What is Disintegration Test
It is the time required for the Tablet / Capsule to break into particles, the disintegration test is a measure of the time required under a given set of conditions (Temperature) for a group of tablets/capsules to disintegrate into particles.
Cycle of shaft holding the tube basket
limit is 29-32 cycles per minutes and distance covered by shaft basket is 50-60
mm and beaker temperature is 35 to 39 º C.
Disintegration is to be Performed to
determine whether tablets or capsules disintegrate within the prescribed time
when placed in a liquid medium at the experimental conditions.
3. What are the Disintegration Time of
tablets :
- Uncoated Tablet 15 min as per BP
- Uncoated Tablet 30 min as per USP
- Sugar Coated Tablet 60 min as per
BP
- Film Coated Tablet 30 min as per
BP
- Plain Coated Tablets DT in
specific medium for 30 min as per USP
- Enteric Coated Tablets DT
in simulated gastric fluid (0.1 M HCl) for 1 hr and then in
simulated intestinal fluid (Phosphate buffer 6.8 pH) until disintegrate as
per USP.
- Dispersible Tablets 3 min ( 15-
25º C ) as per BP.
- Effervescent Tablets 1 tablet in
200 mL water for 5 min ( 15- 25º C )
- as per BP
- Buccal Tablets 4 hrs as per USP.
- Soluble Tablets 3 min ( 15- 25º C
) as per BP.
- Chewable Tablets are not require
to comply with test
4. What are the Disintegration Time of capsules:
- Gastro resistant capsule DT
2 hrs without disk in 0.1 M HCl and phosphate buffer pH 6.8 for
further 60 min as per BP.
- Hard and Soft gelatin
capsule DT 30 min as per BP & USP.
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