PROBLEMS OF TABLET DURING MANUFACTURING

Introduction

An ideal tablet should be free from any visual defect or functional defect. The advancements and innovations in
tablet manufacture have not decreased the problems, often encountered in the production, instead have increased
the problems, mainly because of the complexities of tablet presses; and/or the greater demands of quality.

An industrial pharmacist usually encounters number of problems during manufacturing. Majority of visual defects
are due to inadequate fines or inadequate moisture in the granules ready for compression or due to faulty machine
setting. Functional defects are due to faulty formulation. Solving many of the manufacturing problems requires an
in–depth knowledge of granulation processing and tablet presses, and is acquired only through an exhaustive
study and a rich experience.

Here, we will discuss the imperfections found in tablets along–with their causes and related remedies. The
imperfections are known as: ‘VISUAL DEFECTS’ and they are either related to imperfections in any one or more
of the following factors:

I. Tableting Process

II. Excipient

III. Machine

The defects related to Tableting Process are as follows:

i) CAPPING: It is due air-entrapment in the granular material.

ii) LAMINATION: It is due air-entrapment in the granular material.
iii) CRACKING: It is due to rapid expansion of tablets when deep concave punches are used.

The defects related to Excipient are as follows:

iv) CHIPPING: It is due to very dry granules
v) STICKING
vi) PICKING
vii) BINDING
These problems (v, vi, vii) are due to more amount of binder in the granules or wet granules.

The defect related to more than one factor:

viii) MOTTLING: It is either due to any one or more of these factors: Due to a colored drug, which has different
color than the rest of the granular material? (Excipient- related); improper mixing of granular material (Process-
related); dirt in the granular material or on punch faces; oil spots by using oily lubricant.

The defect related to Machine

Ix) DOUBLE IMPRESSION: It is due to free rotation of the punches, which have some engraving on the punch
faces.

Further, in this section, each problem is described along-with its causes and remedies which may be related to
either of formulation (granulation) or of machine (dies, punches and entire tablet press).
Capping

‘Capping’ is the term used, when the upper or lower segment of the tablet separates horizontally, either partially
or completely from the main body of a tablet and comes off as a cap, during ejection from the tablet press, or
during subsequent handling.

Reason: Capping is usually due to the air–entrapment in a compact during compression, and subsequent
expansion of tablet on ejection of a tablet from a die.

THE CAUSES AND REMEDIES OF CAPPING RELATED TO ‘FORMULATION’ (GRANULATION)

Sr. CAUSES REMEDIES

No.
1. Large amount of fines in the granulation Remove some or all fines through 100 to 200 mesh screen
2. Too dry or very low moisture content Moisten the granules suitably. Add hygroscopic substance
(leading to loss of proper binding action). e.g.: sorbitol, methyl- cellulose or PEG-4000.
3. Not thoroughly dried granules. Dry the granules properly.
4. Insufficient amount of binder or Increasing the mount of binder OR
improper binder.
Adding dry binder such as pre-gelatinized starch, gum acacia,
powdered sorbitol, PVP, hydrophilic silica or powdered sugar.
5. Insufficient or improper lubricant. Increase the amount of lubricant or change the type of
lubricant.
6. Granular mass too cold to compress firm. Compress at room temperature.

THE CAUSES AND REMEDIES OF CAPPING RELATED TO ‘MACHINE’ (DIES, PUNCHES AND
TABLET PRESS)

Sr. CAUSES REMEDIES

No.
1. Poorly finished dies Polish dies properly. Investigate other steels or other
materials.
2. Deep concave punches or beveled-edge faces of Use flat punches.
punches.
3. Lower punch remains below the face of die Make proper setting of lower punch during ejection.
during ejection.
4. Incorrect adjustment of sweep-off blade. Adjust sweep-off blade correctly to facilitate proper
ejection.
5. High turret speed. Reduce speed of turret (Increase dwell time).

Lamination / Laminating

Definition: ‘Lamination’ is the separation of a tablet into two or more distinct horizontal layers.
Reason: Air–entrapment during compression and subsequent release on ejection.
The condition is exaggerated by higher speed of turret.
THE CAUSES AND REMEDIES OF LAMINATION RELATED TO FORMULATION (GRANULATION)
Sr. CAUSES REMEDIES
No.
1. Oily or waxy materials in granules Modify mixing process. Add adsorbent or
 absorbent.
2. Too much of hydrophobic lubricant e.g.: Magnesium- Use a less amount of lubricant or change the
stearate. type of lubricant.

