Components
that
must
be
added
to
the
Therapeutic
Ingredient
are
classified
according
to
their
purpose
and
are
grouped
into:
Essential
components
o Diluent
or
bulking
agent,
binders
or
granulators,
distintegrants
Compression
aids
o Glidants,
lubricants,
antiadhesives
Supplementary
components
o Colors,
flavors,
sweetening
agents,
adsorbents
Diluents
Substances
that
make
up
the
major
portion
of
the
tablet
Lactose,
starches,
mannitol,
sorbitol,
sucrose,
microcrystalline
cellulose
3
factors
for
choosing
diluent
Cost
Biocompatible
with
other
ingredients
Moisture
content
Binders
Substances
that
glue
powders
together
and
cause
them
to
form
granules
Impart
cohesive
qualities
to
the
powdered
material
Liquid
binder
if
API
is
not
affected
by
water
Dry
if
API
affected
by
water
Overwetting
too
much
binder
Underwetting
kulang
binder
Added
in
3
portions
1. Together
with
API
2. Added
to
form
granules
3. Added
before
compression
Dependent
on
the
choice
of
the
proper
binding
agent,
quantity
used
and
form
of
the
binder
when
added
Starch
paste
(10-20%),
aqueous
gelatin
solution
(10-20%),
aqueous
glucose
solution
(25-50%),
alcoholic
solution
of
ethylcellulose
(5%)
Disintegrant
Material
that
help
the
tablet
break
up
and
dissolve
to
release
the
medicament
for
rapid
dissolution
Starches
(corn
and
potato),
clays,
cellulose,
aligins,
gums,
effervescent
mixtures
Glidants
Materials
added
to
the
formulation
to
enable
the
granules
to
flow
from
a
hopper
of
the
tablet
press
to
the
die
and
for
consistent
and
uniform
fill
Talcum,
corn-starch
Lubricants
Materials
which
aid
in
releasing
the
compressed
tablet
from
the
die
Metallic
stearic
acid,
high
melting
point
waxes,
corn
starch
Antiadhesives
Materials
needed
to
preven
tth
eformation
of
residue
fills
of
tablet
granulation
on
the
punches
Talcum,
metallic,
corn
starch
Colorants
FD&C,
D&C,
free
dyes
and
lakes
Lakes
are
best
adsorbed
in
aluminum
hydroxide.
They
are
almost
completely
insoluble
in
water,
in
which
they
may
bleed
slightly
Photosensitive
in
varying
degrees
Main
problem
encountered
mottling
Flavors
and
Sweeteners
Frequently
used
in
chewable
tablets
Flavors
are
available
as
oils
and
as
spray
dried
beadlets.
They
are
never
incorporated
during
wet
processing,
since
subsequent
drying
would
reduce
the
concentration
of
these
volatile
ingredients
Aqueous
flavors
are
not
recommended
since
water
would
interfere
with
tableting
by
causing
sticking
Lactose,
sucrose,
mannitol,
dextrose,
saccharin
(500x
as
sweet
as
sucrose
but
with
bitter
aftertaste)
Adsorbent
Substance
capable
of
holding
quantities
of
fluids
in
an
apparently
dry
state
Useful
when
ethereal
oils,
ethereal
solutions
of
oil-soluble
drugs,
fluid
extracts,
and
eutectic
melts
are
part
of
the
tablet
formulation
Silicon
dioxide
possesses
a
vast
surface
area,
it
can
hold
up
to
50%
of
its
weight
in
water
and
still
as
free
flowing
powder
Magnesium
carbonate,
magnesium
hydroxide,
bentonite,
kaolin,
magnesium
aluminum
silicate,
tricalcium
phosphate,
and
dried
starch
Tablet
Presses
Tablets
are
formed
by
the
compression
of
various
materials
on
stamping
machines
called
presses
Basic
components
of
a
tablet
press
consist
of
hopper,
feed
frame,
dies,
punches,
and
cams
All
other
parts
of
a
tablet
press
are
designed
to
control
the
functioning
of
those
listed
above.
Features
such
as
capacity,
speed,
maximum
weight,
and
pressure
vary
with
the
design
of
the
equipment,
but
the
basic
elements
remain
essentially
the
same
Basic
mechanical
unit
table
compression
involves
the
operation
of
two
steel
punches
(upper
and
lower)
within
a
steel
die
cavity.
