Controlled release formulation of tolterodine

Details Controlled release formulation of tolterodine Controlled release formulation of tolterodine

A - Human Necessities

61

K

A61K 9/50 (2006.01) A61K 31/137 (2006.01)

Patent

CA 2645940

The invention encompasses stable multiparticulate pharmaceutical compositions of tolterodine having at least one pharmaceutically acceptable excipient and at least two populations of multiparticulates each population having tolterodine or a salt thereof and the ratio of the populations is from 90:10 to 10:90 by weight, wherein after storage for 1 month at 40 °C and 75 % relative humidity the difference between the dissolution profile at 4 hours is no more than about 5 % when compared to the dissolution profile at the time of manufacture.

La présente invention englobe des compositions pharmaceutiques stables multiparticulaires de toltérodine comportant au moins un excipient de qualité pharmaceutique et au moins deux populations de microparticules, chaque population comportant la toltérodine ou un sel de ce composé, le rapport des populations étant compris entre 90 : 10 et 10 : 90 en poids, la différence entre le profil de dissolution à 4 heures après stockage pendant 1 mois à 40 °C et 75 % d'humidité relative et le profil de dissolution au moment de la fabrication étant inférieure ou égale à environ 5 %.

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