Sustained-release body and method for producing the same

Abstract

To provide a sustained-release body that can continue stable sustained-release of an active ingredient over a long period of target time, and to provide a method for manufacturing a sustained-release body.SOLUTION: A sustained-release body includes: a substrate; and a vapor deposition polymer film directly formed at a first surface of both end surfaces of the substrate in a thickness direction. The substrate has a structure that contains a volatile active ingredient and emits a vaporized gas of the active ingredient. The vapor deposition polymer film has a function as a sustained-release film that receives a vaporized gas of the active ingredient from the first surface of the substrate and performs sustained-release of the vaporized gas.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to a sustained-release formulation and a method for producing the formulation. [Background technology]

[0002] Conventionally, in order to allow an active ingredient such as an antifungal agent, antibacterial agent, or deodorizer to act on a desired object over a long period of time, a sustained-release body has been proposed that vaporizes the active ingredient and gradually releases (sustained release) it to the outside. Generally, a sustained-release body has an active ingredient layer containing a vaporizable active ingredient on a substrate, and a sustained-release membrane on this active ingredient layer. In this sustained-release body, the sustained-release membrane slowly releases the gas of the active ingredient (vaporized gas) vaporized from the active ingredient layer to the outside. This allows the active ingredient to act on the desired object over a long period of time.

[0003] As such a sustained-release body, for example, Patent Document 1 discloses a sustained-release film in which an active ingredient layer is formed on the surface of a base film and an active ingredient permeation layer is formed on the active ingredient layer. In the sustained-release film described in Patent Document 1, the active ingredient permeation layer functions as a sustained-release membrane that slowly releases vaporized gas of the active ingredient generated from the active ingredient layer to the outside. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Japanese Patent Application Publication No. 2017-226188 Summary of the Invention [Problem to be solved by the invention]

[0005] However, in the conventional sustained-release bodies described above, a gap forms between the active ingredient layer and the sustained-release film as the vaporized active ingredient is gradually released. That is, as illustrated in FIG. 9, in a conventional sustained-release body 100, an active ingredient layer 103 is interposed between a substrate 101 and a sustained-release film 102. Therefore, as the vaporized gas 103a of the active ingredient contained in the active ingredient layer 103 is gradually released from the sustained-release film 102 to the outside, the active ingredient layer 103 continues to decrease in thickness, eventually resulting in a gap 104 between the active ingredient layer 103 and the sustained-release film 102. In this case, because the sustained-release film 102 formed from a vapor-deposited polymerized film is a thin film, damage such as a crack 105 shown in FIG. 9 may easily occur in the sustained-release film 102 due to external forces such as bending or pressing. This causes excessive release of vaporized gas 103a of the active ingredient from the damaged portion of sustained-release film 102, making it difficult to continuously sustain the targeted sustained release of vaporized gas 103a of the active ingredient for a long period of time.

[0006] The present invention has been made in consideration of the above circumstances, and aims to provide a sustained-release body and a method for producing a sustained-release body that can continue to stably release an active ingredient over a targeted long period of time. [Means for solving the problem]

[0007] In order to solve the above-mentioned problems and achieve the object, the sustained-release body of the present invention comprises a substrate and a vapor-deposited polymer film formed directly on the first of both end surfaces in the thickness direction of the substrate, wherein the substrate contains a vaporizable active ingredient and has a structure for releasing vaporized gas of the active ingredient, and the vapor-deposited polymer film receives the vaporized gas of the active ingredient from the first surface of the substrate and sustains its release.

[0008] In addition, the sustained-release body of the present invention is characterized in that, in the above invention, it is provided with a barrier layer formed on a second surface opposite to the first surface of both end surfaces in the thickness direction of the substrate, which blocks the vaporized gas of the active ingredient from the second surface side of the substrate.

[0009] Furthermore, the sustained-release body according to the present invention is characterized in that, in the above invention, the substrate is made of a porous material.

[0010] Furthermore, the sustained-release body according to the present invention is characterized in that, in the above invention, the porous material has an open-cell structure.

[0011] Furthermore, the sustained-release body according to the present invention is characterized in that, in the above invention, the base material is made of a polymer having a non-crystalline portion.

[0012] The sustained-release body according to the present invention is characterized in that the vapor-deposited polymer film has lower gas permeability than the substrate.

[0013] Furthermore, the sustained-release body according to the present invention is characterized in that, in the above invention, the thickness of the vapor-deposited polymer film is in the range of 1 μm or more and 900 μm or less.

[0014] In addition, the method for manufacturing a sustained-release body according to the present invention is characterized by comprising a sustained-release film formation process for forming a sustained-release film made of a vapor-deposited polymer film on a first of both end faces in the thickness direction of a substrate, and an active ingredient introduction process for introducing a volatile active ingredient into the substrate from a second of both end faces in the thickness direction of the substrate that is opposite to the first face on which the sustained-release film is formed.

[0015] In addition, the method for producing a sustained-release body according to the present invention is characterized in that, in the above invention, it includes a barrier layer formation step of forming a barrier layer that blocks the vaporized gas of the active ingredient on the second surface of the substrate after the active ingredient is introduced. [Effects of the Invention]

[0016] According to the present invention, it is possible to achieve the effect of continuing the stable sustained release of the active ingredient over the targeted long period of time. [Brief explanation of the drawings]

[0017] [Figure 1]FIG. 1 is a cross-sectional view showing a structural example of a sustained-release agent according to an embodiment of the present invention. [Figure 2] FIG. 2 is a cross-sectional view showing a structural example of a sustained-release agent according to an embodiment of the present invention when in use. [Figure 3] FIG. 3 is a flowchart showing an example of a method for producing a sustained-release agent according to an embodiment of the present invention. [Figure 4] FIG. 4 is a schematic diagram for specifically explaining the method for producing a sustained-release agent according to an embodiment of the present invention. [Figure 5] FIG. 5 is a schematic diagram showing an example of a film-forming apparatus for forming a sustained-release film of a sustained-release material according to an embodiment of the present invention. [Figure 6] FIG. 6 is a schematic diagram showing an example of an application device for introducing an active ingredient into the substrate of a sustained-release agent according to an embodiment of the present invention. [Figure 7] FIG. 7 is a schematic diagram showing an example of an application device for forming a barrier layer of a sustained-release agent according to an embodiment of the present invention. [Figure 8A] FIG. 8A is a cross-sectional view showing a structural example of a film for a barrier layer attached to the sustained-release film surface of a sustained-release body according to an embodiment of the present invention. [Figure 8B] FIG. 8B is a cross-sectional view showing a structural example of a film for a barrier layer attached to the surface of a substrate of a sustained-release agent according to an embodiment of the present invention. [Figure 9] FIG. 9 is a schematic cross-sectional view illustrating the problems with conventional sustained-release tablets. DETAILED DESCRIPTION OF THE INVENTION

[0018] Preferred embodiments of the sustained-release body and the method for manufacturing the sustained-release body according to the present invention will be described in detail below with reference to the accompanying drawings. Note that the present invention is not limited to these embodiments. It should be noted that the drawings are schematic, and the dimensional relationships and ratios of each element may differ from the actual ones. The drawings may also contain parts with different dimensional relationships and ratios. In addition, the same components are designated by the same reference numerals in each drawing.

