Bioequivalencia de una formulación nacional de Ambroxol
Objectives: To assess the relative bioavailability of two oral formulations of ambroxol commercialized in Chile, a generic syrup and the original product, MucosolvanR from Boehringer Ingelheim. Methods: A randomized, cross-over and double blind study was performed in twelve healthy volunteers who re...
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| Autores principales: | , , , , , , , , , |
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| Lenguaje: | Spanish / Castilian |
| Publicado: |
Sociedad Chilena de Enfermedades Respiratorias
2003
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| Materias: | |
| Acceso en línea: | http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-73482003000100004 |
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| Sumario: | Objectives: To assess the relative bioavailability of two oral formulations of ambroxol commercialized in Chile, a generic syrup and the original product, MucosolvanR from Boehringer Ingelheim. Methods: A randomized, cross-over and double blind study was performed in twelve healthy volunteers who received a single oral dose of either Mucosolvan (90 mg) or the generic formulation with at least a 14 day washout period between each single dose. Multiple blood samples were collected after each dose, the plasma ambroxol concentrations were determined by a validated High Performance Liquid Chromatography assay. Results: The 95% confidence intervals for all parameters were within the accepted range of 80-125% for bioequivalence, suggested by the US FDA. Non statistically significant differences were found in the mean parameters of bioequivalence: mean peak concentration (Cmax), area under the curve calculated from time zero to a determined time (AUC0-t), and area under the curve calculated from time zero to infinity (AUC0-oo), or in other parameters like: time to reach Cmax (t max), rate of absorption (Ka), rate of elimination (Ke), elimination half life (t1/2), and clearance (Cl). Conclusion: Pharmacokinetic results concluded that both formulations of ambroxol are bioequivalent and consequently the preparations can be considered interchangeable between them. |
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