TABLET DEFECTS

Tablet defects or manufacturing defects of tablet are not acceptable. But often tablet defects embarrass

tablet manufacturers or formulators to design a new tablet. This article outlines various remedies that

resolve various tablet defects. We explain various tablet defects with pictures. If you are an industrial

pharmacist or work in product development or formulation research and development, you must know about

these tablet defects and remedies. A formulator or product developer usually encounters all of the tablet

defects during the manufacturing of tablets. Tablet coating defects and remedies.

Presently the tablet is the most broadly used dosage form for drug delivery because of some benefits

include economical, patient convenience, and compliance. Tablet defects are either related to functional

defects or visual defects or both. Tablet defects of the are associated with imperfections in any one or more

of the following factors:

1. Formulation of Tablet

2. Tableting equipment

3. Manufacturing process of Tablet

List of tablet defects

1. Capping

2. Lamination

3. Chipping

4. Sticking

5. Picking

6. Cracking

7. Binding / Binding in the die

8. Edging / Flashing of tablet

9. Mottling

10. High friability

11. Weight Variation

12. Hardness Variation

13. Aging of tablets/ Loss of hardness

14. Protracted Hardness (Hardness increases with time)

15. Disintegration time too long

16. Uneven Breakage

17. Black Spot/Stain

18. Double Impression

19. Bisected/ Score line/ breakline or imprint or logo not sharp or well-defined

20. Splitting of Layered tablets or layer separation

21. Layers not sharply defined bilayer tablet

Generally, tablet defects are appeared by either one or more causes such as capping is occurred when the

granules are too dry and/or the lubricant amount is high. Know all of the tablet defects and remedies and

make sure the smooth production of tablets. One by one, all possible tablet defects with picture and

remedies are discussed below:

Capping
Capping is a term used to describe the partial or complete separation of the top or bottom crowns of a tablet

from the main body of the tablet [1]. In another word, capping is a laminar splitting along the edge of the

crown or band of a compressed tablet [2]. Generally, capping is a common tablet defect during tablet

manufacturing.

Causes and Remedies of capping of tablet associated with the formulation

Causes Remedies

High quantity of fine powder materials in the Use granular or less fine material such as MCC type

granules. 102 or 200 instead of MCC type-101.

 Make proper granules with an optimum amount of fine

powder.

Air-entrapment in the granular materials. Increase the dwell time by reducing the turret speed.

Dry the granules carefully to obtain optimum LOD.

Moisten the granules by the solvent used in

Too dry granules.
granulation. Add hygroscopic excipients to maintain an

optimum moisture level.

Excessive elastic or waxy excipients in the Reduce the amount or change the elastic or waxy

formulation. excipients.

Inadequate quantity of binder or inappropriate Enhance the quantity of binder. Add dry binder such

binder. as pregelatinized starch (starch Rx-1500).

Presence of too much lubricant. Use an optimum amount of lubricant.

Too soft granules. Make granules properly and keep optimum LOD.

Granular mass is too cold to compress firmly. Compressed at room temperature.

Causes and remedies of capping associated with equipment (punches, dies, & compression machine)

Causes Remedies

Poor tooling choice such as the use of deep

Use shallow or standard concave punches.
concave or extra deep concave of punches.

Excessive compaction force. Use optimum compaction force.

Incorrect setup of dies and punch such as lower

punch remains below the face of the die during Set up of dies and punches properly.

ejection.

To facilitate proper ejection, adjust sweep-off blade

Improper sweep-off setting.
suitably.

Lamination
Lamination is the separation of a tablet into two or more distinct horizontal layers. It is a tablet defect in

which a tablet splits or separates into layers.

Causes and Remedies of Lamination of tablet associated with the formulation

Causes Remedies

Use granular or less fine material such as MCC type 102

or 200 instead of MCC type-101.

High quantity of fine powder materials in the

granules. Make proper granules with an optimum amount of fine

powder.

Dry the granules carefully to obtain optimum LOD. Add

Too dry granules. hygroscopic excipients to maintain an optimum moisture

level.

Mixing properly or change of oily, elastic, or waxy

Oily, elastic, or waxy excipients in granules.
excipients.

Air-entrapment in the granular material. Increase the dwell time by reducing the turret speed.

Presence of too much lubricant. Use an optimum amount of lubricant.

Inadequate quantity of binder or inappropriate Enhance the quantity of binder such as copovidone,

binder. pregelatinized starch.

Causes and remedies of Lamination associated with equipment

Causes Remedies

Die wall binding Use an adequate amount of lubricant or use tapered dies.

