JPH08143453A - Laminate for suppressing adhesion of crotamiton - Google Patents

Abstract

PURPOSE: To prevent reduction in an active ingredient of a cataplasm caused by adhesion to a packaging bag by using a plastic material having slight adhesion of crotamiton on the inside of the packaging bag. CONSTITUTION: A laminate comprising a printing base 3 such as a PET film, a barrier layer 2 such as an aluminum foil and a non-adherent inside layer (optionally also used as a sealing layer) is prepared and the laminate is made into a packaging bag for a cataplasm. An acrylonitrile resin or a polyester-based resin is used as the non-adherent sealing layer.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a package for a preparation containing crotamiton used as a poultice, and more particularly to a laminate for producing the package.

[0002]

2. Description of the Related Art Among medicines, there is a poultice for sticking to the skin and used for extinction. As a component of the poultice, methyl salicylate, glycol salicylate and the like have been used so far. In recent years, preparations containing indomethacin, ketoprofen, and flurbiprofen, which have few side effects and exhibit high drug efficacy, have been used. However, in order to use these components as a poultice, it is necessary to mix a "dissolving agent" necessary for applying to a substrate such as cloth and a "side agent" for enhancing the transdermal absorption effect. .

Therefore, in many cases, crotamiton is used as a dissolving agent for the above-mentioned medicinal ingredients, and an indomethacin preparation or the like dissolved in the crotamiton is applied to a base material to be used as a poultice. And for the poultice, a formulation prepared by dissolving the active ingredient in crotamiton is applied to the substrate, and a liner (protective film) is applied on the surface of the formulation to be applied to the skin to protect the drug until use. Has been done.

Conventionally, most of the primary packaging forms of poultices are those in which several poultices are put in a small bag. In the package of a poultice, a general-purpose resin such as polyethylene or polypropylene is used for the innermost layer and the liner that come into contact with the drug in terms of price and the like. Further, since aluminum foil is used as a barrier layer in the package, a resin such as an ionomer or an ethylene-methacrylic acid copolymer having good adhesiveness to the aluminum foil may be used as the innermost layer.

For example, there are the following laminated materials for the package. -Paper / PE / Al / EMAA-PET / PE / Al / PE The above symbols indicate the following substances. The same applies hereinafter. -PE: polyethylene-EMAA: ethylene-methacrylic acid copolymer-Al: aluminum-PET: polyethylene terephthalate

[0006]

However, the above-mentioned polyethylene, polypropylene, ionomer, ethylene-methacrylic acid copolymer and the like have a problem that they do not have sufficient resistance to crotamiton and are deteriorated or deformed by chemicals.
In addition, the sorption of crotamiton on the packaging material may reduce the medicinal effect of the stored formulation. Therefore, a package having a low sorption of crotamiton has been desired as a poultice. An object of the present invention is to solve these problems and to provide a laminated material for producing a package with less sorption of crotamiton.

[0007]

The present invention has solved the above-mentioned problems by using the following laminates for a package of a poultice. A laminate comprising a package of a preparation containing crotamiton, wherein the innermost layer of the package is a plastic material that suppresses sorption of crotamiton. Also, the laminate is characterized in that the plastic material for suppressing the sorption of crotamiton is a polyacrylonitrile resin or a polyester resin resin.

That is, a laminated material is prepared using a resin having a low sorption of crotamiton, and a package of a preparation containing crotamiton is prepared using the laminated material, and the contact surface with the preparation containing crotamiton absorbs crotamiton. It was made to be a resin with less wear. For example, the laminated material is PET / PE / Al / P
The object is achieved by using AN (contact surface with the preparation). (PAN represents a polyacrylonitrile resin, and the same shall apply hereinafter.)

When the laminated material is constructed as described above and used as a package of a preparation containing crotamiton, PAN in the innermost layer has resistance to crotamiton and very little sorption, so that the medicinal effect of the medicinal component can be reduced. Absent. Also, P
Since AN has a sealing property, by using aluminum foil as a barrier layer to form a package, the active ingredient of the preparation can be completely sealed, so that the medicinal component does not volatilize out of the package. The effective period can be retained for a long time.

[0010]

According to the present invention, by using a laminated material made of a plastic material having a low sorption of crotamiton as a package for a preparation containing crotamiton, the sorption of crotamiton on the packaging material is significantly reduced, The shelf life of the formulation can be retained over a long period of time. Also,
By using a plastic material having a low sorption of crotamiton for the liner of the poultice, the effective period can be extended.

[0011]

The present invention will be described in detail below with reference to the drawings based on the embodiments. FIG. 1 is a sectional view showing an example of the laminated body of the present invention, and FIG. 2 is a sectional view showing an example of the transparent laminated body of the present invention. FIG. 3 is a cross-sectional view showing an example of the material of the conventional poultice packaging, and FIG. 4 is a cross-sectional view showing the layered constitution of the poultice. FIG. 5 is a cross-sectional view of a package produced using the laminate of the present invention, and FIG. 6 is a cross-sectional view of the package when an adhesive layer is provided on the laminate of the present invention to produce the package. FIG. 7 is an explanatory diagram when manufacturing a laminated material according to the first embodiment.

