Quality control test for tablets

Question 1

quality of tablet should fulfill 5 certain criteria

Answer 1

i. Dose of active ingredient
ii. Standardised release of active ingredient
iii. Sufficient mechanical strength
iv. Appearance of tablet
v. Packaging

Question 2

what are the Compendial tests

Answer 2

i. Uniformity of content
of active ingredient
(Uniformity of weight and
content)
ii. Disintegration test
iii. Dissolution test
iv. Friability test

Question 3

Non-compendial tests

Answer 3

i. Thickness
ii. Hardness

Question 4

tablet thickness test

Answer 4

Tablet thickness is important for tablet packaging; very thick tablets affect packaging either in blisters or plastic containers.

Factors that determine the thickness
i. Diameter of the tableting machine’s die
ii. Amount of fill allowed to enter the die
iii. Force applied during compression

Measurement of thickness
Tablet thickness should be controlled within a ± 5% variation of standard value.

Question 5

Tablet hardness test

Answer 5

Tablets should be sufficiently hard to resist breaking during normal handling, packaging and shipping, and yet soft enough to disintegrate properly after swallowing.
Hardness of the tablet is controlled by the degree of pressure
applied during the compression stage

• Measurement of hardness
  The test measures crushing strength which is defined as the compressional force applied diametrically to a tablet which just
  fractures it.

A force of about 4 kg is min.

Question 6

Uniformity of active ingredient

Answer 6

Traditionally, dose variation between tablets have been
tested in 2 separate tests:
i. Appendix XII C1: Uniformity of Weight
- i. Randomly select 20 tablets from a batch and weigh them
individually.
ii. Determine the average mass.
Not more than 2 of the individual mass should deviate from the
average weight.

ii. Appendix XII C3: Uniformity of Content

Not required if the uniformity of weight test has been
performed.
* Not required for multivitamin and trace-element preparations and in other justified and authorised circumstances according
to the BP.
-

Question 7

Disintegration is
a soft mass having no palpably firm core

Answer 7

This test is provided to determine whether tablets or capsules
disintegrate within the prescribed time when placed in a
liquid medium under experimental conditions.

Tablets must disintegrate in the time set in the individual monograph, usually 30 mins, but can vary from 2 mins (nitroglycerin sublingual tablets) to up to
4 hrs for buccal tablets

Question 8

disintegration test on enteric coated tablets
and effervescent tablets

Answer 8

Tablets are at first immersed in simulated gastric
fluid (0.1M HCl) for 2 hrs (according to BP) in the
disintegration apparatus.
No signs of disintegration, cracking or softening
must be observed to pass the test.

Question 9

disintegration test on Effervescent tablet

Answer 9

The tablets comply with the test if each of the six
tablets used disintegrated within 5 min or as justified.

Question 10

Factors affecting dissolution?
When dissolution test is prescribed, disintegration test may not
be required.

Answer 10

1. Particle size of drug substance.
2. Solubility and hydrophobicity of the formulation.
3. Type and amount of various component in the tablet
   (disintegrant, binder and lubricant).
4. Manufacturing method (compactness of the granulation and
   compression force used in tableting).

Question 11

Friability test

Answer 11

Friability is the tendency of the tablet to crumble. It
is important for the tablet to resist attrition.
Friability test subjects the tablets to a uniform tumbling
motion for a specified time and weight loss is measured.