32 MESINA, Kimberly Mae N.
3APH
Defect
1. 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.”
2. Mottling
It is the unequal distribution
of color on a tablet, with light
or dark spots standing out in
an otherwise uniform surface
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.
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 ejection from the
tablet press, or during
subsequent handling.
6. Twinning
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.
PHAR6
Illustration 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).
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.
Due to the air-
entrapment and
subsequent expansion of
tablet on ejection of a
tablet from a die.
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 of the
coating in the region of
logo.
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.
- 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 tablet punches with
respect to logo.
32 MESINA, Kimberly Mae N. 3APH
10. Lamination Air-entrapment during
Separation of a tablet into compression and
two or more distinct subsequent release on
horizontal layers. ejection.
11. Blistering Overheating during
It is the local detachment of spraying coating solution.
film from the substrate.
12. Pitting Temperature of the tablet
Pits occur in the surface of a core is greater than the
tablet core without any melting point of the
visible disruption of the film materials used in the
coating. tablet formulation and
inappropriate drying
(inlet air ) temperature.
13. Blooming Due to collection on the
Coating becomes dull surface of low molecular
immediately or after weight ingredients
prolonged storage at high (usually plasticizers)
temperatures. included in the coating
formulation.
14. Infilling Bubble or foam formation
Renders the logo’s haziness. because of air spraying of
a polymer solution.
15. Blushing High coating temperature
Formation of specks or and use of sorbitol in
haziness in the film. formulation which causes
largest fall in the thermal
gelation temperature
Reference:
Rana, A. S., & Kumar, S. L. (2013). Manufacturing defects of tablets: A review. Journal of Drug Delivery &
Therapeutics, 3(6), 200-206
PHAR6
- Increase the amount
of binder.
- Increase the amount
or change the
lubricant.
- Process in a mild
drying condition.
- Preheating
procedures at the
initiation of coating
- Modifying the drying
(inlet air) temperature
- Decrease plasticizer
concentration
- Increase molecular
weight of plasticizer
- Add alcohol
- Use spray nozzle
capable of finer
atomization
- Reduction of the
drying air
temperature
- Avoid use of sorbitol
with Hydroxy Propyl
Cellulose, Hydroxy
Propyl Methyl
Cellulose, Methyl
Cellulose and
Cellulose ethers