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TABLET PROCESSING PROBLEMS

AND ITS REMEDIES


BY-KRISHNA PRIYA JHA & HARISH SHARMA
ND
(B.PHARM 2 YEAR)

•Capping •Mottling
•Cracking
•Small, fine cracks observed on the upper and lower central surface
•Capping is the term used, when the upper or •Mottling is the term used to describe an unequal
of tablets, or very rarely on the sidewall are referred to as Cracks.
lower segment of the tablet separates horizontally distribution of colour on a tablet.
during ejection from the tablet press, or during
subsequent handling. Formulation related Machine related

Formulation related Machine related Causes Remedies Causes Remedies Causes Remedies
Large size of granules. Reduce granule size. Add Tablet expands on ejection Use tapered die. A coloured drug used along with colourless or white-
Causes Remedies Causes Remedies Use appropriate colourants.
fines. due to air entrapment coloured excipients.
Large amount of fines in Remove some or all fines Poorly finished dies Polish dies properly
the granulation through 100 to 200 mesh Too dry granules. Moisten the granules Deep concavities cause Use special take-off Change the solvent system, Change the binder,
screen. properly and add proper cracking while removing A dye migrates to the surface of granulation while drying. Reduce drying temperature and Use a smaller particle
Capping Low moisture content. Moisten the granules. Deep concave punches. Use flat punches
amount of binder. tablets size.

Tablets expand. Add dry binders. Improperly mixed dye, especially during ‘Direct Mix properly and reduce size if it is of a larger size to
Insufficient amount of Increasing or change the Lower punch remains Make proper setting of
Compression’. prevent segregation.
binder or improper binder. type of binder. below the face of die during lower punch during ejection
ejection. Granulation too cold Compress at room

Lamination Insufficient or improper Increase or change the High turret speed Reduce speed of turret
temperature

Improper mixing of a coloured binder solution.


Incorporate dry colour additive during powder blending
step, then add fine powdered adhesives such as acacia
Process lubricant. type of lubricant.
•Chipping
and tragacanth and mix well and finally add granulating
liquid.

Related •Chipping‘ is defined as the breaking of tablet edges,


while the tablet leaves the press or during subsequent
Cracking handling
Formulation related Machine related
•Binding Causes Remedies Causes Remedies •Sticking
Sticking on punch faces
Chipping •Sticking of the tablet to the die and does
Dry the granules properly or Groove of die worn at
increase lubrication. compression point
Polish to open end, reverse
or replace the die.
not eject properly out of the die •Sticking refers to the tablet material
Too dry granules. Moisten the granules Barreled die (center of the Polish the die to make it
die wider than ends) cylindrical adhering to the die wall.
Formulation related Machine related
Visual Causes Remedies Causes Remedies
Defects Formulation Sticking Too moist granules. Dry the granules properly. Poorly finished dies. Polish the dies properly.
Too much binding causes
chipping at bottom.
Optimize binding, or use dry Edge of punch face turned
binders. inside/inward
Polish the punch edges
Formulation related Machine related
Causes Remedies Causes Remedies
Related Insufficient or improper
lubricant.
Increase or change
lubricant
Rough dies due to
abrasion, corrosion.
Investigate other steels. Concavity too deep to Reduce concavity of punch
Granules not dried Dry the granules properly Concavity too deep for Reduce concavity to
compress properly faces. Use flat punches.
Too coarse granules. Reduce granular size. Undersized dies Rework to proper size. properly granulation optimum

Picking Too hard granules for the


lubricant to be effective.
Modify granulation. Reduce
granular size.
Too much pressure in the
tablet press.
Reduce pressure. Too little or improper
lubrication
Increase or change
lubricant
Too little pressure Increase pressure

Granular material too Too much binder Reduce or use another Compressing is too fast. Reduce speed
Reduce temperature.
warm. binder.

•Picking Oily or way materials Modify mixing process.


Binding Add an absorbent
Too soft or weak granules Optimize the amount of
•Picking is a more specific term that describes binder
•Lamination product sticking only within the letters, logos, or
designs on the punch faces.
• Lamination is the separation of a
•Problems and remedies for tablet coating
tablet into two or more distinct Formulation related Machine related
Problem Definition Causes Remedy
horizontal layers.
Causes Remedies Causes Remedies
Machine Double Granules not dried properly Dry the granules properly Rough punch faces Polish faces
BLISTERING It is local detachment of film from
the substrate forming blister.
Effect of temperature on
the strength, elasticity and
Use mild drying condition.

Related Impression Formulation related Machine related Too little or improper lubrication Increase or change lubricant Dividing line is too Reduce depths
adhesion of the film.
Use efficient and optimum
deep drying conditions.
Causes Remedies Causes Remedies It is defect of film coating Inefficient drying.
Low melting point substances, may soften Use high meting point lubricants. Pressure applied is Increase CRATERING whereby volcanic-like craters
Oily or waxy materials in Modify mixing process. Rapid relaxation of the Use tapered dies, i.e. Increase viscosity of
from the heat of compression. not enough pressure to appears exposing the tablet Higher rate of application
granules. Add adsorbent or peripheral regions of a upper part of the die coating solution to
optimum surface of coating solution.
decrease spray application
absorbent tablet, on ejection from a bore has an outward Low melting point medicament in high Refrigerate granules and the rate.
die. taper of 3° to 5°. concentration. entire tablet press.
It is It is defect where isolated Increase the inlet air
Too much of Use a less amount of Rapid decompression Use pre-compression areas of film are pulled away Inefficient drying. temperature
hydrophobic lubricant. lubricant or change the step. Reduce turret Too warm granules when compressing Cool sufficiently before PICKING AND from the surface when the tablet
type of lubricant. speed and reduce the compression. STICKING sticks together or to the pan and Higher rate of application Decrease the rate of
final compression Too much amount of binder Reduce or change binder. then detached from one another of coating solution. application of coating
pressure. or from the pan. solution.

It is defect whereby pits occur in Inappropriate drying (inlet Increase the drying (inlet
the surface of a tablet core without air ) temperature air) temperature
PITTING
any visible disruption of the film
coating
It is defect where coating becomes High concentration and Decrease plasticizer
dull immediately or after prolonged low molecular weight of concentration and
BLOOMING
storage at high temperatures plasticizer. increase molecular weight
of plasticizer.
A defect which involves variation in Improper mixing, uneven Go for geometric mixing,
colour of the film. spray pattern, insufficient reformulation with
COLOR coating, migration of different plasticizers and
VARIATION soluble dyes-plasticizers additives or use mild
and other additives during drying conditions.
drying.

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