Hoashi Yohei, Tozuka Yuichi, Takeuchi Hirofumi
Pharmaceutical Research Center, Nipro Corporation.
Chem Pharm Bull (Tokyo). 2013;61(9):962-6. doi: 10.1248/cpb.c13-00441.
The purpose of this study was to develop and test a novel and simple method for evaluating the disintegration time of rapidly disintegrating tablets (RDTs) in vitro, since the conventional disintegration test described in the pharmacopoeia produces poor results due to the difference of its environmental conditions from those of an actual oral cavity. Six RDTs prepared in our laboratory and 5 types of commercial RDTs were used as model formulations. Using our original apparatus, a good correlation was observed between in vivo and in vitro disintegration times by adjusting the height from which the solution was dropped to 8 cm and the weight of the load to 10 or 20 g. Properties of RDTs, such as the pattern of their disintegrating process, can be assessed by verifying the load. These findings confirmed that our proposed method for an in vitro disintegration test apparatus is an excellent one for estimating disintegration time and the disintegration profile of RDTs.
本研究的目的是开发并测试一种新颖且简单的体外评估速崩片（RDT）崩解时间的方法，因为药典中描述的传统崩解试验由于其环境条件与实际口腔环境不同，结果不佳。在我们实验室制备的6种RDT和5种市售RDT用作模型制剂。使用我们的原始装置，通过将溶液滴下的高度调整为8厘米，负载重量调整为10或20克，观察到体内和体外崩解时间之间具有良好的相关性。通过验证负载，可以评估RDT的性质，例如其崩解过程的模式。这些发现证实，我们提出的体外崩解试验装置方法是一种评估RDT崩解时间和崩解曲线的优秀方法。
