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Tablet Friability Test Specification

What is the purpose of the Friability test?
The Friability test is a technique used by the pharmaceutical industry to test the durability of tablets during transit. It involves repeatedly dropping a sample of tablets over a fixed time, using a rotating wheel with a baffle.


What is the Friability Test of Tablet?
  • Friability is defined as the percentage weight loss of powder from the tablets due to mechanical action and the test is performed to measure the weight loss during transportation. It is a supplement test for Uncoated Tablets.

How do you measure the friability of a tablet?
  • For determination of friability, 0.65 grams of tablets are taken. If the average weight of tablets is more than 0.65 grams, then 10 tablets are taken. Initially, the weight of the tablets is determined, then they are tumbled in a Friabilator for 4 minutes at 100 rpm.

How do you calculate friability?
  • The tablets should be de-dusted prior to weighing. The tablets are then placed into the Friabilator and allowed to rotate 100rpm. The tablets are then re-weighed (W2) having first removed any accumulated dust and the results are calculated in terms of % weight loss utilizing the formula

Who will perform Friability Test?
Quality Assurance (IPQA) 
Quality Control
Production

Friability Drum Specification:
Drum internal diameter: between 283 and 291mm Drum depth: between 36 and 40 mm
Material of construction: Transparent synthetic polymer with polished internal surfaces, and subject to minimum static build-up. One side of the drum is removable. 


The drum's inside radius: Between 75.5 and 85.5 mm which extends from the middle of the drum to the outer wall.
The outer diameter of the central ring: Between 24.5 and 25.5 mm. 

  • 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. 

What is the limit for the friability of tablets?
  • 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 difficult to interpret 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 NMT 1.0% is considered acceptable for most products.

Note that for Effervescent tablets and chewable tablets the friability limits may differ.

In case Tablet Size or Shape causes Irregular Tumbling & why it happens & What to do:
  • Tablets bind together when lying next to each other, which prevents them from falling freely.
  • Adjust the drum base in such a way that the base forms an angle of about 10° with the horizontal surface.
  • In the case of Hygroscopic Tablets, A humidity-controlled environment is required for testing.

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