JPH0728550U - Packaging bag for patches - Google Patents

Abstract

(57) [Summary] [Purpose] To provide a packaging bag for a patch, which can be stored in a stable state without migration or penetration of the drug even when the patch is stored for a long period of time. A packaging bag for accommodating a patch having a pressure-sensitive adhesive layer containing a drug formed on one surface of a support, wherein the inner surface of the packaging bag which is substantially in contact with the patch is thick. 6-5
It is formed from a metal foil 1 of 0 μm.

Description

[Detailed description of the device]

[0001]

[Industrial applications]

 The present invention relates to a patch packaging bag.

[0002]

[Prior art]

 In order to keep the safety and efficacy of pharmaceutical products stable over a long period of time, it is necessary to pay careful attention to their storage, especially in order to prevent decomposition due to temperature, humidity, light, etc., and scattering into the atmosphere. Various methods have been proposed in.

For example, as a method for stably storing a poultice or plaster agent, a support for the poultice or plaster agent and a cover body (liner) are integrally formed into a bag, and the poultice is placed in the bag. A method is disclosed in which the active ingredient does not volatilize even if the packaging bag is in an opened state by separately storing the agent and the plaster agent (Japanese Patent Publication No. 4-37046).

However, in the above method, in order to use the support itself as a constituent element of the bag, a drug-impermeable plastic film is laminated on the back surface of the nonwoven fabric as the support, and the film is further formed into a bag shape. Since the periphery is adhered to the cover body, the flexibility of the support body and the decrease in moisture permeability are unavoidable, and one edge of the bag is cut off to remove the cover body at the time of application, so the edges remain on the remaining three sides, There was a problem that sufficient adhesion could not be obtained.

Further, as a container for storing the poultice, a dish-shaped body formed of a gas impermeable material such as metal foil or thin hard plastic sheet is used to hold the plaster of the poultice. A method has also been disclosed in which a gas impermeable material is laminated on the lid member to prevent the chemicals and moisture from volatilizing from the plaster (Japanese Utility Model Publication No. 60-63344).

However, since the above method uses a metal foil such as aluminum foil or a hard plastic sheet as a support in order to prevent the volatilization of the drug, the adhesiveness to the skin is poor and the skin feels uncomfortable. Further, there is a problem that a large sticking area is required because an adhesive surface is provided around the plaster surface.

Further, there is disclosed a medicine enclosing bag composed of a three-layer laminate material composed of resin / metal / resin (Japanese Utility Model Laid-Open No. 4-90340). However, since the resin is laminated on the inner surface of the drug-sealed bag, there is a problem that the drug content of the patch decreases due to migration of the drug to the resin layer.

[0008]

[Problems to be solved by the device]

 The present invention has been made in view of the above-mentioned drawbacks, and an object of the present invention is to provide a patch that can be stored in a stable state without migration or penetration of the drug even when the patch is stored for a long period of time. It is to provide a packaging bag for agents.

[0009]

[Means for Solving the Problems]

In the patch packaging bag of the present invention, the inner surface of the packaging bag which is substantially in contact with the patch in the packaging bag is formed of a metal foil.

Examples of the metal foil used for the packaging bag include aluminum foil. If the thickness of the metal foil is thin, pin poles are often generated, and damage to deformation easily occurs, impairing the gas barrier property, and if it is thick, it becomes difficult to handle at the time of manufacturing or use. Limited to 50 μm.

As a method for producing a patch packaging bag from the above metal foil, for example, a heat-fusible resin is attached to the peripheral surface of the metal foil in order to bond the metal foils after sealing the patch. And a method of heat-sealing at the time of packaging. Examples of the resin exhibiting heat fusion include polyvinyl chloride, polyester, polypropylene, polyethylene, polyvinyl alcohol, polyacrylonitrile, ethylene-vinyl acetate copolymer, ethylene-vinyl alcohol copolymer and the like.

The resin used for the heat fusion is applied to a necessary portion by a hot melt coating method, a solvent coating method or the like. At this time, the coating amount is preferably ² to 10 g / m ² , because if the coating amount is small, sufficient sealing properties cannot be obtained, and if the coating amount is large, the drug or additive may migrate to the sealed portion.