[0019] (Composition of sustained release body) First, the configuration of a sustained release body according to an embodiment of the present invention will be described. Fig. 1 is a cross-sectional view showing an example of the configuration of a sustained release body according to an embodiment of the present invention. Fig. 2 is a cross-sectional view showing an example of the configuration of a sustained release body according to an embodiment of the present invention when in use. Figs. 1 and 2 show an example of the layered structure of a sustained release body 10 according to this embodiment.

[0020] In this embodiment, for the sake of convenience, a thickness direction D1 and a width direction D2 of the sustained-release body 10 are set, but these directions do not limit the present invention. One end side of the thickness direction D1 (the upper side of the paper in Figures 1 and 2) is the front side, and the other end side of the thickness direction D1 (the lower side of the paper in Figures 1 and 2) is the back side. The width direction D2 is a direction perpendicular to the thickness direction D1. The thickness direction D1 and width direction D2 also apply to each component of the sustained-release body 10.

[0021] The sustained-release body 10 according to this embodiment vaporizes an active ingredient to be applied to a desired target (not shown) and slowly releases it to the outside. As shown in Fig. 1, the sustained-release body 10 includes a substrate 1 containing a vaporizable active ingredient 11, a sustained-release film 2, barrier layers 3 and 7, adhesive layers 4, 5 and 8, and a protective sheet 6.

[0022] As shown in Figure 1, the substrate 1 forms a support layer that supports the sustained-release film 2, and contains a vaporizable active ingredient 11. The substrate 1 also has a structure that releases vaporized gas 11a (see Figure 2) of the contained active ingredient 11. Such a substrate 1 is preferably made of, for example, a polymer or porous material having an amorphous portion.

[0023] Examples of the porous material constituting the substrate 1 include porous resins in which a large number of minute holes have been formed by subjecting a solid resin to processing such as stretching or perforation, foamed resins, and fiber structures. Such porous materials have minute spaces inside and portions that connect the minute spaces to the outside, making them advantageous structures from the viewpoints of ease of containing the active ingredient 11 and ease of releasing the vaporized gas 11a of the active ingredient 11. Furthermore, from the viewpoint that the continuous bubbles in the porous material facilitate the release of the vaporized gas 11a of the active ingredient 11, it is more preferable that the porous material have an open-cell structure.

[0024] Examples of resin components constituting the porous resin include polyesters such as polyethylene terephthalate (PET), nylon, polyvinyl chloride, polyethylene, polypropylene, ethylene-vinyl acetate copolymer, and polytetrafluoroethylene. For example, the micropores in the porous resin can be formed by adding calcium carbonate to polyethylene and stretching the polyethylene. Examples of foamed resins include polyolefin foams, polyurethane foams, and rubber-based foams. Examples of the fiber structures include paper, woven fabrics, and nonwoven fabrics.

[0025] Furthermore, the polymer having the amorphous portion is a polymer having at least an amorphous structure. Examples of polymers having an amorphous portion include amorphous polymers, mixed polymers of crystalline and amorphous, and rubber. Examples of amorphous polymers constituting the substrate 1 include polystyrene and acrylic resins. Examples of acrylic resins include polymethyl methacrylate resin (PMMA). Examples of mixed polymers of crystalline and amorphous include resins with a folded crystalline structure in which crystalline and amorphous structures coexist. Examples of resins with this folded crystalline structure include polyethylene, polypropylene, and nylon. Such an amorphous structure allows the active ingredient to easily penetrate and permeate the gaps between molecular chains, making it an advantageous structure in terms of ease of inclusion of the active ingredient 11 and ease of release of vaporized gas 11a of the active ingredient 11.

[0026] The active ingredient 11 contained in the substrate 1 is selected depending on the intended use of the sustained-release body 10. Examples of the active ingredient 11 include various ingredients such as antifungal agents, antibacterial agents, anticorrosive agents, rust inhibitors, deodorizers, and fragrances. Alternatively, the active ingredient 11 may be a combination of two or more of these ingredients. Examples of compounds constituting such active ingredient 11 include hinokitiol, citronellal, aoba aldehyde (trans-2-hexenal), citronellol, and geraniol. The sustained-release body 10 can also be used as a box for transporting or storing objects such as vegetables, fruits, and flowers, or as packaging for such objects. In addition to these, the sustained-release body 10 can also be used as an antifungal sheet for greenhouse cultivation (e.g., a sheet for preventing powdery mildew), an antifungal sheet for shoe insoles to prevent athlete's foot, an antifungal and deodorizing sheet for shoe cabinets, an antibacterial sheet, and the like.

[0027] The thickness of the substrate 1 is set depending on the content of the active ingredient 11, the target sustained-release period of the vaporized gas 11a, the purpose of the sustained-release body 10, the size during use, etc. For example, the thickness of the substrate 1 is about 10 μm to several mm.

[0028] The sustained-release film 2 is a film for sustainedly releasing the active ingredient 11 vaporized from the substrate 1 to the outside. In detail, as shown in FIG. 1, the sustained-release film 2 is a vapor-deposition polymerized film formed directly on the surface 1a (first surface) of both end surfaces in the thickness direction D1 of the substrate 1. That is, the sustained-release film 2 is formed by vacuum-depositing two or more raw materials onto the surface 1a of the substrate 1. When the barrier layer 7 on the surface 2a is removed, such a sustained-release film 2 receives the vaporized gas 11a of the active ingredient 11 contained in the substrate 1 from the surface 1a of the substrate 1 and sustains the release, as shown in FIG. 2.

[0029] In this embodiment 1, the vaporized gas 11a is an active ingredient gas vaporized by volatilization or evaporation from the active ingredient 11 in the substrate 1. As shown in FIG. 2, the vaporized gas 11a passes through the substrate 1, from the surface 1a of the substrate 1, through the back surface 2b of the sustained-release film 2, and flows into the sustained-release film 2. The vaporized gas 11a then passes through the sustained-release film 2 and is gradually released to the outside of the sustained-release body 10. At this time, since the sustained-release film 2 is a vapor-deposited polymerized film formed directly on the surface 1a of the substrate 1, it gradually releases the vaporized gas 11a while maintaining a state of close contact with the surface 1a of the substrate 1. Therefore, even if the vaporized gas 11a continues to be slowly released, the vaporized gas 11a does not accumulate at the contact interface between the sustained-release film 2 and the substrate 1, i.e., between the back surface 2b of the sustained-release film 2 and the surface 1a of the substrate 1, and the active ingredient 11 is not interposed.

