Preparation and Quality Control of I-131 Capsules for Therapy

The most common abnormalities of the thyroid glands in Indonesia are hyperthyroidism and thyroid cancer.
Radioactive iodine therapy has been commonly used in some hospitals as one effective way for treatment of hyperthyroidism and thyroid cancer. The aim of this study was to completed the production and quality control data of I-131 capsule therapy that have not been well documented. To produce a good and qualified I-131 capsule, a preliminary study of the materials and in process products of I-131 capsules was done by determining the maximum volume filling and dissolution time of I-131 capsule.
Parameters to be validated for I-131 capsule product in this study were variability of activities, pH, radiochemical purity and stability. From the preliminary study, radioactive concentration of I-131 should be more than 1000 mCi / ml, especially for 100 mCi of I-131 capsule, radioactive concentration should be 2000 mCi/ml. Dissolution test results showed that all of I-131
radioactivity has come out from capsule into the water less than 15 minutes and capsule filling volume less than 100 uL per capsule. Variability activities of each capsule showed the activities were less than 10% of the desired activity for capsule size 30 mCi, 50 mCi and 100 mCi. The pH range of I-131 capsule was obtained between 7.5 – 8.0. Radiochemical purity of I-131 capsule in the form of I - was more than 95 %, and iodine-131 capsule was still stable for more than 1 month at room temperature. It is concluded that the quality control test for I-131 capsule included the variability of radioactivity, pH and radiochemical purity still meet the established requirement.