EP0303984A2 - Use of plastics with polar molecule groups for isolation coating of plugs for injection and infusion bottles and coated plugs for injection and infusion bottles - Google Patents

Use of plastics with polar molecule groups for isolation coating of plugs for injection and infusion bottles and coated plugs for injection and infusion bottles Download PDF

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Publication number
EP0303984A2
EP0303984A2 EP88113125A EP88113125A EP0303984A2 EP 0303984 A2 EP0303984 A2 EP 0303984A2 EP 88113125 A EP88113125 A EP 88113125A EP 88113125 A EP88113125 A EP 88113125A EP 0303984 A2 EP0303984 A2 EP 0303984A2
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EP
European Patent Office
Prior art keywords
injection
plastics
plugs
stoppers
infusion bottles
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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.)
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Application number
EP88113125A
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German (de)
French (fr)
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EP0303984A3 (en
Inventor
Karl-Detlev Dr. Schwabe
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Hoechst AG
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Hoechst AG
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Publication of EP0303984A2 publication Critical patent/EP0303984A2/en
Publication of EP0303984A3 publication Critical patent/EP0303984A3/en
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • 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
    • A61J1/1406—Septums, pierceable membranes
    • 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
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S220/00—Receptacles
    • Y10S220/19—Rubber plugs and caps
    • 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
    • Y10T428/31504—Composite [nonstructural laminate]
    • Y10T428/31551—Of polyamidoester [polyurethane, polyisocyanate, polycarbamate, etc.]
    • Y10T428/31569—Next to natural rubber
    • 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
    • Y10T428/31504—Composite [nonstructural laminate]
    • Y10T428/31786—Of polyester [e.g., alkyd, etc.]
    • 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
    • Y10T428/31504—Composite [nonstructural laminate]
    • Y10T428/31826—Of natural rubber
    • Y10T428/31841—Next to cellulosic
    • 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
    • Y10T428/31504—Composite [nonstructural laminate]
    • Y10T428/31855—Of addition polymer from unsaturated monomers
    • 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
    • Y10T428/31504—Composite [nonstructural laminate]
    • Y10T428/31855—Of addition polymer from unsaturated monomers
    • Y10T428/3188—Next to cellulosic
    • Y10T428/31884—Regenerated or modified cellulose
    • 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
    • Y10T428/31504—Composite [nonstructural laminate]
    • Y10T428/31855—Of addition polymer from unsaturated monomers
    • Y10T428/3188—Next to cellulosic
    • Y10T428/31884—Regenerated or modified cellulose
    • Y10T428/31891—Where addition polymer is an ester or halide
    • 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
    • Y10T428/31504—Composite [nonstructural laminate]
    • Y10T428/31855—Of addition polymer from unsaturated monomers
    • Y10T428/31935—Ester, halide or nitrile of addition polymer

Definitions

  • Fluoropolymer film is expensive and fluoropolymer-coated plugs are much more expensive than uncoated plugs and also have serious disadvantages.
  • cellulose eg ®Cellophan
  • cellulose acetate cellulose acetate
  • polyamide eg ®Pla-Sterile
  • polyester polyurethane
  • Cellular glass, polyamide and polyester are particularly preferred.
  • ⁇ -lactam derivatives are cephalosporins, in particular cefotaxime, cefodizime, cefpirom and HOE 111, and their physiologically tolerable salts, optionally in a mixture with pH-regulating compounds.

Landscapes

  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Closures For Containers (AREA)
  • Materials For Medical Uses (AREA)
  • Paints Or Removers (AREA)
  • Details Of Rigid Or Semi-Rigid Containers (AREA)
  • Coating Of Shaped Articles Made Of Macromolecular Substances (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Verwendung von Kunststoffen mit polaren Molekülgruppen zur Isolationsbeschichtung von Stopfen für Injektions- und Infusionsflaschen sowie beschichtete Injektions- und InfusionsflaschenstopfenUse of plastics with polar molecular groups for the insulation coating of stoppers for injection and infusion bottles as well as coated injection and infusion bottle stoppers

Es wird die Verwendung von Kunststoffen mit polaren Molekülgruppen zu Isolationsbeschichtung von Stopfen für Injektions- und Infusionsflaschen beschrieben. The use of plastics with polar molecular groups for insulating coating of stoppers for injection and infusion bottles is described.

