Uji Stabilitas Kit Cair Tetrofosmin pada Berbagai Kondisi Penyimpanan

  • Yunilda Yunilda Pusat Teknologi Radioisotop dan Radiofarmaka, BATAN Kawasan PUSPIPTEK, Serpong, Tangerang Selatan, Indonesia
  • Widyastuti Widjaksana Pusat Teknologi Radioisotop dan Radiofarmaka, BATAN Kawasan PUSPIPTEK, Serpong, Tangerang Selatan, Indonesia
  • Indra Saptiama Pusat Teknologi Radioisotop dan Radiofarmaka, BATAN Kawasan PUSPIPTEK, Serpong, Tangerang Selatan, Indonesia
Keywords: Radiopharmaceutical kit, Technesium-99m tetrofosmin, Radiochemical purity

Abstract

Tetrofosmin radiopharmaceutical compound that is being developed by PTRR BATAN for use as myocardial perfusion imaging agent and cancer diagnostic agent in nuclear medicine. The aim of this study is observe the stability of this liquid kits after stored in various condition to determine its expire date various condition. The stability test was done of 1 hour, 3 hours, 5 hours and 7 hours after labeling. The radiochemical was determined its radiochemical purity has to be ≥ 90 %. Analysis of radiochemical purity was carried out by separation method which using Sep-Pak C18 cartride. Storage condition of tetrofosmin kit was carried out at various temperatures as in the deep freezer (-800C), freezer (-180C), refrigerator (2-60C) and cool box (2-60C). The result showed that the liquid tetrofosmin kits stored in deep freezer, freezer, refrigerator were stable up to 23 months, 8 weeks and 4 days respectively. Simulation of stability test after stored in a cool box was done by observing the temperature of cool box, and the result showed that the temperature in the cool box was constant as in refrigerator for up to 24 hours. Tetrofosmin which has been labeled with technetium-99m can with stand up 7 hours. It is concluded that expiry date of liquid tetrofosmin kit related with storage temperature, the lower the temperature the longer the expiry date of the kits.

References

1. Arceuil HED. Technetium-99m tetrofosmin: Use for myocardial perfusion imaging in the detection of coronary artery disease. Dove Press Journal: Report in Medicinal Imaging. 11 August 2010:1–10.
2. Wai MC, Ottenhof MJ, Boiten HJ, Valkema R, Van Domburg RT, Schinkel AF. Prediction of 8-year cardiovascular outcomes in patients with systemic arterial hypertension: Value of stress 99mTc-tetrofosmin myocardial perfusion imaging in a high-risk cohort. J Nucl Cardiol. 2013 Dec;20(6):1030–40.
3. Arun S, Mittal BR, Bhattacharya A Rohit MK. Comparison of Tc-99m tetrofosmin myocardial perfusion scintigraphy and exercise F18-FDG imaging in patients with coronary artery disease. J Nucl Cardiol. 2015 Feb;22(1):98–110.
4. Vrachimis A, Hermann S, Máthé D, Schober O, Schäfers M. Systematic evaluation of 99mTc-tetrofosmin versus 99mTc-sestamibi to study murine myocardial perfusion in small animal SPECT/CT. EJNMMI Res. 2012;2(1):2-21.
5. Valotassiou V, Leondi A, Angelidis G, Psimadas D, Georgoulias P. SPECT and PET Imaging of Meningiomas. Sci World J. 2012;2012:1–11.
6. Ahlman M, Nietert PJ, Wahlquist AE, Serguson JM, Berry MW, Suranyi P, et al. A single CT for attenuation correction of both rest and stress SPECT myocardial perfusion imaging: A retrospective feasibility study. Int J Clin Exp Med. 2014;7(1):148–55.
7. Fathala A , Al Amer A, Shukri M, Abouzied MM, Alsuqair A. The relationship between coronary artery calcification and myocardial perfusion in asymptomatic women. Ann Saudi Med. 2012 Jul-Aug;32(4):378–83.
8. Alexiou GA, Zikou A, Tsiouris S, Goussia A, Kosta P, Papadopoulos A, et al. Comparison of diffusion tensor, dynamic susceptibility contrast MRI and 99mTc- Tetrofosmin brain SPECT for the detection of recurrent high-grade glioma. Magn Reson Imaging [Internet]. Elsevier Inc.; 2014 Sept;32(7):854–9. Available from:http://dx. doi.org/10.1016/j.mri.2014.04.013
9. Alexiou G.A, Xourgia X, Vartholomatos E, Tsiouris S, Kalef-Ezra J a., Fotopoulos AD, et al. Comparison of 99m Tc-Tetrofosmin and 99m Tc-Sestamibi Uptake in Glioma Cell Lines: The Role of P-Glycoprotein Expression. Int J Mol Imaging [Internet]. 2014;2014:1–5.
10. Alexiou GA, Tsiouris S, Voulgarisn S, Kyritis AP, Fotopoulus AD. Imaging Meningiomas With 99mTc-Tetrofosmin SPECT. Neurosurgery. 2012;70(4):1055-6.
11. Alexiou G., Tsiouris S, Bougias H, Voulgaris S, Fotopoulus A. Current concept in glioblastoma imaging. Chinese J Contemp Neurol Neurosurg. 2012 Dec;12(6):641-4.
12. Silov G, Taşdemir A, Özdal A, Erdoǧan Z, Başbuǧ EM, Arslan AE, et al. Radionuclide imaging for breast cancer diagnosis and management: Is technetium-99m tetrofosmin uptake related to the grade of malignancy? Hell J Nucl Med. 2014May-Aug;17(2):87–9.
13. Sioka C, Exarchopoulos T, Tasiou I, Tzima E, Fotou N, Capizzello A, et al. Myocardial perfusion imaging with 99 m Tc - tetrofosmin SPECT in breast cancer patients that received postoperative radiotherapy : a case- control study. Radiat Oncol. 2011 Nov;6(151):1–7.
14. Widyastuti, Setyowati S, Rustendi CT, Yunilda. Preparasi kit cair tetrofosmin untuk ueteksi kanker dan perfusi jantung. Jurnal Radioisotop dan Radiofarmaka. 2012;15 (2):70-8.
15. International Atomic Energy Agency. Technetium-99mradiopharmaceuticals: Manufacture of kits. Technical Report Series No.466. Vienna. Printed by the IAEA in Austria. August 2008.
16. Kluba CA, Mindt TL. Click-to-chelate: Development of technetium and rhenium-tricarbonyl labeled radio- pharmaceuticals. Molecules. 2013;18(3): 3206–26.
17. El-Sabagh MF, Motaleb MA, El-Kolaly MT, Abdel-Aziz LM, Lashine EM. Preparation and Biological Evaluation of 99mTc-TMPP as a novel Agent for Tumor Diagnosis. International Journal of Advanced Research. 2015;3(10):362-70.
18. Fernandes C, Maria L, Gano L, Santos IC, Santos I, Paulo A. Re(I) and 99mTc(I)
tricarbonyl complexes with ether-containing pyrazolyl-based chelators: Chemistry, biodistribution and metabolism. Jurnal of Organometallic Chemistry.2013:1-11
Published
2016-02-29
How to Cite
1.
Yunilda Y, Widjaksana W, Saptiama I. Uji Stabilitas Kit Cair Tetrofosmin pada Berbagai Kondisi Penyimpanan. jki [Internet]. 29Feb.2016 [cited 20May2022];6(1):23-9. Available from: https://ejournal2.litbang.kemkes.go.id/index.php/jki/article/view/2914
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Articles