WO1999030668A1 - Packing-inner seal composite member and pharmaceuticals sealed by the composite material - Google Patents

Abstract

A packing-inner seal composite member comprising a packing material capable of sealing a mouth of a container, an inner seal member capable of bonding the mouth of the container and bonding means for bonding the packing member with the inner seal member, wherein the bonding means bonds the packing member with the inner seal member at a strength lower than the bonding strength of the inner seal member to the mouth of the container, and the inner seal member holds a desiccant sealably inside the container. This composite member can seal the mouth of the container by the inner seal member and can simultaneously seal the desiccant. The desiccant can be easily removed at the time of use and the container can be sealed once again. Further, because the desiccant does not move inside the container during transportation, no breakage occurs. Because the desiccant can be easily removed simultaneously with the removal of the inner seal at the time of opening, accidental swallowing of the desiccant can be prevented, too. After the seal is open and the content is dissolved by charging water, this composite member can be sealed again and a solution can be preserved in the same container.

Description

 Description Packing-in-one-composite, and preparation sealed with the composite

[Background of the Invention]

 Field of the invention

The present invention relates to a composite for sealing the mouth of a container. In addition, the present invention relates to a medicine obtained by sealing a container containing a medicine, particularly a hygroscopic, time-soluble drug for use, with the composite material.

 Background art

 It is known to seal the mouth of a glass or plastic container with a plastic film or a composite film of an aluminum film and a plastic film. For example, Japanese Unexamined Patent Publication No. 4-31253 discloses a composite material in which a base material, a temporary adhesive, an aluminum film, and a sealing layer are laminated on KM as a composite material for sealing the mouth of a container such as a bottle. Materials have been proposed. The composite material is mounted inside the lid material, and the container is covered with the lid material. Then, the bottle opening and the sealing layer are adhered and sealed by irradiating electromagnetic waves and heating. According to this composite material, the mouth of the container can be securely sealed.

 In the method of sealing the mouth of the container and further closing the mouth by placing a lid material thereon, the member for sealing the mouth of the container is generally called an inner seal material. This inner sealing material is excellent in packaging form, such as high sealing performance, reliability, low equipment load, and prevention of falsification.

When sealing with an inner seal material, it is preferable to put a desiccant in the container. Especially when the content is a hygroscopic drug, it is essential not only to seal the drug in a storage container but also to use a desiccant in order to prevent inferior quality due to moisture absorption. Become. As a method for adding a desiccant, it is common to put the desiccant directly into the container or to adhere the desiccant to the lid of the container or the bottom of the container. However, the method of directing the desiccant into the container must be such that the desiccant or the strength of the container is not damaged as the desiccant moves within the container. Attention must also be paid to prevent accidental drinking of desiccants. In addition, the method of bonding the desiccant to the bottom of the container increases the production cost.

 If the drug is a dissolvable drug at the time of use, the drug is dissolved in water after opening, and a desiccant is not required. In this way, for drugs that require desiccant power before opening and do not require desiccant after opening, use two containers for storage and dissolution, and separate them from the storage container for the amount of use. They are transferred to another container, dissolved and used. In such a case, if the same container can be used, it is preferable from the viewpoint of quality maintenance. However, it is necessary to remove the desiccant when the method of directly putting the desiccant into the container is adopted. When the same container is used, it is preferable that the desiccant can be removed, the drug added with water can be dissolved, and then the container can be sealed again. That is, it is preferable that the container can be sealed again with a so-called packing material or the like that prevents leakage of liquid gas.

 For containers whose mouth is not covered with the inner seal material, a method of directly adding a desiccant into the container and a method of incorporating the desiccant into the lid or inner lid are generally adopted. However, incorporating a desiccant in the lid and inner lid is disadvantageous in terms of cost, such as increasing the number of mounting steps and installing additional molded products to contain the desiccant. In addition, it is necessary to have a structure that allows easy removal of the desiccant when storing a dissolvable drug at the time of use and when incorporated into the lid. Outline of Akira]

The present invention has been made to solve the above-mentioned problems, and the present invention provides an The purpose of the present invention is to provide a packing-inner-seal composite material that can seal a desiccant at the same time as sealing with a sealing material, while easily removing the desiccant at the time of use, and reseal the container. It is a further object of the present invention to provide a formulation sealed with this packing-inner seal composite.

 The packing-inner-seal composite material according to the present invention includes a packing material capable of sealing a container opening, an inner sealing material capable of bonding and sealing a container opening, and bonding the packing material and the inner sealing material. Bonding means, wherein the bonding means bonds the packing material and the inner seal material with a strength smaller than a strength at which the inner seal material is bonded to a container opening. The inner seal material holds the desiccant in the container in a sealable manner.

