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EP1572546B1 - Method for covering a transparent container used in clinical trials, and device therefor - Google Patents

Method for covering a transparent container used in clinical trials, and device therefor Download PDF

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Publication number
EP1572546B1
EP1572546B1 EP03813509.1A EP03813509A EP1572546B1 EP 1572546 B1 EP1572546 B1 EP 1572546B1 EP 03813509 A EP03813509 A EP 03813509A EP 1572546 B1 EP1572546 B1 EP 1572546B1
Authority
EP
European Patent Office
Prior art keywords
container
blinding
covering
half shells
adhesive tape
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.)
Expired - Lifetime
Application number
EP03813509.1A
Other languages
German (de)
French (fr)
Other versions
EP1572546A1 (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
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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

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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

  • the invention thus relates to a usable container for this purpose according to claim 1, which may be formed as a vial, ampoule or disposable syringe, as well as a set with a plurality of such containers according to claim 9.
  • transparent containers with a container wall more or less completely covering envelope are known: So, for example, the FR 2 731 210 A an apparently commercial beverage bottle with a glued-on shell, which has both heat-insulating and aesthetic functions and on the one hand makes the bottle a little more damage-resistant and on the other hand holds the broken pieces together in the event of damage.
  • This prior art envelope is translucent, but apparently not so that with it the color of the bottle contents can be made unrecognizable, since it is not unimportant, especially with beverage bottles, to be able to determine the color of the contents.
  • the US 3,965,920 shows a beverage bottle with a plastic, partially multi-layered, glued shell, which serves to protect the glass against breakage and to hold the splinters in case of breakage.
  • the US 5,261,546 a glass bottle for pharmaceutical liquids.
  • this differs substantially from the container of the present invention in that it has a sleeve with an aperture specifically designed to control the content of the contents.
  • FIG. 1 a partially in section partly drawn in view, containing a liquid container
  • FIG. 2 a view of a shell formed of plastic in the unfolded state, ie, before it is mounted on the container
  • FIG. 3 a view in the direction of arrow III the FIG. 2
  • the FIG. 4 a view of the container with attached plastic shell, with individual parts are broken away and the FIG. 5 a set of five identical containers according to FIG. 4
  • Each container may have a different content.
  • the in the FIGS. 1, 4 and 5 shown and designated as a whole with 1 cylindrical container, hereinafter referred to as vial, has a transparent, for example, glass clear plastic or wall 2 with a bottom 3 and a bottleneck 4 releasably or permanently detachable pin 5 with associated cover 6.
  • the lid 6 is designed and dimensioned such that it protrudes in the attached state over the edge of the filling opening, in the present example on the bottleneck 4.
  • the vial 1 contains a liquid or freeze-dried, that is solid or liquid, galenic formulation 7, the latter still being able to contain dissolvable particles 9 during the dissolution in a liquid.
  • the vial on the entire container wall covering shell 8 is preferably made of colored, thermally deformable plastic, so 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 the same is far limited that can still be determined whether in the liquid undissolved particles are present.
  • Such casings are conveniently prepared by deep-drawing so that first by means of a single or multiple tool in a PVC film several plastic shells, such as in the FIGS. 2 and 3 is shown generated. Subsequently, these are punched out of the film, so that each shell of two identical hinged together at a surface line 8e Half shells 8a and 8b, the inner surfaces correspond exactly to the shape of the vial 1, which thus each have a neck portion 8c and 8d and a bottom part.
  • a security adhesive strip 10 enclosing them and held together.
  • a safety adhesive strip is suitably used a one-sided coated with adhesive plastic strip with cut dividing lines, which serve to destroy the strip when removing, so that a re-attaching is impossible.
  • This tape can be colorless or colored. Conveniently, its not provided with the adhesive layer surface, so the outer surface, so structured that it can be described or printed.
  • FIG. 5 now shows a set of five equal-looking vials 11-15 according to the Figure 4 , Each of these five vials, however, has a different content, with some still unresolved particles.
  • the light transmission of the five shells is now such that the presence of not yet dissolved particles, but not a color difference of the content of the various vials is detectable.
  • the container is described as a vial, the container may also be designed differently, for example as an ampoule or as a syringe.

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  • 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)

Description

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.In medicine, the problem of quality assurance, that is, the knowledge of effects and side effects of remedies is becoming increasingly important. Therefore, these effects are detected and confirmed in clinical trials by numerical statistical investigations.