[0030] Such a vapor-deposited polymerized film constituting the sustained-release film 2 can improve the adhesion between the substrate 1 and the sustained-release film 2. That is, the surface 1a of the substrate 1 is an uneven surface with many tiny openings through which vaporized gas 11a of the active ingredient 11 is released. When the sustained-release film 2 is made of a vapor-deposited polymer, it adheres to the unevenness of the surface 2a, making it difficult for gaps to form between the sustained-release film 2 and the substrate 1, and therefore cracks are less likely to occur in the sustained-release film 2. For example, the sustained-release film 2 made of a vapor-deposited polymerized film is formed by vacuum-depositing and polymerizing two or more types of raw material monomers directly onto the surface 1a of the substrate 1.

[0031] The gas permeability of the sustained-release membrane 2 is lower than that of the substrate 1. In the present invention, the gas permeability is defined as the amount of gas that permeates a unit area of ​​a membrane or layer per unit time. The unit of this gas permeability is [g / m 2 / day]. That is, the sustained-release film 2 reduces the amount of vaporized gas 11a generated from the active ingredient 11 in the base material 1 from the amount of vaporized gas 11a that is based on the gas permeability of the base material 1 to the amount of vaporized gas 11a that is based on the gas permeability of the sustained-release film 2, and releases (slowly releases) it to the outside.

[0032] For example, the gas permeability of the substrate 1 can be measured by conducting a water vapor permeability test using a measurement sample of the substrate 1. As a result, an example of the gas permeability of the substrate 1 is 3000 g / m 2 A water vapor permeation rate of more than 467 g / m 2 / day (>>gas permeability of sustained-release film 2) was obtained. The gas permeability of the sustained-release film 2, which is one of the main components of the sustained-release body 10 according to the embodiment of the present invention, can be measured by forming the sustained-release film 2 on the substrate 1 and then conducting a water vapor permeability test similar to that for the substrate 1. As a result, an example of the gas permeability of the sustained-release film 2 was 467 g / m 2. 2 A water vapor permeation rate of 1 / day was obtained. From the above, it was confirmed that the gas permeation rate when the sustained-release film 2 was formed on the substrate 1 was lower than the gas permeation rate of the substrate 1 alone. In other words, it is clear that the sustained-release amount of vaporized gas 11a of the active ingredient 11 from the substrate 1 can be adjusted by the sustained-release film 2.

[0033] In measuring the gas permeability, a sustained-release film (4 μm thick) made of a vapor-deposited polymer was formed on the surface of a substrate (75 μm thick) made of a porous polyethylene material as a measurement sample for sustained-release film 2. The substrate (75 μm thick) made of the porous polyethylene material was used as a measurement sample for substrate 1. The amount of water vapor permeation was measured under conditions of a temperature of 20 to 40°C and a relative humidity of 60% RH and 90% RH based on the isobaric method specified in the humidity sensor method (JIS K 7129A).

[0034] The thickness of the sustained-release film 2 as described above is set by comprehensively considering the target sustained-release amount of vaporized gas 11a of active ingredient 11 (the sustained-release amount of vaporized gas 11a sustainedly released to the outside from a unit area region of the sustained-release film 2 per unit time), the type and content of active ingredient 11, etc. For example, the thickness of the sustained-release film 2 is preferably within the range of 1 μm or more and 900 μm or less. This is because if the thickness of the sustained-release film 2 is less than 1 μm, cracks are likely to occur in the sustained-release film 2, and if the thickness of the sustained-release film 2 is more than 900 μm, the sustained-release properties of the sustained-release film 2 may deteriorate.

[0035] The barrier layer 3 is intended to prevent the release of vaporized gas 11a of the active ingredient 11 from an unintended side of the sustained-release body 10. Specifically, as shown in FIG. 1 , the barrier layer 3 is made of a material such as resin or metal that has lower gas permeability (preferably gas impermeable) than the sustained-release film 2, and is formed on the back surface 1b of the substrate 1. For example, the barrier layer 3 has an adhesive layer 4 on its surface, and is attached to the back surface 1b of the substrate 1 by the adhesive force of the adhesive layer 4. In this embodiment, the back surface 1b of the substrate 1 is the surface (second surface) opposite to the surface 1a on which the sustained-release film 2 is formed, among both end surfaces of the substrate 1 in the thickness direction D1. That is, the front surface 1a of the substrate 1 is the surface intended for the release (sustained release) of the vaporized gas 11a of the active ingredient 11. The back surface 1b of the substrate 1 is the surface intended for the release of the vaporized gas 11a. The back surface 1b of the substrate 1 is the surface intended for the release of the vaporized gas 11a. The barrier layer 3 blocks the vaporized gas 11a of the active ingredient 11 from the back surface 1b side of the substrate 1. As a result, the barrier layer 3 prevents the vaporized gas 11a of the active ingredient 11 from being released from the back surface 1b of the substrate 1, which is not intended for gas release.

[0036] Examples of the resin constituting the barrier layer 3 include solid crystalline resins and rubbers. Examples of the crystalline resins include polyester and nylon. Examples of the rubbers include vulcanized rubber, silicone rubber, and urethane rubber.

[0037] The area of ​​the side surface 1c (end surface in the width direction D2) of the substrate 1 is extremely small compared to the surface 1a of the substrate 1. Therefore, even if vaporized gas 11a of the active ingredient 11 is released from the side surface 1c of the substrate 1, the amount of vaporized gas 11a released from this side surface 1c is negligibly small compared to the amount of vaporized gas 11a released from the surface 1a of the substrate 1.

[0038] The adhesive layer 5 is for fixing the sustained-release body 10 to a desired location of use. Specifically, as shown in FIG. 1, the adhesive layer 5 is formed on the back surface of the barrier layer 3. For example, before use of the sustained-release body 10 (before the vaporized gas 11a of the active ingredient 11 is slowly released), a protective sheet 6 that protects the adhesive layer 5 is detachably provided on the back surface of the adhesive layer 5. This protective sheet 6 is appropriately peeled off from the back surface of the adhesive layer 5 when using the sustained-release body 10, as shown in FIGS. 1 and 2, for example. This exposes the adhesive surface of the adhesive layer 5, allowing the sustained-release body 10 to be attached and fixed to a desired location of use.

[0039] The barrier layer 7 is intended to prevent the sustained release of vaporized gas 11a of the active ingredient 11 during an unintended period of time from the sustained-release body 10. In detail, as shown in FIG. 1 , the barrier layer 7 is made of the same material as the barrier layer 3 described above, and is detachably provided on the surface 2a of the sustained-release film 2. For example, the barrier layer 7 has an adhesive layer 8 on its back surface, and is attached to the surface 2a of the sustained-release film 2 by the adhesive force of the adhesive layer 8. The barrier layer 7 itself may be made of an adhesive resin or the like, and may be attached to the surface 2a of the sustained-release film 2 by the adhesive force of the barrier layer 7 itself. In either method, the barrier layer 7 is preferably provided so that the adhesive (adhesive layer 8) does not remain on the surface 2a of the sustained-release film 2 after being peeled off from the sustained-release film 2. Such a barrier layer 7 covers the surface 2a of the sustained-release film 2, thereby preventing the sustained-release of the vaporized gas 11a of the active ingredient 11 from the sustained-release film 2 during periods when the sustained release of the vaporized gas 11a of the active ingredient 11 is not intended, such as before use of the sustained-release body 10.

