package

Abstract

To provide a bottle that ensures a proper air pressure inside thereof.SOLUTION: A package features an outer bag 1 with an inner chamber 2, which chamber includes therein: a bottle 5 of a medicinal or nutritional substance 6 with a neck 7 and a pierceable cap 8; and a device 9 for withdrawal and / or reconstitution of the medicinal or nutritional substance. The device comprises: a perforation needle 13 configured to be axially movable with respect to the bottle; and an outflow tube 15 extending out of the bag 1 and equipped with an openable closure 17. The perforation needle is crossed longitudinally by a first channel 18 connecting, after perforation of the cap and with the closure set open, the inside of the bottle to the outflow tube, and a second channel 19 which has a side opening 20 equipped with a hydrophobic filter 21 and is configured to allow, after perforation of the cap, only air or other gaseous fluids to flow from inside the bottle into the inner chamber of the bag or vice versa.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to aseptic or sterile packages (either initially sterile or post-sterilized) for the delivery of pharmaceutical or nutritional substances. [Background technology]

[0002] Aseptic or sterile packages suitable for administration of pharmaceutical or nutritional substances are known, and examples of such packages are disclosed in US Pat.

[0003] In such packages, an outer flexible bag having a sterile or aseptic inner chamber contains a bottle of pharmaceutical or nutritional substance having a pierceable cap in an inverted position and an underlying introduction and withdrawal device, and is provided with a device for connecting with the bottle cap and a device for piercing the cap, as well as a tube with an openable closure extending from the bag.

[0004] The tube may be inserted directly into a flexible bag filled with a liquid diluent to be mixed with the substance withdrawn from the bottle and placed underneath (Patent Documents 1 and 2), or it may have a (male or female) connector at the end which can be connected to a complementary (female or male, respectively) connector of a flexible bag filled with a liquid diluent to be mixed with the substance withdrawn from the bottle and placed underneath, or to a syringe for withdrawal and / or reconstitution of pharmaceutical or nutritional substances contained in the bottle, or to a two-way tap which, depending on the adjustment, connects the connector of the upper bag to a syringe placed on one side of the bag or connects the syringe to the connector of the bag placed underneath, in order to make it possible to mix the substances in the bottle and the lower bag into a dosage (Patent Documents 3 and 4). [Patent Document 1] European Patent No. 2962676 [Patent Document 2] European Patent No. 3158987 [Patent Document 3] European Patent Application Publication No. 3545935 [Patent Document 4] Italian Utility Model Publication No. 2020160000582078 Summary of the Invention [Problem to be solved by the invention]

[0005] In all of the above uses, the same problem exists, namely, maintaining a pressure differential between the interior of the bottle (above the level of the liquid contained therein) and the outflow from the tube with the connector open, so as to cause the substance to flow out of the bottle without the need for external manual pressure on the bag containing the bottle.

[0006] It is an object of the present invention to provide a package that addresses the above-mentioned problems in a simple and safe manner that functions in a closed system and under sterile conditions, without resorting to measures that imply the use of additional instrumentation. [Means for solving the problem]

[0007] To this end, the invention relates to a package for the administration of pharmaceutical or nutritional substances, comprising an outer bag with a sterile or aseptic inner chamber housing a bottle of pharmaceutical or nutritional substances with a pierceable cap in an inverted position and a device for the extraction and / or reconstitution of the substances contained in the bottle, which is placed under the cap of the bottle and can be suspended on the neck of the bottle, the device comprising a needle for piercing the cap of the bottle, which is axially movable relative to the bottle, and an outflow tube extending from the bag, which has an openable closure element, characterized in that the piercing needle is longitudinally pierced by a first channel connecting the interior of the bottle to the outflow tube after piercing the cap and in the open state of the closure element, and a second channel with a hydrophobic filter and a side opening configured to allow only air or other gaseous fluids to flow from the interior of the bottle into the inner chamber of the bag or vice versa after piercing the cap. Effect of the Invention

