Seminar on

AQUEOUS FILM
COATING

GOVARDHAN.P
Department of pharmaceutics
University College Of Pharmaceutical Sciences,
Kakatiya university,warangal-500609.
CONTENTS
INTRODUCTION

AQUEOUS FILM COATING OF DOSAGE FORM

Film formation mechanism
Film formers

Plasticizers and colours

PROCESS PARAMETERS

HOW THE COATING PROCESS WORKS

COATING EQUIPMENTS

COATING DEFECTS

SOLVENT FILM COATING

 Introduction
COATING:
IT is the application of coating
composition on to the moving bed of tablets with
concurrent use of heated air to facilitate
evaporation of the solvent.
 Water Soluble Polymers
Water-soluble coating materials dissolve completely in the gastrointestinal tract and
.
do not modify the drug release characteristics of the dosage. These polymers are applied
as aqueous solutions.

Hydroxypropyl methylcellulose (HPMC)

Methylcellulose (MC)
Hydroxypropyl cellulose (HPC)
Polyvinylpyrrolidone (PVP)
Food starch (modified)
 Hydroxypropyl methylcellulose

ADVANTAGES:

Solubility characteristics of the polymer in gastrointestinal fluid, and in organic

and aqueous solvent systems.

Noninterference with tablet disintegration and drug availability.

Flexibility, chip resistance, and absence of taste or odor.

Stability in the presence of heat, light, air, or reasonable levels of moisture.

Ability to incorporate color and other additives into the film without difficulty.
The interaction of polymer with colorants is rare.

It forms a transparent, tough and flexible film that protects fragile tablets, masks
the unpleasant taste of a drug and improves the appearance.
COMMON FILM FORMING MATERIALS IN
SUSTAINED RELEASE PRODUCTS

Sustained Release:
Ethyl cellulose (EC)

Methacrylic acid copolymers ( Eudragit types)

Enteric Release:
Cellulose acetate phthalate (CAP)

Hydroxypropyl methylcellulose phthalate (HPMCP)

Polyvinyl acetate phthalate (PVAP)

 Ethyl cellulose
This material is completely insoluble in water and
gastrointestinal fluids.

A combination of ethyl cellulose with water soluble

additives has been widely used in preparing
sustained release coatings of fine particles.
Effect of polymer molecular weight on coating properties

Property Effect of increasing polymer molecular weight

Tensile strength Increases.

Elastic modulus Increases.

Film adhesion Decreases.

Solution viscosity Significantly increases.

 PLASTICIZERS
Film coatings prepared from pure polymers tend to be brittle and crack upon
drying. The addition of plasticizers to the coating liquid decreases the
intermolecular forces along the polymer chains by relieving molecular rigidity.

The plasticizer improves the flexibility and reduces the brittleness of the film
coating and makes it more resistant to mechanical stress during the coating
process.

WATER SOLUBLE:

Polyethylene glycol (PEG)

Propylene glycol (PG)

WATER INSOLUBLE:

Tributyl citrate (TBC)

Acetylated monoglyceride (AMG)
Castor oil
 Effects of Plasticizers on the properties of film coatings

Property Effect of increasing plasticizer concentration

Tensile strength Decreased.

Elastic modulus Decreased.

Film adhesion May be increased, but results often variable.

Solution viscosity Increased, and magnitude of effect dependen

molecular weight of plasticizer.

Film permeability can be increased or decreased, depending on chem

nature of plasticizer.

Glass-transition temperature Decreased, but magnitude of effect dependent

compatibility with polymer.
 COLOURS

Primarily used for tablet identification.

Aluminum lakes

Iron oxides or natural colours such as riboflavin and

carotenoids.
 Effects of Pigments on the properties of film coatings

Property Effect of increasing pigment concentration

ensile strength Decreases

lastic modulus Increases

ilm adhesion Little effect.

olution viscosity Increases, but not substantially.

ilm permeability Decreases, unless critical pigment volume concentrat

is exceeded.
Formation of films from aqueous polymeric dispersions
This requires the coalescence of polymer particles into a continuous film.

This process involves:

Rapid evaporation of water, causing the particles of dispersed polymer to be brought
into close contact with one polymer.
Development of pressures (associated with capillary forces within the structure) that
overcome repulsive forces between particles and cause deformation of the polymer
particles.
Gradual coalescence of the polymer particles as a result of viscous flow and movement
of polymer molecules across the interfaces between particles.

