| Popis: |
Background Radiopharmaceuticals obtained from radiopharmaceuticals kits occur in multi-dose flasks. The packaging of syringes for the preparation of patient unit doses is the responsibility of radiopharmacists, because it is not evaluated during the marketing authorisation. In addition, if there are difficulties in patient care (placement of the catheter, lack of personnel, and so on) or equipment problems, the contact time of radiopharmaceuticals with the syringe increases. Purpose Determine the impact of prolonged storage of syringes on the quality of DOTATOC radiolabelled with (99mTc) or (68Ga). Material and methods (99mTc)DOTATOC and (68Ga)DOTATOC were obtained by preparation of Tektrotyd and Somakit-TOCrespectively, according the recommendations of the Summaries of Product Characteristics. Appearance, pH, radiochemical purity, particulate contamination, sterility and endotoxin tests were made according the current European Pharmacopoeia. Adsorption tests of radiopharmaceuticals consist of determining the residual activity in syringes in polypropylene after storage during 2 hour and 3 hour washing with 8 mL of saline. Results No drug radiolysis was observed of the radiopharmaceuticals (appearance, pH and radiochemical purity were unchanged). No impurity was observed after repackaging, and particular contamination and microbiological aspects remained in specification of the current European Pharmacopoeia. Concerning drug adsorption, the storage induces a slight increase in drug adsorption from 1.6% (SD 0.16; n=4) to 2.3% (SD 0.29; n=4) for Tektrotyd and 1.65% (SD 0.31; n=4) to 1.65% (SD 0.57; n=4) for Somakit-TOC. These good results may be related to their hydrophilic nature. The packaging and storage of radiopharmaceuticals could lead to drug alteration through microbiological contamination, drug interaction or adsorption with the packaging and radiolysis. For Somakit-TOC, after this period of time there was 29.3% of the initial activity which could not be compensated by the increase in image acquisition. For Tektrotyd, image acquisition of the patient was performed during 1.5 hours with gamma camera 1 and 4 hours after radiopharmaceutical injection. Thus, a delay greater than 2 hours will disorganise the patient’s care in the nuclear medicine department. Conclusion These radiopharmaceuticals repackaged in plastic medical devices retained their quality after dispensing and prolonged storage for up to 2 hours. References and/or acknowledgements No conflict of interest. |
