Patent Publication Number: US-5833089-A

Title: Packaging for the extemporaneous preparation of drug products

Description:
BACKGROUND OF THE INVENTION 
     This invention concerns an improvement in packaging items intended for the extemporaneous preparation of suspensions or solutions of an active product, generally solid, in a liquid product. The container includes separate hermetically closed flasks, with means of connection serving to establish communication between these two flasks. Thus, in a first step, the liquid is permitted to pass from the first flask in which it is contained to a second flask which contains the solid. In a second step, the solution or suspension thus formed is reaspirated into the first flask. 
     The means of connection may comprise a single plastic molded part having an upper portion threaded internally so that it can be screwed onto the neck of the second flask containing the solid product. The second flask is closed by an elastomer stopper having an axial perforation and closed by a valve which can be perforated and having on the inside a shoulder intended to snap onto one or more circular collars of the neck of the second flask. 
     Such a device is described in U.S. Pat. No. 4,986,322 (European Patent No. 0238629) in the name of the Applicant, said patent being incorporated herein by reference. It presents the feature of having, simply fitting of the upper orifice of this molded part, a protective plastic cap which covers this part after crimping or snapping on the second flask containing the solid. 
     However such a cap represented a substantial cost because it was necessary not only to produce it separately from the threaded part, but also to sterilize it and finally to fit it on the upper orifice of this part. 
     Moreover, this part was simply fitted on; it was not inviolable and nothing in fact guaranteed the user that this protection had not been removed and then replaced, thus making the sterilization of no value. 
     Thus, one of the aims of the invention is to furnish such a device which can be produced almost automatically, and more economically, and operated easily. 
     The goals, as well as others which will appear in the following description, are attained by a packaging device such as described above which is characterized, according to this invention, by the fact that the upper portion is closed hermetically by a cover molded of a single piece with the connecting part and comprises means of manual rupture to release the upper orifice of this upper portion at the moment of utilization. 
     Preferably, the means of manual rupture of the cover comprises a vertical tab intended to undergo the horizontal pressure of the user, and a strut intended to convert this pressure to a vertical tension which, by lever effect on the disk, causes a tearing of the weak zone connecting the disk and the portion of the part and the breaking of a point of connection of this disk on this upper portion. 
     SUMMARY OF THE INVENTION 
     In one embodiment of the invention, the zone of weakness is located at the foot of the tab and the breaking point of connection is at the base of the strut. 
     In another embodiment, the zone of weakness is located at the base of the strut and the breaking point is at the foot of the tab. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     The foregoing and other objects and advantages of the invention will be appreciated more fully from the following description, which is intended to be illustrative and not limiting, with reference to the attached figures among which: 
     FIG. 1 is a vertical section of the flask containing the solid, on which snaps the connecting part according to the prior art. 
     FIG. 2 illustrates a similar connecting part according to the present invention. 
     FIG. 3 is a top view of FIG. 2. 
     FIGS. 4A, 4B and 4C illustrate a first embodiment of the connecting part according to the invention. 
     FIGS. 5A, 5B and 5C illustrate a second embodiment of the connecting part according to the invention. 
    
