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EP1572546A1 - Container comprising a transparent cylindrical container wall - Google Patents

Container comprising a transparent cylindrical container wall

Info

Publication number
EP1572546A1
EP1572546A1 EP03813509A EP03813509A EP1572546A1 EP 1572546 A1 EP1572546 A1 EP 1572546A1 EP 03813509 A EP03813509 A EP 03813509A EP 03813509 A EP03813509 A EP 03813509A EP 1572546 A1 EP1572546 A1 EP 1572546A1
Authority
EP
European Patent Office
Prior art keywords
container
container according
liquid
container wall
containers
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.)
Granted
Application number
EP03813509A
Other languages
German (de)
French (fr)
Other versions
EP1572546B1 (en
Inventor
Alain DÜRR
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.)
Fisher Clinical Services GmbH
Original Assignee
Fisher Clinical Services GmbH
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 Fisher Clinical Services GmbH filed Critical Fisher Clinical Services GmbH
Publication of EP1572546A1 publication Critical patent/EP1572546A1/en
Application granted granted Critical
Publication of EP1572546B1 publication Critical patent/EP1572546B1/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D23/00—Details of bottles or jars not otherwise provided for
    • B65D23/08—Coverings or external coatings
    • B65D23/0842—Sheets or tubes applied around the bottle with or without subsequent folding operations
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D23/00—Details of bottles or jars not otherwise provided for
    • B65D23/08—Coverings or external coatings
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1328—Shrinkable or shrunk [e.g., due to heat, solvent, volatile agent, restraint removal, etc.]
    • Y10T428/1331—Single layer [continuous layer]
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1352—Polymer or resin containing [i.e., natural or synthetic]

Definitions

  • Containers with a transparent cylindrical container wall are provided.
  • test persons take the medicinal products to be tested orally, parenterally or topically over a predetermined period of time and according to a special administration schedule, and the reactions of the test persons and the effects of the medicinal products are registered and statistically evaluated.
  • Dosage forms of this type are also increasingly being used for clinical testing, with the medicinal products to be tested and the control and comparative preparations likewise required for statistical evaluation each being contained in a sealed container, for example a vial, an ampoule or syringe, in these use cases.
  • the invention thus relates to a container which can be used for this purpose and which can be designed as a vial, ampoule or disposable syringe, and also a set with a plurality of such containers.
  • FR 2 731 210 A shows an apparently commercially available beverage bottle with a glued-on shell that has both heat-insulating and aesthetic functions and, on the one hand, the bottle somewhat Damage-resistant and on the other hand holds the fragments together in the event of damage.
  • This previously known shell is translucent, but apparently not so, that it can be used to make the color of the bottle contents unrecognizable, since it is not unimportant to be able to determine the color of the content, especially with drink bottles.
  • US Pat. No. 3,965,920 also shows a beverage bottle with a plastic, partially multi-layered, glued-on shell, which serves to protect the glass against breakage and to hold the splinters together in the event of a breakage.
  • US Pat. No. 5,261,546 now shows a glass bottle for pharmaceutical liquids.
  • this in contrast to the container according to the present invention, this essentially has a casing with an opening which is used specifically for precisely checking the contents.
  • FIG. 1 shows a container containing a liquid, partly in section and partly in view
  • FIG. 2 is a view of an envelope made of plastic in the opened state, i.e. before it is attached to the container,
  • FIG. 3 shows a view in the direction of arrow III of FIG. 2,
  • FIG. 4 shows a view of the container with a plastic cover attached, with individual parts broken away and
  • FIG. 5 shows a set with five identical containers according to FIG. 4, each container having a different content.
  • the cylindrical container shown in FIGS. 1, 4 and 5 and designated as a whole by 1, hereinafter referred to as vial, has a transparent, for example crystal-clear glass or plastic wall 2 with a bottom 3 and a detachable or non-detachably stuck in the bottle neck 4 Pin 5 with associated lid 6.
  • the lid 6 is designed and dimensioned such that in the fastened state it protrudes over the edge of the filling opening, in the present example over the bottle neck 4.
  • Vial 1 contains a liquid or freeze-dried, that is to say solid or liquid, galenic formulation 7, the latter being able to contain particles 9 which are still soluble in a liquid during dissolution.
  • the vial has a casing 8 covering the entire container wall.
  • This cover is preferably made of colored, thermally deformable plastic, for example a PVC or a polyethylene. It is important and essential that the color of this envelope is chosen so that two containers filled with different contents have the same appearance, but the intensity of this color may only be so strong that the transparency through the container wall is only so it is very limited that it can still be determined whether undissolved particles are present in the liquid.
  • Such casings are expediently produced in the deep-drawing process in such a way that a plurality of plastic casings, such as one shown in FIGS. 2 and 3, are first produced in a PVC film using a single or multiple tool. Afterwards, these are punched out of the film, so that each sleeve made of two identical hingedly connected to each other on a surface line 8e There are half-shells 8a and 8b, the inner surfaces of which correspond exactly to the shape of the vial 1, which therefore also each have a neck portion 8c or 8d and a base portion.
  • this sheath 8 consisting of two half-shells has been placed around the vial according to FIG. 1, its two parts are encased by attaching a security adhesive strip 10 surrounding them and held together.
  • This adhesive strip can be colorless or colored.
  • its surface not provided with the adhesive layer that is to say the outer surface, is structured in such a way that it can be written on or printed on.
  • a paper or plastic strip surrounding the container can also be used, one end of which is attached to the container by means of an adhesive and the other end, if necessary, provided with a reusable adhesive is.
  • FIG. 5 now shows a set with five identical vials 11-15 according to FIG. 4. However, each of these five vials has a different content, some of which still have undissolved particles. The translucency of the five shells is now such that the presence of undissolved particles, but not a color difference in the contents of the different vials, can be determined.
  • the container is described as a vial in the above exemplary embodiment, the container can also be configured differently, for example as an ampoule or as an injection syringe.

