UNIT 2
TABLETS
TABLET PROCESSING PROBLEMS
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TABLET PROCESSING PROBLEMS
During the manufacturing process of tablets, Tablets causes defects are
called Tablets manufacturing defects.
1. Capping.
• Capping is the term used, when upper and lower segment of the tablet separates
horizontally, either partially or completely from the main body of a tablet and
comes off a as cap during ejection from the tablet press or during subsequent
handling.
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TABLET PROCESSING PROBLEMS
1. Capping.
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TABLET PROCESSING PROBLEMS
1. Capping.
Causes of Tablet Capping
2. Air Entrapment
• Cause: During compression, air may become trapped inside the tablet mass.
When the tablet is compressed, this trapped air tries to escape, causing the top or
bottom portion of the tablet to pop off (cap).
• Solution: Implement pre-compression techniques to expel the trapped air before
final compression. Slow down the compression speed or increase dwell time (the
time the tablet is under pressure) to allow air to escape.
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TABLET PROCESSING PROBLEMS
1. Capping.
Causes of Tablet Capping
2. Excessive or Improper Compression Force
• Cause: Too much compression force can compact the tablet excessively, resulting
in internal stress that leads to capping.
• Solution: Use optimal compression force specific to the tablet formulation.
Ensure that punches and dies are properly aligned and maintained to avoid uneven
pressure.
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TABLET PROCESSING PROBLEMS
1. Capping.
Causes of Tablet Capping
3. Inadequate or Excessive Binding Agents
• Cause: A lack of sufficient binder can result in poor cohesion between granules,
while excessive binder can cause the granules to be too hard, both of which can
lead to capping.
• Solution: Adjust the amount of binder used in the formulation to strike the right
balance between tablet cohesion and compressibility.
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TABLET PROCESSING PROBLEMS
1. Capping.
Causes of Tablet Capping
4. Granule Characteristics
• Cause: Poorly formed granules, especially those that are too large or uneven in
size, can lead to improper compaction and weak bonding, resulting in capping.
• Solution: Improve the granulation process to produce granules with a uniform
size and distribution. Granules should be neither too fine nor too large to ensure
proper bonding during compression.
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TABLET PROCESSING PROBLEMS
1. Capping.
Causes of Tablet Capping
5. Low Moisture Content
• Cause: If the moisture content in the granules is too low, the granules may not
compress properly, leading to weak bonds that can cause capping.
• Solution: Monitor and maintain appropriate moisture levels during granulation
and before compression. Adjust drying conditions to ensure optimal moisture
content.
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TABLET PROCESSING PROBLEMS
1. Capping.
Causes of Tablet Capping
6. Punch and Die Wear
• Cause: Worn or improperly aligned punches and dies can result in uneven
pressure distribution during compression, leading to capping.
• Solution: Regularly inspect and maintain punches and dies. Replace worn-out
punches and ensure proper calibration of the tablet press.
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TABLET PROCESSING PROBLEMS
1. Capping.
Causes of Tablet Capping
7. Rapid Decompression
• Cause: If decompression occurs too quickly, the tablet may not have enough time
to stabilize under pressure, leading to capping.
• Solution: Gradual decompression during the manufacturing process can reduce
the internal stress and prevent the tablet from capping.
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TABLET PROCESSING PROBLEMS
1. Capping.
Prevention of Tablet Capping
2. Pre-Compression: Utilize a pre-compression step to reduce the air content in
the granules before final compression.
3. Optimize Compression Force: Use the appropriate compression force for the
specific formulation. Avoid excessive force, and ensure that punches and dies
are properly aligned.
4. Moisture Control: Maintain the optimal moisture content in the granules to
promote good compressibility. Avoid over-drying or under-drying.
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TABLET PROCESSING PROBLEMS
1. Capping.
Prevention of Tablet Capping
4. Granulation Optimization: Ensure that granules have uniform size and good
flow properties, with a balance of moisture content, to allow proper bonding
during compression.
5. Lubrication: Use an appropriate amount of lubricant to reduce friction between
the granules and punches during compression.
6. Machine Maintenance: Regularly check and maintain tablet press components
like punches, dies, and springs to ensure smooth, even operation.
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TABLET PROCESSING PROBLEMS
1. Capping.
Prevention of Tablet Capping
7. Adjust Dwell Time: Increase the dwell time or compression speed if necessary
to allow for better air release and bonding of particles.
