Stabilized tolterodine tartrate formulations

摘要

A method of making a pharmaceutical composition containing tolterodine L-tartrate stabilized against degradation with an acid. Acid-stabilized tolterodine L-tartrate may be used as an active ingredient in various types of immediate release and controlled release dosage forms, including tablets, capsules, and beads.

主权项

1. A method of making a drug-containing bead, said method comprising the steps of:
combining tolterodine-L-tartrate with a stabilizing amount of a pharmaceutically acceptable non-polymeric pH-modifying acid having a pKa of less than 5.0 to obtain an acid-stabilized tolterodine-L-tartrate composition which does not contain oxybutynin; depositing a seal layer on an inert core, said seal layer being formed from a non-polymeric hydrophobic material; and depositing a layer containing said acid-stabilized tolterodine-L-tartrate on said seal layer.