Hallouard F, Sauze W, Emery S, Skanjeti A, Rioufol C, Fraysse M
Pharmacy Department, Radiopharmacy Unit, Hospices Civils de Lyon, Lyon Sud Hospital, 165 Chemin du Grand Revoyet F-69310 Pierre-Benite, France.
Nuclear Medicine Department, Hospices Civils de Lyon, Lyon Sud hospital, 165 Chemin du Grand Revoyet F-69310 Pierre-Benite, France.
Curr Radiopharm. 2018;11(2):138-146. doi: 10.2174/1874471011666180703165639.
The present study had determine the impact of prolonged storage in a cartridge or syringe on the quality of the [18F]-radiopharmaceuticals used in our center [18F]fludeoxyglucose and [18F]fluorocholine). [18F]-radiopharmaceuticals registered as ready-to-use drugs are prepared in multidose flasks. When the change of packaging must be made extemporaneously for the preparation of patient unit doses in a syringe or cartridge, this is under the responsibility of radiopharmacists. As drug quality in medical devices (syringe or cartridge) is not evaluated during the marketing authorization of such radiopharmaceuticals, an evaluation of drug stability in such devices seems interesting. In addition, if there are difficulties in patient care (placement of the catheter, lack of personal, etc.) or equipment problems (technical issue with the automated dispenser delaying the delivery of the prepared dose), the contact time of [18F]-radiopharmaceuticals with the medical devices (cartridge or syringe) increases.
Appearance, pH, radiochemical purity, sterility and endotoxin tests were made according the current European Pharmacopoeia. Adsorption tests were made according the literature.
There was no drug absorption of [18F]fludeoxyglucose or [18F]fluorocholine after 1.5h, which may be related to their hydrophilic nature. No drug radiolysis was observed even after dilution of the radiopharmaceuticals (appearance, pH, and radiochemical purity were unchanged). No impurity from medical devices (cartridge or syringe) was observed, and microbiological aspects remained in specification of the current European Pharmacopoeia.
These radiopharmaceuticals repackaged in plastic medical devices retained their quality after dispensing and prolonged storage.
本研究旨在确定在药筒或注射器中长期储存对我们中心使用的[18F]放射性药物（[18F]氟脱氧葡萄糖和[18F]氟胆碱）质量的影响。作为即用型药物注册的[18F]放射性药物是在多剂量烧瓶中制备的。当必须临时更换包装以在注射器或药筒中制备患者单位剂量时，这由放射药剂师负责。由于在此类放射性药物的上市许可过程中未评估医疗器械（注射器或药筒）中的药物质量，因此评估此类器械中药物的稳定性似乎很有意义。此外，如果在患者护理方面存在困难（导管放置、人员不足等）或设备问题（自动分配器的技术问题导致制备剂量的交付延迟），[18F]放射性药物与医疗器械（药筒或注射器）的接触时间会增加。
根据现行欧洲药典进行外观、pH值、放射化学纯度、无菌和内毒素测试。根据文献进行吸附测试。
1.5小时后，[18F]氟脱氧葡萄糖或[18F]氟胆碱没有药物吸附，这可能与其亲水性有关。即使在稀释放射性药物后也未观察到药物放射性分解（外观、pH值和放射化学纯度未改变）。未观察到来自医疗器械（药筒或注射器）的杂质，微生物方面仍符合现行欧洲药典的规定。
这些重新包装在塑料医疗器械中的放射性药物在分装和长期储存后仍保持其质量。