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Details Of Rigid Or Semi-Rigid Containers (AREA)
  • Packages (AREA)

Abstract

The invention relates to a container (1) comprising a transparent cylindrical container wall (2) and an envelope (8) covering the entire container wall. Such containers are used in the form of a vial, an ampulla or a syringe, for example, in clinical tests of medicaments or remedies. According to the invention, the envelope is embodied in an opaque manner such that it can be determined whether undissolved particles are still present in the liquid, but the actual colour of the content cannot be determined.

Description

Behälter mit durchsichtiger zylindrischer Behälterwandung Containers with a transparent cylindrical container wall
BESCHREIBUNGDESCRIPTION
In der Medizin wird das Problem der Qualitätssicherung, also das Wissen um Wirkungen und Nebenwirkungen von Heilmitteln immer wichtiger. Daher werden diese Wirkungen in klinischen Prüfungen mittels numerisch statistischer Untersuchungen festgestellt und gesichert.The problem of quality assurance, i.e. knowledge of the effects and side effects of medicinal products, is becoming increasingly important in medicine. These effects are therefore determined and confirmed in clinical trials using numerical statistical tests.
Bei solchen Prüfungen nimmt eine Grosszahl von Probanden über eine im voraus bestimmte Zeitspanne und gemäss einem speziellen Darreichungsplan die zu testenden Arzneimittel oral, parenteral oder topisch auf, und es werden die Reaktionen der Probanden und die Wirkungen der Arzneimittel registriert und statistisch ausgewertet.In such tests, a large number of test persons take the medicinal products to be tested orally, parenterally or topically over a predetermined period of time and according to a special administration schedule, and the reactions of the test persons and the effects of the medicinal products are registered and statistically evaluated.
Statistisch signifikante Auswertungen von klinischen Untersuchungen erfordern nun, dass innerhalb einer Versuchsreihe verschiedene Präparate und/oder deren Formulierungen und/oder Konzentrationen zum Beispiel in vorbestimmter Reihenfolge eingesetzt werden und dass diese unabhängig von ihrer Erstverpackung, ihrer Farbe, ihrer Erstbeschriftung oder dergleichen ein einheitliches Erscheinungsbild haben, sodass deren Eigenheiten weder von den Probanden noch anderen an der Durchführung der Versuche beteiligten Personen unterschieden werden können.Statistically significant evaluations of clinical examinations now require that different preparations and / or their formulations and / or concentrations are used within a series of experiments, for example in a predetermined order, and that they have a uniform appearance regardless of their first packaging, their color, their first labeling or the like , so that their peculiarities can neither be distinguished from the test persons nor from other persons involved in the execution of the experiments.
Neben den allgemein bekannten, blisterartige Pillen oder Dragees enthaltenden Durchdruckpackungen, welche unter anderem auch für den vorgenannten Verwendungszweck eingesetzt werden, gibt es auch noch andere galenische Darreichungsformen, so z. B. flüssige, die in Spritzen und Ampullen zum Probanden gelangen, sowie Lyophilsate, also gefriergetrocknete Substanzen, die in Vials aufbewahrt und dann vor der Applikation in einer mittels einer Spritze eingebrachten Flüssigkeit wieder aufgelöst werden, damit sie sich oral oder durch Injektion verabreichen lassen. Auch derartige Darreichungsformen werden vermehrt zur klinischen Prüfung eingesetzt, wobei in diesen Anwendungsfällen die zu testenden Arzneimittel wie auch die zur statistischen Auswertung ebenfalls nötigen Kontroll- und Vergleichspräparate je in einem verschlossenen Behälter, also beispielsweise einem Vial, einer Ampulle oder Spritze enthalten sind.In addition to the generally known blister-like pills or dragees containing pressure-sensitive packs, which are also used, inter alia, for the aforementioned purpose, there are also other pharmaceutical dosage forms, such as, for. B. liquid in syringes and ampoules for Subjects arrive, as well as lyophilates, i.e. freeze-dried substances, which are stored in vials and then dissolved again in a liquid introduced by means of a syringe before application, so that they can be administered orally or by injection. Dosage forms of this type are also increasingly being used for clinical testing, with the medicinal products to be tested and the control and comparative preparations likewise required for statistical evaluation each being contained in a sealed container, for example a vial, an ampoule or syringe, in these use cases.
