JP7326825B2 - Adhesive backing film, laminate, and adhesive - Google Patents

Description

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

A patch used in the medical field is a preparation intended to be applied to the skin so that the drug is percutaneously absorbed and taken into the body. A patch consists of a laminate of films and non-woven fabrics. As an example of its configuration, an adhesive layer containing a mixture of a drug and an adhesive is laminated on the surface of a backing, and a release liner is added to the surface of the adhesive layer. There is also a configuration in which the

Here, properties required for the support include drug barrier properties, elongation, and the like. The drug barrier property refers to the property that the support does not absorb or hardly absorbs the drug so as not to interfere with the percutaneous absorption of the drug. If the drug absorption rate of the backing is less than 10% after months of storage, it is defined as having drug barrier properties. On the other hand, elongation is an index expressed by the ratio of elongation until reaching the yield point when the backing is pulled, and the patch should not feel stiff or stiff when applied to the skin. , making it difficult for the patch to come off when the body is moved, and so on.

However, it is often difficult to achieve both drug barrier properties and extensibility. Resins having drug barrier properties include biaxially oriented polyethylene terephthalate (PET), ethylene-vinyl alcohol copolymer (EVOH), cyclic olefin copolymer (COC), and the like. These materials generally have the disadvantages of high strength, small elongation, and low elongation.

In order to solve such a problem, for example, in Patent Document 1, a polyester resin film such as a PET film is used as an adhesive patch support, and groove-like cuts are provided on the surface of the adhesive so that the patch adheres to the skin. We provide patches with improved performance.

Japanese Patent No. 5349837

However, in this case, fine grooves are to be processed on the surface of the formed film, and such processing requires extremely delicate mechanical or electrical adjustments.
An object of the present invention is to provide a film for an adhesive patch carrier, a laminate, and an adhesive patch having drug barrier properties and stretchability with a simple structure.

According to one aspect of the present invention, by having an uneven structure in which concave portions and convex portions are repeated along the surface, it has both drug barrier properties and elongation properties, and furthermore, by controlling the shape of the uneven structure, when peeling from the carrier layer, the Provided is a film for a patch support having a reduced peel strength.

That is, in order to solve the problem, one aspect of the present invention is a film for an adhesive patch support made of a resin having drug barrier properties, wherein the entire film is configured in a undulating shape in the thickness direction. , the adhesive backing film has a concave-convex structure in which concave portions and convex portions are repeated along the surface, the thickness of the film for an adhesive backing is 5 μm or more and 150 μm or less, and the height difference between the concave portions and the convex portions is the same as that of the adhesive backing. The top of the projection and the bottom of the recess each form a flat portion having a flat cross section, and the top of the projection and the bottom of the recess are adjacent to each other, and the top of the projection and the bottom of the recess are connected by an inclined surface, In a cross-section, an angle formed by the top of the protrusion and the slant surface continuous therewith is 110 degrees or more and 150 degrees or less, and the distance L between the bottoms of the adjacent recesses on the side from which the protrusion protrudes. The gist is that the ratio (H/L) of the height difference H to the height is 0.10 or more and 1.00 or less.

According to the aspect of the present invention, by having the concave-convex structure in which concave portions and convex portions are repeated along the surface, it has both drug barrier properties and extensibility, and by controlling the shape of the concave-convex structure, it can be peeled off from the carrier layer. It is possible to provide a film for an adhesive patch support that is easy to apply, a laminate using the film, and an adhesive patch.

1 is a cross-sectional view showing a film for a patch support according to an embodiment of the present invention; FIG. 1 is a perspective view showing a film for a patch support according to an embodiment of the present invention; FIG. FIG. 2 is a schematic diagram showing the relationship between the elongation of the entire film and the stress applied to the film when the film for patch support according to the embodiment of the present invention is pulled. 1 is a cross-sectional view showing a laminate using a film for a patch support according to an embodiment of the present invention; FIG. FIG. 3 is a cross-sectional view showing an example of a laminate of a comparative example using a film for a patch support. FIG. 3 is a cross-sectional view showing an example of a laminate of a comparative example using a film for patch support. FIG. 2 is a cross-sectional view showing an example of a film for a patch support consisting of multiple layers. 1 is a cross-sectional view showing a laminate using a film for a patch support according to an embodiment of the present invention; FIG. 1 is a cross-sectional view showing a laminate using a film for a patch support according to an embodiment of the present invention; FIG. 1 is a cross-sectional view showing an outline of a common patch. FIG. 1 is a cross-sectional view showing a patch using a film for a patch support according to an embodiment of the present invention; FIG. 1 is a cross-sectional view showing a patch using a film for a patch support according to an embodiment of the present invention; FIG. 1 is a front view showing an embodiment of a film for an adhesive patch support according to an embodiment of the present invention in the case of having a plurality of compartments. FIG.

Hereinafter, embodiments of the film for patch support according to the present invention will be described with reference to the drawings.
Each figure is a schematic diagram, and the size and shape of each part are exaggerated as appropriate for easy understanding. In addition, the front side and the back side used in this specification are described for the sake of convenience, and either one of the pair of sides of the film for patch support may be the front side and the back side.

