Pharmacokinetics and bioequivalence of famotidine carried by microemulsions composed of emulsifier OP/isopropanol/isopropyl myristate/water

摘要

To establish a RP-HPLC method for determination of famotidine in rabbit plasma and to study the pharmacokinetics and bioavailability of famotidine microemulsion in New Zealand rabbits. Methods Use HPLC method to determine drug concentration. Column: Hypersil BDS(4.6mm 250mm Sum), Mobile phase: methanol: water: phosphoric acid: triethylamine=16: 84: 0.014:0.019. Flow speed: 1.0mL/min. Detecting ultra-violet wave:265nm. The plasma concentration at different time points was fitted by 3P87 program and to calculate pharmacokinetics parameters. Results The AUC, Cmax and Tmax of microemulsion and tablet in this study were 957.77 ngcentre not h centre not mL~(-1) , 900.89 ngcentre nothcentre notmL~(-1); 1.31 +-0.26h,1.44+-0.32h;243.61+-150.30ngcentre notmL~(-1), 231.83 +-123.46ng/mL, respectively. The relative bioavailability of microemulsion to tablet was (104.6+-10.26)%. No significant difference was found between the AUC of microemulsion and tablet. Conclusion After oral administratin of identical single dose of famptidine tablet and microemulsion,the relative bioavailability of microemulsion to tablet was (104.6+-10.26) %.The analysis of AUC, Cmax and Tmax showed that they were bioequivalence pharmaceutic preparations.