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TESTER

Instrumental
Seminar

Dr. Vikas Saroch


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17/04/2009 Dept. Of Rasashastra
CONTENTS

INTRODUCTION
TABLET HARDNESS
HISTORY
MODERN INSTRUMENTATION
WHY TEST
MEASURING UNIT
TEST METHODS
INSTRUMENTS
CONCLUSION
REFERENCES Dept. Of Rasashastra 2
17/04/2009
INTRODUCTION

The compressed tablet is one of the


most popular dosage forms .
About one-half of all prescriptions
dispensed are for tablets.
Usually one considers a compressed
tablet as an oral medication.
Tablets have many other uses.
The sublingual tablet, the pellet, the
wafer, and the vaginal insert are
manufactured by the same procedure as
an oral tablet. 3
17/04/2009 Dept. Of Rasashastra
TABLET HARDNESS

Defined as The force required to


break a tablet in a diametric
compression test.
Hard enough to withstand
mechanical stress during
packaging, shipment, and handling
by the consumer.
Section <1216> of the USP 24/NF19
outlines a standard tablet friability
test applicable to manufactured 4
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TABLET HARDNESS

There are various devices to test


the hardness of the tablet :
Monsanto tester
Strong- cobb tester
Pfizer tester
Erweka tester.
Schleuniger tester
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HISTORY

The first tablet hardness tester


was introduced around the
mid-1930s.
Purely mechanical device and
is still manufactured today.
Force was applied with a screw
thread and spring until the
tablet fractured and the
hardness was read from a 6
17/04/2009 Dept. Of Rasashastra
Contd
This was followed by the so-
called Strong-Cobb tester,
introduced around 1950.
The testing force was generated
by a manually operated air pump
and the tablet breaking force was
measured on a dial graduated in
30 arbitrary units which were
designated as Strong-Cobbs.
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17/04/2009 Dept. Of Rasashastra
Contd..

The results given by the Strong-Cobb


tester were not consistent with those of
the earlier tester.

Electro-mechanical tablet hardness


testing machines were later introduced
and have evolved into electronic test
instruments such as those produced by
Engineering Systems.
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17/04/2009 Dept. Of Rasashastra
Modern instrumentation

Contain a motor drive system to


generate the force.
Automatically detect the tablet.

Fracture displaying the force in a


variety of units.
Measurements can be printed and /
or downloaded to a computer . 9
17/04/2009 Dept. Of Rasashastra
need for test

Too soft tablets can disintegrate in transport.

Too hard tablets could damage teeth.

Tablet strength testing is necessary for both,

research & development of new formulations,


and for quality control.

The test instruments should provide accurate

results and output these results in standard


units.
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17/04/2009 Dept. Of Rasashastra
MEASURING UNIT

Newton (N) The Newton is the SI


unit of force and is the unit that
should be used for tablet hardness
testing. 9.807 Newton = 1 kilogram
Kilopond (Kp)

Strong Cobb (Sc)


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17/04/2009 Dept. Of Rasashastra
Contd
Strong-Cobb (SC) The Strong-Cobb
is a legacy of the first tablet
hardness testing machines.
An arbitrary unit

Never recognized by the SI system.

1.4 Strong-Cobs are thought to equal


about 1 kg
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17/04/2009 Dept. Of Rasashastra
TEST METHODS

The standard method used for tablet hardness


testing is compression testing.

The tablet is placed between two jaws that crush


the tablet. The machine measures the force
applied to the tablet and detects when it
fractures.

This method is used for research & development


and for quality control.
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Developed
Monsanto Hardness Tester approximately 50 years
ago.
Consists of a barrel
containing a
compressible spring
held between two
plungers.
The lower plunger is
placed in contact with
the tablet ,and a zero
reading is taken.
The upper plunger is
then forced
against a spring by
turning a threaded bolt
until the tablet
fractures.
As a spring is
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compressed, a pointer 14
Dept. Of Rasashastra
Monsanto Hardness Tester

Dept. Of Rasashastra 15
17/04/2009
Strong-cobb tester

Consist of a plunger
activated by
pumping a lever
arm, which forces
an anvil against a
stationary platform
by hydraulic
pressure.
The force required
to fracture the
tablet is read from a
hydraulic gauge.
Dept. Of Rasashastra 16
17/04/2009
Pfizer tester

Operates on the
same mechanical
principle.
1st pliers handles are
squeezed.
Tablet is compressed
between a holding
anvil and a piston
connected to a
direct force reading
gauge.
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17/04/2009
TABLET HARDNESS
TESTER
Can be fitted
on either bench
or tablet ling
machine.

Includes :

Engineered
Dial Gauge,

17/04/2009
Aluminium
Dept. Of Rasashastra
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3 in 1 - Type PTB 311E

Test :
Thickness,
Diameter or
Length and
Hardness of the
same Tablet
Hardness: 2.0 -
approx. 330 N
(Newton) 19
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Tablet Hardness Test Type :
PTB 302

Test the Hardness


of tablets, cores,
capsule shaped
samples.
Hardness:

2.0 - approx.
330 N
(Newton) - 550N
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CONCLUSION

All the different varieties of testing


machines would give the same results
(if used on the same batch of tablets).
Machine accuracy would equal
Machine resolution.

All pharmaceutical companies would


use the same SI unit of measurement
(N or kg) and the same constant (6
mm/min) test speed.
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References
www.pharma-test.com
www.indiamart.com
www.pharmaceuticalonli
ne.com

www.google.com
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THANK YOU

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