WO2008001237A2 - Low-compatible active principles in bipartite bag - Google Patents
Low-compatible active principles in bipartite bag Download PDFInfo
- Publication number
- WO2008001237A2 WO2008001237A2 PCT/IB2007/051969 IB2007051969W WO2008001237A2 WO 2008001237 A2 WO2008001237 A2 WO 2008001237A2 IB 2007051969 W IB2007051969 W IB 2007051969W WO 2008001237 A2 WO2008001237 A2 WO 2008001237A2
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- product
- container
- wrapper
- housing
- apt
- Prior art date
Links
- 230000000144 pharmacologic effect Effects 0.000 claims abstract description 8
- 229940035676 analgesics Drugs 0.000 claims abstract description 4
- 239000000730 antalgic agent Substances 0.000 claims abstract description 4
- 239000004743 Polypropylene Substances 0.000 claims description 5
- -1 polypropylene Polymers 0.000 claims description 5
- 229920001155 polypropylene Polymers 0.000 claims description 5
- BQJCRHHNABKAKU-KBQPJGBKSA-N morphine Chemical compound O([C@H]1[C@H](C=C[C@H]23)O)C4=C5[C@@]12CCN(C)[C@@H]3CC5=CC=C4O BQJCRHHNABKAKU-KBQPJGBKSA-N 0.000 claims description 4
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims description 3
- 229910052782 aluminium Inorganic materials 0.000 claims description 3
- 239000004411 aluminium Substances 0.000 claims description 3
- 238000000605 extraction Methods 0.000 claims description 3
- 239000012530 fluid Substances 0.000 claims description 3
- 238000007789 sealing Methods 0.000 claims description 3
- TVYLLZQTGLZFBW-ZBFHGGJFSA-N (R,R)-tramadol Chemical compound COC1=CC=CC([C@]2(O)[C@H](CCCC2)CN(C)C)=C1 TVYLLZQTGLZFBW-ZBFHGGJFSA-N 0.000 claims description 2
- OZWKMVRBQXNZKK-UHFFFAOYSA-N ketorolac Chemical compound OC(=O)C1CCN2C1=CC=C2C(=O)C1=CC=CC=C1 OZWKMVRBQXNZKK-UHFFFAOYSA-N 0.000 claims description 2
- 229960004752 ketorolac Drugs 0.000 claims description 2
- 239000000463 material Substances 0.000 claims description 2
- 229960005181 morphine Drugs 0.000 claims description 2
- 229960004380 tramadol Drugs 0.000 claims description 2
- TVYLLZQTGLZFBW-GOEBONIOSA-N tramadol Natural products COC1=CC=CC([C@@]2(O)[C@@H](CCCC2)CN(C)C)=C1 TVYLLZQTGLZFBW-GOEBONIOSA-N 0.000 claims description 2
- 208000002193 Pain Diseases 0.000 description 3
- 230000000202 analgesic effect Effects 0.000 description 3
- 238000001990 intravenous administration Methods 0.000 description 3
- 238000011109 contamination Methods 0.000 description 2
- 230000007613 environmental effect Effects 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 238000004806 packaging method and process Methods 0.000 description 2
- 239000004800 polyvinyl chloride Substances 0.000 description 2
- 238000002360 preparation method Methods 0.000 description 2
- 208000004550 Postoperative Pain Diseases 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 238000001802 infusion Methods 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 229940127557 pharmaceutical product Drugs 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 229920003023 plastic Polymers 0.000 description 1
- 229920000915 polyvinyl chloride Polymers 0.000 description 1
- 230000002980 postoperative effect Effects 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2093—Containers having several compartments for products to be mixed
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
- A61J1/10—Bag-type containers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/202—Separating means
- A61J1/2024—Separating means having peelable seals
Definitions
- the present invention refers to a pharmacological product comprising a container for special pharmacological fluids receiving in separate compartments two or more active principles.
- a patient is usually administered an analgesic cocktail apt to relieve postoperative pain.
- 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.
