DE102012102496A1 - Packaging device for a flat dosage form - Google Patents

Abstract

The invention relates to a packaging device (10) for a flat dosage form (40), in particular to a dosage form (40) formed from sections (28) of a ribbon-shaped matrix (30), having at least one heatable cutting device (20), wherein the cutting device (20) at processing conditions and design, in particular surface, length, material and processing temperature of the preparation form to be packaged (40), is adaptable. The invention further comprises a production line (80) for a flat dosage form (40) with at least one finishing device (10) and a method for assembling a two-dimensional dosage form (40), comprising the following steps: entrainment, in particular grinding entrainment of a strip-shaped matrix (30 ) or a matrix section, feeding the matrix (30) to a cutting device (20), and forming a section (28) of defined length from the matrix (30) by the cutting device (20).

Description

The present invention relates to a packaging device for producing a flat dosage form, in particular a dosage form formed from a band-shaped matrix.

Oral administration of drugs is still the most commonly used mode of drug delivery. Traditional dosage forms are, for example, tablets or capsules used as carrier systems for the oral administration of drugs. The tablets or capsules are swallowed in the rule, which requires that the patient holds a liquid, with which he can take this dosage form. However, partially, especially in older patients and children, difficulty swallowing, so they refuse the use of tablets or capsules or take ingested reluctant. This often results in a poor compliance, which has adverse effects on the healing progress or therapeutic success. Another disadvantage of tablets or capsules is that, due to delayed dissolution, they can be removed from the mouth without, for example, attracting attention to the medical staff to be monitored.

In order to overcome the problems described, pharmaceutical dosage forms, e.g. oral films have been developed that can be taken without hydration and that disintegrate rapidly in the oral cavity. Oral films are distinguished, for example, in that they have a small layer thickness and a large surface area and disintegrate in the oral cavity in the shortest possible time. They can be taken anytime, anywhere, as needed by the patient, even discreetly. Concomitant use of fluid is not necessary as the salivary fluid present in the oral cavity is sufficient to dissolve the films and release the drug.

In the production of such oral films, a liquefied, optionally gelatinous matrix material is first mixed with the active substance, then this active substance / carrier material mixture is drawn off as a film having a defined layer thickness or produced in a suitable casting mold in the desired layer thickness.

Due to the uniform layer thickness and the homogeneous distribution of the active ingredient in the carrier material, the desired active ingredient concentration can be adjusted via the size of the sections formed from the matrix material. The final drug concentration is thus a function of layer thickness and area of the oral or orodispersible film.

In order to produce sections of the same area, cutting, punching or knives are used, which divide the supplied film web, for example. Film-like matrix, into uniform sections.

Especially with matrix materials having a tough or sticky consistency, it proves difficult to produce uniform cutting lines and thus to ensure reproducible area sizes of the dosage form formed. Due to the fact that a continuous supply of the matrix material is performed during the cutting process, adhering to the cutting device portions or matrix residues have a disadvantage on the subsequently to be cut or to be formed dosage forms. Not infrequently, there is an overlap of sections, which in turn proves to be disadvantageous in the individual packaging of sections in a downstream packaging or sealing device.

It has been found that below a certain temperature defined for each matrix material, adhesion or sticking of the matrix material or of the sections with the cutting device can be effectively prevented. In the prior art, it is therefore proceeded to set up the corresponding cutting and feeding devices in tempered rooms. The effort that is necessary to set a satisfactory cooling or cutting temperature of the matrix is very high. The temperature of one, a multiple processing stations-containing cutting device also proves to be extremely energy-consuming. As a further measure, an encapsulation of the cutting device is proposed. Although this requires a lower cooling effort to gain access to the cutting device, but must, for example. In case of faults or failures or when replacing the cutting device itself, the entire housing can be opened. This is associated with an increased handling effort and extended downtime of the overall device, which adversely affects the production process.

Object of the present invention is therefore to provide a device in which the cutting result can be significantly improved with reduced cooling costs. The object is achieved by the packaging device described above for a flat dosage form.

At least one temperature-controllable cutting device is provided in the packaging device according to the invention for a two-dimensional dosage form. The cutting device or its temperature is due to the processing conditions and execution, in particular surface, length, material and processing temperature of the dosage form to be tailored. In this case, the two-dimensional administration form is formed, in particular, from a matrix provided in the form of a band.

The two-dimensional dosage form is in particular an orodispersible film. This can be mixed with an active pharmaceutical agent. Of course, the invention is not limited to use with pharmaceutical films. Rather, all dosage forms produced from ribbon-shaped matrices can be processed or created or cut with the finishing device.

The packaging device has a cutting device. The size or length of the prepared dosage form is adjustable via the positioning or the engagement frequency of the cutting device in the matrix. It is provided that the band-shaped matrix material is supplied to the cutting device. This happens, for example, via an electric motorized and / or microcontroller controlled film applicator. Depending on the frequency of intervention of the cutting device so then the size or length of the dosage form is determined. If the cutting device is designed, for example, as a rotating cylinder to which cutting or the like is attached, the size and / or length of the dosage form to be packaged can also be determined or influenced via the positioning and the rotational speed of the cutting device.

The cutting device preferably has a cutting edge. This engages in a defined frequency in the band-shaped starting matrix and forms the sections that represent the two-dimensional dosage form. In order to achieve a satisfactory cutting or trimming result, it is provided that the cutting edge is associated with a counter-blade or a support plate. This forms an abutment and thus allows a clean cut.

The cutting edge is, for example, a blade. This can be formed from steel, ceramics, titanium, titanium nitrite (TiN) and depending on the composition or predetermined processing conditions of the band-shaped matrix have a defined blade grinding or blade geometry. In this case, it is preferably provided that the blade be grounded on both sides or on one side.

To increase the service life of the blades, it is proposed that the blade has a coating of a hard material, in particular titanium nitrite, silicon nitride, silicon carbide, boron carbide, tungsten carbide, vanadium carbide, titanium carbide, tantalum carbide, aluminum oxide or zirconium dioxide. At the same time or alternatively it is possible that an additional diamond coating of the blade is performed.

In order to reduce the sticking tendency of the dosage form, there is the possibility that the blade material additionally has a surface coating of polytetrafluoroethylene (PTFE) or another suitable adhesion-reducing material.

It is considered particularly preferred if the cutting edge, the counter-cutting edge or support plate and / or the engagement region of the cutting edge in the matrix, in particular the band-shaped matrix, can be tempered, in particular cooled or frozen. This embodiment results from the fact that it has surprisingly been found that with a point or line cooling only the cutting surface or the engagement region of the cutting edge in the matrix adhesion can be effectively prevented. At the same time, the cutting result as well as the durability and service life of the cutting edge used for cutting improves.

The temperature control of the cutting edge, counter cutting edge, support plate or the engagement area of the cutting edge in the matrix also avoids complete air conditioning or cooling of the entire packaging device. As a result, the cutting result can be significantly improved in a particularly resource- and energy-saving manner, since the remaining parts of the packaging device can be operated at room temperature.

In order to carry out a temperature control of the cutting edge, counter cutting edge, support plate or the engagement region, it is considered favorable if the cutting edge or the counter cutting edge or support plate temperature can be adjusted via a Peltier element. In this case, the cutting edge or counter-blade or support plate can be connected directly to the temperature-regulating Peltier element. At the same time or alternatively, there is the possibility that such a Peltier element is provided only in the support plate or counter-blade or is assigned to the cutting device. The advantage of using a Peltier element is the small size and the avoidance of any moving components. Gases and liquids that produce a cooling effect need not be provided. At the same time, for example, by reversing the direction of flow with the Peltier element, a heating of the cutting, counter cutting or support plates are performed. This thus allows a completely free configurability of the packaging and thus expands their scope.

