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US 2013/0296439 A1Published application
Stabilized tolterodine tartrate formulations
AssigneeMylan Inc.
InventorsDavid T. Rossi, Boyong Li, James Paul McCall
Life of this patent
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Abstract
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.
Claims20
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.
1 more element
A method of making a solid pharmaceutical composition, said method comprising the steps of:
- combining tolterodine-L-tartrate in solid form with a stabilizing amount of a pharmaceutically acceptable non-polymeric pH-modifying acid having a pKa of less than 5.0 to obtain a solid acid-stabilized tolterodine-L-tartrate composition which does not contain oxybutynin;
- and
- combining said solid acid-stabilized tolterodine-L-tartrate composition with at least one pharmaceutically acceptable excipient to form a solid acid-stabilized mixture.
Dependencies are inferred from the claim text.