In vitro dissolution test and pharmacokinetic study in human volunteers were conducted to evaluate the pharmacokinetic characteristics of 150 mg furbiprofen sustained-release capsule (FPSR-150). As a reference product, 50 mg flurbiprofen conventional-release capsule (FPCR-50) was used. Dissolution tests of two products were run using the paddle method in 450 : 540 (v/v %) mixture of simulated gastric and intestinal fluids (K.P. VI) by adjusting medium pH according to time. FPCR-50 was dissolved very rapidly, and it took about 1.5 hr for FPCR-50 to be dissolved over 90%, whereas 15 hr for FPSR-150. Also, in pharmacokinetic study, ten healthy male volunteers were administered one capsule of FPSR-150 or two capsules of FPCR-50 (FPCR-l00) with randomized two period cross-over study. Significant differences between FPCR-l00 and FPSR-150 were found in mean times to reach peak concentration, mean resident times and mean terminal phase halflives, while not in AUC/Dose (Student's t-test). In ANOVA for AUC/Dose to compare the bioavailabilities of two FP products, there was no significant difference. From the comparison of the simulated steady-state plasma concentration-time curves following multiple medications of FPCR-50 (3 capsules a day, dosing interval=8 hrs) and FPSR-150 (1 capsule a day) based on the above results obtained from single doses of two FP products, it was noted that the medication of FPSR-150 is more useful in clinical application rather than FPCR-50.
DOI 인용 스타일