By Mahbubul Karim

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Historical perspectives of film coating technology

Types of film coating and modern trends
Theories in film coating: Adhesive and cohesive
strength
Polymers used film coating
Physico-mechanical properties of film coating
Thermal properties of film coating
Diffusion properties of polymer films
Effect of solvent on film properties
Effects of plasticizer on film coating
Coating machine and accessories
Processing conditions for both organic and aqueous
system
Film coating problems and remedies.

Tablet coating is the application of a coating material to the exterior of a

tablet with the intention of conferring benefits and properties to the
dosage form over the uncoated variety.
In its widest sense the technology is also applicable to multiparticulate
systems intended for modified release applications. To a much lesser
extent coatings may also be applied to hard-shell and soft elastic capsules.

Film coating
Sugar coating
Microencapsulation
Compression coating
Of these, film coating is the major technique.

Tablet coating is perhaps one of the oldest pharmaceutical processes still in existence. Sugar
coating was one of the earliest methods. In the past sugar coating was mostly borrowed from
the confectionary industry. Compressed tablets were coated with colored or uncolored sugar
layer. The sugar coating involves several steps like, sealing, sub-coating, color coating and
printing. sugar coating technique was time consuming, affecting the productivity and the
quality of finished product was dependent on the skills of operator. Many a times the
companies had to reschedule their production plans due to the non-availability of skillful
coating operator.

While methods (and materials) for coatings date back over 1000 years (early Islam makes
reference to pill coatings based on mucilage of psyllium seeds), the current pharmaceutical
process of sugar coating originated in the middle of the nineteenth century when sugar as a
raw material became plentiful, and the forerunner of modern panning equipment was invented.

Film-coating was developed early in the 1950s to solve many of the problems associated
with sugarcoating . It involves the application of a film-forming polymer onto the surface of a
substrate (such as tablets and granules).This technique was started with the use of organic
solvents but now has been replaced with aqueous film coating due to environmental and
regulatory considerations. Moreover the cost of any organic solvent is far more than the cost of
purified water. The first film-coated product was introduced to the market in late
1953. At that time, film-coating formulations consisted of an extensive list of ingredients,
including film formers, plasticizers, colorants, surfactants, flavors, glossing agents, and
solvents. Since that time such formulations have been refined and simplified, so that a typical
formulation contains polymer. plasticizer. colorant and solvent (or vehicle).

Film coating has supplanted sugar coating as the method of choice for coating pharmaceutical
solid-dosage forms, even though many people consider the elegance of the sugar-coated product
to be superior. The major advantages of film coating (that have made this the preferred process)
include in table 1:

Table 1: Major Differences between Sugar coating and Film coating:

The first hand driven coating pan was described in 1840

and in 1844 the Frenchman Peysson was granted a patent
for a spherical pan.

The evolution of automatic coating operations started in the midFifties.

For years , pan coating was the sole method used to coat tablets
whether enteric or non enteric and the techniques were so
complex and subjective that they took on the trappings of a
secret art.

In the last 25 years tablet coating has undergone several

fundamental changes. Many modifications were advocated to
improve the basic process and film coating chosen in place of
sugar coating.

Some Other Methods

There are other coating methods also that are used to coat
pharmaceutical tablets and capsules. Some of them are:
Compression coating,
hot-melt coating,
supercritical fluid spray coating,
electrostatic coating,
dry powder coating, and
photocurable coating.

Aspects of tablet coating

I. Therapy
i) Avoid irritation of esophagus and stomach
ii) Avoid bad taste & odor
iii) Avoid inactivation of drug in the stomach
iv) Improve drug effectiveness
v) Prolong dosing interval
vi) Improve dosing interval
vii) Improve patient compliance
Viii) Modify release
II. Technology
i) Reduce influence of moisture
ii) Avoid dust formation
iii) Reduce influence of atmosphere
iv) Improve drug stability
III. Marketing
i) Avoid bad taste & odor
ii) Improve product identity
iii) Improve appearance and acceptability

A.

Rapidly disintegrating film coating

B.

Taste Masking film coating

C.

Modified-Release Film Coating

D.

Enteric Film coating

E.

