JP2002166497A - Film for plastering material - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a film for plastering material which is soft, expandable and shrinkable, fits an affected part or the like without a strong oppression, gives no feeling of tight winding and shows good followability when the affected part is moved, no stickiness on the surface and excellent swelling resistance due to migration of a chemical or an organic compound contained in an adhesive agent and the like. SOLUTION: A film for a plastering material is obtained by laminating a surface layer containing 50 to 100 wt.% of a polypropylene-based resin on at least one surface of a base material layer containing 70 to 100 wt.% of a thermoplastic elastomer wherein a ratio of thickness of the base material layer to that of the surface layer is 1/5 to 40/1.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a film for a patch, and more particularly to a flexible and stretchable film, a dissolving agent for applying a drug or a drug to a substrate, and a sub-solvent for enhancing a transdermal absorption effect. The present invention relates to a film for a patch, which exhibits excellent resistance to swelling due to an organic compound such as a preparation and is suitably used for a transdermal absorption preparation and a plaster.

[0002]

2. Description of the Related Art Conventionally, a large number of medical patches such as transdermal preparations and adhesive plasters containing a drug in an adhesive layer have been produced. Generally, an adhesive bandage is obtained by applying an adhesive on one surface of a soft film layer, pasting a gauze or the like thereon, laminating a release paper thereon, and then punching the laminate into a predetermined size. As the soft film used for the bandage, many soft vinyl chloride films have conventionally been used. Transdermal preparations are also formed by applying a drug-containing pressure-sensitive adhesive layer or a drug-containing drug layer and a pressure-sensitive adhesive layer to a support, and by applying the drug to the skin, mucous membranes, etc. It can be treated by absorbing the drug directly from the skin, mucous membranes, etc., and is conventionally used as a local therapeutic agent, such as an anti-inflammatory analgesic, a tape for skin diseases, an antipruritic patch, a wound agent, etc. Transdermal treatment system (TT
Due to the development of S), its use as a systemic treatment such as, for example, an antisickness drug is increasing. Many soft vinyl chloride films have been used as such a support for a transdermal absorption preparation, similarly to the above-mentioned bandage.

However, since a soft vinyl chloride film contains a large amount of a plasticizer, the plasticizer migrates from the film to the pressure-sensitive adhesive layer, and the adhesive strength of the pressure-sensitive adhesive layer is reduced. The adhesive strength between them decreases, and the percutaneous absorption preparations and adhesive plasters peel off, and the adhesive migrates to the periphery and becomes dirty. The use of films made of polyolefin-based resin having properties is being studied, but those with sufficient elasticity and stress relaxation at the time of sticking required for the film have not been obtained, and the film has a strong sense of tightness. Or
The film does not easily follow the skin at the bent part such as the elbow, and the film is peeled off, and the organic compound contained in the adhesive layer or the drug layer is transferred to the film, and the film swells and becomes wrinkled. There was a problem.

Various improvements have been made in order to solve such problems. For example, a film made of a thermoplastic elastomer having a narrow molecular weight distribution can be considerably improved by using it as a film for a patch. However, there is a problem that the surface is sticky when actually used, and when it comes into contact with clothes or the like, the end is turned up and eventually comes off from the skin.

[0005]

DISCLOSURE OF THE INVENTION The present invention relates to a flexible and stretchable material, which fits on an affected part and does not strongly press, has excellent followability when the affected part is moved, and further has an adhesive layer or a drug layer. An object of the present invention is to provide a film for a sticking material that exhibits excellent resistance to swelling due to organic compounds and the like contained in a varnish, has improved surface tackiness and strength, and is hard to be peeled off even when it comes into contact with clothes or the like.

[0006]

The gist of the present invention is to provide a base material containing 70 to 100% by weight of a thermoplastic elastomer on at least one surface of a base material layer containing 50 to 10 parts by weight of a polypropylene resin.
A surface layer containing 0% by weight is laminated, and the thickness ratio of the substrate layer and the surface layer is 1/5 to 40/1.
Wherein the thermoplastic elastomer is a styrene-based thermoplastic elastomer or a polyolefin-based thermoplastic elastomer, and the thermoplastic elastomer is an ethylene-propylene copolymer rubber. Film, the adhesive film having a surface roughness of at least one surface of the film (10-point average roughness (Rz) specified in JIS B0601) of 1 to 80 μm, and a drug coated on one surface of the film. The present invention relates to a percutaneous absorption preparation and a bandage film provided with an adhesive layer on one side of the above film.

