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TABLET FRIABILITY

BSP4C

GLORIOSO, ODELIO P.
FERNANDEZ, KHAYE
FLORENCONDIA, JEAN
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 tablets weight
variation or content uniformity
problems.
Internal and external factors that
affect 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

Methods of removing dust and
excess powder
Aid of air pressure
Brushing
Friability test answers the ff
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
different 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
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.
Different Models of Friabilator
PTF 10E Single
Drum




Speed: 25rpm
(accuracy of +/-
1rpm)
Time: 1 to 9999
sec
Double drum Ptfera friability
tester
Types of Drums
Roche type
Traditional drum used
A drum with a single
chamber and a single
arch

Vankel type
a drum with two
arched bridges which
saves time by allowing
for two test in one
drum

Types of Drums
Abrasion drum
A drum with
internal baffles to
agitate the product
inside
Applied for
products requiring
a high degree of
mechanical stress

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
Operation/procedure
If the tablet size or shape results in
irregular tumbling, adjust the drum
base (base forms and angle 10)



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 difficult 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
New formulations: an initial weight loss
of 0.8% would be permitted until
sufficient packaging data are obtained
to extent the limit to a targeted value
of 1%
FRIABILITY
cracked, cleaved, or broken tablets are
present in the tablet sample after
tumbling, the sample fails the test
Most effervescent tablets and some
chewable tablets undergo high friability
weight loss which is an indication for the
special stack packing that is required for
these types of tablets
In case of hygroscopic tablets a
humidity-controlled environment (relative
humidity less than 40%) is required for
testing