	US 12,144,873 B2
	Stable, concentrated radionuclide complex solutions
Donato Barbato, Ivrea (IT); Clementina Brambati, Turin (IT); Daniela Chicco, Albiano d'Ivrea (IT); Francesco de Palo, Ivrea (IT); Lorenza Fugazza, Ivrea (IT); Maurizio Mariani, Ivrea (IT); and Giovanni Tesoriere, Noicattaro (IT)
Assigned to Advanced Accelerator Applications SA, Rueil-Malmaison (FR)
Filed by Advanced Accelerator Applications SA, Rueil-Malmaison (FR)
Filed on Apr. 19, 2024, as Appl. No. 18/640,891.
Application 18/640,891 is a continuation of application No. 18/494,042, filed on Oct. 25, 2023.
Application 18/494,042 is a continuation of application No. 16/827,606, filed on Mar. 23, 2020, granted, now 11,904,027, issued on Feb. 20, 2024.
Application 16/827,606 is a continuation of application No. 16/175,261, filed on Oct. 30, 2018, granted, now 10,596,276, issued on Mar. 24, 2020.
Application 16/175,261 is a continuation in part of application No. 16/140,962, filed on Sep. 25, 2018, abandoned.
Application 16/140,962 is a continuation in part of application No. 16/045,484, filed on Jul. 25, 2018, abandoned.
Prior Publication US 2024/0285812 A1, Aug. 29, 2024
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 51/00 (2006.01); A61K 33/24 (2019.01); A61K 51/04 (2006.01); A61M 36/14 (2006.01); C22B 59/00 (2006.01)

CPC A61K 51/048 (2013.01) [A61K 33/24 (2013.01); C22B 59/00 (2013.01); A61K 51/0482 (2013.01)]

30 Claims

1. A method of treating a tumor in a patient in need thereof, the method comprising administering to the patient 10 mL to 50 ml of a pharmaceutical aqueous solution comprising:

(a) a complex comprising:

(ai) the radionuclide ¹⁷⁷Lu, and

(aii) a somatostatin receptor binding peptide linked to the chelating agent DOTA; and

(b) at least one stabilizer(s) against radiolytic degradation;

wherein:

the at least one stabilizer(s) against radiolytic degradation is/are present in a total concentration of 0.5 mg/mL to 10.0 mg/mL;

the radionuclide is present in the pharmaceutical aqueous solution in a concentration that provides a volumetric radioactivity of 250 to 500 MBq/mL; and

the pharmaceutical aqueous solution comprises less than 2% ethanol.