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Bellorio K.B.,Institute Ciencias Farmaceuticas Of Estudos E Pesquisas | De Souza Teixeira L.,Institute Ciencias Farmaceuticas Of Estudos E Pesquisas | De Abreu F.C.,Institute Ciencias Farmaceuticas Of Estudos E Pesquisas | Mundim I.M.,Institute Ciencias Farmaceuticas Of Estudos E Pesquisas | And 2 more authors.
Revista Brasileira de Medicina | Year: 2014

The bioavailability of pregabalin in two different formulations of 150 mg hard gelatin capsules was compared by means of a singledose, randomized-sequence, open-label, two period crossover bioequivalence study with 36 Brazilian male healthy volunteers. Blood samples were taken during 48 h and obtained plasma was frozen and kept until time of analysis. Plasmatic concentrations of pregabalin were determined using a validated HPLC-MS/MS method. Chromatographic separation was archieved with a mobile phasecomposed of 2 mM ammonium acetate buffer with 0.025% formic acid and methanol (3:7 v/v), at flow rate of 1.5 mL/min. The employed chromatographic column was ACE 5 C18 (100 x 4.6 mm) and total run time was 2.5 minutes. Mass spectrometric detection was performed using electrospray ionization in positive mode. Confidence intervals (90%) for the peak plasma concentration (Cmax) and area under the concentration-time curve (AUC0-t) were determined by calculating log-transformed data. The test and reference formulations were considered bioequivalent since the 90% CIs for the geometric mean test/reference ratios were within a predetermined range of 80% to 125% according to the Food and Drug Administration (FDA) and Agência Nacional de Vigilância Sanitária (ANVISA). The 90% CI for the geometric mean ratios for Cmax was 99.90% (92.85-107.49%) and for AUC0-t was 102.61% (100.69-104.56%). Therefore, the tested pregabalin 150 mg capsules (Zodiac Produtos Farmacêuticos S.A.) were bioequivalent to Lyrica® 150 mg capsules (Laboratórios Pfizer), according to the rate and extent of absorption. © Copyright Moreira Jr. Editora. Todos os direitos reservados. Source


Cesar I.C.,Institute Ciencias Farmaceuticas Of Estudos E Pesquisas | Cesar I.C.,Federal University of Minas Gerais | Cardoso F.F.D.S.E.S.,Ache Laboratories Farmaceuticos S.A | Mundim I.M.,Institute Ciencias Farmaceuticas Of Estudos E Pesquisas | And 6 more authors.
Revista Brasileira de Medicina | Year: 2012

The bioavailability of a single dose of betahistine hydrochloride 24 mg tablets manufactured by Aché Laboratórios Farmacêuticos S.A. was compared with a reference (at the time of the study) betahistine hydrochloride 24 mg tablets (Labirin®, Apsen Farmacêutica S.A.). The single-dose, randomized-sequence, open-label, two period crossover study was conducted on a total of 34 Brazilian healthy volunteers of both genders. Nineteen blood samples were taken during 24 h. Samples were frozen and kept until time of analysis. Plasma concentrations of 2-pyridylacetic acid, a metabolite of beta-histine, were determined using a validated HPLC-MS/MS method. Confidence intervals (90%) for the peak plasma concentration (Cmax) and area under the concentration-time curve (AUC 0-t) were determined by calculating log-transformed data. The test and reference formulations were considered bioequivalent if the 90% CIs for the geometric mean test/reference ratios were within a predetermined range of 80% to 125%. The 90% Cl for the geometric mean ratios for Cmax was 105.18% (97.31-113.70%) and for AUC 0-t was 99.33% (95.55-103.26%). In conclusion, the tested betahistine hydrochloride 24 mg tablets (Aché Laboratometricrios Farmacêuticos S.A.) were bioequivalent to Labirin® 24 mg tablets, according to the rate and extent of absorption. © Copyright Moreira Jr. Editora. Todos os direitos reservados. Source


Cesar I.C.,Federal University of Minas Gerais | De Souza Teixeira L.,Institute Ciencias Farmaceuticas Of Estudos E Pesquisas | Mundim I.M.,Institute Ciencias Farmaceuticas Of Estudos E Pesquisas | Bellorio K.B.,Institute Ciencias Farmaceuticas Of Estudos E Pesquisas | And 6 more authors.
Revista Brasileira de Medicina | Year: 2013

