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Bioequivalence Comparison between Hydroxyethyl Starch 130/0.42/6 : 1 and Hydroxyethyl Starch 130/0.4/9 : 1

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Abstract

Objective: The aim of this study was to investigate whether a recently developed low molecular, low substituted hydroxyethyl starch (HES 130/0.42/6: 1), altered in molar substitution and C2/C6 ratio, is bioequivalent to the former standard HES preparation (130/0.4/9 : 1).

Methods: The two HES solutions were infused (60g as a single dose within 30 minutes) in healthy volunteers using a randomised, crossover design. HES serum concentrations were used for computation of pharmacokinetic parameters; area under the concentration-time curve from infusion start until 24 hours thereafter (AUC24) and maximum serum concentration (Cmax) were the primary criteria. Haemodilution, colloid osmotic pressure and plasma viscosity were measured as secondary criteria. Pentastarch (HES 200/0.5/5:1) was investigated in the same volunteers and manner during a subsequent period.

Results: Using non-compartmental analysis, significant differences were found for AUC24 (45.97 ± 8.97 mg • h/mL vs 58.32 ± 9.23 mg • h/mL; HES 130/0.42/ 6: 1 vs HES 130/0.4/9: 1) and total apparent clearance (CL; 1.14 ± 0.4 L/h vs 0.81 ± 0.34 L/h). Cmax and elimination half-life (t1/2) were similar, while the AUC24, t1/2 and CL of pentastarch were significantly different from those of low substituted HES solutions.

Conclusion: Being equivalent with pentastarch and HES 130/0.4/9: 1 in terms of colloid osmotic and haemodilution effect, HES 130/0.42/6: 1 shows the fastest clearance from the circulation.

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Notes

  1. The use of trade names is for product identification purposes only and does not imply endorsement.

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Acknowledgements

This study was sponsored by B. Braun AG Melsungen, Melsungen, Germany. The authors have no conflicts of interest that are directly relevant to the content of this study. Prof. Förster, Prof. Marx and Dr Lehmann have carried out paid consultation for B. Braun AG Melsungen. The Department of Anaesthesiology and Intensive Care Medicine of the University of Jena has carried out other research projects in collaboration with B. Braun Melsungen AG, and through this received other funding in the past. The Department of Anaesthesiology and Intensive Care Medicine of the University of Jena has also received educational funds from competitor companies. The Department of Experimental Anaesthesiology of the University of Frankfurt/Main has carried out other research projects in collaboration with B. Braun Melsungen AG, and through this received other funding in the past.

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Authors and Affiliations

  1. Department of Anaesthesiology and Intensive Care Medicine, Rhoen Hospital Bad Berka, Kirchgasse 19b, 99510, Kapellendorf, Germany

    G. Lehmann

  2. Department of Anaesthesiology and Intensive Care Medicine, Friedrich-Schiller University, Jena, Germany

    G. Marx

  3. Department of Experimental Anaesthesiology, Johann-Wolfgang Goethe University, Frankfurt, Germany

    H. Förster

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  1. G. Lehmann
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  3. H. Förster
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Correspondence to G. Lehmann.

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Lehmann, G., Marx, G. & Förster, H. Bioequivalence Comparison between Hydroxyethyl Starch 130/0.42/6 : 1 and Hydroxyethyl Starch 130/0.4/9 : 1. Drugs R D 8, 229–240 (2007). https://doi.org/10.2165/00126839-200708040-00003

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