Hereinafter, the present invention will be described in detail.

[0008]

BEST MODE FOR CARRYING OUT THE INVENTION The base layer of the film of the present invention contains 70 to 100% by weight of a thermoplastic elastomer, preferably 80% by weight.
-100% by weight. Examples of the thermoplastic elastomer include a styrene-based thermoplastic elastomer and a polyolefin-based thermoplastic elastomer.

Examples of the styrene-based thermoplastic elastomer include styrene-butadiene copolymer rubber, styrene-butadiene block copolymer, and styrene-isoprene copolymer rubber. Among them, styrene-butadiene-based thermoplastic elastomers such as styrene-butadiene copolymer rubber and styrene-butadiene block copolymer are preferable. The styrene-based thermoplastic elastomer is preferably hydrogenated.

Also, a polyolefin-based thermoplastic elastomer is provided.
-Ethylene-propylene copolymer rubber, ethylene
-Propylene-non-conjugated diene rubber, ethylene-butadi
Ethylene rubber, polymerized using metallocene catalyst
0.900 g / cm ^ThreeThe following ethylene-α-O
Lefin copolymers and the like can be mentioned. The above thermoplastic elastomer
Each of the tomers may be used alone or in combination.
Other polymers may be mixed and used. Other polymerization mixing
The body is made of polyethylene resin, polypropylene tree
Fats and mixtures thereof. Among them, polyethy
Len-based resins are preferred. These other polymers are present in the substrate layer
Thermoplastic elastomer / other polymer = 100: 0-7
It can be mixed in the range of 0:30 (weight ratio). other
If the ratio of the polymer exceeds 30/70, the
The film swells remarkably due to organic compounds etc.
May not be suitable. As polyethylene resin
Is mainly a homopolymer of ethylene and / or ethylene.
Ethylene and other copolymerizable monomers as a component
With low-density polyethylene (LDPE), linear
Low density polyethylene (LLDPE), high density polyethylene
(HDPE), polymerized using metallocene catalyst
Ethylene-α-olefin copolymer) and the like.
It is. As the polypropylene resin, propylene
Homopolymers and / or copolymers are exemplified. The weight
The coalescence is a run of propylene with another α-olefin.
Dam copolymer, block copolymer or polyolefin
Of propylene with a copolymer based on styrene
Copolymers and the like.

The surface layer of the film of the present invention contains 50 to 100% by weight, preferably 70 to 100% by weight of a polypropylene resin.
% By weight. As the polypropylene-based resin, those described in the above description of the base material layer can be used. Among them, an ethylene-propylene random copolymer is preferable, and an ethylene-propylene random copolymer having an ethylene content of 10% by weight or less is preferable. Copolymers are preferred. Further, a mixture of these polypropylene resins may be used. Further, other polymers such as the thermoplastic elastomer and the polyethylene resin described in the above description of the base material layer may be used for the polypropylene resin. Other polymer = 100: 0 to 50:50 (weight ratio)
Can be mixed. When the ratio of the other polymer is 5
If it exceeds 0/50, the film surface may be inferior in stickiness.

A metallocene catalyst (also referred to as a single-site catalyst or a Kaminski catalyst) is disclosed in
63088, JP-A-7-118431, JP-A-7-148895, etc.
It is a catalyst comprising a metallocene transition metal complex and an organoaluminum compound, and is sometimes used by being supported on an inorganic substance.

[0013] The film of the present invention is obtained by laminating a surface layer made of a polypropylene resin on at least one surface of a substrate layer containing a thermoplastic elastomer. Ratio: substrate layer / surface layer = 1
/ 5 to 40/1. Layer thickness ratio is 1
If it is less than / 5, the flexibility obtained by the base material layer decreases,
If it exceeds 40/1, the mechanical strength is reduced, which hinders use. When the surface layer is provided on both sides of the base material layer, the layer thickness ratio is as follows: surface layer / base material layer / surface layer = 1 to 2.5 / 1 to 20 /
It is appropriately selected from the range of 1 to 2.5, and the ratio of the thickness of both surface layers may not be the same. For example, surface layer / substrate layer / surface layer = 1/7/2. You may. In addition, between the surface layer and the base material layer, an adhesive layer made of a resin having good adhesion to the constituent resins of both layers may be provided in order to improve the interlayer adhesion.

