Dissolution test apparatus

• US 20020119076A1
• Filed: 02/28/2001
• Published: 08/29/2002
• Est. Priority Date: 02/28/2001
• Status: Active Grant

• Current Assignee: Agilent Technologies, Inc.
• Original Assignee: Varian Incorporated (Agilent Technologies, Inc.)
• Inventors: Fernando, C.J. Anthony, Swon, James E., Dean, Stephen D., Shoytush, Paul
• Granted Patent: US 6,962,674 B2
• Time in Patent Office: Days
• US Class Current: 422/68.1
• 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

A dissolution test apparatus comprises a spindle head assembly interconnected between first and second lateral support members. The lateral support members are translatable along a first axis, and the spindle head assembly is translatable along a second axis, such that the spindle head assembly is movable from a front, operative position at which test procedures are effected, to a rear position at which access to the dissolution test apparatus is enhanced. The spindle head assembly includes a dosage delivery mechanism including an actuatable dosage unit-retaining member. A front portion of the dissolution test apparatus has a tapered width to accommodate a triangular or trapezoidal array of test vessels, resulting in high visibility of the vessels.

Claims

1. A dissolution test apparatus comprising:

(a) a frame assembly including a front section and a rear section;

(b) a transport assembly including first and second lateral support members, each of the first and second lateral support members including an upper section and a lower section, wherein each of the first and second lateral support members is movably mounted to the frame assembly and movable along a first axis to and from the front and rear sections of the frame assembly; and

(c) a spindle head assembly interposed between the first and second lateral support members and movably connected to each of the first and second lateral support members, wherein the spindle head assembly is movable along a second axis to and from the upper and lower sections of the first and second lateral support members.

2. The apparatus according to claim 1 comprising a vessel plate mounted at the front section of the frame assembly, the vessel plate including a plurality of apertures defining vessel sites.

3. The apparatus according to claim 2 wherein the vessel plate includes first and second lateral edges defining a tapered width of the vessel plate, the tapered width narrows in a direction from the rear section to the front section, and the apertures of the vessel plate are arranged in a generally triangular array between the first and second lateral edges.

4. The apparatus according to claim 2 comprising a fluid bath container disposed under the vessel plate.

5. The apparatus according to claim 4 comprising a vessel mounted within at least one of the apertures and extending into the fluid bath container.

6. The apparatus according to claim 2 wherein the vessel plate is removably mounted to the frame assembly.

7. The apparatus according to claim 2 comprising a vessel mounted within at least one of the apertures.

8. The apparatus according to claim 7 comprising a heater element attached to a peripheral section of the vessel.

9. The apparatus according to claim 8 comprising a vessel isolation container, wherein the vessel extends into the vessel isolation container and a gap is defined between the vessel and the vessel isolation container.

10. The apparatus according to claim 1 wherein the front section of the frame assembly includes first and second lateral edges defining a tapered width of the front section, and the tapered width narrows in a direction from the rear section to the front section.

11. The apparatus according to claim 1 comprising first and second lateral guide members mounted to the frame assembly and extending generally parallel to the first axis, wherein the first lateral support member movably engages the first lateral guide member and the second lateral support member movably engages the second lateral guide member.

12. The apparatus according to claim 1 comprising first and second vertical guide members respectively mounted to the first and second lateral support members and extending generally parallel to the second axis, wherein the spindle head assembly is movably connected to each of the first and second vertical guide members.

13. The apparatus according to claim 12 comprising first and second slide blocks respectively movably engaging the first and second vertical guide members, wherein the spindle head assembly is connected to each of the first and second slide blocks.

14. The apparatus according to claim 1 comprising a motorized lift assembly operatively coupling the spindle head assembly to the first and second lateral support members.

15. The apparatus according to claim 14 wherein the lift assembly includes a transmission component operatively engaging the first and second lateral support members.

16. The apparatus according to claim 14 wherein the lift assembly includes first and second gear members, the first and second lateral support members respectively include first and second gear meshing components, the first gear member operatively engages the first gear meshing component, and the second gear member operatively engages the second gear meshing component.

17. The apparatus according to claim 14 wherein the lift assembly is supported by the spindle head assembly.

18. The apparatus according to claim 1 comprising a motorized lift assembly operatively coupling the transport assembly and the spindle head assembly.

19. The apparatus according to claim 18 wherein the lift assembly is supported by the spindle head assembly.

20. The apparatus according to claim 1 wherein the spindle head assembly includes a spindle drive mechanism and a dosage delivery mechanism.

21. The apparatus according to claim 20 wherein the spindle head assembly includes a removable spindle head cover, and the spindle head cover includes a dosage inlet aperture communicating with the dosage delivery mechanism.

22. The apparatus according to claim 20 wherein the spindle head assembly includes an evaporation cover having first and second evaporation cover apertures, the spindle drive mechanism extends through the first evaporation cover aperture, and the dosage delivery mechanism communicates with the second evaporation cover aperture.

