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Population pharmacokinetic modelling of tramadol with application of the NPEM algorithms.

Abstract：

BACKGROUND AND OBJECTIVE:Although the kinetic behaviour of tramadol has been described, the present study is the first to our knowledge, to report specifically on the population pharmacokinetic modelling of tramadol hydrochloride. METHODS:The parametric Iterative Two-stage Bayesian Population Model (IT2B) program followed by the Non-parametric Expectation Maximization Population Model (NPEM2) program was used to determine population pharmacokinetic parameter values of tramadol in 138 postoperative orthopaedic Malaysian patients. All patients had received a 100 mg intravenous dose of tramadol, infused over 2-3 min, as their first postoperative analgesic. Blood was sampled at 0 min and subsequently at 15, 30 min, 1, 2, 4, 8, 16, 20 and 24 h for serum tramadol high-performance liquid chromatography analysis. RESULTS AND DISCUSSION:The one-compartmental model pharmacokinetic parameters--volume of distribution (Vd), elimination rate constant (kel) and the total clearance rates (ClT)--found were: mean Vd = 167.6 +/- 63.84 L; median Vd = 161.48 L; mean kel = 0.1241 +/- 0.056 h(-1); median kel = 0.1138 h(-1); ClT = 19.57 +/- 9.51 L/h; median ClT =18.12 L/h. The interindividual coefficient of variation of ClT (48.56%) was higher than that of Vd (38.09%), indicating the presence of other possible influencing factors on tramadol's ClT such as CYP2D6 polymorphism, gender and age. Overall, NPEM2 suggested more diversity in the population than did IT2B.

journal_name

J Clin Pharm Ther

journal_title

Journal of clinical pharmacy and therapeutics

authors

Gan SH,Ismail R,Wan Adnan WA,Zulmi W,Jelliffe RW

doi

10.1111/j.1365-2710.2004.00590.x

subject

Has Abstract

pub_date

2004-10-01 00:00:00

pages

455-63

issue

5

eissn

0269-4727

issn

1365-2710

pii

JCP590

journal_volume

29

pub_type

临床试验,杂志文章

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