JP2015107322A - Eye drop container package - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an eye drop container package capable of suppressing weight loss of an eye drop liquid and preventing dew condensation inside a laminated film.SOLUTION: The eye drop container package 30 is obtained by seal-packaging an eye drop liquid-containing eye drop container 10 with a laminated film 20 as the most external packaging. The eye drop container 10 has water vapor permeability after preserving for 14 days at a temperature of 25±2°C and a relative humidity of 60±5% of a quantity exceeding 0.15% reduced from an initial inner capacity, according to a water vapor permeability test in a plastic medicine container testing method. The eye drop container package 30 obtained by seal-packaging the eye drop container 10 with the laminated film 20 has water vapor permeability of 0.04%-0.10% reduced from an initial inner capacity.

Description

  The present invention relates to an ophthalmic container package formed by hermetically packaging an ophthalmic container containing an ophthalmic solution with a laminated film.

  Conventionally, as an ophthalmic container package for containing ophthalmic solution, a predetermined amount of ophthalmic solution is sealed in a resin ophthalmic container, and if necessary, this ophthalmic container is packaged with a laminated film, and this is packed in a paper box together with instructions Packaged packages are known.

  For example, in the following Patent Document 1, an eyedrop container containing eyedrops is packaged in a packaging bag with a chuck using a non-metallic film having a function of preventing transpiration, and the package for eyedrop containers is stored in a paper box together with instructions. Is disclosed.

JP 2008-148852 A

  The ophthalmic solution needs to suppress transpiration of the ophthalmic solution with a packaging container because of the necessity of maintaining the drug concentration and long-term storage. Specifically, the water vapor permeability is required to be a predetermined value or less in the water vapor permeability test in the plastic drug container test method. This water vapor permeability may be achieved by an eye drop container alone or by an eye drop container package that is an eye drop container + laminated film.

  Usually, the water vapor permeability of a resin eye drop container has a certain level of water vapor permeability because it depends on the material and molding thickness of the resin used. For this reason, it is effective to reduce the water vapor permeability of the ophthalmic container package by packaging with a laminated film, and this aspect is also disclosed in Patent Document 1.

In the package for an eye drop container of Patent Document 1, a transparent film comparable to the barrier property of an aluminum foil is exemplified as a non-metallic film (which generally means a transparent film using a metal oxide). That is, the water vapor permeability of this non-metallic film is the same as that of aluminum foil. In terms of the water vapor permeability of a general film, the water vapor permeability at 40 ° C. and relative humidity 90% according to JIS K7129 is 0.1 g. / M ² / day and close to zero. Thus, from the viewpoint of preventing transpiration, it seems that it is preferable that the water vapor permeability is as low as possible.

  However, according to the knowledge newly obtained by the present inventors, when packaging an eye drop container with a laminated film as in Patent Document 1, if the water vapor permeability of the laminated film becomes too low, the water vapor that has passed through the eye drop container is reduced. Since it cannot pass through the laminated film, condensation occurs in the laminated film, and the appearance when opened is destructed, the user misidentifies condensation as a leak of eye drops, or the enclosed instructions are moistened. It has been found that a serious problem occurs.

  An object of the present invention is to provide an ophthalmic solution package that suppresses the above-described problem, i.e., evaporation of the ophthalmic solution, and prevents condensation in a laminated film.

  The present inventors have found that the above problem can be solved by paying attention to the balance between the water vapor permeability of the eye drop container and the water vapor permeability of the packaging bag formed by the laminated film, and to complete the present invention. It came. Specifically, the present invention provides the following.

(1) An ophthalmic container package comprising an ophthalmic container containing an ophthalmic solution, hermetically sealed with a laminated film as an outer packaging,
According to the water vapor permeability test in the plastic drug container test method, the eye drop container has a reduced water vapor permeability after initial storage at a temperature of 25 ± 2 ° C. and a relative humidity of 60 ± 5% for 14 days. In an amount exceeding 0.15%,
The ophthalmic container package in which the ophthalmic container is hermetically sealed with the laminated film is an ophthalmic container package in which the water vapor permeability is 0.04% or more and 0.10% or less in terms of a reduction from the initial internal volume.

