A sensitive and fast ultra performance liquid chromatography‐electrospray ionization‐tandem mass spectrometry (UPLC‐ESI‐MS/MS) method for measurements of N‐butylscopolamine in plasma was developed and validated. A single protein precipitation was proposed for the clean up of the plasma and N‐methylhomatropine was added as internal standard (IS). The analyses were carried out using a C18 column and mobile phase of acetonitrile: 5 mM ammonium acetate + 0.1% formic acid (90:10, v/v). The triple quadrupole mass spectrometer equipped with an electrospray source in positive mode, was set up in selective reaction monitoring, to detect precursor → product ion 360.0 → 194.0 m/z and 290.3 → 138.0 m/z transitions, for N‐butylscopolamine and IS, respectively. The method was linear in 0.03 (lower limit of quantitation; LLOQ) – 10.00 ng/ml range for N‐butylscopolamine. Satisfactory selectivity, linearity, precision, accuracy, and robustness were obtained for the UPLC‐ESI‐MS/MS method. The proposed method was successfully applied to a pharmacokinetic study of healthy human volunteers; the results showed that the two scopolamine butylbromide formulations tested are not bioequivalent in rate and extent of absorption. Copyright © 2012 John Wiley & Sons, Ltd.
This study was to evaluate and compare the pharmacokinetic and pharmacodynamic behavior of two formulations of furosemide (CAS 54-31-9) 40 mg tablets, administered as a single dose to healthy subjects. Plasma concentrations of furosemide were determined with a validated method by liquid chromatography coupled to mass spectrometry (LC-MS/MS). We obtained the parameters: AUC 0-t , AUC 0-∞ , K el , T 1/2 , C max e T max. The following parameters were determined in urine: Sodium, Potassium and Chlorine and the total volume. The 90% confidence intervals for the ratio of C max (93.63-121.92%), AUC 0-t (96.80-115.72%) and AUC 0-∞ (98.45-117.43%) respectively for test and reference. Statistical analysis of the similarity of the parameters for urinary volume, excretion of sodium, potassium and chlorine and assuming that both formulations reach the same plasma levels, we expect that the pharmacological effect is also the same. Whereas the rate and extent of absorption, both products can be considered therapeutic equivalents.
A sensitive and specific LC/MS/MS method was developed and validated for the determination of scopolamine butylbromide in human plasma. Scopolamine butylbromide and propanolol (internal standard) were extracted from the plasma by liquidliquid extraction with dichloromethane as the extraction solvent and separated on a C18 analytical column (50 4.6 mm id) maintained at 40C. The analytes were eluted at a constant flow rate of 0.45 mL/min; the mobile phase consisted of acetonitrile and a buffer of 5 mM ammonium acetate and 0.1 formic acid (60 + 40, v/v). The mass spectrometer, equipped with an electrospray source in the positive ionization mode, was set up in the multiple-reaction monitoring mode to monitor the transitions m/z 360.6 > 102.5 (scopolamine butylbromide) and m/z 259.7 > 115.6 (propanolol). The chromatographic separation was obtained within 2.0 min, and the responses were linear over the concentration range of 0.1040.00 ng/mL. The mean extraction recoveries of scopolamine butylbromide and propanolol from plasma were 69.00 and 80.76, respectively. Method validation parameters, such as specificity, linearity, precision, accuracy, and stability, were within the acceptable range. Moreover, when the proposed method was successfully applied to a pharmacokinetic study of healthy human volunteers, the results showed that the two scopolamine butylbromide formulations tested are not bioequivalent in rate and extent of absorption.
Secnidazole is an antimicrobial agent used primarily in the treatment of amoebiasis. For this bioequivalence study of secnidazole, twenty-eight healthy female volunteers were enrolled in a randomized crossover study. Each volunteer was given a single oral dose of secnidazole test preparation and then the reference preparation, or vice versa, with a wash out interval of two weeks. The plasma concentrations of secnidazole were determined by HPLC, and the samples were extracted with tert-butyl-methyl-ether: dicloromethane (60:40, v/v). Secnidazole and its parent compound metronidazole were separated on a C18 column with water:acetonitrile (85:15, v/v) as the mobile phase, and monitored at 310 nm. The ratio of mean C max , AUC 0−t and AUC 0−∞ values for the test and reference products were within the predetermined range established by ANVISA, demonstrating that the two formulations are bioequivalent in rate and extent of absorption. Uniterms:Oral formulas/bioequivalence study. Secnidazole/bioavailability. Antimicrobials/ bioavailability. Secnidazol é um agente antimicrobiano utilizado principalmente no tratamento da amebíase. Para este estudo de bioequivalência de secnidazol em voluntários saudáveis, foram incluídos vinte e oito voluntárias mulheres no estudo randomizado cruzado. Cada voluntária recebeu uma única dose oral de secnidazol do produto teste e referência para comparação, com um intervalo de wash-out de duas semanas. As concentrações plasmáticas de secnidazol foram determinados por CLAE, as amostras foram extraídas com terc -butil-metil-éter: dicloromethano (60:40, v/v). O secnidazol e seu padrão interno metronidazol foram separados em uma coluna (C18 ) com fase móvel água ultra-pura:acetonitrila (85:15, v/v) e monitorado em 310 nm. As razões entre as médias geométricas de C máx , ASC 0-t e ASC 0-∞ , encontraramse dentro do estabelecido pela ANVISA, demonstrando que as formulações são bioequivalentes quanto à taxa e extensão de absorção Unitermos: Formulações orais/estudo de bioequivalência. Secnidazol/biodisponibilidade. Antimicrobianos/biodisponibilidade.