- NSAD Non-Steroidal Analgesic Drug
- 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).
- IV intravenous
- 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.
- 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. 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.
- 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.
- FIGS. 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.
- a pharmacological product according to a first embodiment of the invention is generally denoted by 1.
- 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.
- Each of the two housings 21 and 22 contains a respective pharmacological fluid.
- the first housing 21 contains a first active principle 31 of opioid type preferably selected from a group comprising tramadol and morphine
- 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.
- NSAD Non-Steroidal Analgesic Drug
- 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.
- 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.
- 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).
- PVC polyvinyl chloride
- 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.
- 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.
- 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.
- 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.
- the wrapper 7 may have a preferential tearing region 71.
- 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 .
- 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.
Landscapes
- Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Packages (AREA)
- Bag Frames (AREA)
Abstract
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).
Description
LOW-COMPATIBLE ACTIVE PRINCIPLES IN BIPARTITE BAG
Description
The present invention refers to a pharmacological product comprising a container for special pharmacological fluids receiving in separate compartments two or more active principles.
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). 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. 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.
Such a problem is solved by a pharmaceutical product according to claim 1.
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.
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.
Referring to Figure 1, a pharmacological product according to a first embodiment of the invention is generally denoted by 1.
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.
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.
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. 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.
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.
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.
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.
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.
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 .
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.
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.
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. By now, it will have been better appreciated that the invention allows a simpler, more effective and safer management of injectable active principles for pain therapy. The present invention has been hereto described with reference to preferred embodiments thereof. It is understood that other embodiments might exist, all referable to the same inventive kernel, and all comprised within the protective scope of the claims hereinafter.
Claims
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 (J) 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.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP20060425350 EP1859771A1 (en) | 2006-05-24 | 2006-05-24 | Low-compatible active principles in bipartite bag |
| EP06425350.3 | 2006-05-24 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| WO2008001237A2 true WO2008001237A2 (en) | 2008-01-03 |
| WO2008001237A3 WO2008001237A3 (en) | 2008-03-13 |
Family
ID=37038340
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/IB2007/051969 WO2008001237A2 (en) | 2006-05-24 | 2007-05-24 | Low-compatible active principles in bipartite bag |
Country Status (2)
| Country | Link |
|---|---|
| EP (1) | EP1859771A1 (en) |
| WO (1) | WO2008001237A2 (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IT201700120081A1 (en) * | 2017-10-23 | 2019-04-23 | Biofarma S P A | DEVICE AND METHOD FOR ORAL ADMINISTRATION OF ACTIVE PRINCIPLES |
| WO2019082221A2 (en) * | 2017-10-23 | 2019-05-02 | Biofarma S.P.A. | Device and method for oral administration of active principles |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4458811A (en) | 1983-04-21 | 1984-07-10 | Abbott Laboratories | Compartmented flexible solution container |
| GB9319568D0 (en) * | 1993-09-22 | 1993-11-10 | Euro Celtique Sa | Pharmaceutical compositions and usages |
| ZA978002B (en) * | 1996-09-11 | 1998-03-02 | Baxter Int | Containers and methods for storing and admixing medical solutions. |
| WO2000006138A2 (en) * | 1998-07-31 | 2000-02-10 | Vela Pharmaceuticals Inc. | Use of moclobemide for treating pain and other diseases |
| US7175614B2 (en) * | 2002-10-17 | 2007-02-13 | Baxter International Inc. | Peelable seal |
| AU2005230732A1 (en) * | 2004-04-08 | 2005-10-20 | Idd-Eal Manufacturing Company Limited | Container for constituting a formulation in liquid form |
-
2006
- 2006-05-24 EP EP20060425350 patent/EP1859771A1/en not_active Withdrawn
-
2007
- 2007-05-24 WO PCT/IB2007/051969 patent/WO2008001237A2/en active Application Filing
Also Published As
| Publication number | Publication date |
|---|---|
| WO2008001237A3 (en) | 2008-03-13 |
| EP1859771A1 (en) | 2007-11-28 |
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