EP0019807A1 - Container from which solutions of pharmaceutical preparations can be taken without contamination - Google Patents

Container from which solutions of pharmaceutical preparations can be taken without contamination Download PDF

Info

Publication number
EP0019807A1
EP0019807A1 EP80102702A EP80102702A EP0019807A1 EP 0019807 A1 EP0019807 A1 EP 0019807A1 EP 80102702 A EP80102702 A EP 80102702A EP 80102702 A EP80102702 A EP 80102702A EP 0019807 A1 EP0019807 A1 EP 0019807A1
Authority
EP
European Patent Office
Prior art keywords
container
contamination
solutions
removal
taken
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Withdrawn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
EP80102702A
Other languages
German (de)
French (fr)
Inventor
Bernd Dr. Zierenberg
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.)
CH Boehringer Sohn AG and Co KG
Original Assignee
CH Boehringer Sohn AG and Co KG
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 CH Boehringer Sohn AG and Co KG filed Critical CH Boehringer Sohn AG and Co KG
Publication of EP0019807A1 publication Critical patent/EP0019807A1/en
Withdrawn legal-status Critical Current

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
    • A61J1/1443—Containers with means for dispensing liquid medicaments in a filtered or sterile way, e.g. with bacterial filters
    • 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
    • A61J1/1468—Containers characterised by specific material properties
    • 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
    • A61J9/00—Feeding-bottles in general
    • A61J9/001—Feeding-bottles in general with inner liners

Definitions

  • the volume removed When removing liquid from a container, the volume removed must be replaced by an appropriate volume of air.
  • the air access In the case of drug solutions which have to be removed from a storage container in small volumes over a long period of time, the air access has disadvantages. Drugs that are sensitive to oxidation are oxidized by the oxygen, the germs in the air contaminate the drug solution.
  • the negative pressure that arises in the container means that the volumes removed from the storage container by means of metering devices (e.g. peristaltic pumps) become smaller, so that exact metering is no longer possible.
  • metering devices e.g. peristaltic pumps
  • the container according to the invention for the contamination-free removal of drug solutions is characterized in that it consists of a rigid outer container into which air can flow during removal and a flexible, airtightly sealed container connected to it, in which the drug solution is located .
  • the flexible container is generally so large that it completely fills the rigid container and is appropriately provided with a piercing plug.
  • the outer container is preferably also airtight until use, but has a small bore which is made with an easily removable material, e.g. an adhesive strip until it is sealed before use.
  • Plastic bags which can be safely used to store the drug solution, are particularly suitable as material for the inner container.
  • the outer container can consist of any sufficiently rigid material, for example glass, metal, plastic.
  • a standard 20 ml glass injection bottle with a 0.5 mm diameter bore serves as the outer container; the hole is sealed with an airtight adhesive strip until the drug solution is used.
  • a polyethylene bag with a wall thickness of 45 ⁇ m is inserted into the injection vial. After filling with the drug solution, the container is crimped with a piercing rubber stopper.
  • the container was emptied into single doses via a cannula inserted into the crimping plug.
  • the evaluation of the weights of the removed volumes showed no dependence on the degree of emptying.
  • the drug solution could be removed except for a residual amount of less than 1%.

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)
  • Sampling And Sample Adjustment (AREA)

Abstract

The container consists of a rigid outer container into which air can flow during the removal, and, situated in this container and connected to it, a flexible airtight sealed container in which the pharmaceutical solution is present.

Description

Bei der Entnahme von Flüssigkeit aus einem Behälter muß das entnommene Volumen durch ein entsprechendes Luftvolumen ersetzt werden. Bei Arzneistofflösungen, die über einen längeren Zeitraum in kleinen Volumina aus einem Vorratsbehälter entnommen werden müssen, bringt der Luftzutritt Nachteile mit sich. Oxidationsempfindliche Arzneistoffe werden durch den Sauerstoff oxidiert, die in der Luft befindlichen Keime kontaminieren die Arzneistofflösung.When removing liquid from a container, the volume removed must be replaced by an appropriate volume of air. In the case of drug solutions which have to be removed from a storage container in small volumes over a long period of time, the air access has disadvantages. Drugs that are sensitive to oxidation are oxidized by the oxygen, the germs in the air contaminate the drug solution.

Schließt man aus diesen Gründen Luftzutritt aus, so führt der sich im Behälter einstellende Unterdruck dazu, daß die mittels Dosiervorrichtungen (z.B. Schlauchpumpe) aus dem Vorratsbehälter entnommenen Volumina kleiner werden, eine genaue Dosierung also nicht mehr möglich ist.If air access is excluded for these reasons, the negative pressure that arises in the container means that the volumes removed from the storage container by means of metering devices (e.g. peristaltic pumps) become smaller, so that exact metering is no longer possible.

Die Aufgabe, einen Behälter zu schaffen, bei dem die genannten Nachteile nicht auftreten, wird durch die Erfindung auf überraschend einfache Weise gelöst.The object of creating a container in which the disadvantages mentioned do not occur is solved in a surprisingly simple manner by the invention.

