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題 名 | A Pharmacokinetic Study of Nimesulide in Healthy Volunteers: Correlation between in vitro Dissolution and in vivo Absorption |
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作 者 | 蘇聖芳; 黃金鼎; 周辰熹; 朱嘉偉; 蕭嘉玲; 龔朝峰; 李惠玲; 楊俊佑; | 書刊名 | 中華藥學雜誌 |
卷 期 | 53:6 2001.12[民90.12] |
頁 次 | 頁281-290 |
分類號 | 418.2216 |
關鍵詞 | 非類固醇抗炎藥; 抗藥性; 溶解; Pharmacokinetics; Nimesulide; Dissolution; |
語 文 | 英文(English) |
英文摘要 | Nimesulide is a non-steroid anti-inflammatory drug (NSAID) used for the treatment of inflammation and pain. Twelve healthy volunteers were recruited for this study to evaluate the bioequivalence of two nimesulide formulations and to further understand the effects of in vitro dissolution on in vivo absorption. After oral administration of 100 mg of nimesulide, maximal concentrations of 4-6 mg/mL were reached after 2-3 hours. A smaller Cmax and longer Tmax was observed in formulation N, but no difference in t1/2 was found between the two formulations. In addition, a 17 % reduction in AUC was observed for formulation N, indicating that the extent and rate of absorption of nimesulide were not equivalent between two formulations. The results from in vitro dissolution tests showed that 80 % of nimesulide was released in 20 minutes from formulation A, while only 60 % was released in 3 hours from formulation N. This study suggests that the differences in dissolution can account for differences in absorption of nimesulide in vivo. |
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