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32 MESINA, Kimberly Mae N.

Defect
1. Cracking

Definition
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 the unequal
distribution of
color on a tablet,
with light or dark
spots standing
out in an
otherwise
uniform surface

Reason
It is observed
as a result of
rapid
expansion of
tablets,
especially
when deep
concave
punches are
used.
Occurs
because of
variations in
the colors of
ingredients
(drug and
other
additives).

3. Cratering

It is defect of
film coating
whereby
volcanic-like
craters appears
exposing the
tablet surface.

4. Chipping

It is defect where
the film becomes
chipped and
dented, usually
at the edges of
the tablet.

The coating
solution
penetrates the
surface of the
tablet, often at
the crown
where the
surface is more
porous,
causing
localized
disintegration
of the core and
disruption of
the coating.
A Decrease in
fluidizing air or
speed of
rotation of the
drum in pan
coating.

5. Capping

The upper of
lower segment of
the tablet
separates
horizontally
either partially or
completely from
the main body
and comes off as
a cap, during

2. Mottling

Illustration

2APH

Due to the airentrapment


and
subsequent
expansion of
tablet on
ejection of a
tablet from a
die.

PHAR3
Remedy
- Add dry
binders.
- Moisten the
granules
properly.
- Reduce
granule size.
- Use
tapered die.
- Mix
properly.
- Proper
drying by
reducing the
drying
temperature.
- Use
appropriate
colorants.
- Increase
viscosity of
coating
solution to
decrease
spray
application
rate.
-Use efficient
and
optimum
drying
conditions.
- Increase
hardness of
the film by
increasing
the
molecular
weight grade
of polymer.
- Increase
the amount
of binder.
- Use flat
punches.
- Dry the
granules
properly.

32 MESINA, Kimberly Mae N.

6. Twinning

2APH
ejection from the
tablet press, or
during
subsequent
handling.
By their nature,
sugarcoating
formulations are
very sticky,
particularly as
they begin to
dry, and allow
adjacent tablets
to stick together.

7. Orange Peel
Roughness

Inadequate
spreading of the
coating solution
before drying
causes a bumpy
or orange-peel
effect on the
coating.

8. Picking

It is defect where
isolated areas of
film are pulled
away from the
surface when the
tablet sticks
together and
then part.

9. Bridging of
Logos
(Intagliations)

Coating fills in
the letter or logo
on the tablet.

Build up of
multiples when
the tablets
being coated
have flat
surface, which
can easily
come into
contact with
one another.
This is caused
by process
conditions
which
include low
spray rates
coupled with
excessive
drying
conditions and
use of
excessive
atomizing air
pressures.
Conditions
similar to
cratering that
produces an
overly wet
tablet bed
where adjacent
tablets can
stick together
and then break
apart.

A component
of the internal
stress becomes
sufficiently
high so as to
cause partial or
complete
detachment

PHAR3

- Appropriate
choice in
tablet punch
design can
be
effectively
used to
minimize the
problem.
- Adjust the
spray rate
and drying
conditions.

- 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.
- Improve
film
adhesion by
adjusting
plasticizer
content.
- Appropriate
design of

32 MESINA, Kimberly Mae N.

2APH
of the coating
in the region of
logo.

10.Lamination

Separation of a
tablet into two or
more distinct
horizontal layers.

Air-entrapment
during
compression
and
subsequent
release on
ejection.

PHAR3
tablet
punches with
respect to
logo.
- Increase
the amount
of binder.
- Increase
the amount
or change
the
lubricant.

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