Reference: BP/Ph. Eur
Friability is determined on compressed, uncoated tablets.
Apparatus:
A drum, with an internal diameter between 283 - 291 mm and a depth between 36- 40 mm, of transparent synthetic polymer with polished internal surfaces, and subject to minimum static build-up One side of the drum is removable. The tablets are tumbled at each turn of the drum by a curved projection with an inside radius between 75.5 - 85.5 mm that extends from the middle of the drum to the outer wall.
The outer diameter of the central ring is between 24.5 - 25.5 mm. The drum is attached to the horizontal axis of a device that rotates at 251 rpm. Thus, at each turn the tablets roll or slide and fall onto the drum wall or onto each other.
Procedure:
Weigh tablets with a unit mass equal to or less than 650 mg, and take a sample of whole tablets corresponding as near as possible to 6.5 g. For tablets with a unit mass of more than 650 mg, take a sample of 10 whole tablets. Dedust the tablets carefully before testing. Accurately weigh the tablet sample, 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 accurately weigh.
If obviously cracked or broken tablets are present in the tablet sample after tumbling, the Sample fails the test. If the results are difficult to interpret or if the weight loss is greater than the targeted value, repeat the test twice and take the mean of the 3 tests determined. A maximum loss or mass (obtained from a single test or from the mean of 3 tests) not greater than 1.0 percent is considered acceptable for most products.
Tablet size or shape causes irregular tumbling, adjust the drum base so that the base forms an angle of about 10 with the horizontal and the tablets no longer binding together when lying next to each other which prevents them from falling freely.
Revision History
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