JP7016274B2 - Patch - Google Patents

Description

The present invention relates to a patch. More specifically, the present invention relates to a patch having a drug layer.

The patch is a preparation that is used by sticking it on the skin, and examples thereof include a topical action type external preparation such as a poultice (poultice) for the purpose of local action, and a transdermal preparation for the purpose of systemic action. Be done. In recent years, as a means for administering a drug into the body, in addition to injections, oral preparations, ointments, etc., the ease of drug administration, the ease of controlling the amount of the drug, the ease of handling, and the discontinuation of administration when side effects occur. Due to various advantages such as ease of use, a patch is attracting attention as a transdermal preparation to be used by sticking it on the skin surface.

Examples of the patch include a structure in which a support and a drug layer are laminated. As the support, a material having flexibility and a good texture such as vinyl chloride resin, olefin resin, urethane, non-woven fabric, and net cloth is generally used. However, the drug may be transferred from the drug layer to the support, and the support may swell or discolor. Various methods have been studied to suppress the transfer of the drug to the support, for example, a method of arranging another layer between the drug layer and the support (for example, Patent Document 1). 2, 2nd grade).

Patent Document 1 describes an adhesive layer on one side of a composite film made of a resin composition obtained by blending 100 parts by weight of a polyvinyl chloride-polyurethane composite with 2 to 10 parts by weight of a styrene-ethylene-butylene-styrene copolymer. A polyalkylene terephthalate film is adhered to form a base sheet, a primer layer made of a saturated polyester resin is formed on the surface of the polyalkylene terephthalate film of the base sheet, and a drug is further applied on the primer layer. A skin patch sheet characterized by laminating a pressure-sensitive adhesive layer made of a styrene-diene-styrene block copolymer contained therein is disclosed.

In Patent Document 2, a substrate film layer having a thickness of 5 to 300 μm that can be expanded and contracted at room temperature, a vapor-filmed layer having a thickness of 0.5 to 500 nm arranged on the substrate film layer, and a vapor-filmed layer having a thickness of 0.5 to 500 nm are arranged on the vapor-deposited layer. A support for a patch is disclosed, which comprises a protective layer having a thickness of 5 μm or less.

International Publication No. 1999/021537 JP-A-2009-249298

The support used for the patch may swell, discolor, or the like depending on the drug contained in the drug layer. In addition, a substance other than the drug contained in the support may adsorb the drug or react with the drug, so that the effect of the patch may not be fully exhibited. Therefore, the support used for the patch is required to have flexibility to follow the movement of the skin and chemical resistance not affected by the above-mentioned chemicals.

In Patent Document 1, the flexibility of the base sheet may be insufficient due to the low flexibility of the polyalkylene terephthalate film. Further, in the method of forming a thin-film deposition film on the support as in Patent Document 2, the vapor-film deposition film may not follow the expansion and contraction of the support, cracks may occur, and sufficient chemical resistance may not be obtained. rice field. There is also a problem that the method of forming a thin-film deposition film is costly.

The present invention has been made in view of the above situation, and an object of the present invention is to provide a patch having high flexibility and excellent chemical resistance.

The present inventor has focused on the fact that by using a film containing a styrene-based elastomer as a support for a patch, elasticity and flexibility suitable for the support for the patch can be obtained. Further, by arranging a film containing polyethylene having a density of 0.94 g / cm ³ or more between the film containing the styrene-based elastomer and the drug layer, the drug layer is maintained while maintaining appropriate flexibility. We have found that it is possible to suppress the transfer of the drug to the film containing the styrene-based elastomer, and completed the present invention.

The patch of the present invention comprises a first film, a drug layer, and a second film arranged between the first film and the drug layer, and the first film is styrene-based. The second film contains an elastomer and the second film contains polyethylene having a density of 0.94 g / cm ³ or more.

The styrene-based elastomer is preferably a styrene-ethylene-butylene-styrene copolymer.

The total of the thickness of the first film and the thickness of the second film is preferably 10 to 140 μm.

The patch of the present invention has high flexibility and excellent chemical resistance.

The patch of the present invention comprises a first film, a drug layer, and a second film arranged between the first film and the drug layer, and the first film is styrene-based. The second film contains an elastomer and is characterized by containing polyethylene having a density of 0.94 g / cm ³ or more.

