Optimization of the preparation and quality control of 177Lu based therapeutic radiopharmaceuticals: Facilities available at PINSTECH

Isotope Production Division (IPD) at Pakistan Institute of Nuclear Science and Technology (PINSTECH) has established centralized facilities for bulk production of radiopharmaceuticals to be supplied to various nuclear medical centers of the country. Here different groups have been established to look after the production of 99mTc generators, production of sodium iodide (131I) solution and other reactor produced radionuclides; radiopharmaceuticals freeze dried in-vivo diagnostic kits, quality control of radiopharmaceuticals and their dispatch. For this purpose different laboratories including two clean laboratories; one for bulk production of freeze dried in-vivo diagnostic kits and other for 99mTc generators were provided by the IAEA under technical cooperation, have been constructed. Organic laboratory has also been created for synthesis of MAG-3, MIBI, DISIDA, HMPAO, ECD etc. Excellent quality control laboratories have also been established for checking every batch in terms of radionuclidic purity, radiochemical purity, sterility, pyrogenicity and biodistribution in animals. Research activities under IAEA coordinated research programmes related to preparation of therapeutic β-particle emitting radionuclides like 177Lu, 166Ho, 153Sm, 186,188Re etc in PARR-I research reactor and their radiopharmaceuticals formulations with HEDP, EDTMP, FHMA, DOTATATE were also carried out. Studies on the optimization of the production of 177Lu radionuclide by irradiating natural/enriched lutetium targets as solid or liquid in PARR-I reactor for different time intervals were carried out. The irradiation data indicate that specific activity of liquids targets (5.5 Ci/mg) is higher than solid targets (4.6 Ci/mg). Studies on the optimization of 177Lu-EDTMP and 177Lu-DOTA-Tyr3-Octreotate complexes were investigated w.r.t. pH, temperature and incubation period to get a complex of high yield (>99%). Radiochemical purity of 177Lu-DOTA-Tyr3-Octreotate was determined by radio TLC technique. Stability of these complexes was also studied in the buffer and in the saline for 4, 16, 48 hours intervals and the quality control of the complex was performed using TLC technique. The animal study 177Lu-EDTMP and 177Lu-DOTA-Tyr3-Octreotate complexes were also carried out in animal model. (author)