Development of a nano-zirconia based 68Ge/68Ga generator for biomedical applications

Abstract

Most of the commercially available (68)Ge/(68)Ga generator systems are not optimally designed for direct applications in a clinical context. We have developed a nano-zirconia based (68)Ge/(68)Ga generator system for accessing (68)Ga amenable for the preparation of radiopharmaceuticals. Nano-zirconia was synthesized by the in situ reaction of zirconyl chloride with ammonium hydroxide in alkaline medium. The physical characteristics of the material were studied by various analytical techniques. A 740 MBq (20 mCi) (68)Ge/(68)Ga generator was developed using this sorbent and its performance was evaluated for a period of 1 year. The suitability of (68)Ga for labeling biomolecules was ascertained by labeling DOTA-TATE with (68)Ga. The material synthesized was nanocrystalline with average particle size of ~7 nm, pore-size of ~4 Å and a high surface area of 340±10 m(2) g(-1). (68)Ga could be regularly eluted from this generator in 0.01N HCl medium with an overall radiochemical yield >80% and with high radionuclidic (<10(-5)% of (68)Ge impurity) and chemical purity (<0.1 ppm of Zr, Fe and Mn ions). The compatibility of the product for preparation of (68)Ga-labeled DOTA-TATE under the optimized reaction conditions was found to be satisfactory in terms of high labeling yields (>99%). The generator gave a consistent performance with respect to the elution yield and purity of (68)Ga over a period of 1 year. The feasibility of preparing an efficient (68)Ge/(68)Ga generator which can directly be used for biomedical applications has been demonstrated.