<First film>
The first film contains a styrene-based elastomer. The styrene-based elastomer broadly includes an elastomer obtained by copolymerizing styrene with another polymerizable monomer. The styrene-based elastomer includes a hard segment made of polystyrene and a soft segment made of the other polymerizable monomer. Since the styrene-based elastomer contains the hard segment, it is possible to impart appropriate elasticity to the support of the patch. Further, the monomer having a hard segment made of polystyrene, which is a bulky molecular structure, is polymerized, and the bulky molecular structure is uniformly dispersed in the first film, so that the medicinal component invades the first film. You can prevent that. Since the soft segment is included, appropriate flexibility can be imparted.

The other polymerizable monomer is not particularly limited as long as it can be copolymerized with styrene, and for example, a diene compound such as butadiene, isoprene, and chloroprene, an olefin such as ethylene, propylene, butene, and hexene, ( Examples thereof include (meth) acrylic acid and (meth) acrylic acid ester. These may be used alone or in combination of two or more.

The styrene-based elastomer is preferably a styrene-olefin block copolymer from the viewpoint of excellent dimensional stability. The styrene-olefin block copolymer has a polystyrene block phase at both ends of one molecule, and an olefin elastomer phase is introduced into the intermediate phase.

Examples of the styrene-olefin block copolymer include a styrene-butadiene-styrene copolymer (SBS) having a polybutadiene-based intermediate phase and a styrene-isoprene-styrene copolymer (SIS) having a polyisoprene-based intermediate phase. ), Styrene-ethylene-butylene-styrene copolymer (SEBS) whose intermediate phase is a hydrogenated polyolefin, styrene-ethylene-propylene-styrene copolymer (SEPS) and the like can be mentioned. In addition to these, a copolymer (SEP) having a styrene-ethylene / propylene diblock structure, a hydrogenated butadiene rubber (HSBR), and the like can also be mentioned. These may be used alone or in combination of two or more.

Among them, the styrene-based elastomer is preferably a styrene-ethylene-butylene-styrene copolymer. By using SEBS for the first film, excellent flexibility can be obtained. Further, since the SEBS has many side chains, it is considered that it is possible to prevent the drug component from invading the first film while imparting appropriate elasticity. Further, since SEBS does not contain a double bond, it is excellent in weather resistance and heat resistance. As the SEBS, for example, AR-850C, AR-815C (both manufactured by Aronkasei Co., Ltd.), Lavalon SS6302C (manufactured by Mitsubishi Plastics Co., Ltd.) and the like can be used.

The melt flow rate (MFR) of the styrene-based elastomer is preferably 0.01 to 10 g / 10 minutes. The MFR of the styrene-based elastomer can be measured by a method compliant with ISO1133, 230 ° C. × 21.2N).

The first film is a film containing the styrene-based elastomer as a main component. The content of the styrene-based elastomer with respect to the entire first film is preferably 55% by weight or more. If the content of the styrene-based elastomer is less than 55% by weight, flexibility suitable for the support of the patch may not be obtained. The content of the styrene-based elastomer is more preferably 60% by weight or more, further preferably 70% by weight or more. The upper limit of the content of the styrene-based elastomer is not particularly limited, but is, for example, 90% by weight.

The first film further comprises polyethylene such as low density polyethylene (LDPE) and linear low density polyethylene (LLDPE), an ethylene-vinyl acetate copolymer (EVA), a thermoplastic elastomer (TPE), PP and the like. It may be contained.

The first film may further contain various additives. Examples of the additive include a lubricant, an antioxidant, a heat stabilizer, an ultraviolet absorber, a light stabilizer, a colorant, a modifier, a flame retardant, an antistatic agent, a reinforcing agent, an antifogging agent, and a filler. Diluents, antifungal agents and the like can be mentioned.

The thickness of the first film is preferably 5 to 100 μm. If the thickness of the first film is less than 5 μm or more than 100 μm, the flexibility and texture required for the patch may not be obtained. The more preferable lower limit of the thickness of the first film is 15 μm, and the more preferable upper limit is 70 μm. The thickness of the first film is an average value measured at 7 points using a dial gauge having a diameter of 5 mm.

<Second film>
The second film is placed between the first film and the drug layer. By arranging the second film, it is possible to prevent the drug from migrating from the drug layer to the first film and causing the first film to swell or be colored.

