1. Evaluation of tablet dosage form 4) Disintegration
Aram I. Ibrahim
University of sulaimani
College of pharmacy
Dep. Of pharmaceutics

2. Content Introduction Disintegration media
Factors affecting the disintegration time
APPARATUS
Limitations
Procedure

3. Introduction
Disintegration: is the time required for the tablet to break into particles.
The disintegration test is a measure of the time required under a given set of conditions for a group of tablets to disintegrate into particles.

4. Disintegration media Water. simulated gastric fluid (PH = 1.2 HCl)
Simulated intestinal fluid (PH = 7.5, KH2PO4 (phosphate buffer) + pencreatin enzyme +NaOH)

5. Factors affecting the disintegration time
1. Content : especially the quantity and quality of the disintegrant and lubricant, the lubricant increase the disintegration time by decreasing the wettability of the tablets due to its hydrophobicity.
2. Hardness: amount of binder , compression force.

6. APPARATUS
The apparatus consists of a basket­rack assembly, and a 1000­mL beaker.
A thermostatic arrangement for temperature regultion.
A device for raising and lowering the basket in the immersion fluid at a constant frequency rate between 29 and 32 cycles per minute through a distance of not less than 5.3 cm and not more than 5.7 cm.
The volume of the fluid in the vessel is such that at the highest point of the upward stroke the wire mesh remains at least 2.5 cm below the surface of the fluid and descends to not less than 2.5 cm from the bottom of the vessel on the downward stroke.

7. APPARATUS

8. Limitations USP BP Uncoated tablet Medium Temperature Time
Simulated gastric fluid 37
Not exceede 30 min BP
Water
Not exceede 15min

9. Procedure Uncoated Tablets
Place 1 tablet in each of the six tubes of the basket and operate the apparatus, using water maintained at 37 ± 2 as the immersion fluid.
At the end of the time limit specified, lift the basket from the fluid, and observe the tablets:
If 1 or 2 tablets fail to disintegrate completely, repeat the test on 12 additional tablets: not less than 16 of the total of 18 tablets tested disintegrate completely.

10. Procedure Coated Tablets
1. To remove or dissolve the coat, immerse the tablet in distilled water for 5min.
Put the tablet in the apparatus in water or HCL for 30min at 37oC (according to the U.S.P).
If one or two tablets fail to disintegrate, repeat on 12 tablets. So 16 tablets from the 18 must completely disintegrate within the time.
If two or more not disintegrated the batch is rejected.

11. Procedure Enteric coated Tablets
1. Put in distilled water for five minutes to dissolve the coat.
2. Then put in simulated gastric fluid (0.1M HCL) for one hour, if there is no sign of disintegration then for next step.
3. put it in simulated intestinal fluid for two hours.
If one or two tablets fail to disintegrate, repeat this test on another 12 tablets.
So 16 tablets from 18 should completely disintegrate.
If more than two fail to disintegrate the patch must be rejected.