JPS6322828B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a container for enclosing an injectable drug mainly composed of a multilayer plastic film or sheet, and its purpose is to:
There is no foreign matter contamination, the drug contained in the container can be completely isolated from the outside world, and there is no need to take the trouble to open the container with a cutter, and furthermore, the drug does not come into contact with oxygen as much as possible. The object of the present invention is to provide a plastic container for enclosing an injectable drug that can be directly penetrated with an injection needle to take out the drug.

Conventionally, the majority of containers for enclosing injection drugs have been made of glass, as typified by so-called ampoule containers.

These containers are made of glass with a wall thickness of 0.5 to 1.0 m/m and are made to withstand the internal pressure during heating during the sterilization process. It is used by cutting, but when cutting, there are cases where the fingertips are injured by mistake.
In addition to being difficult to handle, such as being damaged by dropping it on the floor, it also has the disadvantage of unavoidable contamination of glass particles into the injectable drug. Furthermore, various measures are required to prevent damage during the production and transportation stages, and a large amount of cushioning material is required for wrapping and packing, which is a factor in high costs. However, since it is made of glass, it is very inconvenient to dispose of it after use, and it is difficult to dispose of it easily.

Of course, by replacing the glass ampoule, which had problems in terms of handling, productivity, economy, etc., with a plastic one,
Although the above-mentioned problems can be solved to a large extent, simply changing the material will cause problems specific to plastic materials, such as foreign matter contamination and gas permeability, especially gas permeability. This type of container made of plastic has significant drawbacks in its applicability, as it is largely limited by the type of drug that can be contained in the container. Among these, components that are particularly susceptible to deterioration due to oxygen,
For example, in the case of drugs containing amino acids or fat emulsions, there were no plastic containers of this type applicable. Furthermore, since the ampule is made of glass, it is not possible to insert a direct injection needle into the ampoule without opening it, which is not only time-consuming, but also makes it impossible to avoid contact with oxygen.

Therefore, this invention solves the above-mentioned problems inherent to glass materials by using plastic materials, and also solves the problems of foreign matter contamination and isolation from the outside world, which are problems when using plastic materials. We used extremely low-contamination materials and adopted a specific multilayer structure as a direct means of penetration for the injection needle. That is, the outer layer, the middle layer,
A multilayer container consisting of a coextruded or laminated three-layer film or sheet with an inner layer made of a gas-proof material such as polyvinylidene chloride or saponified ethylene-vinyl acetate copolymer, which is relatively impermeable to gases. In addition to being composed of layers, the outer layer is made of thermoplastic elastomer with a Shore hardness of approximately 40°, and the inner layer is made of ultra-thin polyethylene or polypropylene, and a drug solution extraction part for penetrating the injection needle is formed in a part of the container.

Hereinafter, as shown in FIG. 1, a lid material 1 made of a coextruded three-layer film or sheet of an outer layer 1a, an air barrier layer 1b, and an inner layer 1c, an outer layer 2a, an air barrier layer 2b formed into a substantially concave shape by vacuum forming, A more detailed explanation will be given by taking as an example a container of this kind constructed by heat-sealing the inner layer 2c and the container body 2 made of a coextruded three-layer film or sheet at the opening edge 3 of the body 2.

The outer layer 2a of the container body 2 maintains the container shape,
Also, in terms of preventing accidental penetration of the tip of the injection needle,
It is desirable to use a hard material, and for example, a film or sheet of hard polyvinyl chloride, polypropylene, polystyrene, etc. can be used. The inner layer 2c is preferably made of a material that prevents elution into the contents, and for example, a film or sheet of polyethylene, polypropylene, etc. can be used. The air barrier layer 2b may be made of a material that is relatively impermeable to gas.
For example, in addition to plastic materials such as polyvinylidene chloride or saponified products of ethylene-vinyl acetate copolymer, aluminum foil and the like can be used.

On the other hand, as the lid material 1, it is naturally possible to use a multilayer sheet or film having the same structure as the container body 2, but it is more preferable to use a relatively flexible material. For example, outer layer 1a
It is conceivable to use soft polyvinyl chloride, polyamide, thermoplastic elastomer, etc. Note that when the injection needle is directly penetrated into the capping material 1 to take out the contents, there is a risk that fragments of film or sheet material may get mixed into the tip of the injection needle during penetration, which is the so-called coring phenomenon. It is appropriate to select a material that does not cause this phenomenon, and in this example, the outer layer 1a is made of a thermoplastic elastomer with a hardness of about 40° (Shorer hardness A), and the inner layer 1c is made of extremely thin polyethylene or polypropylene. A drug solution extraction part A made of a film or sheet for penetrating the injection needle is provided. In this embodiment, the entire lid 1 serves as the chemical solution extraction section A, but it may be provided in a part of the lid 1, or may be provided in other parts other than the lid. No problem.

Furthermore, in addition to the above-mentioned method of directly penetrating the lid material 1 with a syringe needle to take out the contents, other methods of retrieving the contents may also be used. A peeling part of the lid material is formed, and a part or the whole of the lid material is peeled off from this peeling part, and the injection needle is inserted into the container and taken out.

