# US 10,483,008 B2 · Process for the purification of Ga-68 from eluate deriving from 68Ge/68Ga generators and chromatographic columns for use in said process

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- Number: US 10,483,008 B2
- Document ID: US10483008B2
- Status: Granted
- Kind: B2
- Application number: 15/545,510
- Filed: 2016-01-28
- Published: 2018-01-04
- Granted: 2019-11-19
- Earliest claimed: 2015-01-30
- Assignees: Advanced Accelarator Applications International S.A.
- Applicants: Advanced Accelerator Applications International S.A.
- Inventors: Lorenza Fugazza; Maurizio Franco Mariani
- Web page: https://patentgrep.com/patent/US10483008B2

## CPC

- G21F 9/12: by absorption; by adsorption; by ion-exchange
- B01D 15/08: Selective adsorption, e.g. chromatography
- B01D 15/363: {Anion-exchange}
- B01J 20/103: {comprising silica}
- B01J 20/28004: {Sorbent size or size distribution, e.g. particle size}
- B01J 20/283: based on silica
- B01J 41/20: Anion exchangers for chromatographic processes
- C07B 59/008: {Peptides; Proteins}
- C22B 3/42: by ion-exchange extraction
- C22B 58/00: Obtaining gallium or indium {(treatment or purification of solutions by liquid-liquid extraction, by ion-exchange or by adsorption C22B3/20)}
- G21G 1/0005: {Isotope delivery systems (use of radioisotopes as tracers G21H5/02)}
- A61K 51/08: Peptides, e.g. proteins {, carriers being peptides, polyamino acids, proteins}
- G21G 2001/0021: {Gallium}
- G21F: PROTECTION AGAINST X-RADIATION, GAMMA RADIATION, CORPUSCULAR RADIATION OR PARTICLE BOMBARDMENT; TREATING RADIOACTIVELY CONTAMINATED MATERIAL; DECONTAMINATION ARRANGEMENTS THEREFOR (radiation protection by pharmaceutical means A61K8/00, A61Q17/04; in cosmonautic vehicles B64G1/54; combined with a reactor G21C11/00; combined with X-ray tubes H01J35/16; combined with X-ray apparatus H05G1/02)
- B01D: SEPARATION (separating solids from solids by wet methods B03B, B03D; by pneumatic jigs or tables B03B; by other dry methods B07; magnetic or electrostatic separation of solid materials from solid materials or fluids, separation by high-voltage electric fields B03C; centrifuges, vortex apparatus B04; presses per se for squeezing-out liquid from liquid-containing material B30B9/02; treatment of water C02F, e.g. softening by ion-exchange C02F1/42; {arrangements of air intake cleaners in gas turbine plants F02C7/05} ; arrangements or mounting of filters in air-conditioning, air-humidification or ventilation F24F13/28)
- B01J: CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- C07B: GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR (preparation of carboxylic acid esters by telomerisation C07C67/47; telomerisation C08F)
- C22B: PRODUCTION AND REFINING OF METALS (electrolytic C25); PRETREATMENT OF RAW MATERIALS
- G21G: CONVERSION OF CHEMICAL ELEMENTS; RADIOACTIVE SOURCES (applications of radiation in general G21H5/00; handling particles, e.g. neutrons, or electromagnetic radiation not otherwise provided for G21K)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)

## Abstract

Chromatography columns for the purification of eluates from 68Ge/68Ga generators comprising silica as stationary phase and purification processes that use said columns are described.

## Claims

### Claim 1

Process for the preparation of a radiopharmaceutical containing 68Ga wherein a solution of eluates from 68Ge/68Ga generators is passed through a column for chromatography purification comprising a stationary phase of silica having a granulometry less than 100 microns and thereafter the solution collected from the column is directly poured in a container containing a labeling kit, the labeling kit comprising a substrate to be labeled with 68Ga, wherein the substrate subsequently labeled with 68Ga is the radiopharmaceutical.

### Claim 2 (depends on 1)

A radiopharmaceutical kit comprising the radioactive isotope 68Ga produced through the process according to claim 1.