JP2022098961A - Patch support medium film, and patch comprising patch support medium film - Google Patents

Abstract

To provide a patch support medium film capable of achieving proper extension property and flexure rigidity for suppressing peeling, and a patch comprising the patch support medium film.SOLUTION: There is provided a patch support medium film 1 in which, to a resin film comprising medicine barrier properties, in view from a direction being orthogonal to a thickness direction of the resin film, recess parts 2b and salient parts 2a are formed alternately, a 10% modulus value along a direction where the recess parts 2b and salient parts 2a are arranged is falls within a range of 0.1 N/15 mm or greater and 4 N/15 mm or smaller, and a loop stiffness value in a vertical direction in the same plane with respect to the direction where the recess parts 2b and the salient parts 2a are arranged on the resin film, is 1 mN/15 mm or greater and 15 mN/15 or smaller.SELECTED DRAWING: Figure 1

Description

The present invention relates to a patch support film and a patch comprising a patch support film.

The patch used in the medical field is a preparation intended to be percutaneously absorbed by the drug by being attached to the skin and taken into the body. As an example of the structure of the patch, there is a structure in which a pressure-sensitive adhesive layer in which a drug and a pressure-sensitive adhesive are mixed is laminated on the surface of a support, and further, a release liner is laminated on the surface of the pressure-sensitive adhesive layer.
Since the support is in close contact with the adhesive, the adhesive can be easily peeled off from the release liner, and when the adhesive is applied to the skin, the adhesive is covered with the release liner. , It is possible to prevent the adhesive from adhering to clothes and the like.
Other properties required for the support include having a drug barrier property and having extensibility.

The drug barrier property is a property that the support does not absorb the drug or a property that is difficult to absorb because it does not interfere with the transdermal absorption of the drug. As an example, if the drug absorption rate of the support is less than 10 [%] when stored for 1 month in an environment where the temperature is 40 [° C.] and the humidity is 75 [% RH], the drug barrier property is good. Defined to be.
Stretchability refers to the load required to reach a certain stretch rate when the support is pulled, and when the patch is applied to the skin, it does not feel tension or stiffness, and the body does not feel any tension or stiffness. It is an important factor to make it difficult for the patch to come off when the device is moved.

However, it is often difficult to achieve both drug barrier properties and extensibility due to the following factors.
The resin having a drug barrier property is limited to some materials such as polyethylene terephthalate, cycloolefin copolymer, cycloolefin polymer, polyacrylonitrile, ethylene-vinyl alcohol copolymer, and modified polymers thereof. Further, these materials generally have a large Young's modulus and have a drawback that they are difficult to stretch.

In order to solve the above-mentioned problems, for example, Patent Document 1 discloses a film for a patch support formed by using a resin film having a drug barrier property.
In the technique disclosed in Patent Document 1, the entire resin film is formed in a undulating shape in the thickness direction, and has an uneven structure in which concave portions and convex portions are repeated along the surface of the resin film. Further, the top of the convex portion and the bottom of the concave portion each have a flat cross section, the film thickness of the patch support film is 5 μm or more and 150 μm or less, and the height difference between the concave portion and the convex portion is large. , Larger than the film thickness of the patch support film.

Japanese Unexamined Patent Publication No. 2020-63221

However, in the patch formed by using the film for the patch support disclosed in Patent Document 1, it is possible to impart extensibility to the film having no extensibility by forming a structure. However, the effect of suppressing the peeling of the patch generated when the patch is applied to the skin is not sufficient.
According to a study by the inventors of the present invention, it has been found that when the patch is applied to the skin, not only the extensibility of the film but also the bending rigidity of the film affects the suppression of peeling. .. That is, when the bending rigidity of the film is increased, the film's followability to the curvature of the skin and the unevenness caused by the muscles is lowered, so that the film is easily peeled off. Therefore, it is desirable that the bending rigidity of the film is small.

In a configuration in which the stretchability of the film is increased by a concave-convex structure in which concave portions and convex portions are repeated as in the technique disclosed in Patent Document 1, the height of the convex portions is increased and the pitch between the concave portions and the convex portions is narrowed. Configuration is required. However, when a structural design that enhances the extensibility of the film is carried out, there is a problem that the bending rigidity of the film increases in the direction perpendicular to the direction in which the extensibility is imparted, as a trade-off. ..
In view of the above problems, it is an object of the present invention to provide a patch support film having both stretchability and bending rigidity suitable for suppressing peeling, and a patch provided with a patch support film. ..

