4.7 Article

A comparative study of plasma concentrations of liposomal amphotericin B (L-AMP-LRC-1) in adults, children and neonates

Journal

INTERNATIONAL JOURNAL OF PHARMACEUTICS
Volume 238, Issue 1-2, Pages 11-15

Publisher

ELSEVIER SCIENCE BV
DOI: 10.1016/S0378-5173(02)00066-2

Keywords

liposomes; amphotericin B; pharmacokinetics

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Amphotericin B (AmpB) incorporated into small unilamellar liposomes prepared from soya phosphatidylcholine and cholesterol (L-AMP-LRC-1) has been shown to be safe and effective in patients with systemic fungal infections. In this report, we compared the plasma levels of AmpB in adults, children and neonates following administration of L-AMP-LRC-1. A 1.0 mg/kg dose of L-AMP-LRC-1 in adult patients resulted in peak concentrations of 1.02 +/- 0.14 mg/l (mean +/- S.D.) on day 1, which increased to 1.66 +/- 0.19 mg/1 on day 28 after continued therapy. The area under the plasma concentration-time curve also increased from 13.05 +/- 1.52 on day 1 to 19.85 +/- 5.41 mg h/l on day 28. In children, the peak plasma concentration following 1.0 mg/kg per day dose of L-AMP-LRC-1 increased from 0.63 +/- 0.20 on day 1 to 1.10 +/- 0.53 mg/1 on day 28. While in neonates, the levels increased from 0.54 +/- 0.17 on day 1 to 0.73 +/- 0.29 mg/l on day 28. These levels of AmpB in children and neonates were found to be significantly lower than in adults. This may be due to higher volume of distribution, since 1.0 mg/kg per day dose of L-AMP-LRC-1 was found to be effective in neonates. (C) 2002 Elsevier Science B.V. All rights reserved.

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