| 主权项 |
1. An automated method for the preparation of a sterile 123I-labelled radiopharmaceutical composition which comprises an 123I-labelled biological targeting molecule in a biocompatible carrier medium, wherein said method comprises:
(i) providing an automated synthesizer apparatus having a single use, sterile cassette which comprises a reaction vessel and separate aliquots of the following non-radioactive Reagents (A) and (B), each in sterile form: Reagent A: the biological targeting molecule selected from the group consisting of CIT (2-carbomethoxy-3-(4-iodophenyl)tropane), CIT-FP (N-3-fluoropropyl-2-carbomethoxy-3-(4-iodophenyl)nortropane), IBZM (N-{[(2S)-1-ethylpyrrolidin-2-yl]methyl}-2-hydroxy-3-iodo-6-methoxybenzamide), MIBG (meta-iodobenzylguanidine), or BMIPPA (beta-methyl-iodophenyl-pentadecanoic acid), and benzofuran; Reagent B: one or more solvents for the dissolution of Reagent A, which is a biocompatible carrier medium selected from the group consisting of pyrogen-free water for injection, isotonic saline, and aqueous ethanol solution; (ii) providing a sterile supply of 123I-iodide in a suitable container; (iii) radioiodination of the biological targeting molecule by microprocessor-controlled transfer to the reaction vessel of Reagent A and an aliquot of 123I-iodide from (ii) followed by mixing therein to give the 123I-labelled biological targeting molecule; and (iv) optionally subjecting the product of step (iii) to one or more of the following additional processes; chromatographic purification, pH adjustment, dilution, concentration, or terminal sterilisation, to give the desired 123I radiopharmaceutical composition; wherein the automated synthesizer accepts the cassette in a removable and interchangeable manner such that moving parts of the automated synthesizer control the operation of the cassette from the outside of said cassette, and the automated synthesizer performs the processes of steps (iii) and (iv). |
