The disintegration test is a quality control test performed to check whether the dosage forms like tablets, capsules, and suppositories disintegrate within the expected time when these dosage forms are kept in the required medium. This test is done to ensure no remains of the tablet, or any other test product should be retained on the screen of the apparatus. if capsules are under test only the shell should be retained, if coated tablets, only insoluble coating should be present.

DISINTEGRATION APPARATUS

• This apparatus is having a basket-rack assembly
• 1000ml beakers 2 in number with 138-160mm height & inside diameter – 97-115mm for disintegration medium
•  A thermostatic arrangement for heating the fluid and temperature probes (35°–39°)
• It contains a device for raising and lowering of the basket in the medium.
• The frequency of raising and lowering the basket in the medium is 29 to 32 cycles per minute through a distance of not less than 53 mm and not more than 57 mm.

1. The fluid volume in the vessel is such that:
2. – At the highest point of the upward stroke, the wire mesh stays at least 15 mm below the fluid surface.
   – On the downward stroke, the mesh reaches no closer than 25 mm from the vessel’s bottom.
3. – The top of the basket-rack assembly must never become submerged.
4. – The upward stroke time is equal to the downward stroke time.
5. – Stroke direction changes smoothly, avoiding abrupt reversals.
6. – The basket-rack assembly moves vertically along its axis without significant horizontal movement or deviation from vertical alignment.

BASKET-RACK ASSEMBLY

•  The basket-rack assembly consists of six open-ended transparent tubes:
  – Length: 75.0–80.0 mm
  – Inside diameter: 20.7–23 mm
  – Wall thickness: 1.0–2.8 mm
• – The tubes are held vertically by two plates:
  – Diameter: 88–92 mm
  – Thickness: 5–8.5 mm
  – Each plate has six equidistant holes, 22–26 mm in diameter
• – A woven stainless steel wire cloth is attached to the underside of the lower plate:
  – Plain square weave
  – Apertures: 1.8–2.2 mm
  – Wire diameter: 0.57–0.66 mm
• – The apparatus parts are assembled and securely held by three bolts passing through the plates.
• – A suitable mechanism is provided to suspend the basket-rack assembly from a raising and lowering device at a central point.
• – The design of the basket-rack assembly can be slightly varied, provided the glass tubes and screen mesh specifications are maintained.

Disintegration Test For uncoated tablets

Procedure for Uncoated or Plain-Coated Tablets

– Place one dosage tablet into each of the six tubes of the basket-rack assembly. Add a disk if specified.
– Run the apparatus using water or the specified medium as the immersion medium, maintained at 37 ± 2°C.
– At the end of the specified time limit, lift the basket-rack assembly from the medium and observe the tablets.
– All tablets should completely disintegrate. If one or two tablets fail to disintegrate completely, repeat the test with 12 additional tablets.

Acceptance Criteria for Uncoated or Plain-Coated Tablets to pass the DT test

1. When testing six tablets, all six must be disintegrated.
2. When testing 18 tablets, at least 16 out of 18 must be disintegrated.