Awad Eman, Ali Hatim, Lamb James, Al-Momani Ehab
Department of Radiopharmacy, Cyclomedical International, Inc., Knoxville, TN 37922, USA.
Department of Nuclear Medicine, University Hospital Würzburg, 97080, Würzburg, Germany.
Curr Radiopharm. 2022;15(4):341-346. doi: 10.2174/1874471015666220518115244.
The worldwide usage of [F]-sodium fluoride in clinical applications has increased the interest in the facility of its production. The development of a new automated method for multi-preparations of [F]-NaF and [F]FDG on an Explora FDG4 module is described. Explora FDG4 is one of the most widely used synthesizers for FDG production in daily routine use and is specifically designed to run up to four different productions with a single module. Therefore, slight modifications are carried out in order to increase the potential of the synthesizer to perform more radiopharmaceuticals.
A fully automated method for multi-preparations of [F]-NaF and [F]FDG using Explora FDG4 was developed. Slight modifications to the Explora's hardware and software configuration were applied. A new elution vial for NaF preparation was installed and connected to the free position to MVP1. Quality control was carried out using the standard analytical methods applied for GMP production.
This modification successfully provides preparation of [F]-NaF without affecting the daily FDG production using one set preparation. [F]-NaF was obtained in a high radiochemical yield (>90%, n=100) in 10 min total preparation time. The quality control results for both obtained products, FDG (RCP >95%) and NaF (RCP >98%), showed that the radiopharmaceuticals were in compliance with USP and Ph.Eur. specifications and compatible with clinical applications.
A rapid and simple method for multi preparations of [F]-NaF and [F]FDG using a single Explora module was designed. Yet, the chemistry module has the potential to generate more radiopharmaceuticals to decrease the cost of preparation of [F]-NaF compared to the cassette-based synthesizers, reducing radiation exposure resulting from manual preparations and increasing the reproducibility of [F]-NaF preparation.
[F] - 氟化钠在临床应用中的全球使用量增加，引发了人们对其生产设施的兴趣。本文描述了一种在Explora FDG4模块上用于多种制剂的[F] - NaF和[F] - FDG的新型自动化制备方法。Explora FDG4是日常生产中最广泛用于生产FDG的合成仪之一，专门设计为使用单个模块运行多达四种不同的生产。因此，进行了一些轻微修改，以提高合成仪生产更多放射性药物的潜力。
开发了一种使用Explora FDG4进行[F] - NaF和[F] - FDG多种制剂的全自动方法。对Explora的硬件和软件配置进行了轻微修改。安装了一个用于制备NaF的新洗脱瓶，并将其连接到MVP1的空闲位置。使用适用于GMP生产的标准分析方法进行质量控制。
这种修改成功地实现了[F] - NaF的制备，且不影响使用一组制剂进行的日常FDG生产。在总共10分钟的制备时间内，以高放射化学产率（> 90%，n = 100）获得了[F] - NaF。所获得的两种产品FDG（放射性化学纯度> 95%）和NaF（放射性化学纯度> 98%）的质量控制结果表明，这些放射性药物符合美国药典和欧洲药典的规格，并且与临床应用兼容。
设计了一种使用单个Explora模块快速简便地制备[F] - NaF和[F] - FDG多种制剂的方法。然而，与基于盒式的合成仪相比，该化学模块有潜力生产更多放射性药物，以降低[F] - NaF的制备成本，减少手动制备导致的辐射暴露，并提高[F] - NaF制备的重现性。