[0040] On the other hand, the barrier layer 7 is appropriately peeled off from the surface 2a of the sustained-release film 2 when the sustained-release body 10 is used, as shown in Figures 1 and 2. This exposes the surface 2a (sustained-release surface) of the sustained-release film 2, as shown in Figure 2. As a result, the sustained-release film 2 can slowly release the vaporized gas 11a of the active ingredient 11 vaporized from the base material 1 to the outside of the sustained-release body 10 toward a desired target (not shown).

[0041] (Manufacturing method of sustained release tablets) Next, a method for manufacturing the sustained release body 10 according to an embodiment of the present invention will be described. FIG. 3 is a flowchart showing an example of a method for manufacturing the sustained release body according to an embodiment of the present invention. FIG. 4 is a schematic diagram specifically illustrating the method for manufacturing the sustained release body according to an embodiment of the present invention. FIG. 5 is a schematic diagram showing an example of a film-forming device for forming a sustained-release film of the sustained-release body according to an embodiment of the present invention. FIG. 6 is a schematic diagram showing an example of an application device for introducing an active ingredient into the substrate of the sustained-release body according to an embodiment of the present invention. FIG. 7 is a schematic diagram showing an example of an attachment device for forming a barrier layer of the sustained-release body according to an embodiment of the present invention. The method for manufacturing the sustained-release body 10 according to this embodiment includes, for example, a sustained-release film-forming step, an active ingredient-introducing step, a barrier layer-forming step, and a cutting step, as shown in FIG. 3.

[0042] As shown in Fig. 3, in the manufacturing method of the sustained-release body 10 (see Fig. 1), first, a sustained-release film forming step (step S101) is performed. This sustained-release film forming step is a step of forming a sustained-release film 2 made of a vapor-deposited polymer film on the surface 1a (first surface) of both end surfaces in the thickness direction D1 of the substrate 1. In this sustained-release film forming step, for example, a film forming apparatus 30 shown in Fig. 5 is used. As shown in Fig. 5, the film forming apparatus 30 includes a vacuum chamber 31 as a reaction chamber, a connecting portion 32, a housing portion 33, and a vapor-deposited polymer film forming unit 37.

[0043] An exhaust pipe (not shown) communicating with a vacuum pump (not shown) is connected to the vacuum chamber 31, and is joined so as to be able to communicate with the housing 33 via a hollow connecting part 32. When the vacuum pump of the vacuum chamber 31 is operated, air inside the film forming apparatus 30 (specifically, the inside of the vacuum chamber 31, connecting part 32, and housing 33) is exhausted to the outside through the exhaust pipe, thereby creating a vacuum inside the film forming apparatus 30.

[0044] 5, a main roller 34 is installed inside the vacuum chamber 31, and an unwinding roller 35 and a winding roller 36 are installed inside the housing 33. The main roller 34 and the winding roller 36 are each configured to be continuously rotated by a rotary drive device (not shown) such as an electric motor.

[0045] Furthermore, a roll of strip-shaped substrate 1, which will serve as substrate 1 for sustained-release agent 10, is attached to unwinding roller 35. The strip-shaped substrate 1 unwound from unwinding roller 35 is wound around main roller 34, and the strip-shaped substrate 1 sent out from main roller 34 is wound around take-up roller 36. That is, in film formation apparatus 30, strip-shaped substrate 1 is transported from unwinding roller 35 to take-up roller 36 via main roller 34, a so-called roll-to-roll method. Note that, on the transport path within film formation apparatus 30, a plurality of tension rollers 38a to 38h are arranged, as shown in FIG. 5.

[0046] 3, first, the main roller 34 and the take-up roller 36 are driven to rotate, and thereby the strip-shaped substrate 1 is unwound from the unwinding roller 35. The unwound strip-shaped substrate 1 is transported in one circumferential direction (the direction indicated by arrow α in FIG. 5) on the outer peripheral surface of the main roller 34. Then, while the strip-shaped substrate 1 is being transported along the outer peripheral surface of the main roller 34, a vapor-deposited polymer film is formed on the strip-shaped substrate 1 by the vapor-deposited polymer film forming unit 37. The strip-shaped substrate 1 on which the vapor-deposited polymer film has been formed in this manner is taken up by the take-up roller 36.

[0047] As shown in FIG. 5 , the vapor-deposited polymer film-forming unit 37 includes two storage pots 39a and 39b and heaters (not shown) for heating the two storage pots 39a and 39b. The storage pots 39a and 39b each contain raw material monomers 40a and 40b for the vapor-deposited polymer film that constitutes the sustained-release film 2 in a liquid state under a vacuum environment. The vapor-deposited polymer film-forming unit 37 also includes steam supply pipes 41a and 41b, on-off valves 42a and 42b, and a mixing tank 43. The steam supply pipes 41a and 41b each have one end connected to the storage pots 39a and 39b and the other end connected to the mixing tank 43, thereby connecting the storage pots 39a and 39b to the mixing tank 43 in a communicative manner. The on-off valves 42a and 42b are provided at the midpoints of the steam supply pipes 41a and 41b, respectively. Mixing chamber 43 has an outer chamber arranged outside vacuum chamber 31 and an inner chamber arranged inside vacuum chamber 31. Steam supply pipes 41a and 41b are connected to the outer chamber of vacuum chamber 31, as shown in Fig. 5. The inner chamber of vacuum chamber 31 is configured to communicate with the outer chamber, and has an outlet 44 at the end on the main roller 34 side. Outlet 44 is arranged inside vacuum chamber 31 so as to face the outer circumferential surface of main roller 34.

[0048] In the vapor-deposited polymer film forming unit 37, two or more types of raw material monomers (two types of raw material monomers 40a and 40b in FIG. 5) vaporized by a heater are supplied from storage pots 39a and 39b to a mixing tank 43 through vapor supply pipes 41a and 41b, respectively, and sprayed onto the surface 1a of the strip-shaped substrate 1 through an outlet 44. These two or more types of raw material monomers are sequentially vapor-deposited onto the surface 1a of the strip-shaped substrate 1, and polymerization of these two or more types of raw material monomers proceeds on this surface 1a. As a result, a sustained-release film 2 made of a vapor-deposited polymer film is sequentially formed on the surface 1a of the strip-shaped substrate 1, following the minute irregularities present on the surface 1a. As a result, as shown in FIG. 4, a strip-shaped body 15 is produced in which the sustained-release film 2 is formed on the surface 1a of the strip-shaped substrate 1 (state A1). After the formation of the sustained-release film 2 is completed, the strip-shaped body 15 is transported from the main roller 34 through the inside of the connecting part 32 and into the inside of the housing part 33, as shown in FIG. 5. An in-line monitor 45 is installed inside the housing 33, and the web 15 transported into the housing 33 passes through a measurement area of ​​the in-line monitor 45. At this time, the in-line monitor 45 measures the film thickness and film quality of the web 15. The web 15 is then wound into a roll by the winding roller 36, and is removed in the rolled state from the housing 33 and transported to the next process.