Aqueous polymeric dispersions must be processed at temperatures in excess of the

glass-transition temperature of the polymer.
Aqueous Film Coating
Formulation
Film Coating Composition

Film-forming polymer 7.0-18.0%

Plasticizer 2.5-8.0%

Pigment/Colorant 0.5-2.0%
 Process Parameters

Many quality aspects of the final coated product are greatly

influenced by the combined effect of process parameter values
used in aqueous film coating.
Coating process parameters affect the spreading, penetration
and drying (i.e. evaporation of water) of the coating liquid on
the tablet surface and, subsequently, the surface roughness
and the residual moisture of the coated tablets.
 Process Parameters
Spraying air pressure:

The spraying air pressure disperse the coating liquid into droplets and effects
the droplet size distribution and droplet spreading and penetration on the tablet
surface.

The formation of adequate and adhesive film coat, the atomized droplets have
to spread completely over the surface of the tablet.

Increasing the spraying air pressure decreases the surface roughness of coated
tablets and produces denser and thinner films.

If spraying air pressure is excessive the spray loss is great. The formed droplets
are very fine and could spray dry before reaching the tablet bed, resulting in
inadequate droplet spreading and coalescence.

Spraying air pressure is insufficient, the film thickness and thickness variation
greater possibly due to change in film density and smaller spray loss.
 Flow rate of coating solution

Successful aqueous coating process, the flow rate of the coating liquid is
equal to the rate of water evaporation from the coated tablet surface.

Increasing the flow rate allows greater number of droplets to be spread on

to the tablet bed per time and increases droplet size.

The flow rate is important parameter since it impacts the moisture

content and the quality and uniformity of the film.

Low coating liquid flow rate causes incomplete coalescence of polymer

due to insufficient wetting, which result in brittle films.

High coating liquid flow rate may result in over wetting of the tablet surface
and subsequent problems such as picking and sticking.
 Pan air temperature

The pan air temperature effects drying efficiency of

the coating pan and
the uniformity of the coatings.

High inlet air temperature increases drying efficiency

of aqueous film
coating process and decreases in water penetration into
the tablet coating.

Excessive air temperature increases premature drying

of the spray during
application and subsequently decreases the coating
efficiency.
 Rotating speed of the pan
Increasing rotating speed of the pan improves mixing
of the tablets.

The pan speed effects the time the tablet spend on the
spraying zone and subsequently, the homogenous
distribution of the coating solution on the surface
of each tablet throughout the batch.

Increasing the pan speed decreases thickness

variation and improves the uniformity of the coating.

Too rapid rotating speed of the pan will cause the

tablet to undergo excessive attrition and breakage.
 Application of the film
Aqueous film coating requires equipment with high air flow and excellent control

over the coating process.

Aqueous film coating needs tighter control of the coating process than organic
solvent-based coating systems.
The tablets are normally designed to disintegrate in water, so the rate of application o
coating composition is critical;
Too slow or too rapid application of the coating will
cause the tablet to undergo excessive erosion and breakage.

The following coating pans can provide adequate air flow and control to be used for
aqueous film coating:
1.Accela Cota.
2.Hi-Coater.
3.Dria Coater.
.
 Accela Cota

This is an angular pan

operating on a horizontal
axis. Drying air is directed
into the pan, through the
tablet bed, and exhausted
out the perforations in the
periphery of the pan.
 Hi-Coater

This is similar to Accela

Cota, but only a portion of
the pan periphery has
perforations. Like the Accela
Cota, continuous venting of
the exhaust air from the
pan is still attained.
 General procedure

The aqueous coating liqid is commonly applied by pnemutic (air) spray systems
where the pressure of the spraying air disperses the coating liqid as appropritely
sized droplets

The coating of tablets in a coating pan involves spraying the coating compositions
through one or more spray guns onto rotating bed of tablets.
Coating process consists of the continuous application of coating liquids to a small
portion of the tablets in the pan.
The applied coating must dry before it touches the coating pan or receives its next
application.
To attain a continuous coating operation, the rate of water evaporation from the
coated tablets must equal the rate of water applied in the coating liquid.
The coating composition is also significant factor in establishing the tablet coating
rate. Coating compositions that are quite tacky during the drying phase must be
applied at a slower rate to avoid tablets sticking to pan surface or other tablets.
Common Coating Defects &
Causes

Rough/Orange Peel Appearance

Causes:

Not enough vehicle.

