EP1045799B1 - Primary packaging unit for film-like or oblate-like administered shapes - Google Patents

Abstract

A primary packaging unit for film-like or wafer-like administration forms for oral application with an off-cut of an upper web of packaging material and of an lower web of packaging material is characterized in that a plurality of dosage units of a film-like or wafer-like administration form, individually sealed in flat compartments formed without cold or hot forming of the packaging material and spaced at a distance to one another, are present in a primary packaging unit, and there are perforations between the compartments which enable the separation of individual compartments, if necessary.

Description

The present invention relates to a method for producing a primary packaging unit for film-like or wafer-like dosage forms for oral Application. It affects in particular a method for producing a primary packaging unit, which from the film or wafer-like to be packed Dosage form and a section of each Upper and lower packaging material is formed.

Forms of administration in film or wafer form for oral administration are u. a. from the patent or published documents US 3 007 848, DE 24 32 925, DE 27 46 414, EP 219 762 are known. They differ from conventional fixed dosage forms such as tablets or capsules in particular through their geometric shape and by their manufacture. You together is a thin, flat shape, being distinguished by differences in flexibility, brittleness, smoothness or consistency either a film or foil-like, a paper-like or results in an oblate character. For the production were especially those in industrial film production applied extrusion and coating processes recommended.

Depending on the application, there are two basic types of design on. On the one hand, rapidly decaying or quick-release variants for decay in the oral cavity immediately after application with release of an active ingredient, where the term "rapidly disintegrating" in the sense of this invention to a disintegration time of a few seconds up to a few minutes under the influence of saliva should relate. Second, they are slow or practical known non-decaying variants, which are particularly for the slow and continuous release of active ingredients suitable and capable by adding mucoadhesive substances are on the oral mucosa during drug delivery be liable. Both basic types can be designed so that they are in Dependence on the incorporated active ingredient for a local Therapy of the oral mucosa or for systemic drug application are suitable.

The packaging of these dosage forms in primary packaging units can not be easily with the for conventional pharmaceutical products such as capsules or tablets Carry out usual procedures, packaging materials or machines. A modern one Primary packaging unit for single dosage solid dosage forms on the one hand, the product is intended to withstand external influences protect, on the other hand a conscious and verifiable removal a single dose unit at the desired time of intake allow, taking the dose unit from the primary packaging unit must be such that the dosage form is not damaged.

While tablets and capsules are often in larger numbers Glasses or cans are filled, which meets the requirements mentioned barely enough, it is common for dose units to be packed in blister or thermoformed packs. such Primary packaging units contain a plurality of dose units, each individually in a cavity between two packaging material web sections are sealed. The cavity is filled by hot or cold working before filling Bottom of packaging material with the help of an appropriate tool created. After filling the cavities, the top web of packaging material fed and sealed together with the bottom sheet.

A dose unit is removed from modern blister packs in that on the outside of the deformed points the packaging material lower web and thus on the tablet or Capsule, which is in the created by the deformation Cavity, with which finger pressure is exerted, which is sufficient to break through the top web of packaging material and push out the dose unit. However, this is only then possible if the material of the packaging material upper web a certain Strength does not exceed.

This concept for primary packaging units has for conventional dosage forms found widespread use, but is for dosage forms with film or wafer-like Design associated with significant disadvantages. There are two disadvantages in experiments carried out for this turned out to be particularly serious, one of which is the Manufacture the other from taking dose units Primary packaging units of this type concerns.

Oral dosage forms in the form of films or wafers are generally much lighter and less compact than conventional tablets or capsules, particularly in the case of the quick-release variants. The proposed dimensions of the film-like or wafer-like dose units are approximately 1 cm ² (eg DE 27 46 414) to 3 cm ² or more (eg DE 24 32 925) and a thickness of approximately 0.05 to 1 mm (e.g. DE 24 329 25). When using the usual pharmaceutical raw materials, dose units with a mass of about 5 to 100 mg result, whereby the typical and preferred configurations are more likely to be in the lower sector of this range. It has now been shown that it is more difficult to insert such thin films or wafers in blisters. Especially at higher machine speeds, air movement caused by moving machine parts and often also an electrostatic charging of the packaging materials mean that the dose units cannot be positioned correctly in the blister or are blown out of the blister after positioning. Although it is entirely possible to manufacture deep-drawn primary packaging units with oral films or wafers, it is nevertheless a complex and inefficient packaging concept due to the problems presented.