Damaged tooling such as poorly

Use finely polish dies.
finished dies.

Excessive compaction force. Use optimum compaction force.

 Rapid decompression Use precompression and reduce the final compression pressure.

Chipping
Chipping is the breaking of tablet edges during the press process or during the subsequent handling and
coating.

Causes and remedies of chipping related to the formulation

Causes Remedies

Too dry granules. Moisten the granules; Add hygroscopic substances.

Too much or too low

Optimize binding, or use dry binders.
binding.

Sticking on punch faces Dry the granules properly or increase lubrication.

Causes and remedies of chipping related to equipment

Causes Remedies

Sharp edge, elongated tablets Change the tablet punch

Lower punch setting too low at tablet take-

Adjust lower punch flush with the die face

Poor finish or worn punches and dies Polish, reface, or replace punches and dies

Groove of die worn at compression point. Polish to open-end, reverse or replace the die.

Barreled die (center of the die wider than

Polish the die to make it cylindrical
ends)
 Edge of punch face turned inside/inward. Polish the punch edges

Tablet sweep-off blade on feed frameset

Adjust setting
too high

Sticking
Sticking is a defect of the tablet where the tablet surface sticks to the punch face or adhesion of tablet

material to the die wall during compression. Simply, sticking is the adherence of material to the faces of

tablet press punches or dies after compression [2]. In sticking, the tablet surface sticks to the lower punch

face but a small portion from the tablet surface not detached or the pitted surface will not occur.

Causes and remedies of sticking related to formulation

Causes Remedies

Excess moisture in granules Properly dry the granules to keep optimum moisture.

Inadequate lubrication. Increase the amount of lubricant, Use microfine lubricants.

Too much binder. Lessen the amount of binder.

Too much hygroscopic

Lessen the humidity in the compression room.
excipients.

Make granules by wet granulation properly. Add colloid silicon dioxide or

Sticky API or sticky excipient.
microcrystalline cellulose or change the sticky excipient.

Mix low melting point materials by microcrystalline cellulose (MCC).

Low melting point materials.
Exchange with higher melting point materials.

Causes and remedies of sticking related to equipment

 Causes Remedies

Decrease punch concavity or use shallow concave or flat face

Punch concavity too deep.
punches.

Embossed letters or logo on the punch Avoid embossed (letters or logo) punch or Use shallow

surface. embossing punches.

Punch tips burred. Refinish or replace the punch.

Poor finish on punch faces Polish punch faces; refinish

Picking
Picking is the term used when a small amount of material from a tablet is sticking to and being removed

from the tablet-surface by a punch [1]. In other word, the removal of material from the surface of the tablet,

and its adherence to the face of punch is called picking.

Causes and remedies of picking related to formulation

Causes Remedies

Inappropriate dried granules. Properly dry the granules to keep optimum moisture.

Inadequate lubrication. Increase the amount of lubricant. Use microfine lubricants.

Low melting point materials in Mix low melting point materials by microcrystalline cellulose. Exchange

high concentration. with higher melting point materials.

 Too warm granules when Sufficiently cool before compression. compression vs compaction

compressing.

Too much binder. Lessen the amount of binder.

Hygroscopic excipients. Lessen the humidity in compression room.

Causes and remedies of picking related to equipment

Causes Remedies

Rough or scratched punch surfaces. Polish faces to high luster.

Engraving or embossing letters or logo on punch Avoid embossed (letters or logo) punch or Use shallow

faces. embossing punches.

Bevels or break lines too deep. Reduce depths and sharpness.

Cracking
Cracking is a defect of tablet where small, fine cracks observed on the upper and lower central surface of

tablets, or very rarely on the sidewall. Easily visible in the tablet that contains pigment or dye.

Causes and remedies of cracking related to the formulation

Causes Remedies

Reduce granule size. Use proper granular size with sufficient fine materials
Large size of granules.
but fine materials should not be more than 15%.

Too dry granules. Dry properly. Moisten the granules properly.

 Inadequate binder Use a proper quantity of binder.

Rapid expansion of tablets Improve granulation. Add dry binders.

Elastic excipients in
Exchange or lessen elastic excipients.
granules.

Granulation too cold. Compress at room temperature.

Causes and remedies of cracking related to equipment

Causes Remedies

Tablet expands on ejection due to air

Use tapered die.
entrapment.

Deep concavities cause cracking while removing Decrease punch concavity or use shallow concave or

tablets flat face punches.

