Dosage form holder device and methods for immersion testing

• US 7,051,606 B2
• Filed: 01/30/2004
• Issued: 05/30/2006
• Est. Priority Date: 01/30/2004
• Status: Expired due to Fees

• Current Assignee: Andrx Labs LLC (Abbvie Incorporated)
• Original Assignee: Andrx Labs LLC (Abbvie Incorporated)
• Inventors: Nangia, Avinash, Cheng, Xiu Xiu, Tian, Dacheng, Li, Boyong, Cardinal, Jack
• Primary Examiner(s): Williams, Hezron
• Assistant Examiner(s): Rogers, David A.
• Application Number:
  US10/768,277
• Publication Number:
  US 20050166688A1
• Time in Patent Office: 851 Days
• Field of Search: 734/321, 738/649.1, 738/66, 366/140, 366241-261, 422/224
• US Class Current: 73/866
• CPC Class Codes: G01N 13/00 Investigating surface or boundary effects, e.g. wetting power; Investigating diffusion effects; Analysing materials by determining surface, boundary, or diffusion effects scanning-probe techniques or apparatus G01Q
• CPC Class Codes: G01N 2013/006 Dissolution of tablets or the like
• CPC Class Codes: G01N 33/15 Medicinal preparations ; Physical properties thereof, e.g. dissolubility

Abstract

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.

Claims

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.