Disintegration Testing

It has long been recognised that before a tablet/hard gelatine capsule can dissolve and hence allow the active drug to be absorbed into the body, it must first disintegrate into smaller particles.

The current apparatus described in the Pharmacopoeias was designed to provide a reproducible and standardised method of ensuring that disintegration has taken place. Each of the tablets to be tested is placed in one of 6 vertical tubes arranged in a circular basket arrangement. The lower end of the tubes is covered by a sieve mesh.

During testing, the basket assembly is raised and lowered in simulated gastric fluid at 37 degrees C whilst the tablet is continually “hammered” by a plastic disk of defined proportions to simulate in vivo conditions.

The tablet is said to pass the test providing that no tablet residue remains on the mesh after the designated test period.

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