As shown in FIG. 1, the laminate of the present invention basically comprises a printing substrate 3, a barrier layer 2 and a non-sorbing seal layer 1. And in the non-sorbing seal layer 1,
A plastic film with low sorption of crotamiton is used. Further, when a package of a preparation containing crotamiton is produced using this laminated body, as shown in FIG. 5, a bag is made with the non-sorbing seal layer 1 as the inner surface, and crotamiton is stored in the packaging material. Prevent wearing.

Next, the non-sorbing seal layer, the barrier layer, and the printing substrate constituting the laminate of the present invention will be described in more detail. As the plastic film used for the non-sorbing seal layer, it is necessary to use a resin having a low sorption of crotamiton, and as a result of various studies, it was found that polyacrylonitrile resin and polyester resin are suitable. The film thickness of the polyacrylonitrile resin and the polyester resin may be in the range of 10 to 100 μm, but is preferably 20 to 60 μm.

As the barrier layer, aluminum foil is most commonly used, but as other metal foils, gold,
Foil of silver, copper, iron, lead, tin, etc. can also be used. Also, PET
It is also possible to use a vapor deposition film in which a metal thin film of aluminum, tin, brass or the like is formed on the film or the like by vacuum vapor deposition or sputtering. As the transparent barrier layer, a PET film deposited with a metal oxide such as SiO ₂ or Al ₂ O ₃ can also be used.

As the printing substrate, those usually used as a printing substrate can be used, such as polyethylene terephthalate, polypropylene, nylon, polyethylene, plastic films such as polyacrylonitrile resin, paper, cellophane, metal foil, or a composite film thereof. Can be used.

As a method for laminating the above-mentioned printing substrate, barrier layer and non-sorbing seal layer, conventionally known dry lamination method, extrusion lamination method, wet lamination method and the like can be used. For example, PE
When manufacturing a laminated material having a structure of T / Al / PAN, PE
T and Al are laminated by the extrusion lamination method of PE into PET / PE / Al, and this laminated material and PAN are laminated by the dry lamination method (hereinafter referred to as LMD) to form PET / PE / Al / LMD. /
A laminated material having a PAN configuration is produced.

When a biaxially stretched polyethylene terephthalate film having no sealing property is used for the non-sorbing sealing layer, a portion corresponding to the sealing portion at the time of bag making,
Partial coating of the adhesive agent is carried out, and as shown in FIG. 6, the adhesive agent layer 6 is used to make a bag to obtain a packaged product of the target preparation containing crotamiton. In this case, even if a resin that absorbs normal crotamiton is used for the adhesive, it is used only for the adhesive part of the packaging bag, so there is no part that comes in contact with crotamiton, and crotamiton is absorbed in the packaging bag. There is no.

Next, a detailed description will be given with reference to specific examples. (Example 1) As shown in Fig. 7 (a), a biaxially stretched polyethylene terephthalate (hereinafter referred to as PET) film (manufactured by Toray Industries, Inc.) having a thickness of 12 µm was used as a printing substrate 3 by gravure printing. A printed layer 8 was provided, and the printed surface and an Al foil having a thickness of 9 μm were laminated by an extrusion lamination method using PE.

Next, as shown in FIG. 7B, 3 g / m ² (in a dry state) of polyurethane adhesive 7 (manufactured by Takeda Pharmaceutical Co., Ltd.) was applied to the Al foil 2 surface of this laminated film. Then, as the non-sorbing seal layer 1, a PAN having a thickness of 30 μm is used.
A film (Hytron BX manufactured by Tama Poly Co., Ltd.) was laminated by a dry lamination method to prepare the following laminated material. -PET 12 / PE 15 / Al 9 / LMD / PAN 30 The numeral in the above-mentioned layer structure indicates the thickness, and the unit is μm. The same applies hereinafter.

(Example 2) The surface of a paper having a thickness of 79.1 g / m ² was subjected to printing, and the back surface of this printed paper was subjected to Example 1
In the same way as in the extrusion lamination method, thickness 9
A μm Al foil was laminated to produce a laminated paper. Next, a polyurethane adhesive was applied to the Al surface of this laminated paper at 3 g / m ² (in a dry state), and the same PAN film as in Example 1 was laminated by the dry lamination method to prepare the following laminated material. And paper ^{79.1g / m 2 / PE 15 /} Al 9 / LMD / PAN
30

(Example 3) A PET film having a thickness of 12 µm and an Al foil having a thickness of 9 µm were laminated in the same manner as in Example 1 to prepare a laminated film.
A polyurethane adhesive was applied on the 1-side in an amount of 3 g / m ² (in a dry state), and the PET film having a thickness of 12 μm was laminated by a dry lamination method to prepare the following laminated material.・ PET 12 / PE 15 / Al 9 / LMD / PET 12
(Inner surface) Further, a hot-melt adhesive was part-coated on the seal portion on the inner PET surface of the laminated material so that a bag could be made by heat sealing.

