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 (C(max)) 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 (C(max)) and area under serum concentration-time profiles (AUC0-tau) (P > 0.05). The time period reaching maximal serum concentration (T(max)) 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.