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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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0% found this document useful (0 votes)
674 views

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.
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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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

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