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The Influence of Formula Concentration on the Absorption of Darbepoetin Alfa after Subcutaneous Administration

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Author(s): Tomonori Tayama | Kazuki Kawakami | Hirotaka Takama | Daisuke Nakashima | Hideji Tanaka | Takayuki Tsuji | Tatsuo Yamamoto | Sakuo Hoshi | Tadao Akizawa

Journal: Journal of Bioequivalence & Bioavailability
ISSN 0975-0851

Volume: 02;
Issue: 01;
Start page: 001;
Date: 2010;
Original page

Keywords: Darbepoetin alfa | Absorption | Formula concentration | Subcutaneous administration | Bioequivalence

ABSTRACT
Darbepoetin alfa (DA) is a hyperglycosylated analog of recombinant human erythropoietin (rHuEPO) that stimulates red blood cell production. The aim of this study is to investigate the influence of formula concentration on the absorption of DA after subcutaneous administration. Three separate studies were performed to assess thebioequivalence of four different formula concentrations of DA, 100 μg/ml as reference concentration, comparing with 10, 30, 200 μg/ml as test concentration, by the same dosage (60 μg). The mean values of the pharmacokinetic parameters were similar after subcutaneous administration in each study. The 90% confidence intervals for logtransformed Cmax and AUC0-t were within the bioequivalence criteria (0.8-1.25) in each study. In previous studies, the effect in absorption process of insulin was correlated to the formula concentration, the formula concentration of human growth hormone might not affected its absorption. The molecular weight is thought to be causally related to these results. The absorption rate of DA is not affected by its formula concentration because DA, which has relatively higher molecular weight (36,000 Da), is primarily absorbed slowly via lymph vessels regardless of its concentration.
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