Es ist nun Aufgabe der Erfindung, zur Verwendung von flüssigen oder gefriergetrockneten galenischen Darreichungen einen neuartigen Behälter vorzuschlagen, der den bei derartigen Versuchen nötigen Anonymitäts-Anforde- rungen/Verblindung Rechnung trägt.It is an object of the invention to propose a novel container for the use of liquid or freeze-dried galenic formulations, which takes into account the anonymity requirements / blinding necessary in such experiments.
Gegenstand der Erfindung ist also ein zu diesem Zweck verwendbarer Behälter gemäss dem Anspruch 1, der als Vial, Ampulle oder Einmalspritze ausgebildet sein kann, sowie auch ein Set mit mehreren solcher Behälter gemäss dem Anspruch 9.The invention thus relates to a container which can be used for this purpose and which can be designed as a vial, ampoule or disposable syringe, and also a set with a plurality of such containers.
Vorteilhafte Ausführungsformen der Erfindung sind Gegenstand der vom Patentanspruch 1 abhängigen Ansprüche.Advantageous embodiments of the invention are the subject of the claims dependent on patent claim 1.
An sich sind durchsichtige Behälter mit einer die Behälterwand mehr oder weniger vollständig bedeckender Hülle bekannt: So zeigt zum Beispiel die FR 2 731 210 A eine offenbar handelsübliche Getränkeflasche mit einer aufgeklebten Hülle, die sowohl wärmedämmende wie auch ästhetische Funktionen hat und zudem einerseits die Flasche etwas Beschädigungs-resistenter macht und andererseits im Falle einer Beschädigung die Scherben zusammenhält. Diese vorbekannte Hülle ist lichtdurchlässig, jedoch offenbar nicht so, dass mit ihr die Farbe des Flascheninhalts unkenntlich gemacht werden kann, da es ja gerade bei Getränkeflaschen nicht unwichtig ist, die Farbe des Inhalts feststellen zu können.Transparent containers with a shell that more or less completely covers the container wall are known per se: for example, FR 2 731 210 A shows an apparently commercially available beverage bottle with a glued-on shell that has both heat-insulating and aesthetic functions and, on the one hand, the bottle somewhat Damage-resistant and on the other hand holds the fragments together in the event of damage. This previously known shell is translucent, but apparently not so, that it can be used to make the color of the bottle contents unrecognizable, since it is not unimportant to be able to determine the color of the content, especially with drink bottles.
Auch die US 3 965 920 zeigt eine Getränkeflasche mit einer aus Kunststoff bestehenden, teilweise mehrschichtigen, aufgeklebten Hülle, die dazu dient, das Glas gegen Bruch zu schützen und im Falle eines Bruches die Splitter zusammenzuhalten. Im Unterschied dazu zeigt nun die US 5 261 546 eine Glasflasche für pharmazeutische Flüssigkeiten. Diese weist jedoch im wesentlichen Unterschied zum Behälter nach der vorliegenden Erfindung eine Hülle mit einer speziell zur genauen Kontrolle des Inhalts dienenden Öffnung auf.US Pat. No. 3,965,920 also shows a beverage bottle with a plastic, partially multi-layered, glued-on shell, which serves to protect the glass against breakage and to hold the splinters together in the event of a breakage. In contrast to this, US Pat. No. 5,261,546 now shows a glass bottle for pharmaceutical liquids. However, in contrast to the container according to the present invention, this essentially has a casing with an opening which is used specifically for precisely checking the contents.