The adhesive backing film 1 of the present embodiment shown in FIGS. 1 and 2 is a single-layer resin film made of a resin having drug barrier properties. The adhesive backing film 1 has an uneven structure in which concave portions 12A and convex portions 12B are periodically repeated along the surface of the film by forming the entire film in a undulating shape (serpentine shape) in the thickness direction. 12.
The concave portion 12A and the convex portion 12B extend in a direction intersecting with the direction in which the unevenness is arranged. FIG. 2 illustrates a case in which the concave portions 12A and the convex portions 12B extend linearly in the direction orthogonal to the direction in which the concave and convex portions are arranged. There is no limitation on the shape of the extending pattern (projection/recess pattern) of the recesses 12A and the projections 12B, such as extending concentrically.

The patch support film 1 has the concave-convex structure 12, so that it can exhibit high elongation in the direction in which the concaves and convexes are arranged. In addition, the bending rigidity in the direction in which the concave portions 12A and the convex portions 12B extend (the direction intersecting with the direction in which the concave portions 12A and the convex portions 12B are arranged) is improved. The area where the uneven structure 12 is provided may be the entire surface of the film 1 for patch support or a part of the film 1 for patch support in a plan view. Also, a plurality of areas where the uneven structure 12 is provided may be provided as described later.

Moreover, as shown in FIGS. 1 and 2, the top portion 12Ba of the convex portion 12B and the bottom portion 12Aa of the concave portion 12A each have a flat cross-sectional shape (flat shape). The adjacent top portion 12Ba and bottom portion 12Aa are connected by a wall portion 12C. In this embodiment, the wall portion 12C is inclined with respect to the film thickness direction. For this reason, the wall portion 12C is also called an inclined surface portion 12C. The slope portion 12C may be arranged so as to extend in the same direction as the film thickness direction. However, it is preferable that the slope portion 12C is a slope portion that is inclined in a direction in which the adjacent top portion 12Ba and bottom portion 12Aa are separated from each other. Since the wall portion 12C is inclined at an angle larger than 90 degrees with respect to the top portion 12Ba, when the film is pulled in the direction in which the unevenness is arranged, the boundary between the slope portion 12C and the top portion 12Ba, and between the slope portion 12C and the bottom portion 12Aa. The possibility that the stress concentrates on the part and breaks the film is suppressed, and the concave-convex structure 12 becomes easy to stretch.

In the example of FIG. 1, the concave-convex structure 12 has a top upper surface 2a, a slope upper surface 2b, and a bottom upper surface 2c from one edge side (the left end side in FIG. 1) to the other edge side (the right end side in FIG. 1) in the direction perpendicular to the paper surface. and the slope portion top surface 2b are formed repeatedly. It also has a top bottom surface 3a, a slope bottom surface 3b, and a bottom bottom surface 3c at three positions corresponding to the top top surface 2a, the slope top surface 2b, and the bottom top surface 2c, respectively.
Here, in FIG. 1, the distance from one end of the top upper surface 2a in the width direction (the left end in FIG. 1) to one end of the adjacent top upper surface 2a on the same side in the width direction is defined as the film for patch support. 1 is defined as the pitch P of the uneven structure 12 . The pitch P corresponds to the distance between adjacent tops 12Ba. The pitch P may be, for example, the distance between the central portions of adjacent top portions 12Ba.

In addition, as shown in FIG. 1, T is defined as the film thickness of the patch support film 1 . In addition, L is defined as the interval between the bottom upper surfaces 2c of the adjacent recesses 12A on the surface (upper surface side in FIG. 1) from which the protrusions 12B protrude. This interval L is the distance from the boundary between the sloped portion upper surface 2b and the bottom portion upper surface 2c to the boundary portion between the sloped portion upper surface 2b and the bottom portion upper surface 2c adjacent to each other with the top portion upper surface 2a interposed therebetween. It is also called the length L in the width direction.

Furthermore, the height difference in the film thickness direction between the adjacent concave portion 12A and convex portion 12B is called H. As shown in FIG. The height difference H may be the height difference H on the upper surface 2 side or the height difference H on the lower surface 3 side. That is, the height difference H is defined as either the heightwise distance between the top upper surface 2a and the bottom upper surface 2c or the heightwise distance between the top lower surface 3a and the bottom lower surface 3c along the film thickness direction. FIG. 1 illustrates the height difference H on the upper surface side.
Also, in the convex portion 12B, the angle formed at the boundary portion between the top upper surface 2a and the slope portion upper surface 2b continuous with the top upper surface 2a is defined as θ. The angle θ is the angle on the lower surface side (obtuse angle side).

FIG. 3 shows the patch support film 1 having the uneven structure 12 as shown in FIG. FIG. 2 is a schematic diagram showing the relationship between the elongation of the entire film and the stress applied to the film when the patch support film 1 is pulled in the direction in which the irregularities are arranged.
When a flat patch support film without the concave-convex structure 12 is pulled, as indicated by the symbol X1 in FIG. (Hereafter, the starting point where necking starts is called the yield point). After the yield point, plastic deformation accompanied by necking occurs, and when the breaking point is reached, the film breaks.