23. The apparatus according to claim 22 wherein the spindle head assembly includes a probe mechanism, the evaporation cover has a third evaporation cover aperture, and the probe mechanism is aligned with the third evaporation cover aperture.

24. The apparatus according to claim 20 wherein the spindle head assembly includes a probe mechanism.

25. The apparatus according to claim 24 wherein the probe mechanism and the dosage delivery mechanism are integrated into a combined probe/dosage delivery mechanism.

26. The apparatus according to claim 25 wherein the combined probe/dosage delivery mechanism includes:

(a) a dose delivery conduit having a first open conduit end and a second conduit end and defining a dosage delivery passage;

(b) an actuator;

(c) a dosage retaining element operatively connected to the actuator and movable between a closed state wherein the dosage retaining unit obstructs the dosage delivery passage and an open state wherein the dosage retaining unit is disposed in non-obstructive relation to the dosage delivery passage;

(d) a probe member bore;

(e) a probe member movably disposed in the probe member bore;

(f) a probe drive motor; and

(g) a probe drive transmission mechanism operatively coupled between the probe drive motor and the probe member.

27. The apparatus according to claim 20 wherein the spindle drive mechanism includes a disengagable clutch/brake component.

28. The apparatus according to claim 1 wherein:

(a) the spindle head assembly includes an elongate spindle head guide member having upper and lower ends and depending downwardly from the spindle head assembly, the upper end of the elongate spindle head guide member supported by the spindle head assembly;

(b) the spindle head assembly is movable between a rear position, an intermediate position and an operative position;

(c) at the rear position, the spindle head assembly is disposed above the rear section of the frame assembly, and the lower end of the elongate spindle head guide member is spaced above the rear section;

(d) at the intermediate position, the spindle head assembly is disposed above the front section of the frame assembly at a raised elevation, and the lower end of the elongate spindle head guide member is spaced above the front section; and

(e) at the operative position, the spindle head assembly is disposed above the front section of the frame assembly at a lowered elevation, and the lower end of the elongate spindle head guide member extends into the front section of the frame assembly.

29. The apparatus according to claim 28 wherein the front section of the frame assembly includes an alignment bore and the elongate spindle head guide member extends into the alignment bore at the operative position of the spindle head assembly.

30. The apparatus according to claim 28 wherein the first lateral support member of the transport assembly includes a guide rod holder having a guide rod holder bore, and the elongate spindle head guide member extends into the guide rod holder bore.

31. The apparatus according to claim 28 comprising:

(a) a lift rod movably disposed in the elongate spindle head guide member and including an upper end and a lower end; and

(b) a lift rod position sensor operatively aligned with the upper end of the lift rod and adapted to detect upward movement of the lift rod with respect to the elongate spindle head guide member.

32. The apparatus according to claim 1 comprising an elongate spindle head guide member supported by the spindle head assembly and depending downwardly from the spindle head assembly toward the frame assembly.

33. The apparatus according to claim 32 comprising a lift rod movably disposed in the elongate spindle head guide member.

34. The apparatus according to claim 1 comprising a latch assembly mounted to the frame assembly and including a movable latch head releasably engaging the transport assembly into a locked position.

35. The apparatus according to claim 1 comprising a dosage delivery mechanism supported by the spindle head assembly, the dosage delivery mechanism including:

(a) a dose delivery conduit having a first open conduit end and a second conduit end and defining a dosage delivery passage;

(b) an actuator; and

(c) a dosage-retaining element operatively connected to the actuator and movable between a closed state wherein the dosage retaining unit obstructs the dosage delivery passage and an open state wherein the dosage retaining unit is disposed in non-obstructive relation to the dosage delivery passage.

36. The apparatus according to claim 35 wherein the actuator is a rotary actuator and the dose retaining element rotates between the open and closed states about an axis generally parallel to the dosage delivery passage.

37. The apparatus according to claim 35 wherein the actuator is a linear actuator and the dose retaining element rotates between the open and closed states about an axis generally perpendicular to the dosage delivery passage.

38. The apparatus according to claim 1 comprising a spindle drive assembly mounted to the spindle head assembly and movable with the spindle head assembly, and a plurality of vessel operation groups mounted to the spindle head assembly and movable with the spindle head assembly, each vessel operation group including a spindle drive mechanism, a dosage delivery mechanism and a probe mechanism, wherein the spindle drive assembly is operatively coupled to the spindle drive mechanisms.

40. The apparatus according to claim 39 comprising a first axis transport assembly mounted to the frame assembly and a second axis transport assembly movably supported by the first axis transport assembly between the front raised position of the spindle head assembly and the rear position of the spindle head assembly, wherein the spindle head assembly is movably supported by the second axis transport assembly between the front raised position and the front lowered position.

