MXPA00006759A - Primary packaging unit for film-like or oblate-like administered shapes - Google Patents

Abstract

The invention relates to a primary packaging unit for film-like or oblate-like administered shapes used for oral application. The packaging unit each comprises a section of a packing upper (1) and lower (2) web. The invention is characterized in that a plurality of dosing units (5) of a film-like or oblate-like administered shape are arranged at a distancefrom one another and are individual sealed inside compartments (8) of a primary packaging unit. Said compartments are produced without cold or heat forming the packing material. The invention is also characterized by having perforations which are located between compartments (8), said perforations permitting the separation of individual compartments (8) according to need.

Description

Primary packaging unit for forms of presentation in films or wafers The present invention relates to a primary packaging unit intended for presentation forms in films or wafers for oral application. It relates in particular to a primary packaging unit consisting of the presentation form on films or wafers and of an upper and lower band of packaging material for each section. Forms of presentation in films or wafers for oral application are known, inter alia, from the patent disclosures or applications US 3 007 848, DE 24 32 925, DE 27 46 414, EP 219 762. They are distinguished from the forms of presentation traditional, such as pills or capsules, especially for its geometric shape and its manufacturing process. They have in common that their shape is thin and flat, and their differences in flexibility, fragility, smoothness and consistency give them a film or sheet, or paper-like character, similar to that of a wafer. For its manufacture, the extrusion and coating procedures applied in the industrial production of sheets were especially recommended. Depending on the final application, two basic types are offered. One of them comprises the variants of disintegration or rapid release, for the disintegration in the buccal cavity immediately after its application, with release of an active substance, where the concept "rapid disintegration" for the purposes of the present invention is intended to refer to a disintegration time from a few seconds to variants known to disintegrate slowly or practically do not at all, which lend themselves especially to the slow and continuous release of active substance and, if they are added mucoadhesive substances, are in a situation of stick to the buccal mucosa. Both basic types can be shaped so that they adapt, depending on the active substance elaborated, to a topical treatment of the buccal mucosa or to the systemic application of the active substance. The packaging of these forms of presentation in units of primary packaging can not be done without more with the procedures, containers or machines customary used for traditional pharmaceutical products such as capsules or pills. A primary packaging unit conceived from modern points of view for solid forms of presentation in individualized doses has to make it possible, on the one hand, to protect the product from external influences, and on the other hand a conscious and verifiable extraction of a single dose unit in the desired moment of the taking, in which the extraction of the dose unit from the primary packaging unit has to happen in a way that does not alter the presentation form. While pills and capsules are often packed in larger numbers in jars or boxes, which is not sufficient to meet the above requirements, it is often customary to pack dose units in blister or deep drawn. Primary packaging units of this kind contain a plurality of dosage units that are sealed one by one between two sections of the web of packaging material. The gap is created, before filling, by molding in 'hot or cold' of the lower band of the packaging material with the help of the corresponding tool. Once the holes are occupied, the upper band of the packaging material is added and sealed together with the lower band. To extract a dosage unit from modern blisters, finger pressure is exerted on the outer face of the molded positions of the lower band of the packaging material, pressure that is transmitted to the tablet or capsule and that is sufficient to break the upper band of the packaging material and output the dose unit. But this is only possible when the material resistance of the upper band of the packaging material does not exceed a certain value. Although this concept has found widespread distribution in primary packaging units for traditional forms of presentation, it has notable drawbacks in the forms of presentation based on films or wafers. In the investigations carried out for this purpose two drawbacks of special gravity have been established, one of which refers to the manufacture and the other affects the extraction of doses from the primary packaging units of this class. The forms of presentation in films or wafers for oral administration are, in general - especially in the quick release variants - much lighter and less compact than traditional pills or capsules. The proposed extension of the dose units of the film or wafer type ranges from approx. 1 cm2 (for example, DE 2746 414) and 3 cm2 or more (for example, DE 24 32 925) and the thickness between 0.05 and 1 mm (for example, DE 24 32 925). In the use of the usual basic pharmaceutical substances, therefore, dosage units with a mass of approximately 5 to 100 mg result, in which the typical and preferred preparations must be located in the lower sector of this range. Now "Well, it has been shown that inserting these thin films or wafers in a blister involves great difficulties, especially at high speeds in the machine, the movement of air caused by the moving parts of the machines, and often also the possible electrostatic charge of the machine. the packaging materials cause the dose units not to position themselves correctly in the blister or, once placed, they are thrown out of the blister, although there is nothing to prevent the production of primary packaging units with films or oral wafers, but it is a It is also problematic to extract the forms of presentation in films or wafers of blister packs that correspond to the traditional primary packings for tablets or capsules.A flat dose unit deposited in a Depression is difficult to press through the material of the upper packing band: nor does it e the necessary format or the precise mechanical strength. The risk of damaging the dose unit when it is removed by pressure is relatively large. Even if one starts by trying to break the material of the upper packaging band by other means, for example with the nail, it is not easy to grasp and extract a flat dose unit from the exposed depression, unless very depressions are chosen. deep, which in turn is disadvantageous for other reasons, such as for example too large a closed space compared to the small mass of the presentation form. Additional difficulties in the traditional elaboration arise if the forms of presentation in films or wafers have a fragile and brittle nature. While in this case a rigidly shaped blister pack can guarantee some protection of the product during storage, the extraction of the dosage units becomes even more difficult.