A protective layer may be provided on the outer surface of the metal foil in order to improve the strength of the metal foil to prevent breakage, enhance barrier properties, and impart aesthetics. Examples of the material used for the protective layer include resin films of polyester, polypropylene, polyethylene, polyamide, etc., paper, cellophane, etc., and one or more layers of these materials may be subjected to thermal lamination or dry lamination with an adhesive. The protective layer is formed by stacking the layers.

When the thickness of the protective layer is thin, the effect of protecting the metal foil cannot be obtained, and when the thickness is thick, the sealing property is deteriorated and the patch in the packaging bag becomes difficult to be taken out, so that the thickness is 10 to 200 μm. Is preferred.

The patch contained in the above-mentioned patch packaging bag has an adhesive layer containing a drug formed on one surface of a support.

Examples of the above-mentioned support include polyethylene, polypropylene, polystyrene, polyurethane, nylon, polyvinyl alcohol, polyamide, polybutadiene, polybutene, polyisoprene, silicone resin; plasticized polyvinyl chloride, polyurethane-based plasticized polychloride. Vinyl chloride, vinyl chloride resin such as plasticized vinyl acetate-vinyl chloride copolymer; ethylene-based copolymer such as ethylene-vinyl acetate copolymer, ethylene-vinyl chloride copolymer, ethylene-methyl methacrylate copolymer ; (Meth) acrylic acid alkyl ester, styrene-isoprene-styrene block copolymer, styrene-butadiene-styrene block copolymer, styrene-ethylene-butadiene-styrene block copolymer, styrene-butadiene rubber, acetic acid acetate Examples thereof include films or sheets such as sucrose and ethyl cellulose. You may use the said film or sheet individually or in laminate of 2 or more types.

The thickness of the support is preferably 10 to 500 μm, more preferably 25 to 100 μm.

The pressure-sensitive adhesive is not particularly limited and, for example, any of acrylic-based, rubber-based, and silicone-based pressure-sensitive adhesives can be used, but acrylic-based and rubber-based pressure-sensitive adhesives are particularly preferable. .

As the above-mentioned acrylic pressure-sensitive adhesive, those having a (meth) acrylic acid alkyl ester copolymer as a main component are preferable, and as the rubber-based pressure-sensitive adhesive, styrene-isoprene-styrene block copolymer, styrene-butadiene rubber are used. Those containing polybutene, polyisoprene, butyl rubber, natural rubber or the like as a main component are preferable.

The pressure-sensitive adhesive may be of any of solvent type, emulsion type and hot melt type.

The above-mentioned (meth) acrylic acid alkyl ester copolymer is a (meth) acrylic acid alkyl ester monomer obtained from an aliphatic alcohol having 1 to 18 carbon atoms and (meth) acrylic acid, and the (meth) acrylic acid. A copolymer of an alkyl ester monomer and a polymerizable monomer capable of copolymerization is preferable.

Examples of the above-mentioned (meth) acrylic acid alkyl ester monomer include methyl (meth) acrylate, ethyl (meth) acrylate, butyl (meth) acrylate, isobutyl (meth) acrylate, and (meth) acrylic acid. Hexyl, octyl (meth) acrylate, 2-ethylhexyl (meth) acrylate, isooctyl (meth) acrylate, dodecyl (meth) acrylate, etc. are used, and one or more of them are used. To be done.

Examples of the polymerizable monomer include (meth) acrylic acid, N-vinylpyrrolidone, diacetone acrylamide, (poly) ethylene glycol, (meth) acrylic acid polypropylene glycol, (meth) acrylic acid- 2-hydroxyethyl, vinyl acetate, styrene and the like can be mentioned.

The above-mentioned (meth) acrylic acid alkyl ester copolymer is prepared by a conventionally known polymerization method such as solution polymerization or bulk polymerization.

If desired, a tackifier, a liquid rubber, a softening agent, an antioxidant, etc. may be added to the rubber-based pressure-sensitive adhesive.