These
toolings
form
the
tablet.
The
tablet
assumes
the
size
and
shape
of
the
punches
and
dies
used
Curvature
of
the
faces
of
the
punches
determines
the
curvature
of
the
tablets
Weight
of
the
tablet
is
determined
by
the
volume
of
the
material
which
fills
the
die
cavity
Thickness
can
vary
due
to
the
density
of
the
granules,
pressure
applied
to
the
tablet
or
the
speed
of
tablet
compression
5
basic
elements
of
a
tablet
press
Hopper
san
nilalagay
the
granules
Feed
shoe/feed
frame
transport
granules
form
hopper
to
die
Upper
punch
descend
to
compress
Lower
punch
ascend
to
eject
Die
decide
tablet
size
and
shape
2
Types
of
Tablet
Compression
Single
punch
-
<1000tabs/min
Multistation
rotary
presses-
<100,000tabs/min
Granulation
by
Compression
Also
known
as
dry
granulation,
precompression
or
double
compression
method
Involves
compaction
of
finely
divided
powdered
materials
into
large,
poorly
formed
but
firm
masses
called
slugs.
These
are
subsequently
screened
or
milled
in
order
to
produce
a
granular
form
of
tableting
material
possessing
the
essential
characteristics
of
a
good
granulation
Dry
granulation
method
includes
the
following
steps
Weighing
of
ingredients
Mixing
of
ingredients
in
a
suitable
mixer
of
blender
Slugging
by
using
flat
face
punches
7/8
to
1
inch
diameter
Dry
screening
of
slugs
through
a
mesh
screen
(by
hand)
or
through
a
Fitzpatrick
comminuting
mill
Lubrication
through
a
suitable
blender
Compression
into
final
tablets
Bolting
-
addition
of
lubricant
prior
to
compression
Wet
Granulation
Most
widely
used
and
most
general
method
for
preparing
a
tablet
granulation
that
will
satisfy
the
physical
requirements
for
the
compression
of
good
tablets
Disadvantages
of
Wet
method
Involves
several
separate
steps
Requires
longer
processing
time
Labor
cost
is
high
Steps
in
the
Wet
Method
Weighing
of
the
ingredients
Mixing
them
in
a
suitable
mixer
of
blender
Granulating
them
into
a
damp
mass
by
the
addition
of
a
binding
solution
Screening
the
mass
by
forcing
through
a
6-
or
8-
mesh
screen
Drying
in
suitable
ovens
of
fluid
bed
dryers
Dry
screening
through
smaller
mesh
screen
(see
next
table)
Lubrication
in
a
suitable
blender
(Bolting)
Compression
into
final
tablets
Recommended
Screen
size
for
Dry
Screening
Granulation
Tablet
size
(diameter)
Screen
size
Up
to
3/16
inch
20 mesh
16 mesh
14 mesh
12 mesh
Special
Procedures
to
Promote
Fluidity
and
Compressibility
of
Materials
by
Forming
beads:
Spheronization
Spray
drying
Spray
congealing
or
spray
chilling
Spheronization
Form
of
pelletization
which
consists
of
extruding
a
wet
granulation
containing
the
API,
diluent
and
binder
into
the
spheronization
equipment
called
Meramurizer
machine
Extruded
rob
shaped
cylindrical
segments
are
shaped
into
spheres
by
centrifugal
and
frictional
forces
on
a
rotating
screen.
The
pellets
are
then
dried
by
conventional
methods,
mixed
with
suitable
lubricants
and
compressed
into
tablets
Advantage
of
spheronization
Production
of
granules
which
are
regular
in
shape
size
and
surface
characteristics
Low
friability
resulting
in
fewer
fines
Ability
to
regulate
the
size
of
the
spheres
Spray
drying
Consists
of
bringing
together
a
highly
dispersed
liquid
and
a
sufficient
volume
of
hot
air
to
produce
evaporation
and
drying
of
the
liquid
droplets
The
feed
liquid
may
be
a
solution,
slurry,
emulsion,
gel
or
paste,
provided
it
is
pumpable
and
capable
of
being
atomized
Spray-Congealing
or
Spray-Chilling
Similar
to
spray
drying
and
uses
the
same
basic
equipment
Main
difference
lies
in
the
absence
of
heat
in
the
process
Consists
of
melting
solids
and
reducing
them
to
beads
of
powder
by
spraying
the
molten
feed
into
a
steam
of
ambient
or
cooled
air
or
other
gas.
