Automated tablet dissolution apparatus

• US 5,816,701 A
• Filed: 08/02/1996
• Issued: 10/06/1998
• Est. Priority Date: 04/22/1996
• Status: Expired due to Fees

• Current Assignee: Arthur L. Martin
• Original Assignee: Source For Automation, Inc.
• Inventors: McDowell, Ronnie, Martin, James L., Morgan, C. Darryl, Kerr, Warren P., Earle, Richard S., Martin, Arthur L.
• Primary Examiner(s): SOOHOO, TONY GLEN
• Application Number:
  US08/691,407
• Time in Patent Office: 795 Days
• Field of Search: 366/140, 366/144, 366/150.1, 366/177.1, 366/178.2, 366/148, 366/145, 366/197, 366/198, 366/204, 366/207, 366/208, 366/184, 366/191, 366/241, 366/261, 366/285 , 366/292, 366/342, 366/349, 422/62, 422/64, 422/68.1, 422/100, 422/101, 422/99, 422/209, 422/224, 422/225, 422/255, 422/261, 422/263, 422/268, 422/269, 422/270, 422/271, 422/272, 422/273, 422/275 , 422/276, 422/277, 73/53.01, 73/866, 73/61.71
• US Class Current: 366/208
• CPC Class Codes: B01F 2035/99 Heating
• CPC Class Codes: B01F 21/10 using driven stirrers
• CPC Class Codes: B01F 21/22 using additional holders in conduits, containers or pools for keeping the solid material in place, e.g. supports or receptacles
• CPC Class Codes: B01F 2101/23 Mixing of laboratory samples e.g. in preparation of analysing or testing properties of materials
• 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

In a preferred embodiment, the apparatus includes a dissolution vessel removably seated within an aluminum platen. The apparatus also includes an assembly for automatically measuring a desired volume of media, heating and degassing the volume of media and then dispensing the volume of media into the dissolution vessel. In addition, the apparatus includes a carousel having a plurality of compartments, the carousel being rotatably mounted on a stage, the stage being alignable with the vessel. According to one mode of operation, an open-top, cage-type basket is placed in one or more compartments of the carousel, each basket containing a tablet intended for dissolution. The apparatus additionally includes a shaft aligned with the vessel, the bottom end of the shaft being adapted to frictionally fit together with a basket. The shaft is rotatable and vertically movable so that it can fit together with a basket, pick the basket up out of the carousel, lower the basket into the vessel, rotate the basket within the media and remove the basket from the media. The apparatus further includes a catheter automatically movable in and out of the vessel for sampling the media at desired times, an automated mechanism for loading and replacing a depth filter on the input end of the catheter, an automated mechanism for removing the basket from the end of the shaft after testing has been completed and an automated mechanism for removing media from the vessel after testing has been completed. The apparatus also includes a paddle shaft which may be used interchangeably with the basket shaft if tablets are placed directly in the compartments of the carousel and are then dispensed from the carousel into the vessel through an opening in the bottom of each carousel that is alignable with an opening in the stage.

Claims

1. A tablet dissolution apparatus comprising:

(a) a dissolution vessel;

(b) a kit of mechanically-rotatable means alternately positionable in said dissolution vessel for agitating the contents of said dissolution vessel, said kit comprising

(i) a first mechanically-rotatable means, said first mechanically-rotatable means comprising a paddle and

(ii) a second mechanically-rotatable means, said second mechanically-rotatable means comprising a cage-type basket;

(c) means for rotating one of said first and said second mechanically-rotatable means in said dissolution vessel; and

(d) automated means for sampling the contents of said dissolution vessel.

2. The tablet dissolution apparatus as claimed in claim 1 further comprising automated means for volumetrically-obtaining, heating and sparging a quantity of media and for dispensing said quantity of media into said dissolution vessel.

3. The tablet dissolution apparatus as claimed in claim 1 wherein said automated sampling means comprises a cannula having a sampling end insertable into the dissolution vessel and wherein said tablet dissolution apparatus further comprises automated means for loading and ejecting a depth filter onto and off of the sampling end of said cannula.

4. The tablet dissolution apparatus as claimed in claim 3 wherein said automated loading and ejecting means comprises automated means for testing the orientation of a depth filter relative to said cannula prior to attempting to attach the depth filter to said cannula.

5. The tablet dissolution apparatus as claimed in claim 1 further comprising automated means for dispensing a tablet into said dissolution vessel.

6. The tablet dissolution apparatus as claimed in claim 1 further comprising automated means for heating said dissolution vessel, said automated heating means comprising a platen appropriately dimensioned to removably receive said dissolution vessel.

7. The tablet dissolution apparatus as claimed in claim 1 further comprising automated means for emptying the contents of said dissolution vessel, said automated means comprising a comparatively large diameter tube and a comparatively small diameter tube, said comparatively small diameter tube being positioned inside of and extending a short distance out of the bottom of the comparatively large diameter tube.

8. The tablet dissolution apparatus as claimed in claim 1 further comprising means for imaging the contents of the dissolution vessel.

9. A tablet dissolution apparatus comprising:

(a) a dissolution vessel;

(b) mechanically-rotating means positionable in said dissolution vessel for agitating the contents of said dissolution vessel;

(c) a cannula, said cannula having a sampling end insertable into said dissolution vessel for use in withdrawing a sample from the dissolution vessel;

(d) automated means for mounting a depth filter on the sampling end of said cannula; and

(e) automated means for volumetrically-obtaining heating and sparging a quantity of media and for dispensing said quantity of media into said dissolution vessel.

10. The tablet dissolution apparatus as claimed in claim 9 further comprising automated means for inserting the sampling end of said cannula into the dissolution vessel and for withdrawing a sample therethrough.