Sustained or controlled release coating

Film coatings can be described as either functional or
nonfunctional. Nonfunctional (or conventional) film coatings are
typically reserved for situations in which it is necessary to
improve product appearance, ease of swallowing, and product
stability, and for taste masking. Functional film coatings are
used when drug release characteristics need to be modified,
and are represented by enteric coatings and sustained- (or
controlled-) release coatings.

Tablet film coating is performed by two types, one is aqueous

film coating (generally water is used as a solvent) and non
aqueous film coating (generally organic solvent are used.)

Film coating technology, however, has shifted toward aqueousbased systems for environmental and economic reasons and the
majority of polymeric materials used today are applied as
aqueous-based solutions and dispersions.
With aqueous-based systems, the risk of explosion is
diminished, costs of disposing of the solvents are reduced, and
concerns of potential toxicities due to residual solvents within
the film are eliminated. Many commercial polymeric systems
are available as aqueous latex and pseudolatex dispersions,
where colloidal polymer particles are suspended in water.

A. Rapidly disintegrating Film coating:

This type of coating consist either water-soluble polymer or

of mixture of water-soluble and water-insoluble ones.

Widely used water soluble film polymer are cellulose

ethers like Hydroxypropyl methylcellulose(HPMC),
methylcellulose(MC), hydroxypropyl cellulose(HPC) and
sodium carboxymethylcellulose (NaCMC).

Polyvinylpyrrolidone (PVP)
and vinyl pyrrolidone /vinyl
acetate copolymers are also suitable, as well as water
soluble salts of enteric polymer. Ethyl cellulose and
Polymethacrylates
are
suitable
as
water-insoluble
components.

B. Taste Masking film coating:

Polymers with basic amino groups are used for flavoring

and taste masking.

They do not dissolve but swell in saliva, and dissolve only in

acid environment of stomach.

Proven materials for this purpose are poly(butyl

methacrylate,(2-dimethylamino-ethyl) methacrylate,
methyl methacrylate) in ratio of 1:2:1(EudragitE).

According to the United States Pharmacopeia/National Formulary

(USP/NF) a modified-release dosage form is one in which the drugrelease characteristics of time course and/or location are chosen
to accomplish therapeutic or convenience objectives not offered
by conventional dosage forms .
Two types of modified-release dosage form are recognized
1. Extended release: One that permits at least a twofold reduction
in
dosing frequency as compared to the situation in which the drug is
presented as a conventional dosage form (extended-release dosage
forms are often called sustained-release or controlled-release
dosage forms)
2. Delayed release: One that releases the active ingredient at
some
time other than promptly after administration (an enteric-coated
product is an example of this type of dosage form)

D. Enteric Film Coating:

1.

2.

This technique is used to protect the tablet core from disintegration

in the acid environment of the stomach for the following reasons:
To maintain the activity of drugs that are unstable when
exposed to the gastric milieu (e. g., erythromycin and
pancreatin)
To minimize either nausea or bleeding that occurs with
those drugs that irritate the gastric mucosa (e.g. aspirin and
certain steroids).

Polymers used for enteric coating are as follow

i.Cellulose acetate phthalate (CAP)
ii. Acrylate polymers
iii Hydroxypropyl methyl cellulose phthalate
iii. Polyvinyl acetate phthalate

Enteric coating is possible using both sugar- and film-coating

techniques.

E. Sustained or controlled release Film coating:

Film coating provides an extremely effective way of conferring a
controlled-release aspect to a tablet or, more usually, a
multiparticulate system. After coating these particles are filled into
hard gelatin shells, or occasionally compressed directly into
tablets by a process which permits minimal rupture of the applied
film. The coatings involved use polymers with restricted
water solubility or permeability.

Multiparticulates, commonly referred to as 'pellets' or 'beads', find

favor over conventional non-disintegrating tablets for controlled
release use.

Polymers like modified acrylates, water insoluble cellulose

(ethyl cellulose), etc. used for control release coating.

Clearly, modern film-coating practices require that coatings be

formed
from either polymeric solutions or polymeric
dispersions. Since these coating systems are initially liquids, the coating
process involves the conversion of a liquid into a "dry solid." However,
polymers used in film coating are, for the most part, amorphous, and thus
the term dry solid can be misleading. In order to clarify this situation, one
can consider that:

A solid film is one which will not flow significantly under those forces to
which it is subjected at the time of observation .

