Application of accelerated stability assessment program for stability study of dabigatran etexilate capsules
Objective The accelerated stability assessment program(ASAP)was used to establish the degradation kinetic model,screen the packaging and predict long-term stability of dabigatran etexilate capsules under a short-term stressed condition.Methods ASAPprim software was used to design a two-week experimental scheme,in which the temperature range was 55℃～75℃,and the relative humidity range was 0%RH～50%RH.The Arrhenius equation corrected by humidity was employed to establish a degradation kinetic model of impurity A and predict the long-term stability of dabigatran etexilate capsules under different packaging.Results The degradation kinetics model fitted well,and the fitting parameters R2＞0.9,Q2＞0.8.The fitting model predicted that dabigatran etexilate capsules can show good stability at 40℃/75%RH for 6 months and at 25℃/60%RH for 2 years,which was consistent with the experimental accelerated and long-term stability results.In addition,ASAP also suggested that the growth of impurity A in HDPE bottle(built-in desiccant)was lower than that in double aluminum packaging after 6 months at 40℃/75%RH,which was consistent with the measured value.Conclusion The degradation kinetic model established by ASAP can effectively screen suitable packaging and accurately predict the growth of impurity A of dabigatran etexilate capsules in a short time,which is an efficient and reliable evaluation model for shelf-stability of final products.
万方数据
维普
