Gedeon Richter Plc., Formulation R&D, Gyömrői Str. 19-21, 1103 Budapest, Hungary.
Int J Pharm. 2013 May 20;448(2):346-53. doi: 10.1016/j.ijpharm.2013.03.047. Epub 2013 Apr 1.
One of the promising approaches to predict in vivo disintegration time of orally disintegrating tablets (ODT) is the use of texture analyzer instrument. Once the method is able to provide good in vitro in vivo correlation (IVIVC) in the case of different tablets, it might be able to predict the oral disintegration time of similar products. However, there are many tablet parameters that influence the in vivo and the in vitro disintegration time of ODT products. Therefore, the measured in vitro and in vivo disintegration times can occasionally differ, even if they coincide in most cases of the investigated products and the in vivo disintegration times may also change if the aimed patient group is suffering from a special illness. If the method is no longer able to provide good IVIVC, then the modification of a single instrumental parameter may not be successful and the in vitro method must be re-set in a complex manner in order to provide satisfactory results. In the present experiment, an optimization process was developed based on texture analysis measurements using five different tablets in order to predict their in vivo disintegration times, and the optimized texture analysis method was evaluated using independent tablets.
一种有前途的预测口腔崩解片（ODT）体内崩解时间的方法是使用质地分析仪。一旦该方法能够在不同片剂的情况下提供良好的体外体内相关性（IVIVC），它可能能够预测类似产品的口腔崩解时间。然而，有许多片剂参数会影响 ODT 产品的体内和体外崩解时间。因此，即使在大多数研究产品的情况下，测量的体外和体内崩解时间可能会有所不同，并且如果目标患者群体患有特殊疾病，体内崩解时间也可能会发生变化。如果该方法不再能够提供良好的 IVIVC，那么仅修改单个仪器参数可能不会成功，并且必须以复杂的方式重新设置体外方法，以提供满意的结果。在本实验中，基于使用五种不同片剂的质地分析测量，开发了一种优化过程，以预测它们的体内崩解时间，并使用独立片剂评估了优化的质地分析方法。
