Disintegration
Disintegration
Test Apparatus & Method
Typically, the tablets and capsules to be tested are each placed in one of six vertical tubes each measuring approx. 77.5 mm long x 21 mm inside diameter, positioned in a circular basket arrangement.
The lower end of each tube is covered by a 2 mm sieve mesh. Large tablets, capsules and boluses may require a larger basket. The basket assembly is raised and lowered in simulated gastric fluid at body temperature (37 °C) through a distance of 55 mm, at a constant stroke frequency of 30 cycles per minute. A plastic disc of
precise geometry “hammers” the tablet during the operation, thus assisting in the disintegration process. The tablet is said to pass the test providing that no tablet residue remains on the sieve mesh after the designated time, typically 30 minutes for ordinary tablets and 60 minutes for enteric- coated tablets.
A
1.9 ± 0.9
± 1.15 21.85
B
90 ± 2
C
2.6 ± 0.1
A
Basket rack assembly
Basket rack assembly (top view)
B
C
Disc (top view)
9.4 ± 0.2
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