Apart from these drawbacks of traditional blister packs for presentation forms in films or wafers, the choice of suitable packaging materials for blister packs has limitations, since the available materials are not among the cheapest. Some solution principles for creating a primary packaging unit for presentation forms on films or wafers without the drawbacks described in the current state of the art can be found in US 3,007,848. The principles of solution discussed here are interesting in part for all the forms of presentation in films or wafers, although US 3 007 848, unlike the present invention, strictly refers to (1) wafers manufactured by extrusion or by compression of edible sheets, which (2) are not intended for application in the oral cavity, but for swallowing and (3) for this it is optional to seal them in strips of an edible, flat and easy to swallow sheet. Now, said document shows the packaging of wafers by sealing dose units between two sheets which in a generalized sense must be understood as packaging material. It also indicates that the sealing of the dose units has to be "light" to facilitate the opening of the compartments and the extraction of the wafers. Finally, also expose an unsealed area on the edge of the packaging material that facilitates the grip of the sheets of packaging material and their mutual separation for the removal of the wafers. But neither in US 3 007 848, which represents a prior art of the present invention, do all the requirements of a primary packaging unit suitable for presentation forms in films or wafers. Some problems and problems remain unresolved or appear due to the conformation of the proposed packaging unit. On one side, the primary packaging unit proposed therein contains only one wafer when it is separated from the intermediate product, which represents an undefined, but very large quantity of packaged dosage units, so to speak as a roll-up band. But a viable primary packaging unit should generally contain, for many reasons, a well-defined plurality of dosage units. If this requirement is not met, there are clear disadvantages for secondary packaging: first, it is necessary to fill the small primary packaging units according to US 3 007848 with one wafer each, then collect them, count them and collect them in 20-pack quantities. units for example, or that requires a considerable expense and gives rise to secondary formats that are not very manageable. For subsequent extraction, it is necessary to remove a primary packaging unit each time, open it and extract the wafer, a process in which it is very difficult to control the intakes made up to a certain time. For example, in a secondary packaging unit with 50 wafers it would be almost impossible to revise the wafers still available without a costly recount to know if a particular shot has already expired has taken place or not. Accordingly, the object of the present invention is to create a primary packaging unit for presentation forms in films or wafers that meets all the aforementioned requirements without presenting the drawbacks described in the current state of the art. This purpose is achieved through the preparation of a primary packaging unit for presentation forms in films or wafers for oral application, with an upper band and a lower band of packaging material for each section, characterized by existing in a unit of primary packaging several dose units with a form of presentation in films or wafers individually sealed, separated from each other, in pianos compartments, created without cold or hot molding, of the packaging material, and by being between the compartments perforations that allow separates the individual compartments according to need.

This combination of features is necessary to obtain the viable primary packaging unit that is required. That is, you can not simply change the concept of US 3 007 848 only from the fact that the intermediate product, which, for example, is in the form of a roll or band, the solution would be achieved by cutting it, no, as required, after each wafer, but only after every ten wafers. A primary packaging unit thus obtained would, of course, contain a defined plurality of dosage units, but these could not be extracted simply and without problems. Research has shown that, when opening such a package to extract a unit dose, in general the seams or sealing surfaces are opened at the same time, so that several dose units are uncovered and are no longer protected by the primary container.