On the other hand, when the adhesive backing film 1 of the present embodiment is pulled in the direction in which the concave-convex structure 12 is arranged, shape deformation first occurs due to elastic deformation, and then plastic deformation occurs in part of the shape deformation. . If the pulling is continued further, the height difference H of the concave-convex structure 12 becomes smaller due to the tensile stress, and the concave-convex structure 12 becomes closer to being flat, so that the shape cannot be deformed. That is, as shown by the symbol X2 in FIG. 3, the stage where the uneven structure is mainly crushed and spread (the area that stretches without applying much force), and the stage where the collapsed uneven structure is further stretched and become almost flat ( The yield point is reached through a region where force is applied), and finally necking occurs and breaks.

The adhesive backing film 1 of the present embodiment undergoes such multistage shape deformation, so that the amount of elongation before reaching the yield point is greater than that of the conventional adhesive backing film, and Less stress required for elongation. Therefore, the adhesive backing film 1 of the present embodiment can contribute to the property of being easily stretched without necking. As described above, even if the film 1 for patch support of the present embodiment is made of a material generally considered to have low elongation, the shape can be devised. Higher elongation can be imparted. However, since plastic deformation becomes dominant in the end, the breaking strength is equivalent to that of a normal flat patch support film.

As described above, the patch support film 1 of the present embodiment has the uneven structure 12 in which periodic unevenness is formed on the front and back surfaces. The elongation of the film can be enhanced even when the support film is produced.
The film thickness T of the patch support film 1 is 5 μm or more and 150 μm. The film thickness T is more preferably 10 μm or more and 100 μm. The film thickness T of the patch support film 1 does not necessarily have to be uniform.

The height difference H of the uneven structure 12 is designed to be larger than the film thickness T of the film 1 for patch support. If the height difference H of the uneven structure 12 is equal to or less than the film thickness T, it is difficult to obtain the elongation effect by deforming the uneven structure 12 of the film 1 for adhesive backing into a flat state.
The upper limit of the height difference H is preferably 300 μm or less. If the upper limit of the height difference H is within this range, the uneven structure 12 can be stably formed when the film 1 for patch support is produced using various methods such as hot pressing and extrusion molding.

Further, in the concave-convex structure 12, the angle θ between the top upper surface 2a and the slope upper surface 2b at the boundary is 110 degrees or more and 150 degrees or less. When the film 1 for patch support of the present embodiment is produced by co-extrusion by extrusion molding, after manufacturing the laminate 4 of the film 1 for patch support and the thermoplastic resin layer 5, The film 1 and the thermoplastic resin layer 5 are separated for use. At this time, if the adhesive backing film 1 is pulled in the arranging direction of the concave-convex structure 12 and peeled off, the concave-convex structure 12 will be stretched. At the time of peeling, as in the shape shown in FIG. 4, if the angle θ formed at the boundary between the top surface 2a and the slant surface 2b is 110 degrees or more and 150 degrees or less, the adhesive backing film 1 and the thermoplastic resin are separated. It is possible to reduce the peel strength when peeling from the layer 5 and prevent deformation or breakage of the concave-convex structure 12 of the film 1 for patch support during peeling.

In addition, in the patch support film 1, the ratio (H/L) of the height difference H to the length L in the width direction of the uneven structure 12 is 0.10 or more and 1.00 or less. The ratio (H/L) is more preferably 0.10 or more and 0.50 or less. If the ratio (H/L) of the height difference H to the length L in the width direction exceeds 1.00, it becomes difficult to form the concave-convex structure 12 in terms of manufacturing. It is also difficult to keep the thickness of the film 2b and the bottom upper surface 2c uniform. Further, when the ratio (H/L) of the height difference H to the length L in the width direction is less than 0.10, it is difficult to obtain the elongation effect due to the shape deformation of the uneven structure 12 .

As in the comparative example of FIG. 5, when the angle θ between the top upper surface 2a and the inclined surface 2b at the boundary portion is less than 110 degrees, unevenness occurs when the film 1 for patch support and the carrier layer are peeled off. The greater the shear force applied to the structure 12, the greater the likelihood that the relief structure 12 will deform or break. When the angle θ exceeds 150 degrees as in the comparative example of FIG. 6, the concave-convex structure 12 has a nearly flat shape, so the amount of elongation is small, and the elongation of the adhesive backing film 1 is reduced. cause to.

The material of the adhesive backing film 1 is suitable for a desired film-forming method such as casting molding, inflation molding, hot press molding, extrusion molding, calendering, etc., and has barrier properties against desired drugs (drug barrier properties). ) can be appropriately selected. That is, the resin used as the material of the patch support film 1 may be appropriately selected from known resin materials having drug-barrier properties against drugs assumed in the use (application) of the patch.
Examples of the material of the adhesive backing film 1 include resins selected from polyethylene terephthalate, cycloolefin copolymers, cycloolefin polymers, polyacrylonitrile, ethylene-vinyl alcohol copolymers, and modified polymers thereof. . The use of such a resin is preferable because good drug barrier properties are exhibited. Films formed from such materials have drug barrier properties against drugs such as rivastigmine, tulobuterol, and the like.