In order to solve the problem, one aspect of the present invention is to support a patch having concave portions and convex portions alternately formed on a resin film having a drug barrier property when viewed from a direction orthogonal to the thickness direction of the resin film. It is a body film. Further, the 10% modulus value along the direction in which the concave portions and the convex portions are arranged is in the range of 0.1 N / 15 mm or more and 4 N / 15 mm or less. Further, the loop stiffness value in the direction perpendicular to the direction in which the concave portions and the convex portions of the resin film are arranged is in the range of 1 mN / 15 mm or more and 15 mN / 15 mm or less.
Further, one aspect of the present invention is a film for a patch support, a pressure-sensitive adhesive layer laminated on one surface of the film for the patch support, and a surface of the pressure-sensitive adhesive layer facing the film for the patch support. A patch comprising a release liner layer laminated on the opposite surface.

According to the aspect of the present invention, by providing an appropriate concavo-convex structure for a resin film having a drug barrier property, it is possible to suppress an increase in bending rigidity and impart extensibility to the resin film. It becomes possible to do. This makes it possible to provide a patch support that does not easily peel off from the skin, and a patch support film that has both stretchability and bending rigidity appropriate for suppressing peeling, and a patch that includes a patch support film. It becomes possible to provide the agent.

It is a perspective view which shows an example of the structure in the film for a patch support of 1st Embodiment. It is sectional drawing which shows various parameters set in the film for a patch support. It is a schematic diagram which shows the measuring method of a loop stiffness value. It is sectional drawing which shows the structure of a patch.

Hereinafter, embodiments of the present technology will be described with reference to the drawings. In the description of the drawings, the same or similar parts are designated by the same or similar reference numerals, and duplicate description will be omitted. Each drawing is schematic and may differ from the actual one. The embodiments shown below exemplify the devices and methods for embodying the technical idea of the present technology, and the technical idea of the present technology is specified to the devices and methods exemplified in the following embodiments. Not something to do. The technical idea of the present technology can be modified in various ways within the technical scope described in the claims.
It should be noted that each figure is schematically shown, and the size and shape of each part are exaggerated as appropriate for easy understanding. Further, the front surface and the back surface used in the present specification are described for convenience, and any one of the pair of surfaces in the film for the patch support may be the front surface and the back surface.

(First Embodiment)
Hereinafter, the configuration of the patch support film 1 will be described with reference to FIGS. 1 to 3.
As shown in FIG. 1, in the patch support film 1, concave portions 2b and convex portions 2a are alternately formed with respect to a resin film having a drug barrier property when viewed from a direction orthogonal to the thickness direction of the resin film. It has a concavo-convex structure 2 that has been formed. By making the structure of the film 1 for the patch support having the concavo-convex structure 2, the cross section of the film 1 for the patch support is configured to have an undulating shape. By forming the cross section of the patch support film 1 into a wavy shape, it is possible to impart extensibility derived from the shape of the concave-convex structure 2 along the direction in which the concave portions 2b and the convex portions 2a are arranged. It will be possible.

In addition, in FIG. 1, the thickness direction of the resin film is shown as "thickness direction". Further, in FIG. 1, the direction showing the extensibility derived from the shape of the concave-convex structure 2 is shown as "the direction showing the extensibility".
The direction showing the extensibility derived from the shape of the uneven structure 2 is the direction in which the concave portions 2b and the convex portions 2a are alternately arranged.
As shown in FIG. 2, the top of the convex portion 2a and the bottom surface of the concave portion 2b are flat surfaces when viewed from a direction orthogonal to the thickness direction of the patch support film 1.
The connection surface 2c, which is a surface connecting the top of the convex portion 2a and the bottom surface of the concave portion 2b, is formed from the top of the convex portion 2a to the concave portion 2b when viewed from a direction orthogonal to the thickness direction of the film 1 for the patch support. It is a slope that separates from the top of the convex portion 2a toward the bottom surface.

