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Freeze-dried multi-dose kits for the fast preparation of 177Lu-Tyr3-octreotide and 177Lu-PSMA(inhibitor) under GMP conditions

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Abstract

177Lu-Tyr3-octreotide and 177Lu-PSMA(inhibitor) radiopeptides were obtained with radiochemical purities of 98.7–100%, from lyophilized formulations after reconstitution with sterile solutions of 177LuCl3 (40 GBq/mL) without the need for further purification or sterilization processes. More than 50 radiochemical syntheses were performed with a failure rate of 0% and radiochemical yields of 94–97%. From one lyophilized kit of DOTA-Tyr3-octreotide or DOTA-iPSMA, it was possible to obtain from 5 (7.4 GBq) to 10 (3.7 GBq) doses suitable for patients. Also, by using a sterile solution of 177LuCl3 approved as a radiopharmaceutical precursor for human use, it is possible to obtain GMP-compliant 177Lu-peptides from sterile freeze-dried formulations without the need of using commercially-available radiochemical synthesizers.

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Acknowledgements

This research was carried out as part of the activities of the “Laboratorio Nacional de Investigación y Desarrollo de Radiofármacos, (Mexican National Council of Science and Technology, CONACyT)”.

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Authors and Affiliations

  1. Department of Radioactive Materials, Instituto Nacional de Investigaciones Nucleares, Carretera México-Toluca S/N, 52750, Ocoyoacac, Estado de México, Mexico

    Myrna Luna-Gutiérrez, Tania Hernández-Jiménez, Luis Serrano-Espinoza, Alejandro Peña-Flores & Airam Soto-Abundiz

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  1. Myrna Luna-Gutiérrez
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  2. Tania Hernández-Jiménez
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  3. Luis Serrano-Espinoza
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  4. Alejandro Peña-Flores
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  5. Airam Soto-Abundiz
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Correspondence to Myrna Luna-Gutiérrez.

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Luna-Gutiérrez, M., Hernández-Jiménez, T., Serrano-Espinoza, L. et al. Freeze-dried multi-dose kits for the fast preparation of 177Lu-Tyr3-octreotide and 177Lu-PSMA(inhibitor) under GMP conditions. J Radioanal Nucl Chem 314, 2181–2188 (2017). https://doi.org/10.1007/s10967-017-5595-1

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  • DOI: https://doi.org/10.1007/s10967-017-5595-1

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