In addition, by appropriately controlling the uneven shape and uneven pattern of the periodic uneven structure 12 provided on the patch support film 1, the extensibility and the direction of elongation can be arbitrarily controlled. For example, when it is desired to increase the amount of elongation, adjustments such as increasing the height difference H of the concave-convex structure 12 and decreasing the pitch P may be performed. By performing such an adjustment, the amount of elongation of the film 1 to deform the shape of the film 1 for the adhesive backing and approaching a flat state is easily increased, and the extensibility can be enhanced.

Further, as shown in FIG. 1, when observing the cross section of the concave-convex structure 12, the surfaces 2b and 3b of the slope portion 12C do not need to be composed of a straight line in cross section, but composed of a polygonal line (such as a staircase shape) or a curved line. It's okay to be. However, as shown in at least FIGS. 1 and 2, the top portions 12Ba of the convex portions 12B and the bottom portions 12Aa of the concave portions 12A are alternately formed with the slope portions 12C interposed therebetween. With such a shape, when the uneven structure 12 is pulled in the direction in which the unevenness is arranged, stress can be locally concentrated and the possibility of breaking at that location can be suppressed, and the extensibility can be improved.
Here, when the cross-sectional profiles of the surfaces 2b and 3b of the slope portion 12C are linear, as described above, the angle formed at the boundary between the top upper surface 2a and the slope portion upper surface 2b continuing to the top upper surface 2a is is defined as θ. When the surfaces 2b and 3b of the slope portion 12C are composed of a polygonal line (such as a staircase shape) or a curved line, the upper end portion of the slope portion upper surface 2b (connecting portion with the top portion upper surface 2a) and the lower end of the slope portion upper surface 2b The angle between the top surface 2a and the straight line connecting the top surface 2a is defined as θ.

Further, as shown in FIGS. 1 and 2, it is preferable to have a trapezoidal shape in which the top upper surface 2a and the bottom upper surface 2c, and the top lower surface 3a and the bottom lower surface 3c are parallel to each other. In this case, as will be described later, when the adhesive backing film 1 is laminated with other layers such as a thermoplastic resin or an adhesive layer to be used as a laminate or an adhesive patch, This is more preferable because the adhesion between the support film 1 and other layers is improved. Alternatively, the plurality of top upper surfaces 2a may be configured to be positioned on the same virtual plane, and the plurality of bottom upper surfaces 2c may be configured to be positioned on the same virtual plane. Note that the virtual plane may be a gently curved curved surface. If the tops 12Ba of the projections 12B and the bottoms 12Aa of the recesses 12A have a flat cross-sectional shape (flat shape), the tops 12Ba of the projections 12B and the recesses 12A can be formed when another layer is laminated on the film 1 for patch support. The adhesion between the bottom portion 12Aa of and other layers is improved. Furthermore, even if the uneven shape is provided, the adhesion of ink to the top portions 12Ba of the convex portions 12B and the bottom portions 12Aa of the concave portions 12A is improved, resulting in good printability.

Furthermore, in the top upper surface 2a of the uneven structure 12, the angle θ formed at the boundary between the top upper surface 2a and one of the sloped surface 2b and the angle θ formed at the boundary between the top surface 2a and the other sloped surface 2b are preferably equal. If the angles are not equal, when the adhesive backing film 1 is pulled in the direction in which the concave-convex structure 12 is arranged, a stress is applied to either one of the boundary portions between the top upper surface 2a and the slope portion upper surface 2b. are concentrated, and the possibility of tearing the adhesive backing film 1 at this boundary becomes high.

The height difference H of the uneven structure 12 of the patch support film 1 is preferably more than 5 μm and 300 μm or less, and more preferably 10 μm or more and 200 μm or less. If the height difference H is 5 μm or less, it is difficult to obtain the effect of flattening the uneven structure 12 of the film 1 for patch support, and it is difficult to provide the uneven structure 12 with a height exceeding 300 μm in terms of manufacturing. is.
In the patch support film 1, the ratio (W2a/W2c) of the width W2a of the top upper surface 2a in the left-right direction of the paper surface to the width W2c of the bottom upper surface 2c of the upper surface 2 in the left-right direction of the paper surface is 0.10 or more and 10. It is preferably 0.00 or less.

When the ratio of the width W2a to the width W2c (W2a/W2c) is smaller than 0.10, the boundary portions between the top upper surface 2a and the slope portion upper surface 2b contacting at both ends of the top surface 2a are close to each other. Then, when the concave-convex structure 12 of the film 1 for patch support is pulled in the arranging direction, stress is locally concentrated on this boundary portion, which increases the possibility of breakage. Further, when the ratio of the width W2a to the width W2c (W2a/W2c) is greater than 10.00, the boundary portion between the bottom upper surface 2c and the slant surface upper surface 2b, which is in contact with both ends of the bottom upper surface 2c, exists close to each other. . Then, when the concave-convex structure 12 of the film 1 for patch support is pulled in the arranging direction, stress is locally concentrated on this boundary portion, which increases the possibility of breakage.

