Disintegration

Disintegration is a state in which no residues except fragments of un-dissolved coating remain on the screen of test apparatus. If any residue left, it must consists of soft mass having no palpably firm un-moistened core.

 Purpose:

This is the test that is used to check whether your dosage form will disintegrate within the prescribed time when placed in liquid under prescribed experimental conditions.

Components:

1.      Beaker

2.      Thermostat

3.      Lever

4.      Basket/ Rack assembly

5.      Disk

Beaker:

It is 1 litter low form beaker for immersion fluid.

Thermostat:

There is an arrangement in the apparatus for heating the fluid to 35-39 Celsius. It is called thermostat.

Lever:

It is the device for lowering and elevating the basket rack assembly in the emersion fluid at constant frequency of 29-32 cycles per minutes through a distance of 55mm. The volume of the immersion fluid is such that at upward stroke the mesh of basket rack is 15 ±2 mm and at the downward stroke the mesh of the basket track assembly should be 25 mm above the bottom of the vessel. The time required for upward stroke is equal to time required for the downward stroke and there is no abrupt reversal of motion.  

Basket rack assembly:

It consists of six open enabled, transparent tubes. These are held in vertical position by two plates, each plate have six holes on the plate at upper side of the tube and second is at the lower side of the tube. The parts if the basket rack assembly is assembled together by two boards passing through these plates. There is a stainless steel cloth below the lower plate with mesh side 2± 1.8, 2.2 mm. The design of basket rack assembly can be varied can be changed, if dimension of mesh and tubes held constant.

Disk:

Six slatted and perforated disks with 5 holes can be used in the apparatus. It is permitted in the individual monograph. The disk is made of suitable transparent plastic material having specific gravity between 1.18 to 1.2.

Procedure:

Uncoated tablets:

Place one tablet in each of the 6 tubes of basket rack assembly using a disk if permitted in the monograph. Operate the apparatus using water specified medium as the immersion fluid at T of 37 ±2 Celsius. At the end of time in the monograph lift the basket from immersion fluid and observe tablets. All the tablets should be disintegrated. If 1 or 2 tablets fail to disintegrate repeat the procedure on addition of 12 tablets. Not less than 16 out of 18 tablets should be disintegrated.

Plane coated tablets:

Apply the test for the monocoated tablets by operating the apparatus for the specified time for the individual monograph. You will have to do the same procedure given above but the time for the monocoated tablets will be different.

Enteric coated tablets:

Place one tablet in each of the 6 tubes. If the tablet has the soluble external coating then immense the tablets at room temperature in water for 5 minutes then operate the apparatus using the stimulated gastric fluid as the immersion fluid for one hour. After one hour lift the plate from the basket and see if there are any signs of the softening. There must be no softening then operate the procedure again for with the stimulated intestinal fluid environment for the specific time as specified in the monograph for one hour. All the tablets should have disintegrated. At the end of time in the monograph lift the basket from immersion fluid and observe tablets. All the tablets should be disintegrated. If 1 or 2 tablets fail to disintegrate repeat the procedure on addition of 12 tablets. Not less than 16 out of 18 tablets should be disintegrated.

Buckle tablets:

Apply the test for the uncoated tablets and after four hours lift the basket from the immersion fluid and observe disintegration. At the end of time in the monograph lift the basket from immersion fluid and observe tablets. All the tablets should be disintegrated. If 1 or 2 tablets fail to disintegrate repeat the procedure on addition of 12 tablets. Not less than 16 out of 18 tablets should be disintegrated.

Sublingual tablets:

Apply the test for the uncoated tablets. After the specified time lift the basket from the immersion fluid. At the end of time in the monograph lift the basket from immersion fluid and observe tablets. All the tablets should be disintegrated. If 1 or 2 tablets fail to disintegrate repeat the procedure on addition of 12 tablets. Not less than 16 out of 18 tablets should be disintegrated.

Gelatin capsule:

Place one capsule in each of 6 tubes. Place stainless steel woven cloth at the upper side of the plate and operate the apparatus. After the time specified in the individual monograph lift the basket and observe the capsules. All of the capsules have disintegrated. At the end of time in the monograph lift the basket from immersion fluid and observe tablets. If 1 or 2 capsules fail to disintegrate repeat the procedure on addition of 12 capsules. Not less than 16 out of 18 capsules should be disintegrated.

Types of tablets	Disintegration time
Soluble tablets	3 minutes
Effervescence tablets	5 minutes
Uncoated tablets	15 minutes
Film coated tablets	30 minutes
Sugar coated tablets	60 minutes
Enteric coated tablets	2 to 3 hours