High atomization air.

remedy

Moving the nozzle closer to the tablet bed or

reducing the degree of atomization
 Picking

Problem:
Tablets are too wet.

Possible Causes:
Spray rate too high.

Guns too close together.

Insufficient atomizing air.

Pan speed too low.

REMEDY:Reduction in the liquid application rate or

increases in air dry temparature
 Film Cracking

Problem:

Small cracks appear in the coating.

Causes:
Wrong plasticizer.
Insufficient plasticizer.
Solution too concentrated (Thick).
Insufficient atomizing air.
Film Chipping

Problem:

Coating gone from the tablet edge.

Causes:
High pan rpm.
Low spray rate.
Both together.
Sharp tablet edges.
Bridging of the Logo

Problem:
The letters and numbers fill in with dried
suspension.

Causes:
High spray rate

Inadequate atomizing air.

Poor tooling design.

Twins or Twinning

Problem:
Tablets stick together.

Causes:
High spray rate.
Inadequate drying capacity.
Tablet shape/design.
Tablet too long.
Logo Erosion

Problem:
Tablet erodes before coating can adhere to
the surface.

Causes:
Spray rate too slow.
Pan speed too fast.
Both.
 CRACKING
Cracking occurs if internal stress in the
film exceed the tensile strength of the film
can be increased by using higher-
molecular weight polymers or polymer
blends .
 HAZING/DULL FILM
It can occur when to high processing
temperature used for a particular
formulation.
Dulling is particular evident when
cellulosic polymers are applied out of
aqueous media at high processing
temperature.
SOLVENT FILM COATING: AQUEOUS VS. ORGANIC
Aqueous coatings are in many ways less expensive than organic solvent coatings.
The removal of water from water soluble films such as hydroxypropylmethyl
cellulose, methylcellulose, gelatin, or starch requires the use of higher drying
temperatures than does the removal of methanol from a film. This is not surprising
when one considers their heats of evaporation.

Another comparison between aqueous and organic film coating systems has to
relate to time. The processing time for any film coating application is extremely
important to meet production goals. Aqueous coatings require longer processing
time than organic solvent systems.
Water and organic solvents differ in their support facilities. Because of their volatile
and toxic nature, organic solvent must be handled and stored in areas designed for
this purpose.
 Stability and bioavailability are greatly influenced by the selection of coating and the
solvent system from which it is applied. Many drugs react in the presence of water;
thus, residual moisture in the film coated product may present more of a problem than
residual organic solvents. Although moisture can be eliminated by heat, some products
are unstable at higher temperatures or the combination of heat and moisture.

Aqueous films also tend to have a lower gloss level than the same polymers applied
from organic solvents.
CONCLUSION
Cellulosic and acrylic polymeric films have been used to coat pharmaceutical drug
products for decorative, protective and purposes. These materials are generally
applied using a spray-atomization technique. Additional excipients, including
plasticizers, pigments, anti adherents, and surfactants, may be incorporated into the
coating formulation to aid in processing or to improve the esthetic appearance of
the coated solid.
The addition of these excipients, however, may alter polymer properties and affect
drug release rates. In the development of a film coating formulation, various
polymer properties are commonly evaluated and these data are used to make
predictions regarding the dissolution characteristics and long-term stability of the
final product. Adhesion of the polymer is critical to the performance of the film and
may be affected by the physicochemical properties of the substrate, additives in the
coating formulation, and processing conditions.
Sub coats have been used to improve polymer adhesion as well as to separate
reactive components in the film and substrate.
Defects in the polymeric film may be eliminated by adjusting processing
parameters or by reformulating the coating and/or the substrate.
Aging of coated solids may cause changes in the drug release characteristics and
polymer films should be completely coalesced to minimize aging problems.
 REFERENCES
Encyclopedia of pharmaceutical technology by
James Swarbrick, James C.Boyane volume 1
The Theory And practice of Industrial Pharmacy
by Leon Lachmann and Herbert . A.
Liebermann.
Pharmaceutical dosage forms : Tablets volume-3
Liebermann series.
www.pubmed.gov
www.fda.gov
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