A practical definition of a dry film is one that will resist blocking when two
coated surfaces (e.g., two coated tablets) are brought into contact, for 2
seconds, under a pressure of 14 kPa (20 psi).

Such block resistance occurs when the viscosity of the coating exceeds 107
Pa.s (10 8 P).

A viscosity conducive to such blocking occurs when, according to the

relationship proposed by Williams et al , a coating is exposed
to temperature conditions approximately 20C above its glass transition
temperature (Tg ).

1. Initial rapid evaporation of

solvent from the atomized
droplets of coating liquid,
causing
an
increase
in
polymer concentration (and,
hence,
viscosity) and contraction in
volume of the droplets
2. Further loss of solvent from
the film (that is, coalescing on
the surface of the dosage
form) at a slower rate which
is now controlled by the rate
of diffusion of solvent through
the polymer matrix
3. Immobilization of
polymer molecules at
"solidification point

the
the

4. Further gradual solvent

loss from the film at a very
much reduced rate

Fig: Schematic representation of the film-coating process

Forces in the film:

During the application of polymer film to a matrix , sets of forces operate
between the film forming polymer molecules on the one hand ( cohesion)
and between the film and substrate on the other hand ( adhesion)

Cohesion ( or Autohesion ) refers to the ability of contiguous surfaces of

the same material, at a molecular level, to form a strong bond which
prevents or resists separation at the point of contact.

For high levels of cohesion ,Two phenomena are necessary:

1.

The cohesive (autohesive) strength of the material, molecular to

molecular, must be relatively high.

2. The contiguous surface of the film material must coalesce on contact.

The significance of the degree of cohesion in film structures in fundamental
to film properties.

Controllable processing factors affecting Cohesion in

pharmaceutical Film Coatings:
The factors which may increase film cohesion, polymer surface
to polymer surface, not all of which are readily controllable in
the typical pharmaceutical film coating operation include:

Increased contact temperature.

Increased surface contact time
Increased contact pressure.
Coat thickness
Control of coat solution or coat dispersion concentration
Degree of polymer solvation
Viscosity

Temperature :

Temperature is directly related to autohesion.

As the contact temperature increases , the cohesion strength of the

contiguous polymer surface increases over a definite temperature interval
along an exponential curve, not unlike the exponential dependence of
diffusion rate on temperature observed for low molecular weight materials.

A more cohesive warm coating solution to a warm substrate is well known

in coating technology. There are of course ,limits to the amount of heat
which may be the advantageously used, as excessive heat may cause
premature spray drying of the coat, slipping and peeling of the coating.

Increased temperature generally greatly facilitates adhesion between

polymer film and substrate, with the temperature effect probably eliciting
the same phenomena as in cohesion.

Contact pressure and Contact Time:

Contact pressure is not readily controllable

pharmaceutical film coating application.

factor

in

the

typical

Contact time refers to the duration during which a newly deposited

polymer film layer is setting-up and polymer molecules, wholly or in part,
are capable of diffusion and orientation.

Film coating Thickness:

The cohesive film strength( peeling strength) has been found to increase
as zero-order function of film thickness up to some fixed value, dependent
on polymer film chemical class, after which cohesive strength is constant
with further increases in thickness.

Coat solution concentration, solvation, and viscosity:

At low viscosity or at high polymer solvation levels self-diffusion should be
promoted. On the other hand , at low viscosities most coating solutions will
be very diluted, coating times will be unduly long and it will be
comparatively easy for a selected deposited film component forming the
bond to separate from the bulk of the previously homogenous film
substrate. An intermediate viscosity will usually result in the highest
cohesive strength.