(2) The ophthalmic container package according to (1), wherein the laminated film has a water vapor permeability of 0.1 to 1.0 g / m ² / day at 40 ° C. and a relative humidity of 90% according to JIS K7129.

  (3) The ophthalmic container package according to (1) or (2), wherein the laminated film is a laminated film including an aluminum vapor-deposited layer or an alumina vapor-deposited layer.

  (4) The eye drop container package according to any one of (1) to (3), wherein the form of the eye drop container package is a standing pouch made of the laminated film.

  ADVANTAGE OF THE INVENTION According to this invention, the ophthalmic container package which suppresses transpiration | evaporation of eyedrops and prevents dew condensation in a laminated film can be provided.

It is a schematic perspective view which shows one Embodiment of the eyedrop container package of this invention.

  Hereinafter, a preferred embodiment of the eye drop container package of the present invention will be described in detail with reference to the drawings.

  As shown in FIG. 1, the eye drop container package 30 includes an eye drop container 10 contained in a laminated film 20. A predetermined amount of ophthalmic solution (not shown) is filled in the ophthalmic container 10. In this embodiment, the laminated film 20 constitutes a standing pouch, and the eye drop container package 30 is a self-supporting package. In the present invention, “laminated film as outermost package” means a packaging form in which a paper box or the like is not used as the outermost package.

<Eye drops container>
The eye drop container 10 is a resin molded product by conventionally known blow molding, injection molding, or the like, and is preferably transparent to the extent that the ophthalmic solution as the contents can be visually recognized from the outside. The material of the eye drop container 10 is not particularly limited as long as it has water vapor permeability described later. For example, polyethylene terephthalate (PET), polycarbonate (PC), polyarylate (U polymer), polyethylene (PE) , Polypropylene (PP), and a mixture thereof can be preferably exemplified.

  The water vapor permeability of the eye drop container 10 is the initial content of water vapor permeability after storage for 14 days at a temperature of 25 ± 2 ° C. and a relative humidity of 60 ± 5%, in accordance with the water vapor permeability test in the plastic drug container test method. The amount is more than 0.15%, preferably 1% or less. When the water loss exceeds 0.15%, it means that the water vapor permeability of the eye dropper container 10 is high, and it tends to cause dew condensation in the laminated film. Therefore, dew condensation occurs when combined with the laminated film used in the present invention. Can be prevented. Moreover, if the water loss is 1% or less, dew condensation can be effectively prevented by adjusting the water vapor permeability of the laminated film described later.

  Here, the water vapor permeability test in the plastic drug container test method is the Japan General Test Method “Plastic drug container test method 5 first method of water vapor permeability test” (March 28, 1996, Specifically, water vapor permeation after storing a predetermined amount of water in an eye dropper container and storing for 14 days at a temperature of 20 ± 2 ° C. and a relative humidity of 65 ± 5%. Is the value expressed as a percentage reduction from the initial internal capacity. Incidentally, according to this standard, the weight loss is 0.2% or less in the state of an eye drop container alone or an eye drop container package that is an eye drop container + laminated film. In addition, when the laminated | multilayer film 20 exists like this invention, it is a measured value in the state which packaged the eye drop container 10 with the laminated | multilayer film 20. FIG.

<Laminated film>
As will be described later, the laminated film 20 has a water vapor permeability of 0.04% or more and 0.10% or less as a drop from the initial internal volume as the eyedrop container package 30 in which the eyedrop container 10 is hermetically contained. Selected.

The water vapor permeability of the laminated film 20 alone (hereinafter, also simply referred to as film water vapor permeability in order to distinguish from the above-mentioned “water vapor permeability of containers in plastic drug container testing method”) is 40 ° C. relative to JIS K7129. It is preferable that it is 0.1-1.0 g / m < ² > / day under 90% of humidity. The non-metallic film and aluminum foil of Patent Document 1 have a film water vapor permeability of less than 0.1 g / m ² / day, and the film water vapor permeability is too low to prevent condensation in the laminated film 20. On the other hand, when the film water vapor permeability exceeds 1.0 g / m ² / day, transpiration from the eye drop container cannot be effectively suppressed.

