JP2020063221A - Film for patch support body, laminated body, and patch - Google Patents

Abstract

To provide a film for a patch support body which satisfies both medicine barrier property and extensibility while suppressing labor and a cost in manufacturing the film, and a laminated body and a patch using the film.SOLUTION: A film 1 for a patch support body is made of resin having medicine barrier property. The entire film is constituted to have a wavy shape in a thickness direction, and thus the film has an uneven structure 12 in which recesses 12A and protrusions 12B are repeated along a surface. The top part of the protrusions 12B and the bottom of the recesses 12A have a flat shape in a cross section. The film thickness of the film 1 for a patch support body is 5 μm or more and 150 μm or less. A height difference H between the recesses and the protrusions is larger than the film thickness of the film 1 for a patch support body.SELECTED DRAWING: Figure 1

Description

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

  The patch used in the medical field and the like is a preparation intended to be percutaneously absorbed and taken into the body by being stuck to the skin. The patch is composed of a laminate of a film and a non-woven fabric. As an example of the structure of a patch, 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 constituting a film for patch patch support and a release liner is further laminated on the surface of the pressure-sensitive adhesive layer. There is one.

  Here, the properties required of the support include, for example, having a drug barrier property and having extensibility. The drug barrier property refers to a property that the support does not or hardly absorbs the drug because it does not hinder the transdermal absorption of the drug. In the present specification, when the support has a drug absorption rate of less than 10% when stored in an environment of a temperature of 40 ° C. and a humidity of 75% RH for one month, it is defined as having a drug barrier property. On the other hand, extensibility is an important factor in that the patch does not feel tense or stiff when it is applied to the skin, and that the patch does not easily peel off when the body is moved. The extensibility in the present specification refers to a ratio of elongation when a support is stretched before reaching a yield point.

  However, it is often difficult to achieve both the drug barrier property and the extensibility. Resins having a drug barrier property include biaxially stretched polyethylene terephthalate (PET), ethylene-vinyl alcohol copolymer (Ethylene-Vinylalcohol copolymer; EVOH), one of cyclic olefin copolymers (Cyclic Olefin Copolymer); COC, etc. Limited to part materials. These materials generally have the drawback of high strength and low extensibility.

  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 a patch support (film for patch support), and by providing a groove-like cut on the surface thereof, We provide an adhesive patch with improved followability when applied to the skin.

Japanese Patent No. 5349837

In the case of the patch of Patent Document 1, fine grooves are processed on the surface of the film formed. However, such processing requires extremely delicate mechanical or electrical adjustment.
The present invention is intended to solve such problems, and an object thereof is to provide a film for patch support that has both drug barrier properties and extensibility, a laminate and a patch using the film. .

  In order to solve the problems, one embodiment of the present invention is a patch support film made of a resin having a drug barrier property, wherein the entire film is formed in a wavy shape in the thickness direction, Has a concavo-convex structure in which concave portions and convex portions are repeated along the top and bottom portions of the convex portions and the concave portions, respectively, and has a flat cross section, and the thickness of the film for patch support is 5 μm or more and 150 μm or less. The gist is that the height difference between the concave portion and the convex portion is larger than the film thickness of the film for patch support.

According to the aspect of the present invention, it is possible to provide a film for a patch support that has both drug barrier properties and extensibility, a laminate and a patch using the same while suppressing the labor and cost during manufacturing. Become.
Further, even if the uneven structure is provided, by making the top of the convex portion and the bottom of the concave portion flat in cross section, while securing bending rigidity in the extending direction of the convex portion and the concave portion, other pressure-sensitive adhesive layers such as The adhesion to the layer and the printability on the top of the convex portion and the bottom of the concave portion are improved.

It is sectional drawing which showed one Embodiment of the film for adhesive patch supports of this invention. 1 is a perspective view showing an embodiment of a film for patch support of the present invention. FIG. 3 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 present invention is pulled. It is sectional drawing which shows an example of the film for patches support which consists of multiple layers. It is sectional drawing which showed one Embodiment of the laminated body using the film for adhesive patch supports of this invention. It is sectional drawing which showed one Embodiment of the laminated body using the film for adhesive patch supports of this invention. It is sectional drawing which showed one Embodiment of the laminated body using the film for adhesive patch supports of this invention. It is sectional drawing which showed the outline of a general patch. FIG. 3 is a cross-sectional view showing an embodiment of a patch using the film for patch support of the present invention. FIG. 3 is a cross-sectional view showing an embodiment of a patch using the film for patch support of the present invention. It is the front view which showed one Embodiment in the case of having a some division of the film for adhesive patch supports of this invention.