 Further, the preparation according to the present invention is obtained by sealing a container containing a medicine with the packing-inner seal composite material.

[Brief description of Wai]

 FIG. 1 is a sectional view of a packing-inner seal composite according to the present invention. 2 (A) to 2 (D) illustrate a method of using the packing-inner-seal composite according to the present invention.

[Specific description of the invention]

Preferred embodiments of the packing-inner seal composite material according to the present invention will be described below. FIG. 1 shows a cross-sectional view of a packing-inner-seal composite material according to the present invention. The packing-inner-seal composite material according to the present invention comprises a laminated material 10 and a desiccant 6, and the laminated material 10 is a part of the packing material 1 and the inner sealing material joined via an adhesive layer 2 as an adhesive means. Consists of 11 The packing material 1 is configured to be able to seal the container mouth by itself. The inner seal material 11 is made of aluminum It is configured by sequentially laminating an film 3, a plastic film 4, and a seal layer 5. A desiccant 6 is adhered to the seal layer 5. The seal layer 5 is adhered to the container mouth to seal the container. Further, the adhesive layer 2 bonds the 11-layer aluminum film 3 of the inner seal material and the packing material 1 with a strength smaller than that of the seal layer 5 capable of bonding to the container opening.

 FIG. 2 illustrates a method of using the packing-inner seal composite according to the present invention. The packing-inner-seal composite material shown in the figure has a cap 7 further attached to the packing material 1 in addition to the configuration shown in FIG. The cap 7 is attached to the packing material 1 so that the adhesive layer 2 is larger than the bonding material 1 and the inner seal material 11 are bonded to the packing material 1. The packing-inner-seal composite material according to the present invention is adhered to the mouth 9 of the container 8 containing the contents 10 while the desiccant 6 is placed in the container 8. Bonding can be performed according to the material of the seal layer 5. For example, when the sealing layer 5 is made of a hot-melt adhesive, the sealing layer 5 is bonded to the opening 9 by heating. FIG. 2 (A) shows a state in which the packing-inner seal composite according to the present invention is adhered to the container 8.

Next, in use, remove the cap 7 as shown in FIG. 2 (B). At this time, the bonding strength of the bonding layer 2 for bonding the packing material 1 and the inner seal material 11 is determined by the bonding strength between the sealing layer 5 and the opening 9 and the bonding strength between the packing material 1 and the cap 7 ¾ ^ Since it is smaller, the packing material 1 and the inner sealing material 11 are separated. The mouth 9 remains sealed by the inner seal 11. That is, it is not opened simply by removing the cap 7. On the other hand, the cap 7 holds the packing material 1. According to a preferred embodiment of the present invention, as shown in FIG. 2 (B), the adhesive layer 2 is peeled off at the contact surface with the packing material 1 and all remains on the inner seal material 11, and the packing material 1 Is preferably not substantially left on the surface. The packing material 1 is for resealing the mouth 9 as will be described later. The surface is preferably not contaminated by residual components of the adhesive layer 2 or the like.

 The container 8 is opened for the first time by removing the inner seal 11. As shown in FIG. 2 (C), the desiccant 6 is easily removed simultaneously with the opening.

 As described above, the packing material 1 is configured to be able to seal the container mouth by itself. Therefore, as shown in FIG. 2 (D), the mouth 9 of the container 8 can be sealed with the packing material 1. Therefore, for example, it is possible to dissolve the contents 10 by injecting water into the container, and to seal the container 8 again with the cap 7 holding the packing material 1, so that the solution is sanitary and safe until use. Can be held.

 According to the packing-inner-seal composite material of the present invention, the desiccant can be placed in the container at the same time that the mouth of the container is inner-sealed. In addition, the parts can be manufactured with conventional equipment. Further, in the composite material according to the present invention, the desiccant does not move in the container during transportation, so there is no possibility of breakage. Also, at the time of opening, the desiccant can be easily removed at the same time by removing the inner package, so accidents such as accidental ingestion of the desiccant can be effectively prevented. Furthermore, the composite material according to the present invention can be resealed after opening, dissolving the contents by injecting water. Therefore, the advantage is obtained that the lysis solution can be stored in the same container. As the aluminum film of the first layer of the inner seal material 11, general high quality aluminum foil or the like can be used. Also, necessary printing or the like can be performed on the aluminum foil surface. The thickness of the aluminum film is not particularly limited, but is preferably about 5 to 20 uin, more preferably about 5 to: L0 // m, because processing is easy.

