US20080116104A1

US20080116104A1 - Primary Packaging Unit for Flat Administration Forms

Info

Publication number: US20080116104A1
Application number: US11/791,256
Authority: US
Inventors: Ingo Lehrke; Ulrike Vollmer; Stephan Maier
Original assignee: Individual
Current assignee: Labtec GmbH
Priority date: 2004-11-23
Filing date: 2005-11-09
Publication date: 2008-05-22
Also published as: EP1824756B1; WO2006056161A1; CA2595110A1; ATE461128T1; EP1824756A1; ES2342546T3; DE102004056576A1; DE502005009254D1

Abstract

A card-shaped primary packaging unit for a plurality of flat administration forms containing active substances comprises a central web (1) made of a rigid packaging material, a top web (2) made of a thin film, a bottom web (2) made of a thin film, and a plurality of dosage units (4) which remain individually packaged even one of the administration forms (4) is removed from the packaging unit.

Description

The present invention relates to a primary packaging unit for flat forms of administration with active ingredients. In particular, it relates to a primary packaging unit in card form, which is formed by a varying number of flat forms of administration, which are to be packaged, a section of a rigid sheet of packaging material, on which the individual flat forms of administration are applied on both sides and form each case one or more sections of a thin upper and lower sheet of packaging material.
Within the meaning of this application, examples of flat forms of administration are, for instance, cosmetic, medicinal or active ingredient-containing band-aids, such as a wart band-aids, insect bite band-aids or nail band-aids, muco-adhesive band-aids or oral mouth films.
The latter are thin films or platelets for an oral application, which dissolve upon contact with saliva. For this reason, no beverage is required when these mouth films are ingested. This form of medicinal drug is therefore particularly suitable when traveling or for activities or situations, when it is desirable to be able to take the medication quickly and conveniently without a liquid.
The fact that these forms of administration offer rapid help, especially when away from home, for example, when traveling, is a property, which is to be emphasized and is a common feature of all forms of administration, which come under the heading of flat forms of administration within the meaning of this application. Ideally, these forms of administration can be carried along conveniently and unobtrusively ready, as well as at hand, at all times on the person of the user, for example, in a money purse or in a shirt pocket or trouser pocket.
Nevertheless, since the form of administration may be a medicinal drug, each dose must be packaged individually.
Moreover, because of the special ratio of thickness to area of said forms of administration, a thin, flat packaging suggests itself.
A start for solving the problem of creating such a primary packaging unit is found in the DE 298 23 463 U1. Nevertheless, this application, although it describes the prior art that comes closest to the present invention, does not fulfill all the requirements, which must be met by a primary packaging unit, which is intended for and therefore particularly suitable for the purpose described above.
On the one hand, the primary packaging unit proposed there consists only of one section of an upper and a lower sheet of a packaging material, so that the area of the primary packaging unit, which is available, is used only on one side. As a result, in comparison to the invention described here, twice the area of the primary packaging unit is required for the same size of the individually packaged, flat forms of administration. If a meaningful number of individual doses of flat forms of administration of a particularly preferred size of 4-7 cm²are to be carried along, this leads to a package unit, which is so large, that it can no longer be carried conveniently on the person of the user without bending or buckling, which could cause the integrity of the packaging and, with that, of the form of administration to be lost.
Moreover, the perforations, which are provided in the DE 298 23 463 U1 between the compartments, in which the individual forms of administration are located, and which enable the individual compartments to be detached when required, prove to be unsuitable for the purpose, on which this invention is based. Due to the perforations, the stiffness of the primary packaging unit inevitably is lost, so that, especially under a mechanical stress, the bending and pulling apart into the individual compartments, which have already been described previously, easily come about, so that it is no longer possible to carry this packaging unit along loosely.
Furthermore, it is regarded as rather impractical, if individual compartments of the primary packaging unit can be detached since, as a result, there is no active control over the individual doses already used. For example, in the case of a medical drug, which is to be used no more than three times daily, it is difficult to determine how many individual doses have already been used during a day, if it is possible to detach only one or two such compartments and to carry them along.
It is therefore an object of the present invention to create a primary packaging unit for flat forms of administration with active ingredients, which satisfies all the aforementioned requirements, without having the disadvantages described.
This objective is accomplished by making available a primary packaging unit for flat forms of administration (FIG. 2, 4) with a section of a rigid packaging material middle sheet (FIG. 2, 1) and with, in each case one or more sections of a flexible packaging material upper and lower sheet (FIG. 2, 2), which is characterized in that the rigid middle sheet of packaging material, on either side of which a variable number of flat forms of administration may be applied (FIG. 2 b), may be combined, by sealing or gluing, on the one side with one or more sections of a flexible sheet of packaging material and, on the opposite side with one or more sections of a flexible sheet of packaging material into a unit in such a manner, that a stable, yet flexible card, which is not more than 1 mm thick, is obtained, for which the flat forms of administration are and remain packaged individually, even if one of the several forms of administration is removed, without the card having perforations between the individually packaged forms of administration.
This combination of distinguishing features is necessary, in order to arrive at the required, practicable primary packaging unit in a card format, which is referred to in the following as Rapidcard.
