Sibutramina: validação de metodologia e avaliação biofarmacotécnica

Detalhes bibliográficos
Ano de defesa: 2007
Autor(a) principal: Diefenbach, Isabel Cristina Fração
Orientador(a): Não Informado pela instituição
Banca de defesa: Não Informado pela instituição
Tipo de documento: Dissertação
Tipo de acesso: Acesso aberto
Idioma: por
Instituição de defesa: Universidade Federal de Santa Maria
BR
Farmácia
UFSM
Programa de Pós-Graduação em Ciências Farmacêuticas
Programa de Pós-Graduação: Não Informado pela instituição
Departamento: Não Informado pela instituição
País: Não Informado pela instituição
Palavras-chave em Português:
Link de acesso: http://repositorio.ufsm.br/handle/1/5885
Resumo: Sibutramine is therapeutically classified as an anorexigen, being recommended for obesity treatment and reduction of body weight, combined with diet and exercises. Its expected activity is the weight loss through inhibiting serotonin and norepinephrine reuptakes. By dual inhibition, sibutramine reduces body weight, then reducing food ingestion through intensification of post-prandial satisfaction. The drug is commercially available as industrialized capsules and compounded capsules. There are no official monographs up to this moment, to control the quality of this drug in its pharmaceutical forms. In the present work, methods for the quantification and dissolution evaluation of the drug in industrialized capsules were developed and validated. Comparative studies among some commercially formulations were also performed. UV spectrophotometry and liquid chromatography methods were developed and validated for quantitative determination, and showed linearity, precision and accuracy. The selected conditions for the dissolution test were 500 mL of 0.1 M HCl as medium, using basket for capsules, with rotation speed of 75 rpm. The comparative study presented that products not showed quality deviations.