Study Set Content:
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
DISINTEGRATION
For the purposes of this test disintegration does not imply (blank) of the unit or even of its active constituent.
complete dissolution
is defined as that state in which any residue of the unit, 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.
Complete disintegration
Instrumentation
Disintegration apparatus General specifications:
1. Basket rack assembly
2. 1000ml low form beaker
3. Thermostatic control for heating fluid
4. Device for raising and lowering the basket
1. Basket rack assembly
a. 6 open ended transparent tubes
b. 10 mesh wire cloth at the bottom
c. Disks
Use for tablets and capsules that are not greater than 18 mm.
Apparatus A
Apparatus A Consists of:
a basket-rack assembly
a 1000 mL low-form beaker
n height and having an inside diameter of (blank)mm for the immersion fluid
138–160 mm , 97–115
a thermostatic arrangement for heating the fluid between
35 °C and 39 °C
device for raising and lowering the basket in the immersion fluid at a constant frequency rate between (blank) per minute, through a distance of not less than (blank) and not more than(blank)
29 and 32 cycles , 53 mm, 57 mm.
Place one dosage unit in each of the(blank) of the basket and if specified add a (blank)
six tubes , disc
Operate the apparatus using (blank) as the immersion fluid unless another liquid is specified and maintain its temperature at (blank)
water , 35– 39 °C.
At the end of the specified time lift the basket from the fluid and observe the dosage units: all of the dosage units have disintegrated
completely
If one or two dosage units fail to disintegrate repeat the test on
12 additional dosage units.
The requirements of the test are met if not less than (blank) of the 18 dosage units tested are disintegrated
16
For larger tablets and capsules
Apparatus B
The main part of the apparatus is a rigid basket-rack assembly supporting (blank) cylindrical transparent tubes (blank), (blank) in internal diameter and with a wall thickness of (blank)
3 , 77.5 ± 2.5 mm long, 33.0 mm ± 0.5 mm, 2.5 ± 0.5 mm.
Each tube is provided with a cylindrical disc (blank) in diameter
31.4 ± 0.13 mm
Each tube is provided with a cylindrical disc 31.4 ± 0.13 mm in diameter and (blank), made of transparent plastic
15.3 ± 0.15 mm thick
Each tube is provided with a cylindrical disc 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.
