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Pharmacokinetics of betamethasone and betamethasone 17-monopropionate in Chinese healthy volunteers after intramuscular injection of betamethasone phosphate/betamethasone dipropionate.

Arzneimittel-Forschung (2011-09-09)
Chunhui He, Hongwei Fan, Jie Tan, Jianjun Zou, Yubing Zhu, Kun Yang, Qin Hu
ABSTRACT

The aim of this study was to evaluate the pharmacokinetic profiles of betamethasone (BOH, CAS 378-44-9) and betamethasone 17-monopropionate (B17P), the active metabolites of betamethasone phosphate (BSP) and betamethasone dipropionate (BDP), respectively, after administration of betamethasone i.m. (BSP 2 mg and BDP 5 mg). After ten healthy volunteers had received a single-dose intramuscular adminitration of betamethasone i.m., blood samples were collected pre-dose and for 336 h postdose. The plasma levels of B17P and BOH were measured by liquid chromatography-tandem mass spectrometry (LC-MS/ MS). When compared to BOH, B17P exhibited a longer time to maximum concentration (15.0 +/- 9.0 h vs. 2.8 +/- 1.7 h), a lower Cmax (0.6 +/- 0.2 ng/mL vs. 14.5 +/- 3.7 ng/mL), and a much longer half-life (80.8 +/- 22.7 h vs. 9.6 +/- 3.6 h). Betamethasone i.m. produced rapid onset and sustained action through an initial rapid-increased plasma concentration of BOH and a sustained plasma concentration of B17P, respectively.

MATERIALS
Product Number
Brand
Product Description

Sigma-Aldrich
Betamethasone 21-phosphate disodium, ≥97%
Sigma-Aldrich
Betamethasone 17,21-dipropionate
Betamethasone dipropionate, European Pharmacopoeia (EP) Reference Standard
Betamethasone sodium phosphate, European Pharmacopoeia (EP) Reference Standard

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