Olmez S S, Vural I, Sahin S, Ertugrul A, Capan Y
Department of Pharmaceutical Technology, Faculty of Pharmacy, Hacettepe University, Ankara, Turkey.
Pharmazie. 2013 Feb;68(2):110-6.
In this study, clozapine orally disintegrating tablets (ODTs) were prepared by direct compression method. Disintegration time, resistance to crushing of tablets, porosity, friability, dissolution tests were performed and dissolution profiles of ODTs were investigated. Morphological and interaction studies were also performed. Friability values were found to be less than 1%. All tablet formulations disintegrated within 1 min and fulfilled the 3 min disintegration time required for ODTs given in the European Pharmacopoeia. More than 85% of the labeled amount of clozapine was dissolved in 15 min from the ODTs. No interaction or changes were found between active substance and excipients. As a result of the studies, ODT formulations developed in this study can be suggested as promising formulations, which assist development and manufacturing a generic product of clozapine.
在本研究中，采用直接压片法制备了氯氮平口腔崩解片（ODT）。进行了崩解时间、片剂抗压强度、孔隙率、脆碎度、溶出度测试，并研究了ODT的溶出曲线。还进行了形态学和相互作用研究。发现脆碎度值小于1%。所有片剂配方在1分钟内崩解，符合欧洲药典中ODT规定的3分钟崩解时间要求。从ODT中，超过85%标示量的氯氮平在15分钟内溶解。在活性物质和辅料之间未发现相互作用或变化。研究结果表明，本研究开发的ODT制剂可被认为是有前景的制剂，有助于氯氮平仿制药的开发和生产。
