RESUMO
The aim of this paper was to describe the optimized labeling protocol and quality control measures used in the production of [(90)Y]DOTATOC, starting from three different radioactivity levels to treat one, two, or three patients per therapeutic session. We investigated three different starting radioactivity levels. For the low radioactivity preparation we used 5138±280 MBq of [Y] isotope, for the medium radioactivity preparation we used 8893±900 MBq, and for the high radioactivity preparation we used 11250±715 MBq. The radiochemical purity levels for the low radioactivity preparation, medium radioactivity preparation, and high radioactivity preparation were 99.95±0.09, 99.84±0.34, and 99.84±0.53%, respectively, and the radiochemical yields of the labeling procedures were 77.52±1.28, 75.53±3.72, and 78.00±3.20%, respectively. Media fill validation of the process was performed, and the parameters of pH, bacterial endotoxins, sterility, and osmolality were tested at process control. All radiopharmaceutical preparations satisfied the predetermined specifications fixed in our protocol regardless of the starting radioactivity level. The validation of the method guaranteed the safety and quality of the final products, contributing to providing the basis for constructing an informative and successful clinical trial.
Assuntos
Tumores Neuroendócrinos/tratamento farmacológico , Tumores Neuroendócrinos/radioterapia , Octreotida/análogos & derivados , Bactérias/metabolismo , Química Farmacêutica/métodos , Endotoxinas/metabolismo , Neoplasias Gastrointestinais/tratamento farmacológico , Neoplasias Gastrointestinais/radioterapia , Humanos , Concentração de Íons de Hidrogênio , Metástase Neoplásica , Octreotida/química , Octreotida/farmacologia , Concentração Osmolar , Controle de Qualidade , Reprodutibilidade dos TestesRESUMO
We proposed a method of synthesis to produce [11C]Choline using TRACERlab FXc module that utilized gas phase iodination. The product had radiochemical purity of 99.79 ± 0.14 % and specific activity of 45.7 ± 7.59 GBq/µmol. [11C]Choline did not have at the moment a specific monograph in European Pharmacopeia therefore we used, when possible, as quality controls reference the monograph of [18F]FDG and we proposed suitable methods to verify radiochemical purity and to quantify residual DMAE and choline amounts.