 As the plastic film of the second layer, polyethylene, polypropylene, polyvinyl chloride, polyester and the like can be preferably used.

The third layer, the seal layer, is selected in consideration of the adhesion to the dry explosive and the ease of attachment to the container mouth. As a material for the seal layer, for example, a material having a property of melting by heating is used. Can be used. Such materials include hot melt, polyethylene, ethylene-vinyl acetate copolymer (EVA), ionomers, ethylene-acrylic acid copolymer (EAA), ethylene-methyl methacrylate copolymer (EMMA), Ethyl acrylate copolymer (EEA) and the like. According to a preferred embodiment of the present invention, it is possible to use the same material as the container and the same material as the plastic film of the second layer. The thickness of the seal layer may be appropriately selected in consideration of the seal strength, adhesiveness to a container material, and the like. According to a preferred embodiment of the present invention, the mouth of the container and the sealing layer can be adhered and sealed using the high-frequency induction heating described in JP-B-56-35544 and JP-B-50-32540.

 The packing material 1 is not particularly limited as long as it is a material capable of sealing the mouth of the container. For example, as the packing material, a packing material that is usually used by being attached to a cap or the like of a container can be used. Examples of packing materials include paperboard (including surface-treated ones), synthetic paper, nonwoven fabric, rubber materials such as silicone rubber and urethane rubber, soft polyethylene, polyethylene, polypropylene, polystyrene, polyurethane, and vinyl chloride. A foamed plastic material such as a resin may be used. In particular, in consideration of water resistance, dusting properties, lamination workability with other materials, etc., foamed plastic materials are preferred, and foamed polyethylene and foamed polypropylene are most preferably used.

 The bonding means for bonding the packing material and the inner seal material is not particularly limited as long as the packing material and the inner seal material are bonded with a strength smaller than the strength of the inner seal material bonded to the container opening. . For example, it is possible to use the same material as the above-mentioned seal layer while controlling the adhesive strength. According to a preferred embodiment of the present invention, resins such as polypropylene, polyethylene, EVA, ionomer, EAA, EMMA. EEA, wax, etc. can be preferably used.

The thickness and shape of the packing, inner and inner composite material according to the present invention are used in a hermetically sealed container. Also, it may be determined appropriately. According to a preferred embodiment of the present invention, the workability and the loading property of the composite material! From ^, the thickness is usually preferably about 0.2 to 5 mm, and more preferably about 0.5 to 3.0 thighs.

 The inner seal material holds the desiccant inside the container so as to seal the desiccant. The holding of the desiccant may be performed by adhesion or the like. As the desiccant, a known desiccant having a water absorbing ability and used for food and medicine can be used. For example, synthetic zeolite, calcium chloride, silica gel and the like can be mentioned. In addition, the shape may be appropriately determined, and desiccants such as tablets, sheets, and granules can be used. The size of the desiccant may be appropriately selected in consideration of the required water absorption capacity, the size of the container to be applied, the hygroscopicity of the contents to be stored in the container, and the workability during manufacturing. . For example, in the case of a container having a diameter of 30 cm and a content of 40 ml, the use of a desiccant having a diameter of 2 cm, a thickness of 7 mm, and a weight of about 4 g is preferable. According to a preferred embodiment of the present invention, the agent is packaged with a nonwoven fabric or the like and adhered to the surface of the inner sealant. The bonding may be performed using a normal adhesive, and since the inner seal material has adhesiveness to the container mouth, the inner sealant may be bonded using this adhesiveness.

 The packing-inner-inner composite material according to the present invention can be manufactured, for example, by manufacturing it into a sheet and then punching it into a predetermined size corresponding to the diameter of the container to be applied centering on the desiccant. .

 The container according to the invention is a container hermetically sealed with the packing-inner-seal composite according to the invention. The preparation according to the present invention is obtained by sealing a container containing a drug with the packing-inner seal composite according to the present invention. Preferred examples of the stored drug include a hygroscopic, time-soluble drug. This is because the hygroscopic time-use dissolvable drug requires a desiccant power before opening, and dissolves after use to open and is not required because it is desiccant power.

Specific examples of drugs that can be stored in the container according to the present invention include dry syrup, powder Gargle-shaped Preservatives for contact lenses. The present invention is particularly preferably used for storing dry syrup. Dry syrup is an internal medicine preparation containing sucrose, other saccharides, sweeteners and the like, and refers to a preparation to be dissolved or suspended at the time of use. Further, the container according to the present invention containing such a drug can be said to be a drug. Therefore, according to another aspect of the present invention, there is provided a pharmaceutical preparation comprising a container containing a medicine sealed with the packing-inner seal composite according to the present invention.

