Serum concentration fluctuation and bioavailability comparison between indomethacin sustained-release and conventional capsules during steady state.
The comparison between indomethacin conventional capsule (CC) po 25 mg q 8 h or 25 mg tid and indomethacin sustained-release capsule (SRC) po 25 mg bid in human by crossover design showed that both maximal serum concentration (Cmax) and fluctuation index (FI%) of SRC were significantly lower than those of CC during steady state (P < 0.01). No practical differences were observed between the 2 preparations in the trough serum concentration (Cmin) and area under serum concentration-time profiles (AUC0-tau) (P > 0.05). The time period reaching maximal serum concentration (Tmax) of SRC was much more delayed than that of CC (P < 0.01). It suggested that SRC possesses a better controlled release property and could avoid a higher serum peak concentration of CC.
Wang
J P
JP
Department of Pharmacology, School of Pharmacy, Shanghai Medical University, China.
Liu
L
L
Liu
X
X
Yang
X Y
XY
Li
D
D
Ge
G Q
GQ
Huang
Q W
QW
D000328:Adult; D001682:Biological Availability; D002214:Capsules; D003692:Delayed-Action Preparations; D006801:Humans; D007213:Indomethacin / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D008297:Male
D002214:Capsules; D003692:Delayed-Action Preparations; D007213:Indomethacin