Tablet friability,harness and dissolution testing

1. TABLET TABLET
FRIABILITY,HARDNESS AND FRIABILITY,HARDNESS AND
DISSOLUTIONDISSOLUTION
By Don JacobBy Don Jacob

2. Tablet FriabilityTablet Friability
►Tablets are constantly subjected to Tablets are constantly subjected to
mechanical shocks & aberration during the mechanical shocks & aberration during the
manufacturing, packing and transportation manufacturing, packing and transportation
process. process.
►Such stress can lead to capping, aberration Such stress can lead to capping, aberration
or eve breakage of the tabletsor eve breakage of the tablets
►It is there fore important that the tablet is It is there fore important that the tablet is
formulated to withstand such stressformulated to withstand such stress

3. Tablet FriabilityTablet Friability
►In order to monitor the resistance of tablets In order to monitor the resistance of tablets
to such stress and to decide on their to such stress and to decide on their
suitability for further processing such as suitability for further processing such as
coating, tablets are routinely subjected to coating, tablets are routinely subjected to
friability testfriability test

4. Friability TestFriability Test
►Friability is defined as the % of weight loss Friability is defined as the % of weight loss
by tablets due to mechanical action during by tablets due to mechanical action during
the test. Tablets are weighing before and the test. Tablets are weighing before and
after testing and friability is expressed as a after testing and friability is expressed as a
percentage loss on pre test tablet weight.percentage loss on pre test tablet weight.
►Friability refers the ability of the compressed Friability refers the ability of the compressed
tablet to avoid fracture and breaking during tablet to avoid fracture and breaking during
transporttransport

5. Friability TestFriability Test
►Friability is closely related to tablet harness Friability is closely related to tablet harness
and is designed to evaluate the ability of the and is designed to evaluate the ability of the
tablet to with stand aberration in packing, tablet to with stand aberration in packing,
Handling and shipping.Handling and shipping.
►Friability is usually measured by the use of Friability is usually measured by the use of
Roche fibrilator or tumbler test.Roche fibrilator or tumbler test.

6. Friability TestFriability Test
►A number of tablets (20 Nos.) are weighed A number of tablets (20 Nos.) are weighed
and placed in the apparatus where they are and placed in the apparatus where they are
exposed to rolling and repeated shocks as exposed to rolling and repeated shocks as
they fall 6 inches in each turn within the they fall 6 inches in each turn within the
apparatus. After 4 minutes of this treatment apparatus. After 4 minutes of this treatment
or 100 revolutions the tablets are weighed or 100 revolutions the tablets are weighed
and the weight compared with initial weight. and the weight compared with initial weight.
The loss due to abrasion is a measure of The loss due to abrasion is a measure of
tablet friability. The value is expressed in tablet friability. The value is expressed in
percentage.percentage.

7. Friability TestFriability Test
►Minimum weight loss of the tablet should Minimum weight loss of the tablet should
not be NMT 1%.not be NMT 1%.
►There should not be any broken tablet.There should not be any broken tablet.

8. HardnessHardness

9. HardnessHardness
►The resistance of tablets to The resistance of tablets to
capping,aberation or breakage under capping,aberation or breakage under
conditions of storage, transportation and conditions of storage, transportation and
handling before usage depends on its handling before usage depends on its
hardness.hardness.
►Hardness is nothing but crushing strengthHardness is nothing but crushing strength

10. HardnessHardness
►If tablet is too hard, it may not disintegrate If tablet is too hard, it may not disintegrate
in the required period of time and will fail in the required period of time and will fail
dissolution testdissolution test
►If tablet is too soft it may not be able to If tablet is too soft it may not be able to
withstand handling during subsequent withstand handling during subsequent
processing such as coating or packaging processing such as coating or packaging
and shipping operations.and shipping operations.

11. HardnessHardness
►The force required to break tablet is measured in The force required to break tablet is measured in
kilograms and a crushing strength of 4 KG is kilograms and a crushing strength of 4 KG is
usually considered to be the minimum for usually considered to be the minimum for
satisfactory tablets.satisfactory tablets.
►Oral tablets normally have a hardness of Oral tablets normally have a hardness of
4-10kg,However hypodermic and chewable tablets 4-10kg,However hypodermic and chewable tablets
are usually much softer (3 kg) and some are usually much softer (3 kg) and some
substained release tablets are much harder 10-20 substained release tablets are much harder 10-20
kg.kg.

12. HardnessHardness
►Tablet hardness has been associated with Tablet hardness has been associated with
tablet property such as density and porosity.tablet property such as density and porosity.
►Hardness generally increase with normal Hardness generally increase with normal
storage of tablets & depends on the shape, storage of tablets & depends on the shape,
chemical properties, binding agent & chemical properties, binding agent &
pressure applied during compression.pressure applied during compression.

13. HardnessHardness
►Hardness is expressed in Newton.Hardness is expressed in Newton.
►Hardness can also expressed in Kpa.Hardness can also expressed in Kpa.

14. DISSOLUTIONDISSOLUTION

15. DissolutionDissolution
►Active absorption of oral dosage forms Active absorption of oral dosage forms
depends on adequate release of the API depends on adequate release of the API
from the product. Dissolution or solubility of from the product. Dissolution or solubility of
the API play pivotal role in this aspect.the API play pivotal role in this aspect.
►Dissolution testing is used as a tool to Dissolution testing is used as a tool to
identify a crucial effect in the bioavailability identify a crucial effect in the bioavailability
of the API.of the API.