Validation of the preparation of individual doses of (131)I-sodium o-iodohippurate ((131)I-hippuran).

Abstract

The preparation of low activity doses of (131)I-hippuran has a drawback due to its high radioactivity concentration. In this study we diluted the radiopharmaceutical with saline or phosphate buffered saline (PBS) in order to decrease the radioactivity concentration, facilitate the preparation of individual doses and validate these procedures. We prepared doses of approx. 1.85 MBq of (131)I-hippuran from 10 different batches the day before the calibration date: undiluted, and diluted 1:9 with saline or PBS. The radiochemical purity (RCP) was evaluated the day after the expiration date. The percentage of (131)I-hippuran retained on syringes was assessed in vitro, after emptying the syringe and washing it twice with water (n=3 x 27); and in vivo, after the endovenous administration of the dose and washing the syringe twice with the patient's blood (n=3 x 75). Sterility was assessed using fluid thyoglicolate medium (n=3 x 15). All RCP values were greater than those required by the European Pharmacopoeia (>96%) except one of the undiluted (131)I-hippuran (95.8%) doses. No statistical difference was observed among them. The mean undiluted (131)I-hippuran retained in vitro was 5.4% (SD=6.5%), statistically greater (P<0.01) than both saline diluted (mean=1.5%, SD=1.1%) and PBS diluted (mean=2.0%, SD=2.4%). The mean undiluted (131)I-hippuran retained in vivo was 6.4% (SD=5.4%), statistically greater (P<10-5) than both saline diluted (mean=3.1%, SD=2.3%) and PBS diluted (mean=3.1%, SD=3.1%). We concluded that: (1) the dilution of (131)I-hippuran with saline or PBS makes both the preparation of individual doses and its administration to the patient easier without decreasing its radiopharmaceutical quality; and (2) using saline or PBS diluted (131)I-hippuran the percentage of radiopharmaceutical retained on the syringes, after use, is minimized.