Stable therapeutic radionuclide compositions and methods for preparation thereof
OwnerJean-Luc Vanderheyden, Alan R. Fritzberg +3inventors
InventorsJean-Luc Vanderheyden, Alan R. Fritzberg, Joseph E. Bugaj, Fu-Min Su, Prasanna Venkatesan
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Abstract
Stable therapeutic radionuclide compositions comprising, for example, .sup.186 Re, .sup.188 Re and .sup.131 I stably bound to a proteinaceous targeting moiety and suitable for human in vivo administration are disclosed. Stabilizing agents preferably comprise antioxidants and challenging agents, and combination of HSA with an antioxidant and/or challenging agent provides enhanced long term stability. Ascorbic acid is an especially preferred stabilizing agent, which provides stability of therapeutic radionuclide compositions at levels of at least about 90% for several hours up to several days.
Claims12
A stable purified therapeutic radionuclide preparation suitable for in vivo administration comprising a therapeutic radionuclide selected from the group consisting of .sup.186 Re;
- .sup.188 Re;
- and mixtures thereof linked to a proteinaceous targeting moiety, the therapeutic radionuclide preparation also comprising an effective amount of a stabilizing agent comprising ascorbic acid, wherein the radiochemical purity of the therapeutic radionuclide preparation is maintained at a level of at least about 90% for at least about 4 hours.
A therapeutic radionuclide preparation comprising a rhenium radionuclide stably linked to a proteinaceous targeting moiety which retains at least about 90% radiochemical purity during in vitro storage periods of at least about 4 hours in the presence of a stabilizing agent comprising ascorbic acid.
A pharmaceutically acceptable preparation having therapeutic properties comprising:
- a therapeutic radionuclide selected from the group consisting of .sup.186 Re;
- .sup.188 Re;
- and mixtures thereof stably linked to a proteinaceous targeting moiety;
- an effective amount of stabilizing agent comprising ascorbic acid and a pharmaceutically acceptable carrier or diluent.
Dependencies are inferred from the claim text.