WO2011104385A1

WO2011104385A1 - Pharmaceutical product packaging comprising an inspection window

Info

Publication number: WO2011104385A1
Application number: PCT/EP2011/052927
Authority: WO
Inventors: Nino Antonio Manca; Claudio Cassera; Carlo Finazzi; Michael Trapp
Original assignee: Intendis Gmbh
Priority date: 2010-02-26
Filing date: 2011-02-28
Publication date: 2011-09-01
Also published as: WO2011104385A9

Abstract

The application relates to a pharmaceutical product packaging comprising an inspection window (5), which allows the pharmaceutical products to be visually inspected during dispensing and at the same time prevents the faulty dispensing of pharmaceutical products (and optionally added materials), and safety features for indicating intentional or accidental opening of the pharmaceutical product packaging.

Description

Pharmaceutical packaging with viewing window

The present application relates to a drug package having a viewing window that allows for visual inspection of the drugs upon delivery while preventing mis-delivery of drugs (and, optionally, accessories) and safety features to indicate an intentional or unintentional opening of the drug package.

Background and state of the art

Pharmaceutical packaging usually consists of a primary container, such as a tube or a blister. This primary container is usually packed in a secondary container, for example a cardboard box. This secondary container fulfills several purposes: These include the protection of the primary packaging from damage and / or contamination, stackability, printing option for additional information and the ability to attach additional material, such as the leaflet with instructions for use and / or additional materials, such as one or more applicators , In the case of the addition of applicators, the drug repackaging by a secondary container in a special way also helps to promote hygiene.

In dispensing medicines to the end user, there is often a need in Japan to visually inspect the delivered medicament, especially the primary container. In Japan, it is a necessity of the dispensing pharmacist to carry out such an inspection. In this case, it is checked whether the delivered drug complies with the requirement (eg according to the recipe), but also if there is damage to the dispensed container. For this, the drug container (eg drug tube) must be taken out of the outer packaging (eg carton) for conventional pharmaceutical packaging Perform inspection. This is initially associated with a certain amount of time. In addition, separation of the packaged drug from the secondary packaging may result in delivery errors. For example, it is conceivable that the primary container (eg tube) is confused or damaged after unpacking, that the package leaflet is confused or no longer enclosed, or that additional material (eg applicators of all kinds) enclosed with the primary container is not added or added incorrectly ,

In Japan, it is common practice to remove the primary container from the carton and then dispense it without the carton. Among other things, this practice serves to prove that the outer packaging was opened in accordance with the Japanese regulations or the standard procedures for carrying out the visual inspection, but leads to the problems initially described.

Due to the above-mentioned disadvantages and a reduction in the cost price, there is a need for a new packaging that overcomes the disadvantages mentioned above.

Description of the invention

It has been found that a drug package with viewing window, as described in the following examples and claims solves the problems outlined above. It is a drug package with a viewing window that has the largest possible opening to perform the visual inspection, while ensuring that the primary container does not need to be removed from the secondary packaging and thus protected from damage. This also prevents confusion. In addition, it also prevents applicators or other Beipackmaterialien be separated from the drug container.

The pharmaceutical packaging according to the invention is connected essentially in a cuboid. At least one surface of the cuboid is equipped with a viewing window (S). In the simplest case, it is a rectangular punched out of a cuboid surface. In preferred embodiments, one or more sides of this cut-out may also be bent, as shown for example in the figures. It is immediately obvious to the person skilled in the art that the punching out is so is to make that above and below the viewing window still a strip of secondary packaging as a holding strip (S ₀ , S _u ) remains.

The size of the package depends primarily on the size of the content, for example, a drug tube. The length (I) of the package is at most 1 10% of the length of the primary container (e.g., the tube length). With a tube length of 10 cm, the package is therefore no longer than 1 1 cm. Preferably, the length of the package is not longer than 105% of the tube length, more preferably not more than 103% of the tube length.

