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A simple pharmacokinetic model of alendronate developed using plasma concentration and urine excretion data from healthy men
Chungnam Natl Univ, Coll Pharm, Taejon 305764, South Korea..ORCID iD: 0000-0001-6026-7063
NiFDS, New Drug Res Team, Chungcheongbuk Do, South Korea..
Chungnam Natl Univ, Coll Pharm, Taejon 305764, South Korea..
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmaceutical Biosciences. Uppsala Univ, Uppsala Pharmacometr, Uppsala, Sweden..
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2014 (English)In: Drug Development and Industrial Pharmacy, ISSN 0363-9045, E-ISSN 1520-5762, Vol. 40, no 10, 1325-1329 p.Article in journal (Refereed) Published
Abstract [en]

The study of pharmacokinetics of alendronate has been hampered by difficulties in accurately and reproducibly determining their concentrations in serum and urine. Thus, pharmacokinetic characteristics of alendronate have been described in many reports based on urinary excretion data; and plasma pharmacokinetics and the simultaneous pharmacokinetic models of alendronate in plasma and urine are not available. The aims of this study were to measure alendronate concentration in plasma and excretion in urine concurrently and to develop compartmental pharmacokinetic model using urine data. In open-label, single-dose pharmacokinetic study, 10 healthy male volunteers received oral dose of alendronate (70mg tablet). Blood and urine alendronate concentrations were determined using validated high-performance liquid chromatography method. Non-compartmental analysis was performed using WinNonlin program (Pharsight Inc., Apex, NC). A one-compartment pharmacokinetic model was applied to describe pharmacokinetics of alendronate. A peak plasma alendronate concentration of 33.10 +/- 14.32 ng/mL was attained after 1.00 +/- 0.16 h. The cumulative amount of alendronate excreted in urine and peak excretion rate were 731.28 +/- 654.57 mu g and 314.68 +/- 395.43 mg/h, respectively. The model, which included first-order absorption rate for oral dosing, showed good fit to alendronate data obtained from plasma and urine. The absorption rate constant was 2.68 +/- 0.95 h(-1). The elimination rate constants K-urine and Knon-ur were 0.005 +/- 0.004 h(-1) and 0.42 +/- 0.08 h(-1), respectively. The pharmacokinetics of alendronate in plasma and urine of healthy men can be predicted using one-compartment model, and thus the behavior of drug in plasma can be estimated from urinary excretion data.

Place, publisher, year, edition, pages
2014. Vol. 40, no 10, 1325-1329 p.
Keyword [en]
Alendronate, modeling, men, pharmacokinetics, plasma, urine
National Category
Pharmacology and Toxicology
URN: urn:nbn:se:uu:diva-306327DOI: 10.3109/03639045.2013.819880ISI: 000343926400006PubMedID: 23886303OAI: oai:DiVA.org:uu-306327DiVA: diva2:1049442
Available from: 2016-11-24 Created: 2016-10-27 Last updated: 2016-11-24Bibliographically approved

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Chae, Jung-wooYun, Hwi-yeol
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