Embodiments of the present invention will be described below with reference to the drawings.
Note that each drawing is a schematic view, and the size and shape of each portion are exaggerated as appropriate for easy understanding. Further, the front surface and the back surface used in the present specification are descriptions for convenience, and either of the pair of surfaces in the film for patch support may be the front surface and the back surface.

The patch support film 1 of the present embodiment shown in FIGS. 1 and 2 is a single-layer resin film made of a resin having a drug barrier property. The film 1 for patch support has a concavo-convex structure in which concave portions 12A and convex portions 12B are periodically repeated along the surface of the film because the entire film is formed in a wavy shape (meandering shape) in the thickness direction. Have twelve.
The concave portions 12A and the convex portions 12B extend in a direction intersecting the direction in which the irregularities are arranged. Although FIG. 2 exemplifies a case where the concave portions 12A and the convex portions 12B linearly extend in a direction orthogonal to the direction in which the concavities and convexities are arranged, the concave portions 12A and the convex portions 12B extend meanderingly or concentrically. As described above, there is no limitation on the form (concavo-convex pattern) of the extended pattern of the concave portion 12A and the convex portion 12B.

  The patch support film 1 has a concavo-convex structure 12 consisting of periodic concavities and convexities on the front and back sides, due to the shape (meandering shape) in which the entire film is repeatedly undulated in the thickness direction. As a result, high extensibility can be exhibited in the direction in which the irregularities are arranged. Further, bending rigidity in the extending direction of the concave portion 12A and the convex portion 12B is improved. The area where the concave-convex structure 12 is provided may be the entire surface of the patch support film 1 or a part of the patch support film 1 in plan view. Further, a plurality of regions where the uneven structure 12 is provided may be provided as described later.

  Further, the top 12Ba of the protrusion 12B and the bottom 12Aa of the recess 12A each have a flat cross section (flat shape). The adjacent top 12Ba and bottom 12Aa are connected by a wall 12C. In FIG. 1, since the wall 12C is inclined with respect to the film thickness direction, the wall 12C is also referred to as a slope 12C. The wall portion 12C may be arranged so as to extend in the same direction as the film thickness direction. However, it is preferable that the wall portion 12C be an inclined portion that is inclined in a direction in which the positions of the adjacent top portion 12Ba and bottom portion 12Aa are separated. Since the film is inclined, when the film is pulled in the direction in which the concavities and convexities are arranged, the possibility that stress concentrates on the boundary portion between the inclined surface portion 12C and the top portion 12Ba and between the inclined surface portion 12C and the bottom portion 12Aa and the film is prevented from breaking. As a result, the uneven structure 12 is easily stretched.

In the example of FIG. 1, the concavo-convex structure 12 extends 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 vertical direction to the top surface 2a, the sloped surface 2b, and the bottom surface 2c. And the upper surface 2b of the slope portion is repeatedly formed. Further, a top lower surface 3a, a slope lower surface 3b, and a bottom lower surface 3c are provided at lower surface 3 positions corresponding to the top upper surface 2a, the slope upper surface 2b, and the bottom upper surface 2c, respectively.
Here, in FIG. 1, the distance from any one end (the left end in FIG. 1) in the width direction of the top surface 2a to the end on the same side in the width direction of the adjacent top surface 2a is the film for the patch support. It is defined as the pitch P of the uneven structure 12 of 1. The pitch P corresponds to the distance between the adjacent tops 12Ba. The pitch P may be a distance between the central portions of the adjacent top portions 12Ba or the like.

Further, as shown in FIG. 1, the space between the bottoms 2c of the adjacent recesses 12A on the surface (the upper surface side in FIG. 1) on which the protrusion 2B projects is defined as L. This interval L is the distance from the boundary between the slope upper surface 2b and the bottom upper surface 2c to the boundary between the slope upper surface 2b and the bottom upper surface 2c which are adjacent to each other with the top upper surface 2a interposed therebetween. It is also called the length L in the width direction.
Further, the height difference in the film thickness direction between the adjacent concave portion 12A and convex portion 12B is referred to as H. 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, either the distance in the height direction between the top surface 2a and the bottom surface 2c or the distance between the top surface 3a and the bottom surface 3c in the height direction along the film thickness direction is defined as the height difference H.

FIG. 3 shows a film 1 for a patch support having a concavo-convex structure 12 as shown in FIG. 1 and a flat film for a patch support without the concavo-convex structure 12 in the left-right direction of FIG. It is the schematic which showed the elongation of the whole film at the time of pulling in, and the relationship of the stress applied to a film.
When the patch support film 1 having the concavo-convex structure 12 is pulled, as shown by reference numeral X2 in FIG. 3, the concavo-convex structure 12 is mainly crushed and spreads (a region that extends without applying much force), and the crush The concavo-convex structure 12 is further stretched and becomes substantially flat (a region where a force is applied and extended) to reach the yield point. If it is further pulled, plastic deformation occurs, and necking occurs, so that the fracture point is finally reached. Necking refers to a phenomenon in which the entire parallel portion of the film to be stretched does not stretch uniformly, but a constriction locally occurs.

