Process for forming solid oral dosage forms of solifenacin and its pharmaceutically acceptable salts for oral administration

Content Provider	Semantic Scholar
Author	Врбинц, Миха Врецер, Франц Турк, Урска Юрсиц, Урска
Copyright Year	2010
Abstract	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
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Language	English
Access Restriction	Open
Content Type	Text
Resource Type	Article