BSP4A

Group 3

Definition

Applications/
Uses

Advantages/
Disadvantages

Instrumentation

TABLET
HARDNESS TEST
Presented by:
Calingasan, Ana Theresa U.
Cortuna, Nadia Czarina Mae S.
De Guzman, Liza Marie C.

BSP4A
Group 3

Definition

Applications/
Uses

Advantages/
Disadvantages

Instrumentation

TABLET
A solid dosage form of medicinal substances
usually prepared with the aid of suitable
pharmaceutical adjuncts

BSP4A
Group 3

Definition

Applications/
Uses

Advantages/
Disadvantages

Instrumentation

HARDNESS
Is the measure of how resistant solid matter is
to the various kinds of permanent shape
change when a force is applied

BSP4A
Group 3

Definition

Applications/
Uses

Advantages/
Disadvantages

Instrumentation

TABLET HARDNESS
AKA Breaking strength/force
Defined as the pressure force required to
break a tablet in a diametric compression test

BSP4A
Group 3

Definition

Applications/
Uses

Advantages/
Disadvantages

Instrumentation

Tablet Hardness Test is important for the

evaluation of the following properties of
tablets:
a) Ability to withstand the shock of handling,
packaging and shipping
b)An important physical parameter in the
control of tablets
c) Shown to be related to solubility

BSP4A

Definition

Group 3

Applications/
Uses

Advantages/
Disadvantages

Instrumentation

APPLICATIONS & USES:

-to determine the need for pressure adjustments on the

tableting machine

-to check the hardness conformity

*too hard may not disintegrate at required period

*too soft may not withstand handling during subsequent
processing
-Serves as criterion by which to guide product manufacturer of
its quality control specification
--indicates the resistance power to damage its intactness and
reflects the internal bonding strength of granules/powders
which can able to hold composite structure under applied
external force

BSP4A
Group 3

Definition

Applications/
Uses

Advantages/
Disadvantages

Instrumentation

ADVANTAGES:
-to determine the need for pressure adjustments on the tableting
APPLICATIONS & USES:
machine

1. Gives an idea about the amount of force

-to check the hardness conformity
which can able to fracture as well as it will
*too hard may not disintegrate at required period
also help to access compatibility of
*too soft may not withstand handling during subsequent
formulation
processing
-Serves as criterion by which to guide product manufacturer of its
2.
Serves
guideline in handling, packaging
quality
controlas
specification

and storage
ofpower
the toformulation
--indicates
the resistance
damage its intactness and reflects
the internal bonding strength of granules/powders which can able to
hold composite structure under applied external force

BSP4A

Definition

Group 3

Applications/
Uses

Advantages/
Disadvantages

Instrumentation

APPLICATIONS & USES:

-to determine the need for pressure adjustments on the tableting
machine

DISADVANTAGE:
-to check the hardness conformity

hard may
disintegrate
requiredcapping
period
1. *too
Unable
tonot
give
idea atabout
and
*too
soft may not behavior
withstand handling
during
subsequent
lamination
of the
tablet
processing

-Serves as criterion by which to guide product manufacturer of its

quality control specification
--indicates the resistance power to damage its intactness and reflects
the internal bonding strength of granules/powders which can able to
hold composite structure under applied external force

BSP4A
Group 3

Definition

Applications/
Uses

Advantages/
Disadvantages

Instrumentation

TabletDISADVANTAGES:
hardness tester models:
-to determine the need for pressure adjustments on the tableting
APPLICATIONS & USES:

1.
The Monsanto Tester
machine

1. Unable to give idea about capping and

-to check
the hardness conformity
2.
The Strong-Cobb
Tester
lamination behavior of the tablet
*too hard may not disintegrate at required period

3. The Pfizer Tester

*too soft may not withstand handling during subsequent

4. Theprocessing
Erweka Tester
-Serves as criterion by which to guide product manufacturer of its
5.
The
Schleuniger
Tester
quality
control
specification
--indicates
the resistance
6.
The Pharma
Testpower to damage its intactness and reflects
the internal bonding strength of granules/powders which can able to
hold The
composite
structureContestar
under applied external force
7.
Microspan

So what are
these
instruments
being used in
tablet hardness
testing?