The second film contains polyethylene having a density of 0.94 g / cm ³ or more. Hereinafter, polyethylene having a density of 0.94 g / cm ³ or more is also referred to as "high density polyethylene" (HDPE: High Density Polyethylene). When the second film contains high-density polyethylene, it is possible to sufficiently suppress the transfer of the drug from the drug layer to the first film and improve the chemical resistance. In addition, the rigidity of the film can be improved and the film can be made difficult to tear. If the density of the polyethylene is less than 0.94 g / cm ³ , the transfer of the drug from the drug layer to the first film cannot be sufficiently suppressed, and the first film swells or is colored. .. The upper limit of the density of the high-density polyethylene is not particularly limited, but is preferably 1.0 g / cm ³ , more preferably 0.97 g / cm ³ . If the density of the high-density polyethylene exceeds 0.97 g / cm ³ , the rigidity of the second film becomes high and the film may become brittle. The density of the polyethylene is based on ISO1183 and is a density measured by any one of a pycnometer method, an underwater substitution method, a floating and sinking method and a density gradient tube method.

The MFR of the high-density polyethylene is preferably 2.0 g / 10 minutes or less. When the melt flow rate exceeds 2.0 g / 10 minutes, the melt viscosity of the resin is low, so that the calendar roll and the resin composition are in close contact with each other, making it difficult to remove the resin from the calendar roll. May be difficult. When the second film is formed by extrusion molding, the MFR of the high-density polyethylene is preferably 5.0 g / 10 minutes or less. If the MFR exceeds 5.0 g / 10 minutes, the viscosity of the resin is too low, and it is not possible to form a film by extrusion molding under appropriate processing conditions. The lower limit of the MFR of the high-density polyethylene is not particularly limited, but is, for example, 0.05 g / 10 minutes. The more preferable lower limit of the MFR of the high-density polyethylene is 1.0 g / 10 minutes, and the more preferable lower limit is 1.5 g / 10 minutes. The MFR of the high-density polyethylene can be measured by a method according to JIS K 6922-2.

The second film is a film containing the high-density polyethylene as a main component. The content of the high-density polyethylene with respect to the entire second film is preferably 55% by weight or more. If the content of the high-density polyethylene is less than 55% by weight, sufficient chemical resistance may not be obtained.

The high-density polyethylene is not particularly limited as long as it has a density of 0.94 g / cm ³ or more, but may be a homopolymer of ethylene or a copolymer of ethylene and α-olefin or the like. good. Further, it may be polymerized with a metallocene catalyst, a Ziegler catalyst, a Phillips catalyst, or the like. Examples of the polyethylene having a density of 0.94 g / cm ³ or more include T4005 (density: 0.949 g / cm ³ ) and T8150 (density: 0.96 g / cm ³ ) manufactured by Keiyo Polyethylene Co., Ltd.

The second film further comprises polyethylene such as low density polyethylene (LDPE) and linear low density polyethylene (LLDPE), an ethylene-vinyl acetate copolymer (EVA), a thermoplastic elastomer (TPE), PP and the like. It may be contained.

The second film may further contain various additives. Examples of the additive include those similar to those of the first film.

The thickness of the second film is preferably 5 to 40 μm. If the thickness of the second film is less than 5 μm, chemical resistance may not be exhibited. On the other hand, if the thickness of the second film exceeds 40 μm, the flexibility and texture required for the patch may not be obtained. The more preferable lower limit of the thickness of the second film is 8 μm, and the more preferable upper limit is 25 μm. The thickness of the second film can be measured in the same manner as the thickness of the first film.

The laminate of the first film and the second film (hereinafter, also referred to as a laminate) has a role as a support for the patch. The total of the thickness of the first film and the thickness of the second film is preferably 10 to 140 μm. If the total thickness is less than 10 μm, sufficient strength may not be exhibited as a support for the patch. On the other hand, if the total thickness exceeds 140 μm, the flexibility of the support may decrease. The more preferable lower limit of the total thickness is 20 μm, and the more preferable upper limit is 100 μm.

The thickness of the first film is preferably equal to or greater than the thickness of the second film. The ratio of the thickness of the first film to the thickness of the second film is preferably, for example, 1: 1 to 3: 1.

