Manufacturing Science & Technology Manager, Novartis Pharmaceutical-Spain, Barcelona, Spain.
Eur J Pharm Biopharm. 2012 Apr;80(3):638-48. doi: 10.1016/j.ejpb.2011.12.012. Epub 2012 Jan 5.
This article provides a new innovative tool for pharmaceutical preformulation to predict whether a disintegrant excipient or mixture of powder containing API+excipients is suitable to obtain a bucodispersible tablet by direct compression or not. This innovative tool is the new model SeDeM-ODT that provides the Index of Good Compressibility and Bucodispersibility (IGCB index), which is based on the previous SeDeM expert system that indicates the aptitude of a powder to be compressed. The IGCB index is composed of six main factors (from 15 pharmaceutical raw parameters), which indicate whether a mixture of powder has the aptitude to be compressed by direct compression and at the same time indicates whether these tablets are suitable to be used as a bucodispersible tablet (disintegration time lower than 3 min).
本文提供了一种新的创新工具,用于药物预配方,以预测崩解剂辅料或含有 API+辅料的粉末混合物是否适合通过直接压缩获得口腔分散片。这个创新工具是新的 SeDeM-ODT 模型,它提供了可压缩性和口腔分散性的良好指数(IGCB 指数),该指数基于之前的 SeDeM 专家系统,表明粉末的压缩性能。IGCB 指数由六个主要因素(来自 15 个药物原始参数)组成,表明粉末混合物是否有通过直接压缩进行压缩的能力,同时还表明这些片剂是否适合用作口腔分散片(崩解时间低于 3 分钟)。