Another preferred embodiment provides that the cutting edge and / or the counter cutting edge or support plate is assigned at least one nozzle for acting on a cold or cryogenic fluid. This also makes it possible to achieve a punctual line-shaped or band-shaped cooling in the region of the cutting edge or counter-cutting edge or bearing surface. Depending on the orientation of the nozzle, either the cutting edge or counterblade or bearing surface or the matrix material introduced there into which the cutting edge or counterblade engages can be cooled or lowered in temperature so that a satisfactory cutting performance is ensured.

In this context, it is regarded as favorable if a punctiform or planar temperature control, in particular cooling or deep-freezing of the cutting edge, of the counter cutting edge or bearing plate and / or of the engagement region of the cutting edge, is provided in the matrix. By means of the arrangement of the nozzles or the corresponding assignment of Peltier elements, the temperature control can be carried out on a limited, clearly defined surface. In a preferred embodiment, a point or line cooling or freezing of the cutting line is provided on the matrix. At the same time, such point or line cooling or deep cooling prevents low-temperature exposure of the matrix material, which could possibly have a negative effect on the active pharmaceutical ingredients distributed uniformly in the matrix material.

A preferred embodiment of the packaging device provides that the cutting edge and / or counterblade or the support plate is or are resiliently mounted. This makes it possible to adjust the cutting edge or counterknife to the material thickness or type of material of the matrix to be cut. At the same time, the service life of the cutting edge is increased because, due to the resilient mounting, overstressing of the cutting edge or counter cutting edge is prevented. Also, different matrix materials can thus be cut with one and the same cutting edge or counter-cutting edge. The replacement of the cutting edge or counter-blade or the support plate is thus eliminated.

The cutting result is further improved by providing a groove in the counter-cutting edge or bearing surface. During the cutting process, the cutting edge engages in this groove or is in the groove or is guided by the groove. With appropriate cooling of the groove and the cooling of the matrix material entered there is improved and thus favors the cutting process.

The packaging device is described herein in connection with a cutting edge. The term "cutting edge" covers all cutting guides. Thus, for example, the cutting of the matrix sections or the fabrication of the dosage form can be carried out in a stamping process. As punching or cutting here, for example, circle cutters, Marbach punching or punching iron are used. Alternatively, of course, there is also the possibility that a pulling of the cutting edge and thus a cutting guide is performed. All of the aforementioned embodiments and methods are encompassed by the invention. The shape of the dosage form is also defined by the selection of the cutting or punching form. This can in addition to the rectangular also have a three or polygonal shape, including with rounded corners. Alternatively, a round or oval design is conceivable.

In addition to the cutting edge which carries out the complete separation of the matrix material, the cutting device can at the same time also have a perforation blade or blade. As a result, a perforation is introduced into the formed section, so that in a simple manner, the amount of active substance that is included in the sheet dosage form, can be shared. The perforation blade or cutting edge is arranged downstream of the actual cutting edge and forms one or more perforation lines, which subdivide the two-dimensional administration form into uniform sections, thus enabling a simple division of the dosage form.

In addition to the cutting function can be done on the cutting device embossing of the dosage form. Thus, for example, there is the possibility of providing an embossing of the formed administration form at the same time or after the formation of the section by the arrangement of a suitable stamp. Here, for example, logos or the like can be embossed into the formed sections. Of course, there is also the possibility that the embossing or an embossing device of the actual cutting is performed upstream. Also conceivable is a subsequent embossing of the sections formed in a separate embossing device, which is provided upstream, for example, a sealing unit or sealing device.

In order to further improve the cutting result and to favor the positioning of the band-shaped matrix relative to the cutting device, provision is made for a cutting-down device to be assigned to the cutting device. This acts on the matrix or it is the band-shaped matrix introduced into the hold-down and positioned by this during the cutting or punching process relative to the cutting edge.

According to the invention, at least one, preferably at least two cutting edges are arranged on or in the lateral surface of the cylinder. By rotation of the cylinder, the one or more blades engage in the supplied matrix material and thus form the ready-made dosage form. About the rotational speed of the cylinder and / or the arrangement of the cutting the size or length of the ready-made dosage form can be adjusted. The cylinder itself can be made of steel, ceramic or plastic. To improve the surface properties of the cylinder, it may additionally have a coating with a hard material, for example boron nitride, titanium nitride, silicon nitride, silicon carbide, boron carbide, tungsten carbide, vanadium carbide, titanium carbide, tantalum carbide, aluminum oxide, zirconium dioxide or with PTFE or another lubricious coating. As a result, on the one hand, the service life of the cylinder is improved, on the other hand lowered the adhesion tendency of the dosage form on the lateral surface of the cylinder.

In the cylinder, the arrangement of at least one, preferably at least two cutting is provided. These are conveniently position and / or orientation variable on or in the lateral surface of the cylinder can be arranged. For example, several receptacles for cutting can be provided in the lateral surface. Depending on the intended size or length of the dosage form to be packaged, more or fewer cutting edges are then inserted into the lateral surface of the cylinder. As low proves it in this context, when the cutting on the cylinder by screws, plug, clamps or the like can be attached. Of course, there is also the possibility here that one or more blades are arranged on or extendable in the lateral surface. By a corresponding loading mechanism, in particular hydraulically, pneumatically or by electric motor, a fully automated arrangement of the blades can then take place. Thereby, there is the possibility that without replacing the cutting tool, i. Without replacement of the cylinder, an adjustment of the parameters of the dosage form to be packaged can take place.

It is considered advantageous if the cylinder is associated with a driver for the matrix or the ready-made dosage form. Such a driver can be provided as an additional component in the region of the cylinder and causes with rotation of the cylinder a certain length of the band-shaped matrix is supplied. In coordination with the cutting position on the cylinder, a corresponding cutting of the strip-shaped matrix material then takes place on the size or surface of the dosage form which is ultimately provided. The driver can also be integrated into the cylinder in a simple manner in that the cylinder has a surface coating adhering to the matrix or the preformed administration form. Such a surface coating can be provided selectively or in sections on the cylinder or the lateral surface of the cylinder and be designed in particular as a roughening. A feed rate of the matrix and / or the transfer rate of the ready-to-use administration form is then adjustable via the rotational speed of the cylinder or the driver. The adhesive surface coating of the cylinder having jacket region causes a pulling or dragging entrainment of the band-shaped matrix material. By appropriate adjustment of the surface finish, the length of each entrained band-shaped matrix material can be adjusted. That is, the lateral surface moves relative to the matrix material, which partially adheres to the lateral surface and is entrained or entrained by this. About the strength of the attachment, the duration or path length of the entrainment is set. The cutting also arranged on the cylinder then cause the formation of portions of the entrained band-shaped matrix material. Of course, there is a possibility that, in addition to the cylinder equipped with the cutters, another feed cylinder is provided. Over this, the band-shaped matrix material is supplied to the equipped with the cutting cylinder. The two cylinders can in this case, for example. Controlled via a corresponding transmission, have different rotational speeds. At the same time, it is possible to set the rotational speed of the feed cylinder as a function of the preferred length of the sections to be formed.

As an alternative to the surface treatment, there is the possibility that entrainment of the matrix or a transfer of the ready-to-use dosage form takes place by alternately or optionally loading the cylinder or the lateral surface with underpressure or overpressure over the lateral surface. For this purpose, the lateral surface has structures, in particular nozzles, bores or slots, via which pressurisation of the matrix material or of the strip-shaped matrix material or the sections formed can take place. For supplying the band-shaped matrix material, in this case initially a negative pressure is applied to the lateral surface or the band-shaped matrix material. For this purpose, a negative pressure is applied over the lateral surface and the nozzles, bores or slots provided therein, which draws in the band-shaped matrix material and entrains it during cylinder rotation. By further rotation of the cylinder, an engagement of the provided in the lateral surface cutting then takes place in the matrix material. The matrix material still adhering to the lateral surface is hereby separated into sections. After separation, switching from underpressure to overpressure occurs and thus the sections are pushed off the lateral surface. The switchover between underpressure and overpressure is carried out by means of suitable air ducts inside the cylinder. The compressed air guide is made in particular by a rotary feedthrough into the interior of the cylinder.