(Production method)
Various methods such as hot pressing and extrusion molding can be appropriately selected as the method for producing the film 1 for adhesive backing of the present embodiment. As an example of a production method using extrusion molding, a multi-layer film having two or more layers can be obtained by co-extrusion of multiple types of resins by a feed block method or a multi-manifold method using a plurality of extruders. . In the cooling process for forming a film, a continuous uneven structure 12 can be provided on the front and back surfaces of the film by cooling while applying a nip pressure using a cooling roll provided with an uneven shape. Furthermore, at this time, when the height difference H of the uneven structure 12 is large with respect to the film thickness T of the first resin layer in contact with the cooling roll, the uneven structure is also formed on the interface between the first resin layer and the second resin layer. 12 is formed. Therefore, by peeling off the second resin layer from the multilayer film after cooling, the first resin layer having the uneven structure 12 provided on the front and back surfaces can be obtained, and this can be used as the film 1 for adhesive backing. .

In addition, it is possible to manufacture the patch support film 1 by appropriately selecting various methods such as casting molding and calender molding.
The patch support film 1 may be a single layer as shown in FIGS. 1 and 2 . Furthermore, as shown in FIG. 7, a multi-layer structure may be formed by laminating a plurality of films 1 for patch support by increasing the number of co-extruded layer structures. In this case, the back surface of one film 1 for patch support is adhered to the surface of another film 1 for patch support.
In addition, the film 1 for patch support may have a laminated structure of three or more layers. In these cases, a structure in which a functional layer such as a print layer, a vapor deposition layer, a hard coat layer, or an antireflection layer is laminated in a post-process on the film 1 for adhesive support may be employed.

As shown in FIG. 4, a laminate 4 may be formed by laminating a thermoplastic resin layer 5 on at least one of the surface consisting of the upper surface 2 and the back surface consisting of the lower surface 3 of the film 1 for patch support. . FIG. 4 illustrates the case where the thermoplastic resin layer 5 is laminated on the bottom surface. The laminate 4 may be formed by laminating the adhesive backing film 1 and the thermoplastic resin layer 5 which are separately formed, via an adhesive or pressure-sensitive adhesive, or may be formed simultaneously by a co-extrusion method or the like during film formation. You can When the thermoplastic resin layer 5 is laminated, the elongation tends to be slightly reduced. However, the thermoplastic resin layer 5 can be expected to improve the strength of the adhesive backing film 1 and to function as a functional layer such as oxygen barrier properties. The material of the thermoplastic resin layer 5 is not particularly limited. If a material with a low elastic modulus, such as low-density polyethylene, linear low-density polyethylene, or high-density polyethylene, is used as the material for the thermoplastic resin layer 5, the thermoplastic resin layer 5 will not stick even if it is laminated. This is preferable because it suppresses the decrease in elongation of the film 1 for agent support. That is, the thermoplastic resin layer 5 is preferably made of a material having an elastic modulus lower than that of the patch support film 1 . For example, a resin having an elastic modulus of 400 MPa or less is used as the thermoplastic resin layer 5 .

At this time, the peel strength in the extending direction of the uneven structure 12 of the adhesive backing film 1 from the thermoplastic resin layer 5 is 0.001 N/15 mm or more and 0.200 N/15 mm or less when a 180 degree peel test is performed. is preferable. If the peel strength is less than 0.001 N/15 mm, the adhesive backing film 1 and the thermoplastic resin layer 5 are easily peeled off, making it difficult to use as a laminate. If the peel strength is greater than 0.200 N/15 mm, the stress applied to the patch support film 1 will likely deform the uneven structure 12 .

Further, as shown in FIG. 8, another film 6 for patch support may be laminated with the film 1 for patch support in a state in which a gap is partially provided to form a laminate 4 . Alternatively, as shown in FIG. 9, a laminate 4 in which another film 6 for patch support is laminated with the film 1 for patch support via an adhesive layer 7 in a state in which a gap is partially provided. It is good as In these cases, it is preferable to select a functional material having a specific function as the material of the thermoplastic resin layer 5 and the separate patch support film 6 . In addition, it is preferable that the resin of the layers 6 and 7 laminated on the film 1 for patch support having an uneven structure has a lower elastic modulus than the film 1 for patch support. Also, by laminating an adhesive layer and a release liner, which will be described later, on the laminate 4 provided with the film 1 for an adhesive backing having an uneven structure as shown in FIGS. 4 to 9, it can be used as an adhesive. .

FIG. 10 is a cross-sectional view showing an outline of a general adhesive patch 11. As shown in FIG. In the general patch 11 shown in FIG. 10, both sides of the patch support film 8 are flat. 10, the adhesive layer 9 containing the drug and the release liner 10 are laminated in this order on one side of the film 8 for the adhesive backing. . When using such an adhesive patch 11, the release liner 10 is peeled off from the adhesive layer 9, and the adhesive layer 9 is attached to the skin. As a result, the components of the drug contained in the adhesive layer 9 are absorbed through the skin, and the drug exerts a medicinal effect in the living body. The adhesive backing film 8, which constitutes a typical adhesive patch 11, has flat front and back surfaces, and therefore lacks stretchability, and when it is attached to the skin, it feels stiff and stiff, and the body is moved. There is a problem that it is easy to peel off.
On the other hand, the adhesive backing film 1 of the present embodiment and the laminate 4 using the same can be given greater elongation than conventional ones. As a result, it is possible to suppress tension and stiffness when applied to the skin, and to make it difficult to peel off when the body is moved.

