Apparatus and method for visiometric disintegration

摘要

In one version of the invention, an apparatus intended for determining the disintegration time of rapidly disintegrating tablets is designed with a disintegration cell having two liquid inlets and outflow from the top. Visualization of tablet inside the disintegration cell is conducted using a camera aided by a base light source and images captured using a computer or any other recording system. Disintegration medium is introduced into the disintegration cell through both inlets to produce a swirling motion and images of the tablet disintegration process are captured. The captured images are analyzed in real-time or off-line, to determine the tablet disintegration time. A visual non-recording method using projected image may also be used.

主权项

1. An apparatus for determining the disintegration time of a disintegrating dosage form, the apparatus comprising:
a disintegration cell configured to contain the dosage form; and a first liquid jet inlet and a second liquid jet inlet, the first liquid jet inlet and the second liquid jet inlet being positioned on opposite sides of the disintegration cell and unaligned with each other, the first liquid jet inlet and the second liquid jet inlet being configured to introduce a disintegration medium into the disintegration cell simultaneously through the first liquid jet inlet and the second liquid jet inlet to produce a swirling shear force of the disintegration medium within the disintegration cell; the disintegration cell comprising an overhead outlet configured to remove, from the disintegration cell, overflowing disintegration medium and a plurality of disintegrated fragments of the dosage form.