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Tablet Coating Defects

The document lists various tablet coating defects, including blistering, blooming, and cracking, along with their causes and remedies. Each defect is described with specific factors that contribute to its occurrence and suggested solutions to mitigate the issues. The document serves as a comprehensive guide for identifying and addressing common problems in tablet coating processes.

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0% found this document useful (0 votes)
21 views20 pages

Tablet Coating Defects

The document lists various tablet coating defects, including blistering, blooming, and cracking, along with their causes and remedies. Each defect is described with specific factors that contribute to its occurrence and suggested solutions to mitigate the issues. The document serves as a comprehensive guide for identifying and addressing common problems in tablet coating processes.

Uploaded by

mitsbhatt4
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

List of tablet coating defects and

remedies
1. Blistering
2. Blooming/Dull film
3. Blushing
4. Chipping/ Edge Erosion
5. Cratering
6. Cracking/Splitting
7. Color variation
8. Core Erosion/ Surface Erosion
9. Discoloration
10. Logo Bridging
11. Logo In-filling /Break Lines In-filling
12. Orange Peel (Roughness)
13. Pitting
14. Peeling
15. Sticking and Picking
16. Scuffing of Film-coated Tablets
17. Twinning
18. Tablet Breakage

1. Blistering
It is a coating defect where the film becomes detached from the substrate
forming a blister.
Causes and Remedies of Blistering:

Causes Remedies

Entrapment of gases or vapor in or under the film due to overheating either during Use mild drying
1.
spraying or at the end of the coating. conditions.

Use mild drying


2. Effect of temperature on the adhesion, elasticity, and strength of the film.
conditions.

2. Blooming/Dull film
It is a coating defect where the coating becomes dull immediately or after
prolonged storage at high temperatures. In other words, it is the fading or
dulling of a coated tablet color after a prolonged period of storage at a high
temperature.

Causes and Remedies of Blooming:

Causes Remedies

1. High concentration of plasticizer. Use lower concentration of plasticizer.


Low molecular plasticized coating
2. Use high molecular weight of plasticizer.
system.

3. Blushing

It is a coating defect where whitish specks or haziness in the film appear. In


other words, it is a haziness or appearance of white specks in the film coated
tablet.

Causes and Remedies of Blushing

Causes Remedies

Precipitation of coating polymer due to use of a poor solvent


1. Decrease the drying air temperatu
or high coating temperature.

Use of sorbitol in coating formulation which causes major Avoid the use of sorbitol with HP
fall in the thermal gelation temperature of the HPMC (Hydroxy Propyl Methyl Cellulos
2.
(Hydroxy Propyl Methyl Cellulose), HPC (Hydroxy Propyl (Hydroxy Propyl Cellulose), Cell
Cellulose), Cellulose ethers, and Methyl Cellulose. ethers, and Methyl Cellulose.

4. Cratering
It is a coating defect of the film where volcanic-like craters appear on the
tablet surface. In other words, it is a defect in the film’s coating results in
craters appearing on the tablet which in turn results in the exposure of the
tablet’s surface.

Causes and Remedies of Cratering

Causes Remedies

Penetration of coating solution at the surface of the tablet, often at the


Decrease the spray rate and use
1. crown where the surface is more porous causing localized disintegration
optimum drying conditions.
of the core.

Use optimum drying


2. Inefficient drying.
conditions.

Decrease spray application


3. Application of higher rate of the coating solution.
rate.

Increase viscosity of coating


4. Low the viscosity of the coating solution.
solution.

5. Cracking/Splitting
It is a coating defect in which the film either cracks across the crown of the
tablet (cracking) or splits around the edges of the tablet (Splitting).
Causes and Remedies of Cracking/Splitting

Causes Remedies

Higher internal stresses in the film than the tensile Adjusting the type and concentration of
1.
strength of the film. plasticizer.

Use lower molecular weight polymeric blends


2. High molecular weight polymeric blends or polymers.
or polymers.

Coating and core have different thermal expansion


3. Avoid mineral type excipient.
properties.

4. Expansion of core due to overheating. Avoid overheating the tablet core.

5. Low mechanical strength of the coating. Use coating with proper mechanical strength.

6. Inadequate coating formulation. Use proper coating formulation.

7. Insufficient plasticization or too much pigmentation. Use adequate plasticizer or pigment.

6. Color variation
It is a coating defect that involves variation in color of the film. In other words,
color variation is a coating defect where visible differences in color of film
found from tablet to tablet.

Causes Remedies

1. Inadequate mixing of tablets. Use geometric mixing.

2. Poor opacity of suspension. Increase the opacity of suspension.

Inadequate coating or migration of soluble dyes- Use formulation with various plasticizers and
3.
plasticizers and other additives during drying. additives or use optimum drying conditions.