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 subjects take the drugs to be tested orally, parenterally or topically for a predetermined period of time and according to a specific administration plan, and the reactions of the subjects and the effects of the drugs 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 be used, for example, in a predetermined sequence within a test series and that these have a uniform appearance regardless of their initial packaging, their color, their initial inscription or the like so that their peculiarities can not be distinguished from the subjects or other persons involved in the conduct 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 well-known, blister-like pills or pills containing pills, which are used inter alia for the aforementioned purpose, there are also other galenic dosage forms, such. B. liquid, in syringes and ampoules for Subjects, as well as lyophilates, so freeze-dried substances stored in vials and then dissolved before application in a liquid introduced by means of a syringe, so that they can be administered orally or by injection. Also, such dosage forms are increasingly used for clinical testing, in these applications, the drugs to be tested as well as the statistical evaluation also necessary control and comparison preparations are each contained in a sealed container, so for example a vial, an ampoule or syringe.

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-Anforderungen/Verblindung Rechnung trägt.It is an object of the invention to propose a novel container for the use of liquid or freeze-dried galenic preparations, which takes into account the anonymity requirements / blinding required 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 usable container for this purpose according to claim 1, which may be formed as a vial, ampoule or disposable syringe, as well as a set with a plurality of such containers according to claim 9.

Vorteilhafte Ausführungsformen der Erfindung sind Gegenstand der vom Patentanspruch 1 abhängigen Ansprüche.Advantageous embodiments of the invention are the subject of the dependent claims of 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.In itself, transparent containers with a container wall more or less completely covering envelope are known: So, for example, the FR 2 731 210 A an apparently commercial beverage bottle with a glued-on shell, which has both heat-insulating and aesthetic functions and on the one hand makes the bottle a little more damage-resistant and on the other hand holds the broken pieces together in the event of damage. This prior art envelope is translucent, but apparently not so that with it the color of the bottle contents can be made unrecognizable, since it is not unimportant, especially with beverage bottles, to be able to determine the color of the contents.

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.Also the US 3,965,920 shows a beverage bottle with a plastic, partially multi-layered, glued shell, which serves to protect the glass against breakage and to hold the splinters in case of breakage. In contrast, now shows the US 5,261,546 a glass bottle for pharmaceutical liquids. However, this differs substantially from the container of the present invention in that it has a sleeve with an aperture specifically designed to control the content of the contents.

In der US 3,912,100 ist ein Behälter beschrieben, der zum Schutz vor mechanischen Beschädigungen, zum Splitterschutz und zum Zweck erweiterter Gestaltungsmöglichkeiten mit einer Umhüllung versehenen ist, die im oberen Bereich aus einer aufgesprühten und anschliessend thermisch aufgeschmolzenen Beschichtung, im unteren Bereich aus einer thermisch aufgeschrumpften Manschette besteht.In the US 3,912,100 a container is described, which is provided to protect against mechanical damage, for anti-fragmentation and for the purpose of extended design options with a sheath, which consists of a sprayed and then thermally melted coating in the upper part, in the lower part of a thermally shrunk cuff.

Zusätzliche Informationsquellen für Anonymitäts-Anforderungen/Verblindung in klinischen Prüfungen sind durch die Internetseite http://flexikon.doccheck.com/de/Doppelblindstudie und Wikipedia bekannt.Additional sources of information for anonymity requirements / blinding in clinical trials are available at http://flexikon.doccheck.com/en/Double Blind Study and Wikipedia.

Nachfolgend wird anhand der Zeichnung ein Ausführungsbeispiel der Erfindung näher erläutert. In der Zeichnung zeigt
die Figur 1 einen teils im Schnitt teils in Ansicht gezeichneten, eine Flüssigkeit enthaltenden Behälter,
die Figur 2 eine Ansicht einer aus Kunststoff gebildeten Hülle im aufgeklappten Zustand, d.h., bevor sie auf dem Behälter angebracht wird,
die Figur 3 eine Ansicht in Richtung des Pfeiles III der Figur 2,
die Figur 4 eine Ansicht des Behälters mit aufgesetzter Kunststoff-Hülle, wobei einzelne Teile weg gebrochen sind und
die Figur 5 ein Set mit fünf gleichen Behältern gemäss der Figur 4, wobei jeder Behälter einen anderen Inhalt haben kann.An embodiment of the invention will be explained in more detail with reference to the drawing. In the drawing shows
the FIG. 1 a partially in section partly drawn in view, containing a liquid container,
the FIG. 2 a view of a shell formed of plastic in the unfolded state, ie, before it is mounted on the container,
the FIG. 3 a view in the direction of arrow III the FIG. 2 .
the FIG. 4 a view of the container with attached plastic shell, with individual parts are broken away and
the FIG. 5 a set of five identical containers according to FIG. 4 Each container may have a different content.

