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Vol. 1. Núm. 3.
Páginas 155-160 (septiembre - octubre 2005)
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Vol. 1. Núm. 3.
Páginas 155-160 (septiembre - octubre 2005)
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Estudio de la biodisponibilidad en magnitud y en velocidad de comprimidos de ibuprofeno
Study of the extent and rate of bioavailability of ibuprofen tablets
Visitas
21981
M. Farréa,b,
Autor para correspondencia
mfarre@imim.es

Correspondencia: Dr. M. Farré. Unitat de Farmacologia. Institut Municipal d’Investigació Mèdica (IMIM). Doctor Aiguader, 80. 08003 Barcelona. España.
, P.N. Roseta,b,c, J.A. Pascuala,d, S. Abanadesa,b, E. Menoyoa, Y. Álvareza, A. Baenac
a Unitat de Farmacologia. Institut Municipal d’Investigació Mèdica (IMIM). Barcelona. España
b Facultat de Medicina. Universitat Autònoma de Barcelona. Barcelona. España
c Laboratorios Gelos, SL. Barcelona. España
d Facultat de Ciències de la Salut i de la Vida. Universitat Pompeu Fabra. Barcelona. España
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Se estudió la biodisponibilidad en magnitud y en velocidad de ibuprofeno en comprimidos en un ensayo clínico cruzado en 18 sujetos sanos de ambos sexos. El estudio se aprobó por el comité ético del centro y se autorizó por la Agencia Española del Medicamento. Los voluntarios firmaron el consentimiento informado y se incluyeron siguiendo los procedimientos habituales de este tipo de estudios. Los participantes recibieron en 2 sesiones distintas una dosis única de 600 mg de ibuprofeno en Gelofeno® 600 mg comprimidos, Laboratorios Gelos SL, o en la formulación de referencia, Neobrufen® 600 mg comprimidos. Se determinaron las concentraciones plasmáticas de ibuprofeno inmediatamente antes (0 h) y 0,25, 0,5, 0,75, 1, 1,5, 2, 2,5, 3, 4, 6, 8, 10, 12 y 24 h después de la administración del fármaco, y se calcularon los parámetros farmacocinéticos derivados de éstas. En todos los sujetos, Gelofeno® 600 mg comprimidos produjo concentraciones plasmáticas de ibuprofeno por encima del límite de cuantificación entre 15 y 30 min tras su administración, y en 9 (50%) de ellos en 1 h ya se alcanzaron las concentraciones máximas. La mediana del tiempo al que se alcanzó la concentración máxima (tmáx) fue de 1,25 h y la concentración máxima promedio fue de 40,7mg/l. Gelofeno® 600 mg comprimidos resultó bioequivalente, tanto en la magnitud como en la velocidad de su biodisponibilidad comparado con el fármaco de referencia. El preparado presentó una Buena tolerabilidad y no se observaron acontecimientos adversos relacionados con el fármaco administrado.

Palabras clave:
Ibuprofeno
Biodisponibilidad
Farmacocinética
Absorción
Voluntarios sanos

The extent and rate of bioavailability of ibuprofen tablets were determined in a crossover clinical trial in 18 healthy subjects of both sexes. The study was approved by the local ethical committee and was authorized by the Spanish Medicines Agency. Volunteers signed an informed consent form and were included in accordance with the standard procedures for this type of study. In two distinct sessions participants received a single 600 mg ibuprofen dose as Gelofeno® 600 mg tablets (Laboratorios Gelos S.L.), or as the reference formulation, Neobrufen® 600 mg tablets. Ibuprofen concentrations in plasma were determined immediately before (0 h) and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 h after drug administration. The pharmacokinetic parameters were then calculated. In all subjects, Gelofeno® 600 mg tablets produced plasma concentrations above the quantification limit between 15 and 30 minutes after administration, and in 9 (50%) of these subjects maximal plasma concentrations were reached at 1 h. The median tmax was 1.25 h, and the average maximal plasma concentration was 40.7 mg/l. Gelofeno® 600 mg tablets were bioequivalent both in extent and in rate of bioavailability compared with the reference drug. The formulation showed good tolerability and no medication-related adverse effects were observed.

Key words:
Ibuprofen
Bioavailability
Pharmacokinetics
Absorption
Healthy volunteers
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