Comparison of the bioavailability of two formulations of ciprofibrate 100 mg tablets (ciprofibrate 100 mg - Aché Laboratórios Farmacêuticos S/A, test formulation and Oroxadin® 100 mg - Sanofi-Aventis Farmacêutica Ltda, reference formulation) was performed by means of a bioequivalence study with 52 healthy volunteers. The study was carried out using an open-label, randomized, single-dose, two period crossover design, with a nine weeks washout interval. Plasma samples were obtained over a 72 hours interval. Plasmatic concentrations of ciprofibrate were determined by high performance liquid chromatography coupled to mass spectrometry detection (HPLCMS/ MS) with electrospray ionization in positive mode. The pharmacokinetic parameters area under the curve (AUC0-72), maximum plasmatic concentration (Cmax) and maximum time (Tmax) were obtained from the plasmatic concentration - time curve of ciprofibrate. The geometric mean test/reference ratios with 90% confidence interval after log transformation were 89.43% (85.09% - 93.99%) for Cmax and 97.23% (94.73% - 99.79%) for AUC0-72. The test and reference formulations are considered bioequivalents if the 90% confidence intervals for the geometric mean test/reference ratios were within the range of 80% to 125%. Therefore, the tested ciprofibrate 100 mg tablets (Aché Laboratórios Farmacêuticos S/A) were bioequivalents to the Oroxadin® 100 mg tablets, according to the rate and extent of absorption. © Copyright Moreira Jr. Editora.Todos os direitos reservados. Source


Rezeck L.M.,Institute Ciencias Farmaceuticas Of Estudos E Pesquisas | Bellorio K.B.,Institute Ciencias Farmaceuticas Of Estudos E Pesquisas | Fabiana F.S.,Institute Ciencias Farmaceuticas Of Estudos E Pesquisas | Cardoso S.,Institute Ciencias Farmaceuticas Of Estudos E Pesquisas | And 5 more authors.
Revista Brasileira de Medicina | Year: 2013

The study was performed to compare the bioequivalence of two Levodopa 200mg + Benserazide 50 mg (equal to Benserazide Hydrochloride 57 mg tablets formulations (Levodopa + Benserazide from Aché Laboratórios Farmacêuticos S/A. as test formulation and Prolopa® from Produtos Roche Químicos e Farmacêuticos S.A., as reference formulation) in 36 healthy volunteers. The study was conducted as an open randomized, two periods, crossover design with a washout phase of four weeks. Plasma samples were obtained over a 96 hour interval. Plasma concentrations of Levodopa and metabolite 3-O-methyldopa were determined by HPLC/MS/MS equipment using carbidope as internal standard. From the data obtained, the following pharmacokinetics parameters were calculated: AUC0-t, Cmax and Tmax. For levodopa the mean of test and reference formulations for AUC0-t were 5521,848 ng.h/mL and 5758,200 ng.h/mL, for Cmax were 3579,394 ng/mL and 3835,730 ng/mL and for Tmax 1,308 h and 1,081 h, respectively. The geometric mean ratios for levodopa were 95,83 % for AUC0-t and 94,02% for Cmax. For 3-O-methyl the mean of test and reference formulations for AUC0-t were 49000,315 ng.h/mL and 51854,673 ng.h/mL, for Cmax were 2143,352 pg/mL and 2225,818 ng/mL and for Tmax 4,013 h and 4,285 h, respectively. The geometric mean ratios for 3-Omethyldopa were 94,69% for AUC0-t and 95,91% for Cmax. The 90% confidence intervals for levodopa were 92,03-99,79% for AUC0-t and 83,00-106,51 % for Cmax. And for 3-O-methyldopa the 90% confidence intervals were 91,14 - 98,37 % for AUC0-t and 93,03-98,87% for Cmax. Sinde the 90% confidence intervals for Cmax and AUC0-t were within the range of 80-125% proposed by Food and Drug Administration (FDA) and ANVISA (the Nacional Health Surveillance Agency of Brazil), it was concluded that Levodopa 200 mg + Benserazide 50 mg tablet from Aché Laboratórios Farmacêuticos S/A. is bioequivalent to Prolopa® (Levodopa 200 mg + Benserazide 50 mg) tablet, and so the test product can be considered interchangeable in normal medical practice. © Copyright Moreira Jr. Editora. Source

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