FILM COATING

TECHNOLOGY OF SOLID DOSAGE FORM

HISTORICALLY, FILM
COATING WAS
INTRODUCED IN THE EARLY
1950S TO COMBAT THE
SHORTCOMINGS OF THE
SUGAR COATING PROCESS
 ADVANTAGES
Minimal weight increase
(typically 2-3% of tablet core
weight
Significant reduction in
processing times
Increased process efficiency
and output
Increased flexibility in
formulation
Improved resistance to chipping
of the coating
PURPOSES OF FILM COATING
Mask unpleasant odors or tastes

Improve the ease of ingestion

Protect the product from its surrounding environment (air, moisture, or light)

Control the rate of release

Separate incompatible materials

Improve the products’s identification

Facilitate handling

Prevent contaminants from reacting with the products

Apply an active coating to a substrate

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MECHANISM OF FILM COATING

FILM COATING INVOLVES THE APPLICATION OF

THIN (IN THE RANGE OF 20- 200 UM), POLYMER-
BASED COATINGS TO AN APPROPRIATE
SUBSTRATE (TABLETS, BEADS, GRANULES,
CAPSULES, DRUG POWDERS, AND CRYSTALS)
FORMULATION OF FILM COATINGS:
POLYMERS
ALTHOUGH IT IS VERY DIFFICULT TO
GIVE TYPICAL EXAMPLES OF FILM-
COATING FORMULATIONS, SINCE
THESE WILL DEPEND ON THE Other additives: Polymers
anti-adherent,
PROPERTIES OF THE MATERIALS surfactants
U S E D, S U C H F O R M U L AT I O N S
USUALLY ARE BASED ON 5-20% (W/W)
COATING SOLIDS WITH THE HIGHER
CONCENTRATION RANGE PREFERRED Solvents Plasticizers
FOR AQUEOUS FORMULATIONS
CONSIST OF:
1. 60-70% IS POLYMER,
2. 6-7% IS PLASTICIZER, AND Colorants
3. 20-30% IS PIGMENT (RPS 21TH:
955). 

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DESIRED CHARACTERISTICS
OF COATING POLYMERS
Solubility in a wide range of solvent system

Compatible with the product substrate

Low viscosity in order to atomize adequately
Capable to form continuous film

Lack toxicity

Stable to heat, light and moisture

Free from undesirable taste or odor
For special application, it must be soluble in certain condition
 POLYMERS

NON-
ENTERICS
ENTERICS
POLYMERS
Water soluble
Usually added to improve the
appearance of the products or to mask
unpleasant tastes. May also provide
protection from light, air, physical stress.

Water insoluble
Usually have modified release properties
(sustained or enteric release)
NON-
ENTERIC
POLYMERS
PURPOSES OF ENTERIC
COATING
1. P r o t e c t d r u g s f r o m
inactivation by gastric juices
(eg. Pancreatin, erythromycin,
benzimidazoles)
2. Prevent nausea or bleeding by
drugs that irritate the gastric
mucosa (eg, aspirin, steroids)
3. Localise the release of the
drugs (antiseptics for
intestines)
4. Optimal release in intestine

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DESIRED CHARACTERISTICS
OF ENTERIC POLYMERS
1. Resistant against gastric juices
2. Susceptible to intestinal fluids and
permeable to intestinal fluids
3. Incompatible with most
components of coating solutions
and drug base ingredients
4. Stable in single form or in coating
solutions. This thin layer is not
easily changed during storage
5. Forms a thin layer (continuous)
6. Not toxic
7. The cost is cheap
8. Easy to use without having to use
special tools
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MECHANISM OF ENTERIC
COATING POLYMERS
Weak acid

Remains undissociated in low PH

Ionized in pH >
 CELLULOSE POLYVINTL
ACETATE ACETATE
PHTALATE (CAP) PHTALATE (PVAP)

METHACRYLIC
HYDROXYPROPYL
METHYLCELLULOSE
ACID
PHTALATE (HPMCP) COPOLYMERS
(EUDRAGIT L & S)
N AT U R A L LY, P O LY M E R I S
BRIT TLE , THEREFORE IT
MIGHT BE PRONE TO
CRACKING. TO REDUCE THE
BRITTLENESS, PLASTICIZER IS
NEEDED.
 WHY DO WE NEED PLASTICISER?