Description

Zum Verschluß von Injektionsflaschen und Infusionsflaschen mit β-Laktam Antibiotikatrockensubstanzen, wie Cefotaxim, Cefodizim, Cefpirom oder auch 1-[[(6R,7R)-7-[2-(2-­Amino-4-thiazolyl)glyoxylamido]-2-carboxy-8-oxo-5-thia­1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-5,6,7,8-tetra­hydrochinolinium hydroxid, inneres Salz, 7²-(Z)-(0-methyloxim) (auch als HOE 111 bezeichnet), deren physiologisch verträgliche Salze, gegebenenfalls im Gemisch mit pHregulierenden Substanzen, werden Stopfen benötigt, die dem Produkt gegenüber inert sind und es vor schädigenden Umwelteinflüssen schützen, insbesondere muß eine ausreichende Sperrwirkung gegen mikrobielle und partikuläre Kontamination sowie Wasser und Wasserdampf gegeben sein.For the closure of injection bottles and infusion bottles with β-lactam antibiotic dry substances, such as cefotaxime, cefodizime, cefpirom or also 1 - [[(6R, 7R) -7- [2- (2-amino-4-thiazolyl) glyoxylamido] -2-carboxy -8-oxo-5-thia1-azabicyclo [4.2.0] oct-2-en-3-yl] methyl] -5,6,7,8-tetrahydroquinolinium hydroxide, inner salt, 7²- (Z) - (0 -methyloxime) (also referred to as HOE 111), their physiologically compatible salts, optionally in a mixture with pH-regulating substances, require stoppers which are inert to the product and protect it from damaging environmental influences, in particular an adequate barrier action against microbial and particulate contamination as well as water and water vapor.

Stopfen für Injektions- und Infusionsflaschen bestehen normalerweise im wesentlichen aus Gummi. Sie besitzen zwar gute Durchstech- und Wiederverschließeigenschaften, verursachen aber mangelhafte Klarlöslichkeit der Wirksubstanzen, ein nicht tolerierbarer Nachteil für Injektionslösungen und Infusionslösungen.Injection and infusion bottle stoppers are typically made essentially of rubber. Although they have good puncturing and resealable properties, they cause poor solubility of the active substances, an intolerable disadvantage for injection solutions and infusion solutions.

Um diesen Nachteil zu vermeiden, werden gegenwärtig Injektions- und Infusionsflaschenstopfen, deren Zapfen fluorpolymerbeschichtet sind, verwendet (vgl. Deutsche Offenlegungsschrift 3 346 351 entspr. Derwent-Ref. 85-172 215/29). Fluorpolymerbeschichtete Stopfen haben jedoch durch ihren steifen beschichteten Zapfen den Nachteil, daß sie im Vergleich zu unbeschichteten Stopfen die Flaschen weniger dicht verschließen und so insbesondere das Risiko des Eindringens von Feuchte besteht. Auch die Durchstech- und Wiederverschließeigenschaften werden durch die Fluorpolymebeschichtung negativ beeinflußt.In order to avoid this disadvantage, injection and infusion bottle stoppers, the cones of which are fluoropolymer-coated, are currently used (cf. German Offenlegungsschrift 3 346 351 corresponding to Derwent Ref. 85-172 215/29). However, fluoropolymer-coated stoppers have the disadvantage, due to their rigid coated studs, that they seal the bottles less tightly than uncoated stoppers, and there is in particular the risk of moisture penetration. The piercing and resealing properties are also adversely affected by the fluoropolymer coating.

Fluorpolymerfolie ist teuer und Fluorpolymer-beschichtete Stopfen sind wesentlich teurer als unbeschichtete Stopfen und besitzen ebenfalls schwerwiegende Nachteile.Fluoropolymer film is expensive and fluoropolymer-coated plugs are much more expensive than uncoated plugs and also have serious disadvantages.

Bisher wurde noch kein geeignetes Material für Injektionsflaschenstopfen und Infusionsflaschenstopfen für sterile Cephalosporinderivate wie z.B. Cefotaxim, Cefodizim, Cefpirom und HOE 111 und deren physiologisch verträgliche Salze, gegebenenfalls im Gemisch mit pH-regulierenden Verbindungen, beschrieben, das als solches, d.h. unbeschichtet verwendet werden kann ohne daß es zu Trüblösungen, Fragmentation und schädigenden Umwelteinflüssen wegen mangelnder Sperrwirkung kommt.So far, no suitable material for injection bottle stoppers and infusion bottle stoppers for sterile cephalosporin derivatives such as e.g. Cefotaxim, Cefodizim, Cefpirom and HOE 111 and their physiologically tolerable salts, optionally in a mixture with pH-regulating compounds, which as such, i.e. can be used uncoated without causing cloudy solutions, fragmentation and damaging environmental influences due to a lack of barrier effect.