8. Formulation Adjustments: Modify the formula by using better binding agents
or fillers that reduce the likelihood of air entrapment or expansion post-
compression.
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TABLET PROCESSING PROBLEMS
2. Lamination.
• The separation of a tablet into two or more distinct layers is called lamination.
These problems occur immediately after compression, however may occur after
several hours or days.
• It also occur due to air–entrapment during compression and subsequent release on
ejection. The condition is exaggerated by higher speed of turret.
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TABLET PROCESSING PROBLEMS
2. Lamination.
Causes of Tablet Lamination
3. Air Entrapment
• Cause: Air gets trapped in the tablet during compression and tries to escape,
causing the tablet to split into layers.
• Solution: Adjust the compression speed, use pre-compression techniques to expel
trapped air before the final compression, or improve granule size distribution.
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TABLET PROCESSING PROBLEMS
2. Lamination.
Causes of Tablet Lamination
3. Over-Compression
• Cause: Excessive compression force can cause the tablet granules to become
overly compacted, leading to separation into layers after compression.
• Solution: Use optimal compression force and monitor the pressure applied during
the process to prevent excessive compaction.
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TABLET PROCESSING PROBLEMS
2. Lamination.
Causes of Tablet Lamination
3. Insufficient Binding Agents
• Cause: A lack of sufficient binder can cause poor cohesion between granules,
leading to weak bonding and lamination.
• Solution: Ensure the formulation contains adequate binder to maintain structural
integrity.
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TABLET PROCESSING PROBLEMS
2. Lamination.
Causes of Tablet Lamination
4. Granule Characteristics
• Cause: Poorly formed granules, with improper particle size or distribution, can
lead to weak tablets prone to lamination.
• Solution: Optimize the granulation process, ensuring uniform particle size and
adequate bonding between particles.
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TABLET PROCESSING PROBLEMS
2. Lamination.
Causes of Tablet Lamination
5. Excess Moisture Content
• Cause: Excessive moisture in the granules can lead to improper compression,
causing the tablet to split during drying or storage.
• Solution: Control the moisture content of the granules by proper drying and
ensure that environmental conditions during processing are controlled.
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TABLET PROCESSING PROBLEMS
2. Lamination.
Causes of Tablet Lamination
6. Worn Punches and Dies
• Cause: Using old or worn-out punches and dies can result in uneven compression,
leading to lamination of the tablet.
• Solution: Regular maintenance and replacement of punches and dies help ensure
consistent compression quality.
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TABLET PROCESSING PROBLEMS
2. Lamination.
Causes of Tablet Lamination
7. Inappropriate Excipient Use
• Cause: The wrong choice or poor quality of excipients (e.g., binders, fillers) can
cause poor cohesion between layers of the tablet, resulting in lamination.
• Solution: Use excipients that have been proven to provide strong and consistent
bonding, and ensure that they are evenly distributed within the formulation.
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TABLET PROCESSING PROBLEMS
2. Lamination.
Causes of Tablet Lamination
8. Rapid Decompression
• Cause: If the decompression of the tablet press is too rapid, it can cause stress
within the tablet, leading to lamination.
• Solution: Adjust the decompression speed and make sure the process is gradual to
prevent stress fractures in the tablet.
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TABLET PROCESSING PROBLEMS
2. Lamination.
Causes of Tablet Lamination
9. High Speed of Compression
• Cause: If tablets are compressed at too high a speed, the material does not have
enough time to compact properly, leading to lamination.
• Solution: Reduce the speed of compression to allow proper compaction of the
material.
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TABLET PROCESSING PROBLEMS
2. Lamination.
Prevention of Tablet Lamination
3. Optimize Compression Force: Use the appropriate compression force for the
specific formulation to avoid over or under compression.
4. Use Pre-compression: A pre-compression step helps in removing trapped air
from the granules before the final compression.
5. Control Moisture Levels: Proper drying and control of humidity during tablet
production and storage can reduce the risk of lamination
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TABLET PROCESSING PROBLEMS
2. Lamination.
Prevention of Tablet Lamination
4. Ensure Proper Granulation: Optimize the granulation process to produce
uniform and well-formed granules that bond properly during compression.
5. Regular Equipment Maintenance: Maintain and inspect punches, dies, and
compression equipment to ensure they function properly without causing
compression issues.
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TABLET PROCESSING PROBLEMS
3. Chipping
• Chipping is mainly the breaking of tablet edges.
