Bottom C B, Clark M, Carstensen J T
Banner Pharmacaps, Inc., High Point, NC 27261, USA.
J Pharm Sci. 1997 Sep;86(9):1057-61. doi: 10.1021/js960263k.
The problem of pelliculation of soft gelatin capsules on aging has been studied. Pelliculation frequently differs in soft shell capsules from hard shell capsules because of the larger mass of gelatin in the softshell dosage form. Two batches of nifedipine soft shell capsules are described. One batch failed in vivo testing and the other batch did not, after storage at 25 degrees C, yet both batches failed dissolution testing by the USP apparatus II method. The USP dissolution apparatus III-method, however, distinguished correctly between the batches. The study reported here was carried out with acetaminophen and was set up to establish whether the USP apparatus III testing method would be more suitable, and if so, what the most desirable dissolution medium should be. To create controlled pelliculation, samples were made with 0, 20, and 80 ppm of formaldehyde. The resulting capsules were subjected to ambient and accelerated storage and dissolution testing was carried out. It was found that the USP apparatus III method best reflected distinction between acceptable and substandard capsules.
已对软胶囊老化时出现薄膜化问题进行了研究。由于软胶囊剂型中明胶质量较大，软胶囊的薄膜化情况常常与硬胶囊不同。描述了两批硝苯地平软胶囊。一批在25℃储存后体内测试失败，另一批则未失败，但两批通过美国药典（USP）装置II法进行的溶出度测试均失败。然而，USP溶出装置III法能正确区分这两批产品。此处报告的研究以对乙酰氨基酚进行，旨在确定USP装置III测试方法是否更合适，如果是，最理想的溶出介质应该是什么。为产生可控的薄膜化，制备了含0、20和80 ppm甲醛的样品。将所得胶囊进行常温及加速储存，并进行溶出度测试。结果发现，USP装置III法最能体现合格胶囊与不合格胶囊之间的差异。