Es wurde überraschend gefunden, daß Stopfen, die Beschichtungen aus Kunststoffen mit polaren Molekülgruppen haben, wie z.B. Zellglas, Polyamid, Polyester, Polyurethan oder Acetylcellulose bei Cephalosporinderivatsubstanzen keine Trüblöslichkeit hervorrufen und eine ausreichende Sperrwirkung besitzen. Solche Kunststoffe sollten aufgrund der polaren Gruppen als Beschichtungsmaterial weniger geeignet sein als das z.Zt. verwendete als inert geltende Fluorpolymer.It has surprisingly been found that plugs which have coatings made of plastics with polar molecular groups, e.g. Cellophane, polyamide, polyester, polyurethane or acetyl cellulose in cephalosporin derivatives do not cause cloudy solubility and have a sufficient barrier effect. Such plastics should be less suitable as a coating material due to the polar groups than the currently. used fluoropolymer considered inert.

Die Erfindung betrifft daher die Verwendung von Kunststoffen mit polaren Molekülgruppen zur Beschichtung von Stopfen für Injektions- und Infusionsflaschen, insbesondere für β-Laktam-­Antiobiotika sowie mit Kunststoffen mit polaren Molekülgruppen beschichtete Injektions- und Infusionsflaschenstopfen, insbesondere für β-Laktam-Antiobiotika.The invention therefore relates to the use of plastics with polar molecular groups for coating stoppers for injection and infusion bottles, in particular for β-lactam antibiotics, and injection and infusion bottle stoppers coated with plastics with polar molecular groups, in particular for β-lactam antiobiotics.

Als Kunststoffe kommen insbesondere Zellglas (z.B. ®Cellophan), Zelluloseacetat, Polyamid (z.B. ®Pla-Steril), Polyester und Polyurethan in Betracht. Besonders bevorzugt sind Zellglas, Polyamid und Polyester.In particular, cellulose (eg ®Cellophan), cellulose acetate, polyamide (eg ®Pla-Sterile), polyester and polyurethane are suitable as plastics. Cellular glass, polyamide and polyester are particularly preferred.

Als β-Laktam-Derivate kommen in erster Linie Cephalosporine in Betracht, insbesondere Cefotaxim, Cefodizim, Cefpirom und HOE 111, und deren physiologisch verträgliche Salze, gegebenenfalls im Gemisch mit pH-regulierenden Verbindungen.The most suitable β-lactam derivatives are cephalosporins, in particular cefotaxime, cefodizime, cefpirom and HOE 111, and their physiologically tolerable salts, optionally in a mixture with pH-regulating compounds.

Als pH-regulierende Substanzen kommen z.B. Natriumkarbonat, Trinatriumphosphat und basische Aminosäuren in Frage.Examples of pH-regulating substances are Sodium carbonate, trisodium phosphate and basic amino acids in question.

Die Stopfen sind entweder ganz mit dem Kunststoff beschichtet oder es ist nur der Zapfen beschichtet. Die Beschichtung oder Isolierung erfolgt z.B. durch Aufbringen einer Folie aus Kunststoff mit polaren Molekülgruppen, vorzugsweise nur auf den Zapfen. Das Aufbringen des Beschichtungsmaterials kann aber auch durch Sprühcoating erfolgen.The plugs are either completely coated with the plastic or only the plug is coated. The coating or insulation takes place e.g. by applying a plastic film with polar molecular groups, preferably only on the peg. The coating material can also be applied by spray coating.

Die Dicke der Beschichtung kann variieren. Es muß lediglich eine ausreichende Sperrwirkung und eine ausreichende mechanische Stabilität gewährleistet sein.The thickness of the coating can vary. It is only necessary to ensure a sufficient locking effect and sufficient mechanical stability.

Durch Beschichtungen von Stopfen oder Stopfenzapfen mit weichen Folien aus Kunststoffen mit polaren Molekülgruppen können gut abdichtende, leicht zu durchstechende und nach Entfernung der Nadel oder des Überleitungselements wieder schließende Stopfen hergestellt werden, die in β-Laktam Antibiotikatrockensubstanzen keine Trüblöslichkeit verursachen.
Da Folien aus den genannten Materialien preisgünstiger sind, sind Stopfen mit Isolationsbeschichtungen aus Kunststoffen mit polaren Molekülgruppen preisgünstiger herstellbar als solche mit Fluorpolymerbeschichtung.By coating plugs or plug cones with soft foils made of plastics with polar molecular groups, well-sealing, easy-to-pierce plugs that close again after removal of the needle or the transfer element can be produced, which do not cause cloudy solubility in β-lactam antibiotic dry substances.
Since films made from the materials mentioned are less expensive, plugs with insulating coatings made of plastics with polar groups of molecules can be produced more cheaply than those with fluoropolymer coatings.

