PATRICIA DE ANDRADE MARTINS

PATRICIA DE ANDRADE MARTINS

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Dose calibrator and gamma counter
2019 - SILVA, VITOR M.A. da; SOUSA, JURANDIR A. de; MARTINS, PATRICIA de A.; FUKUMORI, NEUZA T.O.; SILVA, NATANAEL G. da; MATSUDA, MARGARETH M.N.
To ensure that pharmaceutical products have and maintain the structure, identity, purity, concentration, potency and safety characteristics required for their use, there is a set of standard procedures called Good Manufacturing Practices (GMP). In Brazil, the National Sanitary Surveillance Agency (ANVISA) regulates the GMP production of medicines through RDC17/2010 and for radiopharmaceuticals through RDC 63/2009 and 38/2008, to ensure their safe and correct use in commercial production and nuclear medicine services, respectively. Most 99mTc radiopharmaceutical monographs have biological distribution specifications. Using invasive method, 99mTcradiopharmaceuticalsare assessed by the injection into animals of defined strains and the radioactivity (as percentage of retainedor injected dose -%RDor%ID)ismeasured in specified organs. Technetium-99m Sestamibi radiopharmaceutical (99mTc-2-methoxy-isobutyl-isonitrile; 99mTc-sestamibi; MIBI-TEC®) monograph is related in USP 41, but the biological distribution assay is not included. At IPEN, the biodistribution test is performed as established in the Radiopharmaceutical Quality Control Manual of ARCAL XV (1999) - International Atomic Energy Agency (IAEA), for each batch. The objective of this work is to compare MIBI-TEC®biodistribution results using dose calibrator and gamma counter with sodium iodide detector by measuring the radioactivity in the organs. Three batches of MIBI-TEC®were used and 1 vial of lyophilized reagent (LR) was labeled with 5-10 mCiin 1-3 mL of 99mTc eluate. 200-300 μCi in 0.2 mLwereinjected in 3 Balb-Cmice. After 30 minutes of biodistribution, heart, lung, muscle, liver, paw, column and tail were withdrawn, weighed and radioactivity was measured in dose calibrator and gamma counter (μCi andcpm, respectively). %ID/g ratio in the organs of interest was calculated using the data obtained by both equipment and the results were compared. No significant differences were observed and it was possible to conclude that either a dose calibrator or a gamma counter can be used in the routine of quality control.
Radiochemical purity determination of technetium (99m)Tc-sestamibi by high performance liquid chromatography (HPLC)
2019 - MARTINS, PATRICIA de A.; FUKUMORI, NEUZA T.O.; SILVA, NATANAEL G. da; MATSUDA, MARGARETH M.N.
The assessment of the extent of reversible or irreversible mitochondrial damage after myocardial ischemia is performed by obtaining myocardial perfusion SPECT-CT images of Technetium-99m Sestamibi radiopharmaceutical (99mTc-2-methoxy-isobutyl-isonitrile; 99mTc-sestamibi; 99mTc-MIBI). For quality control purposes, the monograph of the United States Pharmacopoeia (USP) was followed. The determination of the radiochemical purity of 99mTc-sestamibi involves the use of two chromatographic methods: thin layer chromatography in reverse phase and high performance liquid chromatography. This work aims to determine the radiochemical purity of 99mTc-sestamibi by the HPLC method described in USP. The analyses were performed on a Shimadzu liquid chromatography, LC-20AT model, consisting of two pumps, degasser, automatic sample injector, UV-visible detector and Bioscan radioactivity detector. The column used was μBondapack C18 (3.9 x 300 mm, 10 μm, Waters) and the mobile phase was a mixture of acetonitrile, 0.05 mol L-1 ammonium sulfate and methanol (20:35:45). 5 μL of sample (approximately 250 μCi) was injected with a 2 mL min-1 mobile phase flow. According to the USP monograph, the retention time for 99mTc-sestamibi is 5-10 minutes and for the 99mTc-pentamibidimethylvinylisonitrile impurity is 6-13 minutes. Not less than 90% of the total radioactivity must be present as 99mTc-sestamibi and not more than 5% as 99mTc-pentamibidimethylvinylisonitrile. For 12 analyzed batches of MIBI-TEC® produced at IPEN/CNEN-SP, the product presented a retention time of 7 minutes and the 99mTc-pentamibidimethylvinylisonitrile impurity formation was not observed.
Multielementar determination of trace metals in radioiodine compounds by inductively coupled plasma optical emission spectrometry
2008 - OLIVEIRA, I.M.; MARTINS, P.A.; SILVA, J.L.; RAMOS, M.P.S.; MENGATTI, J.; FUKUMORI, N.T.O.; MATSUDA, M.M.N.
Controle de qualidade de ECD-Tc-99m: um estudo retrospectivo
2013 - MARTINS, P.A.; MENDONÇA, V.; SILVA, G.N.; FREIRE, A.C.; CASTANHEIRA, C.E.; BERNARDES, D.M.L.; MENGATTI, J.; FUKUMORI, N.T.O.; MATSUDA, M.M.N.
Multielemental determination of trace elements in radiopharmaceuticals produced at the radiopharmacy center using ICP-OES technique
2013 - TAVARES, ANGELICA T.; MARTINS, PATRICIA de A.; FUKUMORI, NEUZA T.O.; MENGATTI, JAIR; MATSUDA, MARGARETH M.N.