Device for determining the disintegration time of compressed pharmaceutical mold bodies, such as tablets and capsules, as well as a method for this purpose

An apparatus for determining a disintegration time of compressed pharmaceutical mold bodies (18) comprising a frame (1) lowerable into a vessel (19) filled with a liquid, wherein the frame (1) is furnished with a center column (7) and a floor (3), which floor (3) contains a plurality of holes (5,5′), wherein the holes (5,5′) are covered from below with a grid (4) and wherein test tubes (6,6′) disposed upright are positioned in the holes (5,5′) within the frame (1), wherein a disk (8) with passing through holes (10, 10′) is movably insertable as a weight on the individual pharmaceutical form body (18), wherein the passing through holes (10, 10′) are running in the direction of the center axis of the disk (8), wherein a permanent magnet (11) is disposed at the bottom side of the disk (8) directed toward the floor (3), wherein a magnetic field sensor element (13) is disposed opposite to the permanent magnet (11) below a grid (4) of the floor (3), wherein the center hole (10) of the disk (8) exhibits a bore hole (28) starting from a lower cover face of the disk (8), wherein the permanent magnet (11) is seated in the bore hole (28), wherein the permanent magnet (11) exhibits a permanent magnet hole (25) disposed centeredly in the direction of the center axis (27), which permanent magnet hole (25) is aligned with the center hole (10) within the disk (8), wherein the magnetic field sensor element (13) is disposed in the region of a peripheral edge of a cover face of the permanent magnet in a region of a largest gradient of the magnetic field of the permanent magnet (11) when seen in a top view onto the permanent magnet (11).

A method for determining the disintegration time of compressed pharmaceutical mold bodies comprising the steps of:

• employing an apparatus comprising:
• a frame lowerable into a liquid;
• a center column attached to the frame;
• a floor attached to the center column, wherein the floor contains a plurality of holes;
• a grid covering the holes from below;
• a test tube disposed upright and positioned in one of the holes;
• a disk having passing through holes and movably insertable into the test tube as a weight onto an individual pharmaceutical form body, wherein the passing through holes are running parallel to the direction of the center axis of the disk;
• a permanent magnet disposed centered within the disk and having a magnetic field directed axially, wherein the center hole (10) of the disk exhibits a bore hole starting from a lower cover face of the disk, wherein the permanent magnet is seated in the bore hole, wherein the permanent magnet exhibits a permanent magnet hole centeredly in the direction of a center axis, which permanent magnet hole is aligned with the center hole within the disk,
• a magnetic field sensor element disposed opposite to the permanent magnet below the grid of the floor, wherein the magnetic field sensor element is disposed in the region of a peripheral edge of a cover face of the permanent magnet in a region of a largest gradient of a magnetic field of the permanent magnet when seen in a top view onto the permanent magnet;
• placing a medical mold body into the test tube;
• disposing the disk on top of the medical mold body;
• lowering the frame into the vessel filled with the liquid;
• performing an electrical multiple measurement with successive average value formation durning a disintegration process of the medical mold body.

An apparatus for determining a disintegration time of compressed pharmaceutical mold bodies comprising

• a vessel filled with a liquid;
• a frame lowerable into the vessel filled with the liquid;
• a center column attached to the frame;
• a floor attached to the center column, wherein the floor contains a plurality of holes;
• a grid covering the holes from below;
• a test tube disposed upright and positioned in one of the holes;
• a disk having passing through holes and movably insertable into the test tube as a weight onto an individual pharmaceutical form body, wherein the passing through holes are running parallel to the direction of the center axis of the disk;
• a permanent magnet disposed centered within the disk and having a magnetic field directed axially, wherein the center hole of the disk exhibits a bore hole starting from a lower cover face of the disk, wherein the permanent magnet is seated in the bore hole, wherein the permanent magnet exhibits a permanent magnet hole centeredly in the direction of a center axis, which permanent magnet hole is aligned with the center hole within the disk,
• a magnetic field sensor element disposed opposite to the permanent magnet below the grid of the floor, wherein the magnetic field sensor element is disposed in the region of a peripheral edge of a cover face of the permanent.

An apparatus for determining a disintegration time of compressed pharmaceutical mold bodies comprising

• a frame lowerable into a liquid;
• a center column attached to the frame;
• a floor attached to the center column, wherein the floor contains a plurality of holes;
• a grid covering the holes from below;
• a test tube disposed upright and positioned in the holes;
• a disk having passing through holes and movably insertable into the test tube as a weight onto an individual pharmaceutical form body, wherein the passing through holes are running parallel to the direction of the center axis of the disk;
• a permanent magnet disposed centered within the disk and having a magnetic field directed axially, wherein the center hole of the disk exhibits a bore hole starting from a lower cover face of the disk, wherein the permanent magnet is seated in the bore hole, wherein the permanent magnet exhibits a permanent magnet hole centeredly in the direction of a center axis, which permanent magnet hole is aligned with the center hole within the disk,
• a magnetic field sensor element disposed opposite to the permanent magnet below the grid of the floor, wherein the magnetic field sensor element is disposed in the region of a peripheral edge of a cover face of the permanent magnet in a region of a largest gradient of a magnetic field of the permanent magnet when seen in a top view onto the permanent magnet.

An apparatus for determining a disintegration time of compressed pharmaceutical mold bodies (18) comprising a frame (1) lowerable into a liquid, wherein the frame (1) is furnished with a center column (7) and a floor (3), which floor (3) contains a plurality of holes (5,5′), wherein the holes (5,5′) are covered from below with a grid (4) and wherein test tubes (6,6′) disposed upright are positioned in the holes (5,5′) within the frame (1), wherein a disk (8) with passing through holes (10, 10′) is movably insertable as a weight on the individual pharmaceutical form body (18), wherein the passing through holes (10, 10′) are running in the direction of the center axis of the disk (8), wherein a permanent magnet (11) is disposed at the bottom side of the disk (8) directed toward the floor (3), wherein a magnetic field sensor element (13) is disposed opposite to the permanent magnet (11) below a grid (4) of the floor (3),

• wherein the center hole (10) of the disk (8) exhibits a bore hole (28) starting from a lower cover face of the disk (8), wherein the permanent magnet (11) is seated in the bore hole (28), wherein the permanent magnet (11) exhibits a permanent magnet hole (25) disposed centeredly in the direction of the center axis (27), which permanent magnet hole (25) is aligned with the center hole (10) within the disk (8), wherein the magnetic field sensor element (13) is disposed in the region of a peripheral edge of a cover face of the permanent magnet in a region of a largest gradient of the magnetic field of the permanent magnet (11) when seen in a top view onto the permanent magnet (11).