EXP 9 (POST-LAB)

Question 1

is defined as the state in which any residue of the unit except for the fragments of the insoluble coating or capsule shell remaining on the screen of the test apparatus is a soft mass having no palpably firm core

Answer 1

DISINTEGRATION

Question 2

This test is performed to provide whether tablets or capsules disintegrate within the prescribed time when placed in a liquid medium at experimental conditions

Answer 2

Disintegration Testing

Question 3

DISINTEGRATION APPARATUS PARTS:

Answer 3

1. BEAKER
2. THERMOSTATIC DEVICE
3. DEVICE
4. VESSEL
5. BASKET RACK ASSEMBLY

Question 4

BEAKER DIMENSIONS:

Answer 4

1000mL; 138-160mm in height

Question 5

Part used for heating the fluid

Answer 5

Thermostatic device

Question 6

Part used for raising and lowering the basket

Answer 6

Device

Question 7

Part that contains the fluid to be heated

Answer 7

Vessel

Question 8

Part that contains the sample to be tested

Answer 8

Basket-rack assembly

Question 9

These are substances or agents added to compressed tablets to cause them to “break
apart” or disintegrate, when place in aqueous medium.

Answer 9

Disintegrants

Question 10

DISINTEGRANTS EXAMPLES:

Answer 10

1. Starch
2. Clays
3. Cellulose derivatives

Question 11

Tests:
A. Uncoated tablets and Plain Tablets
Temperature:
Fluid:
Result:

Answer 11

37+/-2C
Water or specified immersion fluid
All of the tablets disintegrate completely, if 1 or 2 tablets fail to disintegrate, repeat the test on 12 addition tablets.

Question 12

Tests:
B. Delayed-Release tablets
Temperature:
Fluid:
Result:

Answer 12

37 +/- 2C
Gastric fluid TS and Intestinal Fluid TS
1. GF TS: After 1 hr, observe. The tablet should
not disintegrate
2. IF TS: all of the tablets should disintegrate
completely.

Question 13

Tests:
C. Buccal tablets
Procedure is same as uncoated tablets. The only difference is the

Answer 13

time of observance.

Question 14

Tests:
D. Sublingual tablets
Procedure is same as uncoated tablets. The only difference is the

Answer 14

Result. At the time limit specified in the individual monograph, all tablets have disintegrated.

Question 15

Tests:
E. Hard Gelatin Capsule and Soft Gelatin
Capsules:
* Same as uncoated tablets.
Difference:

Answer 15

attachment of a removable wire
cloth, which has a plain square weave to the surface of the upper plate of the basket-rack assembly

Question 16

Uncoated Tablets:
Medium:
Time:

Answer 16

Water, 37degreesC+/-degreesC
30mins

Question 17

Buccal Tablets
Medium:
Time:

Answer 17

Water, 37degreesC+/-degreesC
4 hrs

Question 18

Sublingual Tablets
Medium:
Time:

Answer 18

Water, 37degreesC+/-degreesC
3 mins

Question 19

Enteric Coated Tablets
Medium:
Time:

Answer 19

Water, Room temp
Simulated Gastric Fluid, 37°C ± 2°
Simulated Intestinal Fluid, 37°C ± 2°

1 hour

Question 20

How many samples are there in stage 1

Answer 20

6 tablets

Question 21

Criteria for Stage 1

Answer 21

All should disintegrate; if two tablets did not disintegrate proceed to stage 2

Question 22

How many samples should be used in stage 2

Answer 22

additional 12 tablets; totalling to 18 tablets

Question 23

Criteria for Stage 2

Answer 23

nmt 2 of the 18 tablets tested failed to disintegrate