The Causes and Remedies of Lamination related to MACHINE (Dies, Punches and Tablet Press)

Sr. CAUSES REMEDIES

No.
1. Rapid relaxation of the peripheral regions of a Use tapered dies, i.e. upper part of the die bore has an
tablet, on ejection from a die. outward taper of 3° to 5°.
2. Rapid decompression Use pre-compression step. Reduce turret speed and
reduce the final compression pressure.

Chipping

Definition: ‘Chipping’ is defined as the breaking of tablet edges, while the tablet leaves the press or during
subsequent handling and coating operations.

Reason: Incorrect machine settings, specially mis-set ejection take-off.

THE CAUSES AND REMEDIES OF CHIPPING RELATED TO FORMULATION (GRANULATION) ARE

AS FOLLOWS

Sr. CAUSES REMEDIES

No.
1. Sticking on punch faces Dry the granules properly or increase lubrication.
2. Too dry granules. Moisten the granules to plasticize. Add hygroscopic
substances.
3. Too much binding causes chipping at Optimize binding, or use dry binders.
bottom.

THE CAUSES AND REMEDIES OF CHIPPING RELATED TO MACHINE (DIES, PUNCHES AND TABLET
PRESS)

Sr. CAUSES REMEDIES

No.
1. Groove of die worn at compression point. Polish to open end, reverse or replace the die.
2. Barreled die (center of the die wider than Polish the die to make it cylindrical
ends)
3. Edge of punch face turned inside/inward. Polish the punch edges
4. Concavity too deep to compress properly. Reduce concavity of punch faces. Use flat punches.

Cracking

Definition: Small, fine cracks observed on the upper and lower central surface of tablets, or very rarely on the
sidewall are referred to as ‘Cracks’.

Reason: It is observed as a result of rapid expansion of tablets, especially when deep concave punches are used.

THE CAUSES AND REMEDIES OF CRACKING RELATED TO FORMULATION (GRANULATION)

 Sr. CAUSES REMEDIES
No.
1. Large size of granules. Reduce granule size. Add fines.
2. Too dry granules. Moisten the granules properly and add proper
amount of binder.
3. Tablets expand. Improve granulation. Add dry binders.
4. Granulation too cold. Compress at room temperature.

THE CAUSES AND REMEDIES OF CRACKING RELATED TO MACHINE (DIES, PUNCHES AND
TABLET PRESS)

Sr. CAUSES REMEDIES

No.
1. Tablet expands on ejection due to air Use tapered die.
entrapment.
2. Deep concavities cause cracking while Use special take-off.
removing tablets

Sticking / Filming
Definition: ‘Sticking’ refers to the tablet material adhering to the die wall.
Filming is a slow form of sticking and is largely due to excess moisture in the granulation.
Reason: Improperly dried or improperly lubricated granules.

THE CAUSES AND REMEDIES OF STICKING RELATED TO FORMULATION (GRANULATION)

Sr. CAUSES REMEDIES
No.
1. Granules not dried properly. Dry the granules properly. Make moisture analysis to determine
limits.
2. Too little or improper Increase or change lubricant.
lubrication.
3. Too much binder Reduce the amount of binder or use a different type of binder.
4. Hygroscopic granular material. Modify granulation and compress under controlled humidity.
5. Oily or way materials Modify mixing process. Add an absorbent.
6. Too soft or weak granules. Optimize the amount of binder and granulation technique.

THE CAUSES AND REMEDIES OF STICKING RELATED TO MACHINE (DIES, PUNCHES AND
TABLET PRESS)

Sr. No. CAUSES REMEDIES

1. Concavity too deep for Reduce concavity to optimum.
granulation.
2. Too little pressure. Increase pressure.
3. Compressing too fast. Reduce speed.

Picking

Definition: ‘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, as well as the
granular material is improperly dried.

