TABLET PROCESSING PROBLEMS

AND ITS REMEDIES

Background
 An ideal tablet should be free from any visual
defect or functional defect.
 With the development of technology, the

production process had become more simplified

and more mechanized.
Background
 In olden days tablets were initially punched on
small scale with hand operated machines, which
suffered the problem of varied strength and
integrity.
 But now the tablet punching machines are all
mechanized, the mechanical feeding of feed from
the hopper into the die, electronic monitoring of the
press, but tablet process problem still persist.
 Background
 An industrial pharmacist usually
encounters number of problems during
manufacturing.
 Majority of visual defects are due to

inadequate fines or inadequate moisture in

the granules ready for compression or due
to faulty machine setting.
 Functional defects are due to faulty

formulation.
Background
Basic Problems

Mechanical
Mechanical Strength
Strength Related
Related
Release
Weight Content
Profile Visual defects
Variation Uniformity
Hardness
Hardness Friability
Friability
Altered
Background
 The Imperfections known as: ‘VISUAL DEFECTS’
are either related to Imperfections in any one or
more of the following factors:
I. Formulation design
II. Tableting process
III. Machine
 Capping

Process Laminatio
related n

Cracking

Chipping

Visual
Sticking
defects
Formulatio
n related
Picking

Binding

Double
Machine
impressio
related
n
 The defects related to
Tableting Process..
 CAPPING:
Partial or complete separation of the top or bottom of tablet due
to air-entrapment in the granular material.
 LAMINATION:
Separation of tablet into two or more layers due to air-
entrapment in the granular material.
 CRACKING:
Small, fine cracks observed on the upper and lower central
surface of tablets, or very rarely on the sidewall.
 CHIPPING:
Breaking of tablet edges.
 The defects related to Formulation..

 STICKING:
The adhesion of granulation material to the
die wall.
 PICKING:

The removal of material from the surface of

tablet and its adherence to the face of punch.
 BINDING:

Sticking of the tablet to the die and does

not eject properly out of the die
The defect related to Machine..

 DOUBLE IMPRESSION:
Due to free rotation of the punches, having some
engraving on their faces.
 The defect related to more than one factor..

 MOTTLING:

Unequal distribution of color on a tablet

with light or dark areas.
 Further,
in this section, each problem is
described along with its
causes and remedies which may be related to
either of formulation or of machine.
 Capping
 The upper or lower segment of the tablet separates
horizontally, either partially or completely from the
main body and comes off as a cap, during ejection from
the tablet press, or during subsequent handling.
 Reason:
 Due to the air–entrapment in a compact during compression,
and subsequent expansion of tablet on ejection of a tablet from
a die.

Fig: Capping [1]

The Causes and Remedies of Capping related to
‘Formulation’

Sr. CAUSES REMEDIES

No.
1. Large amount of fines in the Remove some or all fines through 100 to 200 mesh screen
granulation

2. Too dry or very low moisture content Moisten the granules suitably. Add hygroscopic substance
(leading to loss of proper binding e.g.: Sorbitol, Methylcellulose or PEG-4000.
action).

3. Not thoroughly dried granules. Dry the granules properly.

4. Insufficient amount of binder or Increasing the amount of binder OR

improper binder.
Adding dry binder such as pre-gelatinized Starch, Gum
acacia, powdered Sorbitol, PVP, hydrophilic Silica or
powdered Sugar.
5. Insufficient or improper lubricant. Increase the amount of lubricant or change the type of
lubricant.
6. Granular mass too cold to compress Compress at room temperature.
firm.
The Causes and Remedies of Capping related to
‘Machine’
CAUSES REMEDIES
Sr.
No.
1. Poorly finished dies Polish dies properly. Investigate other steels
or other materials.
2. Deep concave punches or beveled-edge Use flat punches.
faces of punches.
3. Lower punch remains below the face of die Make proper setting of lower punch during
during ejection. ejection.
4. Incorrect adjustment of sweep-off blade. Adjust sweep-off blade correctly to facilitate
proper ejection.
5. High turret speed. Reduce speed of turret (Increase dwell time).
 Lamination
 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.

