SYN2

SYN2 is a modern radiopharmaceutical designed specifically for myocardial perfusion imaging and non-invasive diagnosis of coronary artery disease using the PET/CT method (positron emission tomography combined with computed tomography).

The SYN2 compound belongs to the group of ammonium salt derivatives, which promotes its rapid and effective uptake by the heart muscle. The compound is characterized by very rapid removal from the bloodstream and low accumulation in the lungs, liver, and other organs of the abdominal cavity..

Thanks to these properties, SYN2 enables high-contrast images to be obtained, free of distorting artifacts, while potentially enabling quantitative measurement of coronary flow. This is especially important in obese patients, women, and individuals with multivessel coronary artery disease, among whom traditional imaging methods often have limited diagnostic value.

SYN2 is a sterile solution of a fluorine-18-labelled acridine derivative. The radioisotope 18F is produced in a cyclotron, a device that accelerates particles to obtain radioactive isotopes.

Simplified, the production process is as follows:

  1. Enriched water is irradiated in the cyclotron and then transported to the synthesis module.
  2. In the synthesis module, the active substance is formed, which then undergoes a multistage purification process.
  3. The purified solution passes to the automatic bottling device, where the doses of the final product are prepared.
  4. By appropriate dilution, the correct radioactive concentration is determined.
  5. Each batch is subject to detailed quality control, and the doses of the medicinal product are released by a qualified person, after confirmation of compliance with the requirements of good manufacturing practice (GMP).

The SYN2 synthesis process has been optimized for full automation, and lasts about 65 minutes. The useful life of the product is 10 hours from the end of synthesis, which allows it to be efficiently distributed to numerous diagnostic centres.