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TABLET PROCESSING PROBLEMS
3. Chipping
Causes of Tablet Chipping
4. Inadequate Formulation
• Cause: The formulation lacks sufficient binding agents, which leads to weak
bonding between particles, making the tablet brittle and prone to chipping.
• Solution: Ensure that the formulation contains the correct quantity and quality of
binders and excipients to create stronger tablets.
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TABLET PROCESSING PROBLEMS
3. Chipping
Causes of Tablet Chipping
4. Over-Drying of Granules
• Cause: When granules are dried excessively, they become too brittle, leading to
easy breakage during compression or handling.
• Solution: Maintain proper drying conditions to avoid making the granules too dry
and brittle. Control moisture content during granulation and drying.
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TABLET PROCESSING PROBLEMS
3. Chipping
Causes of Tablet Chipping
4. Incorrect Compression Force
• Cause: If the compression force is too high, the tablet can become overly hard and
brittle, leading to chipping, especially at the edges.
• Solution: Optimize the compression force to ensure that the tablet is neither too
hard nor too soft. Monitor the compression process to ensure consistent
application of force.
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TABLET PROCESSING PROBLEMS
3. Chipping
Causes of Tablet Chipping
4. Tablet Design (Sharp Edges)
• Cause: Tablets with sharp edges are more prone to chipping because they are less
structurally stable compared to rounded edges.
• Solution: Modify the tablet design to have rounded edges instead of sharp ones.
Tablets with smoother edges tend to be more resistant to chipping.
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TABLET PROCESSING PROBLEMS
3. Chipping
Causes of Tablet Chipping
5. Worn or Poorly Maintained Punches and Dies
• Cause: Worn-out punches and dies can create uneven pressure or poor alignment
during compression, leading to fragile edges that chip easily.
• Solution: Regularly inspect and maintain punches and dies to ensure they are in
good working condition and replace them when worn out.
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TABLET PROCESSING PROBLEMS
3. Chipping
Causes of Tablet Chipping
6. Inadequate Lubrication
• Cause: Insufficient lubrication during compression can cause the tablet to stick to
the punches, resulting in chipping when the tablet is ejected from the die.
• Solution: Ensure that the appropriate type and amount of lubricant (such as
magnesium stearate) is used to reduce sticking and prevent tablet chipping during
ejection.
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TABLET PROCESSING PROBLEMS
4. Cracking
• Cracking is small and fine observed on the upper and lower portion of the tablet.
It is observed as a result of the rapid expansion of tablets. It causes a large size of
granules.
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TABLET PROCESSING PROBLEMS
4. Cracking
Causes of Tablet Chipping
5. Excessive drying,
6. large granules,
7. or excessive compression force.
Solution: Optimize drying conditions, use finer granules, and reduce compression
pressure.
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TABLET PROCESSING PROBLEMS
5. Sticking
• Sticking refers to the tablet material adhering to the die wall. Whereas filming is a
slow form of sticking and is largely due to excess moisture in the granulation.
• Punch surface roughness, compaction force and the blend composition are
significant factors contributing to sticking.
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TABLET PROCESSING PROBLEMS
5. Sticking
Causes of Sticking in Tablets
6. Insufficient Lubrication
• Cause: If there is an inadequate amount of lubricant in the formulation, the
granules may stick to the punch surfaces instead of smoothly releasing from the
dies.
• Solution: Increase the amount of lubricant (e.g., magnesium stearate) or ensure
uniform distribution of the lubricant throughout the formulation.
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TABLET PROCESSING PROBLEMS
5. Sticking
Causes of Sticking in Tablets
6. High Moisture Content in Granules
• Cause: Excessive moisture in the granules can make them sticky, causing material
to adhere to the punches.
• Solution: Ensure proper drying of granules during granulation. Monitor moisture
content to keep it at an optimal level.
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TABLET PROCESSING PROBLEMS
5. Sticking
Causes of Sticking in Tablets
6. Improper Binder Concentration
• Cause: Too much binder in the formulation can make the granules sticky and
more prone to adhering to the punch faces.
• Solution: Optimize the amount of binder in the formulation. Ensure that the
binder concentration is not too high to avoid stickiness.
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TABLET PROCESSING PROBLEMS
5. Sticking
Causes of Sticking in Tablets
6. Soft or Overly Fined Granules
• Cause: When granules are too soft or overly fine, they tend to stick to punch
surfaces during compression.
• Solution: Use larger, well-formed granules with good compressibility and flow
properties. Control particle size distribution to ensure proper tablet formation.