In each layer of the film of the present invention, in addition to the above-mentioned resin components, if necessary, an antioxidant, a light stabilizer, an ultraviolet ray inhibitor, a lubricant, a filler such as talc, calcium carbonate, mica, titanium oxide, etc. Flame retardants, antistatic agents, coloring agents, and the like can be added. When the film of the present invention has at least one surface having a surface roughness (10-point average roughness (Rz) defined by JIS B0601) of 1 to 80 μm,
This is preferable because the apparent thickness is increased relative to the actual thickness of the film, and the feel of the film can be made more flexible. The surface roughness can be obtained by forming irregularities on the surface of the film. The shape of the unevenness may be any of a silk shape, a satin shape, a stripe shape, a lattice shape, a polka dot shape, and the like. In particular, for transdermal preparations, the surface roughness of the film should be 30-70.
It is preferably set to μm.

The film of the present invention may be produced by a known extruder, multi-layer co-extrusion machine or laminator. In order to make the film uneven, embossing rolls or the like imprinted with embossing during film formation may be used. The embossing may be performed in-line, or the film that has been cooled may be heated and softened so that the film can be deformed under pressure, and the uneven pattern may be transferred off-line by pressing against the surface provided with the uneven pattern. .

The method of embossing is not particularly limited. For example, the embossing method may be performed between a metal roll having a fine irregular pattern on its surface and a silicone rubber roll having elasticity and good release properties. A method of transferring the fine uneven pattern provided on the metal roll surface to the film surface by nipping while being heated to a temperature suitable for each compounding composition, and the like.

The thickness of the film of the present invention (the maximum thickness when the surface of the film has irregularities) is not particularly limited, but is preferably 20 to 200 μm. If it is less than 20 μm, the strength at the time of use tends to be insufficient, and if it exceeds 200 μm, the film is too hard, and the texture may be impaired. Further, the film of the present invention may be any of colorless / colored and transparent / opaque.

Further, the film of the present invention preferably has a dimensional change due to swelling (swelling ratio) of less than 0.2% in both the longitudinal and transverse directions. The film of the present invention can be suitably used for applications such as transdermal absorption preparations, adhesive bandages, adhesive plasters, wound guard films, and protect films. Adhesive bandage using the film of the present invention, after applying a corona discharge treatment or an anchor coat on the film surface as necessary, providing an adhesive layer, laminating gauze or the like thereon, and further releasing paper from above And the like are laminated and then punched out to a predetermined size. The type of the pressure-sensitive adhesive is not particularly limited. For example, various pressure-sensitive adhesives such as natural rubber, synthetic rubber, acrylic, urethane, vinyl ether, and silicone are preferably used. May be any of a solution type, an emulsion type, a hot melt type and the like. Further, various types of printing may be performed on any one surface of the film depending on the purpose.

A transdermal preparation using the film of the present invention comprises a drug adhered to one side of the film. The transdermal preparation comprises a film containing a drug and a pressure-sensitive adhesive layer. Or a laminate comprising a drug-containing pressure-sensitive adhesive layer or a drug-containing layer and a pressure-sensitive adhesive layer provided in advance on a release paper or the like, or by coating a film with a drug-containing pressure-sensitive adhesive. To a film by lamination or the like.

The above-mentioned drug is not particularly limited as long as it is absorbed percutaneously into the body and exhibits a pharmacological effect.
Examples thereof include anti-inflammatory agents, analgesics, local stimulants, antihistamines, local anesthetics, blood circulation enhancers, hypnotics and sedatives, tranquilizers, anti-blood pressure agents, antibacterial agents and the like. Note that an additional layer may be provided between the film of the present invention and the pressure-sensitive adhesive layer, if necessary.

