Faster absorption of ibuprofen lysinate than standard ibuprofen acid in pediatric post-surgical pain
Surgery represents one of the most painful events that a child may experience. Advanced pharmaceutical formulations, including salts of ibuprofen, were developed to provide faster drug absorption and rapid onset of analgesic effects. The aim of this pilot study was to evaluate the rate of early drug absorption of ibuprofen lysinate (Algidrin® Pediatrico, FARDI S.A., Barcelona, Spain) compared to standard ibuprofen (MomentKid®, Aziende Chimiche Riunite Angelini Francesco, Rome, Italy) in children receiving the drug for the treatment of post-surgical pain.
Twenty-one children (4-16 years) were enrolled in a randomized, open-label, controlled, pilot study. Patients were randomly assigned to the experimental-group (LYS-group, n = 10, treated with the lysinate formulation after surgery) or the standard-group (STAND-group, n = 11 treated with standard ibuprofen formulation). Four blood samples (immediately before and 5, 15 and 20 minutes after the oral administration) were collected 24-hours after starting ibuprofen; pain (faces pain scale) and vital parameters (heart rate, blood pressure, oxygen saturation) were also considered.
Patients from the LYS-group had significantly higher ibuprofen concentrations at 5 minutes after drug intake compared with those from the STAND-group (11.9 ± 8.6 versus 3.6 ± 3.6 mg/L, p = 0.010), with the same trend for all other pharmacokinetic parameters. Remarkably, ibuprofen basal concentrations, were more than doubled in the LYS- versus STAND-group (5.7 ± 7.8 versus 2.1 ± 1.0 mg/L, p = 0.141). The LYS-group was also associated with a trend for reduced inter-individual variability in the drug exposure compared with the STAND-group (coefficient of variation of the AUC0- 20 min: 52% versus 84%. Pain control was also obtained.
The use of ibuprofen lysinate was associated with an early fast absorption and reduced pharmacokinetic variability compared to the traditional ibuprofen acid formulation, supporting fast action and an improved clinical response to mild-moderate post-surgical pain in children.
Ibuprofen lysinate presents faster absorption and reduced pharmacokinetic variability compared to standard ibuprofen in children.