The structures, i. Nozzles, holes or slots in the lateral surface, preferably have a uniform distribution, in particular a band, line or cluster-shaped distribution. This ensures that there is a uniform underpressure or overpressure of the strip-shaped matrix material or the ready-made dosage form, and that a transfer of the sections to the downstream processing stations can take place.

The cylinder is favorably associated with a control for the negative or positive pressure. In this case, the cylinder has, in particular, a compressed air guide which changes during the rotation, so that an overpressure or underpressure is formed alternately on the lateral surface.

In addition to the previously already carried out temperature exposure of the cutting edge, counter-blade or bearing surface or the matrix to be cut or the engagement region of the cutting, of course, there is also the possibility that the cylinder is wholly or partially tempered. For this purpose, a coolant circuit is preferably provided in the interior of the cylinder. The coolant guide is designed so that a point or surface cooling of the cylinder or its lateral surface can take place. In this case, it is considered to be particularly preferred when a region of the lateral surface which contacts the matrix is cooled.

In this way, the entire cooling effort for the packaging device or the cutting arrangement can be reduced. On the cooling of the cylinder or the lateral surface cooling of the cutting is performed simultaneously. If the cylinder has a correspondingly low temperature, cooling of the entrained matrix material is also achieved, which in turn has an advantageous effect on the cutting quality of the overall device.

By means of the packaging device according to the invention, a selective cooling of the cutting surfaces or of the cutting region is carried out. This results in a temperature difference between the ambient temperature and the cutting edge. While the overall device is operated, for example, at room temperature, a strong cooling takes place in the region of the cutting edge or of the engagement region of the cutting edge into the matrix, which, however, remains limited to the clearly defined region.

An alternative embodiment of the packaging device, which is likewise encompassed by the invention, provides that the cutting device is designed as a rotating or exchangeable cutting wire or as a rotating or in the cutting direction oscillating blade. Here, too, it is provided that the blade or the cutting wire can be tempered. Instead of a punching cut here pulling the blade or the cutting wire is performed. Depending on the design of the matrix material, heating of the cutting wire can also be carried out. The cutting wire acting on the matrix material then causes the dot or line-shaped melting of the matrix and thus leads to the separation of a section. Alternatively, the cutting wire may also have a coating, for example with diamond particles, so that when pulling the cutting wire over the band-shaped matrix material the sections and thus the dosage form are formed.

A preferred embodiment of the packaging device provides that the dosage form is formed as an orodispersible film, in particular as an at least one pharmaceutical active substance containing, at room temperature viscous orodispersible film. Viscose, orodispersible films prove to be particularly difficult to cut, since due to the viscosity of the film material is often adhered to the cutting edge. Surprisingly, it has been shown that adhesion is substantially reduced by punctiform, line-shaped or area-shaped cooling of the cutting area or of the cutting edge or cutting device. Thus, downtime resulting from a necessary, for example. Manual cleaning of the cutting device can be substantially reduced. The entire production process is thus optimized. At the same time, no complete cooling of the packaging device and thus of the viscous film to be cut arranged therein must be carried out.

The invention equally includes a production line for a flat dosage form. This production line has a previously described confectioning device as part. In the production line it is provided that the finishing device upstream in the direction of production, a tape cutting device is arranged. In this tape cutting device, the separation of a flat matrix is carried out in length-configurable strips or sections. These strips are fed to the packaging device and according to the Tailored length and surface specifications to form the two-dimensional dosage form.

Furthermore, the production line provides a feeding device for the matrix. The adjustable feeding speed of the feeding device defines the length of the sections. The feeding device may additionally or alternatively be designed to be synchronizable with an operating speed of the cutting device, preferably the rotational speed of the rotating cylinders or of the rotating rollers. Depending on specifications regarding the length of ready-made administration form, the feed rate is set. In this case, the feeding device and the cutting device can be brought together in one unit, for example, the supply of the strip-shaped matrix material can take place via the rotating cylinders or via a rotating roller assigned to the rotating cylinder.

The production line also provides that stockpiling and feeding of the sheet material, from which initially the band-shaped matrix and then the matrix sections are formed, is stored or supplied in the production line itself.

It is considered advantageous if the packaging device downstream of the production direction a sealing device is arranged. In this sealing device is a packaging or sealing of the formed sections or flat dosage form. The sealing device is designed so that sachets can be formed here. For this purpose, a lower and upper foil is supplied. Between the film webs, the matrix sections, i. the flat dosage form, arranged and finally formed the sachets via a sealing unit. It proves to be particularly advantageous if a synchronization of sealing speed and cutting speed of the packaging takes place. In particular, a gradual or continuous transfer of the ready-made administration form from the packaging device to the sealing device is envisaged.

• (i) Mitnahme, insbesondere schleifende Mitnahme einer bandförmigen Matrix oder eines Matrixabschnittes,
• (ii) Zuführung der Matrix zu einer Schneidvorrichtung, und
• (iii) Bildung eines Abschnittes definierter Länge aus der Matrix durch die Schneidvorrichtung.

The invention also includes a method for packaging a two-dimensional dosage form. The method comprises the following steps:

• (i) entrainment, in particular grinding entrainment of a band-shaped matrix or a matrix segment,
• (ii) feeding the matrix to a cutting device, and
• (iii) forming a section of defined length from the matrix by the cutting device.

In the method it is provided that an at least section or area temperature control, in particular cooling or freezing of the cutting device of the matrix and / or a parting line or cutting line is provided. By section or region temperature control, that is, cooling or freezing, the cutting result can be significantly improved. An adhesion of the matrix material of the band-shaped matrix or of the matrix section to the cutting device is thereby effectively prevented. At the same time, the cutting performance is increased and the service life of the cutting device is improved.

It is considered advantageous if the entrainment of the matrix by the cutting device itself, in particular mediates over the lateral surface of a cylinder provided in the cutting device. For this it is considered favorable if detection of the matrix material, i. a band-shaped matrix, by negative pressure of the cylinder or the lateral surface takes place and thereby the material of the band-shaped matrix is dragged entrained. During the slipping entrainment there is the possibility that the cylinder moves relative to the entrained matrix material and for this purpose an engagement frequency of the cutting device, in particular the cylinder provided cutting and, in turn, the length of the formed sections can be defined.

Preferably, the cylinder is pressurized or pressurized at a pressure of between 1 and 1000 mbar, in particular between 10 and 950 mbar, preferably between 50 and 750 mbar. The device has for this purpose a pressure regulator which controls or regulates the pressurization in dependence on the desired section length.

In a preferred embodiment of the method according to the invention, the definition of the length of the sections formed is based on the rotational speed and / or surface condition of the cylinder and / or the amount and duration of the negative pressure application and the resulting driving time. The rotational speed of the cylinder is preferably between 0.5 and 80 revolutions / minute, in particular at 1 to 40 revolutions / minute, preferably at 20 revolutions / minute.

• (iv) Abstreifen des Abschnittes und
• (v) Weitergabe an eine nachgeordnete Siegel- oder Verpackungseinheit.

The above-described method according to the invention furthermore advantageously comprises the steps

• (iv) stripping the section and
• (v) passing on to a downstream sealing or packaging unit.

