Anwar S, Fell J T, Dickinson P A
School of Pharmacy and Pharmaceutical Sciences, University of Manchester, Manchester M13 9PL, UK.
Int J Pharm. 2005 Feb 16;290(1-2):121-7. doi: 10.1016/j.ijpharm.2004.11.023. Epub 2005 Jan 12.
The purpose of the study was to examine the disintegration of tablets in media designed to simulate conditions pertaining in the stomach. Although many studies have been performed to determine dissolution rates in these media, little work has been undertaken on the preliminary step in dissolution, namely disintegration. Two tablet formulations were prepared. One disintegrated rapidly (under 25 s in water) and the other more slowly (8 min in water). The disintegration times were measured by the BP 2000 test using discs. For the rapidly disintegrating tablets, disintegration times were similar in all media except for whole milk. This media is used to simulate the fed stomach and disintegration times were over five times longer than in the other media (P < 0.05). A similar effect was seen with the poorly disintegrating tablets in milk, and prolonged times were also observed in some of the other media. For these latter media, there was a good correlation between the penetration rate of the fluid into the tablet and the disintegration time. Penetration rates for milk were also slow which may be a reflection of its relatively high viscosity and low surface tension.
该研究的目的是在旨在模拟胃内相关条件的介质中检测片剂的崩解情况。尽管已经进行了许多研究来测定这些介质中的溶出速率，但对于溶出的初步步骤，即崩解，所做的工作很少。制备了两种片剂配方。一种崩解迅速（在水中25秒内），另一种较慢（在水中8分钟）。崩解时间通过使用圆盘的BP 2000试验进行测量。对于快速崩解的片剂，除全脂牛奶外，在所有介质中的崩解时间相似。这种介质用于模拟进食后的胃，其崩解时间比其他介质长五倍以上（P<0.05）。在牛奶中崩解性差的片剂也观察到类似的效果，并且在其他一些介质中也观察到崩解时间延长。对于后一种介质，液体渗入片剂的速率与崩解时间之间存在良好的相关性。牛奶的渗入速率也很慢，这可能反映了其相对较高的粘度和较低的表面张力。
