Stabilized and lyophilized radiopharmaceutical agents

A - Human Necessities – 61 – K

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A61K 51/00 (2006.01)

Patent

CA 2570964

A novel method is set out of preparation of radioactive diagnostic radiopharmaceutical in a stable, shippable, lyophilized form by an apparatus designed to rapidly flash freeze and dehydrate a radiopharmaceutical composition to minimize auto radiolysis. The method proposes rapid cooling and removal of ambient vapor, and then ultra cold removal when the potential of explosive liquid oxygen is eliminated. The radioactive diagnostic radiopharmaceutical requires no further cold or refrigerated storage, including with respect to shipping, subsequent to stabilization. The preferred composition can be reconstituted "on site" by the addition of a suitable diluent to bring the radiopharmaceutical complex into solution at a desired concentration.

La présente invention a trait à un nouveau procédé pour la préparation d'agent radiopharmaceutique de diagnostic radioactif sous forme stable, expédiable, lyophilisée par un appareil destiné à la congélation et déshydratation rapide d'une composition radiopharmaceutique en vue de minimiser la radiolyse. Le procédé propose le refroidissement rapide et l'élimination de la vapeur ambiante, suivis de l'élimination du froid extrême lors de l'élimination du potentiel d'oxygène liquide explosif. L'agent radiopharmaceutique de diagnostic radioactif ne nécessite aucun stockage à froid ou réfrigéré supplémentaire, y compris lors du transport, suite à la stabilisation. La composition préférée peut être reconstituée sur place par l'ajout d'un diluent approprié pour transformer le complexe radiopharmaceutique en solution à une concentration souhaitée.

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