It is preferable that the laminate has an elongation of 80% or more, a 50% modulus of 2 to 50 N / 19 mm, and a breaking strength of 5 to 100 N / 19 mm. It is preferable that the elongation, 50% modulus, and breaking strength satisfy the above numerical ranges in both the flow direction (MD: Machine Direction) and the width direction (CD: Cross Machine Direction) of the laminated body. In the present specification, the elongation, 50% modulus, and breaking strength are each according to JIS Z 0237, strip-shaped pieces having a width of 19 mm and a length of 180 mm, a chuck spacing of 50 mm, and a distance between marked lines of 100 mm. It is a value measured under the conditions of a tensile speed of 300 mm / min and a temperature of 23 ° C. ± 2 ° C.

If the elongation is less than 80%, it may not be able to follow the movement of the skin when it is attached to the skin. The more preferable lower limit of the above elongation is 100%. The upper limit of the above growth is not particularly limited, but is, for example, 1000%. The elongation is expressed by the elongation rate of the following formula (1). In the following formula (1), La is the length of the test piece before the tensile test is performed, and Lb is the length of the test piece when the test piece is broken in the tensile test.
Stretch rate (%) = {(Lb-La) / La} x 100 (1)

If the 50% modulus is less than 2N / 19 mm, the stiffness of the laminated body may decrease and it may become difficult to handle. On the other hand, when the 50% modulus exceeds 50 N / 19 mm, the stiffness of the laminated body becomes strong and the usability may deteriorate. The more preferable lower limit of the 50% modulus is 5N / 19mm, and the more preferable upper limit is 40N / 19mm.

If the breaking strength is less than 5N / 19 mm, the strength of the laminated body may be insufficient. If the breaking strength exceeds 100 N / 19 mm, the stiffness of the laminated body becomes strong and the usability may deteriorate. The more preferable lower limit of the breaking strength is 8N / 19mm, and the more preferable upper limit is 70N / 19mm.

The method for producing the first film and the second film is not particularly limited, but for example, a calendar molding method, an extrusion molding method, or a cast molding method can be used, and the calender molding method or the extrusion molding method is particularly preferable. Is. The laminated body is obtained by laminating by providing an adhesive layer between the first film and the second film.

The second film may have a primer layer, an adhesive layer, or the like between the second film and the drug layer described later, or may be in contact with the drug layer. By having a primer layer, an adhesive layer, or the like between the second film and the drug layer, the adhesion between the second film and the drug layer can be enhanced. When the second film and the drug layer come into contact with each other, the drug is transferred from the drug layer to the first film, and the swelling or coloring of the first film is more effectively suppressed. be able to.

<Drug layer>
The drug layer is a layer containing a drug. The above-mentioned drug may be a systemic action type drug or a local action type drug. Examples of the above-mentioned drugs include indomethacin, felbinac, ketoprofen, flurbiprofen, salicylic acid, glycol salicylate, methyl salicylate, L-menthol, camphor, peppermint oil, timol, citrus fruit extract, arnica tincture, peppermint extract, diphenhydramine, and glycerretin. Examples thereof include acid, crotamitone, isopropylmethylphenyl, nitroglycerin, isosorbide nitrate, turobterol, fentanyl, estradiol, steroids, nicotine and the like. These drugs may be used alone or in combination of two or more.

The patch of the present invention can be used, for example, as a smoking cessation aid (Nichicon patch) containing nicotine as a drug, an anti-inflammatory analgesic (pup agent, plaster preparation) and the like. When the patch of the present invention is used as a smoking cessation aid, the content of the drug varies depending on the treatment stage, but is, for example, about 15 mg to 80 mg per preparation. The anti-inflammatory analgesic contains indomethacin, felbinac, ketoprofen, flurbiprofen, salicylic acid, glycol salicylate, methyl salicylate, L-menthol, camphor, peppermint oil, timol, citrus extract, arnica tincture and the like. Things can be mentioned.

The drug layer is preferably a pressure-sensitive adhesive layer containing a drug. The pressure-sensitive adhesive layer comprises a pressure-sensitive adhesive composition containing the above-mentioned agent and the pressure-sensitive adhesive. Examples of the pressure-sensitive adhesive layer include a layer made of an acrylic pressure-sensitive adhesive, a rubber-based pressure-sensitive adhesive, and a silicone-based pressure-sensitive adhesive. Here, each pressure-sensitive adhesive may be a solvent type, an emulsion type, or a hot melt type.

The method for forming the pressure-sensitive adhesive layer containing the above-mentioned drug is not particularly limited, and for example, the above-mentioned drug and the pressure-sensitive adhesive are mixed to prepare a pressure-sensitive adhesive composition, and the above-mentioned pressure-sensitive adhesive composition is used as the above-mentioned second film. There is a method of applying directly to. After applying the pressure-sensitive adhesive composition to the release paper, it may be bonded to the second film. Further, the pressure-sensitive adhesive composition may be processed into a sheet and then bonded.