(Embodiment 4) As shown in FIG. 4, a cloth-applied base material 11 coated with a poultice 12 is treated to 100 m.
Cut into a size of mx 150 mm, and the same size with a thickness of 3
A 0 μm PAN film (Tatron Poly Co., Ltd. Hytron BX) or a 12 μm thick PET film (Toray Co., Ltd.) was attached as a liner 13. Size 150 mm x 200 m with the laminated material separately manufactured in Examples 1 to 3.
A package having a size of m and a seal width of 8 mm was prepared, and 5 sheets of the above-mentioned poultice were put therein and heat sealed. After storing the package containing the poultice at room temperature for 1 year, the package was opened and the medicinal effect of the poultice was tested. As a result, the medicinal effect was sufficiently retained.

(Sorption test) The innermost layer film used in Examples 1 to 3 and other polyester films, saponified ethylene-vinyl acetate copolymer films,
The sorption amount of crotamiton was measured by the following method for nylon films, and for films such as PE, PP, EMAA, and ionomer used in the packaging of poultices.

6 to 7 of crotamiton (manufactured by Aldrich Chemical Company, Inc.) in a 90 mmφ glass petri dish.
cc, and various films weighed in advance (size 5)
0 mm × 50 mm, thickness 15-40 μm) was immersed.
After covering the dish with the lid and storing at 22 ° C. for 3 weeks,
The test sample was washed off with ethyl alcohol to remove crotamiton attached to the film, left at room temperature for 1 day, sufficiently dried, and then weighed. (Because the boiling point of crotamiton is 150 ° C. or higher, the crotamiton sorbed on the film hardly decreases even after standing for 1 day.) The sorbed amount was calculated by subtracting the initial weight of each test sample from the weight after immersion in crotamiton. The rate of change was calculated from the sorption amount and the initial weight of the sample as follows. Change rate = (sorbed amount / initial sample weight) x 100
[%] The results of the sorption test are shown in Tables 1 and 2.

[0025]

[Table 1]

[0026]

[Table 2]

The symbols in the table are as follows.・ PAN: polyacrylonitrile ・ EVOH: saponified ethylene-vinyl acetate copolymer ・ EMAA: ethylene-methacrylic acid copolymer ・ PE: polyethylene ・ PP: polypropylene ・ PVC: polyvinyl chloride

As can be seen from the test results in Table 1, acrylonitrile resin and biaxially stretched PET have a small sorption amount of crotamiton and are suitable as the inner surface layer of the laminate of the present invention. On the other hand, as shown in Table 2, a nylon film or a saponified ethylene-vinyl acetate copolymer,
Polyethylene, which has been used as a sealing layer,
Polypropylene, ionomers, ethylene-methacrylic acid copolymers, etc. cannot be used in the laminated material of the present invention because of the large sorption amount of crotamiton. In particular, an ionomer having good adhesion to aluminum has a large sorption amount of crotamiton and is not suitable for the seal layer of the laminated material of the present invention. Further, EVOH and ionomer swell due to crotamiton, so they cannot be used as packaging materials for preparations containing them.

[0029]

EFFECTS OF THE INVENTION According to the present invention, the use of a plastic material having a low sorption of crotamiton as the inner surface layer of the package of the preparation containing crotamiton results in a very low sorption of crotamiton on the packaging material. Further, since the drug product has sufficient resistance, the drug product can be maintained for a long period of time. Therefore, the laminated material of the present invention can be widely used as a packaging material for this type of poultice, and the market can be expanded.

[Brief description of drawings]

FIG. 1 is a sectional view showing an example of a laminate of the present invention.

FIG. 2 is a sectional view showing an example of a transparent laminate of the present invention.

FIG. 3 is a sectional view showing an example of a conventional poultice packaging.

FIG. 4 is a cross-sectional view showing the layer structure of a poultice.

FIG. 5 is a cross-sectional view of a package manufactured using the laminate of the present invention.

FIG. 6 is a cross-sectional view when a package is produced by providing an adhesive layer on the laminate of the present invention.

FIG. 7 is an explanatory view when manufacturing a laminated material according to the first embodiment.

[Explanation of symbols]

1 non-sorptive seal layer 2 barrier layer (Al foil) 2a barrier layer (SiO ₂ deposition PET) 3 printing substrate (PET film) 4 polyethylene layer 5 sealing layer 6 adhesive layer (sealing) 7 adhesive (LMD 8) Printing layer 11 Coated base material 12 Pap formulation 13 Liner

Continuation of the front page (51) Int.Cl. ⁶ Identification number Office reference number FI technical display location B32B 27/28 101 9349-4F 102 9349-4F 27/36 9349-4F

Claims (2)

[Claims] 1. A laminate that constitutes a package of a preparation containing crotamiton, wherein the innermost layer of the package is made of a plastic material that suppresses the sorption of crotamiton. 2. The laminate according to claim 1, wherein the plastic material that suppresses the sorption of crotamiton is a polyacrylonitrile resin or a polyester resin.