The stripping of the section takes place, for example, by an additional mechanical Scraper, which is associated with the cutting device arranged in the device. Alternatively, if the cutting device has a cylinder, an overpressurization of the lateral surface of the cylinder take place, so that the sections formed are blown off the lateral surface and from there, for example, stored on a conveyor. The stripping takes place on a step or discontinuous conveyor. At the same time or alternatively, of course, there is the possibility that by a suitable conveyor device, for example. A conveyor belt or the like, a transfer of the formed portions is provided on the step or Unstetigförderer. About the stepper or Unstetigförderer the formed section and thus the flat dosage form is continued to a sealing or packaging unit. This sealing or packaging unit can, as provided in a preferred embodiment, be integrated into the stepper or discontinuous conveyor. In a preferred embodiment of the method, it is provided that the step (i) is preceded by a separation of a matrix material stored flat or as a film strip. By separating then takes place a determination of the width of the flat dosage form.

The formed, flat administration form preferably has a width of 0.5 to 5 cm, in particular from 1 to 3 cm, preferably from 1.25 to 2.5 cm. The length of the formed, flat dosage form is between 1 and 6 cm, in particular between 2 and 5 cm, preferably between 1.6 and 4.2 cm. The matrix material and thus the two-dimensional dosage form preferably has a thickness of between 25 and 750 μm, in particular between 30 and 600 μm, preferably between 50 and 500 μm.

In an embodiment considered advantageous, it is provided that, prior to the formation of the section of defined length from the matrix by the cutting device, a trimming of the edges of the matrix takes place. As a result, the homogeneity of the sheet-like dosage form is substantially improved and the shape and area unified.

The formation of the section of defined length preferably takes place by means of impressing a cutting edge into the matrix or pulling the cutting edge through the matrix. When the cutting edge is pressed in, the section is formed in the manner of a punching process, while alternatively, of course, pulling of the cutting edge through the matrix material can also be carried out.

In the drawings, the invention is shown schematically in several embodiments. Show it:

1a a preferred embodiment of the cutter used in the packaging device in perspective,

1b a schematic representation, arrangement of the cutting device 1a in a packaging device,

2a a sectional view of in 1a illustrated cutting device,

2 B a rotary feedthrough in section,

3 to 5 further preferred embodiments of the cutting device,

6 a detailed representation of the lateral surface of a preferred embodiment of the cutting device according to the invention,

7 a further preferred embodiment of the cutting device according to the invention,

8a to 8f preferred embodiments of the cutting devices usable in the packaging device according to the invention,

9 a preferred embodiment of the flat dosage form,

10 a further preferred embodiment of the cutting device according to the invention,

11 a schematic representation of the production line according to the invention for a flat dosage form.

In the figures, the same or corresponding elements are denoted by the same reference numerals and therefore, if not appropriate, will not be described again.

1a shows a in the packaging device according to the invention 10 suitable cutting device 20 , This has a cylinder 11 on, in its lateral surface 18 in the embodiment a total of three cutting 12 are used. The invention is not limited thereto but can also be used with cutting devices 20 be realized, which cut more or less 12 exhibit. The cutting 12 assigned to the cylinder 11 jet 60 on, about the imposition of the cutting 12 or one with the cutting device 20 sectionable matrix 30 he follows. About the nozzles 60 is a cold or cryogenic fluid in the direction of the cutting edge 12 directed. Due to the associated freezing of the cutting edge can stick of the material of the matrix 30 be prevented at the cutting, in particular, when it comes to the matrix 30 is a polymer matrix that is viscous at room temperature.

The cylinder 11 and thus the cutting device 20 is rotatable in the packaging device 10 stored. From the distance of the cutting edges 12 to each other results, depending on the rotational speed of the cylinder, the final length of the with the confectioning device 10 producible sections 28 the flat dosage form 40 ,

1b shows the in 1a shown cutting device 20 in the installed state in a preferred embodiment of a confectioning device 10 , From the in 1b right side is a band-shaped matrix 30 to the cutting device 20 fed. The cutting device 20 points next to the one with the cutting edges 12 provided cylinder 11 a support surface or support plate 14 on, in which the counter-blade 13 is admitted. The band-shaped matrix 30 is supplied and at the meeting of cutting edge 12 and counter-blade 13 become sections 28 and thus the two-dimensional dosage form 40 from the band-shaped matrix 30 separated. In 1b also recognizable are the nozzles 60 , about which an act of cutting 12 with a cold fluid. The nozzles 60 can also be aligned so that the engagement area 15 the cutting edge 12 or counter-blade 13 with the band-shaped matrix 30 is cooled. As a result, the cutting result is significantly improved and an adhesion of the matrix 30 or the section 28 on the cylinder 11 or the cutting edge 12 prevented.

2a shows the cylinder 11 in section. Inside the cylinder 11 are different channels 21 intended. About these channels 21 can a cooling medium to the lateral surface 18 of the cylinder 11 be introduced. By using a totally cooled cylinder 11 can also cool the cutting edges 12 or the matrix 30 respectively. This achieves the same effect as through the nozzles 60 , The inside of the cylinder 11 provided channels 21 However, they can also be used to convey the cryogenic fluid, for example deep-frozen air or the like, to those in the lateral surface 18 provided nozzles 60 to transport. About these nozzles 60 can then be a cooling of the cutting 12 or the matrix 30 or the intervention area 15 respectively.

The cylinder 11 is rotatable in the packaging device 10 or the bearing shells provided there 31 stored. On the feed side for the corresponding media has the cylinder 11 one, as in 2 B detailed, rotary union 22 on, over which the cooling medium into the interior 29 of the cylinder 11 or to the channels provided there 21 can be directed.

The rotary feedthrough 22 is detailed in 2 B shown. In the 2 B illustrated rotary feedthrough 22 is a total of two columns. About the hollow shaft 23 the coolant or fluid is supplied. About the axial interfaces 24a . 24b the medium or cryogenic fluid is then applied to the cylinder 11 pass and spread over the inside 29 of the cylinder 11 or in the area of the lateral surface distributed channels 21 and leads to a cooling of the entire cylinder 11 , About the seals 25a , b, c, d, the leakage of cooling medium is prevented, even if the cylinder 11 operated at higher speeds. Like from the 2a removed, can be returned via an axial return passage, the coolant through the same rotary feedthrough again and out of the cylinder 11 be removed. The seals 25a -D prevent the escape of cooling medium. It thus forms a closed cooling circuit. The rotary feedthrough 22 secures a coolant circuit even with correspondingly increased rotational speeds of the cylinder 11 , The preferred speed of the cylinder 11 is in the range of 0.5 to 80 revolutions / minute. Depending on the length of the dosage form to be formed 40 The speed is increased or decreased and thus set the desired parameters.

3 shows a preferred embodiment of the cutting device 20 , This points in the area of the cutting edge 12 as well as the counterknife 13 Peltier elements 50 on. About these Peltier elements 50 can be a highly accurate and rapid temperature control of the cutting edge 12 be performed. The counter-blade 13 is formed in the embodiment with a groove into which the cutting edge 12 intervenes. That between the upper and lower Peltier element 50 lying material of the matrix 30 is in the area of the cutting edge 12 or counter-blade 13 or the groove 16 cooled and then cut. The cutting edge 12 is doing in the groove 16 pressed. The counter-blade 13 is in the embodiment in a support surface or support plate 14 sunk in, over which the matrix 30 the cutting device 20 is supplied.