Der erfindungsgemäße Behälter für die kontaminationsfreie Entnahme von Arzneistofflösungen ist dadurch gekennzeichnet, daß er aus einem starren äußeren Behälter, in den bei der Entnahme Luft einströmen kann und einem in diesem befindlichen mit ihm verbundenen flexiblen, luftdicht verschlossenen Behälter besteht, in dem sich die Arzneistofflösung befindet.The container according to the invention for the contamination-free removal of drug solutions is characterized in that it consists of a rigid outer container into which air can flow during removal and a flexible, airtightly sealed container connected to it, in which the drug solution is located .

Der flexible Behälter ist im allgemeinen so groß, daß er gefüllt den starren Behälter völlig ausfüllt und ist zweckmäßig mit einem Durchstechstopfen versehen. Der äußere Behälter ist vorzugsweise bis zur Benutzung ebenfalls luftdicht verschlossen, weist jedoch eine kleine Bohrung auf, die mit einem leicht entfernbaren Material, z.B. einem klebestreifen, bis zur Benutzung abgedichtet ist.The flexible container is generally so large that it completely fills the rigid container and is appropriately provided with a piercing plug. The outer container is preferably also airtight until use, but has a small bore which is made with an easily removable material, e.g. an adhesive strip until it is sealed before use.

Als Material für den inneren Behälter eignen sich insbesondere Kunststoffbeutel, die unbedenklich zur Lagerung der Arzneistofflösung benutzt werden können. Der äußere Behälter kann aus beliebigem genügend steifem Material, z.B. Glas, Metall, Kunststoff bestehen.Plastic bags, which can be safely used to store the drug solution, are particularly suitable as material for the inner container. The outer container can consist of any sufficiently rigid material, for example glass, metal, plastic.

Eine Ausführungsform der Erfindung ist in dem folgenden Beispiel beschrieben.An embodiment of the invention is described in the following example.

Als äußerer Behälter dient eine übliche 20 ml Injektionsflasche aus Glas, die mit einer Bohrung von 0,5 mm Durchmesser versehen ist; die Bohrung ist bis zur Verwendung der Arzneistofflösung mit einem luftdichten Klebestreifen verschlossen. In die Injektionsfläsche ist ein Polyäthylenbeutel mit einer Wandstärke von 45µm eingelegt. Nach Füllung mit der Arzneistofflösung wird der Behälter mit einem Durchstech-Gummistopfen zugebördelt.A standard 20 ml glass injection bottle with a 0.5 mm diameter bore serves as the outer container; the hole is sealed with an airtight adhesive strip until the drug solution is used. A polyethylene bag with a wall thickness of 45 µm is inserted into the injection vial. After filling with the drug solution, the container is crimped with a piercing rubber stopper.

Zur Prüfung der Dosiergenauigkeit wurde der Behälter über eine in den Bördelstopfen eingeführte Kanüle in Einzeldosen entleert. Die Auswertung der Gewichte der entnommenen .Volumina zeigte keine Abhängigkeit vom Entleerungsgrad. Die Arzneistofflösung konnte bis auf eine Restmenge von weniger als 1 % entnommen werden.To check the dosing accuracy, the container was emptied into single doses via a cannula inserted into the crimping plug. The evaluation of the weights of the removed volumes showed no dependence on the degree of emptying. The drug solution could be removed except for a residual amount of less than 1%.

Claims (4)

1. Behälter für die kontaminationsfreie Entnahme von Arzneistofflösungen, dadurch gekennzeichnet, daß er aus einem starren äußeren Behälter, in den bei der Entnahme Luft einströmen kann, und einem in ihm befindlichen, mit ihm verbundenen flexiblen luftdicht verschlossenen Behälter besteht, in dem sich die Arzneistofflösung befindet.1. Container for the contamination-free removal of drug solutions, characterized in that it consists of a rigid outer container, into which air can flow during removal, and a flexible airtight container connected to it, in which there is the drug solution located. 2. Behälter nach Anspruch 1, dadurch gekennzeichnet, daß der innere Behälter vor Beginn der Entnahme den äußeren Behälter vollständig ausfüllt.2. Container according to claim 1, characterized in that the inner container completely fills the outer container before the start of removal. 3. Behälter nach Anspruch 1 oder 2, dadurch gekennzeichnet. daß der äußere Behälter eine kleine Öffnung hat, die bis zum Beginn der Benutzung mit leicht entfernbarem Material luftdicht verschlossen ist.3. Container according to claim 1 or 2, characterized. that the outer container has a small opening which is hermetically sealed with easily removable material until the start of use. 4. Behälter nach Anspruch 1, 2 oder 3, dadurch gekennzeichnet, daß der äußere und der innere Behälter durch einen aufgebördelten Durchstechstopfen gemeinsam verschlossen sind.4. A container according to claim 1, 2 or 3, characterized in that the outer and the inner container are closed together by a crimped piercing plug.
EP80102702A 1979-05-30 1980-05-16 Container from which solutions of pharmaceutical preparations can be taken without contamination Withdrawn EP0019807A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE2921960 1979-05-30
DE2921960 1979-05-30

Publications (1)

