Evaluation of the quality of four Mexican drug products containing sodium naproxen.
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)).


CONCLUSIONS
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 for two of the products tested.


CONCLUSIONS
There was no significant differences in the quality of the pharmaceutical products tested when judged by the USP pharmaceutical quality standards. However, some differences were observed in the dissolution profiles of the brands tested. Whether these differences are clinically meaningful requires in vivo bioequivalence studies.
Hernández-Abad
V J
VJ
Laboratorio de Investigación Farmacéutica, Campus II, Facultad de Estudios Superiores Zaragoza, Universidad Nacional Autónoma de México, and Facultad de Farmacia, Universidad Autónoma del Estado de Morelos, México. vabad@prodigy.net.mx
Castañeda-Hernández
G
G
García-Jiménez
S
S
Marroquín-Segura
R
R
Sánchez-González
E
E
D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000737:chemistry*; D002626:Chemistry, Pharmaceutical; D006801:Humans; D007700:Kinetics; D008800:Mexico; D009288:Naproxen / Q000737:chemistry*; D010602:Pharmacopoeias as Topic; D011786:Quality Control; D013607:Tablets
D000894:Anti-Inflammatory Agents, Non-Steroidal; D013607:Tablets; D009288:Naproxen