Capping

‘Capping’ is the term used, 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.

TABLE.27. THE CAUSES AND REMEDIES OF CAPPING RELATED TO

‘FORMULATION’ (GRANULATION)

Sr.
CAUSES REMEDIES
No.
Large amount of fines in the Remove some or all fines through 100 to 200
1.
granulation mesh screen
Too dry or very low moisture Moisten the granules suitably. Add hygroscopic
2. content (leading to loss of proper substance e.g.: sorbitol, methyl- cellulose or PEG-
binding action). 4000.
3. Not thoroughly dried granules. Dry the granules properly.
Increasing the mount of binder OR
Insufficient amount of binder or
4. Adding dry binder such as pre-gelatinized starch,
improper binder.
gum acacia, powdered sorbitol, PVP, hydrophilic
silica or powdered sugar.
Increase the amount of lubricant or change the
5. Insufficient or improper lubricant.
type of lubricant.
Granular mass too cold to
6. Compress at room temperature.
compress firm.

TABLE.28. THE CAUSES AND REMEDIES OF CAPPING RELATED TO

‘MACHINE’ (DIES, PUNCHES AND TABLET PRESS)

Sr.
CAUSES REMEDIES
No.
Polish dies properly. Investigate other
1. Poorly finished dies
steels or other materials.
Deep concave punches or beveled-edge
2. Use flat punches.
faces of punches.
Lower punch remains below the face of Make proper setting of lower punch during
3.
die during ejection. ejection.
4. Incorrect adjustment of sweep-off Adjust sweep-off blade correctly to
 blade. facilitate proper ejection.
Reduce speed of turret (Increase dwell
5. High turret speed.
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.

TABLE.29. THE CAUSES AND REMEDIES OF LAMINATION RELATED TO

FORMULATION (GRANULATION)

Sr. REMEDIES
CAUSES
No.
Modify mixing process. Add adsorbent or
1. Oily or waxy materials in granules
absorbent.
Too much of hydrophobic lubricant Use a less amount of lubricant or change the
2.
e.g.: Magnesium-stearate. type of lubricant.

TABLE.30. The Causes and Remedies of Lamination related to MACHINE (Dies,

Punches and Tablet Press)

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

Definition: ‘Chipping’ is defined as the 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.

TABLE.31. THE CAUSES AND REMEDIES OF CHIPPING RELATED TO

FORMULATION (GRANULATION) ARE AS FOLLOWS

Sr.
CAUSES REMEDIES
No.
Dry the granules properly or increase
1. Sticking on punch faces
lubrication.
Moisten the granules to plasticize. Add
2. Too dry granules.
hygroscopic substances.
Too much binding causes
3. Optimize binding, or use dry binders.
chipping at bottom.

TABLE.32. THE CAUSES AND REMEDIES OF CHIPPING RELATED TO

MACHINE (DIES, PUNCHES AND TABLET PRESS)

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

Definition: 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.

TABLE.33. THE CAUSES AND REMEDIES OF CRACKING RELATED TO

FORMULATION (GRANULATION)

Sr. No. CAUSES REMEDIES

1. Large size of granules. Reduce granule size. Add fines.
Moisten the granules properly and add proper
2. Too dry granules.
amount of binder.
3. Tablets expand. Improve granulation. Add dry binders.
4. Granulation too cold. Compress at room temperature.

TABLE.34. THE CAUSES AND REMEDIES OF CRACKING RELATED TO

MACHINE (DIES, PUNCHES AND TABLET PRESS)

Sr. No. CAUSES REMEDIES

1. Tablet expands on ejection due to air entrapment. Use tapered die.
Deep concavities cause cracking while
2. Use special take-off.
removing tablets

Sticking / Filming

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.

TABLE.35. THE CAUSES AND REMEDIES OF STICKING RELATED TO
FORMULATION (GRANULATION)

Sr.
CAUSES REMEDIES
No.
Granules not dried Dry the granules properly. Make moisture analysis to
1.
properly. determine limits.
Too little or improper
2. Increase or change lubricant.
lubrication.
Reduce the amount of binder or use a different type of
3. Too much binder
binder.
Hygroscopic granular Modify granulation and compress under controlled
4.
material. humidity.
5. Oily or way materials Modify mixing process. Add an absorbent.
Optimize the amount of binder and granulation
6. Too soft or weak granules.
technique.

TABLE.36. THE CAUSES AND REMEDIES OF STICKING RELATED TO

MACHINE (DIES, PUNCHES AND TABLET PRESS)

Sr. No. CAUSES REMEDIES

1. Concavity too deep for granulation. Reduce concavity to 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.
TABLE.37. THE CAUSES AND REMEDIES OF PICKING RELATED TO
FORMULATION (GRANULATION)

Sr.
CAUSES REMEDIES
No.
Dry properly the granules, determine
1. Excessive moisture in granules.
optimum limit.
Increase lubrication; use colloidal silica as a
2. Too little or improper lubrication. ‘polishing agent’, so that material does not
cling to punch faces.
Low melting point substances, may
Add high melting-point materials. Use high
3. soften from the heat of compression
meting point lubricants.
and lead to picking.
Low melting point medicament in highRefrigerate granules and the entire tablet
4.
concentration. press.
Compress at room temperature. Cool
5. Too warm granules when compressing.
sufficiently before compression.
Reduce the amount of binder, change the
6. Too much amount of binder.
type or use dry binders.

TABLE.38. THE CAUSES AND REMEDIES OF PICKING RELATED TO MACHINE

(DIES, PUNCHES AND TABLET PRESS)

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

TABLE.39. THE CAUSES AND REMEDIES OF BINDING RELATED TO

FORMULATION (GRANULATION)

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

TABLE.40. THE CAUSES AND REMEDIES OF BINDING RELATED TO MACHINE

(DIES, PUNCHES AND TABLET PRESS)

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

TABLE.41. THE CAUSES AND REMEDIES OF MOTTLING

Sr.
CAUSES REMEDIES
No.
A coloured drug used along
1. with colourless or white- Use appropriate colourants.
coloured excipients.
Change the solvent system,

Change the binder,

A dye migrates to the surface
2.
of granulation while drying.
Reduce drying temperature and

Use a smaller particle size.

Improperly mixed dye,
3. especially during ‘Direct
Compression’.
Improper mixing of a
4.
coloured binder solution.
Mix properly and reduce size if it is of a larger size to
prevent segregation.
Incorporate dry colour additive during powder
blending step, then add fine powdered adhesives such
as acacia and tragacanth and mix well and finally add
granulating liquid.

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.

TABLE.42. THE CAUSES AND REMEDIES OF DOUBLE IMPRESSION

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