Establishing a dissolution evaluation method for cefuroxime axetil tablets for in vitro-in vivo correlation by using computer simulation technology
Objective This study explored and established an in vitro-in vivo correlation predictive model for the precursor drug cefuroxime axetil tablets by using computer simulation technology,which was used for the bio-equivalence evaluation of generic drugs.Methods According to the PK parameters from the literature of cefuroxime axetil after oral administration,combining with the data of plasma concentration for reference preparation,GastroPlusTM software was used to establish a pharmaceutical model of cefuroxime axetil tablets.Based on the dissolution behavior in different conditions of dissolution,and in four dissolution media(pH 1.2 hydrochloride acid solution,pH 4.0 acetate buffer solution,pH 6.8 phosphate buffer solution,and water),suitable dissolution conditions were selected.The PK parameters of cefuroxime axetil tablets were predicted using the dissolution curves obtained in various dissolving media as in vivo release curves.These were then compared with the clinical data of the reference preparation,and a dissolution method for cefuroxime axetil tablets for in vitro-in vivo correlation was investigated.Results The dissolution method of cefuroxime axetil tablets for in vitro-in vivo correlation was successfully established by using the paddle method,with a rotational speed of 55 revolutions per minute and a 900 mL dissolution medium of pH 4.0 acetate buffer solution.Conclusion The pharmaceutical prediction model of cefuroxime axetil tablets could be used for virtual evaluation of the bio-equivalence and provided a new idea for evaluating the consistency between the quality and efficacy of the drug.
Computer simulation technologyCefuroxime axetil tabletsDissolution curvesThe model of IVIVCGeneric drug
万方数据
维普
