Patent ID: 9585976
Date: 2017-03-07
CPC Classifications: A61K,A61P

Claim:
1. An automated method for the preparation of a sterile 123 I-labelled radiopharmaceutical composition which comprises an 123 I-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 (iii) radioiodination of the biological targeting molecule by microprocessor-controlled transfer to the reaction vessel of Reagent A and an aliquot of (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 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).