Stability comparison of several entecavir products / 中国药学杂志

ABSTRACT

OBJECTIVE: To compare the stability between imported branded and domestic entecavir active pharmaceutical ingredient(API) and among four Entecavir products (A for the original brand product and B-D for the domestic generic agents) and to provide references for clinical use. METHODS: The influencing factor tests and accelerated tests of the API and the four products were carried out. The stability of the imported and domestic API was studied. The stability of the product was studied by comparing the appearance, weight of tablets, API content, related substance and dissolution. RESULTS: The influence of illumination on the stability was the least, while high temperature and high humidity had the most significant influence. In the accelerated tests, product A was the most stable one while products B-D changed with varying degrees, which showed up in appearance, the API content, the related substances and the dissolution. CONCLUSION: The stability of the API from different sources appeared to be similar, while that of the four products showed differences. The stability of the original product was noticeably superior to the domestic generic agents. Copyright 2012 by the Chinese Pharmaceutical Association.