FRIBILITY TEST AND APPARATUS

The strength of a tablet plays a very important role in its marketing and dissolution. The mechanical strength of tablet or granules can be determined by its hardness and through friability test.

Measuring the hardness of a tablet is not a reliable indicator for tablet strength as some formulations when compressed into very hard tablets tend to 'cap' or lose their crown portions on attrition. Such tablets tend to powder, chip and fragment. They not only lack elegance and consumer acceptance but also spoil the areas of manufacturing such as coating and packaging. In friability test the tablets are prone to abrasion hence enabling us to check for the tablet strength under application of force in different manner. The friabilator is used for fribility test. most commonly used fribilator is Roche Fribilator.

FRIBILATOR APPARATUS r

Use a drum,^* with an internal diameter between 283 and 291 mm and a depth between 36 and 40 mm, of transparent synthetic polymer with polished internal surfaces, and not subject to static build-up (see figure for a typical apparatus). 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 and 85.5 mm that extends from the middle of the drum to the outer wall. The drum is attached to the horizontal axis of a device that rotates at 25 ±1 rpm. Thus, at each turn the tablets roll or slide and fall onto the drum wall or onto each other.

For tablets with a unit mass equal to or less than 650 mg, take a sample of whole tablets corresponding to 6.5 g. For tablets with a unit mass of more than 650 mg, take a sample of 10 whole tablets. The tablets should be carefully dedusted prior to 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.

Generally, the test is run once. If obviously cracked, cleaved, or broken tablets are present in the tablet sample after tumbling, the sample fails the test. If the results are doubtful or if the weight loss is greater than the targeted value, the test should be repeated twice and the mean of the three tests determined. A maximum mean weight loss from the three samples of not more than 1.0% is considered acceptable for most products.

If tablet size or shape causes irregular tumbling, adjust the drum base so that the base forms an angle of about 10 with the bench top and the tablets no longer bind together when lying next to each other, which prevents them from falling freely.

Effervescent tablets and chewable tablets may have different specifications as far as friability is concerned. In the case of hygroscopic tablets, an appropriate humidity-controlled environment is required for testing.

Drums with dual scooping projections, or an apparatus with more than one drum, for the running of multiple samples at one time, are also permitted.