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TABLET PROCESSING PROBLEMS
5. Sticking
Causes of Sticking in Tablets
6. Punch Surface Finish
• Cause: Rough or damaged punch faces can increase friction between the tablet
material and the punch, leading to sticking.
• Solution: Polish or replace worn-out punches to ensure they have a smooth
surface. Regular maintenance of punches and dies is critical.
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TABLET PROCESSING PROBLEMS
5. Sticking
Causes of Sticking in Tablets
6. Low Tablet Press Speed
• Cause: Slow tablet press speed can give more time for the tablet material to
adhere to the punches, increasing the likelihood of sticking.
• Solution: Increase the press speed to minimize the contact time between the
punch faces and the tablet material.
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TABLET PROCESSING PROBLEMS
5. Sticking
Causes of Sticking in Tablets
7. Inadequate Compression Force
• Cause: Low compression force can prevent proper tablet bonding, allowing
material to stick to the punches.
• Solution: Increase the compression force to ensure that the tablet is well-
compressed, reducing the chance of sticking.
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TABLET PROCESSING PROBLEMS
5. Sticking
Causes of Sticking in Tablets
8. Hygroscopic Materials
• Cause: Some active pharmaceutical ingredients (APIs) or excipients are
hygroscopic, meaning they absorb moisture from the environment, becoming
sticky.
• Solution: Use appropriate desiccants or packaging to control moisture, and ensure
environmental controls like humidity reduction during production.
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TABLET PROCESSING PROBLEMS
6. Picking.
• Picking is the term used when a small amount of material from a tablet is sticking to
and being removed off from the tablet-surface by a punch face.
• The problem is more prevalent on the upper punch faces than on the lower ones.
• The problem worsens, if tablets are repeatedly manufactured in this station of tooling
because of the more and more material getting added to the already stuck material on
the punch face.
• Reason: Picking is of particular concern when punch tips have engraving or
embossing letters (some letters such as “A”, “B”, and “O” are difficult to
manufacture cleanly) as well as the RANJAN
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granular material is improperly dried.
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TABLET PROCESSING PROBLEMS
6. Picking.
Causes of Picking in Tablet Manufacturing
7. Inadequate Lubrication
• Cause: A lack of sufficient lubrication in the formulation can cause the granules to
stick to the punch tips, especially in embossed areas like logos or symbols.
• Solution: Increase the amount of lubricant in the formulation (e.g., magnesium
stearate) to ensure smooth release from the punch surfaces.
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TABLET PROCESSING PROBLEMS
6. Picking.
Causes of Picking in Tablet Manufacturing
7. Excessive Moisture Content
• Cause: If the granules or powder have too much moisture, they can become sticky
and adhere to the punch surface, causing picking.
• Solution: Ensure proper drying of granules to reduce moisture content. Use
granules with optimal moisture levels to prevent stickiness during compression.
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TABLET PROCESSING PROBLEMS
6. Picking.
Causes of Picking in Tablet Manufacturing
7. Improper Binder Use
• Cause: Too much or too little binder in the formulation can affect the tablet's
binding properties, leading to poor cohesion and picking from the punch surface.
• Solution: Adjust the amount and type of binder to optimize the cohesion of the
granules. Ensure that the binder is properly mixed into the formulation to provide
uniform strength to the tablets.
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TABLET PROCESSING PROBLEMS
6. Picking.
Causes of Picking in Tablet Manufacturing
7. Soft or Fine Granules
• Cause: When the granules are too soft or fine, they do not compress well and may
adhere to the punch surfaces during compression.
• Solution: Use well-formed granules with the appropriate hardness and particle
size distribution to minimize sticking and picking.
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TABLET PROCESSING PROBLEMS
6. Picking.
Causes of Picking in Tablet Manufacturing
7. Low Compression Force
• Cause: Low compression force can result in poor bonding between the granules,
making it easier for material to be picked off from the surface during
compression.
• Solution: Increase the compression force to create stronger tablets, which are less
likely to lose material during the punching process.
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TABLET PROCESSING PROBLEMS
6. Picking.
Causes of Picking in Tablet Manufacturing
7. Design of Punch Tips
• Cause: Deep, intricate designs or engravings on the punch faces can trap material
and cause picking, especially in logos or symbols.
• Solution: Modify the punch design to reduce the depth of embossing or use
shallower engravings. Using well-polished punches can also help reduce picking.