On the other hand, when a flat patch support film without the concavo-convex structure 12 is pulled under the same conditions, elastic deformation occurs only at a short distance after the film starts to grow, as shown by reference numeral X1 in FIG. Reach the yield point. If it is further pulled, plastic deformation occurs and necking occurs to reach the break point.
As described above, the film 1 for patch support according to the present invention has an elongation amount due to the concavo-convex structure 12 being crushed and expanded before yielding, so that it is yielded as compared with a normal flat film for patch support. The amount of expansion before reaching the point can be set large. However, since the plastic deformation finally becomes dominant, the breaking strength is the same as that of a usual flat film for patch support.

As described above, in the film 1 for patch support of the present embodiment, the patch is made of a material that is generally considered to have low extensibility because it has the concavo-convex structure 12 in which periodic irregularities are formed on the front and back surfaces. Even if a film for a support is produced, the extensibility of the film can be improved.
The thickness of the patch support film 1 is preferably 5 μm or more and 150 μm, and more preferably 10 μm or more and 100 μm. The film thickness for the patch support film 1 does not necessarily have to be uniform, and for example, the top part 12Ba, the slope part 12C, and the bottom part 12Aa may have different film thicknesses.

Further, the height difference H of the concavo-convex structure 12 is designed to be larger than the thickness T of the patch support film 1. If the height difference H of the concavo-convex structure 12 is not more than the film thickness T, it is difficult to obtain the effect of elongation by deforming the concavo-convex structure 12 of the patch support film 1 into a flat state.
The upper limit of the height difference H is preferably 300 μm or less. The reason is that the uneven structure 12 can be stably formed when the patch support film 1 is manufactured by using various methods such as hot pressing and extrusion molding.

The material for the patch support film 1 is suitable for a desired film-forming method such as casting, inflation, hot press molding, extrusion, calender molding, and has a barrier property against a desired drug (drug barrier). The resin having the property) may 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 a drug barrier property against a drug assumed for use (application) of the patch.
Examples of the material of the patch support film 1 include a resin selected from polyethylene terephthalate, cycloolefin copolymer, cycloolefin polymer, polyacrylonitrile, ethylene-vinyl alcohol copolymer, and modified polymers thereof. . The use of such a resin is preferable because a good drug barrier property is exhibited. A film formed of such a material has a drug barrier property against drugs such as rivastigmine and tulobuterol.

Further, by appropriately controlling the concavo-convex shape and concavo-convex pattern of the periodic concavo-convex 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, adjustment such as increasing the height difference H of the concavo-convex structure 12 and decreasing the pitch P may be performed. If such adjustment is performed, the amount of elongation of the film 1 until the shape of the patch support film 1 is deformed to approach a flat state can be easily increased, and the extensibility can be enhanced.
The periodic unevenness of the uneven structure 12 does not need to be a trapezoidal shape as shown in FIGS. 1 and 2, but may be a rectangular shape. There is no particular limitation as long as the top portion 12Ba of the convex portion 12B and the bottom portion 12Aa of the concave portion 12A have an uneven shape with a flat cross section.

Further, as shown in FIG. 1, when observing the cross section of the concavo-convex structure 12, the surfaces 2b and 3b of the wall portion 12C (slope surface portion) do not need to be formed by a straight line in cross section, and a polygonal line (step shape, etc.) or It may be composed of a curved line. However, at least 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 are alternately formed while sandwiching the wall portion 12C. With such a shape, it is possible to improve the extensibility while suppressing the possibility that the stress is locally concentrated and the portion is broken when pulled in the arrangement direction of the unevenness of the uneven structure 12.
Further, as shown in FIGS. 1 and 2, it is preferable that the top surface 2a and the bottom surface 2c are parallel to each other, and the top surface 3a and the bottom surface 3c are parallel to each other. In this case, as will be described later, when the patch support film 1 is used as a laminate or a patch by laminating it with another layer such as a thermoplastic resin or an adhesive layer, the patch It is more preferable because the adhesion between the support film 1 and other layers is improved.

