Department of Nuclear Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan.
Ann Nucl Med. 2010 Apr;24(3):149-55. doi: 10.1007/s12149-010-0343-4. Epub 2010 Feb 23.
"Sodium fluoride ((18)F) injection" is an isotonic NaCl solution containing [(18)F]NaF to be used as bone imaging agent. Although its NDA was approved by the US FDA in 1972, it has not been commercially available since 1975 due to mostly the popularity of (99m)Tc-MDP. Recently, advances in PET/CT technology and the often interrupted (99m)Tc supply have led to the renewed interest in the use of [(18)F]NaF to detect bone metastases in cancer patients. This report introduces an efficient, low-cost and aseptic preparation of "Sodium fluoride ((18)F) injection" for PET scan.
(18)F-Fluoride in target water from cyclotron was adsorbed onto four different forms of anion-exchange resins then desorbed by isotonic NaCl solution into the product vial. One of the resins that yielded the product at the suitable pH was used for the aseptic preparation. The components for this setup, including stopcocks, extension tubes, etc., were all single-use, individually packed and sterile. The process was done in a lead-line isolator maintained in grade A (PIC/S) aseptic condition. The quality of the obtained "Sodium fluoride ((18)F) injection" was analyzed according to its monograph in the European Pharmacopoeia (EP).
The resin in the chloride form yielded the product of pH 6.7 and was chosen for the subsequent preparation. The radiochemical yield was quantitative. The product met all criteria specified in EP, including biological, physical and chemical specifications.
This method is an efficient, space-saving and extremely low-cost operation that easily performed in an aseptic environment meeting GMP standard. The quality of the "Sodium fluoride ((18)F) injection" so yielded meets EP specifications. This setup provides hospital with facility meeting GMP standard a cost effective and efficient method for "Sodium fluoride ((18)F) injection" production without the need for the expensive automatic module and extra QC instrument.
“氟化钠 ((18)F) 注射液”是一种等渗 NaCl 溶液，其中含有 [(18)F]NaF，用作骨成像剂。尽管它的 NDA 于 1972 年被美国 FDA 批准，但自 1975 年以来，由于 (99m)Tc-MDP 的广泛应用，它一直未商业化。最近，PET/CT 技术的进步和 (99m)Tc 供应的经常中断，导致人们重新对使用 [(18)F]NaF 来检测癌症患者的骨转移产生了兴趣。本报告介绍了一种用于 PET 扫描的高效、低成本和无菌制备“氟化钠 ((18)F) 注射液”的方法。
回旋加速器产生的靶水中的 (18)F-氟被吸附到四种不同形式的阴离子交换树脂上，然后用等渗 NaCl 溶液将其洗脱到产品小瓶中。在合适的 pH 值下产生产物的一种树脂用于无菌制备。该设备的组件，包括旋塞、延长管等，均为一次性、单独包装和无菌的。该过程在保持在 A 级（PIC/S）无菌条件的铅线隔离器中进行。根据欧洲药典 (EP) 中的专论对获得的“氟化钠 ((18)F) 注射液”的质量进行分析。
氯形式的树脂产生 pH 值为 6.7 的产物，因此被选为后续制备。放射化学收率为定量。产物符合 EP 中规定的所有标准，包括生物学、物理和化学规格。
该方法是一种高效、节省空间且成本极低的操作，可在符合 GMP 标准的无菌环境中轻松进行。所得“氟化钠 ((18)F) 注射液”的质量符合 EP 规格。该设备为医院提供了符合 GMP 标准的设施，为满足成本效益的要求，提供了一种高效的方法，无需昂贵的自动模块和额外的 QC 仪器即可生产“氟化钠 ((18)F) 注射液”。