Nachfolgend wird anhand der Zeichnung ein Ausführungsbeispiel der Erfindung näher erläutert. In der Zeichnung zeigtAn exemplary embodiment of the invention is explained in more detail below with reference to the drawing. In the drawing shows
die Figur 1 einen teils im Schnitt teils in Ansicht gezeichneten, eine Flüssigkeit enthaltenden Behälter,1 shows a container containing a liquid, partly in section and partly in view,
die Figur 2 eine Ansicht einer aus Kunststoff gebildeten Hülle im aufgeklappten Zustand, d.h., bevor sie auf dem Behälter angebracht wird,FIG. 2 is a view of an envelope made of plastic in the opened state, i.e. before it is attached to the container,
die Figur 3 eine Ansicht in Richtung des Pfeiles III der Figur 2,3 shows a view in the direction of arrow III of FIG. 2,
die Figur 4 eine Ansicht des Behälters mit aufgesetzter Kunststoff-Hülle, wobei einzelne Teile weg gebrochen sind undFIG. 4 shows a view of the container with a plastic cover attached, with individual parts broken away and
die Figur 5 ein Set mit fünf gleichen Behältern gemäss der Figur 4, wobei jeder Behälter einen anderen Inhalt haben kann. Der in den Figuren 1, 4 und 5 dargestellte und als ganzes mit 1 bezeichnete zylindrische Behälter, nachfolgend als Vial bezeichnet, besitzt eine durchsichtige, beispielsweise glasklare Glas- oder Kunststoff-Wandung 2 mit einem Boden 3 und einem im Flaschenhals 4 lösbar oder unlösbar festsitzenden Zapfen 5 mit dazugehörendem Deckel 6. Der Deckel 6 ist dabei derart ausgebildet und dimensioniert, dass er im befestigten Zustand über den Rand der Einfüllöffnung, im hier vorliegenden Beispiel über den Flaschenhals 4,, vorsteht. Das Vial 1 enthält eine flüssige oder gefriergetrocknete, also feste oder flüssige galenische Formulierung 7, wobei letztere während des Auflösens in einer Flüssigkeit noch auflösbare Teilchen 9 enthalten kann.5 shows a set with five identical containers according to FIG. 4, each container having a different content. The cylindrical container shown in FIGS. 1, 4 and 5 and designated as a whole by 1, hereinafter referred to as vial, has a transparent, for example crystal-clear glass or plastic wall 2 with a bottom 3 and a detachable or non-detachably stuck in the bottle neck 4 Pin 5 with associated lid 6. The lid 6 is designed and dimensioned such that in the fastened state it protrudes over the edge of the filling opening, in the present example over the bottle neck 4. Vial 1 contains a liquid or freeze-dried, that is to say solid or liquid, galenic formulation 7, the latter being able to contain particles 9 which are still soluble in a liquid during dissolution.
Erfindungsgemäss weist nun, wie das aus der Figur 4 ersichtlich ist, das Vial eine die ganze Behälterwandung bedeckende Hülle 8 auf. Diese Hülle besteht vorzugsweise aus farbigen, thermisch verformbarem Kunststoff, also beispielsweise einen PVC oder einem Polyethylen. Wichtig und wesentlich ist, dass die Farbe dieser Hülle so gewählt wird, dass zwei Behälter, die mit unterschiedlichem Inhalt gefüllt sind, das gleiche Aussehen erhalten, wobei aber die Intensität dieser Farbe nur so stark sein darf, dass die Durchsichtigkeit durch die Behälterwand nur so weit eingeschränkt ist, dass noch festgestellt werden kann, ob in der Flüssigkeit ungelöste Teilchen vorhanden sind.According to the invention, as can be seen from FIG. 4, the vial has a casing 8 covering the entire container wall. This cover is preferably made of colored, thermally deformable plastic, for example a PVC or a polyethylene. It is important and essential that the color of this envelope is chosen so that two containers filled with different contents have the same appearance, but the intensity of this color may only be so strong that the transparency through the container wall is only so it is very limited that it can still be determined whether undissolved particles are present in the liquid.
