This application is the national phase under 35 U.S.C. § 371 of PCT International Application No. PCT/EP02/00287 which has an International filing date of Jan. 14, 2002, which designated the United States of America.
1. Field of the Invention
The invention relates to a primary package unit for a plurality of separated film laminas as administration forms, which film laminas are arranged in said primary package unit in compartments formed in a plurality of rows especially for circular administration forms.
2. Description of the Related Art
Medicaments in solid form are as a rule separated to form dosage units (administration forms) and packed individually in primary packages in a predetermined number, and dispensed to the patient or consumer as a so-called card containing the administration forms between at least two layers which are sealed to one another. Apart from the known solid administration forms for medicaments, such as tablets or coated tablets there is also the administration form of the “wafer”. This is a film lamina of, for example, a polymer component and an active substance, with a predetermined amount of active substance, which lamina is adapted in terms of its thickness and its dimensions to the active substance amount to be released. In DE 198 00 682 is described a primary pack for such film laminas. This primary pack has a bottom layer and a top layer, between which wafer-shaped film laminas, as administration forms, are enclosed in compartments. The top and bottom layers are joined to one another by sealed seams or sections, wherein, in the regions between the compartments, perforations are introduced as predetermined breaking lines, which, when required, allow detachment of the individual compartments from the primary package unit. To facilitate gripping and tearing open, an unsealed margin can be provided next to each compartment at least one side outside the sealed region, or the top and bottom layers may be offset against each other and joined to one another such that a projecting margin is formed of one of the two layers.
Furthermore, DE 100 08 165 has a primary package unit with a bottom layer and a top layer as its subject matter. In this packaging unit, the two layers are, in predetermined regions, not connected with each other and thereby form an aid for tearing open.
Because of the sheet-like extent of the pharmaceutical preparation, the extent of a free space surrounding the administration form, and the width of the sealed region, primary package units according to DE 198 00 682 reach an extent which impairs handling thereof. Thus, for example, a card (primary package unit) with five wafer-shaped administration forms each having a surface area of 2 cm2, has an overall width of 11 cm and a width of 6 cm. It is difficult to accommodate this card in a purse, for example. A package for one week, with at least 7 administration forms, would thus be even less favourable. The reason for this is the size of the wafer-like administration forms, which substantially have a diameter of 1.5 cm, which leads to a lower packing density in the primary package unit, all the more so as the administration forms must be tightly sealed therein. However, a good handling property, including easy accommodation when carrying the pack, is precisely a declared aim of this new administration form, which is, in particular, offered and administered in a round (wafer-shaped) form in order to suggest a certain proximity to other administration forms and facilitate its establishment.
It is therefore an object of the present invention to configure a primary package unit such that the primary package unit enables a more densely packed package for, especially round, administration forms.
This object is achieved in a package unit for a pluraIity of separated film laminas as administration forms, having a bottom layer and a top layer sealed thereto, between which layers individual compartments, surrounded by sealed regions, are formed for the administration forms in the region of which the top and bottom layers are unsealed.
The invention consists in that—in a primary package unit for a plurality of separated administration forms in the form of film laminas formed of a bottom layer and a top layer sealed to said bottom layer, between which layers individual compartments, surrounded by sealed regions, for the administration forms are formed, in the area of which the top and bottom layers are unsealed—at least two rows of compartments are formed and the compartments and administration forms of the neighbouring rows are arranged offset from one another, or in that, as an alternative, the compartments are arranged in the form of a ring. The positioning in several rows with offset compartments or, also, the ring-shaped positioning of the administration forms leads to a denser packaging per unit area and thereby also to smaller primary package units.
Preferably, the primary package unit is intended to be used for round wafer-shaped film laminas as administration form, with the compartments being arranged such that the offset of the administration forms enclosed in the compartments equals half the distance between the centre points of two neighbouring administration forms of a row, and that all neighbouring administration forms have the same distance from one another. This means that given a distance A between two adjacent administration forms in a row, an administration form of the neighbouring row is offset from these administration forms by 0.5 A. In addition, the connecting lines of the centre points of the administration forms form isosceles triangles. Depending on the embodiment of the invention, however, the offset may also be chosen to be different. In the preferred embodiment, the distance between the borders of two adjacent administration forms is between 3 mm and 50 mm, preferably between 6 mm and 20 mm. The administration forms are preferably circular administration forms with a diameter between 0.5 and 3 cm and with a thickness between 50 and 700 μm.
To improve handling, the primary pack is provided with tear-off tabs formed by the top layer not being connected with the bottom layer within the region of said tabs, and by the top layer, in the region averted from the compartments, being separated from the top layer that is sealed to the bottom layer. The tear tabs verge on predetermined tear lines arranged in the sealed upper layer of the regions surrounding the compartments. With the aid of a tear tab, the top layer is separated from the bottom layer along a predet rmined tear line surrounding a compartment, and the respective compartment is opened. The administration form lying in the compartment is thus accessible. If the compartments are arranged in rows, the tear tabs are advantageously arranged such that they project into the intermediate spaces existing between the compartments of a neighbouring row. In the case of compartments arranged in ring shape, the tear tabs are formed in the region surrounded by the compartments, and are directed towards the centre of the round primary package unit, where they can be easily gripped. The neighbouring compartments remain unaffected and closed when a compartment is torn open.
Suitable materials for the two layers are, in particular, polyethylene (PE), polyethylene terephthalate (PET), polypropylene (PP) and ethylene-vinyl acetate copolymer (EVA), but also paper, aluminium or composits of these materials. The top and bottom layers can be made of different materials. It may also be advantageous to use a transparent material for one of the two layers or only for the top layer.
The primary package unit is produced by drawing a web-shaped medicament form from a stock roll and feeding the same towards a web of the bottom layer material, which is likewise drawn from a stock roll, and by punching or cutting out from the medicament web the administration forms, especially circular administration forms, according to the predetermined arrangement in the primary pack, and separating the remaining material by guiding the web of remaining material over a separating edge whereat the administration forms, detached from the composite, remain on the web of the bottom layer material and are advanced along with the same. Subsequent to the separation, a web of the top layer material is fed onto the bottom web and the administration forms positioned thereon, and this web is sealed with the material of the bottom layer in predetermined regions. Thereafter the top web is punched through and partially punched, in order to form tear tabs and predetermined tear lines. Finally, the sealed composite, together with the administration forms positioned according to the pattern, is separated from the following webs.
The invention will be illustrated in the following by means of examples of embodiments. In the appended drawings
a shows a section along A-A through the same;
Number | Date | Country | Kind |
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101 02 818 | Jan 2001 | DE | national |
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/EP02/00287 | 1/14/2002 | WO | 00 | 10/7/2003 |
Publishing Document | Publishing Date | Country | Kind |
---|---|---|---|
WO02/059012 | 8/1/2002 | WO | A |
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Number | Date | Country | |
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20040050749 A1 | Mar 2004 | US |