Farmacocinética poblacional del ácido acetil salicílico (AAS) oral en individuos sanos

Abstract

The use of acetylsalicylic acid (ASA) is very common in acute and chronic treatments (by its activity analgesic, anti-inflammatory and anti-coagulation). But, It is unknown the population pharmacokinetic behavior of the drug in Ecuadorian population. PopPk is derivative from the difference inter and intra-individual of users of ASA through mixed effects model where fixed, randomized and residual factors are involved. Therefore, the aim of this research was to assess the PopPk of ASA in healthy individuals of a model for possible individual dosage adjustment. Methods: This research was authorized by Committee of Bioethics of Central University of Ecuador. Twenty five healthy volunteers of indifferent sex with age between 18-30 years were evaluated agree with inclusion and exclusion criteria and we got their signed informed consent. ASA were administered 1000mg orally. ASA concentrations were assessed by the method of Trinder at random times. The PopPk parameters was evaluated by mixed effects modeling and simulation using Monolix MLXTRAN v2.4.3 Results: We found that the best model that was adjusted to this study was the michaelian (-2Log V=2059.15). The influence of covariates: gender, weight, age, height, BMI, smoking on the PopPk parameters were evaluated, we found that values for Ka/F=0,001h^(-1) and Vd/F=107L and were affected by smoking, while Vmax=435mg/h and Km/F=64mg/L were modified by gender, weight, BMI and smoking. Conclusion: The covariates studied that showed significant inter and intra-individual variability on PopPk parameters of ASA were gender, weight and body mass, age and smoking.