venkybunnyt@gmail.com

1. PROBLEMS CAUSES AND
REMEDIES IN TABLET
MANUFACTURING
Venkatesh.T,
M.Pharm,
SKIPS.

2. Problem in tablets are either related to
imperfections in any one or more of the
following factors:
I. Tableting Process
II. Excipient
III. Machine

3. 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.

4. Excipient related problems :
• CHIPPING: It is due to very dry granules.
• STICKING: It is due to excess moisture
preasent in the granules.
• PICKING: It is due the improper drying of
the granules.
• BINDING: It is due the excessive binder
present in the granules.
• MOTTLING: uneven distribution of colour

5. Machine related problems :
• DOUBLE IMPRESSION: It is due to free
rotation of the punches, which have some
engraving on the punch faces.

6. 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.

7. 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 hygroscopic
moisture content (leading
2. substance e.g.: sorbitol, methyl- cellulose or
to loss of proper binding
PEG-4000.
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 starch,
4.
binder or improper binder. gum acacia, powdered sorbitol, PVP, hydrophilic
silica or powdered sugar.
Insufficient or improper Increase the amount of lubricant or change the
5.
lubricant. type of lubricant.
Granular mass too cold to
6. Compress at room temperature.
compress firm.

8. CAPPING RELATED TO ‘MACHINE’ (DIES, PUNCHES
AND TABLET PRESS)
Sr.No CAUSES REMEDIES
Polish dies properly. Investigate other
1. Poorly finished dies
steels or other materials.
Deep concave punches or
2. Use flat punches.
beveled-edge faces of punches.
Lower punch remains below the Make proper setting of lower punch
3.
face of die during ejection. during ejection.
Incorrect adjustment of sweep- Adjust sweep-off blade correctly to
4.
off blade. facilitate proper ejection.
Reduce speed of turret (Increase
5. High turret speed.
dwell time).

9. 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.

10. LAMINATION RELATED TO FORMULATION (GRANULATION)
Sr. No CAUSES REMEDIES
Oily or waxy materials in Modify mixing process. Add
1.
granules adsorbent or absorbent.
Too much of hydrophobic Use a less amount of lubricant or
2. lubricant e.g.: change the type of lubricant.
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 of
1. peripheral regions of a the die bore has an outward taper
tablet, on ejection from a die. of 3° to 5°.
Use pre-compression step. Reduce
2. Rapid decompression turret speed and reduce the final
compression pressure.

11. 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.

12. CHIPPING RELATED TO FORMULATION (GRANULATION)
Sr. No CAUSES REMEDIES
Dry the granules properly or
1. Sticking on punch faces
increase lubrication.
Moisten the granules to plasticize.
2. Too dry granules.
Add hygroscopic substances.
Too much binding causes chipping at Optimize binding, or use dry
3.
bottom. binders.
CHIPPING RELATED TO MACHINE (DIES, PUNCHES AND TABLET PRESS)
Sr. No CAUSES REMEDIES
Groove of die worn at compression Polish to open end, reverse or
1.
point. replace the 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.
4.
properly. Use flat punches.

13. 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.

14. CRACKING RELATED TO FORMULATION (GRANULATION)
Sr. No. CAUSES REMEDIES
1. Large size of granules. Reduce granule size. Add fines.
Too dry granules. Moisten the granules properly and add
2.
proper amount of binder.
3. Tablets expand. Improve granulation. Add dry binders.
4. Granulation too cold. Compress at room temperature.
CRACKING RELATED TO MACHINE (DIES, PUNCHES AND TABLETPRESS)
Sr. No. CAUSES REMEDIES
Tablet expands on ejection due
1. Use tapered die.
to air entrapment.
Deep concavities cause cracking
2. while Use special take-off.
removing tablets

15. 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.

16. 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 different
3. Too much binder
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 granulation
6.
granules. technique.

17. 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.

18. 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.

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

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

21. 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.

22. 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 a
2.
lubricant. more effective lubricant.
Reduce granular size, add more fines, and
3. Too coarse granules.
increase the quantity of lubricant.
Too hard granules for the
4. Modify granulation. Reduce granular size.
lubricant to be effective.
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.

