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.
维普
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