Bioequivalence of two paediaric ibuprofen suppositories in healthy volunteers
- Received Date: 2009-03-16
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Key words:
- pediatric ibuprofen /
- suppository /
- LC-MS-MS /
- bioequivalence
Abstract: Objective :To develop a LC-MS-MS assay for the determination of ibuprofen in human serum and to investigate the pharmacokinetics and bioequivalence of two preparation in Chinese healthy volunteers. Methods : A single per rectum dose of 50 mg ibuprofen test suppositories and reference suppositories was given to 20 healthy male volunteers in a randomized double cross-over design.Ibuprofen concentration were determined by LC-MS-MS assay,and pharmacokinetic parameters were calculated with DAS2.0 practical pharmacokinetics program. Results :The calibration curve was linear over the range of 0.05~6.4 mg/L.The main pharmacokinetic parameters of test suppositories and reference suppositories were as follow: t1/2(2.77±0.65) and(3.02±0.99) h,ρmax(2.148±0.643) and(2.013±0.844) mg/L,tmax(3.2±0.7) and(3.1±0.5) h,AUC0-12(11.37±3.56) and(11.30±4.62)mg·h/L. Conclusion :The method applied was convenient,accurate and specific,and the statistical analysis showed that the test and reference preparation bioequivalent.
Citation: | JIANG Nan, YANG Yong-ge, XU Xue-ting, ZHAO Gang-tao, YANG Fan. Bioequivalence of two paediaric ibuprofen suppositories in healthy volunteers[J]. Journal of Pharmaceutical Practice and Service, 2009, 27(4): 258-260,320. |