The film 1 for the patch support is imparted with an extensibility in which the 10% modulus value in the tensile test conforming to JIS K7161 is in the range of 0.1 N / 15 [mm] or more and 4 N / 15 [mm] or less. .. The reason why the 10% modulus value is set within the range of 0.1 N / 15 [mm] or more and 4 N / 15 [mm] or less is that if the 10% modulus value is less than 0.1 N / 15 [mm], it is attached. The reason is that when it is applied to the skin as an agent, it easily stretches and becomes difficult to handle. Further, when the 10% modulus value is larger than 4N / 15 [mm], the stretchability of the film 1 for the patch support is insufficient, it is difficult to follow the expansion and contraction of the skin, and the peeling suppressing effect is insufficient. That's the reason. Further, the 10% modulus value is more preferably in the range of 0.1N / 15 [mm] or more and 2N / 15 [mm] or less, and even more preferably 0.1N / 15 [mm] or more and 1N / 15 [. mm] It is within the following range.

The extensibility of the patch support film 1 is a numerical value that varies depending on the thickness of the resin film, the Young's modulus of the resin film, and the shape of the uneven structure 2. The inventors of the present invention have found through research that when the shape of the concave-convex structure 2 is a trapezoidal shape as shown in FIG. 2, a 10% modulus value can be expressed by using the equation (3). In the formula (3), the thickness of the resin film is T [μm], the Young's modulus of the resin film is E [GPa], and the height difference between the top of the convex portion 2a and the bottom surface of the concave portion 2b is H [μm]. do.
E × T ³ / H × 0.0165… (3)

Further, by satisfying the condition that the 10% modulus value expressed by the equation (3) is in the range of 0.1 or more and 4 or less, it is possible to obtain appropriate extensibility of the film 1 for the patch support. It will be possible. The reason for setting the 10% modulus value expressed using the equation (3) within the range of 0.1 or more and 4 or less is that the 10% modulus value expressed using the equation (3) is less than 0.1. The reason is that when it is applied to the skin as a patch, it easily stretches and becomes difficult to handle. Further, when the 10% modulus value expressed by using the equation (3) is larger than 4, the stretchability is insufficient, it is difficult to follow the expansion and contraction of the skin, and the peeling suppressing effect is insufficient. Further, the 10% modulus value expressed using the equation (3) is more preferably in the range of 0.1 or more and 2 or less, and even more preferably in the range of 0.1 or more and 1 or less.

Further, the film 1 for the patch support has a loop stiffness value of 1 mN / 15 mm or more and 15 mN / 15 mm, which is an index of flexural rigidity, in the direction perpendicular to the direction in which the concave portion 2b and the convex portion 2a are arranged in the same plane. It is within the following range.
In addition, in FIG. 1, the direction perpendicular to the direction in which the concave portion 2b and the convex portion 2a are arranged in the same plane is shown as a “direction indicating bending rigidity”.
The "direction showing flexural rigidity" is a direction perpendicular to the "direction showing extensibility" shown in FIG. 1 in the same plane.

The loop stiffness value is measured under measurement conditions in which the shape of the patch support film 1 having a width of 15 [mm] is loop-shaped, the loop length is 85 [mm], and the pushing distance is 20 [mm]. Be measured. The reason for setting the loop stiffness value within the range of 1 mN / 15 mm or more and 15 mN / 15 mm is that when the loop stiffness value is less than 1 mN / 15 mm, the film is easily bent and the adhesive layer is easily applied to the skin as a patch. The reason is that there are problems in handling such as sticking to each other. Further, when the loop stiffness value is larger than 15 mN / 15 mm, it is difficult to follow the curve of the skin and the unevenness of the skin, and the skin is easily peeled off. Further, the loop stiffness value is more preferably in the range of 1 mN / 15 mm or more and 5 mN / 15 mm or less.

The loop stiffness value is measured by, for example, a loop stiffness test using a "loop stiffness tester" manufactured by Toyo Seiki Seisakusho Co., Ltd.
In the loop stiffness test, as shown in FIG. 3, the loop-shaped patch support film 1 was pushed by the indenter 22 in a loop-shaped state by fixing the patch support film 1 with the chuck 21. This is a test for measuring the load of the indenter 22 at that time. The pushing distance of the indenter 22 is defined by the pushing distance. The pushing distance represents the distance when the indenter 22 and the chuck 21 are closest to each other. The loop stiffness value indicates the maximum value of the load obtained in the loop stiffness test.