The
choice
of
the
latter
depends
on
the
freezing
point
of
the
product
Processing
Problems
Cappping
o Partial
or
complete
separation
of
the
top
or
bottom
of
the
tablet
from
the
main
body
Chipping
o Separation
of
small
piece
of
tablet
after
ejection
Lamination
o Separation
of
a
tablet
into
2
or
more
distinct
layers
Picking
o Removal
or
material
from
the
surface
of
the
tablet,
and
its
adherence
to
the
face
of
the
punch
Sticking
o Adhesion
of
granulation
to
the
die
wall
Mottling
o Unequal
distribution
of
color
on
the
surface
of
the
tablet,
with
light
or
dark
areas
standing
out
in
an
otherwise
uniform
surface
Capping,
chipping
and
lamination
might
be
due
to
uneven
distribution
or
uneven
size
or
granules
Factors
that
may
cause
Splitting
of
Tablets
Excess
fines
or
powder
with
entraps
air
in
the
tablet
mixture
Deep
markings
on
tablet
punches
Worn
and
imperfect
punches
Worn
dies
Too
much
pressure
Unsuitable
formula
Moist
and
soft
granulation
Poorly
machined
punches
Remedies
to
prevent
picking
or
sticking
Desing
letterings
as
large
as
possible
particularly
on
punches
with
small
diameters
Reformulate
to
produce
a
larger
tablet
Plate
the
punch
surface
with
chromium
to
produce
smooth
nonadherent
face
Add
a
polishing
agent
such
as
colloidal
siliva
Add
more
binder
or
change
the
binder
to
make
granules
more
cohesive
Dilution
of
low
melting
API
or
additive
with
high
melting
materials
will
prevent
softening
of
the
granules
due
to
heat
of
compression
and
may
increase
tablet
size
Refrigeration
of
the
press
and
granulation
containing
high
concentration
of
low
melting
medicaments
Redry
the
granulation
Several
factors
which
may
cause
mottling
A
drug
that
differs
in
color
from
its
excipients
or
whose
degradation
products
are
highly
colored.
The
former
is
masked
by
the
use
of
a
dye
Migration
of
dye
during
a
granulation
can
be
remedied
by
change
of
the
solvent
system,
reduction
of
drying
temp,
reduction
of
granulation
to
smaller
particle
size
Addition
of
hot
colored
adhesive
solution
to
a
much
cooler
powder
mixture
will
produce
mottling
because
the
adhesive
that
comes
out
of
the
solution
carries
most
of
the
color
with
it.
Remedies
to
this
situation
are
further
setting,
incorporate
the
adhesive
before
adding
the
granulating
fluid
and
disperse
the
dry
color
additive
during
the
powder
blending
USP
official
test
for
tablets
Weight
variation
Hardness
variation
Double
impression
only
for
tablets
Tablet
disintegration
Tablet
dissolution
Tablet
friability
Tablet
coating
Application
of
a
coating
material
to
the
exterior
of
a
tablet
with
the
intention
of
conforming
benefits
and
properties
to
the
dosage
form
over
uncoated
variety.
Solid
dosage
form
are
coated
for
several
reasons
To
mask
unpleasant
taste
To
protect
components
form
atmospheric
degradation
To
prevent
contact
with
a
drug
which
is
irritating
or
potentially
allergenic
To
separate
reactive
ingredients
To
control
the
site
of
drug
release
(enteric
coating)
To
delay
or
prolong
absorption
of
the
drug
component
by
retarding
release
of
drug
from
the
dosage
form
(sustained
release)
To
improve
appearance
To
change
the
physical
surface
characteristics
of
ing.
