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NO.

40

SEPT. 30, 2015

PESIGAN, LEA ELLANA E.


2E-PH
Name of Defect
1. Chipping

2. Mottling

3. Capping

Description

Defect where
the
film
becomes
chipped and
dented,
usually at the
edges of the
tablet
Unequal
distribution of
color on a
tablet,
with
light or dark
spots standing
out
in
an
otherwise
uniform
surface
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

Illustration

Reason

Remedy

It may be
due
to
sticking or to
damaged
punches or
incorrectly to
tablet
machine.
One reason
for mottling
is
drug
whose colour
differs from
the
tablet
excipients, or
a drug whose
degradation
products are
coloured.

- Increase hardness
of the film by
increasing
the
molecular weight
grade of polymer

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 appropriate
colorants
- Mix properly and
reduce size if it is
of a larger size to
prevent
segregation

- Use flat punches


- Reduce speed of
turret
(Increase
dwell time)
Polish
dies
properly
- Dry the granules
properly

4. Orange
Peel
(Roughnes
s)

Surface defect
resulting in the
film
being
rough
and
nonglossy.
Appearance is
similar to that
of an orange.

5. Blistering

It is local
detachment of
film from the
substrate
forming
blister.

6. Binding

The resistance
of the tablet to
ejection from
the die cavity,
due
to
adherence to
the die wall.

7. Cratering

Defect of film
coating
whereby
volcanic-like
craters appears
exposing the
tablet surface

Inadequate
spreading of
the coating - Adjust the spray
solution
rate and drying
before
conditions.
drying.

Entrapment
of gases in or
Use of mild drying
underneath
the film due condition.
to
overheating
either during
spraying or
at the end of
the coating
run.
Can be solved in
It
is some cases by
generally due modifying
to
granules to reduce
insufficient
granule size or by
lubrication
increasing punch
die clearance.
The coating
solution
- Use efficient and
penetrates
optimum drying
the surface of conditions
the
tablet, Increase
often at the viscosity
of
crown where coating solution to
the surface is decrease
spray
more porous, application rate
causing
localized
disintegration of the
core
and
disruption of
the coating

8. Laminatio
n

It
is
the
separation of a
tablet into two
or
more
horizontal
layers.

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

10.
ng

Picki

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.

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.

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.
- 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.

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