Evaluation and Characterization of The Radiopharmaceutical Lyophilized-Kit of Ciprofloxacin

The 99mTc-ciprofloxacin radiopharmaceutical is available in the lyophilized-kit which is separately packed in two vials, ciprofloxacin lactate and Sn-tartrate, respectively. Preparation of 99mTc-ciprofloxacin was performed by adding 99mTc radionuclide into ciprofloxacin lactate solution, followed by addition of Sn-tartrate solution. The complement information was needed by user in order to assure the successful preparation and utilization of this radiopharmaceutical. Meanwhile, this investigation was performed to obtained the several physicochemical and biological characters of 99mTc-ciprofloxacin prepared from the radiopharmaceutical lyophilized-kit of ciprofloxacin lactate. The radiochemical purity was determined with instant thin layer chromatography (ITLC-SG) using acetone and solution of dichloromethane : methanol : ammonium hydroxide : acetonitrile : (4:4:2:1) as a mobile phases. The plasma binding protein of 99mTc-ciprofloxacin was investigated in-vitro by precipitation method using 5% of trichloro acetic acid solution, whereas the lipophilicity (P) was obtained by determination of octanol-water partition. Beside that, studies on the effect of volume of Na99mTcO4 solution to radiochemical purity of 99mTc-ciprofloxacin has been carried out. From the experiment, it was obtained that 99mTc-ciprofloxacin has 95.85 ± 2.10 % of radiochemical purity, the human plasma binding protein of 58.35 ± 2.05 % and the lipophilicity (P) = 0.024 ± 0.005. The volume more than 2 mL of Na99mTcO4 solution on the labelling of ciprofloxacin gave less than 90 % of radiochemical purity. The labelling efficiency of 44.79 % was obtained after filtration of 99mTc-ciprofloxacin. The stability test on 99mTc-ciprofloxacin and ciprofloxacin lyophilized-kit were performed by determining their radiochemical purities. The 99mTcciprofloxacin was still able to be used until 4 hours after labelling with radiochemical purity of 91.61 ± 1.60 %. The stability determination showed that the ciprofloxacin lyophilized-kit was remained stable 5 month of storage at 4 °C. (author)