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Dissolution test optimization for meloxicam in the tablet pharmaceutical form BJPS
Oliveira,Érika de Fátima Silva; Azevedo,Roberta de Cássia Pimentel; Bonfilio,Rudy; Oliveira,Diego Borges de; Ribeiro,Gislaine Pereira; Araújo,Magali Benjamim de.
Meloxicam is a broadly used drug in the therapeutics for the osteoarthritis and rheumatoid arthritis treatments in adults, and it is available in the Brazilian market, as tablet and capsule pharmaceutical forms. The present work aimed to establish conditions for accomplishment of the dissolution test of 15 mg meloxicam tablets (A and B test products), compared with the reference product, since there is no monograph about dissolution assays for meloxicam in official summaries. To optimize the conditions several parameters were tested and, according to obtained results, the use of pH 7.5 phosphate buffer (900mL, at 37 ± 0.5ºC) as dissolution medium, paddle method (apparatus 2), stirring speed of the dissolution medium at 100 rpm and collect time of 60...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Meloxicam/dissolution; Dissolution kinetics; Tablet pharmaceutical forms/dissolution test; Spectrophotometry.
Ano: 2009 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502009000100008
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Solubility and dissolution studies of tibolone polymorphs BJPS
Bonfilio,Rudy; Souza,Marília Cristina Oliveira; Leal,Jockastta Silva; Viana,Olímpia Maria Martins Santos; Doriguetto,Antônio Carlos; Araújo,Magali Benjamin de.
ABSTRACT Different solid forms of an active pharmaceutical ingredient can have distinct chemical and physical characteristics. In this work, we studied the solubility and dissolution properties of the described tibolone polymorphic forms (I and II). Both forms were successively recrystallized and characterized by powder X-ray diffraction and attenuated total reflection infrared spectroscopy. Equilibrium solubility and dissolution profiles were performed for both forms. Solubility studies demonstrated that form II is statistically more soluble in water, 0.01 mol L-1 HCl and pH 4.5 acetate buffer. The solubility of forms I and II were explained in terms of crystal packing. Dissolution tests of tablets showed a lower release of polymorphic form II than form I...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Tibolone/polymorphs; Powder X-ray diffraction/methods; Infrared spectroscopy/methods; Solubility/drug effects; Dissolution/analysis.
Ano: 2017 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502017000400607
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Analysis of spironolactone polymorphs in active pharmaceutical ingredients and their effect on tablet dissolution profiles BJPS
Resende,Renata Cunha de; Viana,Olímpia Maria Martins Santos; Freitas,Jennifer Tavares Jacon; Bonfilio,Rudy; Ruela,André Luís Morais; Araújo,Magali Benjamim de.
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 bioequivalence between solid-state formulations. In this study, SPR polymorphs in five batches of active pharmaceutical ingredients (APIs) from three manufacturers were characterized using powder X-ray diffraction, infrared spectroscopy, thermal analysis, and solubility measurements. SPR tablets (50 mg) were manufactured in our laboratory using API in pure form II, and API in form II contaminated with...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Spironolactone/dissolution profile; Spironolactone/pharmaceutical equivalence; Spironolactone/solubility; Spironolactone/polymorphism; Drugs/quality assessment..
Ano: 2016 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502016000400613
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Comparative study of analytical methods by direct and first-derivative UV spectrophotometry for evaluation of losartan potassium in capsules BJPS
Bonfilio,Rudy; Favoretto,Lívia Botacini; Pereira,Gislaine Ribeiro; Azevedo,Roberta de Cássia Pimentel; Araújo,Magali Benjamim de.
Losartan potassium is an antihypertensive non-peptide agent, which exerts its action by specific blockade of angiotensin II receptors. The aim of the present study was the validation and application of analytical methods for the quality control of losartan potassium 50 mg in pharmaceutical capsules, using direct and first-derivative UV spectrophotometry. Based on losartan potassium spectrophotometric characteristics, a signal at 205 nm of the zero-order spectrum and a signal at 234 nm of the first-derivative spectrum, were found adequate for quantification. The results were used to compare these instrumental techniques. The linearity between the signals and concentrations of losartan potassium in the ranges of 3.0-7.0 mg L-1 and 6.0-14.0 mg L-1 for direct...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Losartan potassium; Direct UV spectrophotometry; First-derivative UV spectrophotometry.
Ano: 2010 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502010000100017
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