4. Poor spray gun set up. Correct gun set up.

5. Low/high pan load. Load the right quantity of tablets.

6. High core friability. Decrease core friability.

7. Insufficient number of spray guns. Increase the number of spray guns.

8. High coating suspension solid. Reduce suspension solid level.

Use coating formulation with increased hiding


9. Low hiding power of coating suspension.
power.
Reduce coating solids to facilitated equal coating
10. Unequal distribution of coating suspension.
distribution.

11. Insufficient coating suspension applied. Apply a sufficient amount of coating suspension.

Causes and Remedies of Color variation

7. Chipping/ Edge Erosion: a common


tablet coating defect
It is a coating defect where the film becomes chipped or worn away and
dented usually at the edges of the tablet as the coating is being applied.

Causes and Remedies of Chipping/ Edge Erosion

Causes Remedies
Pan loading with insufficient amount of
1. Pan fill with sufficient amount of core tablets.
core tablets.

2. Inappropriate baffles design. Use appropriate baffles design

3. Low coating film strength. Use high film strength coating formula.

4. Pan speed too fast. Use correct pan speed.

5. Worn tablet punch/tooling. Replace tablet tooling.

6. Sharp edge on tablets. Use proper tablet shape.

7. Low spray rate. Use an optimum spray rate.

8. Low coating suspension solid. Increase suspension solid level.

High degree of attrition related to the Increase the hardness of the film by increasing the molecu
9.
coating process. of the coating polymer.

8. Core Erosion/ Surface Erosion


It is a coating defect where tablet surfaces erode as tablets tumble during the
coating process. Especially this problem has happened with the presence of
inappropriate logo.
Causes and remedies of Core Erosion/ Surface Erosion

Causes Remedies

Reduce the amount of hygroscopic excipient s


1. Hygroscopic tablet core.
disintegrant.

2. Spray rate is too high or low. Use appropriate spray rate.

3. Pan speed too high. Use correct pan speed.

4. High friability of core tablet. Use less friable tablet.

Insufficient film strength to provide resistance to edge


5. Use high film strength.
damage.

6. Poor punch design. Use high quality punch.

7. Punch wear. Use a non-wear punch.

8. Poor logo design or placement. Use proper logo design.


9. Low coating suspension solid. Increase suspension solid level.

9. Discoloration
It is a rare coating defect where discoloration is appeared either through or on
the coating caused by interactions of ingredients in the core or by heat from
the process causing ingredients in the core to migrate through the coating.
The problem is commonly seen with nutraceutical products.

Causes and remedies of Discoloration

Causes Remedies

1. Sprayable coating solids are too low. Use film coating formula with higher solids.

Less protection by film from moisture during Use a coating formula that provides enough protectio
2.
storage. moisture.

3. Very high spray rate with low temperature. Decrease spray rate and/or increase processing temp

4. Low pan speed. Increase pan speed to lessen dwell time.

5. Migration and melting of ingredients in the core. Increase spray rate and/or reduce processing tempera
10. Logo Bridging
It is a coating defect where coating bridges formed across a logo or break line.
As more coating is applied to tablet surfaces, the stresses that develop within
the coating as it dries overcome the forces of attachment of the coating to the
tablet surface, causing the coating to pull away within the logo or break line,
making either less visible.

Causes and remedies of Logo Bridging

Causes Remedies

1. Poorly plasticized coating system. Use optimally plasticizer coating.

2. Low adhesion coating system. Use high adhesion coating.

3. Low adhesion core ingredients. Use high adhesion core ingredients.

4. Spray rate too high. Reduce spray rate.

5. Product temperature too low. Increase temperature.


6. Poor logo design. Improve logo design.

11. Logo In-filling /Break Lines In-filling


It is a coating defect where the engraved logo or break line filled with either
particle of dried polymer or solidified foam. Coating droplets are over-dried
before contacting tablet surface, increasing tablet surface roughness and
filling the logo.

Causes and Remedies of Infilling

Causes Remedies

1. High atomizing air pressure. Reduce atomizing air pressure.

2. High drying air temperature. Reduce drying air temperature.

3. High coating suspension solid. Use a low viscosity coating suspension.

4. Too high gun to bed distance. Optimize gun to bed distance.

5. Poor spray gun design. Use proper spray gun design


6. Turbulent air flow. Minimize pan depression.

Use optimized suspension preparation t


7. Aeration of coating suspension.
aeration.

8. Poor logo design. Improve logo design.

9. Excessive foaming of the coating solution. Improve the mixing process.

Foam and Bubble formation because of air spraying of a Add alcohol or use spray nozzle capabl
10.
polymer solution. atomization.