The drug layer may be a drug storage layer containing a drug. In this case, the patch of the present invention may further have an adhesive layer on the surface of the drug layer opposite to the second film. Further, the drug layer may be composed of the drug storage layer and a coating layer covering the drug storage layer. The coating layer is, for example, a layer for adjusting the release rate of the above-mentioned drug.

Further, another layer may be provided between the first film and the second film. For example, a primer layer, an adhesive layer, or the like may be provided in order to improve the adhesion between the first film and the second film.

The patch of the present invention may be surface-treated on the surface of the second film on the drug layer side. This makes it possible to improve the adhesion between the second film and the drug layer. Examples of the surface treatment include conventionally known surface treatments such as corona treatment, plasma treatment, flame treatment, and UV treatment. Among these, corona treatment is common in consideration of film width (wide width is possible) and productivity.

The first film may be embossed on the surface opposite to the second film. Further, the first film may have a printing layer, a surface layer, or the like on the surface opposite to the second film.

The print layer may cover the entire surface of the first film, or may partially cover the surface of the first film. For example, when the print layer has a planar shape corresponding to an arbitrary pattern, information, or the like, the print layer partially covers the surface of the first film.

The printing method for forming the print layer is not particularly limited, but inkjet printing, gravure printing, or the like can be used. When printing a continuous pattern over a large area, gravure printing is suitable. As the ink used for the printing layer, for example, a one-component curing type, a two-component curing type, an ultraviolet curing type ink, or the like can be used.

Hereinafter, the present invention will be described in more detail with reference to examples, but the present invention is not limited to these examples.

<Compounding ingredients>
The compounding raw materials used for producing the following Examples and Comparative Examples are as follows.
(1) Styrene-ethylene-butylene-styrene copolymer (SEBS)
SEBS-1: AR-850C (manufactured by Aronkasei Co., Ltd.)
SEBS-2: Lavalon SS6302C (manufactured by Mitsubishi Plastics Co., Ltd.)
SEBS-3: AR-815C (manufactured by Aronkasei Co., Ltd.)
(2) High density polyethylene (HDPE)
HDPE-1: T4005 (manufactured by Keiyo Polyethylene Co., Ltd.)
HDPE-2: Evolu (registered trademark) H SP3505 (manufactured by Prime Polymer Co., Ltd.)
(3) Vinyl chloride resin (PVC)
Kaneka Vinyl (registered trademark) S1003 (manufactured by Kaneka Corporation)
(4) Linear low density polyethylene (LLDPE)
Evolu (registered trademark) SP0540 (manufactured by Prime Polymer Co., Ltd.)
(5) Polyurethane (PU)
Heimlen (registered trademark) Y-210B (manufactured by Dainichiseika Kogyo Co., Ltd.)

<Making a support>
(Support A)
A resin composition containing 60 parts by weight of SEBS-1, 20 parts by weight of HDPE-1 and 2 parts by weight of Adecaster LS-16 (manufactured by ADEKA Co., Ltd.) as a lubricant was prepared, and the resin composition was extruded. By the method, a film having a thickness of 20 μm was formed and processed to prepare a first film.

The resin composition containing only HDPE-1 was molded into a film having a thickness of 10 μm by an extrusion molding method in the same manner as in the first film to prepare a second film.

The surface of the first film is corona-treated, and the corona-treated surface of the first film and the second film coated with an adhesive are laminated by a dry laminate to form a support A. Made. At this time, the first and second films were laminated so that the flow direction (MD) and the width direction (CD) coincided with each other. For the measurement of the thickness of the first film and the thickness of the second film, the average value measured at 7 points using a dial gauge of 5 mmφ was used as the thickness.

(Supports B to J)
As shown in Table 1 below, supports B to J were prepared in the same manner as the support A, except that the composition and / or the thickness of the first film and / or the second film was changed. .. For the supports D to G, the first film was prepared using the compounding raw materials shown in Table 1 below, and the second film was not laminated. The thicknesses of the first film and the second film were measured in the same manner as in the support A.