In order to produce the above-mentioned patch, a conventionally known method for producing an adhesive tape can be used. A typical example thereof is a solvent coating method, and other examples include a hot melt coating method and an emulsion coating method. When performing solvent coating, for example, a method of dissolving or dispersing the adhesive or drug in a solvent such as ethyl acetate and coating the resulting liquid on a support and drying, or coating on a release paper and drying. A method of forming a pressure-sensitive adhesive layer by transferring onto a support is preferably used.

The thickness of the pressure-sensitive adhesive layer is not particularly limited, but when it becomes thin, a large amount of the drug must be added, and as a result, the adhesive force decreases, and when it becomes thick, the drug in the adhesive patch is 20 to 300 μm is preferable because it cannot be effectively used and the cost cannot be expected to improve, and improvement in performance cannot be expected.

As the shape of the patch, any shape such as a sheet shape, a band shape, a patch shape, a roll shape, or the like is adopted.

[0030]

【Example】

Next, an embodiment of the present invention will be described. Synthesis of acrylic adhesive Dodecyl methacrylate 10 mol% (48.3 g), 2-ethylhexyl acrylate 10 mol% (34.9 g), 2-ethylhexyl methacrylate 80 mol% (301.0 g) and hexamethylene glycol dimethacrylate. 38.4 mg (0.01% by weight based on the total amount of monomers) was supplied to a separable flask equipped with a stirrer and a cooling device, and 256 g of ethyl acetate was further added to adjust the monomer concentration to 60% by weight. The temperature of this solution was raised to 70 ° C. under a nitrogen atmosphere, a solution prepared by dissolving 2.0 g of lauroyl peroxide in 100.0 g of cyclohexane was divided into 10 parts, and 1 was added to a separable flask to start polymerization. . From the 5th hour after the initiation of polymerization, the remaining 9 was added at 1-hour intervals, and the reaction was continued for 19 hours after the completion of the addition. After the reaction was started to adjust the viscosity, 27 parts of ethyl acetate was added 5 times every 5 hours, and polymerization was carried out for a total of 32 hours to obtain a pressure-sensitive adhesive solution having a solid content concentration of 50% by weight.

Example 1 93 parts by weight of the acrylic adhesive, 2 parts by weight of glycol salicylate as a drug, 5 parts by weight of isopropyl myristate as a softening agent and ethyl acetate were added and mixed uniformly to obtain a solid content concentration of 30 parts by weight. % Mixture was obtained. The resulting mixed solution is applied to the release-treated surface of a release paper having a thickness of 50 μm and subjected to silicone release treatment, and then dried at 60 ° C. for 30 minutes to form a pressure-sensitive adhesive layer having a thickness of 80 μm. A 50 μm thick polyurethane film support was laminated on the pressure-sensitive adhesive layer to obtain a patch. As the release paper, a laminate of polyethylene film (20 μm thick) / glassine paper (80 μm thick) / polyethylene film (10 μm thick) / [silicone release treatment] was used.

As shown in FIGS. 1 and 2, the aluminum foil 1 side of the laminate having a 20 μm thick polyethylene terephthalate film laminated as a protective layer 2 on the 15 μm thick aluminum foil 1 was heated and melted at 200 ° C. The fusible resin 3 (polyethylene terephthalate resin) was gravure coated so as to form a frame having a width of 10 mm and an inner frame size of 55 × 65 mm. The two laminates were laminated with the aluminum foil 1 inside so that the gravure coating portions were overlapped with each other, and the three sides were heat-sealed, and the periphery thereof was cut to obtain a packaging bag. After inserting one patch A (40 x 50 mm) from the opening of this packaging bag, heat-sealing the opening and sealing it to obtain a packaging bag containing the patch as shown in Fig. 3. It was

Comparative Example 1 As shown in FIGS. 4 and 5, 170 ° C. is provided on the aluminum foil 6 side of a laminate obtained by laminating a 20 μm-thick polyethylene terephthalate film as a protective layer 4 on a 15 μm-thick aluminum foil 5. The heat-fusible resin 6 (polyethylene resin) that was heated and melted was applied over the entire surface. The two laminates are stacked so that the aluminum foil 5 is on the inside, and the three sides are heat-sealed to form a frame with a width of 10 mm and an inner frame size of 55 × 65 mm, and then the periphery is cut and wrapped. I got a bag. After inserting one patch A (40 x 50 mm) from the opening of this packaging bag, the opening was heat-sealed and sealed to obtain a packaging bag containing the patch as shown in Fig. 6. It was