(surface
modification)
Tablet
coating
have
been
classified
into
4
basic
categories:
Sugar
coating
Film
coating
(
non-enteic
and
enteric)
Compression
Other
new
concepts
Basic
processes
used
in
the
application
of
coating
Pan
coating
Air
suspension
coating
Dip
coating
Tablet
compression
coating
Pan
coating
parang
cement
mixer
Process
is
used
in
both
sugar
and
film
coating
Makes
use
of
coating
pans
provided
with
hot
and
cold
air
input
system
and
an
exhaust
system
to
remove
moisture
and
find
powder
generated
during
the
coating
operation
Other
necessary
equipment
includes
stem
jacketed
tanks
for
the
preparation
of
the
liquids
used,
drying
ovens
necessary
in
the
process
and
polishing
drums
Most
widely
used
by
the
industry
Air
suspension
coating
parang
fluidized
bed
dryer
Most
dependable
methods
for
applying
film
coats
Film
materials
is
atomized
and
applied
to
tablets
as
they
are
suspended
inside
the
columnar
coating
chamber
by
means
of
a
stream
of
hot
air
Major
problems
associated
with
the
air
suspension
coater
is
breakage
As
the
tablets
travel
up
the
center
of
the
column
in
the
main
stream,
velocities
are
so
high
that
collusions
between
tablets
and
the
wall
of
the
coating
chamber
may
produce
excessive
tablet
breakage.
Therefore,
it
is
essential
that
tablets
to
be
subjected
to
the
process
be
formulation
for
minimum
friability
and
be
strong
enough
to
withstand
the
harsh
coating
conditions
Dip
coating
quezo
de
bolaahhh
:O
Materials
to
be
coated
are
usually
placed
in
baskets
and
dipped
into
containers
of
coating
solutions.
The
wet
tablets
are
then
agitated
or
tumbled
in
coating
pans
during
drying
to
prevent
adherence
to
each
other.
The
process
can
be
repeated
a
number
of
times
after
each
coat
is
sufficiently
dry
Has
not
been
widely
accepted
because
of
difficulties
encountered
during
coating
procedure
and
lack
of
coat
and
uniformity
Compression
coating
Makes
possible
some
special
dosage
forms
Two
incompatible
drugs
may
be
separated
by
placing
one
in
the
core,
the
other
in
the
coating
Slow
release
formation
may
be
placed
in
a
core
coated
with
a
fast
releasing
granulation
for
immediate
effect.
Cores
may
also
be
enteric
coated
for
delayed
release
2
types
of
equipment
have
been
created:
One
compresses
a
coating
around
the
cored
that
have
been
made
on
another
press,
the
other
compresses
the
cores
on
one
turret
and
immediately
transfers
them
to
second
for
the
application
of
the
coating
Sugar
coating
Most
widely
used
Involves
several
basic
steps
1. Sealing
done
to
separate
the
core
from
the
water
that
is
used
in
the
coating
process.
Waterproofing
materials
such
as
cellulose
acetate
phthalate,
zein,
shellec,
and
specific
resins
are
adhesivs
in
nature
-
Dusting
compounds
such
as
asbestos-
free
talc
and
terra
alba
are
applied
in
between
2
seal
coats
up
to
6
seal
coasts
to
prevent
the
tablets
from
sticking
with
one
another
and
to
the
coating
pan
2. Subcoating
applied
to
round
off
the
tablet
contour
rapidly,
to
improve
the
bond
between
the
seal
coat
and
the
sugar
coat,
and
to
build
up
or
standardize
tablet
size.
Solutions
used
to
subcoat
are
usually
gelatin
and/or
acacia
3. Syruping
syrup
containing
and
dyeing
phase
of
the
process
is
particularly
demanding.
It
usually
involves
3
basic
phases
such
as
grossing,
heavy
sugar
coating
and
regular
sugar
coating
4. Finishing
initiated
when
the
desired
color
is
attained.
