Formulation and quality control studies of EDTMP lyophilized freeze-dried kit for the preparation of 153Sm-EDTMP

Abstract

Conventionally, metastatic cancer bone pain is managed by localized external radiotherapy and oral administration of analgesics. Due to the availability and cost, the use of bone-targeted radionuclide therapy in Malaysia has been restricted. The development and formulation of radiopharmaceuticals require stringent process and testing prior to clinical use. Stability testing is a quality evaluation of the finished pharmaceutical product subject to the impact of environmental factors such as light exposure, temperature and humidity. Microbiology testing allows the finished pharmaceutical product to be tested for microorganisms or microbial by-products contamination. Three batches of lyophilized freeze-dried ethylenediaminetetramethylene phosphonic acid (EDTMP) kit were produced. Stability and microbiology sterility testing were performed to evaluate the product quality. Freeze-dried EDTMP kits were tested to be sterile and pyrogenic-free. The 153Sm-EDTMP complexes showed good radiochemical purity (stability) up to the storage period. Whole body scintigraphic images of rats revealed good skeletal uptake of the 153Sm-EDTMP complexes. These outcomes have forwarded a closer step towards cancer bone pain relief.