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Test Specification and Calibration for Tablet Friability

What Does a Tablet Friability Test Measure?

Friability is a test used to determine how much weight is lost during transit and is defined as the proportion of powder lost from the surface of tablets owing to mechanical action.

In addition to physical measurements, such as hardness, it is a test for compressed or uncoated tablets (Tablet Breaking Force).

Since some formulations, when crushed into rugged tablets, tend to “cap” or lose their crown parts on attrition, measuring the hardness of a tablet is not a good indicator of tablet strength. These pills frequently powder, chip, and fragment.

As a result of the tablets’ propensity for abrasion during the friability test, we can assess their resistance to force in various ways.

They ruin aspects of manufacturing like coating and packaging in addition to lacking style and market approval.

Who will conduct the Friability Test?

  • Production
  • Quality Control
  • Quality Assurance (IPQA)

Friability Drum Requirements:

It is also acceptable to use an apparatus with more than one drum or a drum with two scooping projections to run numerous samples simultaneously.

How to Conduct a Friability Test?

Take a sample of the whole pill comparable to as close to 6.5 g for tablets with a unit weight of 650 mg or less.

Take a sample of 10 complete tablets when the unit weight of the tablet is more significant than 650 mg.

Tablets need to be dusted off both before and after the test.

Calculation :

Friability (%)  =W1 – W2/ W1  X 100

Where,
W1 = Weight of Tablets (Initial / Before Tumbling) &
W2 = Weight of Tablets (After Tumbling or friability)

  Limit : Friability (%) = Not More Than 1.0 %

Conclusion:

A single run of the test is typical.

The tablet sample fails the test if cracked, split, or broken tablets are found after tumbling.

The test is done twice, and the mean of the three tests is determined if the results are challenging to interpret or if the weight loss exceeds the desired value (NMT 1.0%). A maximum mass loss of NMT 1.0% (obtained from a single test or from the mean of three trials) is regarded as acceptable for most items.

If the size or shape of the tablet produces intermittent tumbling, why it occurs, and what to do about it:

When placed adjacent, tablets bond, preventing them from falling freely.

A 10° angle should be formed between the base of the drum and the horizontal surface once you have adjusted it.

Hygroscopic tablets need to be tested in a humidity-controlled environment.

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