Patent No. EP4541379 (titled "Stable, Concentrated Radionuclide Complex Solutions") was filed by Advanced Accelerator Applications on Sep 25, 2018. The application was issued on Nov 19, 2025.
A process for manufacturing a pharmaceutical aqueous solution involves forming a complex of $^{177}\text{Lu}$ and DOTA-TATE. This is achieved by mixing an aqueous $^{177}\text{Lu}$ solution with an aqueous DOTA-TATE solution containing a first stabilizer (gentisic acid, ascorbic acid, or their salts) and heating the mixture. The resulting complex solution is then diluted with an aqueous dilution solution containing a second stabilizer (gentisic acid, ascorbic acid, or their salts). The final pharmaceutical aqueous solution contains less than 5% ethanol by weight (w/w%), provides a radioactive dose of 7.4 GBq, and has a total volume between 20.5 and 25.0 mL. The solution is designed for high chemical and radiochemical stability for the treatment of neuroendocrine tumors.

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