Binding / Binding in the die

Binding is tablet defect where a tablet adheres, seize or tear in the die or a film is formed on the die area

and hindered the ejection of the tablet or splits during the molding/pressing process. The powder adheres to

punch edges and dies punches may bind in dies difficult ejection.

Tablet binding witk gie ¥¥all

Causes and remedies of binding related to formulation

Causes Remedies

Too moist granules. Dry the granules properly.

Excessive binder. Use proper amount of binder.

Inadequate lubrication. Increase or change lubricant; Increase lubricant blending

 time. Use microfine lubricants.

Too hard granules for the lubricant to be

Modify granulation. Reduce granular size.
effective.

If coarse granules, reduce its size.

Granular material very abrasive and cutting

into dies. Use wear-resistant dies.

Hygroscopic Ingredients Process under low humidity conditions

Increase the lubricant level. Add 0.5% Cab-O-Silk or

Adhesive excipients
Syloid

Causes and remedies of binding related to equipment

Causes Remedies

Poor finish or worn punches and

Polish, reface, or replace tooling
dies

Undersized dies. Too little

Rework to the proper size. Increase clearance.
clearance.

Edging / Flashing of tablet

Edging is a defect of tablets in which burrs (raised edges)/ sharp edges appear on the final compressed

tablet. This type of tablet defect also known as collaring of tablet or flashing.

Causes and remedies of Edging / Collaring of tablet / Flashing related to the formulation

Causes Remedies

Waxy or elastic API or excipients in

Milled these materials and mix properly.
formulation.

Moisture in granules. Dry properly.

Causes and remedies of Edging / Collaring of tablet / Flashing related to equipment

Causes Remedies

Higher compression
Lessen the compression pressure
pressure

Poor design punch or wear

Polish, reface, or replace tooling
punch.

Mottling
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 [1]. This type of tablet defect occurs in tablet formulation with a

dry coloring agent. Simply, mottling is a tablet defect where dark and light patches on the tablet surface

occur.

Causes and remedies of mottling

Causes Remedies

Unequal particle size of coloring agent or pigment. Sieved before use to make equal size particles.

A colored drug used along with colorless or white-

Use appropriate colorants.
colored excipients.

Increase dry mixing time during granulation. Use a

A dye migrates to the surface of granulation while
proper and fine binder. Use a smaller particle-sized
drying.
dye.
 Improperly mixed dye, especially during ‘Direct Mix properly and reduce the size if it is of a larger

Compression’. size to prevent segregation. Use microfine lake

dye. Increase blending time. Mill lake dye with 5%

excipient.

Too small amount of colorant. Increase quantity of colorant.

Preferential absorption of soluble dye by component

Replace soluble dye with microfine lake pigment.
of mix.

High friability
Causes and remedies of High friability

Causes Remedies

Inadequate binder. Increase binder level or change or stronger binder.

Over drying of granules Dry the granules properly.

Some excipient such as microcrystalline cellulose

Replace the excipient; make a tablet with optimum
gives low friability at lower hardness/machine
hardness.
pressures.

Too much or too little compression pressure. Adjust pressure for acceptable friability.

Over-lubrication Use sufficient lubricant with optimum blending time.

Weight Variation
Weight variation is a common defect of tablets occur during tablet manufacturing where average or

individual weight of tablet may outside of the accepted limit. According to USP, BP & IP the accepted limit of

weight variation given below:

IP/BP Accepted Limit use

+ 10%
Tablet weight 80 mg or less Tablet weight 130 mg or less

+ 7.5%
More than 80 mg or Less than 250mg 130 mg to 324 mg

+ SO O
250 mg or more More than 324 mg
Causes and remedies of Weight Variation

Causes Remedies

Poor or erratic flow of granules from the Make uniform size granules; Avoid excess fines excipient for

hopper. direct compression

Improper amount of glidant Use a sufficient amount of glidant.

Make uniform size granules; Avoid excess fines excipient for

Particle size range too wide.
direct compression

Improper drying. Dry the granules properly.

Abnormal uniform mixing of all excipients. Confirm proper mixing; Increase mixing time.

Particle segregation as press RPM’s Narrow the particle size range; Make granules by wet

increase granulation.

Adjust particle size range to recommended optimum for die

Particle size not suitable for die diameter
diameter

Lower punch “hang up” (material between Check for proper clearance between die wall and lower

the lower punch and die wall or lower punch; Increase lubricant concentration in the formulation;

punch and punch guide) Remove below 200 mesh fines.

Improper tool setting of machine. Hi-speed

Use optimum speed.
running of the machine.