41. The apparatus according to claim 40 wherein the second axis transport assembly includes first and second lateral support members, and the spindle head assembly is interconnected between the first and second lateral support members.

42. The apparatus according to claim 39 wherein the spindle head assembly includes a plurality of dosage delivery mechanisms and a plurality of probe mechanisms and, at the front lowered position of the spindle head assembly, each of the dosage delivery mechanisms and each of the probe mechanisms, respectively, is operatively aligned with a corresponding one of the vessel sites.

39. A dissolution test apparatus comprising:

(a) a frame assembly;

(b) a vessel plate supported by the frame assembly and including a plurality of apertures defining vessel sites; and

(c) a spindle head assembly supported by the frame assembly and movable between a front lowered position, a front raised position and a rear position, the spindle head assembly including a plurality of rotatable shafts, wherein

(d) the spindle head assembly at the front raised position is disposed above the vessel plate;

(e) the spindle head assembly at the rear position is disposed in an offset, non-obstructive relation to the vessel sites; and

(f) at the front lowered position of the spindle head assembly, each of the rotatable shafts is operatively aligned with a corresponding one of the vessel sites.

43. A dissolution test apparatus comprising:

(a) a frame assembly including a front section and a rear section;

(b) a first axis transport assembly mounted to the frame assembly;

(c) a second axis transport assembly movably engaging the first axis transport assembly; and

(d) a spindle head assembly including a plurality of rotatable shafts, the spindle head assembly movably supported by the second axis transport assembly between a front lowered position and a front raised position, and the spindle head assembly movable with the first axis transport assembly between a rear position and the front raised position, wherein

(e) the spindle head assembly at the front lowered position is disposed above the front section of the frame assembly; and

(f) the spindle head assembly at the rear position is disposed above the rear section of the frame assembly.

44. The apparatus according to claim 43 comprising a vessel plate including a plurality of apertures defining vessel sites, wherein, at the front lowered position of the spindle head assembly, each of the rotatable shafts is operatively aligned with a corresponding one of the vessel sites.

45. The apparatus according to claim 44 wherein the spindle head assembly includes a plurality of dose delivery mechanisms and a plurality of sampling probe assemblies, wherein, at the front lowered position of the spindle head assembly, each of the dosage delivery mechanisms and each of the sampling probe assemblies, respectively, is operatively aligned with a corresponding one of the vessel sites.

46. The apparatus according to claim 43 wherein the second axis transport assembly includes first and second lateral support members, and the spindle head assembly is interconnected between the first and second lateral support members.

48. The dissolution test apparatus according to claim 47 comprising first and second lateral support members, wherein:

(a) each of the first and second lateral support members includes an upper section and a lower section;

(b) each of the first and second lateral support members is movably mounted to the frame assembly and movable along a first axis to and from the front and rear sections of the frame assembly;

(c) the spindle head assembly is interposed between the first and second lateral support members and movably connected to each of the first and second lateral support members; and

(d) the spindle head assembly is movable along a second axis to and from the upper and lower sections of the first and second lateral support members.

50. The dissolution test apparatus according to claim 49 comprising first and second lateral support members, wherein:

(a) each of the first and second lateral support members includes an upper section and a lower section;

(b) each of the first and second lateral support members is movably mounted to the frame assembly and movable along a first axis to and from the front and rear sections of the frame assembly;

(c) the spindle head assembly is interposed between the first and second lateral support members and movably connected to each of the first and second lateral support members; and

(d) the spindle head assembly is movable along a second axis to and from the upper and lower sections of the first and second lateral support members.

47. A dissolution test apparatus comprising:

(a) a frame assembly including a front section and a rear section, the front section having first and second laterally spaced edges defining a tapered width of the front section, the tapered width narrowing in a direction from the rear section to the front section;

(b) a vessel plate mounted at the front section and including a plurality of vessel mounting apertures, wherein at least a majority of the apertures are disposed along first and second vessel alignment directions, the first vessel alignment direction running parallel to the first edge of the front section and the second vessel alignment direction running parallel to the second edge of the front section; and

(c) a spindle head assembly supported by the frame assembly and including a plurality of rotatable shafts.

49. A dissolution test apparatus comprising:

(a) a frame assembly including a front section and a rear section;

(b) a vessel plate mounted at the front section and including first and second laterally spaced edges defining a tapered width of the vessel plate, the tapered width narrowing in a direction from the rear section to the front section, the vessel plate further including a plurality of vessel mounting apertures, wherein at least a majority of the apertures are disposed along first and second vessel alignment directions, the first vessel alignment direction running parallel to the first edge of the vessel plate and the second vessel alignment direction running parallel to the second edge of the vessel plate; and

(c) a spindle head assembly supported by the frame assembly and including a plurality of rotatable shafts.