Rule of Thumb
- Most primitive way and practical test for
hardness of tablets
-rule of thumb described a tablet to be of
proper hardness if it was firm enough to break with a
sharp snap when it was held between the 2nd and 3rd
fingers using thumb as fulcrum, yet didnt break
when it fell on the floor.

THE MONSANTO TESTER

Description:
-It is manufactured and introduced by Monsanto in
1936. It is the first tablet hardness tester made
available in the market
-It is a hand operated device in the form of a plated
metal cylinder, about 150 mm in length and 25 mm in
diameter
-Also known as the Stokes Hardness tester
-it measures the force required to break the tablet
when the force generated by a coil spring is applied
diametrally to the tablet

THE MONSANTO TESTER

WINTER
Template

- Also known as the

knurled knob.
- The rotation of the
knurled
knob
causes the inner of
the screw to press
against
the
compression spring.

- also called as the

stirrup
- It is a support at the
far end of the device
when the tablet is
compressed

-also

called as
the plunger
- adapted to
engage the tablet

THE MONSANTO TESTER

WINTER

BARREL Template

plunger

stirrup

Knurled knob

THE MONSANTO TESTER

WINTER
Template

THE MONSANTO TESTER

WINTER

Procedures/ Methodology of the use:

1. The tablet to be tested
is taken in the fingers and
Template
held on edge between the plunger and stirrup

2. The knob is rotated, so that the plunger moves

into light contact with the tablet, and the sliding
scale is moved to zero position
3. Further rotation of the knurled knob increases
the spring tension, until the tablet eventually
breaks, by the tensile failure across its diameter
4. The new scale is recorded

THE MONSANTO TESTER

Reminders!!!

WINTER

The operator must Template

always ensure that the tablet is
inserted in such a way that compression takes place
across a diameter: it must not be set an angle
The load must be applied at a steady, reproducible
rate
The spring must be correctly calibrated for its scale,
and must not exhibit fatigue
The jaws must be kept clean, while the plunger must
be free to travel in its housing without undue friction
The zero must be correctly re-set for each new size
of table to be tested

THE MONSANTO TESTER

ADVANTAGES:

WINTER
DISADVANTAGES:

Template

Low priced

Hardness obtained is lesser by

1.5% - 7.5% compared to later
development

Convenient

Instrument uses spring which

has no standard of compression

Small and portable

If many tablets are to be

measured, the procedure is
seen as tedious
operator variability in rates of
loading and difficulties in proper
setup and calibration

THE MONSANTO TESTER

WINTER

ACCEPTABLE RANGE:

Template

a. 4 to 10 kg ordinary compressed tablets

b. 2 kg - sublingual tablets
c. 2 kg chewable tablets
d. 10 kg buccal tablet

THE STRONG-COBB TESTER

Description:
-Introduced in 1953, under US Patent No.
2,645,936 by Robert Albrecht
-Like Stokes Monsanto, it also measures the
diametrically applied force required to break a
tablet.
- It measures the applied force (in Kg)
required to break a tablet across its diameter.
The force is produced by a manually or
pressure-operated pump.

THE STRONG-COBB TESTER

1 Gauge an indicating pressure gauge calibrated in
pounds per square inch, or in any other desired units
of measurement

Plunger as the
pressure increases,
plunger is forced
against the tablet

The strong cobb could

be operated from a
compressed air supply
via
a
pressure
regulator
and
a
needle regulator

2 Cylinder mead air clamp

anvil

THE STRONG-COBB TESTER

1
3
2

THE STRONG-COBB TESTER

Strong-Cobb Unit
- An ad hoc unit of force which is a legacy of one the first
tablet hardness testing machines.
-Although the Strong-Cobb unit is arbitrarily based on the dial
reading of a hardness tester, it became an international
standard for tablet hardness in the 1950s until it was
superseded by testers using SI units in the 1980s.
- The Strong-Cobb is a unit with a very unusual name for a
unit of measurement since it is named after the company,
Strong-Cobb Inc.
Conversion:

1.4 SC = 1 Kg

THE STRONG-COBB TESTER

ADVANTAGES:

DISADVANTAGES:

Did
not
depend
on
the
mechanical properties of a metal
spring, and therefore did not
suffer from metal fatigue through
prolonged use

Air pump get damages. The

cylinder is very susceptible to the
effects of dusts and grits. The
needle valve can be affected by
materials deposited from the
compressed air supply lines

Values obtained are 1.6 times operator variability in rates of

than Stokes Monsanto
loading and difficulties in proper
setup and calibration

THE PFIZER TESTER

Description:

- Patented under US
2,975,630 around 1960

Patent

No.

-Pfizers produced this new portable tester

which was, in principle, like of pliers
- The tablet is crushed in between the
jaws of the device. The force is indicated
on the dial indicator

THE PFIZER TESTER

1 Cylindrical
housing
2 - Jaws
3 - Anvil
4 Piston
5 Spring
6 dial gauge

1
3

2
2
5

THE PFIZER TESTER

2 One of the Jaw consisted of a spring-loaded plunger, connected
to a dial gauge with a ratchet to retain the maximum reading
the other jaw swiveled, and was adjustable to suit tablet of
various diameters

3 Anvil a pivoted anvil

for supporting a tablet

mounted upon one of the jaws (upper)

Piston - The movement of piston detected and is displayed

upon the face of gauge which is accurately calibrated to
dependably indicate imposed force on gauging spring over its
entire range instant the tablet is crushed.

THE PFIZER TESTER

5

Spring - a distance-indicating gauge calibrated in load

units having a sensing finger mounted upon the housing,
and the sensing finger passing through the housing into
contact with piston to permit the gauge to provide a
continuous indication of the load applied to a tablet being
squeezed between said anvil and said piston.

6 Dial gauge where the reading is displayed

THE PFIZER TESTER

THE PFIZER TESTER

Procedures/ Methodology of the use:
1. Tablet is inserted squarely between the jaws, and the
plier handles were squeezed steadily until the
breakage point
2. On the release of hand pressure, the jaws open
immediately
3. The dial gauge could then be re-set by pressure on a
release button
* A limit stop prevented the two jaws from damage by
impact, since otherwise the stored energy in the spring
could have driven the two together as the tablet shattered

THE PFIZER TESTER

Advantages
Four to seven times
faster than Monsanto or
Strong cobb (Fairchild
and Michel)
Portable

Disadvantages
operator variability in
rates of loading and
difficulties in proper
setup and calibration

THE ERWEKA TESTER

Description:
- Uses the principle of a steelyard balance to load
a vertically sliding jaw by means of a weighted
beam.
-a beam fastened to one end to a pivot applies the
breaking force. A motor moves a weight along the
beam at constant speed, and increase the force
against the tail, in which the other end of the
beam rests. The pressure is recorded through an
indicator fastened to the weight.

THE ERWEKA TESTER

1 Beam has a
linkage
which
transmits force
to the jaw

3
1

3 Motor the
sliding mass
which
is
driven along
by means of
this
electric
motor

2 Sliding Mass as the mass moves, it progressively

increases its effective load on the jaw until the tablet
breaks.

THE ERWEKA TESTER

THE ERWEKA TESTER

Advantages
- Reduced scatter
measurements

Disadvantages
of Linear
sliding
mechanisms of high
quality
are usually
quite expensive and
are relatively difficult to
seal against abrasive
particles.

THE SCHLEUNIGER TESTER

Description:
-Also known as Heberlein Model
-Most widely used instrument for tablet hardness
test
-The earliest version of this instrument had no motor
drive, but were operated by means of a handwheel;
the motor was soon added, and by 1969 both
versions were to be seen.
-This instrument uses an ingenious arrangement of
levers to provide a normally constant rate of loading
for a constant speed of jaw travel

THE SCHLEUNIGER TESTER

2

Measuring platens opposite the tablet, movement of measuring jaw

causes the heavy mass to tilt
8
5

Powerized
platens

it
presses
the
tablet
against
the measuring
jaw

6
2

3 Motor it moves the

powerized jaw towards the
measuring jaw

Drive cord as the mass tilts it

moves the drive cord which then
carries an electrical contact across a
horizontal scale; that contact presses,
in turn, against a second frictionally set
contact which maintains power supply
in the motor.

