Chrominfo: Disintegration test procedure for tablets and capsules

Learn the instrumentation and procedure of disintegration test for tablets and capsules dosage forms.

The disintegration test is a quality control test it is performed to evaluate solid dosage forms such as tablets (coated, uncoated, delayed-release enteric-coated), capsules (hard or soft), pessaries, and suppositories, etc. it is used to determine whether the sample is disintegrated within the prescribed time when placed in a liquid medium under the experimental conditions.

There are different quality control tests such as organoleptic, hardness, weight variation, friability, content uniformity, disintegration, and dissolution tests are carried out throughout manufacturing and verified after each batch is completed. They determine whether product quality requirements are met by conducting official or unofficial testing as specified in various pharmacopeias such as the USP, IP, and BP.

Disintegration test apparatus specifications:

The disintegration test apparatus includes a basket-rack assembly, a 1000 ml low-form beaker of 138 to 160 mm in height with an inside diameter of 97 to 115 mm for the immersion liquid, a thermostatic arrangement to maintain the fluid temperature between 35°C and 39°C, and a machine for raising and lowering the basket in the immersion liquid at a constant frequency rate of 29 to 32 cycles per minute.

The quantity of the liquid in the vessel is such that the wire mesh remains at least 15 mm below the surface of the fluid at the highest point of the upward stroke, and lowers to no less than 25 mm from the bottom of the vessel on the downward stroke. The top of the basket-rack assembly should never be submerged. An upward stroke takes the same amount of time as a downward stroke, and the change in stroke direction is a seamless transition rather than a rapid shift in motion. The basket-rack assembly travels vertically along its axis. There is no appreciable horizontal movement or motion of the axis from the vertical.

The disintegration test procedure for tablets and capsules:

Make sure the disintegration test apparatus is properly calibrated before performing the disintegration test procedure.

The disintegration test procedure for coated tablets:

Place one tablet in each tube, suspend the assembly in 0.1 M hydrochloric acid and run for 2 hours without the discs unless otherwise specified in the respective monograph. Remove the assembly from the immersion liquid.

None of the tablets show signs of cracking which allows the contents to escape or disintegrate other than fragments of the coating. Replace the 0.1 M hydrochloric acid with mixed phosphate buffer pH 6.8, add a disc to each tube and run the equipment for another 60 min. Remove the assembly from the immersion liquid. If the tablet fails to comply due to disc adherence, repeat the test on 6 more tablets without the disc.

The disintegration test procedure for uncoated tablets:

Put a sample of dosage unit in each of the six tubes in the basket, along with a disc if prescribed. Run the apparatus using water or a specified medium as the immersion fluid which is maintained at 370C. Lift the basket from the liquid at the end of the time limit stated in the monograph, and inspect the tablets: they have all completely disintegrated. If 1 or 2 tablets have not completely disintegrated, repeat the test on 12 additional tablets. If at least 16 of the total 18 tablets tested have disintegrated, then the criteria are met.

The disintegration test procedure for hard gelatin capsules:

Connect a detachable wire cloth to the surface of the upper plate of the basket-rack assembly, as described under basket-rack assembly that has a simple square weave with 1.8 to 2.2 mm mesh holes and a wire diameter of 0.60 to 0.655 mm. Inspect the capsules within the time limit specified in the individual monograph. All capsules have disintegrated except for fragments from the capsule shell. If 1 or 2 capsules fail to disintegrate completely, take another 12 capsules and repeat the test. Of the total 18 capsules tested, at least 16 capsules completely disintegrate.