WO2008001237A2 - Principes actifs peu compatibles contenus dans une poche à deux parties - Google Patents

Principes actifs peu compatibles contenus dans une poche à deux parties Download PDF

Info

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
Application number
PCT/IB2007/051969
Other languages
English (en)
Other versions
WO2008001237A3 (fr
Inventor
Vittorio Pelloni
Original Assignee
Guardant S.R.L.
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 S.R.L. filed Critical Guardant S.R.L.
Publication of WO2008001237A2 publication Critical patent/WO2008001237A2/fr
Publication of WO2008001237A3 publication Critical patent/WO2008001237A3/fr

Links

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)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Packages (AREA)
  • Bag Frames (AREA)

Abstract

L'invention concerne un produit pharmacologique (1) comprenant : un contenant (2) qui se présente sous la forme d'une poche à deux parties, comprenant un premier (21) et un deuxième logement (22) distincts, disposés l'un à côté de l'autre; un premier principe actif, un opioïde (31), qui est disposé dans le premier logement (21); et un deuxième principe actif, un médicament analgésique non stéoroïdien (NSAD) (32), qui peut être mélangé avec ledit premier principe actif (31) et qui est disposé dans le deuxième logement (22). Selon l'invention, le contenant (2) comprend en outre une paroi de séparation (23) entre le premier (21) et le deuxième logement (22), cette paroi pouvant être déchirée définitivement par application d'une pression à l'extérieur du contenant (2), pour relier le premier (21) et le deuxième logement (22) l'un avec l'autre et entraîner le mélange des deux principes actifs (31, 32) dans le contenant (2).
PCT/IB2007/051969 2006-05-24 2007-05-24 Principes actifs peu compatibles contenus dans une poche à deux parties WO2008001237A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP06425350.3 2006-05-24
EP20060425350 EP1859771A1 (fr) 2006-05-24 2006-05-24 Substances actives à compatibilité faible, comprises dans une poche à deux compartiments.

Publications (2)

Publication Number Publication Date
WO2008001237A2 true WO2008001237A2 (fr) 2008-01-03
WO2008001237A3 WO2008001237A3 (fr) 2008-03-13

Family

ID=37038340

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2007/051969 WO2008001237A2 (fr) 2006-05-24 2007-05-24 Principes actifs peu compatibles contenus dans une poche à deux parties

Country Status (2)

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

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019082221A2 (fr) * 2017-10-23 2019-05-02 Biofarma S.P.A. Dispositif et procédé pour l'administration orale de principes actifs
IT201700120081A1 (it) * 2017-10-23 2019-04-23 Biofarma S P A Dispositivo e metodo per la somministrazione orale di principi attivi

Citations (4)

* 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
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

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB9319568D0 (en) * 1993-09-22 1993-11-10 Euro Celtique Sa Pharmaceutical compositions and usages
AU5243899A (en) * 1998-07-31 2000-02-21 Vela Pharmaceuticals Inc. Methods and compositions for using moclobemide

Patent Citations (4)

* 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
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

Also Published As

Publication number Publication date
WO2008001237A3 (fr) 2008-03-13
EP1859771A1 (fr) 2007-11-28

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