That is, since the top portion 12Ba of the convex portion 12B and the bottom portion 12Aa of the concave portion 12A have a flat cross-sectional shape (flat shape), when laminating another layer on the patch support film 1, the top portion 12Ba of the convex portion 12B is formed. Also, the adhesion between the bottom portion 12Aa of the recess 12A and other layers is improved. Further, even if the uneven shape is provided, the adhesion of the ink to the top portion 12Ba of the convex portion 12B and the bottom portion 12Aa of the concave portion 12A is improved and good printability is obtained.
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. When the height difference H is 5 μm or less, it is difficult to obtain the effect of deforming the uneven structure 12 of the adhesive patch film 1 into a flat state, and it is difficult to provide the uneven structure 12 exceeding 300 μm in terms of manufacturing. Is.

In the film 1 for patch support, the ratio (H / L) of the height difference H to the length L in the width direction of the concavo-convex structure 12 is preferably 0.10 or more and 1.00 or less, and more preferably 0. 10 or more and 0.50 or less. When the ratio (H / L) of the height difference H to the length L in the width direction is larger than 1.00, it becomes difficult to form the concave-convex structure 12 in manufacturing, and the top surface 2a of the top surface 2 and the slope surface It is also difficult to keep the film thickness on 2b and the bottom surface 2c uniform. Further, if the ratio (H / L) of the height difference H to the length L in the width direction is smaller than 0. 10, it is difficult to obtain the effect of elongation due to the shape deformation of the concavo-convex structure 12.
In the patch support film 1, the ratio (W2a / W2c) of the width W2a of the top surface 2a in the left-right direction of the paper to the width W2c of the top surface 2c in the left-right direction of the paper is 0.10 or more 10 It is preferably less than or equal to 0.0.

When the ratio of the width W2a to the width W2c (W2a / W2c) is smaller than 0. 10, the boundary portion between the top surface 2a and the sloped surface 2b which is in contact with both ends of the top surface 2a is close to each other. When the concavo-convex structure 12 of the patch support film 1 is pulled in the direction in which it is aligned, the stress is locally concentrated on the boundary portion and the possibility of breakage increases.
Further, when the ratio of the width W2a to the width W2c (W2a / W2c) is larger than 10.0, the boundary portion between the bottom surface 2c and the slope surface 2b which is in contact with both ends of the bottom surface 2c is close to each other. When the concavo-convex structure 12 of the patch support film 1 is pulled in the direction in which it is aligned, the stress is locally concentrated on the boundary portion and the possibility of breakage increases.

(Production method)
As the method for producing the film 1 for patch support of the present embodiment, various methods such as hot pressing and extrusion molding can be appropriately selected.
In the method by hot pressing, the formed film can be produced by passing it between a pair of heating rolls having an uneven shape on the surface or a pair of heated flat plate presses. At this time, between the pair of heating rolls or between the pair of flat plates, the upper and lower concave shapes and the convex shapes are precisely aligned, and the front and back surfaces of the film after the hot pressing have a continuous uneven structure 12. Is important.
Further, in the extrusion molding method, the resin is heated and melted, extruded from the T-die, and cooled in a cooling step for forming a film by applying a nip pressure using a cooling roll and a nip roll provided with an uneven shape. Then, the concavo-convex structure 12 can be continuously provided on the front and back surfaces of the film. Also in this method, it is necessary to precisely align the uneven shapes of the cooling roll and the nip roll.

  Alternatively, in another method by extrusion molding, a plurality of extruders are used, and a plurality of types of resins are coextruded by a feed block method or a multi-manifold method, whereby a multilayer film having two or more layers can be obtained. In the cooling step 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. Further, 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 similarly formed at the interface between the first resin layer and the second resin layer. 12 is formed. Therefore, when the second resin layer is peeled from the cooled multilayer film, a first resin layer having the uneven structure 12 on the front and back surfaces is obtained, which can be used as the patch support film 1. .

In addition, various methods such as casting molding, inflation molding, calender molding, etc. can be appropriately selected to produce the patch support film 1.
The patch support film 1 may be a single layer as shown in FIGS. 1 and 2. Further, as shown in FIG. 4, a multilayer structure in which a plurality of films 1 for patch support is laminated by increasing the layer structure of coextrusion may be used. In this case, the back surface of one film 1 for patch support is bonded to the front surface of another film 1 for patch support.
Further, the patch support film 1 may have a laminated structure of three or more layers. In these cases, a structure in which a functional layer such as a printing layer, a vapor deposition layer, a hard coat layer, or an antireflection layer is laminated on the patch support film 1 in a later step may be used.

