NO. 40 PESIGAN, LEA ELLANA E.
Name of Defect
1. Chipping
Description
Defect where the film becomes
chipped and dented, usually at the
edges of the tablet
SEPT. 30, 2015
Illustration
Reason
It may be due to sticking or
to damaged punches or
incorrectly
to
tablet
machine.
Remedy
- Increase hardness of the
film by increasing the
molecular weight grade of
polymer
2. Mottling
Unequal distribution of color on a
tablet, with light or dark spots
standing out in an otherwise
uniform surface
One reason for mottling is
drug whose colour differs
from the tablet excipients,
or a drug whose degradation
products are coloured.
-Use appropriate colorants
- Mix properly and reduce
size if it is of a larger size to
prevent segregation
3. Capping
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
Surface defect resulting in the film
being rough and nonglossy.
Appearance is similar to that of an
orange.
It is due to air entrapped in
the die which compressed as
punches move together to
apply pressure, and which
then expands when the
pressure is released.
- Use flat punches
- Reduce speed of turret
(Increase dwell time)
- Polish dies properly
- Dry the granules properly
Inadequate spreading of the
coating solution before
drying.
- Adjust the spray rate and
drying conditions.
Entrapment of gases in or
underneath the film due to
overheating either during
spraying or at the end of the
coating run.
Use of
condition.
4. Orange
Peel
(Roughn
ess)
5. Blisterin
g
6. Binding
7. Craterin
g
8. Laminati
on
It is local detachment of film from
the substrate forming blister.
The resistance of the tablet to
ejection from the die cavity, due to
adherence to the die wall.
Defect of film coating whereby
volcanic-like
craters
appears
exposing the tablet surface
It is the separation of a tablet into
two or more horizontal layers.
It is generally due
insufficient lubrication
to
The
coating
solution
penetrates the surface of the
tablet, often at the crown
where the surface is more
porous, causing localized
disintegra-tion of the core
and disruption of the coating
It is caused by the same
factors as capping but by
exaggerated conditions at
high speed. Its also due to
poorly cohesive or oily
granules.
9. 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
It is due to expansion to
expansion as distinguished
from
capping
and
laminating. It may be also
due to binding or sticking.
mild
drying
Can be solved in some cases
by modifying granules to
reduce granule size or by
increasing
punch
die
clearance.
- Use efficient and optimum
drying conditions
- Increase viscosity of
coating solution to decrease
spray application rate
Modifying mixing process.
Add adsorbent or absorbent.
Another one is to use a less
amount of lubricant or
change the type of lubricant.
Remedied by replacing or
refacing nicked or chipped
punches, resetting the tablet
machine, by increasing
binder or by wetting
granulation. It can also be
corrected
by
polishing
punch tips, removing some
or all lines and by reducing
the granule size.
10.Picking
Defect where isolated areas of film
are pulled away from the surface
when the tablet sticks together and
then part.
It is particular concern when
punch tips have engraving
or embossing letters, as well
as the granular material is
improperly dried.
- Use optimum and efficient
drying
conditions
or
increase the inlet air
temperature
- Decrease the rater of
application
of
coating
solution
by
increasing
viscosity
of
coating
solution.