Kit composition, kit, and one-stage preparation method of the complex oxyrhenium 188 Re(V)-dimercaptosuccinic acid, 188ReVO(DMSA)2 for medical use

摘要

The complex of pentavalent rhenium 188 (Re-188) with dimercaptosuccinic acid is a compound with probable clinical application in the alleviation of pain due to bone metastases. The invention describes a simple method for the preparation in a single stage of the complex oxyrhenium-188 dimercaptosuccinic acid 188Re(V)-DMSA by the use of a kit. The invention also describes a kit of the radioactive drug which enables preparation of oxyrhenium-188 dimercaptosuccinic and 188Re(V)-DMSA in only one stage, the content of the kit being reconstituted with an injectable solution of hyperrhenic (Re-188) sodium, of volume > 1 ml. The kit contains all the ingredients needed for the purpose, in a stable in- vitro composition. The preparation method is particularly easy, effective and pharmaceutically appropriate, and the kit can be stored for a suitable time. The content of the kit is in the form of a lyophilised dry powder free from microbial contamination (sterile) and contains no pyretogens.