The flexural rigidity of the patch support film 1 is a numerical value determined by the thickness of the resin film, the Young's modulus of the resin film, and the shape of the uneven structure 2 as well as the extensibility of the patch support film 1. According to the research by the inventors of the present invention, when the shape of the concave-convex structure 2 is a trapezoidal shape as shown in FIG. 2, the length of the loop is longer than that of the loop-shaped patch support film 1. It has been found that the loop stiffness value measured under the measurement conditions of 85 [mm] and the indentation distance of 20 [mm] can be expressed by using the equation (4). In the formula (4), the thickness of the resin film is T [μm], the Young's modulus of the resin film is E [GPa], and the height difference between the top of the convex portion 2a and the bottom surface of the concave portion 2b is H [μm]. do. Further, in the formula (4), a pitch width of P [μm], which is the length of the adjacent set of the concave portion 2b and the convex portion 2a along the direction in which the concave portion 2b and the convex portion 2a are arranged, is attached. The width of the convex portion 2a seen from the direction orthogonal to the thickness direction of the agent support film 1 is W1 [μm], and the width of the concave portion 2b seen from the direction orthogonal to the thickness direction of the patch support film 1. Is W2 [μm].
(W1 + W2) / P × T / 12 × (3H ² + T ² ) × E × 0.0016… (4)

Further, by satisfying the condition that the loop stiffness value expressed by using the equation (4) is in the range of 1 or more and 15 or less, it is possible to obtain an appropriate bending rigidity of the film 1 for the patch support. .. The reason for setting the loop stiffness value expressed using the formula (4) within the range of 1 or more and 15 or less is that when the loop stiffness value expressed using the formula (4) is less than 1, it is applied to the skin as a patch. The reason is that the film is easily bent at the time of sticking, and there are problems in handling such as the adhesive layers sticking to each other. Further, when the loop stiffness value expressed by using the equation (4) is larger than 15, it is difficult to follow the curve of the skin and the unevenness of the skin, and the skin is easily peeled off. Further, the loop stiffness value expressed by using the equation (4) is more preferably in the range of 1 or more and 5 or less.

The 10% modulus value expressed using the equation (3) and the loop stiffness value expressed using the equation (4) cause peeling at the time of application due to the influence of the physical characteristics of the other even if only one satisfies an appropriate value. It will be easier and must be met at the same time.
Further, the patch film 1 of the present embodiment has a breaking strength of 5 N / 15 mm or more along the direction in which the concave portion 2b and the convex portion 2a are arranged. The reason for setting the breaking strength along the direction in which the concave portion 2b and the convex portion 2a are arranged to be 5N / 15 mm or more is that the breaking strength along the direction in which the concave portion 2b and the convex portion 2a are arranged is less than 5N / 15 mm. This is because there is a risk of breakage when the patch is peeled off from the release liner.

The material of the resin film is not particularly limited, but a material having a drug barrier property is used. As the material having a drug barrier property, for example, polyethylene terephthalate, cycloolefin copolymer, cycloolefin polymer, polyacrylonitrile, ethylene-vinyl alcohol copolymer, and modified polymers thereof can be used. Resin films using polyethylene terephthalates, cycloolefin copolymers, cycloolefin polymers, polyacrylonitrile, ethylene-vinyl alcohol copolymers, and modified polymers thereof, for example, against agents such as ribastigmine and turobterol. It is possible to have a structure having a drug barrier property.

Further, even when a material having no drug barrier property is used as the material of the resin film, the drug barrier layer is imparted by a method such as laminating with a material having a drug barrier property, vapor deposition, or coating. Therefore, it can be used as a material for a resin film.
As for the method for producing the film 1 for the patch support, various methods such as a production method by hot pressing and a production method by extrusion molding can be appropriately selected and used.
In the manufacturing method by hot pressing, the film-formed resin film is passed between a pair of heating rolls having an uneven shape on the surface or a pair of heated flat plate presses to form a film for a patch support 1. It is possible to manufacture. At this time, precise alignment is performed between the pair of heating rolls or between the upper and lower concave shapes and the convex shapes of the pair of flat plates, and the front and back surfaces of the resin film after hot pressing have a continuous uneven structure 2. It is important that it is.

