Southeast University

Department of Pharmacy
BPH 322: Biopharmaceutics and Pharmacokinetics Sessional
Spring 2022; Batch: 34 (A+B)

Experiment Number : 05 Date :

Name of The Experiment : Determination of Disintegration Time

of large tablets and capsule.
Principle :
Before absorption of a drug takes place to the body, it must be in solution. For most
tablets the first important step toward solution is breakdown of the tablet into smaller
particles or granules, a process known as disintegration.

It is a well-known fact that an immediate-release dosage form should disintegrate in order

to efficiently liberate its active ingredient(s) and make it available for absorption.
Therefore, disintegration testing methods were developed.

This test is provided to determine whether tablets or capsules disintegrate within the
prescribed time when placed in a liquid medium under the experimental conditions
presented below. The time that takes a tablet to disintegrate is measured in a device
described in the USP/NF.

Disintegration does not imply complete dissolution of the active constituent. Complete
disintegration is defined as that state in which any residue of the unit(tablet/capsule),
except fragments of insoluble coating or capsule shell, remaining on the screen of the test
apparatus or adhering to the lower surface of the discs, if used, is a soft mass having no
palpably firm core.

Factors Affecting Disintegration Time :

 Tablet hardness: This can he reduced by reducing machine pressure for acceptable
tablet.
 Over lubrication: These can also cause waterproofing. This can be reduced by
blending lubricant only for 5-10 minutes in the final mix and replacing
magnesium stearate with stearic acid.
 Lack of disintegrantes.
 pH of the medium such as gastric fluid & intestinal fluid.

Disintegration Test (EP):

This test is reproduced with permission from The European Pharmacopoeia.

Apparatus.
The main part of the apparatus (Figure 2) is a rigid basket-rack assembly supporting 3
cylindrical transparent tubes 77.5 ± 2.5 mm long, 33.0 mm ± 0.5 mm in internal diameter,
and with a wall thickness of 2.5 ± 0.5 mm. Each tube is provided with a cylindrical disc

Sonia Zaman, Asst. Professor, Dept. of Pharmacy, SEU Page 1

 Southeast University
Department of Pharmacy
BPH 322: Biopharmaceutics and Pharmacokinetics Sessional
Spring 2022; Batch: 34 (A+B)

31.4 ± 0.13 mm in diameter and 15.3 ± 0.15 mm thick, made of transparent plastic with a
relative density of 1.18–1.20. Each disc is pierced by 7 holes, each 3.15 ± 0.1 mm in
diameter, 1 in the centre and the other 6 spaced equally on a circle of radius 4.2 mm from
the centre of the disc. The tubes are held vertically by 2 separate and superimposed rigid
plastic plates 97 mm in diameter and 9 mm thick, with 3 holes. The holes are equidistant
from the centre of the plate and equally spaced. Attached to

Sonia Zaman, Asst. Professor, Dept. of Pharmacy, SEU Page 2

 Southeast University
Department of Pharmacy
BPH 322: Biopharmaceutics and Pharmacokinetics Sessional
Spring 2022; Batch: 34 (A+B)

the under side of the lower plate is a piece of woven gauze made from stainless steel wire
0.63 ± 0.03 mm in diameter and having mesh apertures of 2.0 ± 0.2 mm. The plates are
held rigidly in position and 77.5 mm apart by vertical metal rods at the periphery. A
metal rod is also fixed to the centre of the upper plate to enable the assembly to be
attached to a mechanical device capable of raising and lowering it smoothly at a constant
frequency of between 29 and 32 cycles per minute, through a distance of 55 ± 2 mm. The
assembly is suspended in the specified liquid medium in a suitable vessel, preferably a 1
litre beaker. The volume of the liquid is such that when the assembly is in the highest
position the wire mesh is at least 15 mm below the surface of the liquid, and when the
assembly is in the lowest position the wire mesh is at least 25 mm above the bottom of
the beaker and the upper open ends of the tubes remain above the surface of the liquid. A
suitable device maintains the temperature of the liquid at 35–39 °C.

Method/Procedure:
 Test 6 tablets or capsules either by using 2 basket-rack assemblies in parallel or
by repeating the procedure.
 In each of the 3 tubes, place 1 tablet or capsule and, if prescribed, add a disc;
 suspend the assembly in the beaker containing the specified liquid.
 Operate the apparatus using water as the immersion fluid unless another liquid is
specified for the prescribed period,
 withdraw the assembly and examine the state of the tablets or capsules.
 To pass the test, all 6 of the tablets or capsules must have disintegrated.
 If any residue remains, it must have a soft mass.
 Liquids usually used in disintegration
-Water,
-Simulated gastric fluid (pH = 1.2 HCl),
-or Simulated intestinal fluid (pH = 6.8, KH2PO4 (phosphate buffer)
+ pencreatin enzyme +NaOH)
 Here we used distilled water as the media. If we wanted to create an acidic or
basic media we would use 0.1N HCl or 0.1N NaOH solution.

Supplied Sample :
Generic Name:
Brand Name:
Dose:
Manufacturer:

Sonia Zaman, Asst. Professor, Dept. of Pharmacy, SEU Page 3

 Southeast University
Department of Pharmacy
BPH 322: Biopharmaceutics and Pharmacokinetics Sessional
Spring 2022; Batch: 34 (A+B)

Data :
Disintegration time for ……… tablets as monitored, we found that:
Tablet Disintegration Time (min) Average
number Disintegration Time (min)
1.
2.
3.
4.
5.
6.

Result / Comment :
The supplied tablets have disintegration time of ------- , which meet the USP standard that
means these tablets will disintegrate into small particles and releases the drug before
absorption could take place.

Sonia Zaman, Asst. Professor, Dept. of Pharmacy, SEU Page 4