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Provedor de dados:  BJPS
País:  Brazil
Título:  Development and validation of dissolution method for carvedilol compression-coated tablets
Autores:  Shah,Ritesh
Patel,Sachin
Patel,Hetal
Pandey,Sonia
Shah,Shailesh
Shah,Dinesh
Data:  2011-12-01
Ano:  2011
Palavras-chave:  Carvedilol/coated tablets
Compression coated tablets/dissolution
PH 6.8 citric-phosphate buffer
Hydrochloric acid
Sodium lauryl sulphate
Resumo:  The present study describes the development and validation of a dissolution method for carvedilol compression-coated tablets. Dissolution test was performed using a TDT-06T dissolution apparatus. Based on the physiological conditions of the body, 0.1N hydrochloric acid was used as dissolution medium and release was monitored for 2 hours to verify the immediate release pattern of the drug in acidic pH, followed by pH 6.8 in citric-phosphate buffer for 22 hours, to simulate a sustained release pattern in the intestine. Influences of rotation speed and surfactant concentration in medium were evaluated. Samples were analysed by validated UV visible spectrophotometric method at 286 nm. 1% sodium lauryl sulphate (SLS) was found to be optimum for improving carvedilol solubility in pH 6.8 citric-phosphate buffer. Analysis of variance showed no significant difference between the results obtained at 50 and 100 rpm. The discriminating dissolution method was successfully developed for carvedilol compression-coated tablets. The conditions that allowed dissolution determination were USP type I apparatus at 100 rpm, containing 1000 ml of 0.1N HCl for 2 hours, followed by pH 6.8 citric-phosphate buffer with 1% SLS for 22 hours at 37.0 ± 0.5 ºC. Samples were analysed by UV spectrophotometric method and validated as per ICH guidelines.
Tipo:  Info:eu-repo/semantics/article
Idioma:  Inglês
Identificador:  http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502011000400027
Editor:  Universidade de São Paulo, Faculdade de Ciências Farmacêuticas
Relação:  10.1590/S1984-82502011000400027
Formato:  text/html
Fonte:  Brazilian Journal of Pharmaceutical Sciences v.47 n.4 2011
Direitos:  info:eu-repo/semantics/openAccess
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