Solche Hüllen werden zweckmässigerweise so im Tiefziehverfahren hergestellt, dass zuerst mittels eines Einfach-oder Mehrfachwerkzeuges in einer PVC-Folie mehrere Kunststoff- Hüllen, wie eine in den Figuren 2 und 3 dargestellt ist, erzeugt werden. Nachher werden diese aus der Folie ausgestanzt, sodass jede Hülle aus zwei identischen miteinander an einer Mantellinie 8e gelenkig verbundenen Halbschalen 8a und 8b besteht, deren Innenflächen genau der Form des Vials 1 entsprechen, die also je auch eine Halspartie 8c bzw. 8d sowie eine Bodenpartie aufweisen.Such casings are expediently produced in the deep-drawing process in such a way that a plurality of plastic casings, such as one shown in FIGS. 2 and 3, are first produced in a PVC film using a single or multiple tool. Afterwards, these are punched out of the film, so that each sleeve made of two identical hingedly connected to each other on a surface line 8e There are half-shells 8a and 8b, the inner surfaces of which correspond exactly to the shape of the vial 1, which therefore also each have a neck portion 8c or 8d and a base portion.
Nachdem diese aus zwei Halbschalen bestehende Hülle 8 um das Vial gemäss der Figur 1 gelegt worden ist, werden ihre beiden Teile durch das Anbringen eines sie umschliessenden Sicherheitsklebestreifens 10 ummantelt und zusammen gehalten. Als Sicherheitsklebestreifen verwendet man zweckmässigerweise einen einseitig mit Klebstoff beschichteten Kunststoffstreifen mit eingeschnittenen Trennlinien, die dazu dienen, den Streifen beim Wegnehmen zu zerstören, damit ein Wiederanbringen unmöglich wird. Dieser Klebestreifen kann farblos oder farbig sein. Zweckmässigerweise ist seine nicht mit der Klebeschicht versehene Fläche, also die Aussenfläche, so strukturiert, dass sie beschrieben oder bedruckt werden kann. Falls die zur Verfügung stehende Fläche für die Aufnahme mehrsprachiger Informationen zu klein ist, kann auch ein den Behälter einfach oder mehrfach umgebender Papieroder Kunststoffstreifen verwendet werden, dessen eines Ende am Behälter mittels eines Klebers befestigt ist und dessen anderes Ende nötigenfalls mit einem mehrfach verwendbaren Kleber versehen ist.After this sheath 8 consisting of two half-shells has been placed around the vial according to FIG. 1, its two parts are encased by attaching a security adhesive strip 10 surrounding them and held together. A plastic adhesive strip coated on one side with adhesive with cut-in dividing lines, which serve to destroy the strip when it is removed, is expediently used as the security adhesive strip, so that it cannot be reattached. This adhesive strip can be colorless or colored. Advantageously, its surface not provided with the adhesive layer, that is to say the outer surface, is structured in such a way that it can be written on or printed on. If the available space is too small to hold multilingual information, a paper or plastic strip surrounding the container, one or more times, can also be used, one end of which is attached to the container by means of an adhesive and the other end, if necessary, provided with a reusable adhesive is.
Selbstverständlich ist es auch möglich, die Hülle mittels eines Klebstoffes unlösbar mit dem Behälter zu verbinden.Of course, it is also possible to connect the cover to the container in a non-detachable manner using an adhesive.
Die Figur 5 zeigt nun ein Set mit fünf gleich aussehenden Vials 11-15 gemäss der Abbildung 4. Jedes dieser fünf Vials hat aber einen anderen Inhalt, wobei in einigen noch ungelöste Teilchen vorhanden sind. Die Lichtdurchlässigkeit der fünf Hüllen ist nun so beschaffen, dass zwar das Vorhandensein noch nicht gelöster Teilchen, nicht aber ein Farbunterschied des Inhalts der verschiedenen Vials feststellbar ist. Obwohl im vorstehenden Ausführungsbeispiel der Behälter als Vial beschrieben ist, kann der Behälter auch anders, beispielsweise als Ampulle oder als Injektionsspritze ausgestaltet sein. FIG. 5 now shows a set with five identical vials 11-15 according to FIG. 4. However, each of these five vials has a different content, some of which still have undissolved particles. The translucency of the five shells is now such that the presence of undissolved particles, but not a color difference in the contents of the different vials, can be determined. Although the container is described as a vial in the above exemplary embodiment, the container can also be configured differently, for example as an ampoule or as an injection syringe.

