Quality Assurance- Physical

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.


Introduction to Disintegration Testing

The Disintegration Tester Series DTG is the result of over 50 years experience in the field of pharmaceutical testing.

The series is available with one (DTG 1000), two (DTG 2000), three (DTG 3000) or four (DTG 4000) test stations. Each individual test station is capable of accepting one batch of six tablets or capsules. The DTG 2000IS is also available, which has two test stations, but with independent control over each test station.

All Copley Tablet Disintegration Testers feature:

  • Sturdy, robust design including novel “quick release” basket(s), one-piece water bath and independent digital heater/circulator
  • Simple, easy to use operation ensures that the number of operations required to perform a test are kept to a minimum
  • Full supporting documentation (including full IQ/OQ/PQ qualification documentation if required)
  • Special accessories available for hard/soft gelatine capsules and large tablets, capsules and boluses
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