[0049] Examples of the raw material monomers include amines and isocyanates. Examples of the amines include tris(2-aminoethyl)amine, diethylenetriamine, dipropylenetriamine, bishexamethylenetriamine, 1,6-diaminohexane, 1,12-diaminododecane, 4,4-diphenyldiaminomethane, 1,4-diaminobenzene, and m-xylylenediamine. Examples of the isocyanates include isophorone diisocyanate, 1,3-bis(isocyanatomethyl)cyclohexane, hexamethylene diisocyanate, dicyclohexylmethane 4,4'-diisocyanate, m-xylylene diisocyanate, and 4,4'-methylenediphenyl diisocyanate.

[0050] Examples of vapor-deposited polymer films that constitute the sustained-release film 2 include films of vapor-deposited polymers such as polyurea resin, polyamide resin, polyimide resin, polyamideimide resin, polyester resin, polyazomethine resin, or polyurethane resin, which are produced by the polymerization reaction of amine and isocyanate. Among the above vapor-deposited polymers, polyurea resin and polyurethane resin are polymers produced by polyaddition reactions, and therefore do not produce by-products. Therefore, they are suitable for use as the vapor-deposited polymer film that constitutes the sustained-release film 2. Among these, polyurea resins have a fast reaction rate, which shortens the transport path length and transport time required for curing after the formation of the vapor-deposited polymer film, and also eliminates the need for a heater or other device to promote the curing. The sustained-release film 2, which is a vapor-deposited film, may be formed on the surface 1a of the strip-shaped substrate 1 by vaporizing a single raw material monomer by heating.

[0051] After the sustained-release film forming step of step S101 is performed, an active ingredient introduction step (step S102) is performed as shown in Fig. 3. This active ingredient introduction step is a step of introducing a vaporizable active ingredient 11 into the substrate 1 from the back surface 1b (second surface) of both end surfaces in the thickness direction D1 of the substrate 1, which is opposite to the front surface 1a on which the sustained-release film 2 is formed. In this active ingredient introduction step, for example, an application device 50 shown in Fig. 6 is used. As shown in Fig. 6, the application device 50 includes an unwinding section 51, an application section 52, and a winding section 53.

[0052] As shown in FIG. 6, the unwinding unit 51 includes an unwinding roller 54. The unwinding roller 54 has attached thereto a roll of the strip 15. As shown in FIG. 6, the coating unit 52 includes a coating chamber 55. The coating chamber 55 is a box-shaped structure having an inlet and an outlet through which an object to be coated passes. Inside the coating chamber 55, there are provided a storage pot (not shown) for storing the active ingredient 11 and a dispenser 57 for introducing the active ingredient 11 into the substrate 1 of the strip 15. As shown in FIG. 6, the winding unit 53 includes a winding roller 58. The winding roller 58 winds up the strip 15 into a roll after the active ingredient 11 has been introduced into the substrate 1.

[0053] The roll-shaped strip 15 attached to the unwinding roller 54 passes through the interior of the coating chamber 55 and is wound around the take-up roller 58, and is wound up by the rotational drive of the take-up roller 58. In other words, the strip 15 is transported from the unwinding roller 54 through the interior of the coating chamber 55 to the take-up roller 58, in a so-called roll-to-roll manner.

[0054] Specifically, in step S102, the roll-shaped strip 15 wound up in step S101 described above is first unwound from the unwinding roller 54 and transported toward the coating chamber 55 (the direction indicated by arrow β in FIG. 6). The strip 15 is then transported into the coating chamber 55 and transported to the outside of the coating chamber 55 through the discharge area of ​​the dispenser 57. At this time, the strip 15 is transported so that the back surface 1b of the substrate 1 faces the discharge port of the dispenser 57. The dispenser 57 sequentially applies a predetermined amount of active ingredient 11 to the back surface 1b of the substrate 1 of the strip 15 being transported in this manner. Here, as shown in FIG. 4, a sustained-release film 2 has already been formed on the front surface 1a of the substrate 1 of the strip 15. The active ingredient 11 applied as described above is impregnated into the substrate 1 of this strip 15 from the back surface 1b opposite to the front surface 1a on which the sustained-release film 2 has already been formed (state A2). As a result, a desired amount of the active ingredient 11 is introduced into the substrate 1 of the strip 15. After the introduction of the active ingredient 11 into the substrate 1 is completed as described above, the strip 15 is wound into a roll by the winding roller 58, removed from the coating device 50, and transported to the next process.

[0055] Examples of methods for introducing the active ingredient 11 into the substrate 1 include a wet coating method in which a liquid active ingredient 11 is applied. Examples of wet coating methods for the active ingredient 11 include the above-mentioned dispenser method, inkjet method (inkjet printing method), spin coating method, dip coating method, flow coating method, screen printing method, die coating method, wipe coating method, and gravure roller method.

[0056] After the active ingredient introduction step of step S102 is performed, a barrier layer formation step (step S103) is performed as shown in Fig. 3. This barrier layer formation step is a step of forming a barrier layer 3 that blocks vaporized gas 11a of the active ingredient 11 on the back surface 1b of the substrate 1 after the active ingredient 11 has been introduced. In this embodiment, as an example of the barrier layer formation step, a step in which the barrier layer 3 is formed on the back surface 1b of the substrate 1 and the barrier layer 7 is formed on the front surface 2a of the sustained-release film 2 are performed in parallel will be described. In this barrier layer formation step, for example, an attachment device 60 shown in Fig. 7 is used. As shown in Fig. 7, the attachment device 60 includes an unwinding unit 61, an attachment unit 62, and a winding unit 63.

[0057] As shown in FIG. 7, the unwinding unit 61 includes an unwinding roller 64. The unwinding roller 64 is attached with a roll of the strip 15 after the active ingredient introduction step described above. As shown in FIG. 7, the attaching unit 62 includes a pair of pressure rollers 65a and 65b, two barrier layer rollers 66a and 66b, and two protective sheet take-up rollers 68a and 68b. The pressure rollers 65a and 65b are used to attach the barrier layer films 16a and 16b to the substrate 1 and sustained-release membrane 2 of the strip 15, respectively. Specifically, the outer circumferential surfaces of the pressure rollers 65a and 65b are formed of an elastic material. As shown in FIG. 7, the pressure rollers 65a and 65b are configured to rotate while pressing their outer circumferential surfaces against each other. The barrier layer rollers 66a and 66b are used to unwind the barrier layer films 16a and 16b between the pressure rollers 65a and 65b, respectively. The protective sheet take-up rollers 68a, 68b are used to take up the protective sheet from the barrier layer films 16a, 16b. As shown in Fig. 7, the take-up unit 63 includes a take-up roller 67. The take-up roller 67 is used to take up the strip 15 with the barrier layer films 16a, 16b attached thereto into a roll.

