Filter sterilization for production of colloidal,...

A - Human Necessities – 61 – K

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A61K 49/00 (2006.01) A61K 49/18 (2006.01) A61L 2/00 (2006.01) A61L 2/02 (2006.01) A61L 2/025 (2006.01) G01N 24/00 (2006.01)

Patent

CA 2075994

2075994 9112025 PCTABS00006 An improvement is provided to a method for obtaining an in vivo MR image of an organ or tissue of an animal or human subject, of the type including administering to the subject as a contrast agent to enhance such MR image an effective amount of a colloid including superparamagnetic metal oxide particles dispersed in a physiologically acceptable carrier. In accordance with the improvement, the method includes preparing the colloid in a manner that provides a reduction in toxicity in comparison with that associated with administration of the colloid after terminal sterilization. The improvement may include sterilizing the colloid by filtration. In an additional embodiment, the colloid may be sterilized by filtration and preserved by lyophilization. The colloid may be lyophilized in the presence of a compatible excipient. The excipient utilized may include a dextran or a citrate anion. Other embodiments include related compositions and methods.

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