11. The tablet dissolution apparatus as claimed in claim 9 further comprising automated means for removing a depth filter mounted on the sampling end of said cannula.

12. The tablet dissolution apparatus as claimed in claim 9 further comprising platen means, dimensioned to removably receive said dissolution vessel, for heating said dissolution vessel.

13. The tablet dissolution apparatus as claimed in claim 12 wherein said platen means comprises a metallic platen.

14. A tablet dissolution apparatus comprising:

(a) a dissolution vessel;

(b) a cage-type basket adapted to hold a tablet;

(c) a rotatable shaft aligned with said dissolution vessel and vertically movable between a first vertical position above said dissolution vessel and a second vertical position within said dissolution vessel, said rotatable shaft having a bottom end adapted to removably engage said cage-type basket;

(d) a stage, said cage-type basket being disposed on said stage, said stage being movable between a first translational position wherein said cage-type basket is translationally aligned with said dissolution vessel and the bottom end of said rotatable shaft and is vertically disposed between said dissolution vessel and said rotatable shaft in said first vertical position and a second translational position wherein said stage is not translationally aligned with said rotatable shaft;

(e) automated means for moving said stage between said first translational position and said second translational position;

(f) automated means for vertically moving said rotatable shaft between said first vertical position and an intermediate vertical position wherein the bottom end of said rotatable shaft is positioned to engage said cage-type basket when said stage is disposed in said first translational position and for vertically moving said rotatable shaft between said intermediate vertical position and said second vertical position when said stage is disposed in said second translational position; and

(g) automated means for rotating said rotatable shaft.

15. The tablet dissolution apparatus as claimed in claim 14 further comprising automated means for disengaging said cage-type basket from the bottom end of said rotatable shaft.

16. A tablet dissolution apparatus comprising:

(a) a dissolution vessel;

(b) a rotatable shaft aligned with said dissolution vessel and vertically movable between a first vertical position above said dissolution vessel and a second vertical position within said dissolution vessel, said rotatable shaft having a bottom end adapted to removably engage a cage-type basket;

(c) a rotatable carousel, said rotatable carousel having a plurality of compartments, each of said compartments adapted to hold a cage-type basket;

(d) a plurality of cage-type baskets, each of said cage-type baskets being disposed in a compartment of said rotatable carousel, each of said cage-type baskets being adapted to hold a tablet;

(e) a stage, said rotatable carousel being disposed on said stage, said stage being movable between a first translational position wherein a compartment of said rotatable carousel is translationally aligned with said dissolution vessel and the bottom end of said rotatable shaft and is vertically disposed between said dissolution vessel and said rotatable shaft in said first vertical position and a second translational position wherein said stage is not translationally aligned with said rotatable shaft;

(f) automated means for moving said stage between said first translational position and said second translational position;

(g) automated means for vertically moving said rotatable shaft between said first vertical position and an intermediate vertical position wherein the bottom end of said rotatable shaft is positioned to engage a cage-type basket disposed in a compartment of said rotatable carousel when said stare is disposed in said first translational position and for vertically moving said rotatable shaft between said intermediate vertical position and said second vertical position when said stage is disposed in said second translational position;

(h) automated means for rotating said rotatable carousel when said stage is in said first translational position to align a compartment of said rotatable carousel with the bottom end of said rotatable shaft;

(i) automated means for disengaging a used cage-type basket from the bottom end of said rotatable shaft; and

(j) automated means for rotating said rotatable shaft.

17. The tablet dissolution apparatus as claimed in claim 16 further comprising means for dispensing a quantity of media into said dissolution vessel.

18. The tablet dissolution apparatus as claimed in claim 16 further comprising means for sampling the contents of the dissolution vessel.

19. The tablet dissolution apparatus as claimed in claim 18 wherein said sampling means comprises a cannula having a sampling end insertable into the dissolution vessel and wherein said tablet dissolution apparatus further comprises means for loading and ejecting a depth filter onto and off of the sampling end of said cannula.

20. The tablet dissolution apparatus as claimed in claim 19 further comprising means for emptying the contents of said dissolution vessel.

21. The tablet dissolution apparatus as claimed in claim 20 further comprising means for heating the dissolution vessel.

22. The tablet dissolution apparatus as claimed in claim 21 wherein said media dispensing means, said sampling means, said loading and ejecting means, said emptying means and said heating means are all fully automated.

23. A tablet dissolution apparatus comprising:

(a) a dissolution vessel, said dissolution vessel defining a space in which a quantity of media and a tablet may be placed;

(b) media preheating and dispensing means for preheating a quantity of media to a temperature approximating that desired for dissolution and for dispensing said quantity of preheated media at a desired dissolution temperature into said dissolution vessel;

(c) means for heating the contents of said dissolution vessel so as to keep the contents of said dissolution vessel at said desired dissolution temperature; and

(d) means for agitating the contents of said dissolution vessel.

24. The tablet dissolution apparatus as claimed in claim 23 further comprising means for volumetrically determining the quantity of media to be preheated and dispensed by said media preheating and dispensing means.

25. A tablet dissolution apparatus comprising:

(a) a dissolution vessel;

(b) mechanically-rotating means positionable in said dissolution vessel for agitating the contents of said dissolution vessel;

(c) a cannula having a sampling end insertable into said dissolution vessel for use in withdrawing a sample from the dissolution vessel;

(d) automated means for loading and ejecting a depth filter onto and off of the sampling end of said cannula; and

(e) automated means for testing the orientation of a depth filter relative to said cannula prior to attempting to attach the depth filter to said cannula.