  As shown in FIG. 5, the laminated body 4 may be formed by laminating the thermoplastic resin layer 5 on at least one of the front surface formed by the upper surface 2 and the back surface formed by the lower surface 3 of the patch support film 1. . FIG. 5 illustrates the case where the thermoplastic resin layer 5 is laminated on the lower surface. The laminated body 4 may be formed by laminating the film 1 for adhesive patch support and the thermoplastic resin layer 5 which are separately formed through an adhesive or a pressure-sensitive adhesive, or at the same time by a coextrusion method or the like during film formation. You may. When the thermoplastic resin layer 5 is laminated, the extensibility tends to be slightly reduced. However, the thermoplastic resin layer 5 can be expected to improve the strength of the patch support film 1 and to be effective as a functional layer such as an oxygen barrier property. The material of the thermoplastic resin layer 5 is not particularly limited. When a material having a low elastic modulus such as low density polyethylene, linear low density polyethylene, or high density polyethylene is used as the material of the thermoplastic resin layer 5, the extensibility of the patch support film 1 is reduced. Is suppressed, which is preferable. That is, it is preferable that the thermoplastic resin layer 5 is made of a material having a lower elastic modulus than that of the patch support film 1. For example, as the thermoplastic resin layer 5, a resin having an elastic modulus of 400 MPa or less is used.

Further, as shown in FIG. 6, another patch support film 6 may be laminated with the patch support film 1 in a state where a part of the film is provided to form a laminate 4. Alternatively, as shown in FIG. 7, a laminated body 4 in which another patch film 6 for patch support is laminated with a film 1 for patch support via an adhesive layer 7 in a state in which a gap is provided in a part thereof. Also good. 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 other film 6 for the patch support. The resin laminated on the film 1 for patch support according to the present invention preferably has a lower elastic modulus than that of the film 1 for patch support according to the present invention.
Further, it can be used as a patch by laminating a pressure-sensitive adhesive layer and a release liner, which will be described later, on a laminate 4 provided with the film 1 for patch support according to the present invention as shown in FIGS.

FIG. 8: is sectional drawing which showed the outline of the general patch 11. The general patch 11 of FIG. 8 has a structure in which a pressure-sensitive adhesive layer 9 containing a drug and a release liner 10 are laminated in this order on one surface of the patch support film 8 having flat both surfaces. ing. When such a patch 11 is used, 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 from the skin, and the drug exhibits a medicinal effect in the living body. The film 8 for the patch support, which constitutes the general patch 11, has poor extensibility because its front and back surfaces are flat, and when it is applied to the skin, it feels tense or stiff, and the body was moved. There are problems such as easy peeling.
On the other hand, the patch support film 1 of the present embodiment and the laminate 4 using the same can have greater extensibility than conventional ones. As a result, it becomes possible to suppress bracing and stiffness when it is attached to the skin, and to make it difficult to peel off when the body is moved.

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

In any case, by manufacturing the patch support film 1 with a material having a high drug barrier property, it is possible to prevent the drug from being absorbed by the patch support film 1 and efficiently be absorbed into the skin. become. Further, the unevenness structure 12 provided on the front and back surfaces of the patch support film 1 makes it possible to enhance the extensibility.
Here, in the above description, the case where the entire surface of the patch support film 1 is the region 13 in which the concavo-convex structure 12 is formed is illustrated, but the invention is not limited thereto. For example, a configuration may be adopted in which flat portions in which the concave-convex structure 12 is not formed are provided at the end portion or the central portion in the arrangement direction of the irregularities (the horizontal direction in FIG. 1).

Further, as shown in FIG. 11, a plurality of regions 13 may be arranged in the patch support film 1, and the concavo-convex structure 12 may be formed in each region 13 by an individual concavo-convex pattern.
In FIG. 11, an edge (boundary line) 13a that divides the adjacent regions 13 is represented by a solid line, and in each region 13, the boundary between the top surface 2a and the sloped surface 2b is a dotted line, and the bottom surface 2c is a boundary. The boundary of the upper surface 2b of the inclined surface portion is indicated by a chain line.
In FIG. 11, the patch support film 1 is divided into 16 regions 13, and one edge (referred to as “edge”) of each area 13 on the upper surface 2 is opposite to the other edge. A top surface 2a, a sloped surface 2b, and a bottom surface 2c extend to the edge. The same applies to the lower surface 3 as well (not shown) for the top lower surface 3a, the inclined lower surface 3b, and the bottom lower surface 3c.

Further, in FIG. 11, the concavo-convex pattern in each of the regions 13 is designed so that the adjacent regions 13 have different concavo-convex arrangement directions.
A film having a large extensibility has a problem that it is difficult to form a stable film because the film is stretched due to pulling during processing. On the other hand, as shown in FIG. 11, by dividing one film into a plurality of regions 13 and individually setting the concavo-convex pattern in each region, the extensibility of the entire patch support film 1 is improved. Can be kept small. This enables stable film formation during molding. That is, even if the concavo-convex structure 12 is provided to improve the extensibility, the film 1 for patch support can be easily handled at the time of production or management.

