The document discusses tablet friability testing. Tablet friability is a measure of how well tablets withstand abrasion and breakage during packaging and shipping. A friabilator is used to test tablets by tumbling them for 4 minutes at 25 rpm, then weighing them to calculate weight loss. The USP specification is that tablets can lose no more than 1% of their weight to pass the friability test. Factors like moisture level, punch condition, and excess lubricants can impact a tablet's friability.
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Tablet Friability PDF
The document discusses tablet friability testing. Tablet friability is a measure of how well tablets withstand abrasion and breakage during packaging and shipping. A friabilator is used to test tablets by tumbling them for 4 minutes at 25 rpm, then weighing them to calculate weight loss. The USP specification is that tablets can lose no more than 1% of their weight to pass the friability test. Factors like moisture level, punch condition, and excess lubricants can impact a tablet's friability.
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TABLET FRIABILITY
Umair Mazhar 1087
Mohsin Raza. 1100 Usama Saeed 1284 Hafiz M. Waqar Ashraf 1097 TABLET FRIABILITY ⚫ Also called as “Drop Test” or “Abrasion Test” ⚫ It is a tablet property related to hardness. ⚫ It is the ability to withstand abrasion in packaging, handling and shipping. ⚫ It is the tendency of tablets to powder, chip, or fragment ⚫ Attrition Resistance Test TABLET FRIABILITY ⚫ stress can lead to capping, aberration or even breakage of the tablets ⚫ Friction and shock are the forces that most often cause tablets to chip, break. ⚫ defined as the excessive breakness of tablets during mechanical shocks of handling in manufacture, packaging, and shipping. FRIABILITY TEST ⚫ defined as the % of weight loss by tablets due to mechanical action during the test. Tablets are weighing before and after testing and friability is expressed as a percentage loss on pre test tablet weight. ⚫ Method to determine the physical strength of uncoated tablets upon exposure to mechanical shock or attrition Why do we have to determine the friability of tablets? Tablets that tend to powder, chip & fragment when handled: 1. Lack elegance & consumer acceptance 2. Create excessively dirty processes in areas of manufacturing as coating & packaging 3. Can also add to a tablet’s weight variation or content uniformity problems. Internal and external factors that a ect the friability of tablets ⚫ Punches that are in poor condition or worn at their surface edges, resulting in ‘whiskering’ at the tablet edge and show higher than normal friability values. ⚫ internal factors like the moisture content of tablet granules and finished tablets. Moisture at low and acceptable level acts as a binder Instrumentation ⚫ instrument called friabilator is used to evaluate the ability of the tablet to withstand abrasion in packaging, handling, and shipping. ⚫ commonly used friabilator in laboratories is the Roche friabilator Roche Friabilator ⚫ This instrument consists of a plastic chamber for placing the tablets which is attached to a horizontal axis. The drum has an inside diameter of 287mm and is about 38mm in depth, made of a transparent synthetic polymer with polished internal surface. Operation/procedure ⚫ Drum is attached to horizontal axis (rotates 25+ revolution per minute) ⚫ tablets having individual weight up to 0.650 g take 20 tablets. ⚫ tablets having individual weight above 0.650 g take 10 tablets. ⚫ Dust should be carefully removed from the tablets prior to testing Operation/procedure ⚫ Accurately weigh the tablet sample, and place in the drum ⚫ Rotate the drum 100 times (25rpm for 4 min) ⚫ Remove any loose dust from tablets as before ⚫ If no tablet are cracked, split or broken, accurately weigh the tablets and determine the friability Friability ⚫ Percentage Loss =Initial Wt – Final Wt/ Initial Wt X 100 ⚫ USP Specification = NMT 1% ⚫ maximum mean weight loss from the three samples of not more than 1.0% is considered acceptable for most products. ⚫ If the results are di cult to interpret or if the weight loss is greater than the targeted value, the test should be repeated twice and the mean of the three tests determined Methods of removing dust and excess powder ⚫ Aid of air pressure ⚫ Brushing Friability test answers the defects on tablets
⚫ Capping- is the partial or complete
separation of the top or bottom crown from the main body of tablet ⚫ Lamination- is the separation of the tablet into two or more distinct layers Causes: ⚫ Air entrapment during compression, the resulting tablet expand when the pressure of the tableting is released, resulting in splits or layers in tablet ⚫ Excess amount of lubricant which may decrease the tablet strength due to their interference with the bonding between the particles during compression ⚫ Picking- is the removal of the surface material of the tablet by the punch ⚫ Sticking- is the adhesion of the tablet material to the die wall Causes: ⚫ Excessive moisture or the inclusion of materials with low melting point (PEG & stearic acid) in the formulation ⚫ This problem could managed by addiction of suitable antiadherent ⚫ Tablet Mottling is the unequal color distribution with lighter dark areas ⚫ This problem occurs when a drug has di erent color than the tablet excipients or when a drug has colored degradation products Cause: ⚫ Migration of the soluble dye during the drying stage which may give rise to dry granules with a highly colored outer zone and a colorless interior ⚫ During compaction granules are fractured and colorless interior is exposed resulting to mottled tablet