11 and 12 are cross-sectional views schematically showing an example of a patch 11 using the film 1 for patch support of the present embodiment. The patch 11 of FIG. 11 has a configuration in which an adhesive layer 9 and a release liner 10 are laminated in this order on the lower surface of the film 1 for patch support. Furthermore, like the patch 11 shown in FIG. 12, a laminated structure may be formed in which a thermoplastic resin layer 5 is further laminated on the surface of the patch support film 1 opposite to the side on which the pressure-sensitive adhesive layer 9 is laminated. .

In either case, by manufacturing the adhesive patch backing film 1 from a material with high drug barrier properties, it is possible to prevent the drug from being absorbed into the adhesive backing film 1 and allow the drug to be efficiently absorbed into the skin. become. In addition, the uneven structure 12 provided on the front and back surfaces of the adhesive backing film 1 makes it possible to increase the extensibility. Here, in the above description, the case where the entire surface of the patch support film 1 is the region 13 for forming the concave-convex structure 12 is exemplified, but the present invention is not limited to this. For example, it may be configured to have a flat portion in which the concave-convex structure 12 is not formed at an end portion or a central portion in the direction in which the concave-convex structure is arranged (horizontal direction in FIG. 1). When the concave-convex structure 12 is partially provided, it is preferable to have relatively more concave-convex structures 12 on the center side than on the outer edge side.

Alternatively, as shown in FIG. 13, the patch support film 1 may be partitioned into a plurality of regions 13, and the uneven structure 12 may be formed in each region 13 with an individual uneven pattern. In FIG. 13, edges (boundary lines) 13a that partition adjacent regions 13 are indicated by solid lines. The boundary of the slope portion upper surface 2b is represented by a dashed line. In FIG. 13, the patch support film 1 is partitioned into 16 regions 13, and on the upper surface 2, one edge (referred to as "edge") of each region 13 extends from the other edge opposite thereto. A top upper surface 2a, a slope upper surface 2b, and a bottom upper surface 2c extend to the edges. The same applies to the lower surface 3, the lower surface 3a of the top portion, the lower surface 3b of the slope portion, and the lower surface 3c of the bottom portion (not shown).

Further, in FIG. 13 , the concavo-convex pattern in each region 13 is designed so that the concavo-convex directions of the adjacent regions 13 are different from each other.
A film with high elongation has a problem that it is difficult to form a film stably because the film is stretched by tension during processing. On the other hand, as shown in FIG. 13, by dividing a sheet of film into a plurality of regions 13 and individually setting the uneven pattern in each region, the elongation of the entire film 1 for patch support can be increased. can be kept small. This enables stable film formation during molding. That is, even if the stretchability is improved by providing the uneven structure 12, the handling of the film 1 for the adhesive backing is facilitated during manufacturing and management.

The adhesive backing film 1 as shown in FIG. 13 is used as the raw material for the final product, and each region 13 is cut or punched, so that the final product is stretched in a desired direction. Film 1 can be obtained.
Here, the final product does not have to consist of only one region. For example, one final product may be composed of a plurality of regions 13 such as two or four continuous regions. At this time, the final product may be cut at the central position of each region 13 to have two types of concave-convex structures. In such a case, it is possible to set two or more directions with good elongation in the final product.

Note that FIG. 13 exemplifies the film 1 for adhesive patch support as a raw fabric for manufacturing a plurality of final products having the same structure. Also, the outline of each area 13 does not have to be rectangular, and may have other outline shapes such as a circle.
Also, the boundary between adjacent regions 13 does not have to have a clear boundary line 13a. The number of regions 13 included in film 1 for patch support is arbitrary. In the adhesive backing film 1 of FIG. 13, the boundary between the top upper surface 2a and the inclined surface 2b and the boundary between the bottom upper surface 2c and the inclined surface 2b are provided parallel to or perpendicular to the edges. However, the angle of the boundary with respect to the edge is arbitrary and may be different for each region 13 .

Although the embodiments of the present invention have been described above by way of examples, the present invention is not limited to these embodiments. In addition, it is optional to use the exemplary embodiments in combination as appropriate.

EXAMPLES Next, examples based on the present invention will be described, but the present invention is not limited to these examples.
(Example 1)
As a material for the adhesive backing film 1, Soarnol (registered trademark) D2908, an ethylene-vinylalcohol copolymer (EVOH) manufactured by Nippon Synthetic Chemical Industry Co., Ltd., was selected. Novatec LD (registered trademark) LC701, which is low density polyethylene (LDPE) manufactured by Japan Polyethylene Co., Ltd., was selected as a material for the resin of the carrier layer co-extruded with film 1 for patch support.

These two types of resins were co-extruded by extrusion molding, and then cooled while applying nip pressure using a cooling roll provided with an uneven shape in the cooling step for forming a film. After that, by conducting a peel strength test described later, the co-extruded low-density polyethylene layer is peeled off, so that a continuous uneven structure 12 is provided on the front and back surfaces of the film, which has a shape as shown in FIG. A film 1 for an agent support was produced and referred to as Example 1. The thickness of the bottom upper surface 2c of the adhesive backing film 1 was 30 μm, and the thickness of the low-density polyethylene layer coextruded with the adhesive backing film 1 in this portion was 60 μm. The uneven structure 12 has a height difference H of 60 μm, a length L of 224 μm in the width direction, a pitch P of 255 μm, a width of the top upper surface 2a in the horizontal direction of 155 μm, and an angle θ between the top upper surface 2a and the inclined surface 2b at the boundary portion of 120 degrees.