In principle, a Rapidcard of any convenient size is possible. However, an embodiment, which corresponds in its dimensions to a credit card, as shown in FIGS. 1 and 2, is particularly preferred. These standard dimensions enable the Rapidcard to be carried conveniently in the breast pocket of a shirt, the back pocket of trousers or in the money purse.
In a preferred embodiment of the credit card format, a variation is a specialty preferred, for which 2-10 flat forms of administration, having an area of 2-10 cm²and preferably 3 flat forms of administration, having an area of 4-7 cm², can be packaged on each side of the card.
An inventive example of a variation with 6 rectangular flat forms of administration having an area of 6 cm²is given in FIGS. 1 and 2 and described in greater detail in the following, without thereby limiting the already listed possible variations in any way.
The Rapidcard is characterized in that 6 rectangular flat forms of administration, having an area of 6 cm², are applied on a sealable, flat, stiff middle sheet of packaging material, having a maximum thickness of 0.6 mm (FIG. 3, referred to, in the following, as carrier sheet), for example, of PE, PP, PVC, PETG, PETGAG, COC or multilayer laminates, such as PE/paper/PE, PE/PVC/PE etc.
Moreover, in each case 3 forms of administration are applied on the front side as well as on the back side of the carrier sheet in such a way, that they do not mutually touch one another and that there is sufficient distance between them, in order to enclose completely each form of administration individually by sealing or gluing it onto one or more sections of a flexible upper or lower sheet of packaging material and, with that, protect it against external influences (compare FIG. 2 b).
A flat, thin material, which has a maximum thickness of 0.2 mm and represents a barrier for the moisture and oxygen of the air (FIG. 2, 2 and FIG. 4, referred to in the following as protective film) is used as the upper and lower sheet of packaging material respectively. After the sealing or gluing, this material must have the property of peelability, that is, after one or several sections of this protective film have been sealed or glued onto the rigid carrier sheet, it must be possible to pull it off again from the carrier sheet at a later time with little expenditure of force, in order to remove the corresponding form of administration. For this purpose, film-like materials with different barrier properties come into consideration, depending on the properties of the forms of administration, which are to be packaged. For example, a transparent film having barrier properties with respect to the humidity of the air, such as PE/PCTFE/PE, can be used if the product is to be seen and there is no light sensitivity. In order to be a sufficient barrier for water vapor, the PCTFE must have a minimum sickness of 50 μm.
If the product is light sensitive, a film can be used, which is colored or coated or contains an aluminum layer and by means of which, aside from protection against life, there is also protection against moisture and oxygen from the air.
The 3 flat forms of administration on each side of the carrier sheet are now sealed with the protective film or the latter is glued on in such a manner, that each form of administration is enclosed completely, on all sides, and sealed from its environment, without parts of the form of administration being enclosed in the sealing seam or adhesion surface (FIG. 2, 3) between the carrier sheet and the protective film. In FIG. 5, the adhesion or sealing surfaces are shown in a red.
The machine parameters during the sealing or gluing process, as well as the width of the sealing seam or adhesion surface, obtained during the corresponding process, are selected so that the product is protected efficiently against external, stability-affecting factors for the period of the shelf life that has been determined and that nevertheless, at a later time, a simple opening of the sealing seam or of the adhesion surface for removal is possible.
Unless this is already possible due to the nature of the sealing or adhesion process, the section or sections of the protective film are to be processed furthermore in such a manner, that it is possible to open the sealing seam or adhesion surface of only one individual form of administration and to remove the latter, without thereby opening or damaging the protective packaging of a neighboring form of administration. This can be achieved, for example, owing to the fact that the protective film has a notch between the individual forms of administration (FIG. 2, 5).
Moreover, the protective film may be configured so that it has a tear-open tab for each individual form of administration in order to simplify the opening process (FIG. 2, 2). Such a tab represents part of the protective film, which is in direct contact with the individually packaged form of administration, but is not connected with the carrier sheet by sealing, adhesion or other measures and, instead, rests loosely on the carrier sheet. By lifting this tap and pulling in the direction of the lower edge of the card, the sealing seam or adhesion surface of the corresponding region of the card can be opened and the flat form of administration removed. Instead of a tear-open tab, a predetermined breaking point may also be provided here.
The carrier sheet, as well as the protective films may, if required, be printed with information (FIG. 1).

Claims

1) Primary packaging unit for flat forms of administration with active ingredients, with a section of a middle sheet of packaging material each and with in each case one or several sections of an upper and a lower sheet of packaging material, characterized in that

a) the middle sheet of packaging material is rigid and represents the base of the card,

b) the upper sheet of packaging material represents a thin film with good water vapor barrier properties,

c) the lower sheet of packaging material represents a thin film with good water vapor barrier properties and

d) several dose units, together with the individual components of the card, are combined by sealing or gluing into a unit on an in-line packaging machine in such a manner that the flat forms of administration remain packaged individually, even if one of the forms of administration is removed.

2) The primary packaging unit of claim 1, characterized in that the dimensions of the primary packaging unit correspond to those of a standard credit card.

3) (canceled)

4) The primary packaging unit of claim 1, characterized in that the primary packaging unit has dimensions other than 85×55 mm and, moreover, contains 2-10 flat forms of administration per side.

5) (canceled)

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