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Tablet Friability Test Calibration and Specification

Friability test is the detachment of percentage of powder or powder loss from the outer surface of tablets during mechanical and physically handling during transport. Friability test mainly performed on uncoated tablets.

The alternate parallel, hardness, is also tested to know the strength of tablets which is more important for drugs to withstand throw-out its lifecycle. However, hardness is not only a parameter for tablet strength. Sometimes compressed tablets may lose their crown portion or cap on attrition.

So it is vital to do a friability test to know the percentage of loss powder, which is calculated by the formula. As per the formula, the limits of the friability test shall not be more than 1.0%.

Friability apparatus specifications:

Friability test apparatus diameters

Friability apparatus (MOC) is a rounded shape drum made of a transparent synthetic polymer with a smooth internal surface. It is Specially designed to minimize static charge. The apparatus comes with a single drum or two drums that are horizontally attached to the axis of the apparatus. The Roche friability apparatus is commonly used for the friability procedure.

It complies with USP <1216>, EP<2.9.7>, and other pharmacopeias.

Friability apparatus diameter as per Pharmacopeias:

  • Internal diameters: 283.0 to 291.0 mm ( 287.0 ±4.0mm)
  • Depth: 36.0 to 40.0 mm ( 38.0±2.0mm )
  • Outer diameters: outer diameter of central ring 24.5 to 25.5 mm ( 25.0±0.5mm )
  • Drop height of friability apparatus is around 6 inches or 156±2.0mm
  • Friability apparatus revolution/ minutes = 24 – 26 (25 ± 1)
  • Total Revolution / Test= 100 Revolutions / 4 Minutes

Responsible person to perform test:

  • Production officer/ executive
  • IPQA officer
  • Quality control officer

Friability test procedure:

  1. Collect an equal amount of tablets from both sides of the chute and affix label on it. Take the tablet’s weight equal to or less than 6.5 g if the unit weight is equal to or less than 650 mg.
  2. If tablets having a unit weight of more than 650 mg, then collect ten tablets as a whole sample.
  3. Check calibration status before starting the operation.
  4. Dedust all tablets and note down the weight put the required quantity of tablets into the drum.
  5. Set all parameters (revolution time ) and start the test.
  6. After completion, dedust the whole tablets and weight again.
  7. Now apply the formula to calculate the friability.
  8. If the result falls out of the accepted limits, repeat the test 3 times and calculate its means.

Note: Proper dedusting of tablets to be done before and after the test to avoid problems.

If the shape or size of an uncoated tablet is causing Tambling to be irregular, the friability drum can shift at 10º.

The formula for friability test use in tablets:

friability formula

w1= Initial weight of tablets or weight before a test.

w2= Final weight of tablets or weight after the test.

Friability Limits: According to USP, IP and BP, It should be Not more than 1.0%

calibration of friability test apparatus:

calibration of friability apparatus

Conclusion:

While using the friability apparatus, We can quickly determine the powder loss from the uncoated tablets’ core surface. Friability tests are beneficial to maintain the quality of solid oral dosage forms (tablets) and further stability during their next processing steps.

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