Tablet processing

problems and their

remedies

Baharul Islam
Dept. of Pharmacy, SUB
pharmbahar@gmail.com
 Introduction
A tablet is a solid dosage form. It comprises a mixture
of active substances and excipients, usually in powder
form, which is pressed or compacted from a powder
into a solid dose.

An ideal tablet should be free from any visual defect

or functional defect. Defects in tablet are related to
imperfections in any one or more of the following
factors:

Tableting Process Formulation Machine

 Tablet defects

Capping

Mottling Lamination

Double
Cracking
Impression
Tablet
defects

Binding
Chipping

Picking Sticking
 Capping
• Capping is the term used, when the upper
or lower segment of the tablet separates
horizontally during ejection from the tablet
press, or during subsequent handling.

Formulation related Machine related

Causes Remedies Causes Remedies
Large amount of fines Remove some or all Poorly finished dies Polish dies properly
in the granulation fines through 100 to
200 mesh screen.
Low moisture content. Moisten the granules. Deep concave Use flat punches
punches.
Insufficient amount of Increasing or change Lower punch remains Make proper setting
binder or improper the type of binder. below the face of die of lower punch during
binder. during ejection. ejection
Insufficient or Increase or change the High turret speed Reduce speed of turret
improper lubricant. type of lubricant.
 Lamination
• Lamination is the separation
of a tablet into two or more
distinct horizontal layers.

Formulation related Machine related

Causes Remedies Causes Remedies
Oily or waxy Modify mixing Rapid relaxation of Use tapered dies,
materials in process. Add the peripheral i.e. upper part of
granules. adsorbent or regions of a tablet, the die bore has an
absorbent on ejection from a outward taper of 3°
die. to 5°.
Too much of Use a less amount Rapid Use pre-
hydrophobic of lubricant or decompression compression step.
lubricant. change the type of Reduce turret speed
lubricant. and reduce the final
compression
pressure.
 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.

Formulation related Machine related

Causes Remedies Causes Remedies
Large size of Reduce granule size. Tablet expands on Use tapered die.
granules. Add fines. ejection due to air
entrapment
Too dry granules. Moisten the granules Deep concavities Use special take-off
properly and add cause cracking while
proper amount of removing tablets
binder.
Tablets expand. Add dry binders.
Granulation too cold Compress at room
temperature
 Chipping
Chipping‘ is defined as the breaking
of tablet edges, while the tablet leaves
the press or during subsequent
handling

Formulation related Machine related

Causes Remedies Causes Remedies
Sticking on punch Dry the granules Groove of die worn at Polish to open end,
faces properly or increase compression point reverse or replace the
lubrication. die.
Too dry granules. Moisten the granules Barreled die (center Polish the die to make
of the die wider than it cylindrical
ends)
Too much binding Optimize binding, or Edge of punch face Polish the punch
causes chipping at use dry binders. turned inside/inward edges
bottom.
Concavity too deep to Reduce concavity of
compress properly punch faces. Use flat
punches.
 Sticking

Sticking refers to the tablet material

adhering to the die wall.

Formulation related Machine related

Causes Remedies Causes Remedies
Granules not dried Dry the granules Concavity too deep Reduce concavity to
properly properly for granulation optimum
Too little or improper Increase or change Too little pressure Increase pressure
lubrication lubricant
Too much binder Reduce or use another Compressing is too Reduce speed
binder. fast.
Oily or way materials Modify mixing
process. Add an
absorbent
Too soft or weak Optimize the amount
granules of binder
 Picking
Picking is a more specific term that describes
product sticking only within the letters, logos, or
designs on the punch faces.
Formulation related Machine related
Causes Remedies Causes Remedies
Granules not dried properly Dry the granules properly Rough punch Polish faces
faces
Too little or improper lubrication Increase or change Dividing line is Reduce
lubricant too deep depths
Low melting point substances, Use high meting point Pressure Increase
may soften from the heat of lubricants. applied is not pressure to
compression. enough optimum
Low melting point medicament in Refrigerate granules and
high concentration. the entire tablet press.

