MXPA00003613A - The formation of indicia in the base of a blister pack for transference to a body cast therein - Google Patents

Abstract

In a process for creating one or more blisters in a blister film (4), indicia are formed in the base of the blister in the final stage of a single pass of the blister forming punch (2) or pin. The blister is cold formed by advancing the pin (2) in a direction transversely relative to the plane of the film (4), towards and into engagement with a platen carrying indicia-forming die (12). The end face of the pin is formed with a mould for indicia complementary to the die (2), and movement of the pin (2) towards the platen draws and stretches film (4) predominantly from around the blister, thereby minimizing stretching of the film (4) at the base of the blister.

Description

FORMATION OF INDICATIONS AT THE BASE OF AN AMPOLLETAS PACKAGE. FOR TRANSFER TO BODY MOLDED, IN THE SAME DESCRIPTION OF THE INVENTION This invention is concerned with the use of a laminated film to form packages of ampoules in the vials of which bodies are molded. Such ampoule packages usually comprise polymeric films in which the ampoules are thermally formed. The present invention is concerned in particular with the use of laminated films in which a sheet of metal is sandwiched between two polymeric layers. Ampoule films are particularly suitable for the molding of fragile bodies comprising some pharmaceutical components. These bodies are commonly made using lyophilization or freeze drying processes, but alternative techniques such as those including a dissolution stage are also used. in solid state. The liquid material of the body is poured into the ampoule or ampoules and then subjected to various treatments while it is still in the ampoules. The products remain in the vial until they are ready for use and at this stage they are easily removable.

R - F .: 119573 Polymeric ampoule films suffer from the disadvantage of being permeable, with the consequence that even though the individual ampoules are sealed, there is always a potential storage problem if the contents of the ampoule should be protected from the surrounding atmosphere. With the above points in mind, laminated ampoule films have been developed in which a sheet of metal is sandwiched between polymer films either on one side or the other. Such films are less permeable than fully polymeric films, but some known films can be distorted when subjected to thermal treatments, generating irregularity in the molded products and making subsequent handling of the ampoule package more difficult. Although some laminated films have been developed that are more stable under thermal treatment; see published European patent specifications Nos. 0 646 367 and 0 710 101, in general these laminated films are not suitable for the thermal formation of ampoules therein. The core or center of sheet metal, usually aluminum, is much better suited for cold forming. There is currently a strong demand that products molded in ampoule films as described above carry some indelible marking.

To meet this demand, a hot-formed bulb can be adapted to carry indications on its inner surface, then such indications are reflected on the respective surface of the molded product. In the international patent application filed today with priority date of the British patent applications Nos. 9717491.6 and 9718382.6 have been treated the difficulties of creating indications on the base of an ampoule formed with a laminated sheet of the kind with which this invention it is concerning, simultaneously with formation of an ampoule itself. In that request, the problem is solved by creating the indications in the second stage of the two-stage process in the first of which the ampule is formed. In accordance with the present invention, these two steps are carried out in the single step of the pill or bulb-forming pin by effectively controlling the manner in which the laminated film is stretched to form the ampule. According to the invention, the bulb is cold formed by advancing a bolt in a transverse direction relative to the plane of the film towards and in engagement with a plate carrying an indicator-forming dye thereon. The end face of the bolt is formed with a mold for the indications, complementary with the dye and the movement from the bolt to the plate - pull and stretch. the film predominantly from around the ampule, thereby minimizing the stretching of the film at the base of the ampule. As a consequence, the film at the base of the bulb requires less recovery time before it is again stretched to form the indications, which can be carried out at the end of the individual step of the punch or bolt. In order to ensure that during the initial movement of the bolt the film is stretched from around the bulb instead of from the base thereof, a slightly greater frictional contact between the periphery of the end face of the bolt and the laminated film It can be created. To some extent, this is accomplished by forming the mold on the end face of the bolt, if around the mold the end face is substantially flat. However, the effect can be improved by forming the end face of the pin around the slightly concave mold, whereby a peripheral edge is created, which provides some additional grip or hold. The profile of the bolt itself will of course also substantially influence the manner in which the film is stretched as the bolt advances towards the plate. It has been found that two or more contiguous frustoconical sections are appropriate, with the apex angle of the frustoconical cone adjacent the end face which is substantially 60 degrees and the apex angle of the frustoconical section contiguous thereto which is about 30 degrees. Other means by which the desired differential stretch of the film as the vial is formed can be obtained by using a different material for the end face of the bolt than that used for the flanks. Preferred materials for the punch or bolt in the methods of the invention are stainless steel or polytetrafluoroethylene (PTFE). When this variant is adopted, the punch or bolt is formed of stainless steel, which also forms the end face, with the flanks of the bolt coated with PTFE. One embodiment of the invention will now be described by way of example and with reference to the accompanying drawings, in which Figures 1 to 4 show the progressive steps in forming an ampoule in a laminated film of the kind with which the invention It is concerning. In Figure 1, a punch or bolt 2 is shown on a laminated film 4 of the kind described in published European patent specifications Nos. 0647367 and 0710101, such film 4 comprises a metal sheet with a polymeric layer either on one side or the other of it. Towards the lower end of the bolt 2, as shown, there are two contiguous frustoconical flanks 6 and 8 which are inclined towards an end face 10 in which the mold is formed so that the indications are created at the base of the ampule. The film 4 is fastened in a known manner and as shown in Fig. 2, the bolt 2 advances against it towards a plate 12 carrying an indicator-forming dye therein. During the initial stage shown in Fig. 2, the stretching is relatively "uniform, but the periphery of the end face 10 is of course making contact with the film 4 under a progressively greater pressure, so as the punch advances to its In the final position shown in Figure 3, the stretching at the base of the ampoule that is formed is minimized, the film is stretched from the areas around the ampule, as a consequence, indications can be formed at the base of the ampoule as the bulb itself is created, during the final movement of the point pin against the plate 12. This is commonly within the last millimeter of movement of the punch or bolt, usually within the last 0.3 to 0.5 mm of it. depth within these ranges.