The removal of the film or wafer-like dosage forms from blister packs, which are the conventional primary packaging to match for tablets or capsules is also problematic. A flat dose unit lying in a recess can hardly through the material of the packaging material be pressed; it does not have the necessary format for this nor the mechanical strength. The danger, the dose unit Damaging when pushed out is relatively large. Self if you try the material of the upper packaging material first in another way, e.g. B. to break through with your fingernail it is not easy to disclose a flat dose unit in the To grasp and extract, unless one chooses very large wells, for other reasons such as the too large enclosed air space in relation to the low mass of the dosage form is disadvantageous.

Additional difficulties with conventional packaging arise when the film or wafer-like Dosage forms a rather fragile, fragile nature exhibit. In this case, a rigid blister pack some product protection during Ensuring storage, however, makes the withdrawal of the dose units all the more difficult.

Apart from these disadvantages of conventional blister packaging for film or wafer-like dosage forms Limited choice of suitable packaging materials for blister packs; the available materials are also not included the particularly inexpensive packaging materials.

Some approaches to creating a primary packaging unit for film or wafer-like dosage forms without find the described disadvantages of the prior art in US 3 007 848. The approaches presented here are for all film and wafer-like dosage forms partly interesting, although US 3 007 848 differs to the present invention in the narrower sense on (1) Extrusion or produced by printing edible foils Obtains wafers which (2) are not for use in the mouth, but are intended for ingestion and (3) optional first in foil strips of an edible, smooth and easy to swallow foil. Yet the cited document teaches the packaging of wafers Sealing the dose units between two foils, which in the generalized senses are to be understood as packaging materials. About that she also teaches the "light" sealing of the dose units for easier opening of the compartments and Removal of the wafers. Finally, it also reveals one unsealed edge area in the packing material, which is touching the packaging films and pulling them apart to remove the Relieved wafers.

Nevertheless, US 3 007 848, which is one of the present Is not related to the prior art all requirements for a suitable primary packaging unit fulfilled for film or wafer-like dosage forms; some Disadvantages and problems remain unsolved or arise only through the proposed design of the packaging unit.

Firstly, it contains the packaging unit proposed there only one wafer at a time, apart from the intermediate product, which is an undefined but very large number of packaged dose units, so to speak, as rollable tape goods represents. A practical primary packaging unit should usually a clearly defined one for various reasons Contain a plurality of dose units. From non-compliance There are clear disadvantages to this requirement for secondary packaging: First, the after US 3 007 848 separated small primary packaging units filled with a wafer, collected, in pack sizes of for example, 20 pieces are counted and summarized what is associated with considerable effort and unwieldy secondary packaging formats leads. Should have to be removed later one primary packaging unit removed, opened and the wafer are removed, taking control of the up to a certain point in time, earnings were very high is difficult. For example, it will be in a secondary packaging unit with 50 wafers would be hardly possible without extensive Overview of the remaining wafers, whether a certain due date has already been taken or not.

It is therefore the object of the present invention a method for producing a primary packaging unit for film or wafer-like dosage forms to create all the requirements mentioned is sufficient without the disadvantages of the prior art described exhibit.

The problem is solved by the method according to claim 1 Primary packaging unit for film or wafer-like dosage forms for oral application with one section each a packaging material top and bottom web are produced in which several dose units of a film or wafer-like Dosage form at a distance from each other individually in flat, produced without cold or hot deformation of the packaging material Compartments sealed in a primary packaging unit are present, and both are perforations between the compartments are located, which require the separation of individual Enable compartments.

The method steps of claim 1 are necessary in order to achieve the required practical primary packaging unit to come. It namely, the concept from US 3 007 848 cannot be readily applied vary only to the extent that from the intermediate product, which z. B. is available as a roll or tape, by cutting the same - not, as required, after each wafer, but only after every tenth wafer the solution would have been reached. Such a packaging unit would contain a defined plurality of dose units; these could however, not easily and without problems become. Experiments have shown that when opening a such packaging for removing a dose unit as a rule the sealing seams or sealing surfaces by several dose units can be opened around at the same time, so that several Dose units are exposed and through the primary packaging can no longer be protected. The targeted removal of a single one Dose unit by pushing through the primary packaging material is, as described above, due to the low mechanical Dosage form strength in relation to Primary packaging material is also not possible.

A primary packaging unit must additionally another feature is perforation between the compartments in which the individual Dose units are, and such a perforation that it enables, if necessary, the removal of a single dose unit first the compartment of this dose unit from the Remove the primary packaging unit in order to subsequently remove the To be able to open the compartment without further compartments to damage. The perforation also has the advantage that with the appropriate design, if possible with only a few, small breakpoints also allowed, one compartment without first separating it from the primary packaging unit targeted opening without additional compartments open at the same time.

