Abstract:
OBJECTIVE To compare the dissolution profiles of loxoprofen sodium tablets from 5 manufacturers in 4 dissolution media to evaluate the quality of the drug.
METHODS The dissolution test was carried out with paddle method in dissolution medium at a volume of 900 mL and the rotating speed was 50 r·min
-1. The dissolution profiles of loxoprofen sodium tablets from different manufacturers in the 4 dissolution mediums of hydrochloric acid solution, pH 4.5 acetate buffer solution, water and pH 6.8 phosphate buffer solution were determined, and the dissolution curves were compared with the innovator drug product by the similar factor method.
RESULTS The dissolution profiles of loxoprofen sodium tablets from 5 pharmaceutical manufacturers in hydrochloric acid solution were similar. The dissolution curves of the samples from the 4 manufacturers and the original drug in the water were quite different. There were significant differences between the batches of the 2 manufacturers.
CONCLUSION There are differences in the quality of the drugs produced by generic manufacturers and the original drugs. It is recommended to improve the prescription and production process in combination with bioequivalence tests to improve the quality of the drugs.