Stable, concentrated radionuclide complex solutions

  • US 20200030464A1
  • Filed: 10/30/2018
  • Published: 01/30/2020
  • Est. Priority Date: 07/25/2018
  • Status: Active Grant
First Claim
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1. A process for manufacturing a pharmaceutical aqueous solution, comprising:

  • providing a solution comprising a complex of the radionuclide 177Lu (Lutetium-177) and a somatostatin receptor binding peptide linked to the chelating agent DOTA;

    a first stabilizer against radiolytic degradation, and optionally a second stabilizer against radiolytic degradation different from the first stabilizer; and

    diluting the solution comprising the complex with an aqueous dilution solution comprising at least one stabilizer against radiolytic degradation to obtain the pharmaceutical aqueous solution;

    wherein if the solution comprising the complex comprises only the first stabilizer as an stabilizer against radiolytic degradation and not the second stabilizer, then the aqueous dilution solution comprises at least one stabilizer against radiolytic degradation that is different from the first stabilizer, and in the obtained pharmaceutical aqueous solution, the radionuclide 177Lu is present in a concentration that it provides a volumetric radioactivity of from 250 to 500 MBq/mL and the stabilizers are present in a total concentration of from 1.0 to 5.0 mg/mL.

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