(Example 2)
The uneven structure 12 of the film 1 for patch support was the same as in Example 1, except that the widthwise length L was 143 μm, the pitch P was 174 μm, and the lateral width of the top upper surface 2a was 74 μm. Film 1 was produced and designated as Example 2.
(Example 3)
In the concave-convex structure 12 of the patch support film 1, the width of the top upper surface 2a in the left-right direction was 53 μm, and the angle θ between the top upper surface 2a and the inclined surface 2b at the boundary portion was set to 145 degrees. A patch support film 1 was produced in the same manner as in Example 3.

(Comparative example 1)
In the concavo-convex structure 12 of the adhesive backing film 1, the width of the top upper surface 2a in the left-right direction was 205 μm, and the angle θ between the top upper surface 2a and the inclined surface 2b at the boundary was set to 99 degrees. A patch support film 1 was produced in the same manner as in Comparative Example 1.
(Comparative example 2)
The same EVOH and LDPE as in Example 1 are used as materials, and in the cooling process for film formation by extrusion, flat cooling rolls without unevenness are used to cool while applying nip pressure, so that the front and back surfaces are A flat film was produced with a thickness of 30 μm and designated as Comparative Example 2.
(Comparative Example 3)
Ester Film (registered trademark) E5100 (thickness: 12 μm), which is a biaxially oriented polyethylene terephthalate (PET) film manufactured by Toyobo Co., Ltd., was used as Comparative Example 3. The film of Comparative Example 3 is a film having flat front and back surfaces.

(Peel strength test)
A peel strength test was conducted in order to evaluate the extensibility of the adhesive backing film 1 of each example and the film of each comparative example. A peel strength test and a tensile test described later were performed using a Tensilon universal tester (RTC-1250A) manufactured by Orientec Co., Ltd. The adhesive backing film 1 manufactured by coextrusion with a low-density polyethylene layer and a laminated structure is cut into a width of 15 mm in the direction in which the concave-convex structure 12 is arranged and a width of 100 mm in the extending direction of the concave-convex structure 12 to obtain a patch support. The strength (stress) was measured when the film 1 and the low-density polyethylene layer were peeled off 180 degrees. The measurement conditions were a chuck-to-chuck distance of 50 mm and a pulling speed of 100 mm/min.

(Tensile evaluation)
A tensile test was performed to evaluate the elongation of the adhesive backing film 1 of each example and the film of each comparative example. Using a Tensilon universal testing machine, tensile force was applied until the film broke, and the yield point and elongation percentage (ratio of elongation to initial chuck distance) at break point were recorded. The measurement conditions were a sample width of 15 mm, a distance between chucks of 50 mm, and a pulling speed of 100 mm/min.

(Drug adsorption test)
A drug adsorption test was conducted to evaluate the drug barrier properties of the adhesive backing film 1 of each example and the film of each comparative example. After each film was cut into 100 mm squares, a patch was attached to the center. As the patch, 18 mg of Rivastach (registered trademark) patch manufactured by Ono Pharmaceutical Co., Ltd. containing rivastigmine and 2 mg of Hokunalin (registered trademark) tape manufactured by Mylan Pharmaceutical Co., Ltd. containing tulobuterol were used. It was sealed with aluminum foil so that the chemical would not volatilize or diffuse, and was stored for one month in an environment of 40° C. temperature and 75% RH. 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 longer, and the amount of drug adsorbed was measured by high performance liquid chromatography.

Table 1 shows the material, film thickness, shape, and evaluation results of Film 1 for patch support of each Example and the film of each Comparative Example.

As can be seen from Table 1, the adhesive backing films 1 of Examples 1 to 3 according to the present invention had a peel strength value when peeled from the co-extruded low-density polyethylene layer, which was the same as that of Comparative Example 2. Although higher than the film, it was lower than the film for patch support of Comparative Example 1. This is because the angle formed by the top surface 2a and the slant surface 2b is controlled within an appropriate range in the rugged structure 12 of the patch support film 1, so that shear force is applied to the rugged structure 12 during peeling. presumably because it was suppressed.

In addition, in the patch support film 1 of Examples 1 and 3, the elongation rate when reaching the yield point in the tensile test is smaller than that of the patch support film of Comparative Example 1. In the adhesive backing film 1 of Example 2, the value of the elongation percentage when reaching the yield point in the tensile test was close to the value of the adhesive backing film of Comparative Example 1.
In the adhesive backing film 1 of Example 2, not only the angle formed by the top surface 2a and the slope surface 2b but also the length and pitch in the width direction are controlled within appropriate ranges. It is thought that this is because both low and good elongation are achieved. On the other hand, the adhesive backing films of Comparative Examples 2 and 3 did not have the concave-convex structure 12 on the front and back surfaces and were flat. was significantly smaller than that of the adhesive backing film of Comparative Example 1, and it was confirmed that the stretchability was poor.

In addition, the adhesive backing films 1 of Examples 1 to 3 did not show adsorption for neither rivastigmine nor tulobuterol, and had good drug barrier properties equivalent to the PET film of Comparative Example 3. It could be confirmed.