[0008] When the needle penetrates the cap of the bottle and the closure element of the outflow tube is opened, the pressure difference generated by the above-mentioned structure causes the pharmaceutical or nutrient substance to exit the bottle through the tube and then enter the bag or syringe to which the tube is connected. At this stage, the channel with the side opening equipped with a hydrophobic filter ensures the appropriate air pressure inside the bottle. [Brief description of the drawings]

[0009] [Figure 1] 1 illustrates a package according to the present invention in an initial sealed state. [Diagram 2] 2 shows an extraction and / or reconstitution device used in the package of FIG. 1 to connect and pierce the cap of a bottle of pharmaceutical or nutritional substance placed in an inverted position inside a flexible bag. [Diagram 3] 2 shows the package of FIG. 1 during administration of a pharmaceutical or nutritional substance. [Figure 4] 2 illustrates different adoption options for a package such as that shown in FIG. 1; [Diagram 5] 13 is a first example of a processing sequence for mixing a substance contained in a bottle with that contained in a lower bag using a two-way tap and syringe. [Figure 6] 13 is a second example of a processing sequence for mixing a substance contained in a bottle with that contained in a lower bag using a two-way tap and syringe. [Figure 7] 13 is a third example of a processing sequence for mixing a substance contained in a bottle with that contained in a lower bag using a two-way tap and syringe. [Figure 8] 13 is a fourth example of a processing sequence for mixing a substance contained in a bottle with that contained in a lower bag using a two-way tap and syringe. [Figure 9]5 is a fifth example of a processing sequence for mixing a substance contained in a bottle with that contained in a lower bag using a two-way tap and syringe; DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] Possible embodiments and their applications are illustrated and explained by way of non-limiting examples in the accompanying drawings, in which:

[0011] The package shown in Figure 1 features an outer aseptic or sterile flexible bag 1, for example sterilized using a mixture of ozone or other sterilizing gas and oxygen delivered through a tube 3 equipped with a connector 4 (e.g. of the type with an airtight open / close cap as described in EP 2 667 839 B1), an inner chamber 2 is shown containing an inverted bottle 5 of a pharmaceutical or nutritional substance 6 having a neck 7 and a sealed (openable and automatically airtight releasable) cap 8 at a connecting position, and an extraction and / or reconstitution device 9 suspended over the neck 7 of the bottle 5 and operable from outside the bag 1 to pierce the cap 8 of the bottle 5. The dotted line L generally indicates the water level of the substance 6 inside the bottle 5.

[0012] FIG. 2 shows an enlarged view of the device 9, which is composed of an upper body 10 provided with a flap 11 that can be suspended on the neck 7 of a bottle 5, and a lower body 12 connected to the upper body 10 in an axially sliding manner, comprising a perforation needle 13 with an upwardly projecting perforation tip 14 and a bottom shank 34 sealed within a flexible outflow tube 15 ending in a hermetically openable and automatically releasable end connector 16 (of the kind with an airtight open / close cap as described in EP 2 667 839) and terminating in a frangible closure element 17.

[0013] The piercing needle 13 has two parallel channels 18 and 19 running longitudinally therethrough, the former of which is open at the upper end and closed at the lower end by a frangible element 17, and the latter of which is open at the upper end and permanently communicates with the inner chamber 2 of the bag 1 through a side opening 20 provided with a hydrophobic filter 21 which allows the passage of air and other gaseous fluids but prevents the passage of liquids.

[0014] In the initial state illustrated in FIG. 1, when the lower body 12 of the device 9 is positioned downwardly from the upper body 10 of the device 9, the air or other sterile mixture contained inside the inner chamber 2 of the bag 1 is present outside the bottle 5 which in turn contains the pharmaceutical or nutritional substance 6 in a sealed environment.

[0015] As shown in FIG. 3, when the bottle 5 is pushed from the outer bag 1 towards the lower body 12 of the device 9, the tip 14 of the needle 13 pierces the cap 8 of the bottle 5, thereby connecting the channels 18 and 19 to the interior of the bottle 5.

[0016] This allows the flow of air or other sterile mixture through the hydrophobic filter 21, side opening 20 and upper channel 19 into the bottle 5, and upon rupture of the frangible closure 17, the pharmaceutical or nutritional substance 6 will flow by differential pressure out of the bottle 5, down the outlet tube 15 via channel 18 to the connector 16 and from there to an external user device (such as a syringe for withdrawal and / or reconstitution or a further collection bag). The filter 21 prevents the substance 6 from flowing out the side opening 20.

