Study on pharmacokinetics of pyridostigmine bromide orally disintegrating tablets and common tablets in rabbits

OBJECTIVE To compare the pharmacokinetic characteristics of pyridostigmine bromide orally disintegrating tablets with common tablets in rabbits by oral administration. METHODS Pyridostigmine bromide orally disintegrating tablets and common tablets were orally administrated to rabbits in a randomzied study.The concentration of pyridostigmine bromide in plasma was determined by reversed phase ion pair chromatography.Pharmacokinetic parameters were calculated by DAS2.1.1. RESULTS Pyridostigmine bromide orally disintegrating tablets and common tablets were fitted to the one compartment opened model.The pharmacokinetic parameters of pyridostigmine bromide orally disintegrating tablets and common tablets in rabbit plasma were as follows: Cmax(1.81±0.09)mg·L-1 and(1.71±0.03) mg·L-1;tmax(2.25±0.27)h and(2.67±0.26)h;t1/2(3.0±0.8)h and(3.27±0.0.18)h;AUC0-24(15.8±0.5)mg·h·L-1and(14.85±0.17)mg·h·L-1;AUC0-∞(16.1±0.6) mg·h·L-1 and(15.14±0.19)mg·h·L-1.The relative bioavailability F0-24 was 106.19% and F0-∞ was 106.07%.The main pharmacokinetic parameters analyzed by variance,two side t-test and wilcoxon rank sum test,there was no significant difference between orally disintegrating tablets and market common tablets in vivo. CONCLUSION The two preparations studied are bioequivalent.