  As such a laminated film, a laminated film provided with an inorganic oxide layer such as an aluminum vapor deposition layer or an alumina vapor deposition layer can be preferably exemplified. An aluminum vapor deposition layer and an alumina vapor deposition layer can be provided with said moderate film water vapor permeability, and can be used suitably for this invention. Moreover, since the aluminum vapor deposition layer has a light-shielding property, the ophthalmic solution can be protected from external light (visible light or ultraviolet light) even when a standing pouch is constituted by a laminated film alone as shown in FIG.

  In addition, it is preferable that a laminated | multilayer film is a multilayer film provided with a heat seal layer in the innermost layer. Thereby, sealed packaging by heat sealing can be performed. Specific examples of the layer structure include two or more layers, preferably three or more layers, such as base material / (printing layer) / aluminum vapor deposition film or alumina vapor deposition film / heat seal layer, from the outside. The total thickness of the laminated film is preferably 20 to 200 μm.

<Ophthalmic container packaging>
The eye drop container 10 and the laminated film 20 are combined to obtain the eye drop container package 30 which is a double package. Other items such as instructions may be included as necessary.

  As shown in FIG. 1, the ophthalmic container packaging body 30 in the present embodiment is a so-called standing pouch with a chuck, and by forming a heat seal portion 36 on two sides, the left and right sides, the upper side, and the bottom of the bottom gusset portion. Independence is possible. For this reason, the conventional paper box is unnecessary and it is a simple package compared to Patent Document 1. In addition, the ophthalmic drops which are the contents can be protected from visible light or ultraviolet light by shielding the entire surface of the laminated film 20 with an aluminum vapor deposition film or printing.

  A circular hole 35 for suspension is formed in the center of the upper side of the eye drop container package 30. In addition, a tear portion 33 connected to the cut portion 32 and a chuck portion 34 are formed in parallel on the upper part of the eye drop container package 30. The chuck portion 34 is provided with a chuck that enables re-sealing after opening.

  In the present invention, the eye drop container package is not necessarily a standing pouch, and may be a normal four-way seal bag, a three-way seal bag, or the like.

  The water vapor permeability of the eye drop container package 30 is 0.04% or more and 0.10% or less in terms of weight loss from the initial internal volume. Here, the water vapor permeability is a water vapor permeability test in the plastic drug container test method described above, and is a measured value in a state where the eye drop container 10 is hermetically packaged with the laminated film 20.

  The water vapor permeability in the eye drop container package is based on the balance between the water vapor permeability of the eye drop container and the water vapor permeability of the packaging bag formed from the laminated film. That is, when the water vapor permeability of the eye drop container is a large amount exceeding 0.15% as a reduction from the initial internal volume, the water vapor permeability of the eye drop container> packaging is calculated for each container (packaging bag). If there is an excessive difference between the two in the water vapor permeability of the bag (laminated film), condensation occurs due to too little transpiration from the packaging bag. The package of Patent Document 1 corresponds to this aspect. On the other hand, if the water vapor permeability of the ophthalmic container <the water vapor permeability of the packaging bag (laminated film), transpiration cannot be effectively suppressed, and the weight loss of the ophthalmic solution increases and the quality as an eye drop is improved. It cannot be held.

  Therefore, in the present invention, an eye drop container package in which the water vapor permeability of the packaging bag (laminated film) is set slightly lower than the water vapor permeability of the eye drop container per container, more specifically, an eye drop container. By adjusting the water vapor permeability of the package to 0.04% or more and 0.10% or less by reducing the initial internal volume, transpiration from the eye drops container is suppressed, and condensation in the packaging bag (laminate film) Is to prevent.

  Next, although one Example of this invention is described, this invention is not limited to this.

[Example 1]
<Eye drops container>
A polyethylene terephthalate / polyarylate mixed resin container corresponding to the eye drop container of the present invention was molded and sealed with 12 mL of pure water. The water vapor permeability of this eye drop container when stored for 14 days at a temperature of 25 ° C. and a humidity of 60% was 0.25%.

<Laminated film>
Dry laminate of laminated film of NY (polyamide) / aluminum vapor-deposited PET (polyethylene terephthalate) / LLDPE (linear low density polyethylene) (film water vapor permeability of 0.5 g / m ² / day (40 ° C., 90% RH)) It was produced by the method.