[0017] As shown in FIG. 4, the user device may be an injection or withdrawal syringe 22 having a luer 23 for an opening in the connector 16, a similar injection or withdrawal syringe 24 having a luer 25 and a luer lock device 26, or a simple input or collection bag 27 having a connector 28 having a complementary shape to the connector 16 (or which connects to the outflow tubing 15 of the bag 1), and a two-way diversion tap 29 placed between the connector 16 and a complementary connector 30 on the lower bag, which may be connected to a withdrawal and reconstitution syringe.

[0018] This latter application is shown in detail in Figures 5-9, where items corresponding to those in Figures 1-4 are referenced with the same numbers.

[0019] As shown in FIG. 5, between two bags 1 and 31 (the former containing a pharmaceutical or nutritional substance 6, the latter filled with a suitable liquid diluent 35 (or other liquid substance that can be mixed with the pharmaceutical or nutritional substance 6) and equipped with an inlet tube 51 with a connector 53 and an outlet tube 52 with an openable cap 54) a two-way tap 29 with three nozzles, each with a connector (36, 38, 32) is placed. The first connector can be connected to the connector 16 of the bag 1, the second connector can be connected to the connector 30 of the bag 31, and the third connector is normally sealed but may be open-pierced with a syringe 40 with a sliding plunger 41 and a luer 42 at its end. The tap 29 is adjustable to two positions by operating a rotating component 39. The connection between the tap 29 and the bags 1 and 31 may be permanent and not via the connectors 16, 36 and 30, 38.

[0020] In this case, the tap 29 is adjusted before use to prevent communication with the lower bag 31 while the tube 15 is closed by the closure 17, as shown in FIG.

[0021] To mix the dose of medicinal or nutritional substance 6 with diluent 35, a syringe 40 with plunger 41 pushed all the way in as in Figure 5 is connected to the tap 29 by inserting the luer 42 inside the connector 32, then the rotating component 39 of the tap 29 is rotated to a position that prohibits communication with the tube 15 and opens the connection to the inner chamber of the bag 31, and then the syringe plunger 41 is pulled back until the dose of diluent 35 is withdrawn from the bag 31 (Figure 6).

[0022] The tap 29 is then adjusted to stop communication with the inner chamber of the bag 31, breaking the frangible closure 17 to open the connection between the inner channel 18 of the needle 13 and the tube 15, and the tip of the needle 13 is forced into the cap 8 of the bottle 5 by pressing down on the bottle 5 (Figure 7). The plunger 41 of the syringe 40 is then pressed to deliver the amount of diluent withdrawn from the bag 31 into the bottle 5, creating a mixture 50 of the pharmaceutical or nutrient substance 6 and the diluent 35 therein (Figure 7). At this stage, the air inside the bottle 5 is forced to flow out of the bottle 5 through the channel 19 and the side opening 20 into the inner chamber 2 of the bag 1. The hydrophobic filter 21 allows the flow of air while preventing the flow of the substance 6 or the mixture 50.

[0023] Again, the tap 29 is placed in the position described above, after which a dose of mixture 50 is withdrawn from the syringe 40 by pulling back on the plunger 41, as illustrated in Figure 8. Air that has been forced into the inner chamber 2 of the bag 1 can return to the bottle 5 via the opening 20 with the hydrophobic filter 21 and the channel 18 of the needle 13.