[0058] The roll-shaped strip 15 attached to the unwinding roller 64 passes between a pair of pressure rollers 65a, 65b and is wound around a take-up roller 67, and is wound up by the rotational driving of the pressure rollers 65a, 65b and the take-up roller 67. That is, the strip 15 is transported in a so-called roll-to-roll manner from the unwinding roller 64 to the take-up roller 67 via the pair of pressure rollers 65a, 65b. Note that, as shown in FIG. 7, a plurality of tension rollers 69a to 69c are arranged on the transport path within the joining device 60.

[0059] More specifically, in step S103, the roll-shaped strip 15 wound up in step S102 described above is first unwound from the unwinding roller 64 and transported in a direction toward the gap between the pair of pressure rollers 65a and 65b (the direction indicated by arrow γ in FIG. 7). The strip 15 then passes between the pair of pressure rollers 65a and 65b while being sandwiched and pressed by these pressure rollers 65a and 65b. At this time, a barrier layer film 16a unwound from the barrier layer roller 66a and a barrier layer film 16b unwound from the barrier layer roller 66b are attached to both surfaces in the thickness direction of the strip 15 (the front surface 2a of the sustained-release film 2 and the back surface 1b of the substrate 1), respectively.

[0060] In this embodiment, the barrier layer film 16a is used to form a barrier layer 7 on the surface 2a of the sustained-release membrane 2. FIG. 8A is a cross-sectional schematic diagram showing an example of the configuration of a barrier layer film attached to the sustained-release membrane surface of a sustained-release body according to an embodiment of the present invention. As shown in FIG. 8A, the barrier layer film 16a is a strip-shaped laminate having a laminate structure of a barrier layer 7, an adhesive layer 8, and a protective sheet 9. The barrier layer film 16a is attached to the barrier layer roller 66a in a rolled state. At this time, the barrier layer film 16a is disposed so that the adhesive layer 8 faces the surface 2a of the sustained-release membrane 2 of the strip 15. As shown in FIG. 7, the barrier layer film 16a unwound from the barrier layer roller 66a has only the protective sheet 9 taken up by the protective sheet take-up roller 68a before being attached to the strip 15, and is then transported to the pressure roller 65a. Then, the barrier layer film 16a from which the protective sheet 9 has been peeled off is attached to the surface 2a of the sustained-release film 2 of the strip 15 by being sandwiched between pressure rollers 65a and 65b. As a result, the barrier layer 7 is formed on the surface 2a of the sustained-release film 2 with the adhesive layer 8 interposed therebetween.

[0061] Furthermore, the barrier layer film 16b is used to form a barrier layer 3 on the back surface 1b of the substrate 1 containing the active ingredient 11. FIG. 8B is a cross-sectional schematic diagram showing an example of the configuration of a barrier layer film attached to the substrate surface of a sustained-release form according to an embodiment of the present invention. As shown in FIG. 8B, the barrier layer film 16b is a strip-shaped laminate having a laminated structure of a protective sheet 12, an adhesive layer 4, a barrier layer 3, an adhesive layer 5, and a protective sheet 6. The barrier layer film 16b is attached to the barrier layer roller 66b in a rolled state. At this time, the barrier layer film 16b is disposed so that the adhesive layer 4 faces the back surface 1b of the substrate 1 of the strip 15. As shown in FIG. 7, the barrier layer film 16b unwound from the barrier layer roller 66b has only the protective sheet 12 taken up by the protective sheet take-up roller 68b before being attached to the strip 15, and is then transported to the pressure roller 65b. Then, the barrier layer film 16b from which the protective sheet 12 has been peeled off is sandwiched between pressure rollers 65a and 65b and attached to the back surface 1b of the base material 1 of the strip 15. As a result, a laminate of the barrier layer 3, the adhesive layer 5, and the protective sheet 6 is formed on the back surface 1b of the base material 1 with the adhesive layer 4 interposed therebetween.

[0062] When the strip 15 unwound from the unwinding roller 64 passes between the pair of pressure rollers 65a, 65b, the adhesive layer 8 of the barrier layer film 16a is pressed against the front surface 2a of the sustained-release membrane 2, and the adhesive layer 4 of the barrier layer film 16b is pressed against the back surface 1b of the substrate 1. Therefore, the strip 15 after passing between the pressure rollers 65a, 65b has a layered structure in which the barrier layer 7, the adhesive layer 8, the sustained-release membrane 2, the substrate 1 containing the active ingredient 11, the adhesive layer 4, the barrier layer 3, the adhesive layer 5, and the protective sheet 6 are laminated in the thickness direction. The strip 15 is then wound into a roll by the winding roller 67, and is removed in the rolled state from the application device 60 and transported to the next process.

[0063] The attachment processes of these barrier layers 3 and 7 may be performed in parallel as described above within one barrier layer formation step, or the attachment process of one barrier layer may be performed before the attachment process of the other barrier layer. By performing step S103 in this manner, as shown in Fig. 4, a strip-shaped body 15 is formed having a laminated structure of a substrate 1 containing an active ingredient 11, a sustained-release film 2 provided on the front surface 1a of the substrate 1, an adhesive layer 4, a barrier layer 3, an adhesive layer 5, and a protective sheet 6 provided on the back surface 1b of the substrate 1, and an adhesive layer 8 and a barrier layer 7 provided on the front surface 2a of the sustained-release film 2 (state A3).

[0064] After the barrier layer forming step in step S103 is performed, a cutting step (step S104) is carried out as shown in Fig. 3. This cutting step is a step of cutting the strip 15 into the desired sustained release agents 10.

[0065] Specifically, in step S104, the strip 15 after the barrier layer forming step is first set in a rolled state in a cutting device. The cutting device sequentially cuts the strip 15 while pulling it out from the set roll and transporting it. At this time, as shown in Fig. 4, for example, sustained release agents 10 of desired sizes are sequentially cut from the sequentially transported strip 15 (state A4). In this manner, the desired sustained release agents 10 are sequentially produced.

[0066] As explained above, in the sustained-release body 10 according to an embodiment of the present invention, a sustained-release film 2 made of a vapor-deposited polymer film is formed on the surface 1a of both end surfaces (front and back surfaces) of the substrate 1 in the thickness direction D1, and the sustained-release film 2 is configured to receive the vaporized gas 11a of the volatile active ingredient 11 contained in the substrate 1 from the surface 1a of the substrate 1 and sustainably release it.

