Medical Cyclotron Facility, Regional Centre, Board of Radiation and Isotope Technology, Kolkata, India.
Variable Energy Cyclotron Centre, Homi Bhabha National Institute, Kolkata, India.
Appl Radiat Isot. 2022 Jan;179:110035. doi: 10.1016/j.apradiso.2021.110035. Epub 2021 Nov 19.
A fully automated large-scale production of sodium [F]fluoride ([F]NaF) using SYNTHERA module with a modification in integrated fluidic processor (IFP) is reported. This modified IFP module is used to prepare [F]NaF with more than 98% non-decay corrected radiochemical yield (RCY) within 5 min with specifications in accordance with United State Pharmacopeia (USP) monograph. The graphical user interface (GUI) is designed to perform the synthesis steps either manually or automatically and give information to the operator during the course of production. The desired clinical results add support to indigenously produced [F]NaF as a pharmaceutical grade diagnostic radiopharmaceutical.
本文报道了一种使用 SYNTHERA 模块，通过在集成流控处理器（IFP）中进行改进，实现[F]氟化物（[F]NaF）全自动大规模生产的方法。该改进后的 IFP 模块可在 5 分钟内以超过 98%的非衰变校正放射性化学产率（RCY）制备[F]NaF，符合美国药典（USP）专论的要求。图形用户界面（GUI）用于手动或自动执行合成步骤，并在生产过程中向操作人员提供信息。理想的临床效果支持国产[F]NaF作为一种制药级诊断放射性药物。