Another advantage of this primary packaging unit consists in the relatively small gas space of the compartments, in which the dose units are located. oxidation or Moisture sensitive products can therefore be used with suitable Choice of primary packaging materials largely before the harmful ones Protected against the effects of atmospheric oxygen and humidity become.

Another advantage of this primary packaging unit is in the low packaging material requirement and the handy, see space-saving format. For example, let in a folding box of 1 cm in height 10 or more primary packaging units with 10 dose units each accommodate.

Another advantage of this primary packaging unit exists in the possibility as a packaging material bottom sheet also use materials that are significantly thinner and cheaper are as such that are used to manufacture blister packs and are suitable for cold or hot working and a specific one Minimum thickness and, due to this, a minimum weight must have.

Another advantage of this primary packaging unit consists in the possibility of printing on it Visualize therapy schemes. For example, a packaging unit as a weekly pack with 7 dose units produce a medicine to be taken once a day, the individual compartments of the packaging unit with the names or abbreviations of the days of the week are printed. Based patients can use this printed therapy scheme control your earnings very easily. In a preferred one The packaging unit contains imprints.

Since film or wafer-like dosage forms such. B. in DE 24 32 925 described, particularly advantageous first as Cast film are made from which the dose units go through Cutting or punching can be obtained contains one further embodiment of the primary packaging unit Dose units which sections or Represent die cuts from cast films. Casting films in the sense of this Invention include all sheet-like preparations which by casting carrier materials or coating them with polymer-containing solutions, suspensions or Emulsions with subsequent drying were generated.

Another embodiment of the The primary packaging unit contains sealing seams or sealing surfaces between the packaging material upper section and the - sub-web section, which are peelable. Peelable in the sense of this Invention encompasses all sealing seams or sealing surfaces that with moderate peel force, e.g. B. less than about 10 N / 15 mm, separated can be, usually the integrity of the Packaging material web sections are preserved. To generate such peelable sealing seams are special sealing media, e.g. B. So-called "Peel-PE", a special polyethylene, which is usually contains another polymer such as polystyrene and special sealing conditions (pressure, time, temperature) used. However, it is also possible to use conventional sealing media to seal under such conditions that no bond in the form of a melted sealed seam, but one peelable seam is created.

Another embodiment of the Primary packaging unit provides that next to each compartment outside of the sealing surfaces or sealing seams there is an unsealed edge on at least one side. This serves as handle tabs to the section of the packaging material easily grasp the bottom web and the packaging materials underneath To be able to separate the opening of a compartment. In a continued Embodiment are these tabs or unsealed edges of different lengths for the Packaging material upper and lower web section. If one of the If it protrudes from both packaging material sections on the edge, it is special easy to grip and from the second packaging material web section to bend away, which then also makes it easier to grab is.

Packaging material webs for the production of such primary packaging units can be single-layered, but are usually be multilayered in order to be able to meet the requirements to modern packaging materials and in connection with film or wafer-like dosage forms must be provided. Frequently occurring layers are e.g. B. Kraft paper for Generation of rigidity, plastic films for tensile strength and tightness of the packaging material, sealing wax for better Sealability, protective lacquers for impregnating the kraft paper, Aluminum for particularly high tightness, glue for the cohesion of individual layers, etc. Optimized Packaging material laminates contain from an economic point of view no more layers and no greater layer thicknesses than for the respective purpose is necessary.

In certain cases it will be necessary for one Primary packaging unit a certain packaging laminate both as a packaging material topsheet and as - use subway. If, for example, a particularly high one Gas tightness is required as only with a barrier layer can be achieved from aluminum, this becomes Need element in both packaging material webs.

In other cases, however, the upper and lower lanes can be attached different requirements are made. When a Primary packaging e.g. B. have a certain minimum stiffness should - and used a preferred for better manageability Design of the primary packaging unit a packaging material web with a bending stiffness of at least x with a common minimum thickness of y µm - it is sufficient if this rigidity is mainly due to a the packaging material web is conveyed while the other packaging material web according to other economic or technical aspects can be optimized.

Another variant of the primary packaging unit with two differently constructed packaging material webs contains a transparent packaging material section, through which the dosage units of the dosage form can see through the intact package. It is the definition of top and bottom rail arbitrary; for the purpose of This invention aims at using a transparent and a non-transparent packaging material web is the transparent one Path can be defined as the upper path. One of the advantages of this The variant is the simple visual inspection of the compartments or the dose units and their condition. Another The advantage is that there is a transparent top sheet printing on the top of the lower web or of dose units. Since such prints, such as already described, advantages u. a. regarding the revenue control have a variant of Primary packaging unit a transparent Packaging material upper web section and either one on the top-printed Lower web section or printed on the top Dosage units.