Another preferred embodiment of the cutting device according to the invention 20 is in 4 shown. Here, the cutting device 20 instead of a cylinder a cutting wire 70 on. This is first in the direction of arrow A in the matrix 30 pressed and then moved in the direction of arrow B, wherein a truncation of the section 28 and thus the formation of the flat dosage form 40 is carried out. The matrix 30 becomes the cutting device 20 in the form of a band-shaped matrix 30 fed in the feed direction C continuously or clocked. The bearing surface 14 is in the embodiment at the same time a conveyor for the matrix 30 as well as from the matrix 30 cut off flat dosage form 40 , Over the support surface 14 become the cut off parts of the matrix 30 continued to a packaging or sealing unit or transferred to another conveyor.

5 shows a further preferred embodiment of the cutting device according to the invention 20 , Here is the cutting device 20 again with a cylinder 11 executed, the cutting 12 bears that with a counterknife 13 in a platen or surface 14 interact and thereby of a supplied band-shaped matrix 30 the flat dosage form 40 as sections 28 separates. Here is a cooling of the engagement area 15 the cutting edge 12 or counter-blade 13 intended. For this purpose, both the support plate 14 as well as the cylinder 11 the cutting edge 12 or counter-blade 13 associated nozzles 60 on, over the cold air or other gaseous cooling fluid in the engagement area 15 is initiated. Next to the cutting edge 12 indicates the cylinder 11 in the embodiment of 5 an embossed stamp 26 on. This coins into the matrix 30 or the areal dosage form 40 For example, a logo or the like. For example, information about the concentration of active ingredient, the manufacturer or the shelf life and the pharmaceutical active substance in the two-dimensional dosage form can be obtained via the embossing 40 be introduced. As an alternative to embossing, there is of course the possibility that the embossing stamp 26 is designed as a plunger and here a printing of the matrix 30 or the areal dosage form 40 is carried out.

6 shows a preferred embodiment of the cylinder 11 the cutting device 20 , The cylinder 11 points in its lateral surface 18 Structures on. These are holes 19 , the cluster-shaped in the lateral surface 18 arranged and the cutting edge 12 are provided assigned. About the holes 19 can be a negative or positive pressure of the lateral surface 18 respectively. Will the lateral surface 18 subjected to negative pressure, a suction of the matrix material takes place 30 and its entrainment. Until the intervention of the cutting edge 12 into the matrix 30 and separating a section 28 becomes the lateral surface 18 subjected to negative pressure. After separating a section from the matrix 30 the reversal of the pressurization takes place and the bores now become the section 28 subjected to overpressure and thus from the lateral surface 18 blown off or discontinued. This can then lead to a passing of the section 28 be used to a downstream conveyor. About the duration and amount of pressurization and the residence time of the matrix 30 or the contact duration with the lateral surface 18 determines and thus the length of the ultimately formed sections 28 the matrix 30 , About the height of the pressurization can also only a dragging entrainment of the matrix material through the cylinder 11 which also takes the length of each between the two cutting edges 12 guided matrix sections can be defined.

7 again shows the cutting device 20 as already related to 5 described. In addition, the cutting device 20 here a scraper 17 on. This has one in the direction of the lateral surface 18 aligned arm, which at its end a bend 27 which has the lateral surface 18 almost contacted. By taking the section of the matrix 30 after the cutting edge 12 by means of the cylinder 11 the section becomes the scraper 17 fed. The scraper 17 then causes a lifting of the section of the lateral surface 18 and depositing the section on a downstream conveyor. The scraper 17 thus effectively prevents adhesion of the section 28 on the lateral surface 18 , The wiper opposite a counter-aligned hold-down can be provided, which provides improved delivery of the matrix 30 to the cutting edge 12 causes.

8a shows a possible embodiment of the cutting device 20 , Provided here is a cylinder 11 , in its lateral surface 18 a cutting edge 12 is used. This works with a counter-blade 13 that in a bearing surface 14 is provided or arranged together and separates a section 28 from a fed band-shaped matrix 30 , About the rotation speed of the cylinder 11 In this case, the length of the supplied matrix section is defined.

8b shows a further preferred embodiment of the cutting device 20 , This has a total of two rotatable cylinders 11 on. The lower cylinder 11 has the counter blade 13 on that with a cutting edge 12 in the upper cylinder 11 can be brought into engagement. The lower cylinder 11 can be used in the embodiment, the matrix 30 supply. About the rotation speed of the upper cylinder 11 then becomes the length of the finally formed section 28 Are defined.

8c shows a further embodiment of the cutting device 20 , This has a cutting wire 70 on. In the support surface 14 is a groove 16 let into which the cutting wire 70 can be sunk and thereby from the right fed matrix 30 sections 28 separates. In addition to a simple impressions of the cutting wire 70 into the matrix 30 in the direction of arrow A there is also the possibility that the cutting wire is formed circumferentially and by pulling cutting the section 28 from the matrix 30 separates.

8d shows a trained as a punch or blade cutting device 20 , Again, in the bearing surface 14 a groove 16 let into which the blade designed as a blade or punch 12 engages and a supplied matrix material 30 in sections 28 separates.

8e shows a further preferred embodiment of the cutting device 20 with an embossed stamp 26 , Here is an embossing of the matrix 30 before separating a section. The stamp 26 is therefore also in 8e recognizable cutting edge 12 downstream of the lateral surface 18 appropriate.

8f shows one of a first cutting edge 12 downstream perforation cutting edge 33 , By means of this, in addition to separating a section 28 perforation of the matrix takes place so that it is possible to subdivide the section formed on the perforation line again. This offers particular advantages if a distributed over a period administration of the drug in oral film should be. In 8f is just a perforation cutting edge 33 shown. Of course, there is also the possibility here two and more such cutting 12 to arrange and so a subdivision of the dosage form 40 into several perforated sections.

9 shows an embodiment of the flat dosage form 40 , This is on a carrier foil 41a arranged. In one of the cutting device 20 downstream sealing unit is on the carrier film 41a and flat dosage form 40 another carrier film 41b (not shown) and the edges 45 the carrier foils 41a , b sealed. This will be a sachet 42 educated. After separating the upper and lower carrier film 41a , b can be a removal of the flat dosage form 40 from the sachet 42 respectively. The flat dosage form 40 itself has a perforation 44 on, so that a division of the flat dosage form can be made in two parts. In the 9 illustrated flat dosage form 40 additionally has an imprint 43 on. This may be a logo of the manufacturer or may be information on the active ingredient or the active ingredient concentration. The sachet 42 has a pull-tab 46 on, over which the carrier foils 41a , b can be separated to the dosage form 40 refer to.

10 shows a schematic representation of the cutting device 20 , This also has a cylinder in the embodiment 11 up, over the holes 19 has, via the over- or under pressure of the lateral surface 18 of the cylinder 11 can be done. A cooling of the cylinder 11 takes place via the axial supply of a coolant into the interior of the cylinder 11 over the wave 32 , The distribution of the cutting edges 12 in the lateral surface 18 defines the final formed length of the sections 28 containing the areal dosage form 40 form. In the embodiment of 10 becomes a band-shaped matrix from the right side 30 the cutting device 20 fed. By applying vacuum to the holes 19 there is a dragging entrainment of the band-shaped matrix 30 and finally the engagement of the cutting edges 12 into the matrix material, which then causes the sections 28 the flat dosage form 40 be formed. After separating the sections 28 the pressurization is reversed and there is an overpressurization of the holes 19 , causing the formed sections 28 from the cylinder 11 be lifted and stored on a downstream conveyor.