[0067] Therefore, the sustained-release film 2 is brought into direct contact with the surface 1a of the substrate 1 along the fine irregularities of the surface 1a of the substrate 1, maintaining this close contact between the substrate 1 and the sustained-release film 2, while allowing the vaporized gas 11a of the active ingredient 11 vaporized from the substrate 1 to be gradually released to the outside by the sustained-release film 2. This allows the vaporized gas 11a of the active ingredient 11 to be continuously released without the active ingredient 11 being present at the contact interface between the substrate 1 and the sustained-release film 2. Therefore, even if the content of the active ingredient 11 in the substrate 1 decreases as the vaporized gas 11a of the active ingredient 11 is slowly released, it is possible to avoid the occurrence of unintended gaps (gaps other than the gas release port on the substrate surface) at the contact interface between the substrate 1 and the sustained-release film 2. As a result, damage to the sustained-release film 2 due to these gaps can be prevented, and the vaporized gas 11a of the active ingredient 11 is not excessively released from damaged parts of the sustained-release film 2, allowing the stable sustained release of the vaporized gas 11a of the active ingredient 11 to be continuously achieved over the desired long period of time.

[0068] By using the sustained-release body 10 as described above, it is possible to allow the active ingredient 11 to act on a desired object for a long period of time, and to prevent damage to the object caused by fragments of the sustained-release film 2 detached from the sustained-release body 10 or vaporized gas 11a of the active ingredient 11 released in excess from damaged parts of the sustained-release film 2 adhering to the object. For example, when an antifungal agent is used as the active ingredient 11 and the antifungal agent vaporized from the sustained-release body 10 is applied to food such as fruit, it is possible to prevent damage to the food caused by fragments of the sustained-release film 2 or vaporized gas of the antifungal agent released in excess.

[0069] In addition, methods for imparting sustained-release functionality to the substrate surface (active ingredient release surface) include, in addition to forming a vapor-deposition polymerized film on the substrate surface, attaching a sustained-release film to the substrate surface, or coating the substrate surface with a sustained-release material. However, when a sustained-release film produced by a method other than vapor-deposition polymerization is used, the adhesion between the sustained-release film and the substrate is significantly poorer than that of a vapor-deposition polymerized film, necessitating measures such as forming an adhesive layer between the sustained-release film and the substrate or heat-adhering the sustained-release film to the substrate surface. This results in problems such as a decrease in the vaporization ability of the active ingredient. Furthermore, when a sustained-release material is applied to the substrate surface, variations in the coating thickness occur, making it difficult to achieve uniform sustained release on the substrate surface. In contrast, the present invention combines a micro-irregular surface of the substrate that releases the vaporized gas of the active ingredient with a vapor-deposition polymerized film having sustained-release properties. This allows for both improved adhesion between the substrate surface and the sustained-release film and improved sustained-release function of the sustained-release film, while also reducing the likelihood of cracking of the sustained-release film.

[0070] Furthermore, in the manufacturing method of the sustained-release body according to the embodiment of the present invention, a sustained-release film forming step is performed in which a sustained-release film 2 made of a vapor-deposited polymer film is formed on the surface 1a of the substrate 1, and then an active ingredient introducing step is performed in which a vaporizable active ingredient 11 is introduced into the substrate 1 from the back surface 1b of the substrate 1 (the surface opposite to the surface 1a on which the sustained-release film 2 is formed). As a result, the sustained-release body 10 that enjoys the above-mentioned effects can be easily manufactured.

[0071] Furthermore, since the active ingredient introduction process is performed after the sustained-release film formation process, these two processes are separated, so that the volatile active ingredient does not enter the inside of the vacuum chamber (vacuum tank), and as a result, the active ingredient does not evaporate under vacuum conditions, which prevents a decrease in yield in the production of sustained-release tablets. It also makes it possible to prevent the inside of the vacuum chamber from being contaminated by the vaporized active ingredient.

[0072] Furthermore, in the sustained-release body 10 and its manufacturing method according to the embodiment of the present invention, a barrier layer 3 that blocks the vaporized gas 11a of the active ingredient 11 is formed on the back surface 1b opposite to the front surface 1a (the surface on which the sustained-release film 2 is formed) of the substrate 1. This prevents the vaporized gas 11a of the active ingredient 11 from being unintentionally released from the back surface 1b of the substrate 1, i.e., the surface opposite to the front surface 1a from which the release (sustained release) of the vaporized gas 11a of the active ingredient 11 is intended. This prevents excessive and wasteful release of the vaporized gas 11a of the active ingredient 11 from the sustained-release body 10 and allows the vaporized gas 11a of the active ingredient 11 to be efficiently sustained-released via the sustained-release film 2. As a result, the more stable sustained release of the vaporized gas 11a of the active ingredient 11 can be continued for a desired long period of time. [Example]

[0073] Next, the present invention will be described in detail based on examples. In the examples, the following experiments were carried out to confirm the effects of the present invention. Note that the present invention is not limited to the following examples.

[0074] First, in the examples, a polyethylene film measuring 10 cm long x 10 cm wide x 75 μm thick was used as the substrate. This film was made porous by adding calcium carbonate and stretching it (porous film). Next, a sustained-release membrane consisting of a vapor-deposited polymerized membrane was formed on the first (front) of the two thickness-wise end faces of the porous film by a known vapor deposition polymerization method using two raw material monomers. In the examples, the two raw material monomers used were diethylenetriamine and 1,3-bis(isocyanatomethyl)cyclohexane. In this case, the vapor-deposited polymerized membrane constituting the sustained-release membrane in the examples was a polyurea resin. Then, a vaporizable active ingredient was introduced by a dispenser method into the second (rear) of the two thickness-wise end faces of the porous film, opposite the first (front) side. In the examples, hinokitiol was used as the active ingredient. Samples for the examples were prepared as described above.

[0075] On the other hand, in the comparative example of the present invention, a polyethylene film with a solid structure that is difficult to impregnate with the active ingredient was used as the substrate. The size of the substrate in the comparative example was the same as in the above-mentioned example. Next, a vaporizable active ingredient was applied to the first of both end surfaces in the thickness direction of the polyethylene film using a dispenser method, thereby forming an active ingredient layer on the first surface. The active ingredient in the comparative example was the same as in the above-mentioned example. Then, a sustained-release film consisting of a vapor-deposited polymerized film was formed on the surface of the active ingredient layer using a known vapor deposition polymerization method using two types of raw material monomers. The two types of raw material monomers and the vapor-deposited polymerized film in the comparative example were the same as in the above-mentioned example. In the above manner, the comparative example sample was prepared.

[0076] Each sample of the example and comparative example prepared as above is left in a thermostatic bath, and the test is carried out to evaluate whether cracks occur in the sustained-release film of each sample.In this test, the temperature condition in the thermostatic bath is 20 ℃ and 30 ℃, and the pressure condition in the thermostatic bath is normal pressure.In addition, for each sample of these examples and comparative examples, immediately after preparation, after 48 hours, 168 hours, 1 month and 3 months from the start of leaving in the thermostatic bath, the presence or absence of cracks occurs in the sustained-release film is visually evaluated by multiple workers.As the standard of this visual evaluation, the size of the target crack is 2mm or more, and the crack size of 1cm in the sustained-release film of each sample is 168 hours, 1 month and 3 months from the start of preparation. 2 The number of cracks that occurred per unit time was counted. The evaluation results of the Examples and Comparative Examples are shown in Table 1. In Table 1, "◯" means that no cracks occurred in the sustained-release film (number of cracks occurred = 0), and "×" means that no cracks occurred in the sustained-release film (number of cracks occurred ≧ 1).

