Tablet friability test apparatus is used to determine the durability of tablets throughout the manufacturing process. It is designed to calculate the precise rate of abrasion and impact hardness of the tablets.
Friability is a quality control test for tablet dosage forms that adhere to official standards defined in pharmacopeias (USP/EP) including standard ranges. It is a technique employed to determine the physical strength (% loss) of uncoated and compressed tablets when exposed to mechanical shock and attrition. Friability is significant in the pharmaceutical field as it affects granule particle size distribution, which affecting tablet compressibility, weight variation of the tablet, and granule flowability.
Working principle of USP friability test apparatus:
The apparatus consists of a plastic chamber attached to a horizontal axis to placing the tablet sample. The drum is prepared of a clear synthetic polymer with a polished internal surface and has an interior diameter of 283 to 291 mm and a depth of 36 to 40 mm. For 4 minutes or 100 revolutions, a batch of pre-weighed tablets is placed in a plastic container that rotates at 24-25 rpm. If one tablet weighs less than 650 mg, approximately 6.5 g of total weight has to be taken, and if the tablet weighs more than 650 mg, 10 tablets have to be taken.
Tablets are subject to the combined effects of shock and abrasion. Samples are dropped at a distance of 6 inches on each round. A curving projection extending from the middle of the drum to the outer wall tumbles the tablets with each rotation of the drum. It has an interior radius of 75.5 to 85.5 mm. If the shape or size of the tablet becomes irregular, adjust the drum so that the base of the base makes a 10-degree angle with the bench top and the tablet falls freely when the drum is rotated.
The friability test apparatus should comply with USP, EP, and other pharmacopeias. The manufacturer should provide the Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and design qualification (DQ) as per the requirement. It also requires regular maintenance and calibration.
The measurement of friability loss is generally expressed as a % loss in weight. It is calculated from the formula/equation: Friability Loss % = Initial Weight - Final Weight/ Initial Weight X 100.
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