a Faculty of Pharmacy, Department of Pharmaceutical Technology , Gazi University , Ankara , Turkey.
Pharm Dev Technol. 2018 Jun;23(5):512-519. doi: 10.1080/10837450.2017.1345941. Epub 2017 Jul 18.
Nowadays pharmaceutical industries and regulatory authorities suggest new approaches such as Quality by Design principles to reduce experiments of formulation studies, improve product quality, save cost and time. SeDeM Expert System is a predictive approach for the preformulation studies and it provides information about suitability of API for direct compression by evaluating 12 parameters. The system also allows selecting appropriate excipients by determining same parameters to improve compressibility of API. The objective of this study was to develop direct compressed memantine orally disintegrating tablets using SeDeM Expert System. Memantine was found to have poor flow and compressibility properties. Three different direct compressibility and super disintegrating agents (Ludiflash, Ludipress and Parteck) were used to improve compressibility of memantine and according to SeDeM diagrams, Parteck was selected for final formulation. Memantine direct compressed tablets showed proper friability, hardness and thickness. The disintegration time of the tables were found below 15 s which was suitable for ODTs. It was found that SeDeM Expert System was easy to use and application of this method provided to develop memantine direct compressed ODT formulation was successful.
如今，制药行业和监管机构建议采用质量源于设计原则等新方法，以减少制剂研究的实验次数，提高产品质量，节省成本和时间。SeDeM 专家系统是一种用于预配方研究的预测方法，它通过评估 12 个参数来提供有关 API 是否适合直接压缩的信息。该系统还可以通过确定相同的参数来选择合适的赋形剂，以提高 API 的可压缩性。本研究的目的是使用 SeDeM 专家系统开发直接压片的美金刚口崩片。美金刚的流动性和可压缩性较差。使用三种不同的直接可压缩性和超崩解剂（Ludiflash、Ludipress 和 Parteck）来改善美金刚的可压缩性，根据 SeDeM 图，选择 Parteck 用于最终配方。美金刚直接压片显示出适当的脆性、硬度和厚度。该片的崩解时间低于 15s，适合口崩片。结果发现，SeDeM 专家系统易于使用，该方法的应用成功地开发了美金刚直接压片的口崩片制剂。