It has been found that a primary packaging unit that satisfactorily fulfills the objective of the invention must possess an additional feature, which is a perforation between the compartments in which the individual dose units are located and which said perforation must allow, when It is necessary to remove a single dose unit, first of all separate the compartment of this dose unit from the primary packaging unit in case in order to be able to open the compartment next without damaging the others. The perforation also offers the advantage that in the corresponding configuration it is always possible to open a selected compartment with the minimum of small stopping points without separating it before the primary packaging unit and without opening other compartments at the same time. Another advantage of the primary packaging unit of the invention resides in the relatively small volume of gas in the compartments where the dosage units are located. Therefore, products sensitive to oxidation or moisture may be protected from harmful influences of oxygen and air humidity if the choice of primary packaging materials is appropriate. Another advantage of the primary packaging unit of the invention lies in the low consumption of packaging material and in the manageable format, which saves space. For example, 10 units of primary packaging or more with 10 dose units each can fit without difficulty in a folded cardboard box 1 cm high. Another advantage of the primary packaging unit of the invention lies in the possibility of also using, as a lower band of the packaging material, materials much thinner and cheaper than those essential for the manufacture of blister packs and for cold molding or in hot, which must have a certain minimum thickness and, due to this, a minimum weight. Another advantage of the primary packaging unit of the invention resides in the possibility of viewing on the packaging itself, by printing, treatment schemes. For example, a weekly packaging unit with 7 dose units of a medication to be taken once a day can be manufactured, where the name or abbreviation of the day of the prescription is printed in each compartment of the packaging unit. week. In view of this therapeutic plan, patients can control their taking very easily. In a preferred version, the object of the invention contains printed labels. Since it is very convenient to manufacture the forms of presentation in films or wafers as a cast sheet, as described for example, in DE 24 32 925, of which "Dose units can be obtained by cutting or punching, another form of preferred version of the primary packaging unit of the invention contains dosage units that represent sections or die cuts of cast sheets." Cast sheets for the purposes of the present invention include all film-type preparations that were generated by fusion of carrier materials or their coating with solutions with polymers, suspensions or emulsions with subsequent drying. Another form of preferred embodiment of the primary packaging unit of the invention contains seams or sealing surfaces, between the upper web section of the packaging material and the lower web section of the packaging material, which are peelable. All seams or sealing surfaces that can be separated with application of a moderate force, for example, less than about 10 N / 15 mm, where the integrity of the cross-sections are generally maintained, are considered to be peelable for the purposes of the present invention. the band of packaging material. To create this peelable sealing seams, special packaging materials are used, for example, the so-called "Peel PE", a special polyethylene which generally contains another polymer, such as polystyrene, and special sealing conditions (pressure, time, etc.) are applied. , temperature). However, it is also possible to use conventional sealing materials in the same conditions, since no intimate connection is created in the form of a molten sealing seam, but instead a peelable seam.

