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(11) | EP 1 859 771 A1 |
| (12) | EUROPEAN PATENT APPLICATION |
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| (54) | Low-compatible active principles in bipartite bag |
| (57) A pharmacological product (1) comprising: a container (2) in the form of bipartite
bag, having a first (21) and a second (22) separate housing, arranged side-by-side;
a first opioid (31) received in the first housing (21); and a second NSAD - Non-Steroidal
Analgesic Drug - (32) mixable with the first one (31) and received in the second housing
(22), wherein the container (2) further has a dividing septum (23) of the first (21)
and second (22) housing, apt to be permanently torn by exerting a pressure externally
to the container itself (2) so as to interconnect the first (21) and the second (22)
housing and cause a mixing of the respective active principles (31, 32) within the
container (2) (Figure 1).
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[0001] The present invention refers to a pharmacological product comprising a container for special pharmacological fluids receiving in separate compartments two or more active principles.
[0002] Post-surgery, a patient is usually administered an analgesic cocktail apt to relieve postoperative pain. Such a cocktail is usually obtained with a mixture of two active principles, typically an opioid and a Non-Steroidal Analgesic Drug (so-called NSAD), that are to be suitably diluted and mixed extemporarily at the time of administration, since their mixture is less than stable over time. Such an administration may occur in the form of distinct repeated intravenous (IV) boli performed with a syringe, one per each patient's request during the postoperative course, or by continuous infusion (phleboclysis, best by electronic or elastomeric pump).
[0003] However, the modes providing repeated IV boli to be administered entail several relevant drawbacks. First of all, the repeated performing of boli causes a discontinuous intervention on the pain peak, by administering an amount of drug that however is generally higher than that theoretically necessary to keep pain itself at acceptable intensity levels. Moreover, the active principles to be mixed are typically contained in very low-dosage phials, (generally 1-ml ones). Accordingly, for each administration the health worker should break and pour a high number of phials, with evident risks of environmental contamination of the end solution, due also to the danger that glass shards, deriving just from the breaking of the phials, get thereinto. Additional problems may be accidental cuts and preparation errors.
[0004] Therefore, the technical problem underlying the present invention is that of providing an analgesic cocktail in an adequate pharmaceutical form, allowing to overcome the drawbacks mentioned above with reference to the known art.
[0006] The present invention provides several relevant advantages. The main advantage lies in that the packaging of the analgesic cocktail in bipartite bag allows to obtain an extemporary solution with optimal properties without the risks associated to current preparation modes.
[0007] Other advantages, features and the operation modes of the present invention will be made apparent in the following detailed description of some embodiments thereof, given by way of example and not for limitative purposes. Reference will be made to the figures of the annexed drawings, wherein:
- Figure 1 shows a partially sectional front perspective view of a pharmacological product according to a first embodiment of the invention;
- Figures 2 and 3 show each a respective perspective view of the product of Figure 1 during a clinical use thereof;
- Figure 4 shows a further perspective view of the product of Figure 1 during the tearing of its pack prior of the clinical use thereof.
[0008] Referring to Figure 1, a pharmacological product according to a first embodiment of the invention is generally denoted by 1.
[0009] Product 1 comprises a container 2 substantially in the form of bipartite bag that has just a first and a second separate housing, denoted by 21 and 22, respectively, arranged side-by-side.
[0010] Each of the two housings 21 and 22 contains a respective pharmacological fluid. In particular, the first housing 21 contains a first active principle 31 of opioid type preferably selected from a group comprising tramadol and morphine, and the second housing 22 contains a second Non-Steroidal Analgesic Drug (NSAD)-type active principle 32- mixable with the first one and preferably selected from a group comprising ketorolac.
[0011] Said housings 21 and 22 are separated by a dividing septum 23, which is preferably formed by two opposite walls of the container 2 joined by hot-sealing.
[0012] As it is shown in Figure 2, the septum 23 is apt to be permanently torn by exerting a pressure externally to the container 2 itself so as to interconnect the housings 21 and 22 and cause a mixing of the respective active principles 31 and 32.
[0013] Preferably, the container 2 is externally and internally sterile and see-through and made of a bilaminate material bearing an internal layer, i.e. into contact with the active principles 31 and 32, of polypropylene and an external layer in polyvinyl chloride (PVC). Thus, the container 2 provides to the touch the plastic quality of PVC and keeps the optimal properties of compatibility with the active principles 31 and 32 of polypropylene.
[0014] As it is shown in greater detail in Figure 3, the container 2 has a self-sealing element 4, per se known, apt to allow the single-dose (at one time) or repeated extraction of the cocktail, by a needle or the like.
