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US 2009/0022797 A1Published application
Stabilized tolterodine tartrate formulations
AssigneeMylan Pharmaceuticals Inc.
InventorsDavid T. Rossi, Boyong Li, James Paul McCall
Life of this patent
Estimating the term…
Abstract
A pharmaceutical composition contains tolterodine L-tartrate stabilized against degradation with an acid. Acid-stabilized tolterodine L-tartrate may be used to make various types of immediate release and controlled release dosage forms.
Claims54
1) A solid oral dosage form comprising:
- tolterodine L-tartrate;
- a pharmaceutically acceptable non-polymeric pH-modifying acid having a pKa of less than 5.0;
- and
- pharmaceutically acceptable excipients;
- wherein the acid is present in an amount effective for stabilizing tolterodine L-tartrate.
2 more elements
37) A composition comprising:
- tolterodine L-tartrate;
- and
- a pharmaceutically acceptable non-polymeric pH-modifying acid having a pKa of less than 5.0;
- wherein the acid is present in an amount effective for stabilizing tolterodine L-tartrate.
1 more element
41) 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 pH-modifying acid to obtain an acid-stabilized tolterodine-L-tartrate;
- 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
45) A method of making a tablet, said method comprising the steps of:
- combining tolterodine-L-tartrate with a stabilizing amount of a pharmaceutically acceptable pH-modifying acid to obtain an acid-stabilized tolterodine-L-tartrate;
- combining said acid-stabilized tolterodine-L-tartrate with at least one pharmaceutically acceptable excipients to form an acid-stabilized mixture;
- and
- compressing said acid-stabilized mixture to form a tablet.
1 more element
50) A method of making a capsule, said method comprising the steps of:
- combining tolterodine-L-tartrate with a stabilizing amount of a pharmaceutically acceptable pH-modifying acid to obtain an acid-stabilized tolterodine-L-tartrate;
- combining said acid-stabilized tolterodine-L-tartrate with at least one pharmaceutically acceptable excipients to form an acid-stabilized mixture;
- and
- filling said acid-stabilized mixture into a capsule shell.
1 more element
Dependencies are inferred from the claim text.