Scholarlink

Background <p>Sodium <sup>18</sup>F-fluoride for injection can be easily cyclotron-produced and purified, as a simple inorganic salt, by adsorption/desorption onto an anion-exchange cartridge and then dispensed for clinical use. Since the clinical demand for this radiopharmaceutical is constantly increasing, this study aimed to design and develop a simple, fully automated method for the in-house, rapid, and efficient processing and dispensing of injectable solutions of Sodium <sup>18</sup>F-fluoride without the need of a synthesis module and disposable kit, but using only the dispensing unit.</p> Results <p>A new simple method for the efficient routine production of injectable solutions of [<sup>18</sup>F]NaF was developed through a straightforward modification of the commercial dispenser Clio (Comecer S.p.A., Italy) and without the need of a synthesis module. The full production, processing and dispensing of [<sup>18</sup>F]NaF were entirely carried out on the same batch using only the dispensing module. Process validation was carried according to GMP guidelines to ensure consistency of [<sup>18</sup>F]NaF quality with international standards. The final radiopharmaceutical met all quality criteria specified by Ph. Eur. and chemical, radionuclidic and radiochemical impurities were significantly below the required limits.</p> Conclusion <p>A new simple and reliable procedure developed for the preparation and dispensing of injectable [<sup>18</sup>F]NaF in less than 10&#xa0;min with a radiochemical yield &gt; 97% (decay corrected) has been successfully developed. Notably, the proposed method also allows the preparation of [<sup>18</sup>F]NaF using the residual fluorine-18 activity remaining after a [<sup>18</sup>F]FDG production run, thus making it immediately accessible to patients for further PET imaging investigations.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Development of an automated method for in-house production of sodium 18F-fluoride for injection: process validation as a step toward routine clinical application

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年2月4日

查看全文
  • Marija Atanasova Lazareva,
  • Maja Chochevska,
  • Katerina Kolevska,
  • Maja Velickovska,
  • Filip Jolevski,
  • Paulina Apostolova,
  • Ana Ugrinska,
  • Emilija Janevik-Ivanovska

摘要

Background

Sodium 18F-fluoride for injection can be easily cyclotron-produced and purified, as a simple inorganic salt, by adsorption/desorption onto an anion-exchange cartridge and then dispensed for clinical use. Since the clinical demand for this radiopharmaceutical is constantly increasing, this study aimed to design and develop a simple, fully automated method for the in-house, rapid, and efficient processing and dispensing of injectable solutions of Sodium 18F-fluoride without the need of a synthesis module and disposable kit, but using only the dispensing unit.

Results

A new simple method for the efficient routine production of injectable solutions of [18F]NaF was developed through a straightforward modification of the commercial dispenser Clio (Comecer S.p.A., Italy) and without the need of a synthesis module. The full production, processing and dispensing of [18F]NaF were entirely carried out on the same batch using only the dispensing module. Process validation was carried according to GMP guidelines to ensure consistency of [18F]NaF quality with international standards. The final radiopharmaceutical met all quality criteria specified by Ph. Eur. and chemical, radionuclidic and radiochemical impurities were significantly below the required limits.

Conclusion

A new simple and reliable procedure developed for the preparation and dispensing of injectable [18F]NaF in less than 10 min with a radiochemical yield > 97% (decay corrected) has been successfully developed. Notably, the proposed method also allows the preparation of [18F]NaF using the residual fluorine-18 activity remaining after a [18F]FDG production run, thus making it immediately accessible to patients for further PET imaging investigations.