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TABLET PROCESSING PROBLEMS
AND ITS REMEDIES
BY-KRISHNA PRIYA JHA & HARISH SHARMA
(B.PHARM 2ND YEAR)
Visual
Defects
Process
Related
Capping
Lamination
Cracking
Chipping
Formulation
Related
Sticking
Picking
Binding
Machine
Related
Double
Impression
•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 in
the granulation
Remove some or all fines
through 100 to 200 mesh
screen.
Poorly finished dies Polish dies properly
Low moisture content. Moisten the granules. Deep concave punches. Use flat punches
Insufficient amount of
binder or improper binder.
Increasing or change the
type of binder.
Lower punch remains
below the face of die during
ejection.
Make proper setting of
lower punch during ejection
Insufficient or improper
lubricant.
Increase or change the
type of lubricant.
High turret speed Reduce speed of turret
• Lamination is the separation of a
tablet into two or more distinct
horizontal layers.
•Lamination
Formulation related Machine related
Causes Remedies Causes Remedies
Oily or waxy materials in
granules.
Modify mixing process.
Add adsorbent or
absorbent
Rapid relaxation of the
peripheral regions of a
tablet, on ejection from a
die.
Use tapered dies, i.e.
upper part of the die
bore has an outward
taper of 3° to 5°.
Too much of
hydrophobic lubricant.
Use a less amount of
lubricant or change the
type of lubricant.
Rapid decompression Use pre-compression
step. Reduce turret
speed 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 granules. Reduce granule size. Add
fines.
Tablet expands on ejection
due to air entrapment
Use tapered die.
Too dry granules. Moisten the granules
properly and add proper
amount of binder.
Deep concavities cause
cracking while removing
tablets
Use special take-off
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 faces Dry the granules properly or
increase lubrication.
Groove of die worn at
compression point
Polish to open end, reverse
or replace the die.
Too dry granules. Moisten the granules Barreled die (center of the
die wider than ends)
Polish the die to make it
cylindrical
Too much binding causes
chipping at bottom.
Optimize binding, or use dry
binders.
Edge of punch face turned
inside/inward
Polish the punch edges
Concavity too deep to
compress properly
Reduce concavity of 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
properly
Dry the granules properly Concavity too deep for
granulation
Reduce concavity to
optimum
Too little or improper
lubrication
Increase or change
lubricant
Too little pressure Increase pressure
Too much binder Reduce or use another
binder.
Compressing is too fast. Reduce speed
Oily or way materials Modify mixing process.
Add an absorbent
Too soft or weak granules Optimize the amount of
binder•Picking is a more specific term that describes
product sticking only within the letters, logos, or
designs on the punch faces.
•Picking
Formulation related Machine related
Causes Remedies Causes Remedies
Granules not dried properly Dry the granules properly Rough punch faces Polish faces
Too little or improper lubrication Increase or change lubricant Dividing line is too
deep
Reduce depths
Low melting point substances, may soften
from the heat of compression.
Use high meting point lubricants. Pressure applied is
not enough
Increase
pressure to
optimum
Low melting point medicament in high
concentration.
Refrigerate granules and the
entire tablet press.
Too warm granules when compressing Cool sufficiently before
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
Too moist granules. Dry the granules properly. Poorly finished dies. Polish the dies properly.
Insufficient or improper
lubricant.
Increase or change
lubricant
Rough dies due to
abrasion, corrosion.
Investigate other steels.
Too coarse granules. Reduce granular size. Undersized dies Rework to proper size.
Too hard granules for the
lubricant to be effective.
Modify granulation. Reduce
granular size.
Too much pressure in the
tablet press.
Reduce pressure.
Granular material too
warm.
Reduce temperature.
•Mottling is the term used to describe an unequal
distribution of colour on a tablet.
•Mottling
Causes Remedies
A coloured drug used along with colourless or white-
coloured excipients.
Use appropriate colourants.
A dye migrates to the surface of granulation while drying.
Change the solvent system, Change the binder,
Reduce drying temperature and Use a smaller particle
size.
Improperly mixed dye, especially during ‘Direct
Compression’.
Mix properly and reduce size if it is of a larger size to
prevent segregation.
Improper mixing of a coloured binder solution.
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.
•Problems and remedies for tablet coating
Problem Definition Causes Remedy
BLISTERING It is local detachment of film from
the substrate forming blister.
Effect of temperature on
the strength, elasticity and
adhesion of the film.
Use mild drying condition.
CRATERING
It is defect of film coating
whereby volcanic-like craters
appears exposing the tablet
surface
Inefficient drying.
Higher rate of application
of coating solution.
Use efficient and optimum
drying conditions.
Increase viscosity of
coating solution to
decrease spray application
rate.
PICKING AND
STICKING
It is It is defect where isolated
areas of film are pulled away
from the surface when the tablet
sticks together or to the pan and
then detached from one another
or from the pan.
Inefficient drying.
Higher rate of application
of coating solution.
Increase the inlet air
temperature
Decrease the rate of
application of coating
solution.
PITTING
It is defect whereby pits occur in
the surface of a tablet core without
any visible disruption of the film
coating
Inappropriate drying (inlet
air ) temperature
Increase the drying (inlet
air) temperature
BLOOMING
It is defect where coating becomes
dull immediately or after prolonged
storage at high temperatures
High concentration and
low molecular weight of
plasticizer.
Decrease plasticizer
concentration and
increase molecular weight
of plasticizer.