In this way, by using a container having the above structure, production can be performed in a series of continuous steps, including the step of filling the contents. For example, the process includes a vacuum forming process of a multilayer film or sheet in which a large number of container bodies are integrally and simultaneously formed, a process of filling the contents, a process of sealing the lid material, a process of cutting and separating individual containers, and a process of packaging. In addition, for contents that are particularly susceptible to the effects of oxygen gas, it is preferable to replace the gas in the container with nitrogen gas before sealing the lid, to more effectively control the deterioration of the contents. be able to.

By the way, as mentioned above, the container with the above structure has a lid material 1 made of a coextruded three-layer film or sheet.
and a container body 2 made of a coextruded three-layer film or sheet formed into a substantially concave shape by vacuum forming, which are integrated by heat sealing.
The container according to this type of invention is of course not limited to this. For example, a multilayer laminated film or sheet may be used instead of a coextruded film or sheet, or the container body 2 may not be formed into a substantially concave shape but may be formed into another shape. do not have.

Furthermore, instead of adopting the above-mentioned molding method of integrating the lid material 1 and the container body 2, a multilayer parison having an air barrier layer 4 may be used for blow molding, and the open end thereof may be heat-sealed. . (See Figure 2)
In this case, it is preferable to form a neck part 6 near the heat-sealed part 5, which can be cut by hand, as shown in FIG. 2, and to open the container by cutting this neck part 6. It is appropriate to allow the contents to be removed.

Example: As the material for the container body, a three-layer film consisting of polyethylene (thickness 50μ) for the inner surface, saponified ethylene-vinyl acetate copolymer (thickness 20μ) for the intermediate air barrier layer, and polypropylene (thickness 200μ) for the outer layer is used. This is then vacuum-formed to form a container body, which is filled with an injection drug containing an amino acid or fat emulsion that is highly susceptible to deterioration by oxygen and _N2 gas, and then the lid material is heat-sealed to seal the contents. . The lid material used was a 50μ thick polyethylene layer on the inner surface, a 20μ thick saponified ethylene vinyl acetate copolymer layer for the middle air barrier layer, and a 200μ thick polyamide layer for the outer layer. The injectable drug container containing the drug made in this way has sufficient heat resistance to withstand the sterilization process, and shows no deformation, liquid leakage, or decrease in transparency after the sterilization process. There was no change in the contents due to oxygen.

The plastic materials used in this example all conform to the standards for plastic containers for infusions based on the Japanese Pharmacopoeia.

As described above, since the container for enclosing an injectable drug according to the present invention has a multilayer film or sheet structure made of plastic, it has been able to solve all the problems inherent to the glass material used in conventional so-called ampoule containers. By providing a multilayer film or sheet with an air barrier layer as an intermediate layer, all of the problems peculiar to plastic materials, especially in terms of gas permeability, have been solved, so the applicability of plastic containers for this type of container is remarkable. The range of use for the target drugs has been dramatically expanded, and it is also 50 times cheaper than glass ampoules.
It has achieved cost reductions of as much as 10%, and is extremely superior in terms of oral administration. Furthermore, since there is a special part for taking out the drug solution for penetrating the syringe needle, there is no need to take the trouble of opening the package, and contact with oxygen can be avoided as much as possible, so there is no possibility of deterioration caused by oxygen. This is extremely preferable for chemical solutions that are easily susceptible. Therefore, there is an extremely large contribution to be made to this technical field.

[Brief explanation of the drawing]

The drawing is a sectional view showing an embodiment of a container for enclosing an injection drug according to the present invention. 1... Lid material, 1a... Outer layer, 1b... Air barrier layer,
1c...inner layer, 2...container body, 2a...outer layer,
2b... Air barrier layer, 2c... Inner layer, 3... Opening edge.

Claims (1)

[Scope of Claims] 1. A multilayer container consisting of a three-layer film or sheet of coextrusion or lamination of an outer layer, an intermediate layer, and an inner layer, the intermediate layer being made of polyvinylidene chloride or ethylene, which is relatively impermeable to gas. It consists of an air barrier layer made of saponified vinyl acetate copolymer, etc., and a part of the container has an injection needle penetrating structure, with the outer layer made of thermoplastic elastomer with a Shore hardness of approximately 40° and the inner layer made of ultra-thin polyethylene or polypropylene. 1. A container for enclosing an injectable drug, characterized in that a drug solution extraction portion is formed therein. 2. A container consisting of a lid material made of a three-layer film made by coextrusion or lamination of an outer layer, an air barrier layer, and an inner layer, and a three-layer film made by coextrusion or lamination of an outer layer, an air barrier layer, and an inner layer formed into a substantially concave shape by vacuum forming. 2. The container for enclosing an injection drug according to claim 1, wherein the container is heat-sealed to the main body at the opening edge of the main body. 3 The outer layer of the lid material has a hardness of approximately 40° (Shorer hardness A)
3. The container for enclosing an injection drug according to claim 2, wherein the inner layer is made of extremely thin polyethylene or polypropylene. 4. A container for enclosing an injection drug according to claim 2 or 3, which has a peeling portion of the lid material on a part of the lid material or the container body.