PURPOSE To determine whether tablet or capsule disintegrate with in prescribed time

Complete disintegration is defined as that state in which any residue of the unit ,except fragment of insoluble coating or capsule shell,remaining on the screen of the test apparatus or adhering to the lower surface of the disc ,if used,is a soft mass having no palpably firm core.

BASKET RACK ASSEMBLY LOW FORM BEAKER RESERVIOR THERNOSTATIC ARRANGEMENT A LEVER DISC

TYPE A TYPE B

PROCEDURE
Place one dosage unit in each tube Add a disc Maintain temp at 372 c At the end of specified time,lift the basket al of dosage unit have disintegrated completely.

BASKET RACK ASSEMBLY: Consist of 6 tubes LENGTH : 77.52.5mm DIAMETER: 21.851.15mm THICKNESS OF WALL OF TUBE: 1.90.9mm Tubes are held between 2 plates in vertical position DIAMETER OF TEUB:902

thickness of plate:6.751.75mm HOLE:6 holes in plate Diameter of hole: 242mm Stainless steel wire cloth with 2.0o.2mm mesh aperture Diameter of wire:0.6150.045mm

CAPACITY:1 Lit Height:14911mm Inside diameter:1069mm

35 to39c

LEVER: Frequency rate:29 to 32 cycle/min VOLUME OF FLUID: 15mm below the surface of fluid at highest point on upward stroke. Descend to not less than 25mm from bottom of vessel on downward stroke.

Diameter of disc:20.70.15 Thickness:9.50.15 5 holes in disc One hole is centered and other 4 are parallel to each other.

If 1 or 2 dosage unit fails,repeat the test on 12 additional tablets. The requirement of the test is met if not less than16 of the 18 units have disintegrated.

1.

UNCOATED TABLETS ,PLAN COATED TABLETS AND SUBLINGUAL TABLETS ; Place 1 tablet in each tube Temperature 372 C At the end of 30 minutes ,all the tablets disintegrate compeletly . If 1 or 2 tablet fails to disintegrate then repeat on 12 additional tablets ;not fewer than 16 of total 18 tablet tested disintegrate completely In case of plain coated tablet ,immerse the basket in water at room temperature for 5 min . Same test procedure for sublingual tablets.

2 :DELAYED RELEASE (ENTERIC COATED ) TABLETS: Place 1 tablet in each tube ,immerse the basket in water at room temp. if tablet has soluble external sugar coating. Simulated gastric fluid TS maintained at 372 C as immersion fluid. After 1 hour ,tablet show no evidence of disintegration ,cracking or softening. Simulated intestinal fluid TS ,maintained at 372 C All the tablets disintegrate completely. Specification should be followed.

3 : BUCCAL TABLETS: apply the tablets for uncoated tablets. After 4hour,all the tablets disintegrate completely. Specification should be followed.

4: CAPSULE 9HARD SHELL CAPSULE AND SOFT SHELL CAPSULE) : Apply test for uncoated tablets Temperature 372 C 0.05 M acetate buffer Attach a removable wire cloth ,to the surface of the upper plate At the end of 30 min. all the capsules disintegrate except fragments of capsule shell. Specification should be followed.

TYPE OF TABLETS
soluble tablet Effervescent tablet Film coated tablet Uncoated tablet Sugar coated tablet Enteric coated tablet

DISINTEGRATION TIME
3 min 5 min 30 min 15 min 1 hour 2-3 hour