Publication Number Publication Date
EP0019807A1 true EP0019807A1 (en) 1980-12-10

Family

ID=6072048

Family Applications (1)

Application Number Title Priority Date Filing Date
EP80102702A Withdrawn EP0019807A1 (en) 1979-05-30 1980-05-16 Container from which solutions of pharmaceutical preparations can be taken without contamination

Country Status (8)

Country Link
EP (1) EP0019807A1 (en)
JP (1) JPS5618875A (en)
AU (1) AU5888180A (en)
DK (1) DK232480A (en)
FI (1) FI801719A (en)
IL (1) IL60180A0 (en)
NO (1) NO801598L (en)
ZA (1) ZA803246B (en)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5034080A (en) * 1987-10-15 1991-07-23 Impact International Pty. Ltd. Method of making a laminated tubular body
US5409559A (en) * 1992-05-20 1995-04-25 Impact International Pty Ltd. Making a laminated tubular body

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2310530A1 (en) * 1972-03-22 1973-09-27 Sulzer Ag DOUBLE WALL INFUSION BOTTLE
DE2433643A1 (en) * 1974-07-12 1976-01-29 Pfrimmer & Co J Mass production type two-compartment infusion container - for two chemically or physically incompatible components
DE2612518A1 (en) * 1975-03-31 1976-10-14 Baxter Laboratories Inc DOUBLE CHAMBER CONTAINER, ESPECIALLY FOR BLOOD O.DGL.
CH610271A5 (en) * 1975-03-04 1979-04-12 Smith & Nephew Pharma Package in which a vessel containing a fluid is arranged in an envelope

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2310530A1 (en) * 1972-03-22 1973-09-27 Sulzer Ag DOUBLE WALL INFUSION BOTTLE
DE2433643A1 (en) * 1974-07-12 1976-01-29 Pfrimmer & Co J Mass production type two-compartment infusion container - for two chemically or physically incompatible components
CH610271A5 (en) * 1975-03-04 1979-04-12 Smith & Nephew Pharma Package in which a vessel containing a fluid is arranged in an envelope
DE2612518A1 (en) * 1975-03-31 1976-10-14 Baxter Laboratories Inc DOUBLE CHAMBER CONTAINER, ESPECIALLY FOR BLOOD O.DGL.

Also Published As

Publication number Publication date
FI801719A (en) 1980-12-01
NO801598L (en) 1980-12-01
IL60180A0 (en) 1980-07-31
AU5888180A (en) 1980-12-04
DK232480A (en) 1980-12-01
ZA803246B (en) 1982-02-24
JPS5618875A (en) 1981-02-23

Similar Documents

Publication Publication Date Title
US3557787A (en) Disposable syringe
DE69426023T2 (en) CHILD-SAFE DOSING DEVICE
EP1058657B1 (en) Use of a container for a medicinal liquid in a spraying device
DE2652597C3 (en) Sample container for analyzes that can be closed with a lid
US4781679A (en) Container system with integral second substance storing and dispensing means
DE3878616T2 (en) STERILIZABLE DEVICE FOR STORING BLOOD.
DE2502310A1 (en) THERMOPLASTIC PLASTIC BOTTLE WITH CONTROLLED LATERAL FOLDING
EP0390898B1 (en) Container for the separate sterile storage of at least two substances and for mixing them
DE3231619T1 (en) PLASTIC PACKAGING WITH SEVERAL CHAMBERS FOR SOLID AND LIQUID PRODUCTS
DE19615422A1 (en) Two-chamber cartridge for propellant-free MDIs
JPH024374A (en) Liquid shifting assembly
DE1065138B (en) Container for biological fluids, serums and infusion solutions
DE3016772A1 (en) DIAGNOSTIC SAMPLER, ESPECIALLY SPRAY-LIKE DEVICE AND DISCHARGE DEVICE, AND FOR THIS PROVIDED PISTON
DE1202672B (en) Dosing device for pouring out quantities of liquid of the same volume from liquid containers
US2838046A (en) Container for blood and the like
EP0059297A1 (en) Evacuable blood sampling tube closed with a sealing device
US2142278A (en) Medicinal carrying tube
EP0019807A1 (en) Container from which solutions of pharmaceutical preparations can be taken without contamination
DE1191140B (en) pipette
US2847011A (en) Single dose applicator
DE2749951C2 (en)
CH615589A5 (en) Device for preparing and mixing medical nutrient solutions for the intravenous alimentation of patients
DE2947705A1 (en) Sterile medicine dispensing - from plastic bag sealed in glass flask with vent hole
US2534310A (en) Drop dispensing container
DE10028829A1 (en) Apparatus in the form of a hollow component for preparing, storing, and/or administering solutions comprises means for establishing a connection between its interior and a separate hollow component

Legal Events

Date Code Title Description
PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

17P Request for examination filed
AK Designated contracting states

Designated state(s): AT BE CH DE FR GB IT LU NL SE

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE APPLICATION HAS BEEN WITHDRAWN

18W Application withdrawn

Withdrawal date: 19810819

RIN1 Information on inventor provided before grant (corrected)

Inventor name: ZIERENBERG, BERND, DR.