Further, in another manufacturing method by hot pressing, a plurality of flat films having releasability are stacked, or a flat film holding a plurality of layers having releasability is formed between heating rolls provided with an uneven shape, or. It is possible to impart the uneven structure 2 by passing it through a heated flat plate-shaped press machine. At this time, by adjusting the press depth and the press pressure, a desired uneven shape is imparted to the surface and the layer interface of the flat film, and after cooling, the films of the plurality of layers to which the concave-convex structure 2 is imparted are peeled off. It is possible to manufacture a film 1 for a patch support.

In the manufacturing method by extrusion molding, in the cooling process for heating and melting the resin and extruding it from the T-die to form a film, cooling is performed while applying nip pressure using a cooling roll and a nip roll provided with an uneven shape. Therefore, it is possible to provide a continuous uneven structure 2 on the front surface and the back surface of the film. Even in the manufacturing method by extrusion molding, precise alignment between the cooling roll and the uneven shape of the nip roll is required.

Further, in another manufacturing method by extrusion molding, a plurality of extruders are used, and a plurality of types of resins are co-extruded by a feed block method or a multi-manifold method to obtain a film 1 for a patch support on one side surface. It is possible to obtain a film having a multilayer structure of two or more layers arranged in. At this time, in the cooling step for forming a film, while applying nip pressure to the surface on which the film 1 for the patch support is arranged, a cooling roll having irregularities corresponding to the concave-convex structure 2 is provided on the surface. By cooling, it is possible to form the uneven structure 2. At this time, when the height difference of the uneven structure 2 is large with respect to the thickness of the patch support film 1 in contact with the cooling roll, the interface of the patch support film 1 opposite to the cooling roll is also uneven. Since the structure 2 is added, it is possible to obtain a patch support film 1 having a undulating cross section by peeling the patch support film 1 having the uneven structure 2 after cooling from the multilayer film. Is.

In addition, any manufacturing method to which the concave-convex structure 2 is added, such as injection molding, can be selected, and the method is not particularly limited.
Further, the film 1 for a patch support may be a laminated body in which a functional layer such as a printing layer, a vapor-deposited layer, and an anchor coat layer for improving adhesion to an adhesive is laminated on the surface in a later process. It is possible. Further, the film 1 for the patch support can be a laminated body in which another thermoplastic resin or the like is laminated. As another thermoplastic resin, for example, there are cases where a functional layer as described above is formed, and cases where a functional improvement layer such as strength is formed.
When another layer is provided, it is necessary that the 10% modulus value and the loop stiffness value of the patch support film 1 satisfy the predetermined range after providing the other layer.

(Attachment)
The patch 100 shown in FIG. 4 may be formed by using the patch support film 1 of the first embodiment.
The patch 100 includes a film 1 for a patch support, a pressure-sensitive adhesive layer 10, an ink layer 11, and a release liner 12.
The pressure-sensitive adhesive layer 10 is laminated on one surface (lower surface in FIG. 4) of the patch support film 1.
The ink layer 11 is laminated on the other surface (upper surface in FIG. 4) of the patch support film 1.
The release liner 12 is laminated on the surface of the pressure-sensitive adhesive layer 10 opposite to the surface facing the film 1 for the patch support (lower surface in FIG. 4).
With the configuration shown in FIG. 4, it is possible to provide the patch 100 having both the drug barrier property and the extensibility.
Although the first embodiment of the present invention has been exemplified above, the present invention is not limited to the above-described embodiment. Moreover, it is optional to use two or more embodiments in combination.

Hereinafter, examples based on the present invention will be described, but the present invention is not limited to these examples.
(Example 1)
As the material of the film 1 for the patch support, "EFG70 (Young's modulus: 1.5 GPa)", which is polyethylene terephthalate (PET) manufactured by Bell Polyester Products Co., Ltd., was selected.
Further, as the material of the resin co-extruded with the film 1 for the patch support, "Novatec LD LC600A", which is a low-density polyethylene (LDPE) manufactured by Japan Polyethylene Corporation, was selected.
Then, using the two selected resins, coextrusion was performed by extrusion molding, and then, in the cooling step for forming a film, cooling was performed while applying nip pressure using a cooling roll provided with an uneven shape. .. Then, by peeling off the co-extruded low-density polyethylene layer, a film 1 for a patch support having a continuous uneven structure 2 on the front surface and the back surface of the resin film was produced.
The thickness T is 16 [μm], the uneven structure 2 is a shape in which trapezoidal cross sections are periodically arranged, the height difference H is 30 [μm], and the width W1 is 75 [μm]. ], The width W2 was 14 [μm], and the pitch width P was 124 [μm].