Hardness Variation
Tablet hardness does not remain constant but it has a range. Hardness variation is a common defect of

tablets where individual hardness of tablets may outside the accepted limit. Unlike weight variation,
hardness variation limit is determined by prototype trial of that tablet.

Causes and remedies of Hardness Variation

Causes Remedies

Over-blending. Optimize the blending time.

Weight variation in granules filled in die. Solve the causes of Weight variation.

Improper mixing of lubrication Mixing properly.

Uneven die-fill. Set the compression machine properly.

Aging of tablets/ Loss of hardness

It a tablet defect where hardness of tablet decreases with time.

Causes and remedies of Aging of tablets/ Loss of hardness

Causes Remedies

Use sufficient lubricant with optimum blending time;

Over-lubrication Replace metallic stearates with other lubricants

(e.g., stearic acid).

Tablets with microcrystalline cellulose (MCC) lose Use moisture scavenger or moisture adsorbent

some hardness with time at high humidity, but most such as calcium silicate; Storage the tablet with

of the hardness is quickly regained at normal normal humidity or replace MCC from tablet

humidity. formulation.

Compression force (pressure) too low Increase pressure

Granulation too soft Use sufficient binder.

Some excipients such as too much starch can give

Reduce level of causative excipient.
a soft tablet.

Dry the granules properly; Use moisture scavenger

Moisture content too high
or moisture adsorbent such as calcium silicate.

Moisture pick-up Compress and package under low humidity

conditions; Use moisture scavenger or moisture

adsorbent such as calcium silicate.
 Keep tablet containers well closed.

Protracted Hardness (Hardness increases with time)

Causes Remedies

Can be caused by water of crystallization/hydration

Conduct drug-excipients or excipients-excipients
interacting with ingredients or interactions between
compatibility study and replace causing material.
active materials-excipients or excipient-excipient.

Disintegration time too long

Causes Remedies

Use sufficient lubricant with optimum blending time; Replace metallic

Over-lubrication.
stearates with other lubricants (e.g., stearic acid).

Insufficient disintegrant. Use super disintegrant; Increase quantity.

Too much binder. Use optimum quantity binder.

High hardness tablet. Reduce machine pressure.

Uneven Breakage
Many tablets are designed to be broken into smaller dosages with functional score-line / break lines. It is a

tablet defect where the tablet breaks unevenly into two parts.

Causes Remedies

Coarse granules. Reduce particle size of granulation less than 16 mesh.

Improper mixing. Increase mixing time.

Air-entrapment in the granular

Increase the dwell time by reducing the turret speed.
materials.
 Unequal sizes granules. Make granules with sufficient bonder; Milled properly.

Black Spot/Stain
It is defect of tablet where stains or black spots will appear on tablet surface. Mainly observed in colored

tablets.

Causes Remedies

High temperature is the key factor for penetration

Storage tablet at room temperature.
of the dye into the upper surface.

Observe in the high concentration of

Use an optimum quantity of pigment/dyes.
pigment/dyes.

Incompatibility among excipients and API Replace caustic excipient.

Improper cleaning of punches. Must clean the punches.

Double Impression
Double impression is machine related tablet defect where a monogram or engraving shape or break line/

score line or imprint or logo appears twice on the tablet surface.

Causes and remedies of double impression

Causes Remedies

Uncontrolled rotation of either upper punch Use keying in tooling, i.e. inset a key alongside of the

or lower punch during ejection of a tablet. punch, so that it fits the punch and prevents punch rotation.

Uncontrolled movement of punches with

Using anti-turning devices.
engravings on them.
Bisected/ Score line/ Breakline or Imprint or Logo not sharp or
well-defined
Causes Remedies

Granulation too coarse. Reduce particle size of granulation.

Insufficient binder or binder not strong

Use an adequate quantity of binder or use a stronger binder.
enough.

Faulty punch debossing design Redesign using tapered sides on the punch debossing.

Splitting of Layered tablets or Layer separation

This type of tablet defect mainly appears in bilayer tablet where attached layer is separated.

Causes Remedies

Poor bonding between layers. Use a stronger binder or sufficient quantity.

Compression pressure too

Compress at lower pressures.
high.

Over-lubrication. Use sufficient lubricant with optimum blending time.

Over dried granules. Dry granules properly.

Layers not sharply defined in bilayer tablet

This type of tablet defect mainly appears in bilayer tablet where attached layer is not sharply defined.

Causes Remedies

Coarse granules Reduce particle size of granulation less than 16 mesh.

Too many fines Remove fines below 200 mesh

Insufficient colorant Use sufficient colorant

Improper mixing Increase mixing time