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Pharmacokinetics of oxatomide in preterm infants
C Dani1, E Martelli, G Bertini
1Division of Neonatology, Careggi University Hospital, University of Florence School of Medicine, Viale Morgagni, 85, Florence, Italy. cdani@unifi.it
Insights
Oxatomide oral suspension at 1 mg/kg was safe and effective in preterm infants, reaching therapeutic plasma levels. This supports further studies on its anti-inflammatory effects and chronic lung disease prevention.
Area of Science:
- Neonatal pharmacology
- Pediatric pharmacokinetics
Background:
- Preterm infants are susceptible to chronic lung disease (CLD).
- Oxatomide's anti-inflammatory properties warrant investigation in this population.
Purpose of the Study:
- To assess the pharmacokinetics and tolerability of oxatomide in preterm infants.
- To determine the feasibility of future studies on oxatomide's anti-inflammatory effects and CLD prevention.
Main Methods:
- Administration of oxatomide oral suspension at a dose of 1 mg/kg.
- Measurement of pharmacokinetic parameters: Cmax, t1/2, Vd, and AUC 0-36 h.
Main Results:
- Oxatomide achieved a peak plasma concentration (Cmax) of 42.2 ± 15 ng/ml at 2 hours.
- Elimination half-life (t1/2) was 41.4 ± 2.0 h, volume of distribution (Vd) was 37.4 ± 4.2 L/kg, and AUC 0-36 h was 468 ± 52 ng/ml/h.
- The 1 mg/kg/day dose was well-tolerated and reached therapeutic plasma levels.
Conclusions:
- A 1 mg/kg/day dose of oxatomide is pharmacokinetically suitable for preterm infants.
- Oxatomide demonstrates tolerability, supporting further research into its anti-inflammatory and CLD preventive potential.
Abstract:
The pharmacokinetics and tolerability of oxatomide oral suspension were investigated in preterm infants to evaluate the feasibility of planning a further study to assess its antiinflammatory effects and its effectiveness in preventing chronic lung disease (CLD). Following the administration of oxatomide 1 mg/kg, the peak plasma concentration (Cmax), the elimination half-life (t1/2), the volume of distribution (Vd), and the area under the curve (AUC) 0-36 h were measured and the following results were obtained: 42.2 +/- 15 ng/ml at 2 h after oxatomide administration, 41.4 +/- 2.0 h, 37.4 +/- 4.2 l/kg, and 468 +/- 52 ng/ml/h, respectively. Our study, therefore, demonstrated that a dose of 1 mg/kg/day oxatomide was effective in reaching therapeutic plasma levels in preterm infants without inducing adverse effects.