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Friability is the percentage loss of a solid dosage form after 100 exposures in 4 minutes due to the fribilizer. A maximum loss of mass (derived from one test or the average of 3 tests) of not more than 1.0 percent is considered acceptable for most products.
Why is it important to test for a solid dosage form?
It is also called breaking strength of solid dosage form. This is important in transporting solid dosage forms such as tablets. Successful coating of the tablet also depends on the vulnerability of the tablet. Gentleness is important for coating, blistering and transportation stages.
How do we determine friability?
Use a drum, with an internal diameter of 283-291 mm and a depth of 36-40 mm, transparent synthetic polymer with a polished internal surface and subject to minimal static build-up. One side of the drum is removable. The tablets extend from the center of the drum to the outer wall by a curved projection with an inner radius of 75.5-85.5 mm at each bend of the drum. The outer diameter of the central ring is 24.5-25.5 mm. The drum is attached to the horizontal axis of a device which rotates at 25 ± 1 rpm. Thus, at each turn the tablets roll or slide and fall on the walls of the drum or on each other.
For tablets with a unit mass equal to or less than 650 mg, take a sample of the corresponding whole tablets as close as possible to 6.5 g. For tablets with a unit mass greater than 650 mg, take a sample of 10 whole tablets. Tablets are carefully cut before testing. Weigh the tablet sample accurately and place the tablets in the drum. Rotate the drum 100 times and remove the tablets. Remove any loose dust from the tablets as before and weigh accurately.
