Practical Industrial Pharmacy
Lab 7: Friability Testing
Instructor: Dr. Mohammed Mostafa Al-Mutawakel
Friability
Friability is a measure of the tendency of a
tablet to break or crumble under mechanical
stress, which can occur during handling,
packaging, and transportation.
An instrument called friabilator is used to evaluate the ability of the
tablet to withstand abrasion until it reaches the patient.
Importance of Friability Testing
Ensures tablets have sufficient mechanical strength to withstand
packaging, transport, and handling without disintegrating.
Prevents excessive weight loss in tablets, which could compromise
dosage accuracy and therapeutic efficacy.
Provides essential data for assessing formulation robustness and
ensuring compliance with pharmacopeia standards.
Friability Testing Standards
The U.S. Pharmacopeia (USP) and European Pharmacopeia (Ph.
Eur.) set standards for friability testing, typically allowing a
maximum friability of 1.0% weight loss for conventional tablets.
However, some tablets, such as chewable tablets, have different
acceptable limits.
Types of Friabilators
Single Drum tester:
e.g., Roche Friabilator (standard use).
Double Drum tester:
e.g., Electrolab EF-2W (simultaneous
testing).
Triple Drum tester:
e.g., PTF3DR (high throughput testing).
Experiment: Friability Testing
Objective
To determine the friability of tablets and evaluate their compliance
with pharmacopeia standards.
Materials
Tablet samples (10–20, ≥6.5 g total weight)
Friabilator (Roche or equivalent)
Analytical balance (accuracy: 0.001 g)
Brush (for dust removal)
Procedure (Steps 1-3)
1. Weigh Initial Tablets
• Select 10 tablets and weigh them accurately (initial weight, W1). Use a
minimum of 6.5 g of tablets, typically around 10 to 20 tablets depending
on their size and weight.
2. Friabilator Setup
• Place the tablets into the drum of the friabilator. Set the friabilator to
rotate at 25 rpm for 4 minutes (or 100 revolutions).
3. Collect Tablets
• After the rotation, remove the tablets from the drum. Brush off any
loose dust without applying undue force.
Procedure (Steps 4-5)
4. Weigh Final Tablets
Weigh the tablets again (final weight, W2).
5. Calculate Friability
Use the formula:
• Friability (%) = [(W1 - W2) / W1] × 100
• Compare the friability percentage to the acceptable limits
(typically less than 1%).
Results and Discussion
Results
• Record the initial and final weights of the tablets, calculate the
friability percentage, and determine if it meets the acceptable
criteria.
Discussion
• Discuss factors that might have influenced the friability results,
such as formulation variations, potential errors in handling, and
the implications for product quality.
Conclusion
Conclude whether the tested tablets meet the standard friability
requirements and provide recommendations for improvement if
necessary.
