Arachem (M) Sdn Bhd

Disintegration Testing

Before the active ingredient(s) of an oral solid dose drug can be absorbed into the body, the tablet or capsule in which they are contained must first disintegrate into smaller particles.
Chapters Ph. Eur. 2.9.2 and USP <701> and <2040> describe reproducible and standardised methods for quantifying the disintegration behavior of solid dosage forms.

Typically, the tablets and capsules to be tested are each placed in one of six vertical tubes each measuring approx. 77.5mm long x 21mm inside diameter, positioned in a circular basket arrangement. The lower end of each tube is covered by a 2mm 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 55mm, 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.