Three
or
4
coated
of
regular
syrup
are
applied
rapidly
without
permitting
the
tablet
bed
to
become
dusty
5. Polishing-
done
in
a
canvas
polishing
pan
by
allowing
the
coated
tablets
to
roll
in
wax
solution
until
high
luster
is
produced
6. Printing
not
talaga
kasama
sa
steps
of
coating
-
Any
print
should
be
distinct,
no
smudging
or
broken
print
Common
coating
fault
for
sugar
coated
tablets
Process
defects
spitting
of
coat
on
storage
caused
by
inadequate
drying
during
the
coating
application
Film
coating
Recent
development
which
makes
use
of
cellulose
polymers,
povidone
and
low
to
medium
MW
glycols
as
film
polymers
One
step
lang
:
deposition
spray
lang
a
thin
film
of
polymer
surrounding
the
tablet
core
The
coating
liquid/solution
contain
a
polymer
in
a
suitable
liquid
medium
together
with
the
other
ing.
like
the
pigment
or
plasticizer
(not
sure,
ang
hina
ng
voice
ni
maam
huhu
)
The
solution
is
sprayed
in
a
rotating
mix
tablet
bed
or
fluid
bed,
drying
condition
permit
the
removal
of
the
solvent
so
as
to
leave
a
thin
deposition
of
coating
material
around
each
tablet
core.
Film
coating
suspension
formulation
Polymer
cellulose
derivatives
(hydroxypropyl
methylcellulose),
methacrylate
amino
ester
copolymer
Plasticizer
PEG
400,
organic
esters
(diethyl
phthalate),
oils/glycerides
(fractionized
coconut
oil)
Colorants
iron
oxide
pigments,
titanium
dioxide,
aluminum
lakes
Solvents
organic
solvents
****Drawback
is
the
use
of
organic
solvent
kasi
expensive,
volatile,
therefore
flammable
and
leaves
residues,
and
can
cause
environmental
hazards
Brand
of
Machine
for
film
coating
Accela
Cota
UK
Hi
coater
Japan
Driacoater
Germany
HTF-150
-
Italy
IDA-
France
Basic
process
requirement
for
film
coating
Adequate
means
of
atomizing
the
spray
liquid
for
application
to
the
tablet
core
Adequate
mixing
and
agitation
of
the
tablet
bed
Sufficient
heat
input
in
the
form
of
drying
air
to
provide
the
latent
heat
of
evaporation
of
the
solvent
Good
exhaust
facilities
to
remove
dust
and
solvent
laden
air
Ideal
characteristics
of
film
coated
tablets
Should
display
an
even
coverage
of
film
and
color
there
should
be
no
abrasion
of
tablet
edges
of
crowns
Logos
and
break
lines
should
be
distinct
and
not
filled
in
Tablet
must
also
be
compliant
with
finished
product
specifications
and
any
relevant
compendial
requirements
Coating
faults
(film)
Processing
-
inadequate
drying
conditions
will
permit
coating
previously
deposited
on
the
tablet
surface
to
stick
against
neighboring
tablets.
When
parted,
this
will
reveal
original
core
surface
underneath
Formulation
faults
film
cracking
or
bridging
of
breaking
lines
Advantages
of
film
coating
in
place
of
sugar
coating
Reduction
in
coating
time
and
material
cost
No
significant
increase
in
tablet
weight
No
undercoate
or
waterproof
coat
required
Durability
and
resistance
of
chipping
and
cracking
Allows
monogramming
identification
of
product
Film coating
Time
At least 8 hrs
1.5 2 hours
Appearance
2-3%
Not possible
Possible
Other
types
of
coating
Compression
coating
Electrostatic
coating
Laminated
coating
Compression
coating
Makes
use
of
sophisticated
tablet
compression
machine
which
compresses
a
coating
or
shell
around
a
core
that
has
been
compressed
on
another
press
Electrostatic
coating
Employed
to
apply
films
to
conductive
materials
by
imparting
an
ionic
charge
to
the
substrate
and
an
opposite
charge
to
the
coating
materials.
This
ensures
a
thin
and
continuous
film
to
the
surface
Laminated
coating
Provides
a
second
action
or
layer
of
medicament
for
tablet
as
in
1. A
repeat
action
tablet,
in
which
a
portion
of
the
drug
is
in
the
outer
lamina
or
coating
2. Enteric
tablets,
in
which
one
drug
may
be
made
available
for
gastric
absorption
and
another
(
or
more
of
the
same)
is
released
in
the
intestine
3. Buccal
swallow
tablet,
which
is
admistered
first
SL,
and
upon
signal,
such
as
release
of
a
flavor
from
the
inner
core,
tablet
is
swallowed
and
proceeds
to
disintegrate
as
a
normal
per
oral(?)
tablet.
Mangifera
indica
haha;)