Stock material or miscellaneous articles – Hollow or container type article – Glass – ceramic – or sintered – fused – fired – or calcined metal...
Reexamination Certificate
1997-06-02
2003-03-25
Nolan, Sandra M. (Department: 1772)
Stock material or miscellaneous articles
Hollow or container type article
Glass, ceramic, or sintered, fused, fired, or calcined metal...
C065S060500, C065S060530, C428S426000, C428S428000, C428S446000, C428S698000
Reexamination Certificate
active
06537626
ABSTRACT:
BACKGROUND OF THE INVENTION
Glass containers for the storage of pharmaceutical or diagnostic solutions are intended to come into direct contact with such solutions. Different types of glass containers are used, such as ampuls, small bottles, injection bottles for prefabricated syringes, cylindrical ampuls and container for the taking of blood and blood samples.
It is known with respect to all glass container—seven glass containers made from borosilicate glass which are classified in the highest quality class in accordance with the pharmacopeias (such as the Deutsches Arzneibuch [German Pharmaceutical Book] DAB 10)—that interactions can be documented between the solutions and the glass surface. However, the interactions in the case of glass containers made from lime-natron glass are even substantially greater.
The interaction is based primarily on the leaching of alkalic substances from the glass surface through the aqueous solution. While the solution is being stored, this leaching can lead to an undesired increase in the pH-value (such as in the case of water for injection purposes) of several pH units (see B. Borchert et al., J. of Parenteral Science & Technology, Vol. 43, No. 2 March/April 1989).
With some medications, it is also possible for a portion of the active ingredient to be inactivated by ions dissolved from the glass, which is particularly disruptive in low dosed medications.
SUMMARY OF THE INVENTION
The task of the invention therefore consists of finding a glass container for the storage of pharmaceutical or diagnostic solutions which behaves in a largely inert manner vis a vis these solutions, i.e., a glass container in which the quantity of ions leached from the glass through the solutions is minimized.
This problem is solved by the glass container, specifically for the storage of pharmaceutical or diagnostic solutions, characterized by the fact, that the surface which comes into contact with the solutions is coated with a layer of oxides and/or nitrides of the elements Si, Ti, Ta, Al or mixtures thereof applied by means of a plasma CVD process.
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German Office Action Mar. 12, 1997 (English Translation).
European Search Report Oct. 27, 1997 (German, Not Translated).
Patent Abstracts of Japan vol. 014, No. 446 (C-0763), Sep. 25, 1990 & JP 02 175630 A (Matsumoto Seiyaku Kogyo KK et al), Jul. 6, 1990, Zusammenfassung.
Borchert S.J. et al: “Accelerated Extractable Studies of Borosilicate Glass Containers” Journal of Parenteral Science and Technology, Bd. 43, Nr. 2, Mar. 1, 1989, Seiten 67-79, XP000197458.
Heming Martin
Lohmeyer Manfred
Spallek Michael
Walther Marten
Kilpatrick & Stockton LLP
Marcou George T.
Nolan Sandra M.
Schott Glaswerke
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