| 摘要 |
PURPOSE: A method for manufacturing a stable pharmaceutical composition containing solifenacin is provided to separately formulate an excipient and a lubricant inside and outside granules without a solvent. CONSTITUTION: A method for manufacturing a stable pharmaceutical composition containing solifenacin comprises: a step of mixing solifenacin or a pharmaceutically acceptable salt thereof with an excipient and a lubricant, and preparing granules without water or an organic solvent. The granules contain lactose, starch, hydroxypropyl methyl cellulose, low substitution hydroxyl propyl cellulose, or a mixture thereof as an excipient which does not affect stability. The granule also contains 0.1-5.0 wt%(w/w) of stearic acid, talc, silicone oxide, sodium stearyl furmarate, polyethylene glycol, or a mixture thereof as a lubricant which does not affect stability.
|
