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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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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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Evaluating the discriminatory power of a dissolution assay for rosuvastatin calcium capsules: Solid-state properties and dissolution media BJPS
Ângelo,Marilene Lopes; Ruela,André Luís Morais; Ferreira,Anna Clara Marques; Ramos,Marcus Vinicus de Faria; Montanari,Cristina Martiniano; Silva,Lucélia Magalhães da; Araújo,Magali Benjamim de.
We propose to evaluate the dissolution properties of rosuvastatin calcium (ROSC) capsules in different media to characterize the discriminatory power of the assay method. Dissolution assays were performed in media with different pH, and including the surfactant sodium dodecyl sulfate (SDS). Several immediate-release formulations were manufactured using the commercial raw material characterized as amorphous solid. The hydrophobic adjutant magnesium stearate was employed in some formulations due to its negative effect in the wettability and dissolution efficacy of solid dosages. These formulations showed the lower dissolution efficacy values in media without surfactant; however, when SDS was added to the medium, the dissolution efficacy increased, and the...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Dissolution; Crystal polymorphism; Solid dosage form; X-ray powder diffractometry; Thermal analysis; Solubility.
Ano: 2019 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502019000100527
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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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