Advanced study on development of Iodine-131 oral solution from non-fission Iodine-131 production for diagnosis and therapy of thyroid disorder

The most frequent thyroid disorders in Indonesia are hyperthyroidism and thyroid cancer. One effective way to diagnose and treat hyperthyroidism and thyroid cancer is the radioactive iodine-131 solution. Currently, the iodine-131 solution used in the hospital is imported from overseas. This work aimed to develop a suitable iodine-131 oral solution obtained from non-fission iodine-131 production. The formulations were divided into four different types, namely Fo-1), Fo-2 Fo-3 and Fo-4, which were different in buffer composition and gas purges treatment. Parameters were investigated to check the quality of iodine-131 oral solution, such as stability in the variability of activities at room temperature, radiochemical purity, pH, and clarity. The result shows that all of the formulations were a clear solution. The radiochemical purity test shows that F0-1 is the lowest (92,68%); meanwhile, the Fo-4 is the highest (99,27%) among all the formulations. the pH test result shows that Fo-1 is 9.5 while the others are 9.0. The stability tests were conducted for Fo-1, Fo-2 and Fo-3 in three different activity doses, including 1.85 GBq, 3.70 GBq and 5.55 GBq. The stability test result at activity 1.85 GBq shows that the radiochemical purity of Fo-2 fluctuated. Meanwhile, Fo-2 and Fo-3 remain constant. Fo-3 shows a high and constant radiochemical purity for both 3.70 GBq and 5.55 GBq, but shows a fluctuation after the 6th day and drops to under 97% after the 13th day. Otherwise, Fo-4 shows the best stability of radiochemical purity that is higher than 99% for both 3.70 GBq and 5.55 GBq until the 24th days. It is concluded that Fo-4 is suitable for iodine-131 oral formulation.