Pharmaceutical compositions comprising fesoterodine

A pharmaceutical composition comprising:

• (a) 0.3-5.0% [w/w] of Fesoterodine hydrogen fumarate;
• (b) 5-25% [w/w] sorbitol or xylitol;
• (c) 20-40% [w/w] of a mixture comprising 45-80% (w/w) lactose monohydrate and 55-20% (w/w) microcrystalline cellulose;
• (d) 20-65% hydroxypropyl methylcellulose;
• (e) 1-5% [w/w] glycerol dibehenate;
• and
• (f) 1-5% [w/w] talc.

A pharmaceutical composition comprising Fesoterodine, or a pharmaceutically acceptable salt or solvate thereof, and a pharmaceutically acceptable stabilizer, wherein said stabilizer is identifiable from pharmacologically acceptable excipients of the group of polyols, sugars and sugar alcohols by a method comprising the following steps:

• preparation of a binary granulate of 1 part by weight of Fesoterodine and 9 parts by weight of a polyol, sugar or sugar alcohol;
• storing said granulate under the following three conditions:
• a) 25° C. and 60% r.H. in closed vials for 6 weeks
• b) 40° C. and 75% r.H. in closed vials for 6 weeks
• c) 40° C. and 75% r.H. in open vials for 6 weeks
• determining the content of the active metabolite of formula (II) via HPLC by the area-% method
• and selecting from said polyols, sugars or sugar alcohols a stabilizer which limit the formation of active metabolite of formula (II) during storage under at least two of the above conditions as follows:
• i) about 1 wt % or less under storage condition a)
• ii) about 2 wt % or less under storage condition b)
• iii) about 2 wt % or less under storage condition c)