Purification of 68Ge/68Ga generator eluate from Fe(III) intended to improve specific radioactivity of 68Ga-based radiopharmaceuticals

Patent metadata

Field	Value
Publication number	US-9487410-B2
Application number	US-74571508-A
Country	US
Kind code	B2
Filing date	Dec 1, 2008
Priority date	Dec 3, 2007
Publication date	Nov 8, 2016
Grant date	Nov 8, 2016

Abstract

The present invention provides a method of purifying 68 Ge/ 68 Ga generator produced 68 Ga from Fe (III). The invention further relates to an automated system within an existing Gallea Synthia prototype that provides purification 68 Ga from various cations and preconcentrations of 68 Ga. In general, the present invention further depicts the use of an automated system for the production of 68Ga-radiolabelled PET tracers with high specific radioactivity and a kit for purifying 68 Ge/ 68 Ga generator produced 68 Ga from Fe (III).

First claim

What is claimed is:

1. A method of purifying 68 Ga from Fe(III) in a 68 Ga generator eluate which comprises:
(i) eluting a 68 Ge/ 68 Ga generator column with 0.05-0.1 M aqueous hydrochloric acid to give an eluate containing 68 Ga and Fe(III);
(ii) treatment of the eluate solution from step (i) to:
(a) reduce the Fe(III) therein to Fe(II);
(b) acidify with 30% w/v hydrochloric acid to give [ 68 GaCl 4 ] − in the eluate solution;

wherein step (a) is carried out in the presence of a reducing agent comprising hydrazine, and steps (a) and (b) may optionally be carried out concurrently;
(iii) passing the reduced eluate solution from step (ii) through an anion exchange column comprising HCO 3 − counterions, wherein the [ 68 GaCl 4 ] − is retained on the anion exchange column and the Fe(II) passes through the anion exchange column without retention; and
(iv) passing deionized water through the anion exchange column from step (iii) to elute purified 68 Ga, having Fe(II) and Fe(III) removed therefrom and wherein the purified 68 Ga has a purity that is suitable for use in chemotherapy and radiotherapy.

2. The method of claim 1 where the reduction of step (ii) is carried out by acidification of the eluate solution with said HCl in the presence of said reducing agent.

3. The method according to claim 1 , further comprising converting the purified 68 Ga to a 68 Ga-based radiopharmaceutical.

4. The method according to claim 3 , wherein said method is performed on an automated system.

Assignees

• Langstrom Bengt
• Velikyan Irina
• Ge Healthcare Ltd

Inventors

• Langstrom Bengt
• Velikyan Irina

Classifications

• A61K51/02

  characterised by the carrier {, i.e. characterised by the agent or material covalently linked or complexing the radioactive nucleus} · CPC title

• C01P2006/88

  Isotope composition differing from the natural occurrence · CPC title

• B01J41/04

  Processes using organic exchangers · CPC title

• C01P2006/80

  Compositional purity · CPC title

• C01G15/003 Primary

  Preparation involving a liquid-liquid extraction, an adsorption or an ion-exchange · CPC title