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Registros recuperados: 7
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Using fluid bed granulation to improve the dissolution of poorly water-soluble drugs BABT
Takahashi,Andrea Ikeda; Lourenço,Felipe Rebello; Duque,Marcelo Dutra; Consiglieri,Vladi Olga; Ferraz,Humberto Gomes.
In this study, fluid bed granulation was applied to improve the dissolution of nimodipine and spironolactone, two very poorly water-soluble drugs. Granules were obtained with different amounts of sodium dodecyl sulfate and croscarmellose sodium and then compressed into tablets. The dissolution behavior of the tablets was studied by comparing their dissolution profiles and dissolution efficiency with those obtained from physical mixtures of the drug and excipients subjected to similar conditions. Statistical analysis of the results demonstrated that the fluid bed granulation process improves the dissolution efficiency of both nimodipine and spironolactone tablets. The addition of either the surfactant or the disintegrant employed in the study proved to have...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Fluid bed; Granulation; Dissolution efficiency; Nimodipine; Spironolactone.
Ano: 2012 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1516-89132012000300020
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Comparison of three experimental designs employed in gentamicin microbiological assay through agar diffusion BJPS
Lourenço,Felipe Rebello; Pinto,Terezinha de Jesus Andreoli.
Gentamicin is a broad-spectrum antibiotic complex produced by actinomycetes belonging to Micromonospora genus and classified among aminoglycoside antibiotics, used in the treatment of serious infections derived from Gram-negative microorganisms. Alterations of their antimicrobial activity not shown in chemical assays can be evaluated through microbiological assays. The aim of this work was to compare 5 x 1, 2 x 2 and 3 x 1 experimental designs, evaluating validation parameters of specificity, linearity, range, precision, and accuracy for each experimental design in different levels of concentration, presentation, and lots. It consisted of 81 assays (in 3 replicas) of gentamicin microbiological dosage. The concentrations of the solutions used were employed...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Gentamicin/sulphate; Gentamicin/experimental design; Gentamicin/microbiological dosage; Antibiotics/qualitative analysis; Aminoglycoside antibiotics/antimicrobial activity.
Ano: 2009 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502009000300022
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Antibiotic microbial assay using kinetic-reading microplate system BJPS
Lourenço,Felipe Rebello; Pinto,Terezinha de Jesus Andreoli.
The aim of this study was to determine the optimal experimental conditions to develop a methodology for microbiological assay of apramycin employing microplate and kinetic reading mode, and to validate the developed method, through evaluation of parameters of selectivity, linearity, linear range, limits of detection and quantification, accuracy and precision. The turbidimetric assay principle is simple: the test solution is added to a suspension of test microorganism in culture media, the mixture is incubated under appropriate conditions and the microbial growth is measured by photometric reading. Microplate with kinetic reading mode employed in antibiotic assay is of considerable interest since it allows reduction of material and analysis time and enables...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Antibiotics/microbial assay; Apramycin/microbial assay; Apramycin sulfate; Turbidimetric assay/medicines analysis.
Ano: 2011 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502011000300015
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Measurement uncertainty of dissolution test of acetaminophen immediate release tablets using Monte Carlo simulations BJPS
Romero,Daniel Cancelli; Lourenço,Felipe Rebello.
ABSTRACT Analytical results are widely used to assess batch-by-batch conformity, pharmaceutical equivalence, as well as in the development of drug products. Despite this, few papers describing the measurement uncertainty estimation associated with these results were found in the literature. Here, we described a simple procedure used for estimating measurement uncertainty associated with the dissolution test of acetaminophen tablets. A fractionate factorial design was used to define a mathematical model that explains the amount of acetaminophen dissolved (%) as a function of time of dissolution (from 20 to 40 minutes), volume of dissolution media (from 800 to 1000 mL), pH of dissolution media (from 2.0 to 6.8), and rotation speed (from 40 to 60 rpm). Using...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Acetaminophen tablets/dissolution test/measurement uncertainty; Monte Carlo simulation.
Ano: 2017 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502017000300613
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Comparison of dissolution profile of extended-release oral dosage forms - two one-sided equivalence test BJPS
Lourenço,Felipe Rebello; Ghisleni,Daniela Dal Molim; Yamamoto,Rosa Noriko; Pinto,Terezinha de Jesus Andreoli.
The aim of this work is to present the two one-sided test (TOST) as an alternative approach to compare dissolution profiles of extended-release dosage forms. The dissolution profiles of oxycodone extended-release tablets containing 10 mg, 20 mg and 40 mg (reference and generic) were evaluated according to the requirements described in United States Pharmacopeia. These dissolution profiles were compared using the conventional similarity factor (f2) and the proposed TOST as an equivalence test. TOST is a simple and alternative approach to compare dissolution profiles of extended-release dosage forms. It allows us to identify the time-point (or time-points) that did not show similarity. We concluded that the two one-sided test performed at a significance...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Dissolution profile; Extended-release tablets; Similarity factor; Two one-sided test; Equivalence test.
Ano: 2013 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502013000200019
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Determination of apramycin in oral soluble powder by a HPLC method using pre-column derivatization with o-phthalaldehyde and UV detection BJPS
Antunes,Elisabete de Almeida Barbosa; Lourenço,Felipe Rebello; Pinto,Terezinha de Jesus Andreoli.
A high-performance liquid chromatographic method employing pre-column derivatization with o-phthalaldehyde (OPA) and 2-mercaptoacetic acid was developed for the determination of apramycin, an aminoglycoside antibiotic used in veterinary medicine, in the oral soluble powder form. The chromatographic separation was done by ion-pair HPLC using a C18 reversed-phase column, Synergy Hydro (150 mm x 4.6 mm x 4 µm) and mobile phase composed of 0.005 mol/L sodium octanosulfonate in a mixture of acetonitrile: water: acetic acid (45:55:2) (v/v/v) with a flow rate of 1.0 mL/min; the UV detector was operated at 332 nm. The developed method was validated according to official compendia guidelines, having demonstrated robustness, selectivity and linearity for the...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Apramycin; HPLC; Microbiological Assay; Pre-column Derivatization; OPA.
Ano: 2011 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502011000200007
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Design of Experiments (DoE) applied to Pharmaceutical and Analytical Quality by Design (QbD) BJPS
Fukuda,Isa Martins; Pinto,Camila Francini Fidelis; Moreira­,Camila dos Santos; Saviano,Alessandro Morais; Lourenço,Felipe Rebello.
According to Quality by Design (QbD) concept, quality should be built into product/method during pharmaceutical/analytical development. Usually, there are many input factors that may affect quality of product and methods. Recently, Design of Experiments (DoE) have been widely used to understand the effects of multidimensional and interactions of input factors on the output responses of pharmaceutical products and analytical methods. This paper provides theoretical and practical considerations for implementation of Design of Experiments (DoE) in pharmaceutical and/or analytical Quality by Design (QbD). This review illustrates the principles and applications of the most common screening designs, such as two-level full factorial, fractionate factorial, and...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Design of Experiments (DoE); Quality by Design (QbD); Factorial Designs; Central Composite Designs (CCD); Box-Behnken Designs; Response Surface Methodology (RSM).
Ano: 2018 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502018000700405
Registros recuperados: 7
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