Comparative Example 2 A polyethylene film (20 μm thick) / polyethylene terephthalate film (12 μm thick) / aluminum foil (9 μm thick) laminate was used as a support, and a polyethylene terephthalate film ( Patch A was obtained in the same manner as in Example 1 except that a laminate of (25 μm thickness) / aluminum foil (18 μm thickness) / [silicone release treatment] was used. In the same manner as in Comparative Example 1, the above-mentioned patch A was inserted into a packaging bag whose three sides were heat-sealed, and then the opening was heat-sealed and hermetically sealed, and the patch as shown in FIG. 6 was stored. Got the packaging bag.

The patches obtained in the above Examples and Comparative Examples were evaluated as follows, and the results are shown in Tables 1 and 2. Stability of drug content Immediately after preparation, the patches obtained in Example 1 and Comparative Examples 1 and 2 were punched out into a circle having a diameter of 2 cm to prepare samples. The release paper of this sample was peeled off, solvent extraction was performed, and the amount of drug and the amount of softening agent were measured using a liquid chromatograph. On the other hand, the pressure-sensitive adhesive layer weight was calculated from the weight of the patch before solvent extraction, the weight of release paper, and the weight of support weight obtained after solvent extraction, and the concentrations of the drug and the softening agent in the pressure-sensitive adhesive were obtained. Further, the patch sealed in the packaging bag was stored at 60 ° C. for 2 weeks and then opened, and the concentrations of the drug and the softening agent in the adhesive were determined by the same method as above. Table 1 shows the concentrations of the drug and the softening agent in the adhesive.

[0036]

[Table 1]

Sensitivity test The patches obtained in Example 1 and Comparative Example 2 were applied to the shoulders of 10 male subjects one by one for 6 hours, and the following evaluations were carried out. (1) Followability The "followability" when the test subject was moving was evaluated according to the following criteria. Follows the skin well, usually does not follow the skin and is difficult to move. Table 2 shows the total number of test subjects judged to meet the above criteria.

(2) Uncomfortable Feeling "Uncomfortable feeling" when the subject was stationary was evaluated according to the following criteria. Almost no, I'm pretty worried about it. Table 2 shows the total number of test subjects judged to meet the above criteria.

(3) Moisture of Skin “Moisture of skin” after application for 6 hours was evaluated according to the following criteria. No particular problem, a little stuffy and sweaty, and a lot of stuffiness and whitening of the skin. Table 2 shows the total number of test subjects judged to meet the above criteria.

[0040]

[Table 2]

[0041]

[Effect of device]

 The structure of the patch packaging bag of the present invention is as described above, and since the resin does not exist on the inner surface of the packaging bag that is substantially in contact with the adhesive layer, drugs, additives, etc. may migrate into the resin. , Does not leak outside. Therefore, the patch can be stored in a stable state for a long period of time.

[Brief description of drawings]

FIG. 1 is a plan view showing a laminated body used in Example 1 of the present invention.

FIG. 2 is a side view of the stack of FIG.

FIG. 3 is a schematic cross-sectional view showing a state in which the patch is sealed in a packaging bag obtained by heat-sealing the periphery of the laminate of FIG.

FIG. 4 is a plan view showing a laminated body used in Comparative Examples 1 and 2 of the present invention.

5 is a side view of the stack of FIG.

6 is a schematic cross-sectional view showing a state in which the patch is sealed in a packaging bag obtained by heat-sealing the periphery of the laminated body of FIG.

[Explanation of symbols]

 1,4 Aluminum foil 2,5 Protective agent 3,6 Thermal adhesive resin A Patch

Claims (1)

[Scope of utility model registration request] 1. A packaging bag for accommodating a patch having a pressure-sensitive adhesive layer containing a drug formed on one surface of a support, wherein the inner surface of the packaging bag, which is substantially in contact with the patch in the packaging bag. , Thickness 6
A packaging bag for patches, which is formed of a metal foil of ˜50 μm.