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.The in the FIGS. 1, 4 and 5 shown and designated as a whole with 1 cylindrical container, hereinafter referred to as vial, has a transparent, for example, glass clear plastic or wall 2 with a bottom 3 and a bottleneck 4 releasably or permanently detachable pin 5 with associated cover 6. The lid 6 is designed and dimensioned such that it protrudes in the attached state over the edge of the filling opening, in the present example on the bottleneck 4. The vial 1 contains a liquid or freeze-dried, that is solid or liquid, galenic formulation 7, the latter still being able to contain dissolvable particles 9 during the dissolution in a liquid.

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 shown in FIG FIG. 4 it can be seen, the vial on the entire container wall covering shell 8. This shell is preferably made of colored, thermally deformable plastic, so 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 the same is far limited that can still be determined whether in the liquid undissolved particles are present.

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 conveniently prepared by deep-drawing so that first by means of a single or multiple tool in a PVC film several plastic shells, such as in the FIGS. 2 and 3 is shown generated. Subsequently, these are punched out of the film, so that each shell of two identical hinged together at a surface line 8e Half shells 8a and 8b, the inner surfaces correspond exactly to the shape of the vial 1, which thus each have a neck portion 8c and 8d and a bottom part.

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 Papier- oder 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 these two shells shell 8 around the vial according to FIG. 1 has been placed, their two parts are encased by the attachment of a security adhesive strip 10 enclosing them and held together. As a safety adhesive strip is suitably used a one-sided coated with adhesive plastic strip with cut dividing lines, which serve to destroy the strip when removing, so that a re-attaching is impossible. This tape can be colorless or colored. Conveniently, its not provided with the adhesive layer surface, so the outer surface, so structured that it can be described or printed. If the available area for receiving multilingual information is too small, it is also possible to use a strip of paper or plastic surrounding the container once or several times, one end of which is fastened to the container by means of an adhesive and the other end, if necessary, with a reusable one Adhesive is provided.

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 shell by means of an adhesive undetachably with the container.

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.The FIG. 5 now shows a set of five equal-looking vials 11-15 according to the Figure 4 , Each of these five vials, however, has a different content, with some still unresolved particles. The light transmission of the five shells is now such that the presence of not yet dissolved particles, but not a color difference of the content of the various vials is detectable.

Obwohl im vorstehenden Ausführungsbeispiel der Behälter als Vial beschrieben ist, kann der Behälter auch anders, beispielsweise als Ampulle oder als Injektionsspritze ausgestaltet sein.Although in the above embodiment, the container is described as a vial, the container may also be designed differently, for example as an ampoule or as a syringe.

Claims (9)

  1. Method for blinding a transparent container (1) containing a liquid or freeze-dried galenic formulation (7), characterized in that the entire surface of the container is covered with a covering (8), composed of two articulatedly connected half shells (8a, 8b) made of a colored material having limited transparency, and the color of the material is selected such that the different contents in the container have the same color appearance.
  2. Blinding method according to Claim 1, characterized in that the transparency of the covering (8) is limited in such a way that undissolved particles in the contents of the container (1) are discernible.
  3. Blinding method according to Claim 1, characterized in that after the container is wrapped, the two half shells (8a, 8b) are held together by affixing an adhesive tape (10).
  4. Device for blinding a transparent container (1) containing a liquid or freeze-dried galenic formulation (7) according to Claim 1, characterized by a covering (8), composed of two articulatedly connected half shells (8a, 8b) made of a colored material having limited transparency, for removably covering the entire surface of the container, wherein the color of the material is selected such that the different contents in the container have the same color appearance.
  5. Blinding device according to Claim 4, characterized in that the transparency of the covering (8) is limited in such a way that undissolved particles in the contents of the container are discernible.
  6. Blinding device according to Claim 4, characterized in that the half shells (8a, 8b) are preformed corresponding to the shape of the container in order to completely lie against the container wall.
  7. Blinding device according to Claim 4, characterized in that the two half shells (8a, 8b) are held together by a tamper-evident adhesive tape (10), which surrounds the same.
  8. Blinding device according to Claim 7, characterized in that the tamper-evident adhesive tape (10) can be written on.
  9. Blinding device according to Claim 7, characterized in that the tamper-evident adhesive tape (10) is provided with a printable or writable label.
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
CH217102 2002-12-19
CH02171/02A CH696069A5 (en) 2002-12-19 2002-12-19 Container and its use in a package, for example, remedy package.
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 EP1572546A1 (en) 2005-09-14
EP1572546B1 true EP1572546B1 (en) 2015-07-08

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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

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EP03258070A Withdrawn EP1435329A1 (en) 2002-12-19 2003-12-19 Container and its use in packaging for example for remedies