[0024] The tap 29 is then set to a position that closes the tube 15 and opens communication with the inner chamber of the bag 31, and the plunger 41 is depressed to deliver the dose of mixture 50 previously withdrawn from the bottle 5 into the bag 31 (Figure 9). The bag 31 is now ready for use. [Explanation of symbols]

[0025] 1 outer bag 2 Inner chamber 5 Bottles 6. Pharmaceutical or nutritional substances 7 Neck 8 Cap 9 Equipment 10 Upper body 12 Lower body 13 Puncture needle 15 Outflow Tube 16 End Open / Close Connector 17 Closure Elements 18 Channel 1 19 Channel 2 20 Side opening 21 Hydrophobic Filter 22 Open Syringe 24 Open Syringe 27 Collection Bag 29 Two-way tap 31 More Bags 32 Side Open / Close Connector 34 Bottom Shank 35 Liquid substances 36 Connectors 38 Connectors 40 Open Syringe 41 Plunger

Claims

1. an outer bag (1) with a sterile inner chamber (2); a bottle (5) of pharmaceutical or nutritional substances (6) with a neck (7) and a pierceable cap (8) placed inverted within said inner chamber (2); a device (9) configured to be suspended (7) on the neck of the bottle (5) and to extract or reconstitute the pharmaceutical or nutritional substance (6) contained in the bottle (5), the device comprising a piercing needle (13) configured to move axially relative to the bottle (5) and to pierce the cap (8) of the bottle (5) and a bottom shank (34) extending from a base of the piercing needle (13); and an outflow tube (15) receiving said bottom shank (34) and extending outside said outer bag (1). the bottom shank (34) is provided with a closure element (17) that can open into the passage of the outflow tube (15); The piercing needle (13) has a first channel (18), a second channel (19), and a hydrophobic filter (21); the first channel (18) extends longitudinally from the bottom shank (34) through the piercing needle (13) and provides a fluid communication between the interior of the bottle (5) and the conduit of the outflow tube (15) when the piercing needle (13) has pierced the cap (8) and the closure element (17) is open; the second channel (19) passes through a side opening (20) of the piercing needle (13) to the tip of the piercing needle (13), the side opening (20) being located at the base of the piercing needle (13) above the bottom shank (34) and opening directly into the inner chamber (2) of the outer bag (1); a hydrophobic filter (21) is provided at the side opening (20) of the piercing needle (13) so that after the piercing needle (13) pierces the cap (8), only gas fluid flows between the interior of the bottle (5) and the inner chamber (2) of the outer bag (1); The device (9) comprises: an upper body (10) having a flap (11) that can be suspended on the neck (7) of the bottle (5); a lower body (12) having the piercing needle (13) and the bottom shank (34) and slidably connected to the upper body (10); The package is characterized in that when the perforation needle (13) moves axially upward relative to the bottle (5) and perforates the cap (8) of the bottle (5), the base of the perforation needle (13) extends below the upper body (10).

2. 2. The package according to claim 1, characterized in that the outflow tube (15) terminates in an end connector (16) adapted to open and close the end of the outflow tube (15).

3. 3. The package of claim 2, wherein the end connector (16) is adapted to connect to an open-ended syringe (22, 24).

4. A package according to any one of the preceding claims, characterized in that the outer bag (1) is made of a flexible material.

5. The package according to any one of claims 1 to 4, characterized in that the outer bag (1) comprises a tube (3) with an airtight connector (4) configured to be opened and closed for introducing an ozone or sterilizing gas mixture into the inner chamber (2) of the outer bag (1).

6. a second bag (31) positioned below the outer bag (1) and configured to contain a liquid substance (35) to be mixed with the pharmaceutical or nutritional substance (6); a two-way tap (29) mounted between the outer bag (1) and the second bag (31) and provided with a side connector (32) to which an open-ended syringe (40) having a sliding plunger (41) can be connected; 6. The package according to claim 1, wherein the two-way tap (29) is adapted to be adjusted between a first position, which prohibits communication between the side connector (32) and the second outlet tube of the second bag (31), and a second position, which prohibits communication between the side connector (32) and the outlet tube (15) of the outer bag (1).

7. 7. The package according to claim 6, characterized in that the two-way tap (29) has a first connector (36) connected to an end connector (16) of the outflow tube (15) of the outer bag (1) and a second connector (38) connected to an end connector (30) of the second outflow tube of the second bag (31).

8. 7. A package according to claim 6, characterized in that the two-way tap (29) is always connected to the outlet tube (15) of the outer bag (1) and to the second outlet tube of the second bag (31).

9. A package according to any one of claims 1 to 2 and 4 to 5, further comprising a collection bag (27) positioned below and in communication with the outer bag (1).

Images