A film 1 for a patch support as shown in FIG. 11 is used as a raw material of a final product, and by cutting or punching each region 13, a patch support that extends in a desired one direction as a final product. The body film 1 can be obtained.
Here, the final product does not have to be composed of only one region. For example, one final product may be composed of a plurality of areas 13 such as continuous two areas and four areas. At this time, the final product having two types of concave and convex structures may be obtained by cutting at the center position of each region 13. In such a case, in the final product, it is possible to set two or more directions in which the extensibility is good.

In addition, in FIG. 11, the patch support film 1 is illustrated as a raw material for producing a plurality of final products having the same structure. Further, the contour of each area 13 does not have to be rectangular, and may be another contour shape such as a circle.
The boundary between the adjacent regions 13 may not have a clear boundary line 13a. Further, the number of regions 13 included in the patch support film 1 is arbitrary. In addition, in the film 1 for patch support of FIG. 11, the boundary between the top surface 2a and the sloped surface 2b, and the boundary between the bottom surface 2c and the sloped surface 2b are parallel or orthogonal to the edge. 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 appropriately combine the exemplary embodiments.

(Effect of this embodiment)
(1) The film for patch support of the present embodiment is made of a resin having a drug barrier property, and the entire film is formed in a undulating shape in the thickness direction, so that the concave portion 12A and the convex portion are formed along the surface. 12B having a concavo-convex structure 12 repeating, the top 12Ba of the convex 12B and the bottom 12Aa of the concave 12A each have a flat cross section, and the film thickness of the patch support film is 5 μm or more and 150 μm or less, The height difference H between the concave portion 12A and the convex portion 12B is larger than the film thickness of the patch support film.
According to this configuration, it is possible to provide a film for a patch support that has both drug barrier properties and extensibility, a laminate and a patch using the same, while reducing the labor and cost during manufacturing.
Even if the concavo-convex structure 12 is provided, the top portion 12Ba of the convex portion 12B and the bottom portion 12Aa of the concave portion 12A have a flat cross section, so that the bending rigidity in the extending direction of the convex portion 12B and the concave portion 12A is ensured. Adhesion to other layers such as the pressure-sensitive adhesive layer and printability on the top 12Ba of the protrusion 12B and the bottom 12Aa of the recess 12A are improved.

(2) In the film for patch support of the present embodiment, the resin having a drug barrier property includes polyethylene terephthalate, cycloolefin copolymer, cycloolefin polymer, polyacrylonitrile, ethylene-vinyl alcohol copolymer, and modifications thereof. It is a resin selected from any of polymers.
According to this configuration, the film for patch support surely has the drug barrier property.
(3) In the film for patch support of the present embodiment, the top portion 12Ba of the convex portion 12B and the bottom portion 12Aa of the concave portion 12A are parallel to each other.
According to this configuration, it is possible to more reliably improve the adhesiveness when laminating other layers such as the pressure-sensitive adhesive layer, and the printability on the top 12Ba of the protrusion 12B and the bottom 12Aa of the recess 12A.

(4) In the film for patch support of the present embodiment, the wall portion connecting the top portion 12Ba of the convex portion 12B and the bottom portion 12Aa of the concave portion 12A that are adjacent to each other is a slope portion inclined with respect to the thickness direction of the film. .
According to this configuration, when the film is pulled in the direction in which the concavo-convex structure 12 is arranged, stress may be concentrated on the boundary portions between the inclined surface portion 12C and the top portion 12Ba and between the inclined surface portion 12C and the bottom portion 12Aa, and the film may be broken. As a result, the uneven structure 12 is easily stretched.
(5) In the film for patch support of the present embodiment, the height difference H between the concave portion 12A and the convex portion 12B is more than 5 μm and 300 μm or less.
According to this configuration, the extensibility can be improved more reliably.

(6) In the film for patch support of the present embodiment, the ratio (H / L) of the height difference H to the interval L between the bottom portions 12Aa of the adjacent recesses 2A on the surface on which the projections 2B project is , 0.10 or more and 1.00 or less.
According to this structure, the concavo-convex structure 12 can be easily provided, and the film thicknesses of the top portion 12Ba, the wall portion 12C, and the bottom portion 12Aa can be easily made uniform.
(7) In the film for patch support of the present embodiment, the ratio of the width of the top portion 12Ba to the width of the bottom portion 12Aa is 0.10 in the arrangement direction of the unevenness in the adjacent top portion 12Ba and the bottom portion 12Aa. The above is 10.0 or less.
According to this configuration, it is possible to relieve local stress concentration when the concavo-convex structure 12 is pulled in the arrangement direction.

