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Single vial formulation for theranostic radiopharmaceutical preparation

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Abstract

The present work was aimed at development of pharmaceutical grade single vial kit like formulation of somatostatin analogue, DOTA–Tyr3–Thr8-Octreotide (DOTATATE) suitable for radiolabeling with both diagnostic (68Ga) and therapeutic (177Lu) radioisotope. Single vial kit like formulation of DOTATATE was prepared. Radiolabeling methods with 68Ga and 177Lu were standardized. The pharmaceutical purity and stability of formulation was studied over a period of 6 months. Pharmacokinetics of radiolabeled preparations was studied in Swiss mice. DOTATATE formulation with 4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid buffer was successfully prepared. Both 68Ga–DOTATATE and 177Lu–DOTATATE complexes were formed with >95 % radiochemical purity. Biodistribution studies of 68Ga–DOTATATE and 177Lu–DOTATATE complexes in Swiss mice revealed fast clearance of activity via renal route. Single vial kit like formulation suitable for easy preparation of 68Ga–DOTATATE and 177Lu–DOTATATE at hospital radiopharmacy was successfully demonstrated.

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References

  1. Teunissen JJM, Kwekkeboom DJ, Valkema R, Krenning EP (2011) Endocr Relat Cancer 18:S27–S51

    Article  CAS  Google Scholar 

  2. Chakraborty S, Vimalnath KV, Lohar S, Shetty P, Dash A (2014) J Radioanal Nucl Chem. doi:10.1007/s10967-014-3169-z

  3. Breeman WA, de Blois E, Sze Chan H, Konijnenberg M, Kwekkeboom DJ, Krenning EP (2011) Semin Nucl Med 41:314–321

    Article  Google Scholar 

  4. Brom M, Joosten L, Oyen WJG, Gotthardt M, Boerman OC (2012) EJNMMI Res 2:4

    Article  Google Scholar 

  5. Mukherjee A, Pandey U, Chakravarty R, Sarma HD, Dash A (2014) Mol Imaging Biol. doi:10.1007/s11307-014-0719-2

  6. Maecke HR, Hofmann M, Haberkorn U (2005) J Nucl Med 46:172S–178S

    CAS  Google Scholar 

  7. Das T, Bhadwal M, Banerjee S, Sarma HD, Shinto A, Kamaleshwaran KK (2014) J Radioanal Nucl Chem 299(3):1389–1398

    Article  CAS  Google Scholar 

  8. Maus S, de Blois E, Schreckenberger M, Breeman WAP (2013) World J Nucl Med 12(1):84

    Google Scholar 

Download references

Acknowledgments

The authors are thankful to their colleagues from the Radiopharmaceuticals Division, Bhabha Atomic Research Centre (BARC), India for the supply of 177Lu. The authors are extremely grateful to Dr. M. R. A. Pillai, former Head, Radiopharmaceuticals Division, BARC, India for his valuable suggestions and directions for this work. The authors are thankful to Dr. Gursharan Singh, Head, Radiopharmaceuticals Division and Associate Director (I), Radiochemistry and Isotope Group, BARC, India for constant encouragement and support. The authors gratefully acknowledge IAEA, as a part of this study was conducted under an IAEA Coordinated Research Project.

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Authors and Affiliations

  1. Radiopharmaceuticals Evaluation Section, Isotope Applications and Radiopharmaceuticals Division, Bhabha Atomic Research Centre (BARC), RLG Building, Mumbai, 400 085, India

    Archana Mukherjee, Aruna Korde & Grace Samuel

  2. Experimental Animal Facility and Radioisotope Laboratory, Radiation Biology and Health Sciences Division, Bhabha Atomic Research Centre, Mumbai, 400 085, India

    Haladhar Dev Sarma

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  1. Archana Mukherjee
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  2. Aruna Korde
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  3. Haladhar Dev Sarma
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  4. Grace Samuel
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Correspondence to Archana Mukherjee.

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Mukherjee, A., Korde, A., Sarma, H.D. et al. Single vial formulation for theranostic radiopharmaceutical preparation. J Radioanal Nucl Chem 302, 889–894 (2014). https://doi.org/10.1007/s10967-014-3308-6

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  • DOI: https://doi.org/10.1007/s10967-014-3308-6

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