The height (h) of the cuboid is usually not more than 1 10% of the maximum tube of the primary container, for example the tube. Example: With a maximum tube height of 20 mm, the drug packaging height is not more than 22 mm. In a preferred embodiment of the invention, the maximum packaging height is 105% of the height of the primary packaging. In a particularly preferred embodiment, not more than 103% of the primary packaging. The width (b) of the cuboid is usually not more than 125% of the maximum width of the primary container, for example the tube. Example: With a maximum tube width of 20 mm, the drug packaging height is not more than 25 mm. In a preferred embodiment of the invention, the maximum packaging width 1 is 10% of the width of the primary packaging. In a particularly preferred embodiment no more than 107.5% of the primary packaging.

In a particularly preferred embodiment of the invention, the packaging according to the invention additionally contains a chamber (ZK) for receiving additional materials, such as an applicator. In this case, the total width of the drug package is determined by the width of the primary product receiving chamber (eg, the tube), where the width of the receiving chamber is determined as indicated above and the width of the chamber (bzK) for the applicator. In this case, a viewing window for the applicator (SZK) can also be provided.

The size of the viewing window (S) should be determined so as to maximize the opening to allow the best possible visual inspection of the primary receptacle while still not allowing the primary receptacle to fall out can be removed without damaging the outer packaging. Only this feature ensures that no confusion of primary products can occur. For this purpose, the viewing window is dimensioned so that the maximum height of the viewing window (hs) is a maximum of 70% of the height of the primary container. In a preferred embodiment, the height of the viewing window is 60% of the height of the primary container (for example, the tube height). The remaining coverage of the tube by the packaging according to the invention (in the form of strips S ₀ and S _u ) of at least 30% is usually present in approximately equal parts at the top and at the bottom of the tube. At a packaging length of 10.5 cm, for example, at both ends of the tube about 2.0 cm covered by cardboard (S ₀ and S _u each equal to 2.0 cm). Of course, the viewing window can also be designed differently, wherein it is important that no less than about 10% of the length of the primary container is covered to ensure falling out or taking out of the primary container.

The further details of the sizing may be understood by those skilled in the packaging art, taking into account the usual parameters, e.g. the material strength, be easily determined, without having to be inventive.

A decisive feature of the packaging according to the invention is that the primary container can not be removed without damaging the outer packaging. This is done first the bonding of the end tabs (EL). This prevents the packaging from being opened by opening the tab. In addition, the outer packaging according to the invention has perforations (P) on at least one side surface (SF) of the packaging. These serve as a predetermined breaking point in the event that a pull is applied to the drug wrapper to remove the primary container (for example, the tube). The attempt to remove the primary container by pulling on the outer packaging thus leads to the breakage of the perforation (P) and thus to the indication that such a removal attempt has taken place. The pharmacist, but also the end customer can therefore easily check on delivery whether the delivered drug is still original packed. Of course, it is possible, although not essential, to provide corresponding perforations on both sides of the viewing window.

It is also possible to provide viewing windows on several sides of the package. For stability reasons, usually no more than two viewing windows will be attached. The optionally enclosed applicator can in turn be present in an additional chamber. For this additional chamber, the size ratios can be designed differently. It is also important in this case that the additional material, such as the applicator can not be removed without damaging the drug outer packaging. In the case of an applicator having a length of 10 cm, this can be ensured by a viewing aperture (SZK) having a length of 2.5 cm. In this way it can be visually ensured that the applicator of the package is enclosed, but at the same time can not fall out or be removed. In general, the height of the viewing port of the auxiliary chamber (SZK) may be 20-60% of the length of the attached material (eg applicator).

uses

The packaging according to the invention is preferably used, as described, in the field of medicines. Other uses are conceivable in other areas in which a visual inspection of a primary packaging is desirable, for example in the food industry.

manufacturing

The packaging according to the invention is produced in a manner known to the person skilled in the art from cardboard or cardboard or similar materials (for example composite materials). For this purpose, a sheet of the intended material (for example cardboard or a composite material) is punched out. Possible punching forms are given by way of example as FIGS. 3 and 4. These are folded by machine in the usual way and permanently attached to the tabs, for example glued or laminated. On the back of the package (opposite the window between the perforations) a groove (R) is preferably embossed. This facilitates the folding of the box after opening the perforation. It acts in addition to the perforation as a security feature, as it ensures next to the perforation that even at low tension at one end of the package, the perforation opens and the cardboard is folded on the back accordingly. If desired, the packaging according to the invention may be surrounded by a cellophane film or a similar transparent film. Alternatively, only the viewing window (S) can be covered with a transparent film. In this case, the film is preferably attached to the inside of the package. Description of the figures

