EP0456113B1 - Emballage de verre interne enduite de silicone contenant un produit lyophilisé - Google Patents

Emballage de verre interne enduite de silicone contenant un produit lyophilisé Download PDF

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Publication number
EP0456113B1
EP0456113B1 EP19910107100 EP91107100A EP0456113B1 EP 0456113 B1 EP0456113 B1 EP 0456113B1 EP 19910107100 EP19910107100 EP 19910107100 EP 91107100 A EP91107100 A EP 91107100A EP 0456113 B1 EP0456113 B1 EP 0456113B1
Authority
EP
European Patent Office
Prior art keywords
product
freeze
silicone
dried solid
glass 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.)
Revoked
Application number
EP19910107100
Other languages
German (de)
English (en)
Other versions
EP0456113A3 (en
EP0456113A2 (fr
Inventor
Karin Dr. Klokkers-Bethke
Wilfried Dr. Fischer
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.)
Sanol Schwarz GmbH
UCB Pharma GmbH
Original Assignee
Sanol Schwarz GmbH
Schwarz Pharma AG
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=6405912&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EP0456113(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Sanol Schwarz GmbH, Schwarz Pharma AG filed Critical Sanol Schwarz GmbH
Publication of EP0456113A2 publication Critical patent/EP0456113A2/fr
Publication of EP0456113A3 publication Critical patent/EP0456113A3/de
Application granted granted Critical
Publication of EP0456113B1 publication Critical patent/EP0456113B1/fr
Anticipated expiration legal-status Critical
Revoked legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06—Ampoules or carpules
    • 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
    • B65D23/02—Linings or internal 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.]
    • Y10T428/131—Glass, ceramic, or sintered, fused, fired, or calcined metal oxide or metal carbide containing [e.g., porcelain, brick, cement, etc.]
    • Y10T428/1317—Multilayer [continuous layer]
    • Y10T428/1321—Polymer or resin containing [i.e., natural or synthetic]
    • 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.]
    • Y10T428/31609—Particulate metal or metal compound-containing
    • Y10T428/31612—As silicone, silane or siloxane

Definitions

  • the invention relates to surface-coated glasses in primary packaging of lyophilisates and their use in the production of lyophilisates.
  • Drugs sensitive to moisture that are to be used parenterally by infusion or injection must be stabilized for storage.
  • a common method is to dry the drug solution using lyophilization.
  • aqueous solutions of the medicinal substances are filled into glass ampoules, vials or sting-cap bottles, frozen and freeze-dried under reduced pressure. Once the drying process has ended, glass ampoules are sealed outside the freeze dryer; vials and sting cap bottles can be sealed in the freeze dryer with the freeze dry stoppers already in place.
  • composition and concentration of the active ingredient solution containing excipients influence the pharmaceutical quality.
  • concentration of the active ingredient solution containing excipients influence the pharmaceutical quality.
  • temperature and pressure curve as well as the time of freeze drying, the layer thickness of the solution to be freeze-dried, the container geometry with regard to the contact surface with the coolable and heatable shelf, and the moisture in the product closure influence the pharmaceutical quality.
  • the product residues in the neck of ampoules can be seen in the visual inspection of the bulk goods (these are the already closed product containers) and must be sorted out.
  • the lack of consistency and shape of the product cake leads to a loss of production or yield in the case of ampoules, which increases the cost of production depending on the raw material and manufacturing costs.
  • the product adhesion between the sealing surface of vials with their plugs is not easily recognizable in the visual inspection of the bulk goods; after the protective caps have been applied, it is completely hidden. This leakage leads to the uncontrolled penetration of air humidity into the vials during storage and thus harbors the risk of hydrolytic decomposition of the active substances.
  • Methyltrimethoxysilane is described as being particularly preferred.
  • the treatment with the silane solutions described there produces a surface film on the glass which is intended to generally reduce powder particle adherence to the glass walls, and to impart increased heat resistance and chemical resistance.
  • the object of the present invention is to avoid the disadvantages described above.
  • This object was achieved in that surface-coated glasses are used in the production of lyophilisates and in primary packaging for lyophilisates by means of siliconization.
  • the aforementioned surface-coated glasses are used for the production of lyophilisates which contain the active ingredient PGE 1.
  • siliconized glass surfaces are used under the designation "glass quality II” (Hartke, Mutschler, editor, DAB 9 commentary, volume I, page 353,ticianliche Verlagsgesellschaft mbH Stuttgart, Govi Verlag GmbH, Frankfurt 1987).
  • siliconization is used in injection bottles and ampoules in order to "facilitate the drainage of liquid residues when emptying, which is of particular importance in the case of expensive filling goods such as antibiotics" (H.Sucker, P.Fuchs, P.Speiser, ed Pharmaceutical technology page 762, Georg Thieme Verlag Stuttgart 1978).
  • Siliconization can also be used on syringes to reduce the friction of the plunger or the stopper (in the case of a two-chamber syringe) with the syringe barrel.
  • siliconization serves to reduce the glass adsorption.
  • a further embodiment of the invention relates to a method for preventing product rejection of lyophilisates by placing the product to be lyophilized in glass primary packaging coated with a silicone layer on the inside and lyophilizing to form a compact product template.
  • the method is advantageously used for products to be lyophilized which contain the active ingredient PGE 1.
  • a solution was prepared with a composition per ampoule of 20 »g PGE1 as an approximately 3% inclusion complex of ⁇ -cyclodextrin and 50 mg lactose ⁇ H2O in 400» l water for injections.
  • This solution was metered in volume into 5 ml glass ampoules, glass grade I, or 5 ml glass ampoules, glass grade I with additional baked-on siliconization, which had been applied with a commercially available aqueous silicone oil emulsion.
  • the lyophilization parameters mentioned in Table 1 below were varied and led to the result listed in each case:

Landscapes

  • Health & Medical Sciences (AREA)
  • Mechanical Engineering (AREA)
  • Hematology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Medicinal Preparation (AREA)
  • Laminated Bodies (AREA)
  • Containers Having Bodies Formed In One Piece (AREA)
  • Packging For Living Organisms, Food Or Medicinal Products That Are Sensitive To Environmental Conditiond (AREA)
  • Wrappers (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Glass Compositions (AREA)
  • Drying Of Solid Materials (AREA)
  • Surface Treatment Of Glass (AREA)
  • Processes Of Treating Macromolecular Substances (AREA)

Claims (4)

  1. Utilisation d'emballages de verre internes enduits de silicone sur la surface intérieure respective du verre en vue de la fabrication de produits lyophilisés.
  2. Utilisation d'emballages de verre internes selon la revendication 1 en vue de la fabrication de produits lyophilisés contenant le principe actif constitué par la PGE₁.
  3. Procédé destiné à éviter les déchets de produits lyophilisés, caractérisé en ce que le produit à lyophiliser est mis dans des emballages de verre internes traités par un revêtement de silicone sur leur face interne respective et que ce produit, qui forme une réserve de produit compacte, est lyophilisé.
  4. Procédé selon la revendication 3, caractérisé en ce que le produit à lyophiliser contient le principe actif constitué par la PGE₁.
EP19910107100 1990-05-08 1991-05-02 Emballage de verre interne enduite de silicone contenant un produit lyophilisé Revoked EP0456113B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE19904014665 DE4014665C2 (de) 1990-05-08 1990-05-08 Oberflächenvergütete Gläser in Primärpackmitteln von Lyophilisaten und deren Verwendung bei der Herstellung von Lyophilisaten
DE4014665 1990-05-08

Publications (3)

Publication Number Publication Date
EP0456113A2 EP0456113A2 (fr) 1991-11-13
EP0456113A3 EP0456113A3 (en) 1992-11-25
EP0456113B1 true EP0456113B1 (fr) 1995-07-19

Family

ID=6405912

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19910107100 Revoked EP0456113B1 (fr) 1990-05-08 1991-05-02 Emballage de verre interne enduite de silicone contenant un produit lyophilisé