51. A dissolution test apparatus comprising:

(a) a frame assembly including a front section and a rear section;

(b) first and second lateral support members movable between the front and rear sections along a first axis, each of the first and second lateral support members including an upper section and a lower section;

(c) first and second lateral guide members mounted to the frame assembly, wherein the first lateral support member movably engages the first lateral guide member and the second lateral support member movably engages the second lateral guide member; and

(d) a spindle head assembly interposed between the first and second lateral support members and movably connected to each of the first and second lateral support members, the spindle head assembly including a spindle drive mechanism, a dosage delivery mechanism and a probe mechanism, wherein the spindle head assembly is movable along a second axis to and from the upper and lower sections of the first and second lateral support members.

52. The apparatus according to claim 51 wherein:

(a) the spindle head assembly includes an elongate spindle head guide member having upper and lower ends and depending downwardly from the spindle head assembly, the upper end of the elongate spindle head guide member supported by the spindle head assembly;

(b) a lift rod movably disposed in the elongate spindle head guide member and including an upper end and a lower end; and

(c) a lift rod position sensor operatively aligned with the upper end of the lift rod and adapted to detect upward movement of the lift rod with respect to the elongate spindle head guide member.

53. A dissolution test apparatus comprising:

(a) a frame assembly including a front section and a rear section;

(b) a transport assembly including first and second lateral support members, each of the first and second lateral support members including an upper section and a lower section, wherein each of the first and second lateral support members is movably mounted to the frame assembly and movable along a first axis to and from the front and rear sections of the frame assembly; and

(c) a spindle head assembly interposed between the first and second lateral support members and movably connected to each of the first and second lateral support members, wherein the spindle head assembly is movable along a second axis to and from the upper and lower sections of the first and second lateral support members, the spindle head assembly including a dosage delivery mechanism, the dose delivery mechanism including;

(i) a dose delivery conduit having a first open conduit end and a second conduit end and defining a dosage delivery passage;

(ii) an actuator; and

(iii) a dosage-retaining element operatively connected to the actuator and movable between a closed state wherein the dosage retaining unit obstructs the dosage delivery passage and an open state wherein the dosage retaining unit is disposed in non-obstructive relation to the dosage delivery passage.

54. The apparatus according to claim 53 wherein the dosage delivery mechanism is integrated with a probe mechanism to form a combined probe/dosage delivery mechanism, the combined probe/dosage delivery mechanism comprising:

(a) a body including the dose delivery conduit, wherein the actuator is mounted to the body;

(b) a probe member bore formed in the body;

(c) a probe member movably disposed in the probe member bore;

(d) a probe drive motor mounted to the body; and

(e) a probe drive transmission mechanism operatively coupled between the probe drive motor and the probe member.

55. A dissolution test apparatus comprising:

(a) a frame assembly;

(b) a vessel plate supported by the frame assembly and including a plurality of vessel locations; and

(c) a spindle head assembly supported by the frame assembly and movable between a front position and a rear position, the spindle head assembly including a plurality of dose delivery mechanisms, each dose delivery mechanism including;

(i) a dose delivery conduit defining a dose delivery passage and having a first open conduit end and a second open conduit end;

(ii) an actuator; and

(iii) a dose retaining element operatively connected to the actuator and rotatable between a dose retaining position and a dose delivery position, wherein the dose retaining element blocks the dose delivery passage at the dose retaining position and opens the dose delivery passage at the dose delivery position, and wherein;

(d) at the front position of the spindle head assembly, the second open conduit end of each of the dose delivery mechanisms is operatively aligned with a corresponding one of the vessel locations; and

(e) at the rear position of the spindle head assembly, each of the dose delivery mechanisms is disposed in an offset, non-obstructive relation to the vessel plate.

56. The apparatus according to claim 55 wherein the dosage delivery mechanism is integrated with a probe mechanism to form a combined probe/dosage delivery mechanism, the combined probe/dosage delivery mechanism comprising:

(a) a body including the dose delivery conduit, wherein the actuator is mounted to the body;

(b) a probe member bore formed in the body;

(c) a probe member movably disposed in the probe member bore;

(d) a probe drive motor mounted to the body; and

(e) a probe drive transmission mechanism operatively coupled between the probe drive motor and the probe member.

57. A combined probe/dosage delivery mechanism comprising:

(a) a dose delivery conduit having a first open conduit end and a second conduit end and defining a dosage delivery passage;

(b) an actuator;

(c) a dosage retaining element operatively connected to the actuator and movable between a closed state wherein the dosage retaining unit obstructs the dosage delivery passage and an open state wherein the dosage retaining unit is disposed in non-obstructive relation to the dosage delivery passage;

(d) a probe member bore;

(e) a probe member movably disposed in the probe member bore;

(f) a probe drive motor; and

(g) a probe drive transmission mechanism operatively coupled between the probe drive motor and the probe member.