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Comparison of the pharmacokinetics of ambroxol tablet and oral sulotion (Losolvan)

Cheng Yuan-yuan

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Abstract

Objective and Method To determine the changes of the plasma concentrations of ambroxol in 8 volunteers after the administration of single oral dose of 30 ml Losolvan solution (3 mg/ml) or 90 mg ambroxol tablets by using reverse phase high performance liquid chromatography (RP-HPLC). Results The pharmacokinetics of ambroxol conformed to one-compartment model. Tmax of the oral solution and tablets were (1.95(0.66) and (2.03(0.98) h respectively, Cmax were (161.7(39.3) and (166.9(35.5) ng/ml, t1/2 were (5.89(1.48) and (5.32(1.57) h , and the area under concentration-time curve (AUC) were (1 699.9( 252.0) and (1 637.7(262.4) ngh/ml, which all showed no significant difference by statistical analysis (P0.05). The relative bioavailability of the solution was 104.6%. Conclusion These 2 preparations were bioequivalent.

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What this paper is about

Objective and Method To determine the changes of the plasma concentrations of ambroxol in 8 volunteers after the administration of single oral dose of 30 ml Losolvan solution (3 mg/ml) or 90 mg ambroxol tablets by using reverse phase high performance liquid chromatography (RP-HPLC). Results The pharmacokinetics of ambroxol conformed to one-compartment model. Tmax of the oral solution and tablets were (1.95(0.66) and (2.03(0.98) h respectively, Cmax were (161.7(39.3) and (166.9(35.5) ng/ml, t1/2 were (5.89(1.48) and (5.32(1.57) h , and the area under concentration-time curve (AUC) were (1 699.9( 252.0) and (1 637.7(262.4) ngh/ml, which all showed no significant difference by statistical analysis (P0.05). The relative bioavailability of the solution was 104.6%. Conclusion These 2 preparations were bioequivalent.

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Available abstract

Objective and Method To determine the changes of the plasma concentrations of ambroxol in 8 volunteers after the administration of single oral dose of 30 ml Losolvan solution (3 mg/ml) or 90 mg ambroxol tablets by using reverse phase high performance liquid chromatography (RP-HPLC). Results The pharmacokinetics of ambroxol conformed to one-compartment model. Tmax of the oral solution and tablets were (1.95(0.66) and (2.03(0.98) h respectively, Cmax were (161.7(39.3) and (166.9(35.5) ng/ml, t1/2 were (5.89(1.48) and (5.32(1.57) h , and the area under concentration-time curve (AUC) were (1 699.9( 252.0) and (1 637.7(262.4) ngh/ml, which all showed no significant difference by statistical analysis (P0.05). The relative bioavailability of the solution was 104.6%. Conclusion These 2 preparations were bioequivalent.

Key concepts: Ambroxol, Pharmacokinetics, Bioequivalence, Cmax, Bioavailability, High-performance liquid chromatography, Oral administration, Chromatography

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