Dosage form holder device and methods for immersion testing
View Patent ↗The present invention comprises a device and methods for dissolution or immersion testing and, in particular, a device and methods that improve the consistency of test results by limiting the ability of pharmaceutical or other dosage forms to move or reorient during testing.
1. A method of performing immersion testing comprising the steps of:
placing a dosage form in a device that holds the dosage form in a specific orientation;
placing said device and the dosage form in an apparatus for immersion testing; and
conducting immersion testing wherein the apparatus for immersion testing is a USP 25 <711> Dissolution Type 1 Apparatus.
2. The method of claim 1 wherein the step of placing the dosage form in said device comprises horizontally orienting a dosage form in said device.
3. The method of claim 1 wherein the step of placing the dosage form in said device comprises vertically orienting a dosage form in said device.
4. The method of claim 1 wherein the dosage form is a matrix tablet.
5. The method of claim 1 wherein the dosage form is a tablet.
6. The method of claim 1 wherein the dosage form is an osmotic tablet with at least one passageway.
7. The method of claim 6 wherein the device orients the tablet such that a passageway of the tablet faces in the upward direction.
8. The method of claim 6 wherein the device orients the tablet such that a passageway of the tablet faces in the downward direction.
9. The method of claim 6 wherein the device orients the tablet such that a passageway of the tablet faces to a side.
10. A method of performing immersion testing comprising the steps of:
placing a dosage form in a device that holds the dosage form in a specific orientation;
attaching the device to a secondary holding means;
placing the secondary holding means with the attached device and the dosage form in a vessel for conducting immersion testing; and
conducting immersion testing; wherein the secondary holding means is a basket in a USP 25 <711> Dissolution Type I Apparatus.
11. The method of claim 10 wherein the dosage form is a tablet.