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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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EP1637465A1 (en) * 2004-09-17 2006-03-22 Kurt Oberhofer Drink bottle
US20070295060A1 (en) * 2006-06-13 2007-12-27 Delgado Juan C Ampoule card leak detector assembly
JP4985425B2 (en) * 2008-01-24 2012-07-25 日本電気株式会社 Liquid container, method for producing the same, and liquid extraction method
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
US11542083B2 (en) 2019-09-30 2023-01-03 Fisher Clinical Services, Inc. Vial blinding assemblies and methods of assembly
EP4058371A4 (en) * 2019-11-15 2024-04-17 Merck Sharp & Dohme LLC Labeling shell for a drug vial
US20210186811A1 (en) * 2019-12-23 2021-06-24 Fisher Clinical Services, Inc. Hinged blinding shell for hanging a vial and related methods

Family Cites Families (27)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2317860A (en) * 1940-06-25 1943-04-27 Sorensen Emil Display tablet container
FR1406827A (en) * 1963-10-02 1965-07-23 Continental Can Co Protective cover for containers
US3955020A (en) * 1973-06-20 1976-05-04 Midland Glass Company Glass container with plastic wrapper
US3912100A (en) 1973-06-21 1975-10-14 Owens Illinois Inc Coated glass container and method of making same
US3937853A (en) * 1973-07-12 1976-02-10 Anchor Hocking Corporation Method of making a color decorated, plastic coated glass article
GB1489056A (en) 1973-10-03 1977-10-19 Bailey Meters Controls Ltd Installations for monitoring oil content
US4051265A (en) * 1974-10-10 1977-09-27 Celanese Corporation Package for light and oxygen sensitive food
JPS51141659U (en) * 1975-05-02 1976-11-15
US4181223A (en) * 1978-05-25 1980-01-01 Johnson & Johnson Self-packaged medical device with frangible seal
GB2025352A (en) * 1978-07-13 1980-01-23 Bate F D C Wrapping articles
US4205750A (en) * 1978-11-09 1980-06-03 The Dews Co., Inc. Double-seal container and method
AU538516B2 (en) 1979-01-26 1984-08-16 Yoshino Kogyosho Co., Ltd. Crystallised surface of blow moulding
US4281520A (en) * 1980-01-15 1981-08-04 Norwood Donald D Portable cooler for bottled beverages
US4755405A (en) * 1987-05-20 1988-07-05 Mcneilab Inc. Multi-walled tamper-proof container and method for enhancing tamper evidence
US4948000A (en) * 1987-11-20 1990-08-14 Grabenkort Richard W Container shrouds
US5261546A (en) * 1988-01-25 1993-11-16 Mallinckrodt Medical, Inc. Container for liquid observed for impurities
US5529217A (en) * 1989-11-09 1996-06-25 Siegel; Gerald Squeeze bottle with insulating jacket
JPH0486739U (en) * 1990-11-30 1992-07-28
JP2554136Y2 (en) * 1991-11-20 1997-11-12 株式会社細川洋行 Liquid content discharge container using pump mechanism
EP0565810B1 (en) * 1992-03-10 1996-05-15 The Procter & Gamble Company Labelled container incorporating recycled plastic
US5525383A (en) * 1993-03-09 1996-06-11 Witkowski; Daniel D. Container for diplaying transitory moving images
US5462180A (en) * 1994-01-21 1995-10-31 Electra Form, Inc. Bottle base stand
FR2731210A1 (en) * 1995-03-02 1996-09-06 Block Elisabeth Isothermal display packaging for protecting bottles
DE19851119C2 (en) * 1998-11-06 2001-05-31 Byk Gulden Lomberg Chem Fab Container and device for blinding the administration of non-solid pharmaceutical dosage forms in clinical trials
BR0011044A (en) * 1999-05-28 2002-04-16 Alcoa Closure Systems Int Inc Container lid containing a premium and cover-up method
WO2001087722A2 (en) * 2000-05-16 2001-11-22 Zenith Goldline Pharmaceuticals, Inc. Labelled medical container
US20030021918A1 (en) * 2001-07-27 2003-01-30 Mckillip Barron G. Metalized shrink label and related method of manufacture

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JP4469725B2 (en) 2010-05-26
AU2003303212A1 (en) 2004-07-14
US8007883B2 (en) 2011-08-30
US20060037928A1 (en) 2006-02-23
EP1435329A1 (en) 2004-07-07
CH696069A5 (en) 2006-12-15
WO2004056668A1 (en) 2004-07-08
DK1572546T3 (en) 2015-10-19
US20050016892A1 (en) 2005-01-27
EP1572546A1 (en) 2005-09-14
JP2006501041A (en) 2006-01-12
CA2493089A1 (en) 2004-07-08

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