Claims

PATENTANSPRÜCHE
1. Behälter (1) mit durchsichtiger, zylindrischer Behälterwandung und einer die ganze Behälterwandung bedeckenden Hülle (8) , enthaltend eine flüssige oder gefriergetrocknete, • galenische Formulierung (7), dadurch gekennzeichnet, dass die Hülle (8) derart opak ausgebildet ist, dass sich zwar feststellen lässt, ob im Behälter feste Teilchen oder eine Flüssigkeit oder eine Flüssigkeit mit noch ungelösten Teilchen (9) vorhanden sind, nicht aber, welches die wirkliche Farbe des Inhalts ist.1. Container (1) with a transparent, cylindrical container wall and a covering (8) covering the entire container wall, containing a liquid or freeze-dried, • galenic formulation (7), characterized in that the covering (8) is so opaque that it can be determined whether there are solid particles or a liquid or a liquid with undissolved particles (9) in the container, but not what the actual color of the contents is.
2. Behälter nach Anspruch 1, dadurch gekennzeichnet, dass die Hülle (8) aus farbigem Material besteht.2. Container according to claim 1, characterized in that the envelope (8) consists of colored material.
3. Behälter nach einem der Ansprüche 1 oder 2, dadurch gekennzeichnet, dass die Hülle (8) aus einem thermisch verformbaren Kunststoff besteht.3. Container according to one of claims 1 or 2, characterized in that the casing (8) consists of a thermally deformable plastic.
4. Behälter nach einem der Ansprüche 1 bis 3, dadurch gekennzeichnet, dass die Hülle (8) aus einem an der Behälterwandung satt anliegenden vorgeformten Kunststoffmantel besteht .4. Container according to one of claims 1 to 3, characterized in that the sheath (8) consists of a preformed plastic jacket which fits snugly against the container wall.
5. Behälter nach Anspruch 4, dadurch gekennzeichnet, dass der Kunststoffmantel aus zwei miteinander gelenkig verbundenen Halbschalen (8a, 8b) besteht.5. A container according to claim 4, characterized in that the plastic jacket consists of two half-shells (8a, 8b) which are connected to one another in an articulated manner.
6. Behälter nach Anspruch 5, dadurch gekennzeichnet, dass die beiden Halbschalen durch einen sie umschliessenden Sicherheitsklebestreifen (10) zusammengehalten werden.6. A container according to claim 5, characterized in that the two half-shells are held together by a security adhesive strip (10) surrounding them.
7. Behälter nach Anspruch 6, dadurch gekennzeichnet, dass der Sicherheitsklebestreifen ■ beschreibbar ist oder dass auf ihm eine beschriftete oder beschreibbare Etikette angebracht ist .7. Container according to claim 6, characterized in that the security adhesive strip is ■ writable or that it is attached to a labeled or writable label.
8. Behälter nach Anspruch 5, dadurch gekennzeichnet, dass die Halbschalen (8a, 8b) mit der Behälterwandung (2) unlösbar verbunden sind.8. A container according to claim 5, characterized in that the half-shells (8a, 8b) with the container wall (2) are non-detachably connected.
9. Set mit mehreren Behältern (11-15) nach einem der Ansprüche 1 bis 8, wobei nicht alle Behälter den gleichen Inhalt enthalten, dadurch gekennzeichnet, dass alle Behälter mit einer gleichen Hülle (8) versehen sind, so dass sie nur durch eine Beschriftung oder Numerierung voneinander unterschieden werden können. 9. Set with several containers (11-15) according to one of claims 1 to 8, wherein not all containers contain the same content, characterized in that all containers are provided with the same envelope (8), so that they are only one Labeling or numbering can be distinguished from one another.
EP03813509.1A 2002-12-19 2003-12-15 Method for covering a transparent container used in clinical trials, and device therefor Expired - Lifetime EP1572546B1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CH02171/02A CH696069A5 (en) 2002-12-19 2002-12-19 Container and its use in a package, for example, remedy package.
CH217102 2002-12-19
PCT/CH2003/000817 WO2004056668A1 (en) 2002-12-19 2003-12-15 Container comprising a transparent cylindrical container wall

