Study on pharmacokinetics and relative bioavailability of rapid oral disintegrating tablet of dimenhydrinate
- VernacularTitle:茶苯海明口崩片的人体药代动力学及相对生物利用度研究
- Author:
Wenya CHEN
;
Gaolin LIU
- Publication Type:Journal Article
- Keywords:
dimenhydrinate;
rapid disintegrating tablet in mouth;
pharmacokinetics;
biological availability
- From:
Academic Journal of Second Military Medical University
1981;0(04):-
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To compare the pharmacokinetics and relative bioavailability of rapid oral disintegrating tablet of dimenhydrinate(RODTD) and those of market available tablet of dimenhydrinate(DMH).Methods: Eight healthy volunteers were evenly randomized into 2 groups,one group received RODTD(25 mg) and the other received available market tablet of dimenhydrinate(25 mg).The blood levels of DMH were determined by high performance liquid chromatography(HPLC) before and after drug administration in 2 groups.Chromatography conditions were: Nova-Pak C_(18)as chromatographic column, methanol triethylamine buffer((11),)flow rate: 1.0 ml/min,detection wavelength: 225 nm,and room temperature.The pharmacokinetics and relative bioavailability of RODTD and market available tablets were investigated.Results: The standard curve of DMH in the blank plasma was linear within the range of 5-500 ng/ml,with the regression equation being C=0.004 4 A+4.745 and R~(2)=(0.996.)The limit of detection was 2 ng/ml;the average recovery rate was(90.55?4.69)% and the RSD was 0.041%.The intra-day derivations of 3 different concentrations(low,middle,and high) of plasma were 9.27%,4.93%,and 2.95%,respectively((n=5),) and the inter-day derivations were 9.97%,3.81%,and 3.06%,respectively(n=5).Blood samples(3 ml) were subjected to HPLC assay and significant difference was found between the 2 forms of DMH. The pharmacokinetic parameters of RODTD were: AUC=(602.04?113.82) ng?h?ml~(-1),C_(max)=(95.86?21.28) ng?ml~(-1),and T_(Peak)=(1.8?0.32) h;the pharmacokinetic parameters of market available tablets were:AUC=(342.73?84.96) ng?h?ml~(-1),C_(max)=((46.34?)(10.32)) ng?ml~(-1),and T_(Peak)=(2.65?0.24) h.Statistical analysis showed there was significant difference in the relative bioavailability of 2 forms of DMH(P
