Evaluation of the quality of four Mexican drug products containing sodium naproxen
Por:
Hernández-Abad V.J., Castaneda-Hernandez, G, García-Jiménez S., Marroquín-Segura R., Sánchez-González E.
Publicada:
1 jun 2008
Resumen:
Background: There is currently a lot of concern about the quality and therapeutic effectiveness of Mexican pharmaceutical products, and considerable price differences between alternative products containing the same active principle. Objective: To establish whether four Mexican drug products, a high price and three lower-cost branded drug products containing sodium naproxen (550 mg immediate release tablets) have equivalent, and consistent pharmaceutical qualities. Methods: The four products were acquired in Mexico city. Assay for sodium naproxen, content uniformity, disintegration time and dissolution tests were performed according to USP procedures. Drug dissolution profiles were compared using a similarity factor (f(2)). Results and discussion: All of the tested products met pharmacopeial quality standards with respect to their active pharmaceutical content and a released drug percentage > 70% in 45 min. Lot-to-lot lack of similarity between drug dissolution profiles was observed fo
Filiaciones:
Hernández-Abad V.J.:
Univ Nacl Autonoma Mexico, Fac Estudios Super Zaragoza, Lab Invest Farmaceut, Mexico City 09230, DF, Mexico
García-Jiménez S.:
Facultad de Farmacia, Universidad Autónoma del Estado de Morelos
Marroquín-Segura R.:
Univ Nacl Autonoma Mexico, Fac Estudios Super Zaragoza, Lab Inmunol, Mexico City 09230, DF, Mexico
Sánchez-González E.:
Univ Nacl Autonoma Mexico, Fac Estudios Super Zaragoza, Lab Invest Farmaceut, Mexico City 09230, DF, Mexico
|