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A farily handy instrument for taking quick readings for the hardness
of tablets. It is made of brass turned parts, heavily chrome plated,
the scale is 0 to 20 kg and the index mark and division is in 1 kg
reading. Scale adjustable for zero setting as per size of the tablets.

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Reinforced stinless steel sieve fixed in a wooden frame size

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This apparatus is designed to determine the abrasion rate & impact

hardness of tablet. One transparent acrylic drums rotated by
superior quality constant speed sturdy motor, mounted in painted
sheet metal cabinet with chemical resistant power coating.
Specification :
Speed : 25 ± 1rpm
Motor : 1/8 Hp
Power : Ac/230 Volts 50 Hz Single Phase

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I.P. Standard, UPS and B.P. Standard. Displacement 50-

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125 watts.
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Tablet:Quality control tests for tablets

Contents

• 1 Official Standards as per I.P. / B.P. / U.S.P.

• 2 Non – compendial standards
o 2.1 Hardness tests/ Crushing strength
o 2.2 Friability
o 2.3 Tests for coated tablets
• 3 In – Process Quality Control

• 4 Key Phrases

Official Standards as per I.P. / B.P. / U.S

COMPARISON OF DIFFERENT PHARMACOPOEIAL QUALITY CONTROL
TESTS
PHARMACOPOEIAS TYPE OF TESTS TO BE
TABLET PERFORMED
Content of active
ingredients

For all Disintegration

tablets Uniformity of
content

Labeling
Disintegration
Uncoated test
tablet Uniformity of
weight
Disintegration
Effervescent test
tablet Uniformity of
weight
Disintegration
Coated tablet test
Uniformity of
BRITISH weight
PHARMACOPOEIA
Gastro
Disintegration
resistant
test
tablet
Modified Uniformity of
release tablet weight
Tablet for Uniformity of
use in mouth weight
Disintegration
Soluble test
tablet Uniformity of
weight
Disintegration
test

Dispersible Uniformity of
tablet dispersion

Uniformity of
weight
INDIAN Uncoated Uniformity of
PHARMACOPOEIA tablet container content
 Content of active
ingredient
Uniformity of
weight
Uniformity of
content

Disintegration
test
Enteric Disintegration
coated tablet test

Uniformity of
Dispersible
dispersion
tablet
Disintegration
Soluble Disintegration
tablet test
Disintegration/
Effervescent Dissolution /
tablet Dispersion
test
Bulk density
/Tapped density
of powder

Powder fineness
Loss on drying
Disintegration
test
Physical
Tablet friability
tests
UNITED STATES Dissolution test
applicable to
PHARMACOPOEIA Drug release
tablet
testing
formulation
Uniformity of
dosage form
Container
permeation test

Labeling of
inactive
ingredients

Non – compendial standards

(2,13)

Measurement of mechanical properties is not covered pharmacopoeial monograph. There

are also a number of tests frequently applied to tablets for which there are no
pharmacopoeial requirement but will form a part of a manufacturer’s own product
specification.

Hardness tests/ Crushing strength

The test measures crushing strength property defined as the compressional force applied
diametrically to a tablet which just fractures it. Among a large number of measuring
devices, the most favored ones are Monsanto tester, Pfizer tester, and Strong cobb
hardness tester. All are manually used. So, strain rate depends on the operator. Heberlein
Schleuniger, Erweka, Casburt hardness testers are motor driven.

Friability

(Official in USP)

The tablet may well be subjected to a tumbling motion. For example, Coating, packaging,
transport, which are not severe enough to break the tablet, but may abrade the small
particle from tablet surface. To examine this, tablets are subjected to a uniform tumbling
motion for specified time and weight loss is measured. Roche friabilator is most
frequently used for this purpose.

Tests for coated tablets

I. Water vapor permeability

II. Film tensile strength

III. Coated tablet evaluations:

i)Adhesion test with tensile-strength tester: Measures force required toe peel the film
from the tablet surface.

ii)Diametral crushing strength of coated tablet: Tablet hardness testers are used. This test
gives information on the relative increase in crushing strength provided by the film and
the contribution made by changes in the film composition.

iii) Temperature and humidity may cause film defects. Hence studies are to be carried
out.

iv) Quantification of film surface roughness, hardness, & colour uniformity. Visual
inspection or instruments are used. Resistance of coated tablet on a white sheet of paper.
 Resisilient films remain intact, & no colour is transferred to the paper; very soft coating
are readily “erased” from the tablet surface to the paper.

In – Process Quality Control

(13)

The control of the tableting process in production is concerned with the following :

I. Weight of tablet – Single pan electric balance.

II. Crushing strength – Controls friability and disintegration time.

III. Tablet thickness – Very thick tablet affect packaging particularly into blisters.

IV. Disintegration time.

V. Friability

Problem in tablets are either related to imperfections in any one or more of the following
factors:

. Tableting Process
II. Excipient
III. Machine
Process related problems :
• CAPPING: It is due air-entrapment in the granular material.

