The Friability Test measures the ability of tablets to withstand abrasion and resistance to breaking or wearing away.
Test Objective:
To determine the friability of uncoated or coated tablets.
Test Apparatus:
1. Friability Test Apparatus (e.g., Roche Friabilator)
2. Abrasion Test Apparatus (e.g., Abrasion Tester)
Test Procedure:
1. Prepare tablets (minimum 20-25) for testing.
2. Weigh and record initial tablet weight.
3. Place tablets in friabilator drum.
4. Rotate drum (usually 100-200 revolutions).
5. Remove tablets and re-weigh.
6. Calculate friability (%) using:
Friability (%) = (Initial Weight – Final Weight) / Initial Weight × 100
Acceptance Criteria:
1. Maximum allowable friability: 1% (USP)
2. Maximum allowable weight loss: 1% (Ph. Eur.)
Factors Affecting Friability:
1. Tablet hardness
2. Tablet size and shape
3. Coating thickness and type
4. Excipient properties
5. Manufacturing process
Regulatory Guidelines:
1. USP <671> “Tablet Friability”
2. Ph. Eur. 2.9.3 “Disintegration of Tablets and Capsules”
3. ICH Q6A “Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products”
Importance:
1. Ensures tablet stability during handling and storage.
2. Prevents tablet breakage and dust generation.
3. Maintains product quality and appearance.
Troubleshooting:
1. High friability: adjust tablet formulation or manufacturing process.
2. Low friability: may indicate over-hardness or poor tablet quality.
By conducting the Friability Test, manufacturers ensure tablets meet quality standards.
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