Formulation Factors in Cohesive strength:

Polymer chemistry

Polymer structural properties

Solvent effects

Plasticization

Addition of dispersed solids

Desolvation

in the surface tension of the tablet improves the adhesion of the film
The similar the contact between coating fluid and tablet, the better the film
adhere to the tablet
The smaller the difference between the solubility parameter of the polymer and
solvent, the better the adhesion of the film.
The adhesion of the film is the same at all points around the film-coated tablet.
The higher the compressional force used in the producing the tablet, the poorer
the adhesion of the film.
The Higher the porosity of the tablet, the better the film adhesion to its rough
surface.
Plasticizers have no significant influence on the adhesion of an HPMC film
Further investigation Shown that the adhesion between film and core surface
can be assessed on the basis of solubility parameter.
Fillers, such as titanium oxide and talc, reduce the adhesion of the film core.
With increasing film thickness the adhesion passes through a minimum.
The Adhesion of the film when measured as peel strength depends on the
measuring technique, especially on the rate at which the film is stripped off.
For HPC films with a thickness of less than 20 m it was found that the adhesion
of the film increases with decreasing film thickness.

In the majority of film-coating formulations, the polymer is

the major ingredient. Consequently, this material have the
greatest impact on the final properties of the coating.

A. Cellulosic
B. Acrylic
C. The

system

systems

aqueous dispersion (Latex)

D.Pseudolatex

systems

A. Cellulosic system:

Coating is achieved by spraying a system based upon an aqueous solution

of a modified cellulose material. The material most commonly used for this
purpose is Hydroxypropyl methylcellulose (HPMC).

One advantage of the cellulosics is that the system is comparatively

simple; a typical formulation for spraying would contain a cellulose
polymer , a pigment /opacifier, a plasticizer and water.

Plasticizers have long been used for cellulosic coating systems based on
organic solvents.

For an elegant product, coated in optimum time , the correct balance of

polymer to pigment should be used ratio should be approximately 2:1
( polymer: pigment).

Plasticizer have long been

based on organic solvents.

used for cellulosic coating systems

B. Acrylic system:

When this system is sprayed onto a tablet surface the water

evaporates and the individual discrete particles of polymer start to
coalesce.
e.g.- Acrylic polymers of Eudragit series and their substitution.

One advantage possessed by the acrylics over the cellulosics in

that very high solids concentrations van be sprayed up to 20% or
even higher. The latex particles contribute very little to the
viscosity of the overall system, so they can be used in high
concentrations. This is an advantage ; hence coating times tend to
be correspondingly shorter.

However the system does have some disadvantage.

C. The aqueous dispersions(Latex):

Aqueous dispersions are dispersed substances in the dispersing medium,

water, and can be gas in water( foam), insoluble fluid in water(emulsion) or
solid in water (suspension).when the dispersed phase is build up by
polymer, they called polymeric dispersions.

The term Latex is used for colloidal polymeric dispersions.

Products prepared by direct emulsification of polymers in water are called
artificial latex.

The term pseudo latex is used for dispersions that are prepared by
emulsification of organic polymer solutions in water followed by the
elimination of organic solvents.

The particle size is the most important specification of latex

between 10 to 1000nm.
e.g.Methacrylic acid copolymers,
Methacrylic ester copolymers,
Dimethyl aminoethyl methacrylate copolymer.

and is

D. Pseudolatex systems:

This coating type is represented by Aquacoat (FMC Corporation).

It consists of a pseudolatex type dispersion of final particles of
ethylcellulose in water. As this is a disperse system of very small
particle size , relatively high solids concentrations can be sprayed.

The product has to be sprayed in admixture with a fairly large

quantity of
plasticizer. Because of the inherently water
insoluble nature of the system, it is necessary too incorporate
substantial quantities of water soluble cellulosic polymers in
order to render film water soluble.

Branched molecules in which the branching does not greatly hinder

diffusion may have a greater cohesive strength than non-branched
polymers.
In a homologous series, lower molecular weight fraction exhibit a greater
cohesion and show a greater change in cohesion strength with
temperature change.
In strongly polar polymers, self-adhesion by diffusion in insignificant /

The molecular weight characteristics of the polymer have a

significant effect on coating properties, as shown in table 1.
Table 1 : Effect of polymer molecular weight on coating properties:

Common polymers used in conventional film coating are listed in Table 1.

pH dependent soluble
polymers used in film coating

Water soluble polymers

used in film coating
1.

Methylcellulose

2.

Hydroxypropyl methyl
cellulose

3.

Hydroxypropyl-cellulose

Cellulose acetate phthalate

(CAP)

2.

Hydroxypropyl methyl
cellulose phathalate (HP50)

Hydroxypropyl methyl
cellulose

4.