• LAMINATION: It is due air-entrapment in the granular material.

• CRACKING: It is due to rapid expansion of tablets when deep
concave punches are used.
• Excipient related problems :
• CHIPPING: It is due to very dry granules.
• STICKING: It is due to excess moisture presnt in the granules.
• PICKING: It is due the improper dring of the granules.
• BINDING: It is due the excessive binder present in the granules.
•
• Machine related problems :
• DOUBLE IMPRESSION: It is due to free rotation of the punches,
which have some engraving on the punch faces.
•
• CAPPING:
• Capping happened when the upper or lower segment of the
tablet separates horizontally, either partially or completely
from the main body of a tablet and comes off as a cap, during
ejection from the tablet press, or during subsequent handling.
• Reason: Capping is usually due to the air–entrapment in a
compact during compression, and subsequent expansion of
tablet on ejection of a tablet from a die.
•
CAPPING RELATED TO ‘FORMULATION’ (GRANULATION)

Sr.No. CAUSES REMEDIES

Large amount of fines in Remove some or all fines through 100 to 200
1.
the granulation mesh screen
Too dry or very low
Moisten the granules suitably. Add
moisture content
2. hygroscopic substance e.g.: sorbitol, methyl-
(leading to loss of proper
cellulose or PEG-4000.
binding action).
Not thoroughly dried
3. Dry the granules properly.
granules.
Increasing the mount of binder OR
Insufficient amount of
Adding dry binder such as pre-gelatinized
4. binder or improper
starch, gum acacia, powdered sorbitol, PVP,
binder.
hydrophilic silica or powdered sugar.
Insufficient or improper Increase the amount of lubricant or change
5.
lubricant. the type of lubricant.
Granular mass too cold
6. Compress at room temperature.
to compress firm.
CAPPING RELATED TO ‘MACHINE’ (DIES, PUNCHES AND TABLET PRESS)

Sr.No CAUSES REMEDIES

Polish dies properly. Investigate

1. Poorly finished dies
other steels or other materials.
Deep concave punches or
2. beveled-edge faces of Use flat punches.
punches.
Lower punch remains below
Make proper setting of lower
3. the face of die during
punch during ejection.
ejection.
Incorrect adjustment of Adjust sweep-off blade correctly
4.
sweep-off blade. to facilitate proper ejection.
Reduce speed of turret (Increase
5. High turret speed.
dwell time).
Lamination / Laminating
• Definition: ‘Lamination’ is the separation of a tablet into two or more distinct
horizontal layers.
 • Reason: Air–entrapment during compression and subsequent release on ejection.
• The condition is exaggerated by higher speed of turret.
LAMINATION RELATED TO FORMULATION (GRANULATION)
Sr. No CAUSES REMEDIES

Oily or waxy materials Modify mixing process. Add

1. adsorbent or absorbent.
in granules
Too much of Use a less amount of lubricant or
hydrophobic lubricant change the type of lubricant.
2.
e.g.: Magnesium-
stearate.
Lamination related to MACHINE (Dies, Punches and Tablet Press
Sr. No. CAUSES REMEDIES
Rapid relaxation of the
Use tapered dies, i.e. upper part
peripheral regions of a
1. of the die bore has an outward
tablet, on ejection from a
taper of 3° to 5°.
die.
Use pre-compression step.
2. Rapid decompression Reduce turret speed and reduce
the final compression pressure.
Sticking
• Definition: ‘Sticking’ refers to the tablet material adhering to the die wall.
• Filming is a slow form of sticking and is largely due to excess moisture in the
granulation.
• Reason: Improperly dried or improperly lubricated granules.
STICKING RELATED TO FORMULATION (GRANULATION)
Sr. No. CAUSES REMEDIES
Granules not dried Dry the granules properly. Make moisture
1.
properly. analysis to determine limits.
Too little or
2. improper Increase or change lubricant.
lubrication.
Reduce the amount of binder or use a
3. Too much binder
different type of binder.
Hygroscopic Modify granulation and compress under
4.
granular material. controlled humidity.
Oily or way
5. Modify mixing process. Add an absorbent.
materials
Too soft or weak Optimize the amount of binder and
6.
granules. granulation technique.
STICKING RELATED TO MACHINE (DIES, PUNCHES AND TABLET PRESS)
Sr. No. CAUSES REMEDIES

Concavity too deep for Reduce concavity to

1.
granulation. optimum.
2. Too little pressure. Increase pressure.