Figure 4 shows the punch or bolt 2 being withdrawn and illustrates the resilient response of the laminated film arising from the plate 12. It will be noted that the plate 12 and the surrounding base 16 defining the hollow in which the ampule is created does not they form by themselves a mold against which the laminated film is driven. The punch or pin 2 determines the entire shape of the vial itself, only the indications are formed positively from both sides. It should be understood that the invention is concerned with the application of indications to be reflected on the respective surface of the molded product in the broadest sense of the term. Thus, any form of marking is included and particularly a marking that has a purely functional purpose, such as the creation of break lines. Rupture lines are commonly used in tablets for oral administration where there is occasional need for only a portion of a tablet to be taken at a particular time. Thus, the invention has particular value in the formation on one face of a molded product in a vial of indications or markings that takes the form of or includes a line of rupture. In this regard, it will be appreciated that a break line can be effectively formed by a sequence of depressions or slits; it does not have to be a Slit continues in all circumstances. What is important is that a line of weakness is formed that allows the molten product to be easily broken into two or more pieces as defined by the line or lines of rupture. It is noted that, in relation to this date, the best method known to the applicant to carry out the aforementioned invention, is that which is clear from the present description of the invention.

Claims (6)

1. CLAIMS Having described the invention as above, it is claimed as property, contained in the following claims: 1. A method for forming a laminated film comprising a metal sheet and a polymeric layer either on one side or another of the sheet, With at least one ampule, the base of which carries prominent indications for molding to a body molded therein, the method is characterized in that it comprises the cold forming of the ampule when advancing a pin in a transverse direction relative to the plane of the film towards and in coupling with a plate bearing an indicator-forming dye therein, the end face of the bolt is formed with a mold for indications, complementary to the dye, wherein the movement of the bolt towards the plate attracts and stretches the film from around the vial and minimizes stretching of the film at the base of the vial.
2. 2. A method in accordance with the claim 1, characterized in that the end face of the bolt is formed of a material different from that which forms the flanks thereof.
3. 3. A method according to claim 1 or 2, characterized in that the flank or flanks of the bolt are trained to get in contact progressively with the film of the extreme face.
4. 4. A method according to claim 3, characterized in that the bolt is formed with at least two contiguous frusto-conical sections adjacent to the end face of the bolt.
5. A method according to any of the preceding claims, characterized in that the end face of the bolt around the mold is substantially flat.
6. 6. A method according to any of claims 1 to 4, characterized in that the end face of the pin around the mold is concave and forms a peripheral edge.