Determination of Disintegration Time For Tablet
Introduction:
Disintegration test is official test.
It is the time required for the tablet to break into particles, the disintegration test is a measure
only of the time required under a given set of conditions for group of tablets to disintegrate into
particles.
Disintegration test is not performed for controlled and sustained release tablets.
Purpose:
This test is performed to determine that whether the tablets disintegrate within the prescribed
time when placed in a liquid medium under the specified experimental conditions.
Apparatus construction
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Circular basket rack assembly
Suitable vessel for immersion fluid (1 liter beaker)
Thermostatic arrangement for maintaining the temperature at 37+2 oC
A device for raising and lowering of basket rack in immersion fluid at constant
frequency of 28-32 cycles/min through a distance of 2.5 cm below the liquid surface
and 2.5 cm above the surface of beaker bottom.
Basket-rack assembly:
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The basket-rack assembly consists of 6 open-ended transparent tubes and a rack for
holding these tubes in vertical direction.
Each tube is 77.5 ± 2.5 mm (3 inch) long and open at the top and 10 mesh (1.8-2.2 mm)
screen at the bottom end.
The tubes are held in a vertical position by two plastic plates which are circular in shape
and made up of transparent material having six holes of a diameter that allow the tube
to be inserted.
A suitable means is provided to suspend the basket-rack assembly from the raising and
lowering device using a point on its axis.
A perforated disc is used to keep tablet inside the tubes during process.
Disintegration Apparatus:
Disintegration test of various tablets:
S.No
1
Type of tablets
Compressed Uncoated
2
3
Sugar Coated
If 1or 2 tablets fails
Film Coated
4
Enteric Coated
5
Dispersible/
Effervescent
Buccal
6
Fluid Medium
Limit
15 minutes or as per individual
monograph
Water
60 minutes or as per individual
0.1 N HCL
monograph
Water
30 minutes or as per individual
monograph
0.1 N HCL & Phosphate 1 hour or as per individual monograph
buffer pH 6.8
Water
Less than <3 minutes or as per
individual monogram
Simulated Saliva
4 hours or as per individual monogram
Water
Procedure:
Place 1 tablet in each of the six tubes of basket and operate the apparatus using water maintained
at 37±20 0C. At the end of time limit, lift the basket from the fluid and observe the tablets,
if all of the tablets have disintegrated, test is pass, if 1-2 tablets fail to disintegrate, repeat the
test at 12 additional tablets.
Acceptance criteria:
All the 6 tablets or capsules must be disintegrated. If 1 or 2 dosage unit/s fails to disintegrate
than repeat the test with additional 12 tablets. The requirements of the test are meet if not less
than 16 of the 18 dosage units tested are disintegrated.
Acceptance/rejection criteria:
1. Uncoated tablets:
 One tablet in each tube.
 Operate the apparatus using water for 15 minutes..
 Lift the basket from fluid and observe.
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If one or two of 6 tablets fails to disintegrate completely, repeat the test on 12
additional tablets, not less than 16 of total 18 tablets disintegrate completely. If more
than 2 tablets (from 18 tabs) fail to disintegrate, the batch must be rejected.
 According to USP disintegration time must be less than 30min.
 According to BP disintegration time must be less than 15min.
2. Enteric coated tablets:
 One tablet in each tube.
 Operate the apparatus using simulated gastric fluid till 1-2 hours.
 Lift the basket from fluid and observed the tablets.
 There should be no evidence of disintegration, cracking and softening.
 Operate the apparatus using simulated intestinal fluid for one hour or the time
specified in the monograph.
 If one or two of 6 tablets fails to disintegrate completely, repeat the test on 12
additional tablets, not less than 16 of total 18 tablets disintegrate completely. If more
than 2 tablets (from 18 tabs) fail to disintegrate, the batch must be rejected.
3. Plain coated tablets (film/sugar coated):
 One tablet in each tube.
 Operate the apparatus using water for 60 minutes..
 Lift the basket from fluid and observe.
 If one or two of 6 tablets fails to disintegrate completely then perform the test by using
0.1 N HCL medium.
 If one or two of 6 tablets fails to disintegrate completely, repeat the test on 12
additional tablets, not less than 16 of total 18 tablets disintegrate completely. If more
than 2 tablets (from 18 tabs) fail to disintegrate, the batch must be rejected.
4. Buccal tablets:
 One tablet in each tube.
 Operate the apparatus using water or specified medium, if prescribed.
 After 4 hours all the tablets should have disintegrated.
 If one or two of 6 tablets fails to disintegrate completely, repeat the test on 12
additional tablets, not less than 16 of total 18 tablets disintegrate completely. If more
than 2 tablets (from 18 tabs) fail to disintegrate, the batch must be rejected.