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 vial 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.
• the 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 reliable exact volume metering of the materials to be dried are just as crucial for production-based production Solution into the container without solution reaching the ampoule neck or the vial rim, as well as avoiding all circumstances which can lead to product residues in the spit or shoulder of the ampoules or between the contact and sealing surface between the vial and stopper.
• the latter contributes decisively to ensuring the removability of the declared dose as well as risks to product stability that occur in the event of product buildup on the sealing surface of the vial rim with the help of ensuring the content homogeneity in the individual ampoules or vials of a batch and the content conformity from batch to batch Avoid plug caused by insufficient sealing.
• 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.
• the object of the present invention is to avoid the disadvantages described above.
• This object has been achieved in that surface-coated glasses are used in the production of lyophilisates and in primary packaging for lyophilisates by means of siliconization.
• siliconized glass surfaces are used under the designation "glass grade II” (Hartke, Mutschler, editor, DAB 9 commentary, volume I, page 353, Scientific publishing company 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 particularly important 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); U.S. P 2,504,482; GB patent 702,292.
• 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 glass adsorption; Franz et al. U.S.-P 3,717,498.
• a further embodiment of the invention relates to a method for preventing the product rejection of lyophilisates by placing the product to be lyophilized in glass primary packaging material coated on the inside with a silicone layer and lyophilizing to form a compact product template.
• Baysilon H® is an aqueous emulsion made of polydimethylsiloxane from Bayer AG, Leverkusen, Germany.
• the silicone is dried or stoved in a continuous oven, the throughput time being 40 minutes at a temperature of 300 ° C.
• the siliconized ampoules are subjected to a three-time washing process with bi-distilled water at 50 ° C and a subsequent sterilization phase of 3 minutes at 300 ° C without damaging the silicone film.
• a solution 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 was prepared for injections.
• This solution was metered in volume in alternatively 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, as described above.
• the glass ampoules containing PGE 1 solution were then subjected to a standard lyophilization process and the same process, but with variations in freeze-drying time, temperature and drying time.
• the ampoules are finally removed from the chamber and sealed by melting the ampoule ends.

Landscapes

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

Applications Claiming Priority (2)

Publications (3)

Family

ID=6405912

Family Applications (1)

Country Status (8)

Cited By (2)

Families Citing this family (9)

Citations (2)

Family Cites Families (9)

• 1990
  • 1990-05-08 DE DE19904014665 patent/DE4014665C2/de not_active Expired - Lifetime
• 1991
  • 1991-05-01 JP JP9993391A patent/JP3293840B2/ja not_active Expired - Fee Related
  • 1991-05-02 AT AT91107100T patent/ATE125223T1/de not_active IP Right Cessation
  • 1991-05-02 DK DK91107100T patent/DK0456113T3/da active
  • 1991-05-02 EP EP19910107100 patent/EP0456113B1/fr not_active Revoked
  • 1991-05-02 ES ES91107100T patent/ES2075909T3/es not_active Expired - Lifetime
  • 1991-05-02 DE DE59106007T patent/DE59106007D1/de not_active Revoked
• 1992
  • 1992-11-05 US US07/972,076 patent/US5335769A/en not_active Expired - Lifetime
• 1995
  • 1995-09-13 GR GR950402488T patent/GR3017371T3/el unknown

Patent Citations (2)

Non-Patent Citations (1)

Also Published As

Similar Documents

Legal Events