Research Journal of Pharmacy and Technology

Linezolid (LZD) being a narrow therapeutic index drug and having limited clinical data in pediatric hospitalized patients, taking account of the risks of both overdose and underdose and the complexity of the modified pharmacokinetic behavior in pediatric subjects, optimizing the dosage is necessary. This study is proposed to optimize the dosage regimen in the South Indian pediatric population using the population pharmacokinetics approach. The study was done using the standardized protocol, Albendazole was selected as the internal standard. To ascertain Linezolid serum concentration, HPLC was employed modified from a partially validated method and the data analyses were done using PUMAS - AI software. The bioanalytical method adopted for the quantification of the study drug in the plasma was found robust and validated as per the recommended standards. In this study, the clearance and volume of distribution of Linezolid were estimated to be, 0.49L/hour with a 43% variance and 0.14L/hour with a 32% variance. 2 out of 5 patients experienced thrombocytopenia [40%], hence dosage adjustment should be recommended in those patients. Using bootstrap analysis, the model was validated internally, and the results demonstrated statistical significance. Further studies must be undertaken with larger sample sizes and a greater number of plasma samples, to determine the covariates influencing the primary pharmacokinetic parameters.