Die Sperrwirkung durch die erfindungsgemäß ganz oder teilweise beschichteten Stopfen ist sehr gut. Gibt man mit solchen Stopfen verschlossene Flaschen z.B. in Wasser, so ist keine Gewichtszunahme festzustellen. Das Risiko, daß die Zubördelung nicht ausreichend dicht ist, ist äußerst gering, denn das Beschichtungsmaterial besitzt im Vergleich zu Fluorpolymer eine gewisse Elastizität.The blocking effect due to the stoppers coated entirely or partially according to the invention is very good. If you put bottles with such stoppers in water, for example there is no weight gain. The risk that the crimp is not sufficiently tight is extremely low because the coating material has a certain elasticity compared to fluoropolymer.

Stopfen, die ganz oder teilweise mit Kunststoffen mit polaren Molekülgruppen beschichtet sind, halten einer Sterilisation z.B. durch Begasen mit Formaldehyd aber auch einer Sterilisation im Autoklaven, die bevorzugt ist, stand.Plugs that are completely or partially coated with plastics with polar molecular groups keep sterilization e.g. by fumigation with formaldehyde but also sterilization in an autoclave, which is preferred.

Die nachstehenden Beispiele zeigen, daß eine Beschichtung oder Isolierung der Stopfen mit Folien aus den genannten Kunststoffen die für Arzneistoffe vorgeschriebene Klarlöslichkeit auch unter verschiedenen Arten der Belastung gewährleisten, während bei Verwendung nicht isolierter Stopfen bereits mit dem Auge eine Trüblöslichkeit wahrnehmbar ist. Beispiel I Cefodizim-di-Na-Salz mit verschiedenen Stopfen für Injektionsflaschen: Belastung Unbeschichtete Injektionsflaschenstopfen Injektionsflaschenstopfen mit Polyamidfolie isoliert Injektionsflaschenstopfen mit Zellglasfolie isoliert Injektionsflaschenstopfen mit Polyesterfolie isoliert 7 Tage rollen trüblöslich klarlöslich klarlöslich klarlöslich 7 Tage Lagerung kopfstehend bei Raumtemperatur nach 1 h rollen trüblöslich klarlöslich klarlöslich klarlöslich 7 Tage Lagerung kopfstehend bei +40°C nach 1 h rollen trüblöslich klarlöslich klarlöslich klarlöslich Beispiel II Cefotaxim-Na-Salz mit verschiedenen Stopfen für Injektionsflaschen: Belastung Unbeschichtete Injektionsflaschenstopfen Injektionsflaschenstopfen mit Polyamidfolie isoliert Injektionsflaschenstopfen mit Zellglasfolie isoliert Injektionsflaschenstopfen mit Polyesterfolie isoliert 7 Tage rollen trüblöslich klarlöslich klarlöslich klarlöslich 7 Tage Lagerung kopfstehend bei Raumtemperatur nach 1 h rollen trüblöslich klarlöslich klarlöslich klarlöslich 7 Tage Lagerung kopfstehend bei +40°C nach 1 h rollen trüblöslich klarlöslich klarlöslich klarlöslich Beispiel III Cefpiromsulfat - Natriumkarbonatgemisch mit verschiedenen Stopfen für Injektionsflaschen: Belastung Unbeschichtete Injektionsflaschenstopfen Injektionsflaschenstopfen mit Polyamidfolie isoliert Injektionsflaschenstopfen mit Zellglasfolie isoliert Injektionsflaschenstopfen mit Polyesterfolie isoliert 7 Tage rollen trüblöslich klarlöslich klarlöslich klarlöslich 7 Tage Lagerung kopfstehend bei Raumtemperatur nach 1 h rollen trüblöslich klarlöslich klarlöslich klarlöslich 7 Tage Lagerung kopfstehend bei +40°C nach 1 h rollen trüblöslich klarlöslich klarlöslich klarlöslich The examples below show that coating or isolating the plugs with foils made of the plastics mentioned ensures the clear solubility prescribed for medicinal products even under various types of stress, whereas when using non-insulated plugs, a cloudy solubility is already perceptible to the eye. Example I Cefodizim di Na salt with different stoppers for injection bottles: burden Uncoated injection bottle stopper Injection bottle stopper insulated with polyamide film Injection bottle stopper isolated with cellophane film Injection bottle stopper insulated with polyester film Roll 7 days cloudy clearly soluble clearly soluble clearly soluble Roll upside down for 7 days at room temperature after 1 hour cloudy clearly soluble clearly soluble clearly soluble Roll upside down for 7 days at + 40 ° C after 1 h cloudy clearly soluble clearly soluble clearly soluble Cefotaxime Na salt with various stoppers for injection bottles: burden Uncoated injection bottle stopper Injection bottle stopper insulated with polyamide film Injection bottle stopper isolated with cellophane film Injection bottle stopper insulated with polyester film Roll 7 days cloudy clearly soluble clearly soluble clearly soluble Roll upside down for 7 days at room temperature after 1 hour cloudy clearly soluble clearly soluble clearly soluble Roll upside down for 7 days at + 40 ° C after 1 h cloudy clearly soluble clearly soluble clearly soluble Cefpirom sulfate - sodium carbonate mixture with various stoppers for injection bottles: burden Uncoated injection bottle stopper Injection bottle stopper insulated with polyamide film Injection bottle stopper isolated with cellophane film Injection bottle stopper insulated with polyester film Roll 7 days cloudy clearly soluble clearly soluble clearly soluble Roll upside down for 7 days at room temperature after 1 hour cloudy clearly soluble clearly soluble clearly soluble Roll upside down for 7 days at + 40 ° C after 1 h cloudy clearly soluble clearly soluble clearly soluble