THE CAUSES AND REMEDIES OF PICKING RELATED TO FORMULATION (GRANULATION)

Sr. CAUSES REMEDIES

No.
1. Excessive moisture in granules. Dry properly the granules, determine optimum limit.
2. Too little or improper lubrication. Increase lubrication; use colloidal silica as a ‘polishing
agent’, so that material does not cling to punch faces.
3. Low melting point substances, may soften from Add high melting-point materials. Use high meting
the heat of compression and lead to picking. point lubricants.
4. Low melting point medicament in high Refrigerate granules and the entire tablet press.
concentration.
5. Too warm granules when compressing. Compress at room temperature. Cool sufficiently
before compression.
6. Too much amount of binder. Reduce the amount of binder, change the type or use
dry binders.

THE CAUSES AND REMEDIES OF PICKING RELATED TO MACHINE (DIES, PUNCHES AND TABLET
PRESS)

Sr. CAUSES REMEDIES

No.
1. Rough or scratched punch faces. Polish faces to high luster.
2. Embossing or engraving letters on punch faces Design lettering as large as possible.
such as B, A, O, R, P, Q, G.
Plate the punch faces with chromium to produce a
smooth and non-adherent face.
3. Bevels or dividing lines too deep. Reduce depths and sharpness.
4. Pressure applied is not enough; too soft tablets. Increase pressure to optimum.

Binding

Definition: ‘Binding’ in the die, is the term used when the tablets adhere, seize or tear in the die. A film is formed
in the die and ejection of tablet is hindered. With excessive binding, the tablet sides are cracked and it may
crumble apart.

Reason: Binding is usually due to excessive amount of moisture in granules, lack of lubrication and/or use of
worn dies.

THE CAUSES AND REMEDIES OF BINDING RELATED TO FORMULATION (GRANULATION)

Sr. CAUSES REMEDIES

No.
1. Too moist granules and extrudes around Dry the granules properly.
lower punch.
2. Insufficient or improper lubricant. Increase the amount of lubricant or use a more effective
lubricant.
 3. Too coarse granules. Reduce granular size, add more fines, and increase the
quantity of lubricant.
4. Too hard granules for the lubricant to be Modify granulation. Reduce granular size.
effective.
5. Granular material very abrasive and If coarse granules, reduce its size.
cutting into dies.
Use wear-resistant dies.
6. Granular material too warm, sticks to the Reduce temperature.
die.
Increase clearance if it is extruding.

THE CAUSES AND REMEDIES OF BINDING RELATED TO MACHINE (DIES, PUNCHES AND TABLET
PRESS)

Sr. CAUSES REMEDIES

No.
1. Poorly finished dies. Polish the dies properly.
2. Rough dies due to abrasion, Investigate other steels or other materials or modify
corrosion. granulation.
3. Undersized dies. Too little clearance. Rework to proper size.

Increase clearance.
4. Too much pressure in the tablet press. Reduce pressure. OR

Modify granulation.

Mottling

Definition: ‘Mottling’ is the term used to describe an unequal distribution of colour on a tablet, with light or dark
spots standing out in an otherwise uniform surface.
Reason: One cause of mottling may be a coloured drug, whose colour differs from the colour of excipients used
for granulation of a tablet.

THE CAUSES AND REMEDIES OF MOTTLING

Sr. CAUSES REMEDIES
No.
1. A coloured drug used along with Use appropriate colorants.
colorless or white-coloured
excipients.
2. A dye migrates to the surface of Change the solvent system,
granulation while drying. Change the binder,
Reduce drying temperature and
Use a smaller particle size.
3. Improperly mixed dye, especially Mix properly and reduce size if it is of a larger size to prevent
during ‘Direct Compression’. segregation.
4. Improper mixing of a coloured Incorporate dry colour additive during powder blending step, then
binder solution. add fine powdered adhesives such as acacia and tragacanth and mix
well and finally add granulating liquid.
Double impression

Definition: ‘Double Impression’ involves only those punches, which have a monogram or other engraving on
them.

Reason: At the moment of compression, the tablet receives the imprint of the punch. Now, on some machines, the
lower punch freely drops and travels uncontrolled for a short distance before riding up the ejection cam to push
the tablet out of the die, now during this free travel, the punch rotates and at this point, the punch may make a new
impression on the bottom of the tablet, resulting in ‘Double Impression’.

