Abstract
OBJECTIVES: Despite extensive caffeine use in preterm infants, the pharmacokinetics (PKs) data are limited because of the studies are complicated to do in these patients. This research was investigated the PK profile of two various dosages of caffeine in premature neonates. MATERIALS AND METHODS: The PK values of caffeine in premature neonates with Apnea were predicted by using all of computer-based simulation (Simcyp(®)), population-based PK, and modeling (P-Pharm(®)). We assayed the plasma levels of caffeine in two groups. The information was analyzed utilizing nonlinear mixed-effects modeling approach. The PK parameters were assessed simulating virtual clinical considers with subjects got 20 mg. kg(-1) of caffeine in both groups, which was followed by a 5 mg. kg(-1) once daily in Group 1 or 2.5 mg. kg(-1) twice daily in Group 2. All statistical analysis was executed utilizing SSPS issue 19 and a P value of 0.05 was chosen significance. RESULTS: In the present study, the means CL, volume of distribution, and T1/2 of caffeine in preterm infants were 0.0476 L. h(-1), 1.1081 L, 16.2284 h, respectively. Whereas our simulated means by Simcyp were 0.090 L. h(-1), 1.841 L, and 14.653 h in Group 1 and 16.223 h in Group 2, respectively. CONCLUSIONS: There was overall good agreement between predicted and measured PK values in our study. This study provides an initial demonstration of Simcyp simulation advantage on anticipating of PK parameters.