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TABLET PROCESSING PROBLEMS
6. Picking.
Causes of Picking in Tablet Manufacturing
7. Hygroscopic Materials
• Cause: Hygroscopic ingredients can absorb moisture from the environment,
making the tablet material stickier and more prone to picking.
• Solution: Control the environmental conditions, especially humidity, and use
appropriate desiccants if needed. Modify the formulation to reduce the
hygroscopic properties of the ingredients.
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TABLET PROCESSING PROBLEMS
7. Double impression
• Double Impression in tablet manufacturing is a defect where the tablet shows a
repeated or duplicated imprint of a logo, symbol, or any embossed design.
• This defect usually occurs due to improper control of punch movement during the
compression process, causing the tablet to be stamped twice.
• It involves only those punches which have engraving or monogram on them.
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TABLET PROCESSING PROBLEMS
8. Double impression
Causes of Double Impression in Tablet Manufacturing
9. Free Rotation of Punches (Upper or Lower)
• Cause: If the punches (especially the upper punch) rotate freely during the
compression cycle, the punch may rotate slightly after the first impression and
apply a second, slightly shifted impression when ejected or re-compressed.
• Solution: Use keyed punches or anti-rotation punch guides that prevent the
punches from rotating during compression.
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TABLET PROCESSING PROBLEMS
8. Double impression
Causes of Double Impression in Tablet Manufacturing
9. Punches Without Keying
• Cause: Non-keyed punches can rotate freely during compression, especially when
the punches are not guided. This is a common cause of double impressions in
tablets.
• Solution: Use keyed punches (punches with a groove or notch) and punch guides
to prevent rotation. Keyed punches are designed to fit into a guide that restricts
rotation, ensuring a single, consistent impression.
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TABLET PROCESSING PROBLEMS
9. Mottling
• Mottling is an unequal distribution of color on a tablet with light and dark spots on
the surface of the tablet
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TABLET PROCESSING PROBLEMS
9. Mottling
Causes of Mottling in Tablets
10. Uneven Distribution of Colorants
• Cause: If the coloring agent is not uniformly mixed into the formulation, areas of
the tablet may have higher concentrations of color, while others have little to no
color, resulting in a mottled appearance.
• Solution: Ensure uniform mixing of the coloring agents with the formulation. Use
efficient mixing techniques such as geometric dilution or blending with high-shear
mixers.
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TABLET PROCESSING PROBLEMS
9. Mottling
Causes of Mottling in Tablets
10. Color Migration During Drying
• Cause: During the drying process, especially in wet granulation, the coloring
agent can migrate to the surface of the granules, leading to color concentration on
the tablet's surface and causing mottling.
• Solution: Optimize the drying process, ensuring controlled drying conditions to
minimize migration. Using colorants that are less prone to migration can also help
reduce the problem.
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TABLET PROCESSING PROBLEMS
9. Mottling
Causes of Mottling in Tablets
10. Incompatible Dyes or Pigments
• Cause: Some dyes or pigments may not be compatible with certain excipients or
active ingredients, leading to color changes or degradation that cause mottling.
• Solution: Select colorants that are stable and compatible with the other
components in the formulation. Conduct preformulation studies to ensure the
stability of colorants in the tablet mixture.
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TABLET PROCESSING PROBLEMS
9. Mottling
Causes of Mottling in Tablets
10. Moisture Variations
• Cause: Variations in moisture content can cause colorants to dissolve unevenly,
resulting in patches of discoloration. This is particularly a problem in tablets with
hydrophilic ingredients that can absorb moisture.
• Solution: Control the moisture content of the formulation and the manufacturing
environment to prevent uneven moisture absorption. Ensure proper drying of
granules or powders before compression.
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TABLET PROCESSING PROBLEMS
9. Mottling
Causes of Mottling in Tablets
10. Large Particle Size of Colorants
• Cause: If the colorant particles are too large, they may not mix evenly with the
other tablet ingredients, leading to visible specks of color or mottling.
• Solution: Use colorants with fine and consistent particle size to ensure uniform
distribution. Particle size reduction techniques like milling can help improve
homogeneity.
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TABLET PROCESSING PROBLEMS
9. Weight variation
• Significant differences in the weight of individual tablets within a batch.
• Causes: Improper flow of granules in the hopper, inconsistent feeding, or
segregation of granules.
• Solution: Improve granule flow, ensure uniform mixing, and monitor tablet press
settings.
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Thank you……
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