[0077] [Table 1]

[0078] As can be seen from Table 1, in the sample of the comparative example, cracks occurred in the sustained-release film after one month at a temperature of 20°C and after 168 hours at a temperature of 30°C. In contrast, in the sample of the example, regardless of the temperature conditions of the thermostatic bath, no cracks occurred in the sustained-release film even after three months had passed. From these evaluation results, it was confirmed that the sustained-release form of the present invention can maintain a stable sustained release amount of the vaporized active ingredient for a long period of time.

[0079] In the above-described embodiment, the liquid active ingredient 11 is contained in the base material 1, but the present invention is not limited to this. For example, the solid active ingredient 11 may be contained by being embedded inside the base material 1, and the vaporized gas 11a sublimated from the solid active ingredient 11 may be gradually released.

[0080] In the above-described embodiment, the barrier layer 3 that blocks the vaporized gas 11a of the active ingredient 11 is provided on the back surface 1b of the substrate 1, but the present invention is not limited to this. For example, the barrier layer 3 may be provided not only on the back surface 1b of the substrate 1 but also on the side surface 1c of the substrate 1. That is, the barrier layer 3 may be configured to cover the back surface 1b and side surface 1c of the substrate 1 (the remaining substrate surface excluding the surface 1a on which the sustained-release film 2 is formed). Alternatively, the sustained-release film 2 may be provided not only on the front surface 1a of the substrate 1 but also on the side surface 1c of the substrate 1. That is, the sustained-release film 2 may be configured to cover the front surface 1a and side surface 1c of the substrate 1 (the remaining substrate surface excluding the back surface 1b on which the barrier layer 3 is formed). This allows the vaporized gas 11a of the active ingredient 11 to be slowly released from the front surface 1a and side surface 1c of the substrate 1 through the sustained-release film 2.

[0081] Furthermore, in the above-described embodiment, the barrier layer 3 on the back surface 1b of the substrate 1 and the barrier layer 7 on the front surface 2a of the sustained-release film 2 are formed in one process (within the barrier layer forming process of step S103 shown in FIG. 3), but the present invention is not limited to this. For example, these barrier layers 3 and 7 may be provided on the substrate 1 or the sustained-release film 2 in separate processes. In this case, the process of providing the barrier layer 3 on the back surface 1b of the substrate 1 may be performed first, and then the process of providing the barrier layer 7 on the front surface 2a of the sustained-release film 2 may be performed, or vice versa.

[0082] Furthermore, in the above-described embodiment, a laminate (e.g., barrier layer film 16b) having a laminated structure of barrier layer 3, adhesive layer 5, etc. is provided on back surface 1b of substrate 1 via adhesive layer 4 from the barrier layer 3 side, but the present invention is not limited to this. For example, the barrier layer 3 and adhesive layer 5 with protective sheet 6 may be formed separately from each other, and the barrier layer 3 may be provided on back surface 1b of substrate 1, and then the adhesive layer 5 and protective sheet 6 may be provided sequentially on the back surface of this barrier layer 3.

[0083] Furthermore, the present invention is not limited to the sustained-release form and its manufacturing method according to the above-described embodiment, and any suitable combination of the above-described components and manufacturing steps is also included in the present invention. For example, the active ingredient introduction step S102 and the barrier layer formation step S103 may be performed by a single device, or the active ingredient introduction step S102, the barrier layer formation step S103, and the cutting step S104 may be performed by a single device. Furthermore, all other embodiments, examples, and operational techniques made by those skilled in the art based on the above-described embodiments are included in the scope of the present invention. [Explanation of symbols]

[0084] 1 Base material 1a surface 1b back side 1c side 2 Sustained release membrane 2a surface 2b Back side 3 Barrier layer 4, 5 Adhesive layer 6 Protective Sheet 7 Barrier Layer 8 Adhesive layer 9 Protective Sheet 10 Sustained release form 11 Active ingredients 11a Vaporized gas 12 Protective sheet 15. Band 16a, 16b Barrier layer film 30 Film deposition equipment 31 Vacuum chamber 32 Connecting part 33 Housing 34 Main Roller 35 Unwinding roller 36 Winding roller 37 Vapor deposition polymer film forming unit 38a~38h Tension roller 39a, 39b Containment pot 40a, 40b raw material monomer 41a, 41b Steam supply pipe 42a, 42b Opening and closing valves 43 Mixing tank 44 Air Outlet 45 Inline Monitor 50 Coating equipment 51 Unwinding section 52 Application section 53 Winding section 54 Unwinding roller 55 Coating room 57 Dispenser 58 Winding roller 60 Pasting device 61 Unwinding section 62 Attachment part 63 Winding section 64 Unwinding roller 65a, 65b Pressure rollers 66a, 66b Barrier layer roller 67 Winding roller 68a, 68b Protective sheet take-up rollers 69a~69c Tension roller 100 Conventional sustained-release 101 Base material 102 Sustained release membrane 103 Active ingredient layer 103a Vaporized gas 104 Gap 105 Crack D1 thickness direction D2 width direction α, β, γ arrows

Claims

1. A substrate; a vapor-deposited polymer film formed directly on a first surface of both end surfaces of the substrate in the thickness direction; Equipped with the substrate contains a vaporizable active ingredient and has a structure that releases vaporized gas of the active ingredient; the vapor-deposited polymerized film receives the vaporized gas of the active ingredient from the first surface of the substrate and gradually releases it; A sustained-release body characterized by:

2. a barrier layer formed on a second surface of both end surfaces of the substrate in the thickness direction opposite to the first surface, the barrier layer blocking vaporized gas of the active ingredient from the second surface side of the substrate; The sustained-release formulation according to claim 1 .

3. The substrate is made of a porous material. The sustained-release formulation according to claim 1 or 2.

4. The porous material has an open-cell structure. The sustained-release formulation according to claim 3 .

5. The substrate is made of a polymer having an amorphous portion. The sustained-release formulation according to claim 1 or 2.

6. the vapor-deposited polymerized film has a lower gas permeability than the substrate; The sustained-release formulation according to any one of claims 1 to 5.

7. The thickness of the vapor-deposited polymer film is in the range of 1 μm or more and 900 μm or less. The sustained-release formulation according to any one of claims 1 to 6.

8. a sustained-release film forming step of forming a sustained-release film made of a vapor-deposited polymerized film on a first surface of both end surfaces of the substrate in the thickness direction; an active ingredient introduction step of introducing a vaporizable active ingredient into the substrate from a second surface of the substrate opposite to the first surface on which the sustained-release film is formed, among both end surfaces in the thickness direction of the substrate; A method for producing a sustained-release agent, comprising:

9. a barrier layer forming step of forming a barrier layer that blocks vaporized gas of the active ingredient on the second surface of the base material after the active ingredient is introduced, The method for producing a sustained-release agent according to claim 8.

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