Radiopharmaceuticals – principles of manufacturing

Radiopharmaceuticals – principles of manufacturing

Poster

Tsvetelina Stefanova1, Evgeni Grigorov 2,3
1Faculty of Pharmacy, Medical University „Prof. D-r Paraskev Stoyanov”, Varna, Bulgaria
2Department of Organization and economics of pharmacy, Faculty of Pharmacy, Medical University „Prof. D-r Paraskev Stoyanov”, Varna, Bulgaria 3National Center of Public Health and Analyses, Sofia, Bulgaria

Introduction: Radiopharmaceutical preparations (RPs) are pharmaceutical formulations made up of a radionuclide and a vehicle molecule with high affinity or binding power for a tissue or specific function of a human body. These specific products are used either for therapeutic or for diagnostic purposes. Aim: The aim of the study is to study the principles of manufacturing radiopharmaceuticals. Methods and materials: A review of information data is held based on keywords radiopharmaceuticals, manufacturing, GMP, radionuclide production, radiolabeling, nuclear synthesis using the following databases PubMed, ScienceDirect, Springer, Embase, Scopus and GoogleScholar. We emphasize on the process of radionuclide synthesis and production development principles. Results: Radiopharmaceuticals are specific agents of importance for innovative therapeutic approach and diagnostics. The process of PRs production takes into consideration the design, preparation and quality control. For the aim of this study, we assess the manufacturing process – methods of radionuclide synthesis and radiolabeling. The main ways of radionuclide synthesis are nuclear fission, charged particle bombardment, neutron bombardment, radionuclide generators. Alone the radionuclide is not a therapeutic or diagnostic agent. For this purpose, it should be radiolabeled appropriately. The final formulation must fulfill the requirements for the dosage form needed. Conclusion: Radiopharmaceuticals are specific drugs for therapy of diagnostics that contain a certain amount of radioisotopes that can be produced by bombarding particles inside a generator or in cyclotrons. Once produced, radionuclides need to be radiolabeled based on their biological characteristics to serve their medical purposes. The production of the RPs must comply with the codes of current GMP.
Key words: radiopharmaceuticals, radionuclide production, radiolabeling, nuclear synthesis