Abstract:
OBJECTIVE To do the test of
in vitro-in vivo correlation(IVIVC) for discussing whether or not drug dissolution test of Furosemide tablets produced in the domestic could be replaced by bioequivalency(BE).
METHODS The tested and control preparations of furosemide were selected. According to methods of requirements of the Chinese Pharmacopoeia 2015 and monitoring of fiber-optic in site dissolution testing equipment, the percent of accumulation furosemide dissolution were monitored and similar factor
f2 were calculated. The blood drug concentration of tested and control dosage forms
in vivo were determined and the pharmacokinetic parameters were counted. The percent of absorption, bioavailability(BA) and BE were measured. IVIVC of Furosemide tablets was analyzed.
RESULTS Two furosemide dissolution curves of tested and control preparations were similar by the way of similar factor
f2 evaluation. The differences of main pharmacokinetic parameters such as
tmax,
Cmax, AUC
0-24 and AUC
0-∞, BA and BE between two preparations were significant. The discrepancy of the percent of absorption
in vivo and IVIVC of Furosemide tablets were not significant.
CONCLUSION The BE of Furosemide tablets produced in the domestic can't replaced by the drug dissolution test at present.