Measurement uncertainty of dissolution test of acetaminophen immediate release tablets using Monte Carlo simulations
Braz. J. Pharm. Sci. (Online)
; 53(3): e00163, 2017. tab, graf
Artigo
em Inglês
| LILACS
| ID: biblio-889391
Biblioteca responsável:
BR40.1
Localização: BR40.1
ABSTRACT
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 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.
Texto completo:
Disponível
Coleções:
Bases de dados internacionais
Contexto em Saúde:
Agenda de Saúde Sustentável para as Américas
Problema de saúde:
Objetivo 4: Financiamento para a saúde
Base de dados:
LILACS
Assunto principal:
Comprimidos
/
Método de Monte Carlo
/
Acetaminofen
Tipo de estudo:
Avaliação econômica em saúde
/
Estudo prognóstico
Idioma:
Inglês
Revista:
Braz. J. Pharm. Sci. (Online)
Assunto da revista:
Farmacologia
/
Teraputica
/
Toxicologia
Ano de publicação:
2017
Tipo de documento:
Artigo
País de afiliação:
Brasil
Instituição/País de afiliação:
Univerity of São Paulo/BR