    
     DETAILED DESCRIPTION OF THE DRAWINGS 
     Referring first to FIG. 1, one sees a flask A, similar to flask A of the aforementioned European patent, and intended to contain a freeze-dried solid P which is to be set in solution in a liquid contained in a second flexible flask (not represented) when this second flask is made to communicate with the previous one thanks to a connecting part designated by the general reference 1. 
     As in the prior European patent, this connecting part comprises an upper portion 2 and a lower portion 3, made in a single piece by molding a plastic material, for example, polyethylene. 
     The upper portion 2 is threaded at 5 so that it can be screwed on the second flask containing the liquid and the lower part 3 snaps at 4 on the shoulder of the neck of the flask A. 
     All these features are known from the aforementioned European patent and it is therefore not necessary to describe them in further detail. 
     In the prior execution, a separate cap 6 is snapped onto the upper orifice of portion 2. 
     The flask A containing the freeze-dried product P is closed by an elastomer stopper 7 which is perforated at 8 and surmounted by a valve 9 made of an aluminum/polyethylene composition suitable for perforation was thus supplied to the user equipped with the part 1 covered by the cap 6. 
     As a result, even if the product P was well preserved in sterile conditions, the interior space of part 1 remained sterile only as long as the cap 6 was kept in place and snapped in a sealed manner. If, for any reason, the cap 6 was removed and then replaced, it was possible for any polluting impurity to penetrate the interior space, then to be introduced in the flask A with the liquid at the moment the valve 9 was perforated. 
     Referring to FIG. 2, in order to avoid this danger, according to the invention, the top of the portion 2 is closed by a cover or disk 10, which may be molded in a single part with the connecting part 1 and which, also according to the invention, can easily be broken by a push of the thumb against an off-centered vertical tab 11 connected to the cover 10 by a strut 12. 
     A breakable point of attachment 14 or 114 (see FIGS. 5a and 5b) situated between the disk 10 and the part 1 serves as a pivot to avoid the penetration of the disk inside the upper portion 2 of the part 1. 
     This point of attachment is easily broken by a rotary movement of the cover 10. 
     According to one embodiment of this device such as represented in FIGS. 4A, 4B and 4C, by exerting a horizontal pressure against the tab 11 in the direction indicated by the arrow F 1, the zone of weakness 13, situated at the base of this tab 11, in the connection of the cover 10 with the upper portion 2 undergoes an onset of breakage and the disk 10 descends slightly in the direction of this thrust (FIG. 4A). 
     By a slight pressure in the opposite direction in the direction of the arrow F 2 (FIG. 4B), the zone of weakness 13 tears completely about the disk 10 while remaining ultimately attached to the edge by a breakable point of attachment 14. 
     The user now only has to detach this cover 10 by a simple movement of rotation F 3 which causes this point of attachment 14 to break. 
     By the fact of the breakage of the zone of weakness 13 and of the point of attachment 14, the disk 10 (FIG. 4C) is totally released and the orifice of the upper portion 2 of the part 1 is free, thus making it possible to screw a second flask in the threading 5, as is known. 
     The strut 12, which is fixed and preferably unitary with the disk 10 and the tab 11, serves to convert the horizontal pressure exerted on the tab 11 to a vertical traction on this disk; this causes tearing of the zone of weakness 13 connecting the disk 10 to the connecting part 1. 
     According to a second embodiment of the invention represented in FIGS. 5A, 5B and 5C, in which the elements identical to those of FIGS. 4A, 4B and 4C bear the same reference numbers, a horizontal pressure is exerted against the top of the tab 11, in the direction of the arrow F 4  so as to create an onset of breakage in the zone of weakness 113 which is situated at the base of the strut 12. 
     Continuing the thrust in the direction of the arrow F 4 , the zone of weakness 113 breaks, thus allowing the disk 10 (FIG. 5B) to pivot about the point of attachment 114 located at the base of the tab 11. The disk 10 remains attached to the edge of the part 1 by the point of connection 114. The user now has only to detach this cover 10 by a simple movement of rotation, in the direction of the arrow F 5 , which causes the rupture of this breakable point of attachment 114. 
     As represented in FIG. 5C, the disk 10 is totally detached. The orifice of the upper portion 2 of the connecting part 1 is therefore free, thus making it possible to screw a second flask in the threading 5, as is known. 
     In this embodiment, the strut 12, which is fixed to and preferably unitary with the disk 10 and the tab 11, makes it possible to retain this tab 11 in a position substantially perpendicular to the disk 10 throughout the opening phase: it thus converts the horizontal pressure exerted against the tab 11 in a vertical traction on the disk 10, as in the first mode of execution. 
     As has been mentioned before, such a device affords the following advantages, namely: 
     the molding in a single piece represents a saving; 
     the interior sterility of the part is maintained until and during the utilization of the device; 
     the installation of the part can be made completely inviolable; and 
     the closing element of the part is both inviolable, since it must be broken before the device can be utilized, and easy.