EP1859771A1 - Substances actives à compatibilité faible, comprises dans une poche à deux compartiments. - Google Patents

Substances actives à compatibilité faible, comprises dans une poche à deux compartiments. Download PDF

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Publication number
EP1859771A1
EP1859771A1 EP20060425350 EP06425350A EP1859771A1 EP 1859771 A1 EP1859771 A1 EP 1859771A1 EP 20060425350 EP20060425350 EP 20060425350 EP 06425350 A EP06425350 A EP 06425350A EP 1859771 A1 EP1859771 A1 EP 1859771A1
Authority
EP
European Patent Office
Prior art keywords
product
container
wrapper
housing
apt
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP20060425350
Other languages
German (de)
English (en)
Inventor
Vittorio Pelloni
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Guardant Srl
Original Assignee
Guardant Srl
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Guardant Srl filed Critical Guardant Srl
Priority to EP20060425350 priority Critical patent/EP1859771A1/fr
Priority to PCT/IB2007/051969 priority patent/WO2008001237A2/fr
Publication of EP1859771A1 publication Critical patent/EP1859771A1/fr
Withdrawn legal-status Critical Current

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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).
  • the modes providing repeated IV boli to be administered entail several relevant drawbacks.
  • 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.
  • 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.
  • 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.
  • 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.
  • the invention allows a simpler, more effective and safer management of injectable active principles for pain therapy.

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)
EP20060425350 2006-05-24 2006-05-24 Substances actives à compatibilité faible, comprises dans une poche à deux compartiments. Withdrawn EP1859771A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP20060425350 EP1859771A1 (fr) 2006-05-24 2006-05-24 Substances actives à compatibilité faible, comprises dans une poche à deux compartiments.
PCT/IB2007/051969 WO2008001237A2 (fr) 2006-05-24 2007-05-24 Principes actifs peu compatibles contenus dans une poche à deux parties

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP20060425350 EP1859771A1 (fr) 2006-05-24 2006-05-24 Substances actives à compatibilité faible, comprises dans une poche à deux compartiments.

Publications (1)

Publication Number Publication Date
EP1859771A1 true EP1859771A1 (fr) 2007-11-28

Family

ID=37038340

Family Applications (1)

Application Number Title Priority Date Filing Date
EP20060425350 Withdrawn EP1859771A1 (fr) 2006-05-24 2006-05-24 Substances actives à compatibilité faible, comprises dans une poche à deux compartiments.

Country Status (2)

Country Link
EP (1) EP1859771A1 (fr)
WO (1) WO2008001237A2 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT201700120081A1 (it) * 2017-10-23 2019-04-23 Biofarma S P A Dispositivo e metodo per la somministrazione orale di principi attivi
WO2019082221A3 (fr) * 2017-10-23 2019-08-15 Biofarma S.P.A. Dispositif et procédé pour l'administration orale de principes actifs

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4458811A (en) 1983-04-21 1984-07-10 Abbott Laboratories Compartmented flexible solution container
WO1998010733A1 (fr) * 1996-09-11 1998-03-19 Baxter International Inc. Recipients et procedes de stockage et de melange par addition de solutions medicales
US5763452A (en) * 1993-09-22 1998-06-09 Euro-Celtique, S.A. Pharmaceutical compositions and usages
US20020032197A1 (en) * 1998-07-31 2002-03-14 Klein Donald F. Methods and compositions for using moclobemide
US20040078023A1 (en) * 2002-10-17 2004-04-22 Paul-Andre Gollier Peelable seal
WO2005097040A1 (fr) * 2004-04-08 2005-10-20 Idd-Eal Manufacturing Company Limited Contenant permettant de constituer une formulation sous forme liquide

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4458811A (en) 1983-04-21 1984-07-10 Abbott Laboratories Compartmented flexible solution container
US5763452A (en) * 1993-09-22 1998-06-09 Euro-Celtique, S.A. Pharmaceutical compositions and usages
WO1998010733A1 (fr) * 1996-09-11 1998-03-19 Baxter International Inc. Recipients et procedes de stockage et de melange par addition de solutions medicales
US20020032197A1 (en) * 1998-07-31 2002-03-14 Klein Donald F. Methods and compositions for using moclobemide
US20040078023A1 (en) * 2002-10-17 2004-04-22 Paul-Andre Gollier Peelable seal
WO2005097040A1 (fr) * 2004-04-08 2005-10-20 Idd-Eal Manufacturing Company Limited Contenant permettant de constituer une formulation sous forme liquide

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT201700120081A1 (it) * 2017-10-23 2019-04-23 Biofarma S P A Dispositivo e metodo per la somministrazione orale di principi attivi
WO2019082218A1 (fr) * 2017-10-23 2019-05-02 Biofarma S.P.A. Dispositif et procédé pour l'administration orale de principes actifs
WO2019082221A3 (fr) * 2017-10-23 2019-08-15 Biofarma S.P.A. Dispositif et procédé pour l'administration orale de principes actifs

Also Published As

Publication number Publication date
WO2008001237A3 (fr) 2008-03-13
WO2008001237A2 (fr) 2008-01-03

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