Too warm granules when Cool sufficiently before

compressing compression.
Too much amount of binder Reduce or change binder.
 Binding
Sticking of the tablet to the die and does not
eject properly out of the die

Formulation related Machine related

Causes Remedies Causes Remedies
Dry the granules Polish the dies
Too moist granules. Poorly finished dies.
properly. properly.
Insufficient or Increase or change Rough dies due to Investigate other
improper lubricant. lubricant abrasion, corrosion. steels.
Rework to proper
Too coarse granules. Reduce granular size. Undersized dies
size.
Too hard granules for
Modify granulation. Too much pressure in
the lubricant to be Reduce pressure.
Reduce granular size. the tablet press.
effective.
Granular material too
Reduce temperature.
warm.
 Mottling
Mottling is the term used to describe
an unequal distribution of colour on a
tablet.

The Causes And Remedies

Causes Remedies
A coloured drug used along with colourless or
Use appropriate colourants.
white-coloured excipients.
Change the solvent system, Change the binder,
A dye migrates to the surface of granulation
Reduce drying temperature and Use a smaller
while drying.
particle size.
Improperly mixed dye, especially during Mix properly and reduce size if it is of a larger
‘Direct Compression’. size to prevent segregation.
Incorporate dry colour additive during powder
blending step, then add fine powdered
Improper mixing of a coloured binder solution.
adhesives such as acacia and tragacanth and
mix well and finally add granulating liquid.
 Double impression
It is due to free rotation of punches which have some engraving or
monogram on the punch faces. During his 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

Causes Remedies
-Use keying in tooling, i.e. inset a
key alongside of the punch, so that
it fits the punch and
Free rotation of either upper punch or
prevents punch rotation.
lower punch during ejection of a
tablet.
-Newer presses have anti-turning
devices, which prevent punch
rotation.
 Problems and remedies for tablet coating
Problem Definition Causes Remedy
Effect of temperature
It is local detachment of Use mild drying
BLISTERING on the strength,
film from the substrate condition.
elasticity and adhesion
forming blister.
of the film.
Use efficient and
optimum drying
Inefficient drying.
It is defect of film coating conditions.
CRATERING whereby volcanic-like
Higher rate of
craters appears exposing the Increase viscosity of
application of coating
tablet surface coating solution to
solution.
decrease spray
application rate.

It is It is defect where
isolated areas of film are
pulled away from the
PICKING AND
surface when the tablet
STICKING
sticks together or to the pan
and then detached from one
another or from the pan.
Increase the inlet air
Inefficient drying.
temperature
Higher rate of
Decrease the rate of
application of coating
application of coating
solution.
solution.
 Problems and remedies for tablet coating
Problem Definition Causes Remedy
It is defect whereby pits occur Inappropriate drying Increase the drying
in the surface of a tablet core (inlet air ) temperature (inlet air) temperature
PITTING without any visible disruption
of the film coating

It is defect where coating High concentration Decrease plasticizer

becomes dull immediately or and low molecular concentration and
BLOOMING after prolonged storage at high weight of plasticizer. increase molecular
temperatures weight of plasticizer.

A defect which involves Improper mixing, Go for geometric

variation in colour of the film. uneven spray pattern, mixing, reformulation
insufficient coating, with different
migration of soluble plasticizers and
COLOR
dyes-plasticizers and additives or use mild
VARIATION
other additives during drying conditions.
drying.
 Problems and remedies for tablet coating
Problem Definition Causes Remedy
Rapid Drying Use mild drying
It is surface defect resulting in
ORANGE conditions.
the film being rough and non
PEEL High solution
glossy. Appearance is similar
EFFECT viscosity Decrease viscosity of
to that of an orange.
solution.
•High spray rate •Reduce spray rate
•High viscosity of •Reduce viscosity
This occurs when the coating solution, •Reduce percentage of
BRIDGING fills in the lettering or logo on •High percentage of solid
the tablet solids in the solution, •Use proper
•Improper atomization atomization pressure
pressure.

CRACKIN
or
SPLITTING
Thank u all
It is defect in which the film
either cracks across the crown
of the tablet (cracking) or
splits around the edges of the
Use of higher
molecular weight
polymers or polymeric
blends.
Use lower molecular
weight polymers or
polymeric blends.
Also adjust plasticizer
tablet (Splitting). type and
concentration.