<Making a patch>
Each of the above supports was cut into a width of 15 mm and a length of 15 mm, and as shown in Table 1 below, the support and the nicotine preparation (nicotine (registered trademark) patch 20, manufactured by Novartis Pharma Co., Ltd.) were laminated and carried out. The patches of Examples 1 to 3 and Comparative Examples 1 to 7 were prepared. In Examples 1 to 3 and Comparative Examples 5 to 7, the release liner was peeled off from the nicotine preparation and bonded so that the pressure-sensitive adhesive layer of the nicotine preparation and the second film were in contact with each other. In Comparative Examples 1 to 4, the first film and the pressure-sensitive adhesive layer of the nicotine preparation were bonded so as to be in contact with each other.

[Evaluation test]
For the support, (1) 50% modulus, (2) breaking strength, and (3) elongation were measured by the following methods. Further, (4) chemical resistance was evaluated for the patches of the above Examples and Comparative Examples.

(1) 50% modulus The obtained supports were cut into 19 mm × 180 mm, respectively, to prepare test pieces. For each support, the MD measurement test piece cut out so that the long side of the test piece is in the flow direction (MD) of the support, and the long side of the test piece is in the width direction (CD) of the support. A cut-out test piece for CD measurement was prepared. For the 50% modulus, the load when the MD measurement test piece and the CD measurement test piece were each extended by 50% in the longitudinal direction of the test piece was measured using an automatic recording type tensile tester. The above 50% modulus, the following breaking strength and the following elongation were measured by a method according to JIS Z 0237.

Each test piece was sandwiched between chucks, and each test piece was extended in the longitudinal direction under the following conditions. When the 50% modulus in the flow direction and the width direction was 2 to 50 N / 19 mm, it was determined that the support had flexibility suitable for the patch.
Measurement temperature: 23 ° C ± 2 ° C
Distance between marked lines: 100 mm
Distance between chucks: 50 mm
Tensile speed: 300 mm / min

(2) Breaking strength Each test piece was stretched under the same conditions as the above-mentioned 50% modulus measurement, and the strength at the time of breaking was measured. When the breaking strength in the flow direction and the width direction was 5 to 100 N / 19 mm, it was determined that the support had flexibility suitable for the patch.

(3) Elongation Each test piece was elongated under the same conditions as the above-mentioned 50% modulus measurement, and the elongation rate when broken was defined as "elongation". The elongation rate was calculated by the following formula (1). In the following formula (1), La is the length of the test piece before the tensile test is performed, and Lb is the length of the test piece when the test piece is broken in the tensile test. When the elongation in the flow direction and the elongation in the width direction was 140% or more, it was determined that the support had flexibility suitable for the patch.
Stretch rate (%) = {(Lb-La) / La} x 100 (1)

(4) Chemical resistance The patches of Examples and Comparative Examples were placed in a bag made of an aluminum / polyethylene film laminate and sealed with a heat seal. This was left in an oven at 60 ° C. for 2 days. Then, each patch was taken out, the nicotine preparation was peeled off from the support, and the state of the surface of the support in contact with the nicotine preparation was visually observed. The state of the surface of the support was evaluated according to the following evaluation criteria.
3: No change in surface condition (good without wrinkles or discoloration)
2: There is a slight change in the surface condition (wrinkles and discoloration have occurred a little).
1: Significant change in surface condition (significant wrinkles and discoloration)

Examples 1 to 3 were excellent in flexibility and chemical resistance. On the other hand, Comparative Examples 1 to 4 having no second film had insufficient chemical resistance, and remarkable changes such as wrinkles and discoloration were observed on the surface of the first film in contact with the nicotine preparation. rice field. In Comparative Example 5 using the second film containing polyethylene having a density of less than 0.94 g / cm ³ , a remarkable change was observed in the surface of the first film in contact with the nicotine preparation. Although not as much as in Comparative Example 5, changes were observed on the surface of the first film. In Comparative Example 7 in which the compositions of the first film and the second film were exchanged, although not as much as in Comparative Examples 1 to 4, sufficient chemical properties could not be obtained, and the surface of the first film was in contact with the nicotine preparation. There was a change in.

Claims (2)

A first film, a drug layer, and a second film disposed between the first film and the drug layer are provided.
The first film contains a styrene-ethylene-butylene-styrene copolymer and contains.
The second film is a patch containing polyethylene having a density of 0.94 g / cm ³ or more. The patch according to claim 1 , wherein the total of the thickness of the first film and the thickness of the second film is 10 to 140 μm.