Claims (9)

1. Verwendung von Kunststoffen mit polaren Molekülgruppen zur Isolationsbeschichtung von Stopfen für Injektions- und Infusionsflaschen.1. Use of plastics with polar molecular groups for the insulation coating of stoppers for injection and infusion bottles. 2. Verwendung von Kunststoffen mit polaren Molekülgruppen zur Isolationsbeschichtung von Injektions- und Infusionsflaschenstopfen für β-Laktam-Antibiotika.2. Use of plastics with polar molecular groups for the insulation coating of injection and infusion bottle stoppers for β-lactam antibiotics. 3. Verwendung von Kunststoffen mit polaren Molekülgruppen zur Isolationsbeschichtung von Injektions- und Infusionsflaschenstopfen für Cephalosporinderivate.3. Use of plastics with polar molecular groups for the insulation coating of injection and infusion bottle stoppers for cephalosporin derivatives. 4. Verwendung von Kunststoffen mit polaren Molekülgruppen zur Isolationsbeschichtung von Injektions- und Infusionsflaschenstopfen für Cefotaxim, Cefodizim, Cefpirom, und HOE 111 und deren physiologisch verträgliche Salze, gegebenenfalls im Gemisch mit pH-regulierenden Verbindungen.4. Use of plastics with polar molecular groups for the insulation coating of injection and infusion bottle stoppers for cefotaxime, cefodizime, cefpirom, and HOE 111 and their physiologically tolerable salts, optionally in a mixture with pH-regulating compounds. 5. Verwendung von Zellglas, Zelluloseacetat, Polyamid, Polyester oder Polyurethan als Material zur Isolationsbeschichtung von Injektions- und Infusionsflaschenstopfen.5. Use of cellophane, cellulose acetate, polyamide, polyester or polyurethane as a material for the insulation coating of injection and infusion bottle stoppers. 6. Verwendung von Zellglas, Zelluloseacetat, Polyamid, Polyester oder Polyurethan als Material für Isolationsbeschichtung von Injektions- und Infusionsflaschenstopfen von Cephalosporinderivaten.6. Use of cellophane, cellulose acetate, polyamide, polyester or polyurethane as a material for the insulation coating of injection and infusion bottle stoppers of cephalosporin derivatives. 7. Stopfen für Injektions- und Infusionsflaschen, dadurch gekennzeichnet, daß sie mit Kunststoffen mit polaren Molekülgruppen beschichtet sind.7. Stopper for injection and infusion bottles, characterized in that they are coated with plastics with polar groups of molecules. 8. Stopfen für Injektions- und Infusionsflaschen, gemäß Anspruch 7, dadurch gekennzeichnet, daß sie mit Zellglas, Zelluloseacetat, Polyamid, Polyester oder Polyurethan beschichtet sind.8. Stopper for injection and infusion bottles, according to claim 7, characterized in that they are coated with cellophane, cellulose acetate, polyamide, polyester or polyurethane. 9. Verfahren zur Isolationsbeschichtung von Stopfen für Injektions- und Infusionsflaschen, dadurch gekennzeichnet, daß man die Stopfen oder deren Zapfen mit Kunststoffen mit polaren Molekülgruppen beschichtet.9. Process for the insulation coating of stoppers for injection and infusion bottles, characterized in that the stoppers or their cones are coated with plastics with polar groups of molecules.
EP19880113125 1987-08-19 1988-08-12 Use of plastics with polar molecule groups for isolation coating of plugs for injection and infusion bottles and coated plugs for injection and infusion bottles Withdrawn EP0303984A3 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE3727626 1987-08-19
DE19873727626 DE3727626A1 (en) 1987-08-19 1987-08-19 USE OF PLASTICS WITH POLAR MOLECULE GROUPS FOR THE INSULATION COATING OF INJECTION PLUGS AND INFUSION PLUGS AND COATED INJECTION AND INFUSION PLUGS