The 11 shows a production line 80 , This has a centrally arranged packaging device 10 , Preceded in the production direction is a tape cutting device 82 intended. In this one will be on a first roll 81a stocked matrix 30 length-configurable strips formed, which then the confectioning device 10 be supplied. The packaging device 10 causes a dragging entrainment of the band-shaped matrix 30 or the length-configurable strip and a feed of the matrix 30 to the cutting device 20 also in the packaging device 10 is provided. In the packaging device 10 or by the cutting device 20 be from the band-shaped matrix 30 sections 28 separated and passed. Right after the cutting device 20 is from a second role 81b a lower carrier foil 41a fed on the sections 28 be filed. Together with the carrier foil 41a become the sections 28 to a sealing device 83 continued. There is one on a third roll 81c stocked upper carrier film 41b in the sealing device 83 and there is the formation of sachets 42 in the sealing device 83 by giving the the flat dosage form 40 ie the sections 28 surrounding edges of the backing sheets 41a , b are sealed. Optionally, there is the possibility that the sealing device downstream of a stamping, laminating or printing device 84 is provided in the information on the flat dosage form 40 on the sachets 42 be applied. In the production line 80 only cooling takes place in the region of the cutting device 20 , Due to the packaging device according to the invention 10 provided cutting device 20 is no further cooling of the entire production line 80 necessary. Overall, this leads to the saving of energy and to a much lower-maintenance construction of the production line.

The sealing device 83 is set so that a gradual transfer of the sections takes place. During this gradual transfer, the sealing of the sachets takes place at the same time 42 ,

The invention comprises the following items:

An assembly device for a flat administration form, in particular a dosage form formed from sections of a band-shaped matrix, with at least one heatable cutting device, the cutting device being adaptable to processing conditions and design, in particular to surface, length, material and processing temperature of the dosage form to be packaged.

The aforementioned packaging device, wherein the size and / or length of the sections is / are adjustable via the positioning and / or engagement frequency of the cutting device in the matrix.

The aforementioned packaging device, wherein the cutting device has a cutting edge and / or the cutting edge is associated with a counter cutting edge or support plate and / or additionally or alternatively a perforation cutting edge and / or an embossing or pressure stamp.

The aforementioned packaging device, wherein the cutting edge is formed as a punch.

The aforementioned packaging device, wherein the cutting edge is formed of steel, in particular band steel or ceramic.

The aforementioned assembly device, wherein the cutting edge has a coating, in particular wherein the coating is selected from the group consisting of hard material, in particular boron nitride, titanium nitride, silicon nitride, silicon carbide, boron carbide, tungsten carbide, vanadium carbide, titanium carbide, tantalum carbide, aluminum oxide or zirconium dioxide, PTFE or ceramics.

The aforementioned assembly device, wherein the cutting edge, the counter-blade or support plate and / or an engagement region of the cutting edge in the matrix is temperature-controlled, in particular cooled or deep-cooled, in particular wherein a cutting temperature and / or a Gegenschneiden- or platen temperature is adjustable via a Peltier element and / or the cutting edge and / or the counter-blade or support plate is associated with a temperature-regulating Peltier element or wherein preferably the cutting edge and / or the counter-blade or support plate is associated with at least one nozzle for applying a cold or cryogenic fluid.

The above-mentioned confectioning device, wherein a punctiform or planar temperature, in particular cooling or deep cooling of the cutting edge, the counter-blade or support plate and / or the engagement region of the cutting edge is provided in the matrix.

The aforementioned packaging device, wherein a point and / or line cooling or freezing of a cutting line is provided on the matrix.

The aforementioned packaging device, wherein the cutting edge and / or the counter-blade or the support plate is resiliently mounted / are.

The aforementioned packaging device, wherein in the counter-blade or platen, a groove is provided, wherein the cutting edge is engageable with the groove during a cutting operation, is in the groove or guided by the groove.

The aforementioned packaging device, wherein the cutting device ( 20 ) is assigned a hold-down for the matrix, in particular wherein the band-shaped matrix can be supplied via the hold-down of the cutting device and / or by the hold-down the band-shaped matrix can be clamped or forced.

The aforementioned packaging device, wherein the cutting device is associated with a scraper for the ready-made dosage form, in particular wherein the scraper has a relative to a conveying direction angled arm and / or the scraper engages behind the section and lifts from the cutting device.

The aforementioned packaging device, wherein the cutting device comprises a rotating cylinder and at least one, preferably at least two cutting edge (s) is arranged on or in a lateral surface of the cylinder / are.

The aforementioned packaging device, wherein the cylinder made of steel, ceramic or plastic is formed.

The aforementioned assembly device, wherein the cylinder has a coating, in particular a coating with a hard material, preferably boron nitride, titanium nitride, silicon nitride, silicon carbide, boron carbide, tungsten carbide, vanadium carbide, titanium carbide, tantalum carbide, aluminum oxide, zirconium dioxide or with PTFE, ceramic or a friction-reducing plastic having.

The aforementioned manufacturing device, wherein the cutting edge (s) position and / or variable in orientation on or in the lateral surface of the cylinder can be arranged / are.

The aforementioned packaging device, wherein the cutting edge on the cylinder releasably fixed, in particular screw, clamped or plugged can be arranged.

The aforementioned packaging device, wherein the size and / or length of the ready-made administration form over the rotational speed of the cylinder and / or number and arrangement of the cutting edge (s) is adjustable.

The aforementioned assembly device, wherein the cylinder is associated with a carrier for the matrix or the ready-made dosage form and / or the cylinder has an adhering to the matrix or the ready-made dosage form surface coating, in particular roughening, wherein a feed rate of the matrix and / or a propagation speed of the Ready-made dosage form on the rotational speed of the cylinder or the driver is adjustable.

The above-mentioned packaging device, wherein entrainment of the matrix or a transfer of the ready-made dosage form is provided by selectively pressurizing the cylinder and / or the lateral surface with negative pressure or over-pressure provided in the lateral surface structures, in particular nozzles, holes or slots.

The aforementioned assembly device, wherein the structures have a uniform distribution, in particular band, line or cluster-shaped.

The aforementioned packaging device, wherein the cylinder is associated with a control for the negative or positive pressure, in particular wherein the cylinder has a changing during the rotation compressed air guide for alternately forming an overpressure or underpressure on the lateral surface.

The above-mentioned packaging device, wherein the cylinder is wholly or partially tempered.

The aforementioned packaging device, wherein a coolant circuit is provided in the interior of the cylinder.

The above-mentioned packaging device, wherein a point or area cooling of the cylinder and / or the lateral surface, in particular of a region of the lateral surface contacted by the matrix, is provided.

The aforementioned assembly device, wherein the cutting device is designed as a rotating or exchangeable cutting wire or as a rotating or in the cutting direction oscillating blade, in particular wherein the blade or the cutting wire is designed to be tempered.

The aforementioned packaging device, wherein the dosage form is formed as an orodispersible film, in particular as an at least one active substance containing, at room temperature viscous orodispersible film.

The invention also encompasses a production line for a flat dosage form with at least one packaging device as described above.

The above-mentioned production line, wherein the fabricating device upstream of a tape cutting device is arranged in the production direction, wherein a separation of a flat matrix is provided in length-configurable strips or sections in the tape cutting device.

The aforementioned production line, wherein a supply device for the matrix is provided, in particular wherein a feed speed of the feed device manually or automatically adjustable and / or synchronized with an operating speed of the cutting device, preferably the rotational speed of the rotating cylinder or the rotating roller.

The aforementioned production line, wherein a storage and supply of the sheet material is provided within the production line.

The aforementioned production line, wherein the finishing device downstream of the production direction, a sealing device, in particular for the formation of the flat dosage form containing sachets is arranged, and a synchronization of sealing speed and cutting speed of the packaging is provided.

The aforementioned production line, wherein a gradual or continuous transfer of the ready-made dosage form is provided by the device for packaging to the sealing device.

