Biocompatible pharmaceutical articles

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Reexamination Certificate

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Details

C604S272000

Reexamination Certificate

active

06800073

ABSTRACT:

FIELD OF THE INVENTION
The present application relates to pharmaceutical articles that come into contact with pharmaceutically active materials and are compatible with the same.
BACKGROUND OF THE INVENTION
Pharmaceutically active materials typically come into contact with other materials at various points in the product life cycle, including manufacture, analysis, storage and delivery. Frequently, these other materials are constructed of a material component that is believed to be compatible with the pharmaceutically active material.
For instance, it is known to contact pharmaceutically active materials with various pharmaceutical articles, including medical devices as well as manufacturing, storage and transport equipment, which have metallic and/or polymeric components. Metallic components selected for this purpose are numerous and include certain titanium alloys (e.g., nickel-titanium super-elastic alloys such as nitinol) and stainless steel. These materials are commonly used for this purpose as they are formable, have desirable mechanical properties and are commonly believed to be substantially inert. Also used are numerous polymeric components that are commonly believed to be substantially inert, including certain polycarbonate, polyimide, acrylonitrile/butadiene/styrene resin, poly ether ether ketone, epoxy, and nylon materials.
The present inventors have found, however, that such materials can be relatively incompatible with certain pharmaceutically active materials. As a result, there is at present a need in the art to overcome these incompatibilities and others like them.


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