芬太尼新型基质透皮给药系统与市售储库制剂的比较生物等效性研究。
Comparative bioequivalence study between a novel matrix transdermal delivery system of fentanyl and a commercially available reservoir formulation.
作者信息
Marier Jean-Francois, Lor Mary, Morin Josée, Roux Lionel, Di Marco Marika, Morelli Gaetano, Saedder Eva Aggerholm
机构信息
MDS Pharma Services, Montreal (St-Laurent), Quebec, Canada.
出版信息
Br J Clin Pharmacol. 2007 Jan;63(1):121-4. doi: 10.1111/j.1365-2125.2006.02758.x. Epub 2006 Aug 30.
Abstract
AIM
To determine the pharmacokinetics, safety and performance of a novel matrix formulation of fentanyl.
METHODS
Transdermal fentanyl was administered as the novel matrix and the Durogesic reservoir formulations (24 subjects, 100 microg h(-1)) in a randomized, fully replicate, four-way crossover study. Serum concentrations of fentanyl were assayed by LC/MS/MS. Pharmacokinetic parameters of fentanyl and performance (adherence and skin irritability) were evaluated.
RESULTS
Test/reference ratio (90% confidence intervals) for AUC(0-t), AUC(inf) and C(max) were 105.5% (99.4, 112.0), 105.3% (99.3, 111.6) and 111.4% (100.4, 123.6), respectively. Adherence and skin irritability results of the two formulations were similar.
CONCLUSION
The two formulations are expected to result in similar efficacy for the management of severe pain.
摘要
目的
确定一种新型芬太尼基质制剂的药代动力学、安全性和性能。
方法
在一项随机、完全重复、四交叉研究中，将新型基质透皮芬太尼和多瑞吉储库制剂（24名受试者，100μg·h⁻¹）给药。采用液相色谱-质谱/质谱法测定血清中芬太尼浓度。评估芬太尼的药代动力学参数和性能（贴附性和皮肤刺激性）。
结果
AUC(0-t)、AUC(inf)和C(max)的试验/对照比值（90%置信区间）分别为105.5%（99.4，112.0）、105.3%（99.3，111.6）和111.4%（100.4，123.6）。两种制剂的贴附性和皮肤刺激性结果相似。
结论
预期这两种制剂在治疗重度疼痛方面疗效相似。
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