Stable formulations for radionuclide complexes
AssigneeITM Solucin GmbH
InventorsSebastian Marx, Oliver Leib, Luke Heames, Elena Maria Andreolli
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Abstract
The present invention provides a pharmaceutical composition comprising a radiolabeled complex comprising a radionuclide and a targeting molecule linked to a chelating agent; and a stabilizer against radiolytic degradation comprising ascorbic acid and/or a salt thereof; wherein the composition does not comprise gentisic acid or a salt thereof. The pharmaceutical composition of the present invention provides high stability against radiolytic degradation. The present invention also provides a process for preparing such a pharmaceutical composition.
Claims20
A pharmaceutical composition comprising:
- a) a radiolabeled complex comprising (i) 177Lu (Lutetium-177) and (ii) a cell-targeting molecule linked to a chelating agent;
- and
- b) a stabilizer against radiolytic degradation comprising 40 to 60 mg/ml of sodium ascorbate, and 1.11 mg/ml±1.1 mg/ml ascorbic acid, wherein the weight ratio of sodium ascorbate:ascorbic acid is between 30:1 and 70:1,
- wherein the composition does not comprise (i) gentisic acid or a salt thereof and does not comprise (ii) a sequestering agent, and wherein the composition retains greater than 98% radiochemical purity (RCP) for at least 96 hours after end of synthesis (EOS).
Dependencies are inferred from the claim text.