Disintegration Test

 

Disintegration Test

Disintegration

¨  Disintegration test is a physical test performed to determine that whether Tablets, Capsule and granules are broken in small particles in a liquid medium within the prescribed time and conditions.

¨  Disintegration doesn’t need complete dissolution of the given units or the active ingredients.

¨  With the help of disintegration we came to know that tablets, capsules and granules turns into small particles due to which the surface area is increased and the drug is more  available for the body.

¨  In disintegration we observe the behavior of the test samples that is it completely converts to small particles except the insoluble coating material and capsules shells.

Disintegration Apparatus and its Operation

¨  The apparatus used for disintegration test is called Disintegration apparatus and consist of basket rack assembly.

¨  A 1000ml beaker having height of 138- 160mm and diameter of 97-115mm is used for the immersion fluid.

¨  Temperature should be maintained in between 35◦C to 39◦C

¨  A device used for lowering and raising of the basket-rack in the immersion fluid.

¨  The frequency of upward and downward movement should be 29 to 32cyles/minute.

¨  During upward stroke the wire mesh should remain 15mm below the surface of the fluid.

¨  During downward stroke the assembly should descend NLT 25 mm from the bottom of the beaker.

¨  The basket-rack assembly must move vertically in smooth condition along the axis.

Basket-rack Assembly

¨  Basket-rack assembly consist of 6 transparent glass tubes open at both ends.

¨  Length of tubes is from 75 to 80mm and its diameter is 20.7 to 23mm. The thickness if the walls is 1 to 2.8mm.

¨  Two plates having diameter 88 to 92 mm holding the tubes in vertical direction.

¨  The plates have 6 holes having diameter of 22 to 26mm and are equally distanced from the centre.

¨  A stainless steel wire mesh having 1.8 to 2.2 mm aperture is attached at the under surface of the lower plate.

¨  DISC

¨  Discs are used when given in any individual monograph for the unit to be tested.

Procedure

¨  Unless otherwise given in an individual monograph place one tablet or capsule in each tube.

¨  Suspend the assembly in the beaker containing the prescribed liquid and operate for the specified time.

¨  If all the tablets or capsule disintegrate the test is considered to be passed.

¨  If 1 or 2 tablets or capsules didn’t disintegrate carry out the test on further 12 tablets or capsule.

¨  The test is considered to be passed if 16 out of 18 tablets or capsule completely disintegrate in the specified time.

Disintegration time for Different Dosage forms

Dosage form	Specified Disintegration Time
Uncoated Tablets	15  minutes
Soluble Tablets and Dispersible Tablets	03 minutes
Effervescent Tablets	05 minutes
Buccal Tablets	04 hours
Sublingual tablets	Time Specified in individual monograph
Film Coated Tablets	30 minutes
Other Coated Tablets	60 minutes
Enteric Coated Tablets	0.1 M HCl 2 hours, no cracking, softening or disintegration. Buffer Stage: 60 minutes or as given individual monograph

 

Hard and Soft Capsules	60 minutes or as given individual monograph
Delayed Release Capsules	0.1 M HCl 2 hours, no cracking, softening or disintegration. Buffer Stage: 60 minutes or as given individual monograph