11. Over drying of spray. Optimum drying of spray.

12. Orange Peel (Roughness)


It is a coating defect where the surface of the applied film coating is extremely
rough and nonglossy, often taking on the appearance of the skin of an orange.

Causes and Remedies of Orange Peel (Roughness)

Causes Remedies
1. Rapid Drying. Use mild drying conditions.

2. Too high coating suspension viscosity. Reduce the viscosity coating suspensio

3. Too low atomizing air pressure. Increase Atomizing air pressure.

4. High spay rate/ Over-wetting. Decrease spray rate.

5. Poor spray gun performance. Use better spray guns.

6. Inadequate distribution of the coating suspension. Decrease in viscosity of coating suspe

7. Very close gun to bed distance. Adjust gun to bed distance.

13. Pitting
It is a coating defect where pits appear on the surface of a tablet core without
any visible disruption of the film coating. In other words, pitting is the
deformation of the core of the tablet without any visible signs of disruption of
the film coating.

Causes and Remedies of Pitting

Causes Remedies
Use appropriate drying (
1. Inappropriate drying (inlet air) temperature.
temperature.

Melting or dissolution of lubricant on tablet surface or melting of core


2. Use control drying temp
ingredient due to high core temperature.

14. Peeling
It is a coating defect where peels off the tablet during or after the coating
process. Peeling refers to the formation of uneven or rough irregularities on
the surface of a coating film applied on a core tablet surface.

Causes and Remedies of Peeling

Causes Remedies

1. Low adhesion core ingredients. Use high adhesion core ingredients.

Use proper composition with improved mecha


2. Low mechanical strength of the coating.
strength.

3. Low adhesion coating system. Use high adhesion coating.


Coating is rubbing off due to excessive attritional
4. Reduce pan speed.
effects.

15. Sticking and Picking


It is a coating defect where part of film of tablets momentarily stick together
or stick to the pan, often just after they pass through the spray zone, and then
sticked area being detached from the tablet surface.

Causes and Remedies of Sticking and Picking

Causes Remedies

1. Inadequate drying. Use optimum drying conditions.

2. High viscosity of coating solution. Increasing viscosity of coating solution.

3. Spray rate too high. Reduce spray rate.

4. Too low drying air volume Increase air volume.

5. Too low drying air temperature. Increase the inlet air temperature.

6. Pan speed too low. Increase pan speed.


7. Low atomization pressure. Increase atomization pressure.

8. Poor spray gun set up. Improve spray gun setting.

9. Surface solubility. Increase gun to bed distance.

10. High tablet surface porosity. Improve core characteristics.

16. Scuffing of Film-coated Tablets


It is a coating defect in which gray to black marks on the surface of white (or
lightly colored) film-coated tablets appear. Scuffing is appeared when tablets
are more sliding rather than trembling.

Causes and Remedies of Scuffing of Film-coated Tablets

Causes Remedies

Larger the tablets and the denser the core Avoid the use of high density mineral excipient like dicalcium
1.
formulation. phosphate, calcium carbonate.

2. Elongated shapes or caplet shaped tablets. Use appropriate tablet shape.


3. Long duration of the coating process. Reduce the coating duration.

4. Pan speed too low. Increase pan speed.

Pan loading with an insufficient amount


5. Pan fill with sufficient amount of core tablets.
of core tablet.

17. Twinning
It is a coating defect where tablets stick together especially when two tablets
stick together.

Causes and Remedies of Twinning

Causes Remedies

1. Commonly flat surfaces along the edges of capsule-shaped tablets. Change tablet shape.

2. Excessively tacky coating formulation. Use coating formulation which is less tacky.

3. Inappropriate tablet shape. Use appropriate tablet shape.


4. Pan speed too low. Increase pan speed.

5. Spray droplet size too large. Increase atomizing air pressure.

6. Spray rate too high. Reduce spray rate.

7. Insufficient drying. Use optimum drying conditions.

18. Tablet Breakage


It a defect where tablets break apart during pan loading or while tumbling in
the pan or during the coating process, or during unloading of the coating pan.

Causes and Remedies of Tablet Breakage

Causes Remedies

1. Core tablets are too soft. Change core formulation.

2. Tablets are too brittle. Change core compression parameters.

3. Poor tablet shape for coating. Use appropriate tablet shape.


4. Poor baffle design. Change baffle design.

5. Too high pan speed. Reduce pan speed.

6. Loading and unloading tablets from the coating pan. Carefully load and unload tablets.

7. Less binder used in the formula. Use optimum binder quantity.

References

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