3. Compressing too fast. Reduce speed.

Picking
• Definition: ‘Picking’ is the term used when a small amount of material from a
tablet is sticking to and being removed off from the tablet-surface by a punch
face.
• The problem is more prevalent on the upper punch faces than on the lower ones.
The problem worsens, if tablets are repeatedly manufactured in this station of
tooling because of the more and more material getting added to the already stuck
material on the punch face.
• Reason: Picking is of particular concern when punch tips have engraving or
embossing letters, as well as the granular material is improperly dried.
PICKING RELATED TO FORMULATION (GRANULATION)
Sr.No CAUSES REMEDIES
Excessive moisture in Dry properly the granules,
1.
granules. determine optimum limit.
Increase lubrication; use colloidal
Too little or improper silica as a ‘polishing agent’, so that
2.
lubrication. material does not cling to punch
faces.
Low melting point
substances, may soften from Add high melting-point materials.
3.
the heat of compression and Use high meting point lubricants.
lead to picking.
Low melting point
Refrigerate granules and the entire
4. medicament in high
tablet press.
concentration.
Compress at room temperature.
Too warm granules when
5. Cool sufficiently before
compressing.
compression.
Reduce the amount of binder,
6. Too much amount of binder.
change the type or use dry binders.
PICKING RELATED TO MACHINE (DIES, PUNCHES AND TABLET PRESS)
Sr.No CAUSES REMEDIES
Rough or scratched punch
1. Polish faces to high luster.
faces.
 Design lettering as large as
Embossing or engraving possible.
2. letters on punch faces such as Plate the punch faces with
B, A, O, R, P, Q, G. chromium to produce a smooth
and non-adherent face.
Bevels or dividing lines too
3. Reduce depths and sharpness.
deep.
Pressure applied is not
4. Increase pressure to optimum.
enough; too soft tablets.
Binding
• Definition: ‘Binding’ in the die, is the term used when the tablets adhere, seize or
tear in the die. A film is formed in the die and ejection of tablet is hindered. With
excessive binding, the tablet sides are cracked and it may crumble apart.
• Reason: Binding is usually due to excessive amount of moisture in granules, lack
of lubrication and/or use of worn dies.
BINDING RELATED TO FORMULATION (GRANULATION)
Sr.No CAUSES REMEDIES
Too moist granules and
1. extrudes around lower Dry the granules properly.
punch.
Insufficient or improper Increase the amount of lubricant or use
2.
lubricant. a more effective lubricant.
Reduce granular size, add more fines,
3. Too coarse granules.
and increase the quantity of lubricant.
Too hard granules for the Modify granulation. Reduce granular
4.
lubricant to be effective. size.
Granular material very
If coarse granules, reduce its size.
5. abrasive and cutting into
Use wear-resistant dies.
dies.
Granular material too Reduce temperature.
6.
warm, sticks to the die. Increase clearance if it is extruding.
BINDING RELATED TO MACHINE (DIES, PUNCHES AND TABLET PRESS)
Sr.No. CAUSES REMEDIES

1. Poorly finished dies. Polish the dies properly.

Rough dies due to Investigate other steels or other
2.
abrasion, corrosion. materials or modify granulation.

Undersized dies. Too little Rework to proper size.

3.
clearance. Increase clearance.
 Too much pressure in the Reduce pressure. OR
4.
tablet press. Modify granulation.
Mottling
• Definition: ‘Mottling’ is the term used to describe an unequal distribution of
colour on a tablet, with light or dark spots standing out in an otherwise uniform
surface.
• Reason: One cause of mottling may be a coloured drug, whose colour differs
from the colour of excipients used for granulation of a tablet.
•
Causes And Remedies Of Mottling:
Sr.No. CAUSES REMEDIES
A coloured drug used
along with colourless
1. Use appropriate colourants.
or white-coloured
excipients.
Change the solvent system,
A dye migrates to the
Change the binder,
2. surface of granulation
Reduce drying temperature and
while drying.
Use a smaller particle size.
Improperly mixed
Mix properly and reduce size if it is of a
3. dye, especially during
larger size to prevent segregation.
‘Direct Compression’.
Incorporate dry colour additive during
Improper mixing of a powder blending step, then add fine
4. coloured binder powdered adhesives such as acacia and
solution. tragacanth and mix well and finally add
granulating liquid.
Double impression Double impression
• Definition: ‘Double Impression’ involves only those punches, which have a
monogram or other engraving on them.
• Reason: At the moment of compression, the tablet receives the imprint of the
punch. Now, on some machines, the lower punch freely drops and travels
uncontrolled for a short distance before riding up the ejection cam to push the
tablet out of the die, now during this free travel, the punch rotates and at this
point, the punch may make a new impression on the bottom of the tablet, resulting
in ‘Double Impression’.
• If the upper punch is uncontrolled, it can rotate during the short travel to the final
compression stage and create a double impression.
CAUSES AND REMEDIES OF DOUBLE IMPRESSION:
Sr. No. CAUSE REMEDIES
 -Use keying in tooling, i.e. inset a key
alongside of the punch, so that it fits
Free rotation of either
the punch and
upper punch or lower
1. prevents punch rotation.
punch during ejection
of a tablet.
-Newer presses have anti-turning devices,
which prevent punch rotation.