| abstract |
The present solution relates to a coated tablet, comprising the active ingredient solifenacin succinate and the binder hydroxypropyl methyl cellulose, wherein the tablet comprises solifenacin I in the range of 3 to 10% wt. of the solifenacin base and methocel as the binder in the range of 0.5 to 5% wt., related to the core weight, wherein after 3-month stability tests at the 75% relative humidity and 40 °C an increase of the content of the N-oxide impurity of formula II is lower than 0.1% of the HPLC integrated area. Another solutions consist in a pharmaceutical preparation comprising the coated tablet packed in a blister package and a manufacturing method of the coated tablets, wherein a powder mixture containing the active ingredient and the binder is granulated by addition of water, whereafter the granulate is tabletted, the resulting tablets are coated and packed. |