Plasma monitoring and pharmacokinetic assessment are important tools used in therapeutic control. Sufentanil is responsible for the hemodynamic stabilization of patients, providing better suppression of the neuroendocrine response compared to its analogue fentanyl. This study aims to use the plasma monitoring of sufentanil in patients undergoing cardiac surgery with extracorporeal circulation (ECC, group 1) or without ECC (group 2) to assess the pharmacokinetics of the compound.The 42 patients in this study received 0.5 μg/kg of sufentanil through bolus injection followed by a maintenance infusion of 0.5 μg/kg.h. Serial blood samples were collected during the post induction intraoperative period and during the postoperative period until 36 h after sufentanil administration. The plasma concentrations were determined by a validated method utilizing liquid chromatography coupled to mass spectrometry. The pharmacokinetic modeling was performed using a 3-compartment model fit.The surgical patients included in the protocol were adults of both genders, with 30 patients in the ECC group and 12 in the group without ECC. The plasma concentrations obtained were significantly different between the 2 groups. During the extracorporeal circulation procedure, intense fluctuations were observed in the sufentanil plasma concentrations. Compared with the results of group 2, the ECC procedure reduced the terminal or gamma half-life from 36.35 ± 6.37 h to 23.25 ± 2.75 h in group 1. In addition, the ECC procedure promoted higher fluctuations in the sufentanil plasma concentrations without causing alterations in the area under the curve, distribution volume, clearance or the distributional (alpha) and rapid elimination (beta) half-lives (t1/2α and t1/2β, respectively).
Introdução: O câncer colorretal é a neoplasia mais frequente do trato gastrointestinal, sendo a segunda principal causa de morte por câncer no mundo. Objetivo: Traçar um perfil clínico-epidemiológico do câncer colorretal na Região Oeste do Paraná (Brasil), entre 2016 e 2018. Método: Estudo observacional analítico do tipo transversal, construído a partir da análise de resultados de exames anatomopatológicos, realizados entre 2016 a 2018. Realizaram-se análises por estatística descritiva, teste de associação qui-quadrado e U de Mann-Whitney. Adotou-se nível de significância de 5%. Resultados: A análise de 509 laudos positivos para câncer colorretal permitiu identificar o predomínio de pacientes do sexo masculino e a idade média de diagnóstico de 62 anos. A malignidade mostrou-se mais incidente na faixa etária de 61 a 70 anos (29,9%), e considerável número de casos ocorreu em pacientes abaixo de 50 anos (19,6%). Houve predomínio em cólon esquerdo e do tipo histológico adenocarcinoma infiltrativo moderadamente diferenciado. Verificou-se associação entre topografia da doença e sexo, com maior predominância do sexo feminino para tumores do cólon direito e do sexo masculino para tumores do cólon esquerdo (p=0,0081). Conclusão: A partir deste estudo, delineia-se um perfil clínico-epidemiológico do câncer colorretal na Região Oeste do Paraná, com maior incidência da doença em homens, sexagenários, além de predomínio de tumores em cólon esquerdo e do tipo adenocarcinoma infiltrativo moderadamente diferenciado. Tais achados são relevantes considerando a possibilidade de aplicação assertiva de protocolos internacionais de rastreio do câncer nessa população.
É crescente, nas últimas duas décadas, o número de estudos brasileiros sobre a incidência do câncer de mama, contudo, ainda há carência de trabalhos que avaliem este indicador em populações agrícolas. Objetivou-se analisar a incidência de câncer de mama feminino em trabalhadoras agrícolas residentes no estado do Paraná, no período de 2003 a 2018. Foi realizado um estudo ecológico, exploratório, transversal, constituído pelos casos novos de mulheres diagnosticadas com câncer de mama notificados no Registro Hospitalar de Câncer, entre 2003 e 2018. Calculou-se a taxa de incidência dos novos casos de câncer de mama, usando como referência o número de trabalhadoras agrícolas registradas na Relação Anual de Informações Sociais (RAIS). A regressão linear simples foi utilizada para avaliar as variações anuais da taxa, com intervalo de confiança de 95% (IC95%). E ainda, foram estimadas as Razão de Chances ou Odds Ratio (OR) (IC95%) de ocorrência do agravo para esse grupo ocupacional. A taxa de incidência variou de 136,61 casos por 100 mil trabalhadoras agrícolas em 2003 a 1.225,49/100 mil em 2018. Houve acréscimo significativo de 0,014 casos/100 mil a cada ano (p<0,001) ao longo dos 16 anos da série temporal. As trabalhadoras agrícolas tiveram, em todo o período, maiores chances de desenvolver câncer de mama, quando comparadas com trabalhadoras de outros setores (OR 14,85, IC95% 12,70 - 17,36 em 2018). Conclui-se que a incidência do câncer de mama em trabalhadoras agrícolas é significativa no Paraná e que, ser estar empregada neste setor, aumentou significativamente as chances de desenvolver câncer de mama. A partir desses dados, espera-se auxiliar na elaboração de políticas, orientando prioridades e ações de redução da incidência e mortalidade deste agravo, contribuindo com o alcance da meta 3 “saúde e bem estar’ dos Objetivos do Desenvolvimento Sustentável (ODS).
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