Small-scale dissolution test screening tool to select potentially substandard and falsified (SF) medicines requiring full pharmacopoeial analysis

Abstract The purpose of this study was to design a convenient, small-scale dissolution test for extracting potential substandard and falsified (SF) medicines that require full pharmacopoeial analysis. The probability of metronidazole samples complying with the US Pharmacopoeia (USP) dissolution test...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Mohammad Sofiqur Rahman, Naoko Yoshida, Hirohito Tsuboi, Yuichiro Ishii, Yoshio Akimoto, Kazuko Kimura
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/67724864f4df43e1b2edbb663fe02b6a
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:67724864f4df43e1b2edbb663fe02b6a
record_format	dspace
spelling	oai:doaj.org-article:67724864f4df43e1b2edbb663fe02b6a2021-12-02T17:52:41ZSmall-scale dissolution test screening tool to select potentially substandard and falsified (SF) medicines requiring full pharmacopoeial analysis10.1038/s41598-021-91443-52045-2322https://doaj.org/article/67724864f4df43e1b2edbb663fe02b6a2021-06-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-91443-5https://doaj.org/toc/2045-2322Abstract The purpose of this study was to design a convenient, small-scale dissolution test for extracting potential substandard and falsified (SF) medicines that require full pharmacopoeial analysis. The probability of metronidazole samples complying with the US Pharmacopoeia (USP) dissolution test for immediate-release tablet formulations was predicted from small-scale dissolution test results using the following criteria: (1) 95% confidence interval lower limit (95% CIlow) of the average dissolution rate of any n = 3 of n = 24 units of each sample, and (2) average and minimum dissolution rates for any n = 3 of n = 24 units. Criteria values were optimized via bootstrap sampling with Thinkeye data-mining software. Compliant metronidazole samples in the USP first-stage and second-stage dissolution test showed complying probabilities of 99.7% and 81.0%, respectively, if the average dissolution rate of n = 3 units is equal to or greater than the monograph-specified amount of dissolved drug (Q; 85% of labeled content for metronidazole). The complying probabilities were 100.0% and 79.0%, respectively, if the average dissolution rate of n = 3 units is 91% or higher and the minimum dissolution rate is 87% or higher. Suitable compliance criteria for the small-scale dissolution test are: average dissolution rate of n = 3 units is Q + 6% or more and minimum dissolution rate is Q + 2% or more.Mohammad Sofiqur RahmanNaoko YoshidaHirohito TsuboiYuichiro IshiiYoshio AkimotoKazuko KimuraNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-9 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Mohammad Sofiqur Rahman Naoko Yoshida Hirohito Tsuboi Yuichiro Ishii Yoshio Akimoto Kazuko Kimura Small-scale dissolution test screening tool to select potentially substandard and falsified (SF) medicines requiring full pharmacopoeial analysis
description	Abstract The purpose of this study was to design a convenient, small-scale dissolution test for extracting potential substandard and falsified (SF) medicines that require full pharmacopoeial analysis. The probability of metronidazole samples complying with the US Pharmacopoeia (USP) dissolution test for immediate-release tablet formulations was predicted from small-scale dissolution test results using the following criteria: (1) 95% confidence interval lower limit (95% CIlow) of the average dissolution rate of any n = 3 of n = 24 units of each sample, and (2) average and minimum dissolution rates for any n = 3 of n = 24 units. Criteria values were optimized via bootstrap sampling with Thinkeye data-mining software. Compliant metronidazole samples in the USP first-stage and second-stage dissolution test showed complying probabilities of 99.7% and 81.0%, respectively, if the average dissolution rate of n = 3 units is equal to or greater than the monograph-specified amount of dissolved drug (Q; 85% of labeled content for metronidazole). The complying probabilities were 100.0% and 79.0%, respectively, if the average dissolution rate of n = 3 units is 91% or higher and the minimum dissolution rate is 87% or higher. Suitable compliance criteria for the small-scale dissolution test are: average dissolution rate of n = 3 units is Q + 6% or more and minimum dissolution rate is Q + 2% or more.
format	article
author	Mohammad Sofiqur Rahman Naoko Yoshida Hirohito Tsuboi Yuichiro Ishii Yoshio Akimoto Kazuko Kimura
author_facet	Mohammad Sofiqur Rahman Naoko Yoshida Hirohito Tsuboi Yuichiro Ishii Yoshio Akimoto Kazuko Kimura
author_sort	Mohammad Sofiqur Rahman
title	Small-scale dissolution test screening tool to select potentially substandard and falsified (SF) medicines requiring full pharmacopoeial analysis
title_short	Small-scale dissolution test screening tool to select potentially substandard and falsified (SF) medicines requiring full pharmacopoeial analysis
title_full	Small-scale dissolution test screening tool to select potentially substandard and falsified (SF) medicines requiring full pharmacopoeial analysis
title_fullStr	Small-scale dissolution test screening tool to select potentially substandard and falsified (SF) medicines requiring full pharmacopoeial analysis
title_full_unstemmed	Small-scale dissolution test screening tool to select potentially substandard and falsified (SF) medicines requiring full pharmacopoeial analysis
title_sort	small-scale dissolution test screening tool to select potentially substandard and falsified (sf) medicines requiring full pharmacopoeial analysis
publisher	Nature Portfolio
publishDate	2021
url	https://doaj.org/article/67724864f4df43e1b2edbb663fe02b6a
work_keys_str_mv	AT mohammadsofiqurrahman smallscaledissolutiontestscreeningtooltoselectpotentiallysubstandardandfalsifiedsfmedicinesrequiringfullpharmacopoeialanalysis AT naokoyoshida smallscaledissolutiontestscreeningtooltoselectpotentiallysubstandardandfalsifiedsfmedicinesrequiringfullpharmacopoeialanalysis AT hirohitotsuboi smallscaledissolutiontestscreeningtooltoselectpotentiallysubstandardandfalsifiedsfmedicinesrequiringfullpharmacopoeialanalysis AT yuichiroishii smallscaledissolutiontestscreeningtooltoselectpotentiallysubstandardandfalsifiedsfmedicinesrequiringfullpharmacopoeialanalysis AT yoshioakimoto smallscaledissolutiontestscreeningtooltoselectpotentiallysubstandardandfalsifiedsfmedicinesrequiringfullpharmacopoeialanalysis AT kazukokimura smallscaledissolutiontestscreeningtooltoselectpotentiallysubstandardandfalsifiedsfmedicinesrequiringfullpharmacopoeialanalysis
_version_	1718379171850223616

Small-scale dissolution test screening tool to select potentially substandard and falsified (SF) medicines requiring full pharmacopoeial analysis

Ejemplares similares