• (i) Mitnahme, insbesondere schleifende Mitnahme einer bandförmigen Matrix oder eines Matrixabschnittes,
• (ii) Zuführen der Matrix zu einer Schneidvorrichtung, und
• (iii) Bildung eines Abschnittes definierter Länge aus der Matrix durch die Schneidvorrichtung,

wobei eine wenigstens abschnitts- oder bereichsweise Temperierung, insbesondere Kühlung oder Tiefkühlung der Schneidvorrichtung, der Matrix und/oder einer Trennlinie vorgesehen ist.The invention also relates to a method for packaging a two-dimensional dosage form, comprising the steps:

• (i) entrainment, in particular grinding entrainment of a band-shaped matrix or a matrix segment,
• (ii) feeding the matrix to a cutting device, and
• (iii) forming a section of defined length from the matrix by the cutting device,

wherein an at least sections or regions of temperature, in particular cooling or freezing of the cutting device, the matrix and / or a dividing line is provided.

The aforementioned method, wherein the entrainment of the matrix by the cutting device, in particular mediated over the lateral surface of the cylinder provided in the cutting device is provided.

The aforementioned method, wherein a detection by negative pressure of the cylinder and / or the lateral surface takes place.

The aforementioned method, wherein the negative pressure is between 1 and 1000 mbar, in particular between 10 and 950 mbar, preferably between 50 and 750 mbar.

The aforementioned method, wherein a lifting of the section takes place by pressurizing the cylinder and / or the lateral surface.

The aforesaid process, wherein the overpressure is between 1 and 1000 mbar, in particular between 10 and 950 mbar, preferably between 50 and 750 mbar.

The aforementioned method, wherein the definition of the length over the rotational speed and / or surface condition of the cylinder and / or the height and duration of the negative pressure and the resulting entrainment is adjustable.

The aforesaid method, wherein the cylinder has a rotational speed of between 0.5 and 80 rpm, in particular between 1 and 40 rpm, preferably 20 rpm. having.

• (iv) Abstreifen des Abschnittes und
• (v) Weitergabe an eine nachgeordnete Siegel- oder Verpackungseinheit.

The aforementioned method, further comprising the steps of

• (iv) stripping the section and
• (v) passing on to a downstream sealing or packaging unit.

The aforesaid method wherein stripping to or passing by a step or discontinuous conveyor is provided.

The aforesaid method, wherein the step or discontinuous conveyor has a conveying speed of between 0.5 and 7.5 m / min, in particular of between 1 and 6 m / min, preferably of 5 m / min. having.

The aforementioned method, wherein the sealing or packaging unit has a conveying speed of between 0.5 and 7.5 m / min., In particular of between 1 and 6 m / min., Preferably of 5 m / min. having.

The aforementioned method, wherein the sealing or packaging unit is integrated in the step or discontinuous conveyor.

The aforementioned method, wherein the step (i) is a separation of a planar or as a foil strip stocked matrix material is provided, in particular wherein during the separation of a determination of the width of the two-dimensional dosage forms.

The aforementioned method, wherein the two-dimensional dosage form has a width of 0.5 to 5, in particular 1 to 3, preferably 1.25 to 2.5 cm and / or a length of between 1 and 6, in particular 2 to 5, preferably 1 , 6 to 4.2 cm.

The aforementioned method, wherein the flat dosage form has a thickness of between 25 and 750 microns, especially between 30 and 600 microns, preferably between 50 and 500 microns.

The aforesaid method, wherein prior to step (iii) forming a portion, trimming the edges of the matrix.

The aforesaid method, wherein step (iii) is accomplished by indenting a blade into the matrix or pulling the blade through the matrix.

LIST OF REFERENCE NUMBERS

10

configurator

11

cylinder

12

cutting edge

13

against cutting

14

Platen / Area

15

engagement area

16

groove

17

scraper

18

lateral surface

19

drilling

20

cutter

21

channel

22

Rotary union

23

hollow shaft

24a, b

interface

25a-d

poetry

26

dies

27

angling

28

section

29

Inner

30

matrix

31

bearing shell

32

wave

33

Perforationsschneide

40

flat dosage form

41a, b

support film

42

Sachet

43

embossing

44

perforation

45

edge

46

pull tab

50

Peltier element

60

jet

70

cutting wire

80

production line

81a, b, c

role

82

Tape cutter

83

sealer

84

printing device

Claims (25)

