Stable radiopharmaceutical compositions and methods for...

A - Human Necessities – 61 – K

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A61K 51/04 (2006.01) A61K 51/08 (2006.01)

Patent

CA 2413538

The present invention provides stable radiopharmaceutical compositions including a therapeutic radionuclide and an effective stabilizing amount of an aromatic stabilizer (e.g., a polyhydroxylated aromatic compound, an aromatic amine, or a hydroxylated aromatic amine), alone or in combination with other antioxidants or stabilizers, to inhibit radiolytic degradation of radiopharmaceuticals. The present invention also provides improved radiopharmaceutical formulations by the use of an aromatic stabilizing agent (e.g., a polyhydroxylated aromatic compound, an aromatic amines, or a hydroxylated aromatic amine), and/or low temperature storage. The present invention also provides processes for making stable radiopharmaceutical compositions. The present invention also provides the use of the pharmaceutical compositions in medical therapy and/or medical diagnosis.

L'invention concerne des compositions radiopharmaceutiques stables contenant un radionucléide thérapeutique et une quantité stabilisante efficace d'un stabilisant aromatique (par exemple, un composé aromatique polyhydroxylé, une amine aromatique, ou une amine aromatique hydroxylée), seul ou combiné avec d'autres antioxydants ou stabilisants, afin d'empêcher la détérioration radiolytique des produits radiopharmaceutiques. La présente invention concerne des préparations radiopharmaceutiques améliorées grâce à l'utilisation d'un agent stabilisant aromatique (par exemple, un composé aromatique polyhydroxylé, une amine aromatique, ou une amine aromatique hydroxylée), et/ou au stockage à basse température. L'invention concerne également des procédés permettant de fabriquer ces compositions radiopharmaceutiques, ainsi que l'utilisation de telles compositions à des fins de thérapie médicale et/ou de diagnostic médical.

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