Adhesive backing film that can be easily peeled off from the carrier layer while reducing labor and cost during manufacturing, and has both drug barrier properties and stretchability, and lamination using the film by using the technology of the present invention It becomes possible to provide a body and a patch. The film for a patch support according to the present invention can be expected to be used as a patch used in the medical field.

1 Adhesive support film 2a Top upper surface 2b Slope upper surface 2c Bottom upper surface 3a Top lower surface 3b Slope lower surface 3c Bottom lower surface 4 Laminate 5 Thermoplastic resin layer 6 Adhesive support film 7 Adhesive layer 8 Adhesive support Body film 9 Adhesive layer 10 Release liner 11 Patch 12 Concavo-convex structure 12A Concave portion 12Aa Bottom portion 12B Convex portion 12Ba Top portion 12C Wall portion (inclined portion)
13 Region 13a edge (boundary)
H Height difference P Pitch L Length in width direction

Claims (18)

A film for a patch support made of a resin having drug barrier properties,
By configuring the entire film in a undulating shape in the thickness direction, it has an uneven structure in which concave and convex portions are repeated along the surface,
The thickness of the film for a patch support is 5 μm or more and 150 μm or less,
the height difference between the concave portion and the convex portion is greater than the film thickness of the film for a patch support,
The top of the convex portion and the bottom of the concave portion each constitute a flat portion having a flat cross section,
The top of the adjacent protrusion and the bottom of the recess are connected by a slope, and the angle formed by the top of the protrusion and the slope connected thereto in a cross section is 110 degrees or more and 150 degrees or less,
A ratio (H/L) of the height difference H to the interval L between the bottoms of the adjacent recesses on the surface on which the protrusions protrude is 0.10 or more and 1.00 or less,
The interval L is 143 μm or more and 224 μm or less,
In the top portion and the bottom portion adjacent to each other, the width of the top portion in the direction in which the concave portion and the convex portion are arranged is 53 μm or more and 205 μm or less,
The resin having drug barrier properties is a resin selected from polyethylene terephthalate, cycloolefin copolymer, cycloolefin polymer, polyacrylonitrile, ethylene-vinyl alcohol copolymer, and modified polymers thereof. ,
A film for a patch support, characterized by: The above-mentioned resin having drug barrier properties is a resin selected from any one of cycloolefin copolymers, cycloolefin polymers , ethylene -vinyl alcohol copolymers, and modified polymers thereof. 2. The film for patch support according to 1. 2. The film for a patch support according to claim 1 , wherein the resin having drug barrier properties is an ethylene -vinyl alcohol copolymer . The film for patch support according to any one of claims 1 to 3, wherein the tops of the projections and the bottoms of the recesses are parallel to each other. Claims 1 to 3, characterized in that, in a cross section, the angle formed by the apex of the protrusion and one of the slanted surfaces continuous therewith is equal to the angle formed by the apex of the protrusion and the other slanted surface continuous with it. The film for patch support according to claim 4 . 6. The film for an adhesive patch support according to any one of claims 1 to 5 , wherein the difference in height between the concave portion and the convex portion is more than 5 µm and not more than 300 µm. 1 to 1, characterized in that, in the adjacent top portion and bottom portion, a ratio of the width of the top portion to the width of the bottom portion in the direction in which the concave portion and the convex portion are arranged is 0.10 or more and 10.00 or less. The film for patch support according to claim 6 . 8. The film for a patch support according to any one of claims 1 to 7 , wherein the film has a plurality of regions, and the uneven structure is formed with an individual uneven pattern for each region. . The patch support according to any one of claims 1 to 8, wherein the width of the bottom portion in the direction in which the concave portions and the convex portions are arranged in the adjacent top portion and the bottom portion is 31 µm. Film for. The barrier material is made of an ethylene-vinyl alcohol copolymer,
The height difference is greater than 5 μm and 300 μm or less,
The film for patch support according to any one of claims 1 to 9, wherein the film for patch support has a thickness of 30 µm or more and 150 µm or less. A laminate obtained by laminating a thermoplastic resin layer on one or both sides of the adhesive backing film according to any one of claims 1 to 10 . 12. The laminate according to claim 11, wherein the thermoplastic resin layer is a layer formed of a material having a lower elastic modulus than the film for patch support. 13. The laminate according to claim 12, wherein the thermoplastic resin layer is a layer formed of a resin having an elastic modulus of 400 MPa or less. A laminate obtained by laminating a functional layer on one or both sides of the adhesive backing film according to any one of claims 1 to 10 . A laminate obtained by laminating a plurality of films for patch support according to any one of claims 1 to 10 . A peel strength of 0.001 N/15 mm or more and 0.200 N/15 mm or less when a 180-degree peel test with the thermoplastic resin layer is carried out in the extending direction of the concave-convex structure in the adhesive backing film. The laminate according to any one of claims 11 to 13 , characterized in that A patch comprising a pressure-sensitive adhesive layer and a release liner layer laminated in this order on one or both sides of the film for a patch support according to any one of claims 1 to 10 . A patch comprising a pressure-sensitive adhesive layer and a release liner layer laminated in this order on one or both sides of the laminate according to any one of claims 11 to 16 .

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