Country Status (8)

Country Link
US (1) US5335769A (fr)
EP (1) EP0456113B1 (fr)
JP (1) JP3293840B2 (fr)
AT (1) ATE125223T1 (fr)
DE (2) DE4014665C2 (fr)
DK (1) DK0456113T3 (fr)
ES (1) ES2075909T3 (fr)
GR (1) GR3017371T3 (fr)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5531683A (en) * 1992-08-13 1996-07-02 Science Incorporated Mixing and delivery syringe assembly
US5595687A (en) * 1992-10-30 1997-01-21 Thomas Jefferson University Emulsion stability
DE19535669A1 (de) * 1995-09-26 1997-04-03 4P Rube Goettingen Gmbh Behälter
US20030190307A1 (en) 1996-12-24 2003-10-09 Biogen, Inc. Stable liquid interferon formulations
WO2003061687A1 (fr) * 2002-01-18 2003-07-31 Asahi Kasei Pharma Corporation Preparation a concentration elevee de thrombomoduline soluble
US8372419B2 (en) * 2004-03-10 2013-02-12 Scil Technology Gmbh Coated implants, their manufacturing and use thereof
US7784638B2 (en) * 2005-02-03 2010-08-31 Wki Holding Company, Inc. Glassware with silicone support
US7575127B2 (en) * 2005-02-03 2009-08-18 Wki Holding Company, Inc. Glassware with silicone gripping surfaces
US7943189B2 (en) 2007-10-26 2011-05-17 Lee Ferrell Food preservation packaging system
USD620817S1 (en) 2009-03-21 2010-08-03 Wki Holding Company, Inc. Measuring container
EP2861526A4 (fr) * 2012-06-18 2015-12-16 Innova Dynamics Inc Réduction d'agglomération dans une suspension de nanofils stockée dans un conteneur

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2504482A (en) * 1949-06-17 1950-04-18 Premo Pharmaceutical Lab Inc Drain-clear container for aqueous-vehicle liquid pharmaceutical preparations
GB702292A (en) * 1950-09-13 1954-01-13 Pfizer & Co C Improvements in or relating to liquid containers
DE1621011A1 (de) * 1967-04-13 1971-04-29 Telefunken Patent Verfahren zum Oberflaechenvergueten von Bauteilen
US3654926A (en) * 1969-11-17 1972-04-11 Parke Davis & Co Mixing vial
GB1488006A (en) * 1974-02-13 1977-10-05 Ono Pharmaceutical Co Prostaglandin analogues
US3954787A (en) * 1974-06-18 1976-05-04 Pfizer Inc. Stabilized E-series prostaglandins
US3952004A (en) * 1974-06-18 1976-04-20 Pfizer Inc. Stabilized E-series prostaglandins
JPS6021936B2 (ja) * 1978-01-18 1985-05-30 武田薬品工業株式会社 ガラス成形品の表面処理方法
US4289648A (en) * 1979-03-20 1981-09-15 Ortho Diagnostics, Inc. Blood gas controls composition, method and apparatus
US4254456A (en) * 1980-02-27 1981-03-03 General Electric Company Luminaire for assembly line
DE3707213A1 (de) * 1987-03-06 1988-09-15 Behringwerke Ag Verfahren zur herstellung von faktor viii:c-mangelplasma und ein so erhaltenes mangelplasma

Also Published As

Publication number Publication date
GR3017371T3 (en) 1995-12-31
DE4014665C2 (de) 1994-06-01
US5335769A (en) 1994-08-09
DE59106007D1 (de) 1995-08-24
DE4014665A1 (de) 1991-11-14
EP0456113A3 (en) 1992-11-25
JP3293840B2 (ja) 2002-06-17
ATE125223T1 (de) 1995-08-15
ES2075909T3 (es) 1995-10-16
DK0456113T3 (da) 1995-12-11
EP0456113A2 (fr) 1991-11-13
JPH05261138A (ja) 1993-10-12

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