Perfil farmacocinético da talidomida nas doses de 200mg e 400mg em voluntários sadios do sexo masculino

Detalhes bibliográficos
Ano de defesa: 2012
Autor(a) principal: Leite, Ana Lourdes Almeida e Silva
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: Não Informado pela instituição
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://www.repositorio.ufc.br/handle/riufc/4828
Resumo: Formulation of thalidomide 100mg tablet was evaluated for its bioavailability (Thalidomide, Fundação Ezequiel Dias - FUNED) in 24 healthy male volunteers. The study conducted was open, randomized, with two treatments, and with a two-period crossover design, during which the volunteers were administered 200mg or 400mg of thalidomide with a seven day washout period. Plasma was obtained over a 36h interval. The thalidomide concentrations were analyzed by combined reversed phase liquid chromatography and tandem mass spectrometry (LC-MS-MS) with positive ion electrospray ionization using selected daughter ion monitoring (MRM). The pharmacokinetic data (mean ± standard deviation) obtained from the formulations containing thalidomide 200mg and 400mg were 12663.54 ± 23056.11 2123.99 and 3437.08ng * h/mL for AUC0-24, 13282.84 ± 2065.91 and 26292.67 ± 4187.85ng * h/mL for AUC0-∞, 861.58 ± 187.30 and 1131.63 ± 266.93ng/mL for Cmáx, 4.52 ± 1.53 and 6.88 ± 4.71h to Tmáx, 6.89 ± 1.44 and 11.01 ± 4.36h to t1/2, 0.10 ± 0.02 and 0.07 ± 0.03 1/h for Ke, respectively. The comparison between pharmacokinetic parameters, at doses of 200 and 400mg, presented proportional curves. When comparing the pharmacokinetic parameters of this study and those found in studies of TEO et al., 1999, NOORMOHAMED et al., 1999 and PAGANOTTO, 2002 it was observed that the FUNED formulation presents smaller and slower absorption than the others