Problems in tablet manufacturing

Introduction
(62,63)
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 partial or complete separation of the top or bottom of tablet due air-entrapment in the
granular material.
ii) LAMINATION: It is separation of tablet into two or more layers due to 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: It is the adhesion of granulation material to the die wall
vi) PICKING: It is the removal of material from the surface of tablet and its adherance to the face of
punch.
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 coloured drug, which has
different colour 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
(1,5)
‘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.
TABLE.27. THE CAUSES AND REMEDIES OF CAPPING RELATED TO ‘FORMULATION’
(GRANULATION)
Sr.
CAUSES REMEDIES
No.
Large amount of fines in the Remove some or all fines through 100 to 200 mesh
1.
granulation screen
Too dry or very low moisture Moisten the granules suitably. Add hygroscopic
2. content (leading to loss of proper substance e.g.: sorbitol, methyl- cellulose or PEG-
binding action). 4000.
3. Not thoroughly dried granules. Dry the granules properly.
Increasing the mount of binder OR
Insufficient amount of binder or Adding dry binder such as pre-gelatinized starch,
4.
improper binder. gum acacia, powdered sorbitol, PVP, hydrophilic
silica or powdered sugar.
Increase the amount of lubricant or change the type of
5. Insufficient or improper lubricant.
lubricant.
Granular mass too cold to compress
6. Compress at room temperature.
firm.
TABLE.28. THE CAUSES AND REMEDIES OF CAPPING RELATED TO ‘MACHINE’ (DIES, PUNCHES
AND TABLET PRESS)
Sr.
CAUSES REMEDIES
No.
Polish dies properly. Investigate other steels
1. Poorly finished dies
or other materials.
Deep concave punches or beveled-edge
2. Use flat punches.
faces of punches.
Lower punch remains below the face of Make proper setting of lower punch during
3.
die during ejection. ejection.
Adjust sweep-off blade correctly to facilitate
4. Incorrect adjustment of sweep-off blade.
proper ejection.
5. High turret speed. Reduce speed of turret (Increase dwell time).

Lamination / Laminating
(1,5)
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.
TABLE.29. THE CAUSES AND REMEDIES OF LAMINATION RELATED TO FORMULATION
(GRANULATION)
Sr. REMEDIES
CAUSES
No.
Modify mixing process. Add adsorbent or
1. Oily or waxy materials in granules
absorbent.
 Too much of hydrophobic lubricant e.g.: Use a less amount of lubricant or change the
2.
Magnesium-stearate. type of lubricant.
TABLE.30. The Causes and Remedies of Lamination related to MACHINE (Dies, Punches and Tablet
Press)

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

Chipping
(1)
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.

TABLE.31. 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.
Moisten the granules to plasticize. Add
2. Too dry granules.
hygroscopic substances.
Too much binding causes chipping
3. Optimize binding, or use dry binders.
at bottom.

TABLE.32. 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.
Barreled die (center of the die wider than
2. Polish the die to make it cylindrical
ends)
3. Edge of punch face turned inside/inward. Polish the punch edges
Reduce concavity of punch faces. Use flat
4. Concavity too deep to compress properly.
punches.

Cracking
(1)
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.

TABLE.33. THE CAUSES AND REMEDIES OF CRACKING RELATED TO FORMULATION

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

TABLE.34. THE CAUSES AND REMEDIES OF CRACKING RELATED TO MACHINE (DIES, PUNCHES
AND TABLET PRESS)
Sr. No. CAUSES REMEDIES
1. Tablet expands on ejection due to air entrapment. Use tapered die.
Deep concavities cause cracking while
2. Use special take-off.
removing tablets

Sticking / Filming
(1)
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.

TABLE.35. THE CAUSES AND REMEDIES OF STICKING RELATED TO FORMULATION

(GRANULATION)
Sr.
CAUSES REMEDIES
No.
Dry the granules properly. Make moisture analysis to
1. Granules not dried properly.
determine limits.
Too little or improper
2. Increase or change lubricant.
lubrication.
Reduce the amount of binder or use a different type of
3. Too much binder
binder.
Hygroscopic granular Modify granulation and compress under controlled
4.
material. 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.

TABLE.36. THE CAUSES AND REMEDIES OF STICKING RELATED TO MACHINE (DIES, PUNCHES
AND TABLET PRESS)
Sr. No. CAUSES REMEDIES
1. Concavity too deep for granulation. Reduce concavity to optimum.
2. Too little pressure. Increase pressure.
3. Compressing too fast. Reduce speed.

Picking
(1)
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.
TABLE.37. THE CAUSES AND REMEDIES OF PICKING RELATED TO FORMULATION
(GRANULATION)
Sr.
CAUSES REMEDIES
No.
Dry properly the granules, determine optimum
1. Excessive moisture in granules.
limit.
Increase lubrication; use colloidal silica as a
2. Too little or improper lubrication. ‘polishing agent’, so that material does not
cling to punch faces.
Low melting point substances, may soften
Add high melting-point materials. Use high
3. from the heat of compression and lead to
meting point lubricants.
picking.
Low melting point medicament in high
4. Refrigerate granules and the entire tablet press.
concentration.
Compress at room temperature. Cool
5. Too warm granules when compressing.
sufficiently before compression.
Reduce the amount of binder, change the type
6. Too much amount of binder.
or use dry binders.
TABLE.38. 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.
Design lettering as large as possible.
Embossing or engraving letters on punch
2. Plate the punch faces with chromium to
faces such as B, A, O, R, P, Q, G.
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 Increase pressure to optimum.
 tablets.

