Exipients Function Examples

Sugar compounds e.g. lactose, dextrin,

glucose, sucrose, sorbitol
Provide bulk and enable accurate dosing
Diluents of potent ingredients Inorganic compounds e.g. silicates,
calcium and magnesium salts, sodium or
potassium chloride

Binders, Mainly natural or synthetic polymers

Bind the tablet ingredients together
compression aids, giving form and mechanical strength
e.g. starches, sugars, sugar alcohols and
granulating agents cellulose derivatives

Aid dispersion of the tablet in the

Compounds which swell or dissolve in
gastrointestinal tract, releasing the active
Disintegrants ingredient and increasing the surface area
water e.g. starch, cellulose derivatives
and alginates, crospovidone
for dissolution

Improve the flow of powders during

tablet manufacturing by reducing friction Colloidal anhydrous silicon and other
Glidants and adhesion between particles. Also silica compounds
used as anti-caking agents.
 Exipients Function Examples

Similar action to glidants, however, they

may slow disintegration and dissolution.
Stearic acid and its salts (e.g.
Lubricants The properties of glidants and lubricants
magnesium stearate)
differ, although some compounds, such
as starch and talc, have both actions.

Protect tablet from the environment (air,

Sugar (sucrose) has now been replaced
light and moisture), increase the
by film coating using natural or
mechanical strength, mask taste and
Tablet coatings and synthetic polymers. Polymers that are
smell, aid swallowing, assist in product
films identification. Can be used to modify
insoluble in acid, e.g. cellulose acetate
phthalate, are used for enteric coatings
release of the active ingredient. May
to delay release of the active ingredient.
contain flavours and colourings.

Mainly synthetic dyes and natural

Improve acceptability to patients, aid
colours. Compounds that are themselves
Colouring agents identification and prevent counterfeiting.
natural pigments of food may also be
Increase stability of light-sensitive drugs.
used.
Name of Defect Description Illustration Reason Remedy

Defect where the - Increase

film becomes It may be due to hardness of the
chipped and sticking or to damaged film by
Chipping
dented, usually at punches or incorrectly increasing the
the edges of the to tablet machine. molecular weight
tablet grade of polymer

Unequal One reason for -Use appropriate

distribution of mottling is drug whose colorants
color on a tablet, colour differs from the - Mix properly
Mottling with light or dark tablet excipients, or a and reduce size if
spots standing out drug whose it is of a larger
in an otherwise degradation products size to prevent
uniform surface are coloured. segregation
Upper or lower
segment of the
tablet separates
horizontally, It is due to air - Use flat punches
either partially or entrapped in the die - Reduce speed of
completely from which compressed as turret (Increase
the main body of a punches move together dwell time)
Capping
tablet and comes to apply pressure, and - Polish dies
off as a cap, which then expands properly
during ejection when the pressure is - Dry the granules
from the tablet released. properly
press, or during
subsequent
handling
Surface defect
resulting in the
film being rough Inadequate spreading - Adjust the spray
Orange Peel
and nonglossy. of the coating solution rate and drying
(Roughness)
Appearance is before drying. conditions.
similar to that of
an orange.
Entrapment of gases in
It is local or underneath the film
detachment of due to overheating Use of mild
Blistering
film from the either during spraying drying condition.
substrate forming or at the end of the
blister. coating run.
 Can be solved in
The resistance of some cases by
the tablet to modifying
ejection from the granules to
Binding It is generally due to
die cavity, due to reduce granule
insufficient lubrication
adherence to the size or by
die wall. increasing punch
die clearance.
The coating solution
- Use efficient
penetrates the surface
and optimum
Defect of film of the tablet, often at
drying conditions
coating whereby the crown where the
- Increase
Cratering volcanic-like surface is more porous,
viscosity of
craters appears causing localized
coating solution
exposing the tablet disintegra-tion of the
to decrease spray
surface core and disruption of
application rate
the coating

Modifying
It is caused by the mixing process.
same factors as Add adsorbent or
It is the separation capping but by absorbent.
Lamination of a tablet into two exaggerated conditions Another one is to
or more horizontal at high speed. It’s also use a less amount
layers. due to poorly cohesive of lubricant or
or oily granules. change the type
of lubricant.
Remedied by
replacing or
refacing nicked
or chipped
punches, resetting
Small, fine cracks
the tablet
observed on the It is due to expansion
machine, by
upper and lower to expansion as
Cracking increasing binder
central surface of distinguished from
or by wetting
tablets, or very capping and
granulation. It
rarely on the laminating. It may be
can also be
sidewall are also due to binding or
corrected by
referred to as sticking.
polishing punch
‘cracks’
tips, removing
some or all lines
and by reducing
the granule size.
 - Use optimum
and efficient
drying conditions
Defect where
It is particular concern or increase the
isolated areas of
when punch tips have inlet air
film are pulled
engraving or temperature
away from the
Picking embossing letters, as - Decrease the
surface when the
well as the granular rater of
tablet sticks
material is improperly application of
together and then
dried. coating solution
part.
by increasing
viscosity of
coating solution.