<Ophthalmic container packaging>
By heat-sealing the four sides of the two laminated films with the LLDPE side as the inner surface, the ophthalmic container is hermetically packaged so that the surface area of the space where the films do not overlap is 0.022215 m ^2. A container package was obtained.

[Example 2]
As a laminated film, a laminated film prepared by dry lamination of alumina-deposited PET (deposited inside surface) / PE laminated film (film water vapor permeability of 0.3 g / m ² / day (40 ° C., 90% RH)). A four-side sealed eye drop container package was obtained in the same manner as in Example 1 except that was used.

[Example 3]
Laminate film produced by dry laminating method of laminating film of alumina vapor-deposited PET (deposited inside surface) / PE (film water vapor permeability of 0.6 g / m ² / day (40 ° C., 90% RH)). A four-side sealed eye drop container package was obtained in the same manner as in Example 1 except that was used.

[Example 4]
As the laminated film, a laminated film prepared by dry lamination of PET / alumina-deposited PET / LLDPE laminated film (film water vapor permeability of 1.0 g / m ² / day (40 ° C., 90% RH)) was used. Except for the above, an ophthalmic container package with a four-side seal was obtained in the same manner as in Example 1.

[Comparative Example 1]
Implemented except that a laminated film made of a PET / aluminum foil / LLDPE laminated film (film water vapor permeability 0 g / m ² / day (40 ° C., 90% RH)) by a dry lamination method was used as the laminated film. In the same manner as in Example 1, an ophthalmic container package with a four-side seal was obtained.

[Comparative Example 2]
Laminated film produced by dry laminating method of laminating film of alumina vapor-deposited PET (deposited inside surface) / PE (film water vapor permeability of 0.05 g / m ² / day (40 ° C., 90% RH)). A four-side sealed eye drop container package was obtained in the same manner as in Example 1 except that was used.

[Comparative Example 3]
The same procedure as in Example 1 was performed except that only an eye drop container was used without using a laminated film.

[Test example]
About the eye drop container package of Examples 1 to 4 and Comparative Examples 1 and 2, and the eye drop container of Comparative Example 3 (each n = 20), store in a constant temperature and humidity chamber set to a temperature of 25 ° C. and a humidity of 60%, The sample was taken out after 14 days, the weight of each sample was measured, the amount of water reduction (average value of n = 20) was calculated, and whether or not water droplets were generated in the pouch was visually confirmed. The results are shown in Table 1.

From Table 1, in Examples 1 of the laminated film of the water vapor permeability of ^{0.3g / m 2 /day~1.0g/m 2 / day} 4, you can reduce the water permeability, water droplets adhering to the inside of the pouch There wasn't. On the other hand, in Comparative Examples 1 and 2 of laminated films having a water vapor permeability of 0.05 g / m ² / day or less, the water permeation amount can be greatly reduced, but water droplets adhered to the pouch. Further, in Comparative Example 3 without the outer film, the weight loss on the 14th day was as large as 0.25%.

10 eye drop container 20 laminated film 30 eye drop container package (standing pouch)
32 notch 33 notch 34 chuck 35 hole

Claims (4)

An ophthalmic container package comprising an ophthalmic solution containing an ophthalmic solution and hermetically wrapping the laminated film as an outermost package,
According to the water vapor permeability test in the plastic drug container test method, the eye drop container has a reduced water vapor permeability after initial storage at a temperature of 25 ± 2 ° C. and a relative humidity of 60 ± 5% for 14 days. In an amount exceeding 0.15%,
The ophthalmic container package in which the ophthalmic container is hermetically sealed with the laminated film is an ophthalmic container package in which the water vapor permeability is 0.04% or more and 0.10% or less in terms of a reduction from the initial internal volume. The ophthalmic container package according to claim 1, wherein the laminated film has a water vapor permeability of 0.1 to 1.0 g / m ² / day at 40 ° C and a relative humidity of 90% according to JIS K7129.   The ophthalmic container package according to claim 1 or 2, wherein the laminated film is a laminated film comprising an aluminum vapor-deposited layer or an alumina vapor-deposited layer.   The ophthalmic container package according to any one of claims 1 to 3, wherein the form of the ophthalmic container package is a standing pouch made of the laminated film.

Images