mentioned.   The said support layer has a some area | region, The said uneven structure is formed in the uneven pattern of each area | region, The sticking as described in any one of Claims 1-12 characterized by the above-mentioned. Film for agent support.   A laminate in which a functional layer is laminated on the surface of the film for patch support according to any one of claims 1 to 14 on the support layer side.   An adhesive layer and a release liner are formed in this order on one surface side of the support layer in the film for patch support according to any one of claims 1 to 14 or the laminated body according to claim 15. Applied patch.   In the film for patch support according to any one of claims 1 to 14, after peeling off the protective layer, a functional layer is laminated on the peeled surface of the support layer on which the protective layer is laminated. The manufacturing method of the laminated body characterized by performing.   The method for producing a laminate according to claim 17, wherein an adhesive layer and a release liner are formed in this order on one surface side of the support layer.

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