Another form of preferred embodiment of the primary packaging unit of the invention provides that adjacent to each compartment, on one of the sides at least, is an unsealed edge, outside the sealing surfaces or seams. This edge serves as a grip flap which makes it easy to grasp the section of the upper and lower bands of the packaging material in order to separate the packaging materials and open a compartment. In another form of In a preferred embodiment, these unclogged flaps or edges have a different length in the upper section of the packaging material and in the lower section. That is to say, if one of the two sections of the band of packaging material protrudes at the edge, the grip and folding of the same with respect to the second section of the band is maximized, and then it is also easier to hold . The webs of packaging material for making primary packaging units can be single layer, but can also consist of several layers to meet the requirements that arise for modern packaging materials and in relation to forms of presentation in films or wafers. . Layers frequently used are, for example, Kraft paper for the creation of stiffness, plastic sheets for the tensile strength and sealing of the packaging material, sealing sealing to improve this, protective lacquer for impregnating Kraft paper, aluminum if a high tightness is desired, glue for the cohesion of the different layers, etc. The laminates of packaging material optimized from the economic point of view have no more layers than necessary and none of them is thicker than necessary for the purpose for which they are intended. In certain cases it is necessary to use, for a primary packaging unit according to the invention, a laminate of a given material for both the upper band of the packaging material and the lower one. If it is necessary, for example, a high gas tightness, as can only be achieved with an aluminum layer, this element will be essential in the two bands of the packaging material. But in other cases, different requirements are imposed on the upper band and the lower band. If a primary packaging is to have, for example, a certain minimum stiffness - and if to be more manageable, a preferred form of the primary packaging unit according to The invention employs a band of packaging material with a resistance to bending. and at least x with a minimum common thickness of y Dm - it is sufficient to calculate this preferred stiffness for one of the bands of packaging material, while the other band can be optimized from other economic or technical points of view. Another preferred variant of the primary packaging unit of the invention with two bands of packaging material of different structure contains a section of the upper band of the packaging material that is transparent and allows to see, through the undamaged container, the dosage units of the form of presentation. Although the definition of upper and lower band is arbitrary, for the purposes of this patent, if a band of transparent and a non-transparent packaging material is used, the transparent band has to be defined as an upper band. One of the advantages of this variant is the simplicity of the visual verification of the compartments or dose units and their status. A further advantage is that a printed labeling on the upper face of the lower band or also on the dose units can be recognized by means of a transparent band. As these impressions have shown that they have, among other advantages, the control of the intakes, a preferred variant of the primary packaging unit according to the invention includes a transparent section of the upper band of the packaging material and the section of the lower band it has a labeling on its upper face or the dose units are labeled on the upper face. The packaging units of the invention are suitable for all forms of presentation in films or wafers corresponding to the current state of the art. These include single-layer single preparations that usually disintegrate immediately following the action of the mucosa, but also multilayer systems that adhere 'for a longer time to the mucous membrane and yield their active substance, and whose layers have a different composition as befits this case, where at least one layer disintegrates gradually in the saliva or does not decompose at all and another layer It has mucoadhesive properties. The packaging units of the invention can be machined efficiently and quickly. A preferred method, which is depicted in the scheme of Figure 1, for manufacturing packaging units with square or rectangular dose units (5) is composed of at least the following steps of principle, which if necessary are completed with other steps for printing, additional conformation of the container unit or others. In a first step, an upper band of the packaging material (1) and a lower one (2) without cold or hot molding are carried on each other by a guide shaft (3) each, and at the same time the shape of the presentation in films or wafers (4) is conducted between the two bands of packaging material with the help of rollers or pulling tongs (17). It is advantageous if the presentation form in films or wafers is already introduced in the form of a band - in a band or in several parallel bands separated from each other - with the desired width for the dose units (5). It is also advantageous to choose the diameter of the guide shafts smaller than the length of the dose units in the direction of travel of the band. In another step of the process, dosage units (5) of the presentation form of the band are individualized by means of a transverse cutting device (6), which is placed in front of the guide shafts. In another step of the process, the two bands of packaging material are sealed together with the aid of a hot sealing tool (7), so that the individualized dose units (5) are enclosed in compartments (8) and surrounded completely by seams or sealing surfaces (9). In another process step, perforations are created between the compartments (8) with a punching device (12). In another step of the process, primary packaging units (11) can be separated by a second transverse cutting or die cutting device. Especially when dose units (5) with a geometry other than rectangular or square are desired, it is preferable to apply another multi-step manufacturing method, which is represented in the scheme of figure 2. Also the steps of the procedure described herein they can be supplemented or varied in order if necessary. The process contains in one step the preparation of a laminate (13) of the presentation form in films or wafers (4) which arrives in the form of a band and a support sheet (14), from which in another step they are punched out the dose units (5) with a punching machine (15) without the support sheet (14) being traversed. In another step of the process, the die-cut laminate (13) is deflected by means of rollers or pinchers (17) by a guide edge or axis (18) so that the dose units (5) are detached from the sheet support (14). If necessary, a separator (16) can also be used. In another step of the process, an upper band of the packaging material (1) and a lower one (2), without cold or hot molding, are carried on each other by a guide shaft (3) each, and at the same time time the dose units (5) that are detached from the support sheet (14) are conducted between the two bands of packaging material (1 and 2). In another step of the process, the two bands of packaging material are sealed together with the aid of a hot sealing tool (7) according to figure 1 so that the individualized dose units (5) are enclosed in compartments (8) and are completely surrounded by seams or sealing surfaces (9). In another process step, perforations are created between the compartments (8) with a punching machine (12). In another step of the process, primary packaging units (11) can be separated by a second transverse cutting or die cutting device.

Claims (4)

Claims

1. Procedure for the creation of a primary packaging unit for presentation forms in films or wafers for oral application, which in each section has an upper (1) and lower (2) band of the packaging material, in which several units of doses (5) are sealed in flat compartments (8) and perforations are provided between the compartments, characterized by preparing the presentation form in films or wafers by means of a laminate in the form of a strip with a support sheet, by cutting the dose of the laminate and then move the cut laminate (13) so that the dose units (5) are detached from the support sheet (14) and conducted between the bands of packaging material (1, 2) and then these (1, 2) are sealed against each other in sections so that compartments (8) are formed with dose units (5).

2. Process according to claim 1, characterized by extracting rollers or pulling clamps (17) the laminate (13) of a feeding roll for the individualization of the dose units, after which they cut it and lead it in front of the edge or roller of guide (18).

Method according to claim 1, characterized in that the strips of packaging material (1, 2) are guided one on top of the other by means of a guide roller (3) each and at the same time the dose units (5) that come off from each other. the support sheet (14) are driven between the two bands of packaging material (1, 2).

4. A method according to claim 1, characterized in that primary packaging units (11) are separated in a subsequent step by means of a transversal cutting or die cutting device.