Publications (2)

Publication Number Publication Date
EP1572546A1 true EP1572546A1 (en) 2005-09-14
EP1572546B1 EP1572546B1 (en) 2015-07-08

Family

ID=32477154

Family Applications (2)

Application Number Title Priority Date Filing Date
EP03813509.1A Expired - Lifetime EP1572546B1 (en) 2002-12-19 2003-12-15 Method for covering a transparent container used in clinical trials, and device therefor
EP03258070A Withdrawn EP1435329A1 (en) 2002-12-19 2003-12-19 Container and its use in packaging for example for remedies

Family Applications After (1)

Application Number Title Priority Date Filing Date
EP03258070A Withdrawn EP1435329A1 (en) 2002-12-19 2003-12-19 Container and its use in packaging for example for remedies

Country Status (8)

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US (2) US8007883B2 (en)
EP (2) EP1572546B1 (en)
JP (1) JP4469725B2 (en)
AU (1) AU2003303212A1 (en)
CA (1) CA2493089A1 (en)
CH (1) CH696069A5 (en)
DK (1) DK1572546T3 (en)
WO (1) WO2004056668A1 (en)

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USD746045S1 (en) 2013-12-03 2015-12-29 Novo Nordisk A/S Container for medical purposes
JP6933886B2 (en) * 2015-08-11 2021-09-08 エーザイ・アール・アンド・ディー・マネジメント株式会社 Labels, clinical trial bottles, labeling methods and methods that make it difficult to identify the contents
GB2577291B (en) 2018-09-20 2022-11-09 Simon Aylett Moore Kenneth Masking package
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US20210186811A1 (en) * 2019-12-23 2021-06-24 Fisher Clinical Services, Inc. Hinged blinding shell for hanging a vial and related methods

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Also Published As

Publication number Publication date
JP4469725B2 (en) 2010-05-26
DK1572546T3 (en) 2015-10-19
CH696069A5 (en) 2006-12-15
JP2006501041A (en) 2006-01-12
US20050016892A1 (en) 2005-01-27
AU2003303212A1 (en) 2004-07-14
US20060037928A1 (en) 2006-02-23
EP1572546B1 (en) 2015-07-08
WO2004056668A1 (en) 2004-07-08
EP1435329A1 (en) 2004-07-07
CA2493089A1 (en) 2004-07-08
US8007883B2 (en) 2011-08-30

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