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