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Pharmacokinetics of tiaprofenic acid in infants after a single oral dose
A Pariente-Khayat1, M C Dubois, F Vauzelle-Kervroëdan
1Département de Pharmacologie Périnatale et Pédiatrique, Hopital Saint-Vincent de Paul, Paris, France.
Insights
This study on tiaprofenic acid (TA) in infants found that its pharmacokinetic parameters are similar to older children, suggesting adult dosing may be appropriate. Further research is needed to confirm efficacy and tolerance relationships.
Area of Science:
- Pharmacology
- Pediatric Medicine
- Drug Metabolism
Background:
- Tiaprofenic acid (TA) is a nonsteroidal anti-inflammatory drug.
- Understanding drug pharmacokinetics in infants is crucial for safe and effective treatment.
Purpose of the Study:
- To determine the pharmacokinetic profile of tiaprofenic acid (TA) in healthy infants.
- To compare infant TA pharmacokinetics with data from older children and adults.
Main Methods:
- Ten healthy infants received a single oral dose of tiaprofenic acid (3 mg/kg).
- Plasma and urine samples were collected over 12 hours.
- High-performance liquid chromatography (HPLC) was used to measure TA concentrations.
Main Results:
- Mean pharmacokinetic parameters including Cmax, Tmax, AUC, t1/2, Cl/F, and VZ/F were determined.
- Renal clearance was calculated, and 32% of the dose was recovered in urine, mostly as conjugates.
- Area under the curve (AUC) increased with age, and infant parameters were comparable to those in 3-11-year-old children.
Conclusions:
- Tiaprofenic acid exhibits pharmacokinetic parameters in infants that are similar to older children.
- Slight differences in TA kinetics between infants and adults were observed.
- The current data suggest that the tiaprofenic acid dosage regimen for infants may not require adjustment compared to adults, pending further efficacy and tolerance studies.
Abstract:
Ten healthy infants (15.2 +/- 10.6 months old, range 6-35) anesthetized for minor surgery were given a single oral dose (3 mg x kg-1) of tiaprofenic acid (TA). Seven venous blood samples and 0-12 h urine were collected. TA concentrations in plasma and urine were measured by HPLC. Within the whole group the mean +/- SD kinetic parameters were: Cmax: 10.55 +/- 3.31 mg x l-1, Tmax: 1.73 +/- 0.87 h, AUC0-1 32.53 +/- 4.42 mg x l-1 x h, AUC0-infinity 35.33 +/- 4.73 mg x l-1 x h, t1/2 1.82 +/- 0.48 h, Cl/F: 0.09 +/- 0.01 l x h-1 x kg-1, VZ/F: 0.23 +/- 0.08 l x kg-1. Renal clearance was 0.030 +/- 0.009 l x h-1 x kg-1. 32% of the TA dose was recovered in urine, 60% of which was conjugated. AUC0-8h increased significantly with age. The TA kinetic parameters were close to those in 3 to 11-year-old children. The present study suggests slight differences in the TA kinetics between infants and adults. However, the lack of an evidenced direct relationship between plasma TA concentration and either efficacy or tolerance suggests that the TA dose regimen in infants may not have to be different from that in adults.