If the upper punch is uncontrolled, it can rotate during the short travel to the final compression stage and create a
double impression.

THE CAUSES AND REMEDIES OF DOUBLE IMPRESSION

Sr. CAUSE REMEDIES

No.
1. Free rotation of either upper punch or -Use keying in tooling, i.e. inset a key alongside of the   
lower punch during ejection of a tablet. punch, so that it fits the punch and prevents punch rotation.

-Newer presses have anti-turning devices, which prevent

punch rotation.

Problems and remedies for tablet coating

Blistering

Definition: It is local detachment of film from the substrate forming blister.

Reason: Entrapment of gases in or underneath the film due to overheating either during spraying or at the end of
the coating run.

THE CAUSE AND REMEDY OF BLISTERING

Sr. No. CAUSE REMEDY

1. Effect of temperature on the strength, elasticity and adhesion of the Use mild drying
film. condition.

Chipping

Definition: It is defect where the film becomes chipped and dented, usually at the edges of the tablet.
Reason: Decrease in fluidizing air or speed of rotation of the drum in pan coating.

THE CAUSE AND REMEDY OF CHIPPING

Sr. CAUSE REMEDY
No.
1. High degree of attrition associated with the Increase hardness of the film by increasing the molecular
coating process. weight grade of polymer.
 

Cratering

Definition: It is defect of film coating whereby volcanic-like craters appears exposing the tablet surface.
Reason: 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.

THE CAUSES AND REMEDIES OF CRATERING

Sr. CAUSES REMEDIES

No.
1. Inefficient drying. Use efficient and optimum drying conditions.

 
2. Higher rate of application of coating Increase viscosity of coating solution to decrease spray
solution. application rate.

Picking

Definition: It is defect where isolated areas of film are pulled away from the surface when the tablet sticks
together and then part.

Reason: Conditions similar to cratering that produces an overly wet tablet bed where adjacent tablets can stick
together and then break apart.

THE CAUSES AND REMEDIES OF PICKING

Sr. CAUSE REMEDY

No
.
1. Inefficient drying. Use optimum and efficient drying conditions or increase the inlet air
temperature.
2. Higher rate of application of Decrease the rater of application of coating solution by increasing
coating solution viscosity of coating solution.

Pitting

Definition: It is defect whereby pits occur in the surface of a tablet core without any visible disruption of the film
coating.

Reason: Temperature of the tablet core is greater than the melting point of the materials used in the tablet
formulation.

TABLE.47. THE CAUSE AND REMEDY OF PITTING

Sr. CAUSE REMEDY

No.
1. Inappropriate drying Dispensing with preheating procedures at the initiation of coating and modifying
(inlet air ) temperature the drying (inlet air) temperature such that the temperature of the tablet core is
not greater than the melting point of the batch of additives used.

Blooming
Definition: It is defect where coating becomes dull immediately or after prolonged storage at high temperatures.

Reason: It is due to collection on the surface of low molecular weight ingredients included in the coating
formulation. In most circumstances the ingredient will be plasticizer.

THE CAUSE AND REMEDY OF BLOOMING

Sr. CAUSE REMEDY

No.
1. High concentration and low molecular Decrease plasticizer concentration and increase molecular
weight of plasticizer. weight of plasticizer.

Blushing

Definition: It is defect best described as whitish specks or haziness in the film.

Reason: It is thought to be due to precipitated polymer exacerbated by the use of high coating temperature at or
above the thermal gelation temperature of the polymers.

THE CAUSES AND REMEDIES OF BLUSHING

Sr. CAUSES REMEDIES

No.
1. High coating temperature Decrease the drying air temperature
2. Use of sorbitol in formulation which causes largest fall in the Avoid use of sorbitol with Hydroxy Propyl
thermal gelation temperature of the Hydroxy Propyl Cellulose, Hydroxy Propyl Methyl
Cellulose, Hydroxy Propyl Methyl Cellulose, Methyl Cellulose, Methyl Cellulose and Cellulose
Cellulose and Cellulose ethers. ethers.

Color variation

Definition: A defect which involves variation in colour of the film.

Reason: Alteration of the frequency and duration of appearance of tablets in the spray zone or the size/shape of
the spray zone.

