Friability Test Procedure Quiz

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Questions and Answers

Which test measures the tablet's resistance to abrasion?

Disintegration Test

Friability Test (correct)

Dissolution Test

Hardness Test

Which test evaluates the time it takes for a tablet to break down into smaller particles?

Uniformity of Dosage Unit Test

Thickness and Diameter Test

Disintegration Test (correct)

Weight Variation Test

Which test assesses the ability of a tablet to withstand mechanical shocks?

Dissolution Test

Friability Test (correct)

Appearance Test

Assay Test

Which test measures the force required to break a tablet?

Hardness Test Signup and view all the answers

Which test determines the amount of active ingredient in a tablet?

Assay Test Signup and view all the answers

Which test evaluates the tablet's ability to release the active ingredient over time?

Dissolution Test Signup and view all the answers

Which test is used to determine the weight variation among individual tablets in a sample?

Weight Variation Test Signup and view all the answers

According to the USP design, how many tablets must contain not less than 85% and not more than 115% of the labeled drug content?

9 of the 10 tablets Signup and view all the answers

In the USP design, if 1 tablet is outside 85-115% of claimed content but within 75-125%, how many additional tablets are assayed?

Another 20 tablets Signup and view all the answers

How many tablets must be outside the range of 85-115% for the USP design to require a repeat test on additional 20 tablets?

More than two tablets Signup and view all the answers

What is the maximum allowed RSD for the USP design after the repeat test on additional 20 tablets?

7% Signup and view all the answers

For coated and uncoated tablets containing less than 50 mg of an active ingredient comprising less than 50% of the weight of one dosage unit, how many tablets must contain labeled amount ± 15% according to the USP design?

9 of 10 Signup and view all the answers

If the RSD is greater than what percentage, the USP design requires another 20 tablets to be assayed?

6% Signup and view all the answers

What is the acceptable range for labeled drug content as per the USP design?

+/-15% Signup and view all the answers

In the USP design, how many tablets may not fall outside of the 85 to 115% range after the remaining 20 tablets are assayed?

All 20 tablets Signup and view all the answers

For tablets containing less than 50 mg of an active ingredient comprising less than 50% of the weight of one dosage unit, what is the maximum allowed RSD as per the USP design?

<7.5% Signup and view all the answers

What is the main purpose of scoring tablets?

To make smaller doses Signup and view all the answers

What is the primary factor that determines tablet stability during manufacturing, packaging, and shipping?

Tablet hardness Signup and view all the answers

Which method of granulation generally results in harder tablets?

Wet granulation Signup and view all the answers

What could decrease tablet strength despite improving tablet flow?

Lubricants Signup and view all the answers

What is the primary purpose of adding lubricants to tablets?

To improve tablet flow Signup and view all the answers

Which type of tablets has the highest hardness?

Sustained-release tablets Signup and view all the answers

How is the tendency of tablets to crumble or break evaluated?

Using a friabilator Signup and view all the answers

What is the purpose of friability testing for tablets?

To test the tablets' resistance to abrasion and shock Signup and view all the answers

What is the maximum percentage loss allowed in friability testing for tablets?

1% Signup and view all the answers

Which type of tablets may require special packaging due to their high friability?

Effervescent tablets Signup and view all the answers

What does the shipping test method evaluate for tablets?

Ability to withstand transportation and handling Signup and view all the answers

What do weight and content uniformity tests indicate for tablets?

Consistency of active ingredients and tablet weight Signup and view all the answers

What fluid is used for testing weight uniformity in compressed uncoated tablets?

Water at 37°C Signup and view all the answers

What is the maximum limit set by USP for content uniformity variation in tablets?

5% Signup and view all the answers

Study Notes

Friability testing of tablets is conducted using a plastic chamber that revolves at 25 rpm, causing tablets to experience abrasion and shock
After 4 minutes, the tablets are weighed to determine percentage loss, or friability, which must be less than or equal to 1%
Friability testing applies to most tablets, but some chewable and effervescent tablets require special packaging due to their high friability
A shipping test method is used to evaluate a product's ability to withstand transportation and handling
Official standards, such as the British Pharmacopoeia (B.P.) and US Pharmacopoeia (USP), provide tests and specifications for tablets
A tablet's uniformity of dosage form is tested through weight and content uniformity, which indicate the consistency of active ingredients and tablet weight for a given batch
For compressed uncoated tablets, testing fluid is water at 37°C, while coated tablets and some others require longer test times
Tests for weight and content uniformity involve weighing and comparing individual tablets, and the USP sets a limit of 5% for content uniformity variation
British Pharmacopoeia test design for weight uniformity requires that none of the 20 tablets deviate from the average weight by more than double the % deviation, and no more than two tablets can deviate by more than the % deviation.

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Description

Test your knowledge of the friability test procedure for tablets, which evaluates their ability to withstand wear and abrasion. Understand the steps involved in conducting the test, including the rotation speed, dropping distance, and acceptance criteria for percentage weight loss.