Assembly device ( 10 ) for a flat dosage form ( 40 ), in particular one of sections ( 28 ) a band-shaped matrix ( 30 ) ( 40 ), with at least one temperature-controllable cutting device ( 20 ), wherein the cutting device ( 20 ) on processing conditions and execution, in particular on surface, length, material and processing temperature of the preparation form to be packaged ( 40 ) is customizable. Assembly device according to claim 1, characterized in that the size and / or length of the sections ( 28 ) about positioning and / or engagement frequency of the cutting device ( 20 ) into the matrix ( 30 ) is / are adjustable. Packaging device according to claim 1 or 2, characterized in that the cutting device ( 20 ) a cutting edge ( 12 ) and / or the cutting edge ( 12 ) a counter-blade ( 13 ) or platen ( 14 ) and / or additionally or alternatively a perforation cutting edge ( 33 ) and / or an embossing or printing stamp ( 26 ) and / or the cutting edge ( 12 ) is formed as a punch and / or the cutting edge ( 12 ) is formed of steel, in particular strip steel or ceramic, in particular wherein the cutting edge ( 12 ) has a coating, in particular wherein the coating is selected from the group consisting of hard material, in particular boron nitride, titanium nitride, silicon nitride, silicon carbide, boron carbide, tungsten carbide, vanadium carbide, titanium carbide, tantalum carbide, aluminum oxide or zirconium dioxide, PTFE or ceramic. Packaging device according to claim 3, characterized in that the cutting edge ( 12 ), the counter blade ( 13 ) or platen ( 14 ) and / or an intervention area ( 15 ) of the cutting edge ( 12 ) into the matrix ( 30 ) is temperature-controlled, in particular designed to be cooled or frozen, and / or a cutting temperature and / or a counter-cutting or platen temperature via a Peltier element ( 50 ) is adjustable and / or the cutting edge ( 12 ) and / or the counter blade ( 13 ) or platen ( 14 ) a temperature-regulating Peltier element ( 50 ) and / or the cutting edge ( 12 ) and / or the counter blade ( 13 ) or platen ( 14 ) at least one nozzle ( 60 ) is assigned to the application of a cold or cryogenic fluid, in particular wherein a point or area temperature, in particular cooling or freezing the blade ( 12 ), the counter blade ( 13 ) or platen ( 14 ) and / or the intervention area ( 15 ) of the cutting edge ( 12 ) into the matrix ( 30 ) is provided and / or a point and / or line cooling or freezing a cutting line on the matrix ( 30 ) is provided. Confectioning device according to one of claims 3 or 4, characterized in that the cutting edge ( 12 ) and / or the counter blade ( 13 ) or the platen ( 14 ) is resiliently mounted / are. Packaging device according to one of claims 3 to 5, characterized in that in the counter cutting edge ( 13 ) or platen ( 14 ) a groove ( 16 ), the cutting edge ( 12 ) during a cutting operation with the groove ( 16 ) is engageable in the groove ( 16 ) or through the groove ( 16 ) is guided. Packaging device according to one of the preceding claims, characterized in that the cutting device ( 20 ) a hold-down for the matrix ( 30 ), in particular wherein the band-shaped matrix ( 30 ) via the holding device of the cutting device ( 20 ) is fed and / or by the hold-down the band-shaped matrix ( 30 ) is clampable or enforceable. Packaging device according to one of the preceding claims, characterized in that the cutting device ( 20 ) a scraper ( 17 ) for the ready-made dosage form ( 40 ), in particular wherein the scraper ( 17 ) has a relative to a conveying direction (C) angled arm and / or the scraper ( 17 ) the section ( 28 ) and from the cutting device ( 20 ) takes off. Packaging device according to one of the preceding claims, characterized in that the cutting device ( 20 ) a rotating cylinder ( 11 ) and at least one, preferably at least two cutting edge (s) ( 12 ) on or in a lateral surface ( 18 ) of the cylinder ( 11 ) is arranged, in particular wherein the cylinder ( 11 ) is made of steel, ceramic or plastic and / or the cylinder ( 11 ) has a coating, in particular a coating with a hard material, preferably with boron nitride, titanium nitride, silicon nitride, silicon carbide, boron carbide, tungsten carbide, vanadium carbide, titanium carbide, tantalum carbide, aluminum oxide, zirconium dioxide or with PTFE, ceramic or a friction-reducing plastic and / or the cutting edge ( n) ( 12 ) positionally and / or orientation variable on or in the lateral surface ( 18 ) of the cylinder ( 11 ) is / are and / or the cutting edge ( 12 ) on the cylinder ( 11 ) releasably fixed, in particular screw, clamped or plugged can be arranged. Packaging device according to claim 9, characterized in that the size and / or length of the ready-made dosage form ( 40 ) about the rotational speed of the cylinder ( 11 ) and / or number and arrangement of the cutting edge (s) ( 12 ) is adjustable and / or the cylinder ( 11 ) a driver for the matrix ( 30 ) or the ready-made dosage form ( 40 ) and / or the cylinder ( 11 ) one for the matrix ( 30 ) or the ready-made dosage form ( 40 ) adhering surface coating, in particular roughening, wherein a feed rate of the matrix ( 30 ) and / or a transfer speed of the ready-made administration form ( 40 ) about the rotational speed of the cylinder ( 11 ) or the driver is adjustable. Packaging device according to one of the preceding claims, characterized in that a take-along of the matrix ( 30 ) or a transfer of the ready-made dosage form ( 40 ) by optionally loading the cylinder ( 11 ) and / or the lateral surface ( 18 ) with underpressure or overpressure over in the lateral surface ( 18 ) provided structures, in particular nozzles, bores ( 19 ) or slits is provided, in particular wherein the structures have a uniform distribution, in particular band, line or cluster-shaped. Packaging device according to one of claims 9 to 11, characterized in that the cylinder ( 11 ) is associated with a controller for the under- or over-pressurization, in particular wherein the cylinder ( 11 ) a compressed air guide changing during the rotation for alternately forming an overpressure or underpressure on the lateral surface ( 18 ) and / or the cylinder ( 11 ) is wholly or partially tempered, in particular wherein a coolant circuit in the interior ( 29 ) of the cylinder ( 11 ) is provided and / or a point or surface cooling of the cylinder ( 11 ) and / or the lateral surface ( 18 ), in particular one of the matrix ( 30 ) contacted area of the lateral surface ( 18 ), is provided. Packaging device according to one of the preceding claims, characterized in that the cutting device ( 20 ) as a rotating or exchangeable cutting wire ( 70 ) or as a circumferential or in the cutting direction oscillating blade is formed, in particular wherein the blade or the cutting wire ( 70 ) is designed to be temperable. Packaging device according to one of the preceding claims, characterized in that the dosage form ( 40 ) is formed as an orodispersible film, in particular as a substance containing at least one active, viscous at room temperature orodispersible film. Production line ( 80 ) for a flat dosage form ( 40 ) with at least one confectioning device ( 10 ) according to one of the preceding claims 1 to 14, in particular wherein the packaging device ( 10 ) upstream in the production direction, a tape cutting device ( 82 ), wherein a separation of a two-dimensional matrix ( 30 ) in length-configurable strips or sections ( 28 ) in the tape cutting device ( 82 ) is provided. Production line according to claim 15, characterized in that a feed device for the matrix ( 30 ) is provided, in particular wherein a feed speed of the feeder manually or automatically adjustable and / or with an operating speed of the cutting device ( 20 ), preferably the rotational speed of the rotating cylinder ( 11 ) or the rotating roller is synchronized and / or a storage and supply of the sheet material within the production line ( 80 ) is provided. Production line according to claim 15 or 16, characterized in that the confectioning device ( 10 ) downstream of a sealing device ( 83 ), in particular for the formation of the flat dosage form ( 40 ) containing sachets ( 42 ), and a synchronization of sealing speed and cutting speed of the packaging device ( 10 ), in particular wherein a gradual or continuous transfer of the ready-made dosage form ( 40 ) from the device for packaging to the sealing device ( 83 ) is provided. Process for the preparation of a two-dimensional dosage form ( 40 ), comprising the steps of: (i) entrainment, in particular grinding entrainment of a band-shaped matrix ( 30 ) or a matrix section, (ii) feeding the matrix ( 30 ) to a cutting device ( 20 ), and (iii) forming a section ( 28 ) of defined length from the matrix ( 30 ) by the cutting device ( 20 ), wherein an at least sections or regions of temperature, in particular cooling or freezing of the cutting device ( 20 ), the matrix ( 30 ) and / or a dividing line is provided. Method according to claim 18, characterized in that the entrainment of the matrix ( 30 ) by the cutting device ( 20 ), in particular mediates over the lateral surface ( 18 ) in the cutting device ( 20 ) provided cylinder ( 11 ), in particular wherein a detection by negative pressure of the cylinder ( 11 ) and / or the lateral surface ( 18 ) and the negative pressure is preferably between 1 and 1000 mbar, in particular between 10 and 950 mbar, preferably between 50 and 750 mbar. A method according to claim 18 or 19, characterized in that a lifting of the section ( 28 ) by pressurizing the cylinder ( 11 ) and / or the lateral surface ( 18 ) and the overpressure is preferably between 1 and 1000 mbar, in particular between 10 and 950 mbar, preferably between 50 and 750 mbar. Method according to one of claims 18 to 20, characterized in that the definition of the length over the rotational speed and / or surface condition of the cylinder ( 11 ) and / or the amount and duration of the negative pressure application and the concomitant duration of entrainment is adjustable, in particular wherein the cylinder ( 11 ) a rotational speed of between 0.5 and 80 U / min., In particular of between 1 and 40 U / min., Preferably 20 U / min. having. The method of any one of claims 18 to 21, further comprising the steps of (iv) stripping the portion (15). 28 ) and (v) passing on to a downstream sealing or packaging unit. A method according to claim 22, characterized in that the stripping on or a passing through a step or Unstetigförderer is provided, in particular wherein the step or discontinuous conveyor a conveying speed of between 0.5 and 7.5 m / min., In particular from between 1 and 6 m / min., Preferably 5 m / min. and / or the sealing or packaging unit has a conveying speed of between 0.5 and 7.5 m / min., in particular of between 1 and 6 m / min., preferably of 5 m / min. in particular, wherein the sealing or packaging unit is integrated in the stepper or discontinuous conveyor. Method according to one of claims 18 to 23, characterized in that the step (i) is provided a separation of a surface or as a foil strip stocked matrix material, in particular wherein during the separation of a determination of the width of the two-dimensional administration forms ( 40 ), in particular wherein the planar dosage form ( 40 ) has a width of 0.5 to 5, in particular 1 to 3, preferably 1.25 to 2.5 cm and / or a length of between 1 and 6, in particular 2 to 5, preferably 1.6 to 4.2 cm and / or the flat dosage form ( 40 ) has a thickness of between 25 and 750 μm, in particular between 30 and 600 μm, preferably between 50 and 500 μm. Method according to one of claims 18 to 24, characterized in that prior to step (iii) formation of a section ( 28 ) a trimming of the edges of the matrix ( 30 ), in particular wherein step (iii) by means of impressing a cutting edge ( 12 ) into the matrix ( 30 ) or pulling the cutting edge ( 12 ) through the matrix ( 30 ) he follows.

Images