1.

3.

Hydroxypropyl methyl
cellulose phathalate (HP55)

From the stress strain curve ( fig

1) Physical characteristic of the
film samples may be determined

Types of different mechanical

properties of polymer film

Impact strength

Tensile strength

Flexural strength

Yield point

Coat stability to temperature

Breaking strength

change

Modulus of elasticity

Peel strength

Plastic deformation

Flexibility

Other Properties

Coat resistance to physical

stress

The Modulus of elasticity ,

also known as Youngs
modulus.

The extensibility, brittleness, plasticity, elasticity and hardness of

a film former are of the major practical significance , since all
these properties together determine the resistance of the film to
mechanical stress.
A bar of cross section q and length L0 ,for example is subjected to
tensile force Kx what applies according to Hookes law is then with

x = tensile stress[N/mm2]
E elastic modulus [Mpa=N/mm2]
The force Kx is automatically recorded as a function of the change
length(L)(Stress-strain diagram)
The elastic modulus can be calculated from the initial rise at very
small elongations.

Tensile stress:
The tensile stress is the tensile force per smallest initial
cross section of the specimen measured at any given time
during the test.
Tensile Strength:
The tensile strength is the tensile stress at maximum force
and the tensile strength at break is the tensile stress at the
moment of specimen failure.
Modulus of elasticity:
The modulus of elasticity can be measured more easily in
the torsion pendulum test. If it is measured as a function of
temperature, it also provides the dynamic glass transition
temperature.

In compliance with their mode of action, Plasticizers the tensile strength

at break and the extensibility.

Pigments reduce the extensibility as well as the tensile strength at break.

The more flexible the polymer chain, the more elastic more crystalline the
polymer and the harder and more brittle the film.

The tensile strength of HPMC films is reduced in the presence of titanium

dioxide and aluminum lakes.

The elastic modulus of HPMC films decreases if the plasticizer is PEG 400.

Ageing of unplasticized HPMC films at 370 C and 75% RH impairs the

mechanical properties of these films owing to increased chain flexibility
and associated lowering of the molecular order.

Other Physico-mechanical properties:

1. Viscosity and molecular weight:

The relationship between the molecular weight and the
apparent viscosity ( measured in mPas) can be expressed in
the form:

-----------(1)
------------(2)
Where

app is apparent viscosity.

K and n are constant for each polymer determined by

regression analysis.
[] is the intrinsic viscosity of the polymer

2. Effect of molecular weight on mechanical properties of

Film:
The molecular weight characteristics of the polymer have a significant
effect on coating properties, as shown in table 1. At low molecular weights,
they are relatively weak but as the molecular weight increases their
strength also increases proportionally until at some critical molecular
weights there is no further increase.
Table 1 : Effect of polymer molecular weight on coating properties:

Table 1 : Effect of polymer molecular weight on coating properties:

3. Refractive Index

The refractive index of a polymer film former is importance in determining the

appearance of film coatings containing pigments.

4.Surface activity

The surface activity of a polymer film former is importance in determining the

degree of wetting of the substrate and hence spreading of the spray droplet
during film coating.

5. Stability of water and pH:

All the water soluble polymers absorb moisture from the air. At any given relative
humidity the equilibrium moisture content:
Methylcellulose>Hydroxypropyl methylcellulose>Hydroxypropyl cellulose

For optimum stability the pH of the solution is unaffected over the pH range 2-11.
For optimum stability the pH of the solution should be held between 6 and 8.

6. Stability of heat and light

In the dry state all the polymers and the films produced from
them are stable to the temperatures currently used during
stability testing i.e bellow 500 C and have good light stability.
7. Biological stability
In the dry state or as films all the polymer show good resistance
to degradation by moulds and bacteria. Aqueous solutions of
methylcellulose, hydroxypropyl cellulose and hydroxypropyl
methylcellulose
does not readily support the growth of
microorganisms but are not bacteriostatic. If contamination
does occur , degradation and loss of viscosity can result.

Polymer properties as a function of

temperature:

Enthalpy,

Mass,

Melting temperature,

Heat of fusion,

Glass transition temperature

Minimum film forming temperature(MFT):

The term minimum film forming temperature is used for
that temperature in degree Celsius above which a
continuous film, is formed under distinct drying condition of
the dispersion.