(Example 2)
The thickness T is 16 [μm], the uneven structure 2 is a shape in which trapezoidal cross sections are periodically arranged, the height difference H is 45 [μm], and the width W1 is 75 [μm]. ], The width W2 was 47 [μm], and the pitch P was 175 [μm]. The film 1 for the patch support of Example 2 was produced in the same manner as in Example 1 under other conditions.
(Example 3)
As the material of the film 1 for the patch support, "Soanol D2908 (Young's modulus: 1 GPa)", which is an ethylene-vinyl alcohol copolymer (EVOH) manufactured by Nippon Synthetic Chemical Industry Co., Ltd., was selected.
The thickness T is 16 [μm], the uneven structure 2 is a shape in which trapezoidal cross sections are periodically arranged, the height difference H is 60 [μm], and the width W1 is 75 [μm]. ], The width W2 was 31 [μm], and the pitch P was 175 [μm]. The film 1 for the patch support of Example 3 was produced in the same manner as in Example 1 under other conditions.

(Example 4)
The thickness T is 10 [μm], the uneven structure 2 is a shape in which trapezoidal cross sections are periodically arranged, the height difference H is 60 [μm], and the width W1 is 75 [μm]. ], The width W2 was 31 [μm], and the pitch P was 175 [μm]. The film 1 for the patch support of Example 4 was produced in the same manner as in Example 1 under other conditions.
(Example 5)
The thickness T is 8 [μm], the uneven structure 2 is a shape in which trapezoidal cross sections are periodically arranged, the height difference H is 45 [μm], and the width W1 is 75 [μm]. ], The width W2 was 47 [μm], and the pitch P was 175 [μm]. The film 1 for the patch support of Example 5 was produced in the same manner as in Example 1 under other conditions.

(Comparative Example 1)
The thickness T is 25 [μm], the uneven structure 2 is a shape in which trapezoidal cross sections are periodically arranged, the height difference H is 30 [μm], and the width W1 is 75 [μm]. ], The width W2 was 14 [μm], and the pitch P was 124 [μm]. The film 1 for the patch support of Comparative Example 1 was produced in the same manner as in Example 1 under other conditions.
(Comparative Example 2)
The thickness T is 16 [μm], the uneven structure 2 is a shape in which trapezoidal cross sections are periodically arranged, the height difference H is 60 [μm], and the width W1 is 75 [μm]. ], The width W2 was 31 [μm], and the pitch P was 175 [μm]. The film 1 for the patch support of Comparative Example 2 was produced in the same manner as in Example 1 under other conditions.
(Comparative Example 3)
The thickness T is 16 [μm], the uneven structure 2 is a shape in which trapezoidal cross sections are periodically arranged, the height difference H is 100 [μm], and the width W1 is 205 [μm]. ], The width W2 was 189 [μm], and the pitch P was 425 [μm]. The film 1 for the patch support of Comparative Example 3 was produced in the same manner as in Example 1 under other conditions.

(Comparative Example 4)
The thickness T is 5 [μm], the uneven structure 2 is a shape in which trapezoidal cross sections are periodically arranged, the height difference H is 60 [μm], and the width W1 is 75 [μm]. ], The width W2 was 31 [μm], and the pitch P was 175 [μm]. The film 1 for the patch support of Comparative Example 4 was produced in the same manner as in Example 1 under other conditions.
(Comparative Example 5)
The thickness T is 8 [μm], the uneven structure 2 is a shape in which trapezoidal cross sections are periodically arranged, the height difference H is 5 [μm], and the width W1 is 75 [μm]. ], The width W2 was 47 [μm], and the pitch P was 175 [μm]. The film 1 for the patch support of Comparative Example 5 was produced in the same manner as in Example 1 under other conditions.