Figure 1: punched sheet of a drug package according to the invention (without

Numeral)

FIG. 2: punched sheet of a drug package according to the invention (with

Numeral)

FIG. 3: punched sheet of a particularly preferred invention

Drug repackaging with additional chamber (without reference)

Figure 4: punching sheet of a particularly preferred invention

Pharmaceutical outer packaging with additional chamber (with reference numeral) FIGS. 5a / b-7a / b: Illustrations of a particularly preferred invention

Drug repackaging (contents: tube) with additional chamber (contents: applicator) with broken perforation

Figure 8a / b: Figure of a particularly preferred invention

Drug repackaging (contents: tube) with additional chamber (content: applicator) with undamaged perforation, front side

Figure 9a / b: Figure of a particularly preferred invention

Drug repackaging (content: tube) with additional chamber (content: applicator) with undamaged perforation, back

Figure 10a / b: Illustration of a particularly preferred invention

Drug repackaging (content: tube) with additional chamber (content:

Applicator) with undamaged perforation, top view

Figure 1 1 a / b: Illustration of a particularly preferred invention

Drug repackaging (contents: tube) with additional chamber (contents: applicator) with undamaged perforation, view from below Figure 12a / b: Illustration of a particularly preferred invention

Drug repackaging (contents: tube) with additional chamber (content: applicator) with undamaged perforation, view of the right side Illustration of a particularly preferred inventive drug package (content: tube) with additional chamber (content: applicator) with undamaged perforation, view of the left side

Illustration of a drug package according to the invention (content: tube) with undamaged perforation, front side

Illustration of a drug package according to the invention (content: tube) with undamaged perforation, back

Illustration of a drug package according to the invention (content: tube) with undamaged perforation, right side

Illustration of a drug package according to the invention (content: tube) with undamaged perforation, left side

Illustration of a drug package according to the invention (contents: tube) with undamaged perforation, view from below

FIG. 19a / b: Illustration of a drug package according to the invention (content:

Tube) with undamaged perforation, view from above

List of reference numbers

b: Width of the packaging according to the invention. BZK width of the additional chamber

EL: push-in tab

h: height of the packaging according to the invention hs: height of the viewing window

I: length of the package according to the invention P: perforation

R: groove

RF: Rear surface

S: viewing window

SF: side surface

S ₀ : Holding strip above the viewing window S _u : Holding strip below the viewing window SZK: Viewing window of the additional chamber

ZK: additional chamber

Claims

claims:

1 . ) Rectangular secondary packaging with viewing window (S), characterized by

a length l which shall not exceed 1 10% of the length of the primary product, a height h which shall not exceed 1 10% of the height of the primary product, a width b which shall not exceed 125% of the width of the primary product, at least one window (S) on the front side of the secondary packaging means, with a height of the viewing window (hs) of at most 70% of the height of the secondary packaging means, wherein above each of the viewing window and a holding strip (S ₀ , S _u ) for holding the primary product is present, the sum of Width of the holding strips (S ₀ , S _u ) is 30-40% of the height h of the primary product and wherein both retaining strips (S ₀ , S _u ) have approximately the same width, a perforation (P) on at least one side surface (SF) of the secondary packaging

and glued end tabs (EL).

2.) Rectangular secondary packaging with viewing window (S), according to

Claim 1, further characterized by an additional chamber (ZK) with a viewing window (SZK), wherein the viewing window is a height of 20-60% of the height of the viewing window (SZK).

3.) Rectangular secondary packaging with viewing window (S), according to

Claim 1 or, further characterized by a groove (R) on the rear surface (RF) at the level of the perforation (P).

4.) Rectangular secondary packaging with viewing window (S), according to

Claim 1, 2 or 3, characterized in that in the viewing window, a transparent film is attached.

5.) Use of a cuboid secondary packaging with viewing window

(S), according to claim at least one of claims 1 -4 for packaging medicament blister or tubes.