Binding
(1)
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.
TABLE.39. THE CAUSES AND REMEDIES OF BINDING RELATED TO FORMULATION
(GRANULATION)
Sr.
CAUSES REMEDIES
No.
Too moist granules and extrudes
1. Dry the granules properly.
around lower punch.
Increase the amount of lubricant or use a more
2. Insufficient or improper lubricant.
effective lubricant.
Reduce granular size, add more fines, and increase
3. Too coarse granules.
the quantity of lubricant.
Too hard granules for the lubricant to
4. Modify granulation. Reduce granular size.
be effective.
Granular material very abrasive and If coarse granules, reduce its size.
5.
cutting into dies. Use wear-resistant dies.
Granular material too warm, sticks to Reduce temperature.
6.
the die. Increase clearance if it is extruding.
TABLE.40. 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.
Rough dies due to abrasion, Investigate other steels or other materials or modify
2.
corrosion. granulation.
Undersized dies. Too little Rework to proper size.
3.
clearance. Increase clearance.
Too much pressure in the tablet Reduce pressure. OR
4.
press. Modify granulation.

Mottling
(1)
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.
TABLE.41. THE CAUSES AND REMEDIES OF MOTTLING
Sr.
CAUSES REMEDIES
No.
A coloured drug used along
1. with colourless or white- Use appropriate colourants.
coloured excipients.
Change the solvent system,
A dye migrates to the surface Change the binder,
2.
of granulation while drying. Reduce drying temperature and
Use a smaller particle size.
Improperly mixed dye,
Mix properly and reduce size if it is of a larger size to
3. especially during ‘Direct
prevent segregation.
Compression’.
Incorporate dry colour additive during powder blending
Improper mixing of a coloured
4. step, then add fine powdered adhesives such as acacia and
binder solution.
tragacanth and mix well and finally add granulating liquid.

Double impression
(1)
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.
TABLE.42. THE CAUSES AND REMEDIES OF DOUBLE IMPRESSION
Sr.
CAUSE REMEDIES
No.
-Use keying in tooling, i.e. inset a key alongside of
Free rotation of either upper punch the punch, so that it fits the punch and prevents
1. or lower punch during ejection of a punch rotation.
tablet. -Newer presses have anti-turning devices, which
prevent punch rotation.

Problems and remedies for tablet coating

Blistering
(1,64)
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.
TABLE.43. THE CAUSE AND REMEDY OF BLISTERING
Sr.
CAUSE REMEDY
No.
Effect of temperature on the strength, elasticity and adhesion of Use mild drying
1.
the film. condition.

Chipping
(1,64)
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.
TABLE.44. THE CAUSE AND REMEDY OF CHIPPING
Sr.
CAUSE REMEDY
No.
High degree of attrition associated Increase hardness of the film by increasing the
1. with the coating process. molecular weight grade of polymer.

Cratering
(1,64)
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.

TABLE.45. THE CAUSES AND REMEDIES OF CRATERING

Sr.
CAUSES REMEDIES
No.
Inefficient drying.
1. Use efficient and optimum drying conditions.

Higher rate of application of Increase viscosity of coating solution to decrease

2.
coating solution. spray application rate.

Picking
(1,64)
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.
TABLE.46. THE CAUSES AND REMEDIES OF PICKING
Sr.
CAUSE REMEDY
No.
Use optimum and efficient drying conditions or increase the
1. Inefficient drying.
inlet air temperature.
 Higher rate of application of Decrease the rater of application of coating solution by
2.
coating solution increasing viscosity of coating solution.

Pitting
(1,64)
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.
Dispensing with preheating procedures at the initiation of coating
Inappropriate drying
and modifying the drying (inlet air) temperature such that the
1. (inlet air )
temperature of the tablet core is not greater than the melting point of
temperature
the batch of additives used.

Blooming
(1,64)
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.
TABLE.48. THE CAUSE AND REMEDY OF BLOOMING
Sr.
CAUSE REMEDY
No.
High concentration and low molecular Decrease plasticizer concentration and increase
1. weight of plasticizer. molecular weight of plasticizer.

Blushing
(1,64)
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.

TABLE.49. THE CAUSES AND REMEDIES OF BLUSHING

Sr.
CAUSES REMEDIES
No.
1. High coating temperature Decrease the drying air temperature
Use of sorbitol in formulation which causes largest Avoid use of sorbitol with Hydroxy
fall in the thermal gelation temperature of the Propyl Cellulose, Hydroxy Propyl
2.
Hydroxy Propyl Cellulose, Hydroxy Propyl Methyl Methyl Cellulose, Methyl Cellulose
Cellulose, Methyl Cellulose and Cellulose ethers. and Cellulose ethers.
Colour variation
(1,64)
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.
TABLE.50. THE CAUSE AND REMEDY OF COLOUR VARIATION
Sr.
CAUSE REMEDY
No.
Improper mixing, uneven spray pattern, Go for geometric mixing, reformulation
1. insufficient coating, migration of soluble dyes- with different plasticizers and additives or
plasticizers and other additives during drying. use mild drying conditions.

Infilling
(1,64)
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.

TABLE.51. THE CAUSE AND REMEDY OF INFILLING

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

Orange peel/Roughness
(1,64)
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.
TABLE.52. THE CAUSES AND REMEDIES OF ORANGE PEEL/ROUGHNESS
Sr. No. CAUSES REMEDIES
1. Rapid Drying Use mild drying conditions
2. High solution viscosity Use additional solvents to decrease viscosity of solution.

Cracking/Splitting
(1,64)
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.
TABLE.53. THE CAUSE AND REMEDY OF CRACKING/SPLITTING

Sr. CAUSE REMEDY

No.
Use of higher molecular weight Use lower molecular weight polymers or polymeric
1.
polymers or polymeric blends. 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