Title
Dosage performance tests: Disintegration test for sugar-coated tablets
Aim
To determine the time
taken to disintegrate tablet in water at 37C.
Introduction
Disintegration test is test used to determine whether
tablets and capsules disintegrate within a prescribed time when placed in an
immersion fluid under prescribed experimental conditions. The definition of
complete disintegration is the state in which no residue of the tablet of
capsule, except fragments of undissolved coating or capsule shell, remains on
the screen of the test apparatus or, if any other residue remains, it consists
of a soft mass having no palpably firm, unmoistened core. This test is
performed as pharmacopoeial standards. Disintegration is a measure of the
quality of the oral dosage form like tablets and capsule.
In this experiment, the tablet used is Mefa tablet which
is a non-steroidal anti inflammatory drug and the temperature of the water is
37°C
to mimic the temperature inside human body.
Materials
and apparatus
6 Mefa tablets
Basket rack assembly
Disc
Distilled water
Procedure
1. The apparatus needed
for disintegration was set up.
2. The temperature of
the water is at 37°C.
3. One mefa tablet was
introduced into each tube and then the disc is added.
4. When all six tablets
has been inserted, the operation is started and the time when the all the
tablets have fully disintegrate was taken.
5. If there’s any
tablets that failed to disintegrate, the test were repeated using new Mefa
tablets but the disintegration water was replaced with 0.1M HCl.
6. Mefa tablets comply
with the test if all 6 tablets disintegrate in the acidic medium.
Results
Mefa tablet (NSAIDs)
|
Time taken to fully disintegrate
|
All 6 tablets
|
5 minutes 16seconds
|
Discussion
Disintegration test is done by using the disintegration
apparatus. The tablets will be tested by using distilled water at 37°C.
This test is widely used to evaluate the quality of tablet and disintegration
capability of the formulation.
Mefa
tablet is a film-coated tablet. For disintegration test, the maximum time taken
for disintegration of tablet is 60minutes. Mefa tablet in the other hand has
disintegrate in 5minutes and 16seconds. Thus, Mefa tablet has succeeded this
test.
However,
the time taken does not really accurate once the patient consuming this tablet.
This is due to this experiment does not really imitate the real situation in a
human body. Some conditions need to be taken into account such as pH,
conditions of gastrointestinal tract and the motility of the tablets in
different parts of human body. The tablet will be fully disintegrated in human
body because this test is also used to reduce drug candidate thus saving time
and money.
Conclusion
All 6 tablets disintegrate completely in the
disintegration medium not more than 1 hour.The disintegration test is
succeeded.
Reference
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