EXPERIMENT 15

DISINTEGRATION TEST

Disintegration test is provided to determine whether tablets or capsules

disintegrate within the prescribed time when placed in a liquid medium at the required

experimental conditions. The specification of this test depends on the type of tablets

and capsules, that is, troches, chewable tablet and extended-release or delayed-release

tablets or capsules.

Complete disintegration is not complete solution. Complete disintegration is

defined as “in which any residue of the samples remaining on the screen of the test

apparatus or adhering to the lower surface of the disk (if used), is a s soft mass having

no palpably firm core”.

Figure 11. Disintegration Tester

OBJECTIVE :To be able to determine the compliance of the disintegration time, as per

the requirements of the sample product.

APPARATUS / GLASSWARE :Disintegration Tester

MATERIALS / SAMPLES :6 tablets 6 capsules

PROCEDURE:

A. Uncoated Tablets & Plain Coated Tablets

1. Place 1 tablet in each of the six tubes of the basket, if specified, add a

disk, and operate the apparatus, using water maintained at 37⁰C+ 2⁰C as

the immersion fluid unless otherwise other medium is specified.

2. Turn on the drive and set the timer on.

3. Lift the basket from the fluid, stop the drive and timer, observe the tablets,

if complete disintegration is observed, record the disintegration time.

4. If 1 or 2 tablets fail to disintegrate completely after the prescribed time,

repeat the test on 12 additional tablets.

5. After the 12 additional tablets, not less than 16 of the 18 tablets tested

should disintegrate completely.

B. Hard Gelatin Capsules and Soft Gelatin Capsules

1. Place 1 capsule in each of the six tubes of the basket, if specified, add a

disk, and operate the apparatus, using water maintained at 37⁰C+ 2⁰C as

the immersion fluid unless otherwise other medium is specified.

2. Attach a removable wire cloth. The wire cloth must have a palin square

weave with 1.8 to 2.2 mm mesh s hole opening and with a wire diameter

of 0.60 to 0.655 mm, to the surface of the upper portion of the basket –

rack assembly.

3. Turn on the drive and set the timer on.

4. Lift the basket from the fluid, stop the drive and timer, and observe the

capsule. If complete disintegration is observe, record the disintegration

time.

5. If 1 or 2 capsules fail to disintegrate completely after the prescribed time,

repeat the test on 12 additional capsules.

6. After the 12 additional capsules, not less than 16 of the 18 capsules tested

should disintegrate completely.

C. Delayed-Release (Enteric-coated) Tablets

1. Place 1 tablet in each of the six tubes of the basket.

2. Turn on the apparatus using simulated gastric fluid TS maintained at 37 ±

2⁰ as the immersion fluid, and set the timer on.

3. After 1 hour the process in the simulated gastric fluid TS, lift the basket

from the fluid, and observe the tablets. The tablets must show no evidence

of disintegration, cracking or softening.

4. Change the immersion fluid, using simulated intestinal fluid TS maintained

at 37 ± 2⁰.

5. Turn on the drive and set the timer on.

6. Lift the basket from the fluid, stop the drive and timer, and observe the tablets.

If complete disintegration is observed, record the disintegration time.

7. If 1 or 2 tablets fail to disintegrate completely after the prescribed time,

repeat the test on 12 additional tablets.

8. After the 12 additional tablets, not less than 16 of the 18 tablets tested

must disintegrate completely.

WORKSHEET

Name : Date:

Group no.: Score:

EXPERIMENT 15

DISINTEGRATION TEST

A. Uncoated Tablets & Plain Coated Tablets

Sample Product Name:

Disintegration Time:

Remarks:

DATA AND RESULT:

B. Hard Gelatin Capsules and Soft Gelatin Capsules

Sample Product Name:

Disintegration Time:

Remarks:

C. Delayed-Release (Enteric-coated) Tablets

Sample Product Name:

Disintegration Time:
Remarks:

QUESTIONS:

1. How is Simulated gastric fluid TS prepared?

2. How is Simulated intestinal fluid TS prepared?

3. What is the purpose of enteric coated tablets?

4. What is the importance of the disintegration test?