45. VIZCARRA, Ana Kristina B.

2GPH
10/03/2016

Defects of FC Tablets
Name

Lamination

Capping

Orange
Peel Effect

Illustration

Definition

- separation of
the tablet in
to two or
more distinct
horizontal
layers.

- the upper
layer or
lower
segment of
the tablets
separates
horizontally
during
ejection from
the tablet
press, or
during
subsequent
handling.
- surface defect
resulting in
the film
being rough
and non
glossy.
- appearance is
similar to
that of an
orange.

Cause
Oily or waxy
materials in
granules.

Rapid
decompression

Large amount
of fines in the
granulation

Insufficient
amount of
binder or
improper
binder

Remedy
Modify mixing
process.
Add adsorbent
or absorbent
Use precompression
step. Reduce
turret speed
and reduce the
final
compression
pressure
Remove some
or all fines
through 100 to
200 mesh
screen.

Increasing or
change the
type of binder

Rapid drying

Use mild
drying
conditions

High solution
viscosity

Use additional
solvents to
decrease the
viscosity of
solution

45. VIZCARRA, Ana Kristina B.

2GPH
10/03/2016

Defects of FC Tablets
- small, fine
cracks
observed on
the upper
and lower
central
surface of
tablets, or
very rarely
on the
sidewall
- It is local
detachment
of film from
the substrate
forming a
blister

Higher internal
stresses in the
film (more
than tensile
strength of the
film)

Adjust the
plasticizer &
pigment types
and
concentration
to minimize
internal
stresses

Over heating
during
spraying
coating
solution

use mild drying

condition

Bridging

- Coating fills in
the letter or
logo on the
tablet

High
percentage of
solid in coating
solution

Increase
plasticizer
contents or
change
plasticizer
concentration

Chipping

- it is the defect
where film
become
chipped and
dented,
usually at
the edges of
tablet

Excessive
attrition during
coating
process

Increase
hardness of the
film

Mottling

- an unequal
distribution
of colour on
a tablet.

A coloured
drug used
along with
colourless or
white-coloured
excipients.

Use
appropriate
colorants.

- sticking of the
tablet to the
die and does
not eject
properly out
of the die

Too moist
granules.

Dry the
granules
properly

Cracking

Blistering

Binding

45. VIZCARRA, Ana Kristina B.

2GPH
10/03/2016

Defects of FC Tablets

Picking

- product
sticking only
within the
letters,
logos, or
designs on
the punch
faces.

Too little or
improper
lubrication

Increase or
change
lubrication