Entity

Time filter

Source Type


Borges N.C.C.,Synchrophar Assessoria e Desenvolvimento de Projetos Clinicos S S Ltda | Borges N.C.C.,University of Campinas | Astigarraga R.B.,Magabi Pesquisas Clinicas e Farmaceuticas | Sverdloff C.E.,Synchrophar Assessoria e Desenvolvimento de Projetos Clinicos S S Ltda | And 5 more authors.
Current Clinical Pharmacology | Year: 2012

In the present study, a novel, fast, sensitive and robust method to quantify clozapine in human plasma using quetiapine as the internal standard (IS) is described. The analyte and the IS were extracted from plasma using a single protein precipitation extraction technique with methanol and analyzed by high performance liquid chromatography coupled to the electrospray ionization tandem mass spectrometric (HPLC-ESI-MS/MS). The method was linear over the range 20 to 1500 ng.mL-1. The intra-assay precisions ranged from 3.8 to 5.9%, while inter-assay precisions ranged from 4.2 to 6.0%. The intra-assay accuracies ranged from 99.3 to 107.5%, while the inter-assay accuracies ranged from 98.9 to 101.7%. This method agrees with the requirements proposed by the US Food and Drug Administration of high sensitivity, specificity and high sample throughput and was used to evaluate the pharmacokinetic profiles and bioequivalence of the two clozapine formulations in twenty six schizophrenic patients affected by refractory schizophrenia under steady-state conditions. During the hospitalization period the patients received the 100 mg clozapine formulation tablets corresponding to the same dose they were using 14 days before hospitalization. The clozapine pharmacokinetic did not differ significantly after administration of both test and the reference formulations. The Tmax and T1/2 for the test formulation were 2.26 and 10.92 h, respectively. In addition, the Tmax and T1/2 for the reference formulation were 2.44 and 11.08 h, respectively. The 90% confidence interval of the mean ratio of lnAUC0-t was within 0.80-1.25 range which indicates that the test formulation was bioequivalent to the reference formulation when orally administered to schizophrenic patients regarding both the rate and extent of absorption. © 2012 Bentham Science Publishers. Source


Borges N.C.D.C.,SSSA | Borges N.C.D.C.,University of Campinas | Astigarraga R.B.,Magabi Pesquisas Clinicas e Farmaceuticas | Sverdloff C.E.,SSSA | And 6 more authors.
Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences | Year: 2011

In the present study, a novel, fast, sensitive and robust method to quantify budesonide in human plasma using 3-keto-desogestrel as the internal standard (IS) is described. The analyte and the IS were extracted from human plasma by liquid-liquid extraction (LLE) using ether. Extracted samples were analyzed by high performance liquid chromatography coupled to Atmospheric pressure photoionization tandem mass spectrometry (HPLC-APPI-MS/MS). Chromatography was performed isocratically on a C18, 5μm analytical column. The temperature of the autosampler was kept at 6°C and the run time was 4.00min. A linear calibration curve over the range 7.5-1000pgml -1 was obtained and the lowest concentration quantified was 7.5pgml -1, demonstrating acceptable accuracy and precision. This analytical method was applied in a relative bioavailability study in order to compare a test budesonide 64μg/dose nasal spray formulation vs. a reference 64μg/dose nasal spray formulation (Budecort Aqua) in 48 volunteers of both sexes. The study was conducted in an open randomized two-period crossover design and with a one-week washout period. Plasma samples were obtained over a 14h interval. Since the 90% CI for both C max, AUC last and AUC 0-inf were within the 80-125% interval proposed by the Food and Drug Administration and ANVISA, it was concluded that budesonide 64μg/dose nasal spray was bioequivalent to Budecort Acqua ® 64μg/dose nasal spray, according to both the rate and extent of absorption. © 2010 Elsevier B.V. Source


Moreno R.A.,University of Campinas | Oliveira-Silva D.,University of Sao Paulo | Sverdloff C.E.,University of Campinas | Borges B.C.,University of Medical Sciences of Costa Rica | And 4 more authors.
Biomedical Chromatography | Year: 2010