(Measurement of 10% modulus value)
A 10% modulus value was measured as an index of the extensibility of the patch support film 1 in Examples and Comparative Examples. The evaluation of the 10% modulus value was carried out using a "Tensilon universal material tester (RTC-1250A)" manufactured by A & D Co., Ltd. Further, according to JIS K7161, the patch film 1 for the patch support breaks under the conditions that the sample width is 15 [mm], the distance between chucks is 50 [mm], and the tensile speed is 100 [mm / min]. A tensile test was conducted to measure the load when the tensile force was applied. The tensile test is performed on the film 1 for the patch support in the direction in which the concave portions 2b and the convex portions 2a are arranged, and the tensile load when the film 1 for the patch support is stretched by 10% is applied. It was set to a 10% modulus value.
That is, the 10% modulus value is a numerical value measured in the "direction showing the extensibility" shown in FIG.

(Measurement of loop stiffness value)
The loop stiffness value was measured as an index of the flexural rigidity of the patch support film 1 in Examples and Comparative Examples. The evaluation of the loop stiffness value was carried out using "Loop Stiffness Tester (DA-S)" manufactured by Toyo Seiki Seisakusho Co., Ltd. Under the conditions that the sample width is 15 [mm], the loop length is 85 [mm], and the pushing distance (chuck-indenter distance) is 20 [mm], the concave portion 2b and the convex portion of the patch support film 1 are convex. It was performed in the direction perpendicular to the same plane as the direction in which the portions 2a were arranged, and the maximum load when the loop was pushed was taken as the loop stiffness value.
That is, the loop stiffness value is a numerical value measured in the "direction indicating the bending rigidity" shown in FIG.

(Calculation of 10% modulus value)
The 10% modulus value is calculated by performing the numerical calculation when the thickness T [μm], Young's modulus E [GPa], and height difference H [μm] in the examples and comparative examples are applied to the equation (3). did.
(Calculation of loop stiffness value)
The thickness T [μm], Young's modulus E [GPa], height difference H [μm], pitch P [μm], width W1 [μm], and width W2 [μm] in Examples and Comparative Examples are expressed in the formula (4). The loop stiffness value was calculated by performing a numerical calculation at the time of fitting.

(Evaluation of resistance to peeling)
With respect to the film 1 for the patch support in the examples and the comparative examples, the adhesive 10 was applied to the samples of the examples and the comparative examples in order to evaluate the resistance to peeling when the film 1 was applied to the skin, and 5 [cm]. It was cut into four sizes. Then, the cut-out sample was attached to the skin. The adhesive area ratio immediately after application to the skin was set to 100%, and the adhesive area ratio after 1 day was used as an index of resistance to peeling.
If the adhesive area after 1 day was maintained at 90% or more, it was evaluated as "◯", and if it was smaller than 90%, it was evaluated as "x".

(Evaluation of ease of handling)
In order to evaluate the ease of handling of the patch support film 1 in Examples and Comparative Examples, the pressure-sensitive adhesive 10 was applied to the samples of Examples and Comparative Examples, laminated on the release liner 12, and then 5 [ cm] Cut out to a size of four sides. After that, when the laminate of the film 1 for the patch support and the adhesive 10 is peeled off from the release liner 12, the laminate of the film 1 for the patch support and the adhesive 10 is stretched or is applied to the skin. It was confirmed that the adhesives 10 did not stick to each other during the pasting work. The evaluation was performed by each of the five subjects five times, and if no problem occurred, it was evaluated as "○", and if the problem occurred even once, it was evaluated as "x".

(Comprehensive evaluation)
Those that were "x" in either "difficulty of peeling" or "ease of handling" were evaluated as "x", and those that were both "○" were evaluated as "○".
Table 1 shows the conditions in Examples and Comparative Examples and a list of evaluation results.

As can be seen from Table 1, in the film 1 for the patch support of Examples 1 to 5 based on the present invention, the 10% modulus value and the loop stiffness value are within an appropriate range, and the overall evaluation is also “◯”. rice field.
On the other hand, in Comparative Examples 1 to 3, it is considered that the 10% modulus value or the loop stiffness value is out of the appropriate range, and the evaluation result of the resistance to peeling is “x”. In particular, Comparative Examples 2 and 3 have a low 10% modulus value, and the result is that they are easily peeled off even though they have good extensibility. That is, the evaluation result shows that the property required for the film 1 for the patch support is not only the extensibility, and suggests that the bending rigidity is also the required property.