Such packaging units are suitable for everyone film-like or wafer-like dosage forms that correspond to the stand are known in the art. This includes simple, single-layer Preparations that usually disintegrate quickly in saliva, however, multi-layer systems that last longer Stick to the mucous membrane and release its active ingredient, and accordingly their layers are composed differently are slow, with at least one layer in the saliva or is not decayable at all and another layer has mucoadhesive properties.

Such primary packaging units can be surprising efficient machine production. A manufacturing process schematically shown in Fig. 1, for packaging units with square or rectangular dose units (5) consists of at least the following principal ones Process steps together, if necessary by further Steps for printing, additional shaping of the packaging unit or the like. Here are in one the first step is a top web of packaging material (1) and a bottom web (2) without cold or hot deformation via a deflection shaft (3) brought together, at the same time the film or wafer-like dosage form (4) with the help of roles or Pliers advantages (17) between the two packaging material webs to be led. It is advantageous if the film or wafer-like Dosage form already as a web product - single lane or multi-lane parallel at a distance from each other - with the desired one Width of the dose units (5) is supplied. Equally beneficial is smaller than the diameter of the deflection shafts the length of the dose units in the direction of travel of the webs choose. In a further process step, dose units (5) from the sheet-like dosage form by a Cross cutting device (6) isolated, which immediately before the deflection shafts is positioned. In a further step the two packaging material webs with the help of a heated sealing tool (7) sealed against each other in such a way, that the individual dose units (5) in compartments (8) be sealed and completely by sealing seams or sealing surfaces (9) are surrounded. In a further step are perforations through a punching device (12) stamped between the compartments (8). In another The process step can be carried out by primary packaging units (11) a second cross cutting or punching device can be divided.

A manufacturing method according to the invention is shown schematically in Fig. 2. The ones described here Process steps can be supplemented if necessary. The procedure contains the provision of a laminate in one process step (13) from the web-like, film or wafer-like dosage form (4) and a carrier film (14), from which in one further step with a punching device (15) the dose units (5) are punched out without the carrier film (14) is punched through. In a further step the punched laminate (13) with the help of rolls or Pliers advantages (17) over an edge or deflection shaft (18) see above deflected that the dose units (5) from the carrier film Loosen (14). If necessary, this can also be done additionally a scraper (16) can be used. In a further step a packaging material top web (1) and a - lower web (2) without cold or hot deformation over one each Deflection shaft (3) brought together, at the same time the dose units (5) detaching from the carrier film (14) be guided between the two packaging material webs (1 and 2). In a further process step, the two packaging material webs with the help of a heated sealing tool (7) accordingly Figure 1 sealed against each other so that the isolated Dose units (5) sealed in compartments (8) and completely of sealing seams or sealing surfaces (9) are surrounded. In a further step perforations between a punching device (12) the compartments (8) are stamped. In a further step can primary packaging units (11) by a second cross cutting or punching device can be separated.

Claims (4)

1. Process for manufacturing a primary packaging unit for film-like or wafer-like administration forms for oral application with a section of an upper web of packaging material (1) and of a lower web of packaging material (2), with a plurality of dosage units (5) being sealed in flat compartments (8), and perforations being provided between said compartments, characterized in that the film-like or wafer-like administration form is provided by a web-like laminate comprising a carrier sheet, that the dosage units are punched out of the laminate and subsequently the punched-out laminate (13) is advanced and diverted in such a way that the dosage units (5) become detached from the carrier sheet (14) and are led between the packaging material webs (1, 2), and that subsequently the latter (1, 2) are sealed to each other in sections in such a way that compartments (8) comprising dosage units (5) are formed.
2. Process according to Claim 1, characterized in that for partitioning off of the dosage units, the laminate (13) is drawn from a supply roll by means of pulling devices (17) in the form of rolls or tongs, is punched and led around the edge or the deflecting roll (18).
3. Process according to Claim 1, characterized in that the webs of packaging material (1, 2) are conveyed on top of one another by means of one deflecting roll (3) per web while simultaneously the dosage units (5) which are becoming detached from the carrier film (14) are pushed between the two webs of packaging material (1, 2).
4. Process according to Claim 1, characterized in that in a further step, individual primary packaging units (11) are severed by means of a cross-cutting or punching device.

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