23. 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 abrasion, Investigate other steels or other materials
2.
corrosion. 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.

24. 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.

25. Causes And Remedies Of Mottling:
Sr.No. CAUSES REMEDIES
A coloured drug used
along with colourless or
1. Use appropriate colourants.
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 dye,
Mix properly and reduce size if it is of a larger
3. especially during
size to prevent segregation.
‘Direct Compression’.
Incorporate dry colour additive during powder
Improper mixing of a
blending step, then add fine powdered
4. coloured binder
adhesives such as acacia and tragacanth and
solution.
mix well and finally add granulating liquid.

26. 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.

27. 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 the
Free rotation of either
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.

28. TABLET COATING DEFECTS
• PICKING AND STICKING
• TWINNING
• COLOR VARIATION
• ORANGE PEEL
• ROUGHNESS
• BRIDGING
• BLISTERING
• EROSION
• PEEALING AND FROSTING

29. PICKING AND STICKING

30. TWINNING
• This is the term for two tablets that stick
together, and it’s a common problem
with capsule shaped tablets.

31. REMEDY
• Assuming you don’t wish to change the
tablet shape, you can solve this problem
by balancing the pan speed and spray
rate. Try reducing the spray rate or
increasing the pan speed. In some cases,
it is necessary to modify the design of the
tooling by very slightly changing the
radius. The change is almost impossible to
see, but it prevents the twinning problem.

32. COLOR VARIATION
• This problem can be caused by processing
conditions or the formulation. Improper
mixing, uneven spray pattern and insufficient
coating may result in color variation. The
migration of soluble dyes, plasticizers and
other additives during drying may give the
coating a mottled or spotted appearance.
REMEDY:
1. The use of lake dyes eliminates dye
migration.

33. ORANGE PEEL
• Inadequate spreading of the coating
solution before drying causes a bumpy or
“orange-peel” effect on the coating
• REMEDY: Thinning the solution with
additional solvent may correct this
problem.

34. ROUGHNESS
• A rough or gritty surface is a defect often
observed when coating is applied by a spray.
Some of the droplets may dry too rapidly
before reaching the tablet bed, resulting in the
deposits on the tablet surface of “spray dried”
particles instead of finely divided droplets of
coating solution.
• REMEDY: Moving the nozzle closer to the
tablet bed and reducing the degree of
atomization can decrease the roughness.

35. BRIDGING
• This occurs when the coating fills in the
lettering or logo on the tablet and is typically
caused by improper application of the solution,
poor design of the tablet embossing, high
coating viscosity, high percentage of solids in
the solution, or improper atomization pressure
• REMEDY: Increasing the plasticizer content or
changing the plasticizer can decrease the
incidence of bridging.

36. BLISTERING
• When coated tablets require further drying
in ovens, too rapid evaporation of the
solvent from the core and the effect of
high temperature on the strength, elasticity
and adhesion of the film may result in
blistering.
REMEDY: Milder drying conditions are
warranted in this case.

37. EROSION
• This can be the result of soft or friable tablets
(and the pan turning too fast), an over-wetted
tablet surface, inadequate drying, or lack of
tablet surface strength.

38. Peeling and frosting
This is a defect where the coating peels
away from the tablet surface in a sheet.
Peeling indicates that the coating solution
did not lock into the tablet surface. This
could be due to a defect in the coating
solution, over-wetting, or high moisture
content in the tablet core which prevented
the coating to adhering.

39. REFERENCES
• http://www.labequipmentsindia.com/product/image/2252.jpg
• http://product-image.esuppliersindia.com/00431839/s/3/Tablet-Punching-M
• http://www.gmpchina.net/image/p/gzpt1060.jpg
• The theory and practice of industrial pharmacy by Leon Lachman,
Herbert A Lieberman.
http://www.authorstream.com/Presentation/sabapathi-369361-problems-ta
•
http://www.justice.gov/dea/programs/forensicsci/microgram/mg0206/mg02
• http://upload.wikimedia.org/wikipedia/en/2/27/Tabletfailure.jpg