THE SCHLEUNIGER TESTER

6 Pointer adjacent to the scale to indicate

5 Scale where the

the breaking force

force applied to the

tablet will be shown
8
5
7

7 Drag contact
as drag contact
moves to the
right, it contacts a
pointer,
which
shows the force
applied to the
tablet on a linear
scale.

6
2

8 Reset motor - the pointer is returned

to zero via reset motor

THE SCHLEUNIGER TESTER

Platens - two platens between which tablets

is placed and compressed and the value of
the hardness is measured.

THE SCHLEUNIGER TESTER

REMINDERS!!
- The platens should be parallel.
-Their faces should be polished smooth and precisionground perpendicularly to the direction of movement.

- Perpendicularity must be preserved during platen

movement, and the mechanism should be free of any
bending or torsion displacements as the load is applied.
-The contact faces must be larger than the area of
contact with the tablet.

THE SCHLEUNIGER TESTER

-Either the rate of platen movement or the rate at
which the compressive force is applied (i.e., the
loading rate) should be constant. Maintaining a
constant loading rate avoids the rapid buildup of
compressive loads, which may lead to
uncontrolled crushing or shear failure and greater
variability in the measured breaking force.
*However, constant loading rate measurements
may be too slow for real time monitoring of tablet
production.

THE SCHLEUNIGER TESTER

THE SCHLEUNIGER TESTER

Advantages

- Reliable and more accurate

Summary
Apparatus
Stokes-Monsanto
Strong-Cobb
Pfizer
Erweka
Schleuniger

Mechanism
Spring
Air pump
Hard pliers
Suspended weight
Platens

THE PHARMA TEST

-Pharma Tests are apparatus manufacturers from West Germany.

Features of Pharma Test Hardness Tester:

1. Has a horizontally moving jaw, rather on the lines of

those used by the Schleuniger instrument
2. The rate of loading is controlled electronically, rather than
swinging mass
3. There is an automatic feeder, which can draw a
continuous procession of tablets from a hopper and can
present them, one at a time.
4. The machines claimed resolution of 0.1 kg and an
absolute accuracy of 1%.
5. The moving jaw travels at a relatively fast, fixed, feed
rate

THE PHARMA TEST

THE PHARMA TEST HARDNESS TESTER

THE MICROSPAN CONTESTAR

Features:

-It has been designed with the object of providing

measurement not only of tablet hardness, but also
thickness and weight.
-This machines is unique that it can accepted mixed
batches of tablets of different shapes and sizes,
automatically moving them to stations for the
successive measurement of thickness, weight and
hardness
-It incorporates a microprocessor and can print out
statistical analysis of its accumulated readings

THE MICROSPAN CONTESTAR

ADDITIONAL INFORMATION:
Factors affecting strength
(hardness) of tablets:
-Speed

of compression
-Solid state structure
-Particle Size
-Solid bridges
-Mechanical Interlocking
-distance force
-Bonding Mechanisms
-Volume reduction mechanisms of powder
-Surface Area change

There is no such official specification

given in any pharmacopoeia
about hardness of material and hardness
test. Formulator should have to decide
and maintain the range of hardness
during preparation based upon
requirement as well as type of
formulation.
e.g. effervescent or mouth dissolving
tablet should have low hardness as
compared to conventional immediate
release tablet or enteric coated tablet.

REMINDERS!!!
Hardness can affect the disintegration. So if the
tablet is too hard, it may not disintegrate in the
required period of time. And if the tablet is too
soft, it will not withstand the handling during
subsequent processing such as coating or
packaging.
In general, if the tablet hardness is too high, we
first check its disintegration before rejecting the
batch . And if the disintegration is within limit,
we accept the batch.

END