Freston J W, Kukulka M J, Lloyd E, Lee C
University of Connecticut Health Center, Farmington, CT 06030-1111, USA.
Aliment Pharmacol Ther. 2004 Aug 15;20(4):407-11. doi: 10.1111/j.1365-2036.2004.02086.x.
Lansoprazole orally disintegrating tablet, which rapidly disintegrates on the tongue or in water, provides a dosing alternative for patients with difficulty in swallowing. Gastric and nasogastric tubes are increasingly placed in patients with more severe swallowing disorders.
This study assessed the pharmacokinetic profile of lansoprazole orally disintegrating tablet dispersed in a small volume of water and administered through a small-bore nasogastric tube.
Forty healthy adult men and women (18-43 years) received two single 30 mg lansoprazole orally disintegrating tablet doses (one administered directly onto the tongue without water, and one dispersed in water and administered via nasogastric tube) in a randomized, crossover fashion.
The total plasma exposure to lansoprazole was comparable following both dosing regimens; mean AUC values for the lansoprazole orally disintegrating tablet nasogastric dispersion were < or =8.6% greater than those for the intact lansoprazole orally disintegrating tablet. Lansoprazole Cmax for the lansoprazole orally disintegrating tablet nasogastric dispersion was 20.9% greater than that for the intact lansoprazole orally disintegrating tablet, a difference of no clinical significance.
Dispersion of the lansoprazole orally disintegrating tablet in a small volume of water and administering via nasogastric tube does not reduce the pharmacokinetic profile of the intact lansoprazole orally disintegrating tablet. This alternative dosing method may be useful in patients with nasogastric or gastric tubes.
兰索拉唑口腔崩解片可在舌上或水中迅速崩解,为吞咽困难的患者提供了一种给药方式。对于吞咽障碍更严重的患者,越来越多地放置胃管和鼻胃管。
本研究评估了兰索拉唑口腔崩解片分散于少量水中并通过细径鼻胃管给药后的药代动力学特征。
40名健康成年男女(18 - 43岁)以随机交叉方式接受两次30毫克兰索拉唑口腔崩解片的单剂量给药(一次直接置于舌上不用水,一次分散于水中并通过鼻胃管给药)。
两种给药方案后兰索拉唑的血浆总暴露量相当;兰索拉唑口腔崩解片鼻胃管分散剂的平均AUC值比完整的兰索拉唑口腔崩解片高≤8.6%。兰索拉唑口腔崩解片鼻胃管分散剂的Cmax比完整的兰索拉唑口腔崩解片高20.9%,差异无临床意义。
兰索拉唑口腔崩解片分散于少量水中并通过鼻胃管给药不会降低完整的兰索拉唑口腔崩解片的药代动力学特征。这种替代给药方法可能对有鼻胃管或胃管的患者有用。