Bioequivalence Study
Mostrando 1-12 de 53 artigos, teses e dissertações.
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1. In vitro characterization and in vivo performance of mefenamic acid-sodium diethyldithiocarbamate based liposomes
Mefenamic acid (MFA) is a hydrophobic drug with low dissolution rate. This study aimed to develop stable and reproducible aqueous formulations of MFA using liposomes as drug carriers. The drug entrapment, particles size and drug release profiles, and stability and reproducibility of the liposomes were determined. In addition, the maximum tolerated dose (MTD)
Braz. J. Pharm. Sci.. Publicado em: 25/11/2019
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2. Determination of Gemifloxacin in human plasma by high performance liquid chromatography using Ultra Violet detector and its application to a bioequivalence study
A liquid chromatography method was developed and validated for the determination of gemifloxacin in human plasma using chloramphenicol as internal standard to achieve lower quantification limit. Acetonitrile was used to precipitated and extracted analyte and internal standard from plasma by Protein Precipitation. Analysis was performed isocratically on C18 c
Braz. J. Pharm. Sci.. Publicado em: 08/04/2019
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3. Analysis of spironolactone polymorphs in active pharmaceutical ingredients and their effect on tablet dissolution profiles
ABSTRACT Spironolactone (SPR) is a steroidal drug administered as a potassium-sparing diuretic for high blood pressure treatment. The drug shows incomplete gastrointestinal absorption due to its poor aqueous solubility. The physicochemical properties of SPR in crystal forms I and II suggest that differences in their aqueous solubility may lead to a lack of b
Braz. J. Pharm. Sci.. Publicado em: 2016-12
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4. Using a single tablet daily to treat latent tuberculosis infection in Brazil: bioequivalence of two different isoniazid formulations (300 mg and 100 mg) demonstrated by a sensitive and rapid high-performance liquid chromatography-tandem mass spectrometry method in a randomised, crossover study
The recommended treatment for latent tuberculosis (TB) infection in adults is a daily dose of isoniazid (INH) 300 mg for six months. In Brazil, INH was formulated as 100 mg tablets. The treatment duration and the high pill burden compromised patient adherence to the treatment. The Brazilian National Programme for Tuberculosis requested a new 300 mg INH formu
Mem. Inst. Oswaldo Cruz. Publicado em: 02/06/2015
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5. Dissolution efficiency and bioequivalence study using urine data from healthy volunteers: a comparison between two tablet formulations of cephalexin
O objetivo do presente estudo foi avaliar a bioequivalência de duas formulações de cefalexina disponíveis no mercado brasileiro (produto A como formulação referência e produto B como formulação teste). A eficiência de dissolução (DE%) foi calculada para ambas as formulações para avaliar suas características biofarmacêuticas. O estudo de bi
Braz. J. Pharm. Sci.. Publicado em: 2015-06
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6. Average bioequivalence of single 500 mg doses of two oral formulations of levofloxacin: a randomized, open-label, two-period crossover study in healthy adult Brazilian volunteers
A bioequivalência média de duas formulações de levofloxacino disponíveis no Brasil, Tavanic(c) (Sanofi-Aventis Farmacêutica Ltda, Brasil, produto referência) e Levaquin(c) (Janssen-Cilag Farmacêutica Ltda, Brasil, produto teste) foi determinada por meio da realização de ensaio aleatório, aberto, cruzado, com dois períodos e duas sequências, em 2
Braz. J. Pharm. Sci.. Publicado em: 2015-03
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7. Determination of levodopa in human plasma by high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS): application to a bioequivalence study
A sensitive, accurate and simple method using HPLC-MS/MS was developed and validated for levodopa quantitation in human plasma. Analysis was achieved on a pursuit® C18 analytical column (5 µm; 150 x 4.6 mm i.d.) using a mobile phase (methanol and water , 90:10, v/v) containing formic acid 0.5% v/v, after extracting the samples using a simple protein plasma
Quím. Nova. Publicado em: 2013
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8. Estudo da biodisponibilidade comparativa de duas formulações de fenoximetilpenicilina / Compartive bioavailability study of two phenoxymethylpenicillin
This study aimed to compare the bioequivalence between Phenoxymethylpenicillin tablets (500.000 UI), a test formulation Meracilina by Aché Laboratórios S/A, and the Pen-Ve-Oral® tablet formulation elaborated by Eurofarma Laboratórios Ltda., Brazil, in healthy human volunteers of both sexes. The study was carried out by using an open, randomized-crossover
IBICT - Instituto Brasileiro de Informação em Ciência e Tecnologia. Publicado em: 20/06/2011
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9. Method development and validation for naratriptan determination in human plasma by HPLC with tandem mass spectrometry detection, and its application to bioequivalence study
Os autores desenvolveram um método simples, sensível e específico de cromatografia líquida-espectrometria de massa-tandem (LC-MS/MS) para a quantificação de naratriptan (NP) em plasma humano empregando naratriptan-d3 (NPD3) como padrão interno de referência (IS). A separação cromatográfica foi realizada em coluna Zorbax SB-C18, 75 x 4,6 mm, 3,5 μ
Brazilian Journal of Pharmaceutical Sciences. Publicado em: 2011-03
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10. A sensitive and robust lc-ms/ms method with monolithic column and electrospray ionization for the quantitation of efavirenz in human plasma: application to a bioequivalence study
An LC-MS/MS method has been developed for the determination of efavirenz (EFZ) in human plasma using hydrochlorothiazide as internal standard (I.S.). An ESI negative mode with multiple reaction-monitoring was used monitoring the transitions m/z 313.88→69.24 (EFZ) and 296.02→204.76 (I.S.). Samples were extracted using liquid-liquid extraction. The total r
Química Nova. Publicado em: 2011
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11. Determination of phenobarbital in human plasma by a specific liquid chromatography method: application to a bioequivalence study
A liquid chromatography method was developed and validated for the determination of phenobarbital in human plasma using phenytoin as internal standard. The drugs were extracted from plasma by liquid-liquid extraction and separated isocratically on a C12 analytical column, maintained at 35 ºC, with water:acetonitrile:methanol (58.8:15.2:26, v/v/v) as mobile
Química Nova. Publicado em: 2010
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12. Biodisponibilidade comparativa de duas formulações de losartan em voluntarios humanos sadios apos administração de dose unica / Comparative bioavailability of two losartan formulations in healthy human volunteers after a single dose administration
This dissertation focus in the evaluation of the bioavailability of two formulations of potassium losartan immediate release tablet 50mg (Losartan from Laboratórios Cristália Ltd., Brazil, as a test formulation and Cozaar® from Merck Sharp &Dohme Farmacêutica Ltd., Brazil as a reference formulation). The bioequivalence study was conducted using an open,
Publicado em: 2009