 As the container that can be used in the present invention, a commonly used material such as glass or plastic can be used. In the case of glass, it is preferable to use brown glass because it is possible to block the influence of light. Examples of plastic containers include containers made of polyethylene, polypropylene, polyester, and the like. The shape of the container is not particularly limited, and can be appropriately selected and used. When the contents are used after dissolving in water after opening, it is preferably a bottle shape.

[Example]

 Example 1: Production of packing-inner seal composite

 The aluminum foil side of the inner seal material, which is made by laminating polyethylene (thickness 20 βm) as a plastic film on an aluminum foil (thickness 0.7) and hot melt as a sealing layer, and the surface treatment A packing material (thickness: 0.9 mm) made of the prepared paperboard was prepared. A wax adhesive layer (30 thighs) was sandwiched between the inner seal material and the packing material to form a laminated material.

On the other hand, a synthetic zeolite desiccant (25 mm 0) is packed in a non-woven fabric, and high-frequency induction heating is used to irradiate high frequency on the sealing layer surface of the laminated material to soften the hot melt and fuse the desiccant and the laminated material. I let it. This packing-inner-seal composite is punched into a circular shape with a diameter of 40 mm centering on the desiccant. Obtained.

 Example 2: Production of a formulation sealed with packing-inner seal composite

 The packing-inner-shell composite material obtained in Example 1 was attached to the back surface of the container cap with the packing material side inside. On the other hand, a brown glass container (capacity: 160 ml) was filled with 15 g of dry syrup of sevditoren pivoxil.

 A cap fitted with a packing-inner-seal composite material was fitted into the opening of the filled container and sealed. Finally, high-frequency induction heating is used to irradiate the aluminum foil of the inner seal from the upper side of the cap of the container sealed with the cap, thereby melting the hot menoleto, which is the seal layer, and forming a seal layer on the container mouth. It was fused and sealed completely.

 Example 3: Drying test of contents sealed with Packinina-Seal composite

 A brown glass container (capacity: 160 ml) was filled with lactose (20 g) in the same manner as in Example 2, and the packing-inner seal composite material obtained in Example 1 was used and sealed. Similarly, lactose was sealed using a laminated material without a desiccant. The above two sealed containers were stored for 2 weeks in an environment at a temperature of 40 ° C and a humidity of 75 H, and the contents were examined for changes in water content. Lactose sealed with a laminated material without a desiccant did not show any change from a moisture of 5! ¾, whereas lactose sealed with a packing-inner seal composite with a desiccant had a moisture content of 2%. The decline was observed.

 There are many pharmaceutical preparations whose stability is improved by lowering the water content, and it is considered that such preparations are useful.

 Example 4: Use of a formulation sealed with packing-inner-seal composite

 An example of the use of the preparation obtained in Example 2 is as follows.

1) When the cap of the preparation was removed, the packing material and the inner seal material were separated from the adhesive layer, and the mouth of the container remained sealed with the inner seal with a desiccant. The cap was held while holding the packing material. 2) Next, the seal was opened by removing the inner seal. The desiccant integrated with the inner seal was also removed at the same time, so it was discarded together.

 3) A predetermined amount of water was poured into the container, the container opening was resealed using the cap removed in 1), and the container was shaken to dissolve the drug.

 4) The cap was opened and the dissolved drug was used. The remaining drug was closed and stored in the refrigerator until it was used up.

Claims

The scope of the claims 1. A packing material that can seal the container mouth and an inner that can seal and seal the container mouth A packing-inner seal composite material comprising: a sealing material; and bonding means for bonding the packing material and the inner seal material.  The adhering means is for adhering the inner and outer seal members to the inner seal member with a strength smaller than the strength at which the inner seal member is adhered to the container mouth, and the inner seal material includes a desiccant inside the container. Packing-inner-seal composite material that sealably holds the seal. 2. The packing / inner seal composite according to claim 1, wherein the inner seal material is a laminate in which an aluminum film, a plastic film, and a seal layer are sequentially laminated. 3. The packing inner seal composite according to claim 1, wherein the desiccant is in a shape of a particle, a particle, or a sheet, and is adhered to the inner seal material. 4. A container sealed with the packing-inner seal composite material according to any one of claims 1 to 3. 5. A preparation comprising a container containing a drug, which is hermetically sealed with the packing-seale composite according to any one of claims 1 to 3. 6. The formulation of claim 5, wherein the drug is a hygroscopic, time-soluble drug.