[0015] Moreover, the container 2 has an inserting or collecting element 5 for a multiple-collection connector 6, it also per se known. The connecting element 5 is in the form of a channel making a seat for the connector 6 and connecting the internal housings of the container 2 itself to the outside. As in other bags per se known, such a channel has a transversal septum apt to be torn at the first use, by a mere folding of, or pressure onto the channel-shaped seat.
[0016] At the packaging of the product 1, the container 2 is completely enclosed in a preferably sterile first external wrapper 7, which is removed at the time of use of the product 1 itself. For this purpose, the wrapper 7 may have a preferential tearing region 71.
[0017] Preferably, the external wrapper 7 is see-through, so as to allow the view of the container 2 and of the active principles 31 and 32, and made of polypropylene.
[0018] Moreover, product 1 provides a further external wrapper 8, which encloses the first wrapper 7 and is it also removable at the time of using the product 1 itself. The second wrapper 8 is apt to shield the active principles 31 and 32 from light and environmental contaminations, and is preferably made of aluminium. It also may have a preferential tearing region.
[0019] Of course, variant embodiments could provide the use of only one of the two above-described wrappers 7, 8. However, the provision of a double wrapper shielding the actual container 2 from contact with the environment assures an optimal preservation of the active principles 31 and 32 and their use under perfectly sterile conditions.
[0020] Product 1 is usually provided with the connector 6 being separate, so as to allow an autoclave sterilizing of the container 2 and of the wrappers 7 and 8.
1. A pharmacological product (1) comprising:
- a container (2) substantially in the form of bipartite bag, having a first (21) and a second (22) separate housing, arranged side-by-side and each apt to receive a respective pharmacological fluid;
- a first opioid active principle (31) received in said first housing (21); and
- a second NSAD - Non-Steroidal Analgesic Drug - (32) mixable with the first one (31) and received in said second housing (22),
wherein said container (2) further has a dividing septum (23) of said first (21) and second (22) housing, apt to be permanently torn by exerting a pressure externally to the container (2) itself so as to interconnect said first (21) and second (22) housing and cause a mixing of said respective active principles (31, 32) within said container (2).2. The product (1) according to claim 1, wherein said first opioid active principle (31)
is selected from a group comprising tramadol and morphine.
3. The product (1) according to claim 1 or 2, in cui wherein said second active principle
(32) is selected from a group comprising ketorolac.
4. The product (1) according to any one of the preceding claims, wherein said container
(2) is transparent.
5. The product (1) according to any one of the preceding claims, wherein said container
(2) is made of a bilaminate material.
6. The product (1) according to the preceding claim, wherein said container (2) has an
internal layer, into contact with said active principles active principles (31, 32),
of polypropylene.
7. The product (1) according to claim 5 or 6, wherein said container (2) has an external
layer of PVC.
8. The product (1) according to any one of the preceding claims, wherein said container
(2) is sterile.
9. The product (1) according to any one of the preceding claims, wherein said container
(2) comprises a self-sealing element (4) apt to allow the repeated extraction of said
active principles (31, 32) by a needle.
10. The product (1) according to any one of the preceding claims, wherein said container
(2) comprises a connecting element (5) for a multiple-collection connector (6).
11. The product (1) according to the preceding claim, wherein said connecting element
(5) has a transversal septum (51) apt to be torn at the first use.
12. The product (1) according to any one of the preceding claims, further comprising a
multiple-collection connector (6) for the extraction of said active principles (31,
32).
13. The product (1) according to any one of the preceding claims, comprising an external
wrapper (7; 8) that completely shields said container (2) from contact with the environment
and is removable at the time of use.
14. The product (1) according to the preceding claim, wherein said external wrapper (7)
is sterile.
15. The product (1) according to claim 13 or 14, wherein said external wrapper (7) is
made of polypropylene.
16. The product (1) according to any one of the claims 13 to 15, wherein said external
wrapper (8) is apt to shield said container (2) from light.
17. The product (1) according to any one of the claims 13 to 16, wherein said external
wrapper (8) is made of aluminium.
18. The product (1) according to any one of the claims 13 to 15, wherein said external
wrapper (7) is transparent.
19. The product (1) according to any one of the preceding claims, comprising a first wrapper
(7) enclosing said container (2) and a second wrapper (8) enclosing said first wrapper
(7) and shielding it completely from contact with the environment, both said wrappers
(7, 8) being removable at the time of use.
20. The product (1) according to the preceding claim, wherein said first wrapper (7) is
transparent.
21. The product (1) according to claim 19 or 20, wherein said first wrapper (7) is sterile.
22. The product (1) according to any one of the claims 19 to 21, wherein said second wrapper
(8) is apt to shield said container (2) from light.
23. The product (1) according to any one of the claims 19 to 22, wherein said second wrapper
(8) is made of aluminium.