In the present study a fast, sensitive and robust validated method to quantify chlorpheniramine in human plasma using brompheniramine as internal standard (IS) is described. The analyte and the IS were extracted from plasma by LLE (diethyl ether-dichloromethane, 80:20, v/v) and analyzed by HPLC-ESI-MS/MS. Chromatographic separation was performed using a gradient of methanol from 35 to 90% with 2.5 mM NH4OH on a Gemini Phenomenex C8 5 μm column (50 x 4.6 mm i.d.) in 5.0 min/run. The method fi tted to a linear calibration curve (0.05-10 ng/mL, R > 0.9991). The precision (%CV) and accuracy ranged, respectively: intra-batch from 1.5 to 6.8% and 99.1 to 106.6%, and inter-batch from 2.4 to 9.0%, and 99.9 to 103.1%. The validated bioanalytical procedure was used to assess the comparative bioavailability in healthy volunteers of two dexchlorpheniramine 2.0 mg tablet formulations (test dexchlorpheniramine, Eurofarma, and reference Celestamine® , Schering-Plough). The study was conducted using an open, randomized, two-period crossover design with a 2 week washout interval. Since the 90% confi dence interval for Cmax and AUC ratios were all within the 80-125% interval proposed by ANVISA and FDA, it was concluded that test and reference formulations are bioequivalent concerning the rate and the extent of absorption. Copyright © 2009 John Wiley & Sons, Ltd. Source


Pinto G.A.,Eurofarma Laboratorios | Pastre K.I.F.,Magabi Pesquisas Clinicas e Farmaceuticas | Bellorio K.B.,Institute Ciencias Farmaceuticas | de Souza Teixeira L.,Institute Ciencias Farmaceuticas | And 6 more authors.
Biomedical Chromatography | Year: 2014

An improved LC-MS/MS method for the quantitation of indapamide in human whole blood was developed and validated. Indapamide-d3 was used as internal standard (IS) and liquid-liquid extraction was employed for sample preparation. LC separation was performed on Synergi Polar RP-column (50×4.6mm i.d.; 4μm) and mobile phase composed of methanol and 5mm aqueous ammonium acetate containing 1mm formic acid (60:40), at flow rate of 1mL/min. The run time was 3.0min and the injection volume was 20μL. Mass spectrometric detection was performed using electrospray ion source in negative ionization mode, using the transitions m/z 364.0→m/z 188.9 and m/z 367.0→m/z 188.9 for indapamide and IS, respectively. Calibration curve was constructed over the range 0.25-50ng/mL. The method was precise and accurate, and provided recovery rates >80% for indapamide and IS. The method was applied to determine blood concentrations of indapamide in a bioequivalence study with two sustained release tablet formulations. The 90% confidence interval for the geometric mean ratios for maximum concentration was 95.78% and for the area under the concentration-time curve it was 97.91%. The tested indapamide tablets (Eurofarma Laboratórios S.A.) were bioequivalent to Natrilix®, according to the rate and extent of absorption. © 2014 John Wiley & Sons, Ltd. Source


Borges N.C.,Synchrophar Assessoria e Desenvolvimento de Projetos Clinicos S S Ltda | Borges N.C.,University of Campinas | Barrientos-Astigarraga R.E.,Magabi Pesquisas Clinicas e Farmaceuticas | Sverdloff C.E.,Magabi Pesquisas Clinicas e Farmaceuticas | And 7 more authors.
Biomedical Chromatography | Year: 2012

In the present study a simple, fast, sensitive and robust method to quantify mirtazapine in human plasma using quetiapine as the internal standard (IS) is described. The analyte and the IS were extracted from human plasma by a simple protein precipitation with methanol and were analyzed by high-performance liquid chromatography coupled to an electrospray tandem triple quadrupole mass spectrometer (HPLC-ESI-MS/MS). Chromatography was performed isocratically on a C18, 5μm analytical column and the run time was 1.8min. The lower limit of quantitation was 0.5ng/mL and a linear calibration curve over the range 0.5-150ng/mL was obtained, showing acceptable accuracy and precision. This analytical method was applied in a relative bioavailability study in order to compare a test mirtazapine 30mg single-dose formulation vs a reference formulation in 31 volunteers of both sexes. The study was conducted in an open randomized two-period crossover design and with a 14day washout period. Since the 90% confidence interval for Cmax, AUClast and AUC0-inf were within the 80-125% interval proposed by the Food and Drug Administration and ANVISA (Brazilian Health Surveillance Agency), it was concluded that mirtazapine 30mg/dose is bioequivalent to the reference formulation, according to both the rate and extent of absorption. Copyright © 2012 John Wiley & Sons, Ltd. © 2012 John Wiley & Sons, Ltd. Source

Discover hidden collaborations