(8) In the film for patch support of the present embodiment, the film has a plurality of regions 13 and each of the regions 13 is formed with the concavo-convex structure 12 in an individual concavo-convex pattern.
With this configuration, when used as a raw material for the final product, the elongations of the respective regions 13 offset each other to some extent, and excessive elongation is suppressed. The film 1 can be easily handled.
Further, when it is used as the film 1 for the patch support of the final product, it is easy to set the easy-to-stretch directions to two or more directions.
(9) A functional layer may be laminated on both surfaces or one surface of the patch support film to form a laminate.
According to this structure, it is possible to provide a laminate having good stretchability.

(10) A plurality of films for the patch support of the present embodiment may be laminated to form a laminate.
According to this configuration, for example, by laminating a patch support film made of a resin having a particularly excellent drug barrier property and a patch support film having excellent elongation properties, a laminate having different properties can be obtained. Can be provided.
(11) A patch may be prepared by laminating an adhesive layer and a release liner layer in this order on both sides or one side of the film for patch support of the present embodiment or the above laminate.
According to this structure, it is possible to provide a patch having both the drug barrier property and the extensibility.

Next, examples based on the present invention will be described, but the present invention is not limited to these examples.
(Example 1)
Soarnol (registered trademark) D2908 which is an ethylene-vinyl alcohol copolymer (Ethylene-Vinylalcohol copolymer; EVOH) manufactured by Nippon Synthetic Chemical Industry Co., Ltd. was selected as a material of the film 1 for patch support.
In addition, Novatec LD (registered trademark) LC701, which is Low Density PolyEthylene (LDPE) manufactured by Japan Polyethylene Corporation, was selected as a material of the resin coextruded with the film 1 for patch support.

The two kinds of resins were co-extruded by extrusion molding, and then cooled in a cooling step for forming a film while applying a nip pressure using a cooling roll provided with an uneven shape. Thereafter, the coextruded low density polyethylene layer was peeled off to manufacture a film 1 for patch support having a continuous concavo-convex structure 12 on the front and back surfaces of the film, which was referred to as Example 1.
The film thickness on the bottom surface 2c of the patch support film 1 was 30 μm, and the film thickness of the resin coextruded with the patch support film 1 at this portion was 45 μm.
Further, the uneven structure 12 has a height difference H of 100 μm, a length L236 μm in the width direction, a pitch P425 μm, and a width 205 μm in the left-right direction of the top surface 2a.

(Example 2)
The patch support film 1 was produced in the same manner as in Example 1 except that the uneven structure 12 of the patch support film 1 had a height difference H of 80 μm, a width direction length of L230 μm, and a pitch of P340 μm. It was set to 2.
(Example 3)
A patch support film 1 was produced in the same manner as in Example 1 except that the unevenness structure 12 of the patch support film 1 had a height difference H of 80 μm, a width direction length of L230 μm, and a pitch of P450 μm. It was set to 3.
(Example 4)
The patch support film 1 was produced in the same manner as in Example 1 except that the uneven structure 12 of the patch support film 1 had a height difference H of 60 μm, a width direction length of L224 μm, and a pitch of P255 μm. It was set to 4.

(Comparative Example 1)
The same EVOH as in Example 1 was used as the material, and in the cooling step for forming a film by extrusion molding, cooling was performed while applying a nip pressure using a flat cooling roll without unevenness, so that the front and back surfaces were flat. A film having a film thickness of 30 μm was produced and was used as Comparative Example 1.
(Comparative example 2)
Comparative Example 2 was an ester film (registered trademark) E5100 (film thickness 12 μm), which is a biaxially oriented polyethylene terephthalate (PET) film manufactured by Toyobo Co., Ltd. The film of Comparative Example 2 is a film whose front and back surfaces are flat.
(Comparative example 3)
A film 1 for patch support was produced in the same manner as in Example 1 except that the uneven structure 12 of the film 1 for patch support was made to have a height difference H5 μm, a length L206 μm in the width direction and a pitch P255 μm. It was set to 3. The film of Comparative Example 3 is a film in which the height difference H is smaller than the film thickness T.

(Tension evaluation)
In order to evaluate the extensibility of the patch support film 1 of each Example and the films of each Comparative Example, a tensile test was performed.
The test was carried out by using Tensilon Universal Testing Machine (RTC-1250A) manufactured by Orientec Co., Ltd., and applying a tensile force until the film broke, and an elongation percentage when the yield point and the rupture point were reached (the initial chuck interval). The ratio of elongation to distance) was recorded. The measurement conditions were a sample width of 15 mm, a chuck distance of 50 mm, and a pulling speed of 100 mm / min.

