COATING
TECHNOLOGY
[Link] KIRAN
13080040
LALITHA COLLEGE OF PHARMACY
TABLET COATING
Tablet coating is the
application of coating
material to the exterior
of a tablet with the
intention of conferring
benefits and properties
to a dosage form over
the uncoated variety
WHY TABLET COATING??
The core contains a material
which has a bitter taste in
the mouth or an unpleasant
odor.
Coating will protect the drug
from surroundings with a
view to improve its stability
Coating will increase the
ease by which a tablet can
be ingested by the patient.
CONT…..
The core contains a substance
which is incompatible in the
presence of the light and subject
atmospheric oxidation.
The core is inelegant.
The active substance is colored and
migrates easily to stain hands and clothes.
Coating can modify the drug release
profile. E.g., enteric coating, pulsatile
delivery.
BASIC PRINCIPLE OF TABLET
COATING
Tablet coating is the
application of coating
composition to moving bed
of tablets with concurrent
use of heated air to
facilitate evaporation of
solvent.
TYPES OF TABLET COATING
Sugar coating
Film coating
Enteric coating
Controlled release coating
Specialized coating
Compressed coating
Electrostatic coating
Dip coating
Vacuum film coating
SUGAR COATING
sugar coating is a multistep
process.
Its use of labour is more, require
a fair degree of skill.
In suitable sugar-coating
equipment the tablet cores are
successively treated with aqueous
sucrose solutions which,
depending on the stage of coating
reached, may contain other
functional ingredients,…e.g. fillers,
colors, etc.
ADVANTAGES OF S.C
Constituent raw materials are
widely accepted—no regulatory
problems.
No complex equipment or
services are required.
For high humidity climates, it
generally offers a stability
advantage over film-coated
tablets.
STAGES IN SUGAR COATING
Sugar coating is a multi step
process.
1. SEALING
Applied directly to the
tablet core to protect it from
the water that is used in the
remainder of the coating
process.
2 SUB COATING
The actual sugar coating
which leads to 50-100%
increase in weight.
CONT…
3. SMOOTHING
Additional smoothing prior to color
coating can also be applied to opacify the
subcoat to promote a brighter final color
4. COLORING
The most critical step of sugar coating,
consists of multi-step application of syrup
containing the required
color(dye/pigment)
CONT……
5. POLISHING
Imparts the required gloss to the final
product.
In many applications, the sealing &/or
smoothing steps may be omitted.
SUGAR COATING FAULTS
A common fault is cracking and
splitting of the sugar coat which is
caused by excess residual moisture
from the processing.
Inversion and stickiness are caused
by the presence of inverted sugar
which is difficult to dry adequately.
Sugar coatings are unfortunately
brittle and are prone to chipping if
subjected to an inappropriate
mechanical stress.
FILM COATING
Film coating is a thin polymer-based coat applied to
a solid dosage form.
The thickness of such a coating is usually between
20 and 100 μm.
Each and every tablet is passed through a spray
zone, where the adherent material is sprayed and
allowed to dry before the next portion of coating
and this process is repeated number of times.
FORMULATION
Film-coating formulations usually contain
the following components:
• Polymer.
• Plasticizer.
• Pigment.
• Vehicle.
POLYMERS
The vast majority of the
polymers used in film coating
are either cellulose derivatives,
such as the cellulose ethers, or
acrylic polymers and
copolymers.
Basically there are two classes
of such
material depending upon the
method of preparation; true
latexes and pseudolatexes.
POLYMER CHARACTERISTICS
Solubility
Viscosity
Permeability
Mechanical properties
Tackiness
PLASTICIZERS
Plasticizers are simply relatively
low molecular weight materials
which have the capacity to alter
the physical properties of a
polymer to render it more useful
in performing its function as a
film-coating material.
There are often chemical
similarities between a polymer.
CONT…
The commonly used plasticizers can be categorized into three
groups:
1. Polyols
(a) glycerol (glycerin);
(b) propylene glycol;
(c) polyethylene glycols PEG (generally the 200–6000 grades).
2. Organic esters
(a) phthalate esters (diethyl, dibutyl);
(b) dibutyl sebacete;
(c) citrate esters (triethyl, acetyl triethyl, acetyl tributyl);
(d) triacetin.
3. Oils/glycerides
(a) castor oil;
(b) acetylated monoglycerides;
(c) fractionated coconut oil.
COLOURANTS
This group of materials are
commonly used as ingredients in
film-coating formulae.
They obviously contribute to the
aesthetic appeal of the product,
but they also enhance the product
in other ways:
1. Identification of the
product
[Link] reinforce brand
imaging
[Link] the ability of the
coating to protect the active
ingredient against the action of
light.
CONT….
Organic dyes and their lakes
Sunset Yellow
Tartrazine
Erythrosine.
Inorganic colors
Titanium dioxide
Iron oxide yellow, red and black
Talc.