Excess
Tg temperature Plasticizer

• < Tg à rigid
polymer
• > Tg à flexible ↓ Tg
polymer
PLASTICIZERS MUST BE
MISCIBLE AND INTERACT
WITH POLYMER THEY
PLASTICIZE
EXCESS PLASTICIZER
WILL CREATE STICKY
AND AGGLOMERATION
OF THE PRODUCT
 WATER WATER
SOLUBLE INSOLUBLE
• PEG (POLYETHYLENE
GLYCOL). LOW MW
FOR SMALL
• CASTOR OIL
PARTICLE, HIGH MW • ACETATE ESTERS
FOR TABLET • TRIACETIN
• PG (PROPYLENE • PHTHALATE ESTERS
GLYCOL). PRODUCES
SOFTER, MORE
FLEXIBLE FILM THAN
PEG
1. CAN DISSOLVE OR DISPERSE POLYMER SYSTEMS
2. I T C A N E A S I LY D I S P E R S E T H E O T H E R
COMPONENTS OF THE COATING SOLUTION
3. SMALL CONCENTRATIONS OF POLYMERS (2-10%)
SHOULD NOT PRODUCE A VERY VISCOUS
SYSTEM SOLUTION (> 300 CPS).
4. IT HAS NO TASTE, COLOR AND SMELL, IS
INEXPENSIVE, NON-TOXIC, NEUTRAL, NON-
FLAMMABLE
5. HAS A FAST DRYING RATE (HAS THE ABILITY TO
OVERLAY 300 KG IN 3 TO 5 HOURS)
6. SHOULD NOT HAVE AN IMPACT ON THE
ENVIRONMENT
 Flammabil
Toxicity ity hazards
hazards

cost

AQUEOUS
SYSTEM
TYPES OF COLORANTS
Water-soluble dyes (e.g•• FD&C Yellow #5 and FD&C
Blue #2)

Aluminum lakes (of FD&C water-soluble dyes)

Other lakes (e.g•• D&C Red #6)

Inorganic pigments (e.g •• titanium dioxide, iron oxides.

calcium sulfate, calcium carbonate)

"Natural" colorants (e. g •• riboflavin, tumeric oleoresin.

carmine 40)
PIGMENT AS
COLORANTS
A. They are unlikely to interfere with bioavailability" as do
some water-soluble dyes.
B. They help to reduce the permeability of the coating to
moisture.
C. They serve as bulking agents to increase the overall
solids content in the coating dispersion without
dramatically increasing viscosity.
D. They tend to be more light stable.
 FORMULATION
IN FILM COATING
GUIDELINES/LIMITATION
Film mechanical strength
Plasticizer level
Pigment level
Solids in Film Formulation
Formulation Viscosity
Stability
Compatibility
PREFORMULATED COATING BLENDS

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 TYPES OF FILM COATINGS
MASKING/
AESTHETIC
BARRIER
COATING COATING
ACTIVE SUSTAINED-
RELEASE
COATING COATING

ENTERIC
COATING

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SEO KS, ET AL. PHARMACEUTICAL APPLICATION OF TABLET FILM COATING.
PHARMACEUTICS, 12 (853). 2020
EQUIPMENT TYPE I: CONVENTIONAL PAN

AIR FLOWS ONTO THE SURFACE OF THE TUMBLING TABLE BED. MOIST, DUST-
LADEN AIR IS REMOVED VIA AN EXHAUST DUCT. ROTATION IS DONE IN A
HORIZONTAL AXIS AT 25º ANGLE.

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EQUIPMENT TYPE II: PERFORATED PAN

PERFORATED PANS. ALMOST SIMILAR WITH CONVENTIONAL PANS, THE

PRIMARY DIFFERENCE IS THAT THE AIR IS EXHAUSTED FROM THE PAN VIA
PERFORATED SURFACE.

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EQUIPMENT TYPE III: FLUID BED

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SPRAY TYPES
A.Airless (or hydraulic) spray, where the coating liquid is
pumped under pressure to a spray nozzle with a small
orifice and atomization or the liquid occurs as it
expands rapidly on emerging from the nozzle. This is
analogous to the effect achieved when one places one's
finger over the end of a garden hose.
B.Air spray, where liquid is pumped, under little or no
pressure, to the nozzle and is subsequently atomized by
means of a blast of compressed air that makes contact
with the stream of liquid as it passes through the nozzle
aperture.

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SPRAY SYSTEM
The open loop arrangement is
typically used with a hydraulic spray
gun, while the recirculation loop is
used with pneumatic spray guns.

For recirculation system, when the

spray is off, the coating formulation is
recirculated back to the solution
tank, providing mixing in the tubing
to prevent the precipitation of solids.
A separate agitator in the solution
tank should be employed for coating
formulations prone to precipitation.

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CONSIDERATION
• Loading Volume
• Humidity
• Temperature
• Pan speed
• Spray rate (suspension viscosity, spray pattern width,
product movement)

• Droplet size distribution

• Coating zone/pattern
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TYPICAL PROCESS IN FILM COATING
loading/charging

pre-heat/dedusting

seal/barrier coat (if needed)

film coating

gloss coat

wax addition

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EVALUATION
SUGAR COATED
1. UNIFORMITY
2. DISINTEGRATION TIME 60 MINS

FILM COATING
1. UNIFORMITY
2. DISINTEGRATION TIME 30 MINS (LIKE NORMAL
TABLET)
3. DISINTEGRATION TEST IN ACID AND ALKALINE
SOLUTION (FOR ENTERIC TABLETS)
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