Pharmaceutical Manufacturing Lecture HW

32 MESINA, Kimberly Mae N.
3APH PHAR6
Defect Illustration Reason Remedy
1. Cracking It is observed as a result - Add dry binders.
Small, fine cracks observed of rapid expansion of - Moisten the
on the upper and lower tablets, especially when granules properly.
central surface of tablets, or deep concave punches - Reduce granule size.
very rarely on the sidewall are used. - Use tapered die.
are referred to as “cracks.”
2. Mottling Occurs because of - Mix properly.
It is the unequal distribution variations in the colors of - Proper drying by
of color on a tablet, with light ingredients (drug and reducing the drying
or dark spots standing out in other additives). temperature.
an otherwise uniform surface - Use appropriate
colorants.
3. Cratering The coating solution - Increase viscosity of
It is defect of film coating penetrates the surface of coating solution to
whereby volcanic-like craters the tablet, often at the decrease spray
appears exposing the tablet crown where the surface application rate.
surface. is more porous, causing -Use efficient and
localized disintegration of optimum drying
the core and disruption of conditions.
the coating.
4. Chipping A Decrease in fluidizing - Increase hardness of
It is defect where the film air or speed of rotation of the film by increasing
becomes chipped and the drum in pan coating. the molecular weight
dented, usually at the edges grade of polymer.
of the tablet.
5. Capping Due to the air- - Increase the amount

The upper of lower segment entrapment and of binder.
of the tablet separates subsequent expansion of - Use flat punches.
horizontally either partially or tablet on ejection of a - Dry the granules
completely from the main tablet from a die. properly.
body and comes off as a cap,
during ejection from the
tablet press, or during
subsequent handling.
6. Twinning Build up of multiples - Appropriate choice
By their nature, sugarcoating when the tablets being in tablet punch design
formulations are very sticky, coated have flat surface, can be effectively
particularly as they begin to which can easily come used to minimize the
dry, and allow adjacent into contact with one problem.
tablets to stick together another.
7. Orange Peel Roughness This is caused by process - Adjust the spray rate
Inadequate spreading of the conditions !which include and drying conditions.
coating solution before low! spray rates coupled
drying causes a bumpy or with excessive drying
orange-peel effect on the conditions and use of
coating. excessive atomizing air
pressures.
8. Picking Conditions similar to - Use optimum and
It is defect where isolated cratering that produces efficient drying
areas of film are pulled away an overly wet tablet bed conditions or increase
from the surface when the where adjacent tablets the inlet air
tablet sticks together and can stick together and temperature.
then part. then break apart. - Decrease the rater of
application of coating
solution by increasing
viscosity of coating
solution.
9. Bridging of Logos A component of the - Improve film
(Intagliations) internal stress becomes adhesion by adjusting
Coating fills in the letter or sufficiently high so as to plasticizer content.
logo on the tablet. cause partial or complete - Appropriate design
detachment of the of tablet punches with
coating in the region of respect to logo.
logo.
32 MESINA, Kimberly Mae N. 3APH PHAR6
10. Lamination Air-entrapment during - Increase the amount
Separation of a tablet into compression and of binder.
two or more distinct subsequent release on - Increase the amount
horizontal layers. ejection. or change the
lubricant.
11. Blistering Overheating during - Process in a mild

It is the local detachment of spraying coating solution. drying condition.
film from the substrate.
12. Pitting Temperature of the tablet - Preheating

Pits occur in the surface of a core is greater than the procedures at the
tablet core without any melting point of the initiation of coating
visible disruption of the film materials used in the - Modifying the drying
coating. tablet formulation and (inlet air) temperature
inappropriate drying
(inlet air ) temperature.
13. Blooming Due to collection on the - Decrease plasticizer
Coating becomes dull surface of low molecular concentration
immediately or after weight ingredients - Increase molecular
prolonged storage at high (usually plasticizers) weight of plasticizer
temperatures. included in the coating
formulation.
14. Infilling Bubble or foam formation - Add alcohol

Renders the logo’s haziness. because of air spraying of - Use spray nozzle
a polymer solution. capable of finer
atomization
15. Blushing High coating temperature - Reduction of the

Formation of specks or and use of sorbitol in drying air
haziness in the film. formulation which causes temperature
largest fall in the thermal - Avoid use of sorbitol
gelation temperature with Hydroxy Propyl
Cellulose, Hydroxy
Propyl Methyl
Cellulose, Methyl
Cellulose and
Cellulose ethers
Reference:
Rana, A. S., & Kumar, S. L. (2013). Manufacturing defects of tablets: A review. Journal of Drug Delivery &
Therapeutics, 3(6), 200-206

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32 MESINA, Kimberly Mae N.

5. Capping Due to the air- - Increase the amount

11. Blistering Overheating during - Process in a mild

12. Pitting Temperature of the tablet - Preheating

14. Infilling Bubble or foam formation - Add alcohol

15. Blushing High coating temperature - Reduction of the

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