Fig:
The Causes and Remedies of Lamination related to
‘Formulation’

Sr. CAUSES REMEDIES

No.
1. Large amount of fines in the Remove some or all fines through 100 to 200 mesh screen
granulation

2. Too dry or very low moisture content Moisten the granules suitably. Add hygroscopic substance
(leading to loss of proper binding e.g.: Sorbitol, Methylcellulose or PEG-4000.
action).

3. Not thoroughly dried granules. Dry the granules properly.

4. Insufficient amount of binder or Increasing the amount of binder OR

improper binder.
Adding dry binder such as pre-gelatinized Starch, Gum
acacia, powdered Sorbitol, PVP, hydrophilic Silica or
powdered Sugar.
5. Insufficient or improper lubricant. Increase the amount of lubricant or change the type of
lubricant.
The Causes and Remedies of Lamination related to
‘Machine’

CAUSES REMEDIES
Sr.
No.
1. Rapid relaxation of the peripheral Use tapered dies, i.e. upper part of the die
regions of a tablet, on ejection from a bore has an outward taper of 3° to 5°.
die.
2. Rapid decompression Use pre-compression step. Reduce turret
speed and reduce the final compression
pressure.
 Chipping

 Breaking of tablet edges, while the

tablet leaves the press or during
subsequent handling and coating
operations.
 Reason:

Incorrect machine settings, specially

mis-set ejection take-off.
The Causes and Remedies of Chipping related to
‘Formulation’

Sr. CAUSES REMEDIES

No.
1. Sticking on punch faces Dry the granules properly or increase lubrication.
2. Too dry granules. Moisten the granules to plasticize. Add
hygroscopic substances.
3. Too much binding causes chipping Optimize binding, or use dry binders.
at bottom.
The Causes and Remedies of Chipping related to
‘Machine’

Sr. CAUSES REMEDIES

No.
1. Groove of die worn at compression Polish to open end, reverse or replace the
point. die.
2. Barreled die (center of the die wider Polish the die to make it cylindrical
than ends)
3. Edge of punch face turned Polish the punch edges
inside/inward.
4. Concavity too deep to compress powder Reduce concavity of punch faces. Use flat
blend. punches.
Cracking

 Small, fine cracks observed on the upper

and lower central surface of tablets, or very
rarely on the sidewall are referred to as
‘Cracks’.
 Reason:
 It is observed as a result of rapid expansion of
tablets, especially when deep concave punches are
used.
The Causes and Remedies of Cracking related to
‘Formulation’

Sr. No. CAUSES REMEDIES

1. Large size of granules. Reduce granule size. Add fines.

2. Too dry granules. Moisten the granules properly and add proper amount of
binder.

3. Tablets expand. Improve granulation. Add dry binders.

4. Granulation too cold. Compress at room temperature.

The Causes and Remedies of Cracking related to
‘Machine’

CAUSES REMEDIES
Sr. No.

1. Tablet expands on ejection due to air entrapment. Use tapered die.

2. Deep concavities cause cracking while Use special take-off.

removing tablets
Sticking

 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.

Fig: Sticking on punch face

The Causes and Remedies of Sticking related to
‘Formulation’

Sr. CAUSES REMEDIES

No.
1. Granules not dried properly. Dry the granules properly. Make moisture analysis to
determine limits.
2. Too little or improper Increase or change lubricant.
lubrication.
3. Too much binder Reduce the amount of binder or use a different type of
binder.
4. Hygroscopic granular Modify granulation and compress under controlled
material. humidity.
5. Oily or way materials Modify mixing process. Add an absorbent.
The Causes and Remedies of Sticking related to
‘Machine’

CAUSES REMEDIES
Sr. No.
1. Concavity too deep for granulation. Reduce concavity to optimum.
2. Too little pressure. Increase pressure.
3. Compressing too fast. Reduce speed.
 Picking
 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.