THE CAUSE AND REMEDY OF COLOUR VARIATION

Sr. CAUSE REMEDY

No.
1. Improper mixing, uneven spray pattern, insufficient Go for geometric mixing, reformulation with
coating, migration of soluble dyes-plasticizers and different plasticizers and additives or use mild
other additives during drying. drying conditions.

Infilling

Definition: It is defect that renders the intagliations indistinctness.

Reason: Inability of foam, formed by air spraying of a polymer solution, to break. The foam droplets on the
surface of the tablet breakdown readily due to attrition but the intagliations form a protected area allowing the
foam to accumulate and “set”. Once the foam has accumulated to a level approaching the outer contour of the
tablet surface, normal attrition can occur allowing the structure to be covered with a continuous film.

THE CAUSE AND REMEDY OF INFILLING

Sr. CAUSE REMEDY

No.
1. Bubble or foam formation because of air spraying of a Add alcohol or use spray nozzle capable of
polymer solution finer atomization.

Orange peel/Roughness

Definition: It is surface defect resulting in the film being rough and nonglossy. Appearance is similar to that of an
orange.
Reason: Inadequate spreading of the coating solution before drying.

THE CAUSES AND REMEDIES OF ORANGE PEEL/ROUGHNESS

Sr. CAUSES REMEDIES
No.
1. Rapid Drying Use mild drying conditions
2. High solution viscosity Use additional solvents to decrease viscosity of solution.

Cracking/Splitting

Definition: It is defect in which the film either cracks across the crown of the tablet (cracking) or splits around
the edges of the tablet (Splitting)
Reason: Internal stress in the film exceeds tensile strength of the film.

THE CAUSE AND REMEDY OF CRACKING/SPLITTING

Sr. CAUSE REMEDY
No.
1. Use of higher molecular weight Use lower molecular weight polymers or polymeric blends. 
polymers or polymeric blends. Also adjust plasticizer type and concentration.

Key Phrases

During tablet manufacture, an industrial pharmacist usually encounters many problems.

Solving these problems requires an in-depth knowledge of tablet-formulation as well as
machine-operating processes.

 Capping and Lamination are the defects arising as a result of air-entrapment in the
granular material.

 Chipping is a defect related arising due to very dry granules.

  Cracking is due to rapid expansion of tablets, when deep concave punches are
used.

 Sticking, Picking and Binding are the imperfections related to more amount of
binder in granules.

 Mottling is an imperfection arising due to more than one factor: a coloured drug,
dirt in granules or the use of an oily lubricant.

 Double-Impression is related to a machine defect: it is caused by the free rotation

of punches that have some engraving on the punch-faces.

Coating defects:

 Blistering is related to entrapment of gases in or underneath the film due to

overheating either during spraying or at the end of the coating run. Use of mild
drying conditions can solve this problem.

 Chipping is related to higher degree of attrition associated with the coating process.
Increase in hardness of the film by increasing the molecular weight grade of
polymer can solve this problem.

 Cratering is related to penetration of the coating solution into 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. Decrease in spray
application rate and use of optimum and efficient drying conditions can solve this
problem.

 Pitting is defect in which temperature of the tablet core is greater than the melting
point of the materials used in tablet formulation. Dispensing with preheating
procedures at the initiation of coating and modifying the drying (inlet air)
temperature can solve this problem.

 Blooming or dull film is generally because of higher concentration and lower

molecular weight of plasticizer. So use lower concentration and higher molecular
grade of plasticizer.

 Blushing/Whitish specks/Haziness of the film is related to precipitation of polymer

exacerbated by the use of high coating temperature at or above the thermal
gelation temperature of the polymers.

 Colour variation is because of improper mixing, uneven spray pattern, insufficient

coating or migration of soluble dyes during drying. Geometric mixing, mild drying
conditions and reformulation with different plasticizers can solve this problem.

 Infilling is because of bubble/foam formation during air spraying of a polymer

solution. Addition of alcohol or use of spray nozzle capable of finer atomization can
solve this problem.

 Orange peel/Roughness is related to inadequate spreading of the coating solution

before drying. So decrease in viscosity of coating solution can counter this defect.
 Cracking is seen when internal stresses in the film exceeds tensile strength of the
film. This is common with higher molecular weight polymers or polymeric blends.
So use lower molecular weight polymers or polymeric blends