A Freeze-Dried Kit for the Preparation of Re-188-HEDP for Bone Pain Palliation: Preparation and Preliminary Clinical Evaluation

摘要

Re-188-HEDP is an established radiopharmaceutical used for pain palliation in patients with osseous metastasis. Considering commercial availability of W-188/Re-188 generator, the accessibility to a lyophilized kit would make preparation of this radiopharmaceutical feasible at the hospital radiopharmacy having access to a generator. A protocol for the preparation of a single-vial lyophilized hydroxyethane 1,1-diphosphonic acid (HEDP) kit was developed and its consistency was checked by preparing six batches. Each sterile lyophilized kit prepared as per the protocol contained 9mg of HEDP, 3mg of gentisic acid, and 4mg of SnCl2 center dot 2H(2)O. Randomly selected kits from all six batches were subjected to thorough quality control tests that were passed by all batches. Re-188-HEDP could be prepared by addition of 1mL of freshly eluted Na (ReO4)-Re-188 (up to 3700 MBq) containing 1 lmol of carrier ReO4- (perrhenate) and heating at 100 degrees C for 15 minutes. Re-188-HEDP with > 95% radiochemical purity could be consistently prepared using the lyophilized kits. Sterile Re-188-HEDP prepared using the lyophilized kit was evaluated in patients with osseous metastasis. Post-therapy images of the patient were compared with Tc-99m-MDP bone scan and found to be satisfactory. The bone-to-background as well as tumor-to-normal bone uptake ratio was found to be significant. All patients who received therapy reported significant pain relief within a week to 10 days post-administration of Re-188-HEDP.