(Drug adsorption test)
In order to evaluate the drug barrier properties of the patch support film 1 of each example and the film of each comparative example, a drug adsorption test was carried out.
After each film was cut into 100 mm square, a patch was applied to the center. As the patch, 18 mg of Rivastouch (registered trademark) patch manufactured by Ono Pharmaceutical Co., Ltd. containing rivastigmine as a drug and 2 mg of Hokunarin (registered trademark) tape manufactured by Mylan Pharmaceutical Co., Ltd. containing tulobuterol were used. It was sealed with an aluminum foil so that the chemicals would not volatilize and diffuse, and stored for 1 month in an environment of a temperature of 40 ° C. and a humidity of 75% RH. Thereafter, 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 high performance liquid chromatography.

  Table 1 shows the evaluation results of the film 1 for patch support of each example and the film of each comparative example.

  As can be seen from Table 1, in the film 1 for patch support of Examples 1 to 4 according to the present invention, Comparative Examples 1 and 2 in which the front and back surfaces are flat, and a comparison in which the height difference value is smaller than the film thickness value As compared with the film of Example 3, the elongation rate at the yield point reached a high value in the tensile test, and it was confirmed that the film had high elongation. The elongation at the time of reaching the breaking point in the tensile test is higher than that of the flat PET film of Comparative Example 2, but the flat film of Comparative Example 1 and the value of the height difference are the film thickness values. The value was lower than the smaller film of Comparative Example 3. It is considered that this is because the provision of the uneven structure 12 facilitated necking.

  In addition, the film 1 for patch support of Examples 1 to 4 showed no adsorptivity for both drugs of rivastigmine and tulobuterol, and was confirmed to have good drug barrier properties equivalent to those of the PET film of Comparative Example 2. did it.

  By using the technique of the present invention, it becomes possible to manufacture a film for a patch support which has both drug barrier properties and extensibility while suppressing the labor and cost during the production. The film for patch support of the present invention can be expected to be used as a patch used in the medical field.

1 Film for Patch Support 2a Top Top 2b Slope Top 2c Bottom Top 3a Top Bottom 3b Top Bottom 3c Bottom Bottom 3c Bottom Bottom 4 Laminate 5 Thermoplastic Resin Layer 6 Patch Support Film 7 Adhesive Layer 8 Patch Support Body film 9 Adhesive layer 10 Release liner 11 Patch 12 Concavo-convex structure 12A Recess 12Aa Bottom 12B Convex 12Ba Top 12C Wall (slope)
13 Area 13a Edge (boundary)
H Height difference P Pitch L Length in width direction

Claims (12)

A film for a patch support comprising a resin having a drug barrier property,
Since the entire film is formed in a wavy shape in the thickness direction, it has a concavo-convex structure in which concaves and convexes are repeated along the surface,
The top portion of the convex portion and the bottom portion of the concave portion each have a flat cross section,
The film thickness for the patch support is 5 μm or more and 150 μm or less,
The film for adhesive patch support, wherein the height difference between the concave portion and the convex portion is larger than the film thickness of the film for adhesive patch support.   The resin having the drug barrier property is 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 claim 1, which is characterized in that.   The film for a patch support according to claim 1 or 2, wherein the top of the protrusion and the bottom of the recess are parallel to each other.   The wall part connecting the top part of the said convex part and the bottom part of the said recessed part which are adjacent is a slope part inclined with respect to the thickness direction of a film, The claim | item 1 characterized by the above-mentioned. Film for adhesive patch support.   The difference in height between the concave portion and the convex portion is more than 5 μm and 300 μm or less, and the film for patch support according to any one of claims 1 to 4.   The ratio (H / L) of the height difference H to the distance 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 film for patch support according to any one of claims 1 to 5.   The ratio of the width of the top to the width of the bottom is 0.10 or more and 10.0 or less in the direction in which the unevenness is arranged between the top and the bottom adjacent to each other. The film for patch support according to any one of 1.   The patch film for a patch according to any one of claims 1 to 7, wherein the film has a plurality of areas, and the uneven structure is formed in each area with an individual uneven pattern. .   A laminate in which a functional layer is laminated on both sides or one side of the film for patch support according to any one of claims 1 to 8.   A laminate comprising a plurality of films for a patch support according to any one of claims 1 to 8 laminated.   A patch comprising an adhesive layer and a release liner layer laminated in this order on both sides or one side of the film for patch support according to any one of claims 1 to 8.   An adhesive patch comprising a pressure-sensitive adhesive layer and a release liner layer laminated in this order on both sides or one side of the laminate according to claim 9 or 10.

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