Fig: Picking
Picking
Reason:
 Picking is of particular concern when punch tips have
engraving or embossing letters.
Granular material is improperly dried.
The Causes and Remedies of Picking related to
‘Formulation’
CAUSES REMEDIES
Sr.
No.
1. Excessive moisture in granules. Dry properly the granules, determine optimum limit.

2. Too little or improper lubrication. Increase lubrication; use colloidal silica as a

‘polishing agent’, so that material does not cling to
punch faces.
3. Low melting point substances, may soften Add high melting-point materials. Use high meting
from the heat of compression and lead to point lubricants.
picking.

4. Low melting point medicament in high Refrigerate granules and the entire tablet press.
concentration.

5. Too warm granules when compressing. Compress at room temperature. Cool sufficiently
before compression.

6. Too much amount of binder. Reduce the amount of binder, change the type or use
dry binders.
The Causes and Remedies of Picking related to
‘Machine’

Sr. CAUSES REMEDIES

No.
1. Rough or scratched punch faces. Polish faces to high luster.
2. Embossing or engraving letters on punch Design lettering as large as possible.
faces such as B, A, O, R, P, Q, G.
Plate the punch faces with chromium to
produce a smooth and non-adherent face.
3. Bevels or dividing lines too deep. Reduce depths and sharpness.
4. Pressure applied is not enough; too soft Increase pressure to optimum.
tablets.
Binding

 Sticking of the tablet to the die and does not eject

properly out of the die.
 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:
Usually due to excessive amount of moisture in granules,
lack of lubrication and/or use of worn dies.
The Causes and Remedies of Binding related to ‘Formulation’

Sr. CAUSES REMEDIES

No.
1. Too moist granules and extrudes Dry the granules properly.
around lower punch.
2. Insufficient or improper lubricant. Increase the amount of lubricant or use a more
effective lubricant.
3. Too coarse granules. Reduce granular size, add more fines, and
increase the quantity of lubricant.
4. Too hard granules for the lubricant Modify granulation. Reduce granular size.
to be effective.
5. Granular material very abrasive and If coarse granules, reduce its size.
cutting into dies.
Use wear-resistant dies.
6. Granular material too warm, sticks Reduce temperature.
to the die. Increase clearance if it is extruding.
The Causes and Remedies of Binding related to ‘Machine’

Sr. CAUSES REMEDIES

No.
1. Poorly finished dies. Polish the dies properly.
2. Rough dies due to abrasion, Investigate other steels or other materials or modify
corrosion. granulation.
3. Undersized dies. Too little Rework to proper size.
clearance.
Increase clearance.
4. Too much pressure in the tablet Reduce pressure. OR
press. Modify granulation.
Mottling

 Unequal distribution of color on a

tablet, with light or dark spots.
 Reason:

Colored drug, whose color differs from

the color of excipients used for
granulation of a tablet.
 The Causes and Remedies of Mottling

Sr. CAUSES REMEDIES

No.
1. A coloured drug used along Use appropriate colourants.
with colourless or white-
coloured excipients.
2. A dye migrates to the surface Change the solvent system,
of granulation while drying. Change the binder,
Reduce drying temperature and
Use a smaller particle size.
3. Improperly mixed dye, Mix properly and reduce size if it is of a larger size to
especially during ‘Direct prevent segregation.
Compression’.
4. Improper mixing of a coloured Incorporate dry colour additive during powder blending
binder solution. step, then add fine powdered adhesives such as acacia
and tragacanth and mix well and finally add granulating
liquid.
Double Impression

 Involves only those punches, which have a

monogram or other engraving on them.
 If the upper punch is uncontrolled, it can

rotate during the short travel to the final

compression stage and create a double
impression.
Double Impression

 Reason:
At the moment of compression, the tablet
receives the imprint of the punch.
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’.
 The Causes and Remedies of Double Impression

Sr. CAUSE REMEDIES

No.
1. Free rotation of either upper -Use keying in tooling, i.e. inset a key alongside of
punch or lower punch during the punch, so that it fits the punch and prevents
ejection of a tablet. punch rotation.
-Newer presses have anti-turning devices, which
prevent punch rotation.