Effect of Water Intake on Pharmacokinetics of Lansoprazole from Past Disintegrating Tablet in Human Subjects

Abstract

Lansoprazole fast disintegrating tablet (LFDT) has been developed as a multiple unit formulation to increase the QOL of patients, i.e., easy intake without water. However, there is a possibility that patients intake LFDT in accordance with clarithromycin and amoxicillin with water. To study the effect of water on the absorption of lansoprazole (LPZ), the study was carried out using human volunteers. After selected by phenotype of LPZ metabolism, extensive metabolizers (EMs) of LPZ were used in this study. Twelve healthy male EMs intook LFDT containing 30 mg LPZ with 150 mL of water and without-water, i.e., with saliva, to study the pharmacokinetics of LPZ from the gastrointestinal tract by a cross-over manner with one-week washout period under fasted condition in the morning. The mean AUC(0-24s) were 2004.4+/-973.6 ng.h/mL in without-water experiment and 2018.5+/-1159.6 ng.h/mL in the case of with-water experiment. Mean C(maxs) were 851.9+/-450.8 ng/mL in without-water experiment and 830.8+/-456.8 ng/mL in with-water experiment, respectively. ANOVA was applied to the log-transformed AUC(0-24) and C(max) values. The 90% two sided confidence intervals for log-transformed AUC(0-24) was 0.78-1.22 and that for log-transformed C(max) was 0.67-1.37, respectively. By comparing these pharmacokinetic parameters, we may state that there was no significant difference between the two administration modes.