[0021]

EXAMPLES The present invention will be described in more detail with reference to the following Examples, which should not be construed as limiting the scope of the present invention. <Evaluation method> (Tensile modulus) The tensile modulus of the film was measured according to JIS K7127. (Initial / Residual Stress) A film having a shape described in JIS K 6732 was used as a test piece, stretched 10% at a test speed of 300 mm / min, and then held.
(10) and the residual stress f (10) after 5 minutes were measured. (Tensile strength of film) A film having a textured surface (irregularity) is difficult to accurately compare with a film without textured because of its apparent thickness when tensile strength is expressed by stress. Therefore, the tensile strength was expressed by the load and elongation per unit width at the time of tensile breaking, excluding the influence of the thickness, under the following conditions.

Condition test piece: A film formed into a strip having a width of 19 mm and a distance between marked lines set to 4 cm. Speed of tensile tester: 200 mm / min (degree of swelling due to solvent, etc.) Adhesive having the following composition was coated on the silicon surface. It is applied on the treated release paper and the thickness after drying is 1
It was adjusted to be about 5 μm. This was adhered to a film to give an adhesive material.

Next, the patch was allowed to stand for one week in an atmosphere of 50 ° C., and the dimensional change due to swelling was measured to determine the dimensional change rate (swelling rate). It should be noted that swelling of 0.2% or more hinders practical use. Swelling ratio (%) = (dimension after one week−initial dimension) × 10
0 / initial size Adhesive: 100 parts by weight of natural rubber and 10 parts by weight of hydrogenated rosin acid ester added to toluene at a concentration of 10 parts
% By weight, and glycol salicylate further dissolved to a concentration of 2% by weight. (Skin Adhesion) The patch was adhered to the elbow, and after one day, the adhesion of the patch was evaluated.

：: Good adhesion. Δ: The edge is slightly turned up. ×: The end was greatly turned up or completely peeled off. Examples 1 to 4 and Comparative Examples 2 and 3 Using the compositions shown in Table 1, a surface layer was prepared using a T-die multilayer film forming machine (65 mm extruder: 500 mm width T-die) manufactured by Toshiba Machine Co., Ltd. A three-layer film composed of the substrate layer / surface layer or a two-layer film composed of the substrate layer / surface layer was prepared. At this time, the surface of the film was embossed using a silk-shaped embossing roll.

The obtained film was evaluated, and the results are shown in Table 1. Comparative Example 1 Using the compositions described in Table 1, a film consisting of only the base material layer was prepared using a T-die single-layer film forming machine (65 mm extruder: 500 mm width T-die) manufactured by Toshiba Machine Co., Ltd. .

The obtained film was evaluated, and the results are shown in Table 1.

[0027]

[Table 1]

[0028]

The film for an adhesive material of the present invention is flexible and stretchable, fits on an affected part, does not strongly press, has no feeling of tightness, follows the movement of the affected part, It is excellent in strength without stickiness and also excellent in resistance to swelling due to migration of drugs and organic compounds contained in adhesives and the like, so that it is preferably used as a film for a patch material such as a transdermal absorption preparation or a bandage. .

 ──────────────────────────────────────────────────の Continued on the front page F-term (reference) 4C076 AA78 BB31 EE03 FF01 4C081 AA03 AA12 BB07 BB08 BC02 CA022 CA032 CA122 CB012 CC01 DA02 4F100 AH00D AK03A AK07B AK07C AK12A AK64A AL09A BA10B01 BA10 BA03 BA04 BA10 BA03 BA04 JK13 JK17 JL13D YY00A

Claims (6)

[Claims] 1. A surface layer containing 50-100% by weight of a polypropylene resin is laminated on at least one surface of a substrate layer containing 70-100% by weight of a thermoplastic elastomer, and the substrate layer and the surface layer Wherein the layer thickness ratio of the base material layer / surface layer = 1/5 to 40/1. 2. The adhesive film according to claim 1, wherein the thermoplastic elastomer comprises a styrene-based thermoplastic elastomer or a polyolefin-based thermoplastic elastomer. 3. The adhesive patch film according to claim 1, wherein the thermoplastic elastomer comprises an ethylene-propylene copolymer rubber. 4. The sticking according to claim 1, wherein the film has a surface roughness of at least one surface (10-point average roughness (Rz) defined by JIS B0601) of 1 to 80 μm. Material film. 5. A transdermal absorption preparation comprising the film according to claim 1 and a drug adhered to one surface of the film. 6. A bandage film comprising the film according to claim 1 and a pressure-sensitive adhesive layer provided on one surface of the film.