Manufactrure Of Full Automatic Synthesizer To Prepare 18f-Fch Radio Pharmaceutical

Abstract

Introduction: 18F-Fluoromethylcholine ([18F]FCH) Pharmaceuticals is used in PET/CT scans to diagnose prostate cancer and hepatocellular carcinoma. Due to lack of automatic synthesizer then the [18F]FCH production is not yet performed in Vietnam. This study aims to prepare [18F]FCH radiopharmaceuticals to fulfill the demand of pre-clinical studies and routine clinical practice. The objective of the study is to design and manufacture a full automatic synthesizer to produce [18F]FCH.
Method: Automatic synthesizers are designed and manufactured to produce [18F]FCH in 8 steps with the general principle as follows: Dibromomethane 10% in Acetonitrile is fluorinated to produce Fluorobromomethane which reacts with precursor Dimethylaminethanol 10% in Dimethyl Sulfoxide preloaded on Sep-Pak C18 Plus Short cartridge to produce 18F-FCH. The obtained 18F-FCH was purified by solid-phase extraction (SPE) using Sep-Pak CM Plus Short cartridge. The final product is the [18F]FCH in 5 ml Saline.
Results: The automatic synthesizer is easy to use and stable in operation. All commands control the 8 steps of the synthesis process are performed accuracy 100%. Test for [18F]FCH synthesis using this synthesizer confirmed that total time of the synthesis of a [18F]FCH batch is 50 ± 5 min; synthesis yield is 11.7± 0.2% with no decay correction and radiochemical purity is more than 99,9% that meet the requirements of European Pharmacopoeia 2017.
Conclusion: The full automatic synthesizer could supply a sufficient amount of [18F]FCH for both of pre-clinical studies and clinical practice, especially for early detection of prostate cancer and hepatocellular carcinoma in Vietnam.