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Single vial kit formulation of DOTATATE for preparation of 177 Lu‐labeled therapeutic radiopharmaceutical at hospital radiopharmacy
Author(s) -
Mukherjee Archana,
Lohar Sharad,
Dash Ashutosh,
Sarma Haladhar Dev,
Samuel Grace,
Korde Aruna
Publication year - 2015
Publication title -
journal of labelled compounds and radiopharmaceuticals
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.432
H-Index - 47
eISSN - 1099-1344
pISSN - 0362-4803
DOI - 10.1002/jlcr.3267
Subject(s) - biodistribution , vial , radionuclide therapy , nuclear medicine , chemistry , octreotide , medicine , somatostatin , radiochemistry , chromatography , biochemistry , in vitro
The clinical applications of radiolabeled somatostatin analogue 177 Lu‐DOTA‐Tyr 3 ‐Thr 8 ‐Octreotide ( 177 Lu‐DOTATATE) constitute a promising treatment option for patients with disseminated and inoperable neuroendocrine (NET) tumors. Formulation of 177 Lu‐DOTATATE in hospital radiopharmacy under aseptic conditions in a safe and reliable manner is a major constraint for its extensive use. The present work was intended to develop a kit for the safe preparation of the therapeutic radiopharmaceutical, viz. 177 Lu‐DOTATATE of high quality that can be easily adapted at conventional hospital radiopharmacies. Single vial kits of DOTATATE were formulated and evaluated for suitability for radiolabeling as well as stability on its storage. Patient dose of 177 Lu‐DOTATATE (7.4 GBq) could be successfully prepared using semi‐automated in‐house setup that assures safe handling and high yields of product of pharmaceutical purity suitable for clinical use. Fast clearance of activity via renal route was observed in preclinical biodistribution studies of 177 Lu‐DOTATATE carried out in normal Swiss mice. Deployment of in‐house produced 177 LuCl 3 , cold kits and easy adaptability of synthesis setup at hospital radiopharmacy for preparation is likely to expand applications of peptide receptor radionuclide therapy.