White Point(WP):
The white point is defined as the temperature below which
no film and only a white powdery mass is formed. The
white point is normally some degrees below the MFT.

Dynamic Glass Transition temperature:

The viscoelastic behavior of the polymers at various
temperature can be determined in a torsion pendulum
analysis, and a damping maximum is found in the melting
area. This value is normally higher than Tg.

Glass transition temperature(Tg):

Most of the polymers that are used in pharmaceutical film

coatings are amorphous in nature. One characteristic of these
polymers is that as the temperature is lowered, a point known as
the glass transition temperature (Tg) is reached, below which
there is a critical cessation of molecular motion on the local scale.
At temperatures below the Tg of the polymer, the material
generally behaves as a hard and brittle glass, whereas the
behavior of the polymer changes to soft and elastic at
temperatures above the Tg. For this reason ,the glasstransition temperature is often described as one below
which a polymer is brittle, and above which it is flexible.

Plasticizers reduce the glass-transition temperature of amorphous

polymers and impart flexibility.

Table 1 shows the Tg of an acrylic

polymer plasticized with several citrate
esters.
The addition of 10% plasticizer in the
film coating produced a significant
decrease in the Tg of the polymer for
all compounds studied and
Higher concentrations of the plasticizer
further lowered the Tg of the film.
These data demonstrate that the
citrates effectively plasticized the
acrylic polymer.
In contrast to plasticizing agents, other
additives in film coating formulations,
such as talc, titanium dioxide, and
lactose, may increase the Tg of the
film due to a restriction in the mobility
of the polymer chains or a rise in the
crystallinity of the polymer

Mechanism of permeability:
The permeability of polymeric film coating involves 3
processed of interest to the pharmaceutical scientist.

1.

Gas diffusion processes, notably oxygen permeation, through

the film.

2.

Water and water vapor sorption and permeation(Liquid

permeation process)

3.

Dialysis process concerned with the dialysis and permeation of

soluble component across the intact or modified film.

Scientist bent reported that Gas permeation is proportional to the volume

of the amorphous phase of a film structure.

P = PaXa
Where,
Pa-permeability for amorphous phase.
Xa-volume fraction of amorphous phase in the film structure.
Methods of controlling the film membrane diffusion coefficient of
pharmaceutical films as function of

Added dispersed solids

Films structure and orientation
Salt concentration
Ion ratios
Film membrane-solution interaction
Acid and base concentrations
Liquid boundary layer thickness.

Gas and water vapor permeability :

The gas permeability q (ml/m2.d.atm) is defined as the volume of a gas
converted to 00 C and 760 torr which permeates 1 m2 of the film to be
tested within one day at a specific temperature and pressure gradient.
Gas vapor permeability is calculated by following formula:

Where,
Po= normal pressure in atm
To= normal temperature in K
T= experimental temperature in K
A= sample area in m2
T= time interval in hrs between two measurements
Pu= pressure in test chamber between sample and mercury thread
Pb= atmospheric pressure in atm
Q= cross section of the capillaries in cm
= sink rate of the mercury thread in cm/hr

The water vapor permeability

WVP

( g/m2d) is defined as that

amount of water which permeates 1 m 2 of sample area under

specified conditions within one day. It is calculated according to the
formula:

Where,
m= weight difference between the last two weighing in g
t= time interval between the last two weighing in hrs
A= specimen area m2

The diffusion of gases and vapors occurs in three phases:

1.

Adsorption of the gas molecules to the surface of the film in accordance with
their chemical affinity

2.

Diffusion across the film and

3.

Desorption at the other side of the film

The facts and findings on polymer film permeability:

Solvent residues increase the water permeability of a film.

Plasticizer increase or decrease the water vapor permeability, depending

on whether they are hydrophilic or lipophilic and on the quantity added.

The permeability P decreases with increasing crystallinity of the film

former.

Pigments lower the permeability since they themselves are impermeable.

Hydrophilic pigments promote water vapor permeability, owing to their

solvation shells.

