多层片释药系统的研究进展

与单层缓控释片相比,多层片有其独特的优点,近年来得到了快速发展。根据其不同设计如层数、几何形状、各层位置等的不同,该释药系统可分为控释型、快/慢释药型、延迟缓释或脉冲释药、双峰释药及多相释药等。在多层片的制备中,工艺参数和处方因素如硬度、层与层之间的黏附力、阻滞辅料用量等对片剂的成形和药物的释放速度存在较大的影响,需严格控制。现对多层片的不同释药模式、制备工艺及参数进行综述。

Advances of multi-layered tablets

Multi-layered tablet as drug delivery system,compared with conventional sustained-release tablets,has definite advantages and developed rapidly in recent years.According to different designs which contain the differences of the number of layers,different location of each layer and various geometries,this system can be classified into several dissolution patterns such as zero-order sustained release,quick/slow delivery system,pulsatile or delayed delivery and bimodal release.During the preparation of multi-layered tablets,process and formulation parameters(hardness,adhesion strength between layers,polymer concentration in barriers) have great influence on the formation and release rate of tablets.Therefore,formulation parameters should be controlled more strictly.In this article,we reviewed various dissolution patterns,process and formulation parameters of the multi-layered tablet.