医药导报2012,Vol.31Issue(10):1350-1354,5.DOI:10.3870/yydb.2012.10.033
咪达那新口腔崩解片的制备及处方优化
Preparation and Optimized Formation of Orally Disintegrating Tablets of Imidafenacin
摘要
Abstract
Objective To investigate the preparation and formulation of orally disintegrating tablets of Imidafenacin. Methods The orally disintegrating tablets of imidafenacin were prepared by using the technology of direct compression and sublimation drying. The formulation was optimized by single factor test, in which, the kind of disintegrants, amount of disintegrants and sublimation agent were investigated. All formulations were evaluated by flow properties, wetting time, and in vitro disintegration time (DT). Based on the established formulation, the relationship between tablet hardness and disintegration time was studied. The best prescription and the orally disintegrating tablets with high porosity and good hardness were obtained. Results The tablets were composed of mnnitol, 40% MCC, 5% PVPP, and 10% Ammonium bicarbonate, with the hardness of 4.0-6.0 kg, the optimal product was prepared after drying in vacuum oven at 60 °C for 90 min. Conclusion The method is simple and accurate in preparation.关键词
咪达那新/口崩片/升华干燥/崩解剂Key words
Imidafenacin/ Orally disintegrating tablet/ Sublimation agent/ Disintegrants分类
医药卫生引用本文复制引用
李丽然,郭红,王成港,任晓文..咪达那新口腔崩解片的制备及处方优化[J].医药导报,2012,31(10):1350-1354,5.基金项目
国家重点基础研究发展计划项目(973计划)(2010CB735602) (973计划)