Natural colors
Riboflavine
Carmine
Anthocyanins
SOLVENTS/VEHICLES
• water
• alcohols
• ketones
esters
• chlorinated hydrocarbons.
Mechanism of film formation
ENTERIC COATING
An enteric coating is a
barrier applied to oral
medication that controls the
location in the digestive
system where it is absorbed.
Enteric refers to the small
intestine, therefore enteric
coatings prevent release of
medication before it reaches
the small intestine.
Composition of coatings
methyl acrylate-methacrylic acid copolymers
cellulose acetate succinate
hydroxy propyl methyl cellulose phthalate
hydroxy propyl methyl cellulose acetate
succinate (hypromellose acetate succinate)
polyvinyl acetate phthalate (PVAP)
methyl methacrylate-methacrylic acid
copolymers
Sodium alginate and stearic acid
Specialized coating
Electrostatic coating
Electrostatic coating is a
manufacturing process that employs
charged particles to more efficiently
coat a tablet.
Dip coating
Dip coating is a popular way of
creating thin films for research
purposes. Uniform films can be
applied onto flat or cylindrical
substrates.
CONT….
Vacuum film coating
Vacuum coating is a mechanized
process for applying coatings to
lengths of materials. The product
to be coated is motivated or
conveyed in a lengthwise fashion
at a constant speed, and these
speeds can be as high as 500 feet
per minute.
IDEAL CHARACTERS OF COATING
MATERIAL
Solubility in the coating solution.
Low cost
Ease of application without specialized
equipment.
Capacity to produce elegant looking product.
Stability in the presence of water, heat, air,
moisture and substrate being coated and no
change properties with aging.
CONT….
Essentially no color, odor or taste.
Compatibility with common coating
solution additives.
Nontoxic and ease of application.
Resistance to cracking and should act as
barrier.
Ease of printing procedure on high speed
equipment
METHODS OF PREPARATION- COATING
SOLUTION
1. EMULSION-SOLVENT EVAPORATION
2. PHASE INVERSION
EMULSION-SOLVENT
EVAPORATION
Polymer is first dissolved in water-
immiscible organic solvent and
then mixed with an aqueous phase
containing surfactant and stabilizer.
The mixture is then emulsified to
form an o/w type of emulsion
which is then subjected to
ultrasonification or homogenization
to generate a fine emulsion
containing submicron droplets
Solvent is evaporated (EX-
aquacoat)
PHASE INVERSION
Polymers and plasticizer first undergoes
hot melting or solvent gelation and
combined with long chain fatty acids to
form a homogenous mixture.
A dil Alkali solution is slowly added to the
mixture under vigorous agitation to form
initially a w/o type of emulsion (water in
polymer)
As more aqueous alkali is added, phase
inversion occurs and a dispersion of
polymers in water is produced
COATING DEFECTS
PICKING & STICKING
BRIDGING
CAPPING
EROSION
TWINNING
PEELING AND FROSTING
CHIPPING
MOTTLED COLOR
ORANGE PEEL
WAITING PERIOD
BATCH SIZE
SOLUTION PREPARED
GUN GEOMETRY
SPRAY GUN CALIBRATION
GUN NOZZLES
PAN LOADING
CLEANING
. PICKING & BRIDGING
STICKING This occurs when the
This is when the coating coating fills in the
removes a piece of the lettering or logo on the
tablet from the core. It is tablet and is typically
caused by over wetting caused by improper
the tablet or by poor application of the
tablet quality solution, poor design of
tablet embossing, high
viscosity, high %age of
solids in the solution etc.
CAPPING EROSION
This is when the This can be the result
tablet separates in of soft tablets, an
laminar fashion. This over wetted tablet
occurs due to surface, inadequate
improper tablet drying or lack of
compression tablet surface
strength
TWINNING PEELING & FROSTING
2 tablets stick The coating peels away from
together. the tablet surface in a sheet.
This indicates the coating
Common problem with solution didn’t lock into the
capsules. tablet surface.
Reduce spray rate or Due to over wetting, defect in
increase the pan coating solution or high
speed. moisture content in the
tablet core.
CHIPPING MOTTLED COLOR
This is the result of high Happens when coating
pan speed, a friable tablet solution is improperly
core or a coating solution prepared, the actual spray
that lacks plastizer. rate differs from target rate.
TABLET QUALITY SPRAY GUN
Tablets must have the CALIBRATION
proper porosity, surface, Must check the calibration
hardness and moisture of the guns every time
content. you change products.
WAITING PERIOD Means checking the gun’s
Most tablets cannot be overall condition, its
coated after being filter, nozzle alignment
compressed. The energy and needle condition.
within the tablet will be CLEANING
pretty high, in fact it will Each component of the
be warm. Hence the spraying system must be
tablet should be kept cleaned and dried.
aside for sometime.
GUN NOZZLES PAN LOADING
The spray gun nozzles While loading the tablets
must be kept clean and look for tablets that are
free of product buildup. broken, capped,
Use a flash light during chipped.
coating to look into the
cabinet and check the
nozzles.