DISINTEGRATION TEST APPARATUS/DISINTEGRATION
TESTER
Disintegration Tester is a solid state instrument designed for the accurate estimation of
disintegration time of tablets as per IP/USP standards. The instrument is designed to test two
batches of six tablets, simultaneously. The unit is extremely useful for pharmaceutical industries.
It is used in quality control and R & D to determine compliance with the disintegration
requirement of the tablet and capsule as per USP/BP/IP standards.
The instrument has two basket assemblies with independent timers and motors. The timers and
temperature are displayed on 5 digit and 3 digit seven segment red LED displays respectively.
Each timer can be set and used individually. The baskets are automatically positioned at the top
when the test is over.
The unit is provided with two glass beakers having capacity of 1000 ml with arrangement to hold
temperature sensor placed in the sturdy, acrylic water bath. The large spread out stainless steel
heater ensures perfectly uniform heating. The instrument has a dual channel temperature system
with sensors to monitor the test temperature of disintegration beaker as well as water bath. The
temperature of the water bath and vessels are accurately maintained using highly accurate
sensors and microcontroller tec
What are Disintegration and Principle:
Disintegration is defined as that state in which no residue of the tablet and
capsule remains on the screen of the apparatus or, if a residue remains, it may be
consists of a fragment of insoluble coating of the tablet or capsule shells or is a
soft mass with no palpable core.
If Discs have been used with capsules, any residue remaining on the lower
surface of discs only consists of fragments of their shells.
Disintegration Test apparatus assembly:
DT apparatus assembly Consists of the following parts:
1. Rigid Baskets
2. Tube
3. Plates
4. Cylindrical Disks
5. Assembly
6. Thermostat
1. Rigid Baskets:
Rack assembly supports six cylindrical glass tubes, 77.5 ± 2.5 mm long, 21.5 mm
in internal diameter, and a wall thickness of about 2 mm.
2. Tube:
The tube is held vertically by two superimposed, transparent plastic plates, 90
mm in diameter and 6 mm thick, perforated by six holes having the same
diameters as tubes.
The hole is equidistant from the center of the plate and is equally spaced from
one another, that is attached to the lower side of the lower plate is a piece of
woven gauze made from stainless steel wire (10 mesh screen size). These are 635
mm in diameter and have a nominal mesh aperture of 2.00 mm.
The upper plate is secured with a tempered stainless steel circle punctured by six
gaps, each around 22 mm in breadth, accommodating our cylinders and holding
them between the plastic plates. The hole coincides with those of the upper
plastic plate and the upper open ends of glass tubes.
3. Plates:
Plates are held inflexibly in position and 77.5 mm separated by vertical metal
rods on the outskirts. The upper plate center is fixed to the metal rod enabling
the assembly to be attached to a mechanical device capable of raising and
lowering it quickly at a constant frequency of between 29 and 32
cycles/minute through a distance of 50 to 60 mm.
The design of the basket-rack assembly may be somewhat different provided
specifications for the glass tubes, and the screen mesh sizes are unchanged.
4. Cylindrical Disks:
The dimensions of each hole inside disk are 20.7 ± 0.15 mm and 9.5 ± 0.15 mm
thick and made of transparent plastic with a density of 1.18 to 1.20, and pierced
with five holes, each of 2 mm in diameter, one at center and another four spaced
equally on a circle of radius 6 mm from the center of the disc and Four similarly
divided groove is cut in the horizontal surface of the circle so that at the upper
surface of the plate, they are 9.5 mm wide and 2.55 mm deep, and at the lower
surface 1.6 mm square.
5. Assembly:
Assembly is suspended in the liquid medium in a suitable vessel, preferably in a
1000 ml beaker. The height of the wire mesh is a minimum of 25 millimeters
below the liquid surface, and at its lower purpose is a minimum of 25 millimeters
on top of the beaker.
6. Thermostat:
A Thermostat is an Arrangement for heating the liquid and maintaining the
temperature around 37 ± 2° C.
Disintegration Test Method:
Unless otherwise explicit within the individual monograph, introduce one tablet
or capsule into every glass tube or six tablets. If directed within the acceptable
general monograph, add a disc to every tube.
Suspend the assembly within the beaker containing the desired liquid, operate
the equipment for the desired time, and take away the assembly from the liquid.
The tablets and capsules pass the test if all of them have completely
disintegrated.
If one or two tablets/capsules fail to disintegrate, repeat the test on 12
additional tablets/capsules; not less than 16, of a total of 18 tablets/capsules ,
tested for disintegration.
If the tablets or capsules adhere to the disc and the examined preparation fails
to comply, repeat the test omitting the disc. The preparation complies with the
test if all the tablets or capsules disintegrate in a repeat test.
Different types of tablets Disintegration times
Tablets Types Disintegration Time
Uncoated tablets 15 min (BP, IP), 30 min (USP)
Film-coated 30 min (BP), others coated tablets 60 min
Sugar-coated 60 min (BP)
Effervescent tablets <5 min (BP, IP)
Dispersible tablets <3 min (BP, IP)
With 0.1N Hcl- No disintegration in 120 min
Enteric-coated tablets
With 6.8 pH phosphate buffer in 60 min
Hard gelatin Capsules 30 min as per BP, and USP
Soft gelatin Capsules 30 min as per BP
FAQs
1. What is the endpoint of disintegration?
State at which no residues remain of tablets on-screen of apparatus, besides
fragments of coated tablets.
2. What is the stroke length for the Disintegration test?
55 mm ± 2 strokes/minute.
3. What is the Disintegration time?
Disintegration time is the time required to break the unit dosages into small
granules under specified conditions.
5. Why Disk is used during the disintegration test?
The disk is used to Allow the tablets to stay deep in the water during the entire
process.
