PATRICIA DE ANDRADE MARTINS

PATRICIA DE ANDRADE MARTINS

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Evaluation of dithiol spectrophotometric method for tin determination in lyophilized reagents
2021 - CASTRO, HIGOR R.G.; COURI, VICENZO S.F.; MARTINS, PATRICIA de A.; SANTOS, JOEL M. dos; MATSUDA, MARGARETH M.N.
Proposal of an identification test for MIBI-TEC® lyophilized reagent using infrared spectroscopy
2019 - SANTOS, JOEL M. dos; FUKUMORI, NEUZA T.O.; OLIVEIRA, IDELI M. de; MARTINS, PATRICIA de A.; SILVA, NATANAEL G. da; MATSUDA, MARGARETH M.N.
Quality Control is part of the Good Manufacturing Practices (GMP) responsible for the evaluation and release of pharmaceutical components, including active ingredients and excipients, to assure compliance with the specifications in pharmacopoeias. GMP for radiopharmaceuticals is regulated by RDC N. 17/2010 and RDC N. 63/2009 (ANVISA) establishing the minimum quality standards in industrial manufacture. Pharmacopoeias have the specifications for lyophilized reagents (LR) labeled with 99mTc regarding radiochemical purity, biodistribution and, in case of parenteral use, bacterial endotoxins and sterility tests must be performed. In radiopharmaceutical monographs, the necessity of non radioactivity assays for releasing lyophilized reagents are not well described, but ANVISA requires assays to assure the quality of the lyophilized powder, as active ingredient quantification and identification assays, stannous ion quantification and moisture determination. Infrared (IR) spectroscopy is widely used for identification of substances, mainly raw materials. The aim of this work is to propose an identification assay for MIBI-TEC® LR powder using IR spectroscopy. MIBI-TEC® batches were produced at IPEN/CNEN-SP and about 2 mg of the LR powder were mixed with 200 mg KBr, pressed at 80 kgf during 5 minutes into the holder to obtain a transparent pellet. The pellet was placed in ABB IR spectrometer, FTLA 2000 model, and a spectrum in the medium infrared region of 450 to 4000 cm-1 was acquired using Grams software. Tetramibi cuprous tetrafluoroborate, stannous chloride dihydrate, cysteine hydrochloride monohydrate, sodium citrate and mannitol had their respective IR spectrum recorded and the main characteristic absorptions were established for each formulation component. In the MIBI-TEC® spectrum, it was possible to observe a well characterized absorption in 2193 cm-1 which represents the presence of C≡N binding of tetramibi cuprous tetrafluoroborate active ingredient, free of interference, indicating that IR spectrum can be used as identification assay of the LR.
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.
Evaluation of the particle size of radiopharmaceuticals by membrane filtration
2009 - OLIVEIRA, I.; MARTINS, P.; VICENTIN, C.; MENGATTI, J.; FUKUMORI, N.; MATSUDA, M.
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.
Evaluation of different parameters for labeling ciprofloxacin with technetium-99m
2002 - MARTINS, P.A.; FAINTUCH, B.L.; MURAMOTO, E.; SOSA de PEREIRA, N.; SILVA, C.P.G.
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.
Produção de MAG-3-Tc99m no IPEN: resultados iniciais
2013 - SILVA, G.N.; MARTINS, P.A.; CASTANHEIRA, C.E.; 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.
Alternative methods for radiochemical purity testing in radiopharmaceutical
2011 - OLIVEIRA, IDELI M. de; MARTINS, PATRICIA de A.; SILVA, JOSE L. da; RAMOS, MARCELO P.S.; LIMA, JOSE A.S.; PUJATTI, PRISCILLA B.; FUKUMORI, NEUZA T.O.; MATSUDA, MARGARETH M.N.