Zirconium-89 is a promising radionuclide for nuclear medicine. The aim of the present work was to find a suitable method for obtaining zirconium-89 solutions for radiopharmaceutical purposes. For this purpose, the ion exchange behavior of zirconium-89 solutions was studied. Radio-TLC (thin layer chromatography) and biodistribution studies were carried out to understand speciation of zirconium-89 complexes and their role in the development of new radiopharmaceuticals. Three methods of zirconium-89 isolation were studied using ZR (hydroxamate) and Chelex-100 resins. It was found that ZR-resin alone is not enough to obtain stable zirconium-89 formulations. An easy and effective method of reconstitution of [⁸⁹Zr]Zr-oxalate to [⁸⁹Zr]Zr-citrate using Chelex-100 resin was developed. Developed procedures allow obtaining [⁸⁹Zr]Zr-oxalate (in 0.1 M sodium oxalate solution) and [⁸⁹Zr]Zr-citrate (in 0.1–1.0 M sodium citrate solution). These solutions are perfectly suitable and convenient for radiopharmaceutical purposes. Our results prove [⁸⁹Zr]Zr-citrate to be advantageous over [⁸⁹Zr]Zr-oxalate. During evaluation of speciation of zirconium-89 complexes, a new TLC method was developed, since it was proved that there is no comprehensive method for analysis or zirconium-89 preparations. The new method provides valuable insights about the content of “active” ionic form of zirconium-89. The interrelation of the chromatographic behavior of zirconium-89 preparations and their biodistribution was studied.

One of the prerequisites for successful application of nuclear medicine technologies is the production and clinical use of radiopharmaceuticals (RPs) of a reliably high quality. The aim of the review is to discuss specific properties of RPs, which stipulate specific approaches to their production (or preparation) and quality control. The decisive requirement for the management of RPs at all stages of their life cycle is the observance of the radiation safety rules and regulations. The paper considers the main approaches to assessing the risks of medical radiation exposure to patients and radiation protection of nuclear medicine staff. The choice of a particular quality parameter and the corresponding analytical procedure should be made taking into account the duration of the test, which, like the production time, should be comparable with the radionuclide half-life. The feasibility of the analytical procedure should also be taken into account, given the high radioactivity of the samples tested. Now that theranostics has caught on, new approaches are being developed all over the world concerning regulatory aspects of transition from preclinical studies of RPs to clinical trials, because, according to experts, this is becoming a key condition for rapid implementation of nuclear medicine achievements. The results and conclusions of the present study can be used in the development and expert review of monographs and other specifications required for RP marketing and use. The results of the analysis suggest that it is necessary to develop specific requirements and guidelines for RP testing and evaluation for their successful promotion on the EAEU market.

In recent years, more and more attention has been paid to nanoparticles (NPs) as target drug delivery systems. Silicon-based nanoparticles are one of the most biocompatible nanomaterials that have become widespread. In this research, we studied the possibility of gallium-68 sorption on silicon (Si-SiO_x) and silicon dioxide (SiO₂) nanoparticles without their surface modification. Conditions allowing to obtain ⁶⁸Ga-NPs with radiochemical yield ≥ 90% were found. ⁶⁸Ga-SiO₂ showed much higher stability over ⁶⁸Ga-Si-SiO_x in both in vitro and in vivo experiments.

The main quality attributes of radiopharmaceuticals that ensure their effectiveness and safety and are unique to their specifications are activity, radionuclide identity, radionuclide purity, and radiochemical purity. The aim of this study was to analyse the possibility of formation and methods for determination of various impurities in radiopharmaceuticals based on radionuclides of several groups: technetium-99m and rhenium-188; iodine and fluorine-18 isotopes; and gallium-68 and some other metallic radionuclides used in theranostic schemes combining radionuclide diagnostics and radionuclide therapy. The article analyses the sources for the formation of radionuclide, radiochemical, and chemical impurities; the influence of these impurities on visualisation quality and dosimetric characteristics of radiopharmaceuticals; various approaches to the methods of impurity detection and quantification; compendial requirements to the quality of radiopharmaceuticals; and research results reported in publications. The article demonstrates the need for the development and certification of Russian reference standards for testing quality attributes of radiopharmaceuticals as part of harmonisation of the State Pharmacopoeia of the Russian Federation with the Pharmacopoeia of the Eurasian Economic Union and the European Pharmacopoeia.

INTRODUCTION . The concept of pharmacy preparation of radiopharmaceuticals (RPs) was first introduced in Russia with the entry into force of the Federal Law No. 61-FZ “On Circulation of Medicines” of 12 April 2010. Recently, significant legislative changes have been gained regarding RP production and preparation. Today it has become possible to make unregistered RPs at a medical organisation covering the in-house needs, which will allow to promptly advance new methods and means to treat malignant neoplasms as well as some other diseases. AIM . This study aimed to analyse main growth vectors for Russian organisations planning to preparing RPs. DISCUSSION . The term “nuclear pharmacy” is applied to a special unit of a medical organisation where RFLP synthesis and quality control is carried out. The practice of foreign hospital nuclear pharmacies has proven their advantages in terms of ensuring the shortest route of vital drugs to patients. The article analyses the main requirements of Russian regulatory documents and recommendations on the functioning of a nuclear pharmacy, as well as the experience of the first nuclear pharmacy based on A.F. Tsyb Medical Radiological Research Center — Branch of the National Medical Research Center of Radiology of the Ministry of Health of the Russian Federation. Regular work of the radiopharmacy allows to treat up to several hundred patients with vital but not yet registered drugs. However, nuclear pharmacies are far from being a routine practice for Russia, and a number of issues has to be addressed to allow for a proper function of these pharmacies: creating a training system for radiopharmacists; defining the scope of preliminary studies of RPs extemporaneously produced at a pharmacy; updating radiation safety documents regulating process launch for new radionuclides at a pharmacy, and so on. CONCLUSIONS . The world practice of hospital radiopharmacies has proven this system effective for RP commerce. Globally, approaches to RP preparation may be defined at the national or regional level. Pharmacies authorised to prepare RPs is a new type of pharmacy not previously known in the EAEU Member states. The creation of a regulatory framework for RP preparation should accommodate world practices with proven efficiency. The high-priority tasks to be addressed are training specialised personnel; revising a variety of documents on radiation safety; creating an expert panel assisting numerous issues associated with developing radiopharmacies; and obtaining funding sources for RP treatment.