A comparative bioavailability study of two ibuprofen formulations after single-dose administration in healthy volunteers

Abstract

Abstrak Penelitian ini dilakukan untuk mengetahui apakah bioavailabilitas formulasi ibuprofen suppositoria 125 mg yang diproduksi oleh PT 90, 89, dan 85,16% untuk C max 0 (control), 20 min; 40 min; 1; 1,5; 2; 2,5; 3; 4; 6; 8; and 10 were, respectively, 28.59(3.37) µg.h.mL -1 , 30.47(3.56) µg.h.mL -1 , 8.24(1.44) µg/mL, and 1.33(0.44)

Rectal Administration of Ibuprofen: Comparison of Enema and Suppository Form

“…The rectal route of ibuprofen suppository has been proven efficacious in Indonesian children [10]. In the previous studies with the suppository form, the T max occurred at 1.79 ± 0.33 h and 1.85 ± 0.34 h, indicating a slower rate of absorption [11,12]. Rectal delivery system by enema has been developed for both systemic and local effects.…”

“…Individual with potentially hypersensitive to ibuprofen, and those who have hemorrhoids or other diseases of the rectum and who had any gastrointestinal tract problem were excluded from the study. Based on data from previous studies, the intra-subject coefficient of variation were approximately 19.4 % for AUC [12]. The sample size n = 18 subjects is sufficient to ensure power of 80 % for correctly concluding bioequivalence under the following assumption: α = 0.05, 0.95 < µ T /µ R < 1.05 and an intra-subject coefficient of variation of 20 % [16].…”

“…Ibuprofen suppositories for children were developed and are being marketed in Indonesia and several European countries. Previous studies have described the pharmacokinetic profiles of ibuprofen suppository and the mean peak times of ibuprofen suppository were around 1.8 hours, indicating a slower rate of absorption [10][11][12][13].…”