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学科主题: 药学
题名:
Pharmacokinetics of indomethacin, a metabolite of acemetacin, following a single dose and multiple doses administered as acemetacin sustained-release tablets in healthy male volunteers
作者: Li, DM; Lu, WL; Wang, XQ; Wang, JC; Zhang, H; Zhang, RJ; Wang, GL; Zhang, X; Zhang, Q
关键词: acemetacin ; dissolution ; indomethacin ; pharmacokinetics ; sustained-release capsule ; sustained-release tablet
刊名: JOURNAL OF HEALTH SCIENCE
发表日期: 2005-06-01
卷: 51, 期:3, 页:308-316
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Toxicology
研究领域[WOS]: Toxicology
关键词[WOS]: RHEUMATOID-ARTHRITIS ; DOUBLE-BLIND ; LONG-TERM ; THERAPY ; EFFICACY
英文摘要:

The objective of this study was to estimate the pharmacokinetics of the newly developed once-daily acemetacin sustained-release tablets compared with those of the commercial acemetacin sustained-release capsules. Ten male healthy Chinese volunteers were included in the study. The administration schedule was a randomized crossover design. Each volunteer received 90 mg of the tablet or the capsule in the single-dose study, and each received 90 mg of the tablet or the capsule once daily for 6 consecutive days in the multiple-dose study. The areas under the concentration-time curve (AUC(0-24hr)), maximal concentrations of indomethacin (C-max), time to reach peak concentration (T-max and elimination half-life (T-1/2) values of indomethacin (an active metabolite of acemetacin) were 6.72 +/- 0.99 mu g.hr/ml, 0.82 +/- 0.08 mu g/ml, 4.2 +/- 0.6, and 10. 1 +/- 4.2 hr, respectively. The steady-state AUC(120-144hr) and steady-state maximal concentration of the tablets increased to 10.33 +/- 1.06 mu g.hr/ml and 1.14 +/- 0.10,mu g/ml, respectively. The pharmackinetic parameters (AUC(0-24hr) C-max T-1/2 and mean residence time) for two formulations were not significantly different but the average T-max., of the tablets was delayed by I hr compared with that of the capsules (4.2 +/- 0.6 vs. 3.2 +/- 0.6 hr, p < 0.05). The mean relative bioavailability of the tablets was 97.9 +/- 14.8% compared with that of the capsules. It could be concluded that the pharmacokinetic parameters of the newly developed sustained-release tablets are similar to those of the sustained-release capsules, excluding the T-max value. A significant correlation was obtained between the in vivo mean absorption rate and the in vitro mean dissolution rate for the newly developed sustained tablets.

语种: 英语
WOS记录号: WOS:000229868300008
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/63316
Appears in Collections:北京大学药学院_药剂学系_期刊论文

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作者单位: Peking Univ, Sch Pharmaceut Sci, Dept Pharmaceut, Beijing 100083, Peoples R China

Recommended Citation:
Li, DM,Lu, WL,Wang, XQ,et al. Pharmacokinetics of indomethacin, a metabolite of acemetacin, following a single dose and multiple doses administered as acemetacin sustained-release tablets in healthy male volunteers[J]. JOURNAL OF HEALTH SCIENCE,2005,51(3):308-316.
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