%0 Journal Article
%T Bioequivalence study of Montelukast 5 mg chewable tablets Estudio de bioequivalencia de Montelukast tabletas masticables de 5 mg
%A 芍ngela Piedad Medina
%A Francisco Javier Olaya
%A M車nica Patricia Navas
%A 芍ngela Mar赤a Tilano
%J Biom谷dica
%D 2012
%I Instituto Nacional de Salud
%X Introduction. The importance of generic drugs is the possibility of reduced costs in the national health system without sacrificing quality of service and the efficacy and safety of treatments. It is important to note that bioequivalence studies purporting to show that the pharmacokinetic profiles of the test product and reference product are similar and interchangeable. Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age or older. It is generally well tolerated and adverse reactions are more frequent in patients treated with the drug than in those treated with placebo. Objectives. To compare the bioavailability of AMISPED   Montelukast 5 mg chewable tablets manufactured by Sanofi-Aventis and Montelukast 5 mg chewable tablet (Singulair  ) developed by Merck. Materials and methods. We compared the magnitude and rate of absorption of Montelukast in 18 healthy volunteers using a randomized complete crossover design. The bioassay was performed by high performance liquid chromatography. Results. Results are for the generic and innovator respectively: Tmax (h) 2.17㊣0.73, 2.28㊣0.88; Cmax (ng/mL) 607.42㊣122.92, 627.69㊣134.17; AUC0-t (ng*h/mL) 3316.39㊣861.57, 3545.40㊣1070.07; AUC0-﹢ (ng*h/mL) 3450.92㊣904.89, 3722.03㊣1120.60; Ke (1/h) 0.25㊣0.05, 0.23㊣0.04 in the confidence range of 0.99-1.00 for lnCmax and 0.94-1.06 for lnAUC0-﹢. Conclusions. The formula tested in AMISPED   from Sanofi-Aventis, is bioequivalent to the reference formulation of Merck Singulair  . Introducci車n. La importancia de los medicamentos gen谷ricos radica en la posibilidad de la disminuci車n de los costos en el sistema nacional de salud sin sacrificar la calidad del servicio como la eficacia y la seguridad de los tratamientos. Es importante resaltar que los estudios de bioequivalencia pretenden demostrar que los perfiles farmacocin谷ticos del producto de prueba y del producto de referencia son similares e intercambiables.El Montelukast s車dico est芍 indicado para la profilaxis y el tratamiento cr車nico del asma en adultos y pacientes pedi芍tricos de 12 meses de edad o m芍s. En general, es bien tolerado y las reacciones adversas son poco frecuentes en los pacientes tratados con el f芍rmaco que en los tratados con placebo.Objetivos. Comparar la biodisponibilidad de AMISPED  Montelukast 5 mg tabletas masticables fabricadas por Sanofi-Aventis contra Montelukast 5 mg tabletas masticables (Singulair ) elaboradas por Merck.Materiales y m谷todos. Se compar車 la magnitud y la velocidad de la absorci車n de Montelukast en 18 voluntar
%U http://www.revistabiomedica.org/index.php/biomedica/article/view/708