CoordenaÃÃo de AperfeiÃoamento de Pessoal de NÃvel Superior / O perfil farmacocinÃtico de duas diferentes formulaÃÃes de norfloxacino - comprimido revestido de 400 mg - como formulaÃÃo teste versus a formulaÃÃo referÃncia, Floxacin comprimido revestido de 400 mg (Merck Sharp & Dohme) foi avaliado em 32 voluntÃrios saudÃveis de ambos os sexos. A pesquisa consistiu de um estudo aberto, aleatorizado, cruzado, com 2 tratamentos, 2 perÃodos (duas sequÃncias) com intervalo mÃnimo de sete dias entre os internamentos. Amostras de sangue foram coletas em intervalos regulares para construÃÃo das curvas de concentraÃÃo plasmÃtica versus tempo. As concentraÃÃes de norfloxacino foram analisadas por Cromatografia LÃquida de Alta EficiÃncia acoplada à Espectrometria de Massa (LC-MS/MS). A mÃdia geomÃtrica do Norfloxacino teste/Norfloxacino referÃncia e o intervalo de confianÃa (IC) de 90% para Cmax e ASCo-t Ãltimo foram 103,9020% (89,5247-120,5881%) e 99,3030% (87,8186-112,2892%) respectivamente. Considerando que as formulaÃÃes estudadas apresentaram razÃo entre as mÃdias de Cmax e ASC0-tÃltimo entre 80 e 125%, e considerando um intervalo de confianÃa de 90% como proposto pelo Food and Drug Administration e ANVISA, conclui-se que as duas formulaÃÃes de norfloxacino apresentaram biodisponibilidades semelhantes tanto na taxa quanto na extensÃo de absorÃÃo. / The pharmacokinetic profile of two different formulations of Norfloxacin tablets - 400 mg; as test formulation versus FloxacinÂ, Norfloxacin reference formulation (- 400 mg; Merck Sharp & Dohme) was evaluated in 32 healthy volunteers of both sexes. The research was consisted of an open, randomized, crossover study, designed with two treatments, two periods (two sequences) with a minimum interval of seven days (washout) between the admissions. Blood samples were collected at regular intervals to construct the plasma concentration versus time curves. The concentrations of Norfloxacin were analyzed by High Performance Liquid Chromatography coupled to Mass Spectrometry (HPLC-MS/MS). The geometric mean of test Norfloxacin / reference Norfloxacin and confidence interval (CI) of 90% for Cmax and AUC0-t last were 103.9020% (89.5247 to 120.5881%) and 99.3030% (87.8186 - 112.2892%) respectively. Whereas the studied formulations showed the ratio between the mean Cmax and AUC0-t last between 80 and 125%, considering a confidence interval of 90%, as proposed by the Food and Drug Administration and ANVISA, it appears that the two formulations of Norfloxacin showed similar bioavailability in rate and in extent of absorption.
| Identifer | oai:union.ndltd.org:IBICT/oai:www.teses.ufc.br:5630 |
| Date | 02 August 2010 |
| Creators | Renata Amaral de Moraes |
| Contributors | Aldo Ãngelo Moreira Lima, Francisca ClÃa FlorenÃo de Sousa, Gisela Costa CamarÃo |
| Publisher | Universidade Federal do CearÃ, Programa de PÃs-GraduaÃÃo em Farmacologia, UFC, BR |
| Source Sets | IBICT Brazilian ETDs |
| Language | Portuguese |
| Detected Language | English |
| Type | info:eu-repo/semantics/publishedVersion, info:eu-repo/semantics/masterThesis |
| Format | application/pdf |
| Source | reponame:Biblioteca Digital de Teses e Dissertações da UFC, instname:Universidade Federal do Ceará, instacron:UFC |
| Rights | info:eu-repo/semantics/openAccess |
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