Publications (2)

Publication Number Publication Date
EP0303984A2 true EP0303984A2 (en) 1989-02-22
EP0303984A3 EP0303984A3 (en) 1990-11-28

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EP19880113125 Withdrawn EP0303984A3 (en) 1987-08-19 1988-08-12 Use of plastics with polar molecule groups for isolation coating of plugs for injection and infusion bottles and coated plugs for injection and infusion bottles

Country Status (10)

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US (1) US4977027A (en)
EP (1) EP0303984A3 (en)
JP (1) JPS6470056A (en)
KR (1) KR890003844A (en)
AU (1) AU608885B2 (en)
DE (1) DE3727626A1 (en)
DK (1) DK464888A (en)
IL (1) IL87481A (en)
PT (1) PT88292A (en)
ZA (1) ZA886088B (en)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3727627A1 (en) * 1987-08-19 1989-03-09 Hoechst Ag USE OF FILMS FROM PLASTICS WITH POLAR MOLECULE GROUPS AS A PRIMARY PACKING AGENT FOR SS-LACTAM-ANTIBIOTICS AND PLASTIC BAGS
DE19531559A1 (en) * 1995-08-28 1997-03-06 Basf Lacke & Farben Powder-coated container closure
JP2000288067A (en) * 1999-04-02 2000-10-17 Sumitomo Pharmaceut Co Ltd Storage container of human growth hormone-containing weakly acidic solution preparation, cartridge for injection thereof, and storage method thereof
CN110384704A (en) * 2019-07-25 2019-10-29 汕头金石粉针剂有限公司 A kind of cefodizime sodium for injection and preparation method thereof
JP2021187118A (en) * 2020-06-03 2021-12-13 大日本印刷株式会社 Method for manufacturing rubber bonded body and rubber bonded material

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3993751A (en) * 1972-11-27 1976-11-23 Cybersol, Inc. Process for stabilizing therapeutic compositions and article
US4254884A (en) * 1978-10-20 1981-03-10 Toppan Printing Co., Ltd. Plug body for a container
JPS5571268A (en) * 1978-11-17 1980-05-29 Tsukasa Eguchi Sealing rubber stopper
DE3346351A1 (en) * 1983-12-22 1985-07-11 Pharma-Gummi Wimmer West Gmbh, 5180 Eschweiler PHARMACEUTICAL PLUG, PISTON OD. DGL. AND METHOD FOR PRODUCING PHARMACEUTICAL PLUGS, PISTON OD. DGL.
JPS61247459A (en) * 1985-04-25 1986-11-04 テルモ株式会社 Plug body for medical container

Also Published As

Publication number Publication date
PT88292A (en) 1989-06-30
DK464888D0 (en) 1988-08-18
US4977027A (en) 1990-12-11
DE3727626C2 (en) 1989-12-07
ZA886088B (en) 1989-04-26
JPS6470056A (en) 1989-03-15
AU608885B2 (en) 1991-04-18
AU2105688A (en) 1989-02-23
JPH0523786B2 (en) 1993-04-05
IL87481A (en) 1993-07-08
IL87481A0 (en) 1989-01-31
DK464888A (en) 1989-02-20
KR890003844A (en) 1989-04-18
DE3727626A1 (en) 1989-03-02
EP0303984A3 (en) 1990-11-28

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