Lausier J M, Chiang C W, Zompa H A, Rhodes C T
J Pharm Sci. 1977 Nov;66(11):1636-7. doi: 10.1002/jps.2600661137.
The aging of direct compression tablets made using dibasic calcium phosphate dihydrate as the tablet matrix was investigated over 16 weeks. The formula included 6% amaranth as a dye tracer. Two sets of stress storage conditions were used: 25 degrees and 50% relative humidity and 45 degrees and 75% relative humidity. Tablets were evaluated periodically by visual inspection; determination of the weight of 10 separate tablets, the size of 10 tablets measured by a micrometer screw gauge, and the hardness of 10 tablets as indicated by a Strong-Cobb hardness tester; the USP disintegration time test; and the USP dissolution test. Tablets stored at 25 degrees and 50% relative humidity showed an approximately linear increase in disintegration and dissolution time over 16 weeks with no other significant changes. Storage at 45 degrees and 75% relative himidity resulted in significant changes in most measured parameters; tablets showed blotching, substantial weight loss, and complex changes in disintegration and dissolution. The changes at elevated temperatures are related to loss of water of hydration; changes at 25 degrees must be due to other causes.
以二水磷酸氢钙作为片剂基质制备的直接压片在16周内的老化情况进行了研究。配方中含有6%的苋菜红作为染料示踪剂。采用了两组加速储存条件：25℃和50%相对湿度，以及45℃和75%相对湿度。定期通过目视检查对片剂进行评估；测定10片单独片剂的重量、用千分尺测量10片片剂的尺寸、用Strong-Cobb硬度测试仪测定10片片剂的硬度；进行美国药典崩解时间测试和美国药典溶出度测试。储存在25℃和50%相对湿度下的片剂在16周内崩解和溶出时间呈近似线性增加，无其他显著变化。在45℃和75%相对湿度下储存导致大多数测量参数发生显著变化；片剂出现斑点、大量失重以及崩解和溶出的复杂变化。高温下的变化与水合水的损失有关；25℃下的变化必定是由其他原因引起的。
