| 摘要 |
The invention relates to a process for the preparation of a solid oral dosage form for oral administration comprising: a) an effective amount of crystalline solifenacin or its pharmaceutically acceptable salt, b) pharmaceutically acceptable excipients suitable for the preparation of solid oral dosage forms for oral administration, in the absence of a solvent, the process comprising the steps of: 1) subjecting a homogenous mixture of crystalline solifenacin or its pharmaceutically acceptable salt and pharmaceutically acceptable excipients to compression to form a comprimate, 2) converting the comprimate to form a granulate, and 3) compressing/tabletting the granulate to form the solid oral dosage form for oral administration; and also to an embodiment of said process, to a solid oral dosage form prepared by the proposed processes, and to the use thereof in the treatment of, alleviation and/or prevention of overactive bladder syndrome, urinary urgency and increased urinary frequency. The invention makes it possible to omit the problems observed with direct compression, such as poor uniformity of content and sticking to the punches, while at the same time providing a pharmaceutical formulation of solifenacin or its salts with high bioavailability, less prone to degradation, and with excellent uniformity |