COLOR
VARIATION
A defect which involves variation in
colour of the film.
Improper mixing, uneven
spray pattern, insufficient
coating, migration of
soluble dyes-plasticizers
and other additives during
drying.
Go for geometric mixing,
reformulation with
different plasticizers and
additives or use mild
drying conditions.

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Tablet processing problems and its remedies for poster presemntation

  • 1. TABLET PROCESSING PROBLEMS AND ITS REMEDIES BY-KRISHNA PRIYA JHA & HARISH SHARMA (B.PHARM 2ND YEAR) Visual Defects Process Related Capping Lamination Cracking Chipping Formulation Related Sticking Picking Binding Machine Related Double Impression •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 in the granulation Remove some or all fines through 100 to 200 mesh screen. Poorly finished dies Polish dies properly Low moisture content. Moisten the granules. Deep concave punches. Use flat punches Insufficient amount of binder or improper binder. Increasing or change the type of binder. Lower punch remains below the face of die during ejection. Make proper setting of lower punch during ejection Insufficient or improper lubricant. Increase or change the type of lubricant. High turret speed Reduce speed of turret • Lamination is the separation of a tablet into two or more distinct horizontal layers. •Lamination Formulation related Machine related Causes Remedies Causes Remedies Oily or waxy materials in granules. Modify mixing process. Add adsorbent or absorbent Rapid relaxation of the peripheral regions of a tablet, on ejection from a die. Use tapered dies, i.e. upper part of the die bore has an outward taper of 3° to 5°. Too much of hydrophobic lubricant. Use a less amount of lubricant or change the type of lubricant. Rapid decompression Use pre-compression step. Reduce turret speed 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 granules. Reduce granule size. Add fines. Tablet expands on ejection due to air entrapment Use tapered die. Too dry granules. Moisten the granules properly and add proper amount of binder. Deep concavities cause cracking while removing tablets Use special take-off 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 faces Dry the granules properly or increase lubrication. Groove of die worn at compression point Polish to open end, reverse or replace the die. Too dry granules. Moisten the granules Barreled die (center of the die wider than ends) Polish the die to make it cylindrical Too much binding causes chipping at bottom. Optimize binding, or use dry binders. Edge of punch face turned inside/inward Polish the punch edges Concavity too deep to compress properly Reduce concavity of 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 properly Dry the granules properly Concavity too deep for granulation Reduce concavity to optimum Too little or improper lubrication Increase or change lubricant Too little pressure Increase pressure Too much binder Reduce or use another binder. Compressing is too fast. Reduce speed Oily or way materials Modify mixing process. Add an absorbent Too soft or weak granules Optimize the amount of binder•Picking is a more specific term that describes product sticking only within the letters, logos, or designs on the punch faces. •Picking Formulation related Machine related Causes Remedies Causes Remedies Granules not dried properly Dry the granules properly Rough punch faces Polish faces Too little or improper lubrication Increase or change lubricant Dividing line is too deep Reduce depths Low melting point substances, may soften from the heat of compression. Use high meting point lubricants. Pressure applied is not enough Increase pressure to optimum Low melting point medicament in high concentration. Refrigerate granules and the entire tablet press. Too warm granules when compressing Cool sufficiently before 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 Too moist granules. Dry the granules properly. Poorly finished dies. Polish the dies properly. Insufficient or improper lubricant. Increase or change lubricant Rough dies due to abrasion, corrosion. Investigate other steels. Too coarse granules. Reduce granular size. Undersized dies Rework to proper size. Too hard granules for the lubricant to be effective. Modify granulation. Reduce granular size. Too much pressure in the tablet press. Reduce pressure. Granular material too warm. Reduce temperature. •Mottling is the term used to describe an unequal distribution of colour on a tablet. •Mottling Causes Remedies A coloured drug used along with colourless or white- coloured excipients. Use appropriate colourants. A dye migrates to the surface of granulation while drying. Change the solvent system, Change the binder, Reduce drying temperature and Use a smaller particle size. Improperly mixed dye, especially during ‘Direct Compression’. Mix properly and reduce size if it is of a larger size to prevent segregation. Improper mixing of a coloured binder solution. 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. •Problems and remedies for tablet coating Problem Definition Causes Remedy BLISTERING It is local detachment of film from the substrate forming blister. Effect of temperature on the strength, elasticity and adhesion of the film. Use mild drying condition. CRATERING It is defect of film coating whereby volcanic-like craters appears exposing the tablet surface Inefficient drying. Higher rate of application of coating solution. Use efficient and optimum drying conditions. Increase viscosity of coating solution to decrease spray application rate. PICKING AND STICKING It is It is defect where isolated areas of film are pulled away from the surface when the tablet sticks together or to the pan and then detached from one another or from the pan. Inefficient drying. Higher rate of application of coating solution. Increase the inlet air temperature Decrease the rate of application of coating solution. PITTING It is defect whereby pits occur in the surface of a tablet core without any visible disruption of the film coating Inappropriate drying (inlet air ) temperature Increase the drying (inlet air) temperature BLOOMING It is defect where coating becomes dull immediately or after prolonged storage at high temperatures High concentration and low molecular weight of plasticizer. Decrease plasticizer concentration and increase molecular weight of plasticizer. COLOR VARIATION A defect which involves variation in colour of the film. Improper mixing, uneven spray pattern, insufficient coating, migration of soluble dyes-plasticizers and other additives during drying. Go for geometric mixing, reformulation with different plasticizers and additives or use mild drying conditions.