Measurement uncertainty of dissolution test of acetaminophen immediate release tablets using Monte Carlo simulations
Autor(a) principal: | |
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Data de Publicação: | 2017 |
Outros Autores: | |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Brazilian Journal of Pharmaceutical Sciences |
Texto Completo: | https://www.revistas.usp.br/bjps/article/view/140184 |
Resumo: | 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 Monte Carlo simulations, we estimated measurement uncertainty for dissolution test of acetaminophen tablets (95.2 ± 1.0%), with a 95% confidence level. Rotation speed was the most important source of uncertainty, contributing about 96.2% of overall uncertainty. Finally, it is important to note that the uncertainty calculated in this paper reflects the expected uncertainty to the dissolution test, and does not consider variations in the content of acetaminophen. |
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Brazilian Journal of Pharmaceutical Sciences |
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Measurement uncertainty of dissolution test of acetaminophen immediate release tablets using Monte Carlo simulationsAcetaminophen tablets/dissolution test/measurement uncertaintyMonte Carlo simulationAnalytical 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 Monte Carlo simulations, we estimated measurement uncertainty for dissolution test of acetaminophen tablets (95.2 ± 1.0%), with a 95% confidence level. Rotation speed was the most important source of uncertainty, contributing about 96.2% of overall uncertainty. Finally, it is important to note that the uncertainty calculated in this paper reflects the expected uncertainty to the dissolution test, and does not consider variations in the content of acetaminophen.Universidade de São Paulo. Faculdade de Ciências Farmacêuticas2017-01-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://www.revistas.usp.br/bjps/article/view/14018410.1590/s2175-97902017000300163Brazilian Journal of Pharmaceutical Sciences; Vol. 53 Núm. 3 (2017); e00163-Brazilian Journal of Pharmaceutical Sciences; v. 53 n. 3 (2017); e00163-Brazilian Journal of Pharmaceutical Sciences; Vol. 53 No. 3 (2017); e00163-2175-97901984-8250reponame:Brazilian Journal of Pharmaceutical Sciencesinstname:Universidade de São Paulo (USP)instacron:USPenghttps://www.revistas.usp.br/bjps/article/view/140184/135330Copyright (c) 2018 Brazilian Journal of Pharmaceutical Sciences (Impresso)info:eu-repo/semantics/openAccessRomero, Daniel CancelliLourenço, Felipe Rebello2017-10-27T12:52:08Zoai:revistas.usp.br:article/140184Revistahttps://www.revistas.usp.br/bjps/indexPUBhttps://old.scielo.br/oai/scielo-oai.phpbjps@usp.br||elizabeth.igne@gmail.com2175-97901984-8250opendoar:2017-10-27T12:52:08Brazilian Journal of Pharmaceutical Sciences - Universidade de São Paulo (USP)false |
dc.title.none.fl_str_mv |
Measurement uncertainty of dissolution test of acetaminophen immediate release tablets using Monte Carlo simulations |
title |
Measurement uncertainty of dissolution test of acetaminophen immediate release tablets using Monte Carlo simulations |
spellingShingle |
Measurement uncertainty of dissolution test of acetaminophen immediate release tablets using Monte Carlo simulations Romero, Daniel Cancelli Acetaminophen tablets/dissolution test/measurement uncertainty Monte Carlo simulation |
title_short |
Measurement uncertainty of dissolution test of acetaminophen immediate release tablets using Monte Carlo simulations |
title_full |
Measurement uncertainty of dissolution test of acetaminophen immediate release tablets using Monte Carlo simulations |
title_fullStr |
Measurement uncertainty of dissolution test of acetaminophen immediate release tablets using Monte Carlo simulations |
title_full_unstemmed |
Measurement uncertainty of dissolution test of acetaminophen immediate release tablets using Monte Carlo simulations |
title_sort |
Measurement uncertainty of dissolution test of acetaminophen immediate release tablets using Monte Carlo simulations |
author |
Romero, Daniel Cancelli |
author_facet |
Romero, Daniel Cancelli Lourenço, Felipe Rebello |
author_role |
author |
author2 |
Lourenço, Felipe Rebello |
author2_role |
author |
dc.contributor.author.fl_str_mv |
Romero, Daniel Cancelli Lourenço, Felipe Rebello |
dc.subject.por.fl_str_mv |
Acetaminophen tablets/dissolution test/measurement uncertainty Monte Carlo simulation |
topic |
Acetaminophen tablets/dissolution test/measurement uncertainty Monte Carlo simulation |
description |
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 Monte Carlo simulations, we estimated measurement uncertainty for dissolution test of acetaminophen tablets (95.2 ± 1.0%), with a 95% confidence level. Rotation speed was the most important source of uncertainty, contributing about 96.2% of overall uncertainty. Finally, it is important to note that the uncertainty calculated in this paper reflects the expected uncertainty to the dissolution test, and does not consider variations in the content of acetaminophen. |
publishDate |
2017 |
dc.date.none.fl_str_mv |
2017-01-01 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
https://www.revistas.usp.br/bjps/article/view/140184 10.1590/s2175-97902017000300163 |
url |
https://www.revistas.usp.br/bjps/article/view/140184 |
identifier_str_mv |
10.1590/s2175-97902017000300163 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
https://www.revistas.usp.br/bjps/article/view/140184/135330 |
dc.rights.driver.fl_str_mv |
Copyright (c) 2018 Brazilian Journal of Pharmaceutical Sciences (Impresso) info:eu-repo/semantics/openAccess |
rights_invalid_str_mv |
Copyright (c) 2018 Brazilian Journal of Pharmaceutical Sciences (Impresso) |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf |
dc.publisher.none.fl_str_mv |
Universidade de São Paulo. Faculdade de Ciências Farmacêuticas |
publisher.none.fl_str_mv |
Universidade de São Paulo. Faculdade de Ciências Farmacêuticas |
dc.source.none.fl_str_mv |
Brazilian Journal of Pharmaceutical Sciences; Vol. 53 Núm. 3 (2017); e00163- Brazilian Journal of Pharmaceutical Sciences; v. 53 n. 3 (2017); e00163- Brazilian Journal of Pharmaceutical Sciences; Vol. 53 No. 3 (2017); e00163- 2175-9790 1984-8250 reponame:Brazilian Journal of Pharmaceutical Sciences instname:Universidade de São Paulo (USP) instacron:USP |
instname_str |
Universidade de São Paulo (USP) |
instacron_str |
USP |
institution |
USP |
reponame_str |
Brazilian Journal of Pharmaceutical Sciences |
collection |
Brazilian Journal of Pharmaceutical Sciences |
repository.name.fl_str_mv |
Brazilian Journal of Pharmaceutical Sciences - Universidade de São Paulo (USP) |
repository.mail.fl_str_mv |
bjps@usp.br||elizabeth.igne@gmail.com |
_version_ |
1800222913296596992 |