Further, Comparative Examples 4 and 5 achieved sufficient peeling resistance when they could be applied, but the 10% modulus value or the loop stiffness value was too low, which made it difficult to handle, and peeled off from the peeling liner to the skin. There was a problem in the process of pasting.
Further, as can be seen from Table 1, the 10% modulus value and the loop stiffness value are calculated from the Young's modulus of the film 1 for the patch support, the film thickness, and the shape of the film, according to the equations (3) and (4). It showed a value close to. From this, it is proved that the film 1 for a patch support satisfying the formulas (1) and (2) has no problem in handling at the time of sticking and is hard to peel off when used as a patch. rice field.

Since the patch using the patch support film of the present invention as a support has an appropriate range of extensibility and bending rigidity, it is difficult to peel off when the film is attached to the skin. Therefore, the film for a patch support of the present invention has high possibility of being used as a patch used in the medical field.

1 ... Film for patch support, 2 ... Concavo-convex structure, 2a ... Convex part, 2b ... Concave part, 2c ... Connection surface, 10 ... Adhesive layer, 11 ... Ink layer, 12 ... Release liner, 21 ... Chuck, 22 ... Ink, H ... height difference, T ... film thickness, P ... pitch width, W1 ... convex width, W2 ... concave width, 100 ... patch

Claims (8)

With respect to the resin film having a drug barrier property, concave portions and convex portions are alternately formed when viewed from a direction orthogonal to the thickness direction of the resin film.
The 10% modulus value along the direction in which the concave portion and the convex portion are arranged is in the range of 0.1 N / 15 mm or more and 4 N / 15 mm or less.
A patch support whose loop stiffness value in the direction perpendicular to the direction in which the concave portion and the convex portion are arranged is in the range of 1 mN / 15 mm or more and 15 mN / 15 mm or less. Film for. The top of the convex portion and the bottom surface of the concave portion are flat surfaces when viewed from a direction orthogonal to the thickness direction.
The surface connecting the top and the bottom is a slope that separates from the top as it goes from the top to the bottom when viewed from a direction orthogonal to the thickness direction.
The width of the convex portion is W1 [μm], the width of the concave portion is W2 [μm], and the concave portion of the adjacent set of the concave portion and the convex portion, as viewed from a direction orthogonal to the thickness direction. The pitch width, which is the length along the direction in which the convex portions are arranged, is P [μm], the thickness of the resin film is T [μm], and the height difference between the top and the bottom surface is H [μm]. The film for a patch support according to claim 1, wherein the young ratio of the resin film is E [GPa], and the following formulas (1) and (2) are satisfied.
0.1 ≤ E x T ³ / H x 0.0165 ≤ 4 ... (1)
1 ≦ (W1 + W2) / P × T / 12 × (3H ² + T ² ) × E × 0.0016 ≦ 15… (2) The film for a patch support according to claim 1 or 2, wherein the breaking strength along the direction in which the concave portion and the convex portion are arranged is 5 N / 15 mm or more. The resin forming the resin film is polyethylene terephthalate, cycloolefin copolymer, cycloolefin polymer, polyacrylonitrile, ethylene-vinyl alcohol copolymer, and polyethylene terephthalate, cycloolefin copolymer, cycloolefin polymer, polyacrylonitrile, ethylene-. The patch support film according to any one of claims 1 to 3, wherein at least two of the vinyl alcohol copolymers are polymerized modified polymers. The film for a patch support according to any one of claims 1 to 4, wherein the 10% modulus value is in the range of 0.1 N / 15 mm or more and 2 N / 15 mm or less. The film for a patch support according to claim 5, wherein the 10% modulus value is in the range of 0.1 N / 15 mm or more and 1 N / 15 mm or less. The film for a patch support according to any one of claims 1 to 6, wherein the loop stiffness value is in the range of 1 mN / 15 mm or more and 5 mN / 15 mm or less. The film for a patch support according to any one of claims 1 to 7.
The pressure-sensitive adhesive layer laminated on one surface of the patch support film,
A patch comprising a release liner layer laminated on a surface of the pressure-sensitive adhesive layer opposite to a surface facing the patch support film.

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