ANSWER THE FOLLOWING QUESTIONS BRIEFLY:

1. What is complete disintegration?

A 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 disk, if used, is a soft mass having no palpably firm core.

2. What is the importance of performing disintegration tests?

Disintegration testing can save time and cost for QC departments in the
pharmaceutical industry due to its simplicity. It also provides critical safety data on
drug bioavailability in the body without having to utilize in vivo methods.

3. What are the different disintegration media used in this test? Give examples of
product that makes use of these disintegration media?
Distilled water – paracetamol, metronidazole
Simulated Gastric Fluid TS – calcium supplement products
Simulated Intestinal Fluid TS – dietary supplement products

4. Do capsules and enteric coated tablets have to undergo disintegration test?

Yes. Disintegration testing is typically performed on tablets, capsules and enteric
coated tablets. Because this testing accurately measures, under standard conditions,
the ability of a sample to break into smaller particles.