Sprayed films are more permeable that cast ones

The water vapor permeability is influenced by the history of the film

The plasticizers diethyl phthalate and Triethyl citrate as well as talc lower
the water vapor permeability, whereas titanium dioxide increases it.

PEG the water vapor permeability of HPMC films, but this effect is
reduced by increasing the molecular weight to the PEG.

Solvents are used to dissolve or disperse the polymers for

pharmaceutical film coating purposes.

Ideal requirement are summarized below:

i) Should be either dissolve/disperse polymer system
ii) Should easily disperse other additives into solvent system
iii) Small concentration of polymers (2-10%) should not in an extremely
viscous solution system creating processing problems
iv) Should be colorless, tasteless, odorless, inexpensive, inert, nontoxic and
nonflammable
v) Rapid drying rate
vi) No environmental pollution

The primary criteria for the selection of a solvent for a particular

polymer system include solvency, volatility, toxicity, and pollution control.
The most superior films, showing the greatest combined strength of
cohesiveness, have been reported when the coating solution solvation and
polymer chain
extension are at a maximum.

Types of solvents for coating:

Three different types of solvents are distinguished:

Active Solvents: Contain groups which overcome the
intermolecular forces of the polymers, form new
intermolecular forces and dissolve the polymers.

Latent solvents: also contain dispersing groups, but are

unable to overcome the intermolecular forces of the
polymer on their own.

Diluents: They are low boiling liquids which lower the

viscosity of the solution, thereby making it easier to
process.

Common solvents used in film coating:

Mostly solvents are used either alone or in combination with water, ethanol,
methanol, isopropanol, chloroform, acetone, methylene chloride, etc. Water is
more used because no environmental and economic considerations. For drugs
that readily hydrolyze in presence of water, non aqueous solvents are used.

Theory of Solubility:
When selecting a particular solvent or solvent blend there are several factors that must be
considered. The first prerequisite is the ability to form a solution with the polymer of choice.
One method for determining interactions between the polymer and solvent. and aiding in selecting
the most suitable solvent for a given polymer, is to use the solubility parameter approach. This
approach is based on the theoretical treatment of the familiar free energy equation as proposed by
Hildebrand and Scott [38] and is expressed in this way:

Solubility parameters permit semi empirical assessment of

the interaction between solvents and the substances to be
dissolved. They are defined as the square root of the
cohesive energy density, e, and can be derived as

Where
L-molecular heat of vaporization of the substance at
temperature T
V-Molar volume of the substance
R-gas constant

Factors affecting solubility of pharmaceutical

polymers:
Solubility properties of colloidal macromolecules in organic
solvents are depends on
Chemical
Electrical
Structural and
Steric effects,
which lead to mutual interactions between solute and solvent.

Definition:
Plasticizer may be defined as non-volatile ,low molecular weight substance which,
when added to a polymer, changes its physical properties in such a manner that
the finished product is in a more useful form.

Properties of Plasticizers:
Colorless

Classification of plasticizer:

Odorless

Polyols

Non-volatile

Organic esters

Thermally stable
Water-resistant
Chemically stable
Non-migrating in films
Non-toxic

Vegetable oils and glycerides

Reasons for adding Plasticizer:

Many pharmaceutical polymers exhibit brittle properties and require the addition of a
plasticizing agent to obtain an effective coating, free of cracks, edging, or splitting.
Plasticizers function by weakening the intermolecular attractions between
the polymer chains and generally cause a decrease in the tensile strength
and the glass transition temperature and an increase in the flexibility of
the films.

Plasticizers are necessary components ----

to reduce brittleness,

to improve flow,

to impart flexibility, and

to increase toughness, strength, and tear resistance of the film.

These plasticizers play a critical role in the performance of polymeric film coatings.

Depending upon solubility plasticizers can be classified into two classes :

(a) water soluble : Propylene glycol, glycerin etc.
(b) water insoluble : Triacetin, Acetylated monoglycerides etc.
In general, only water-miscible plasticizers can be used for aqueous-based spray systems.

Table 1 :Common Plasticizers Used in Conventional Film coating:

Combination of plasticizer may be used to get desired effect. Concentration of

plasticizer is expressed in relation to the polymer being plasticized. Recommended
levels of plasticizers range from 1-50 % by weight of the film former. The
effectiveness of a plasticizing agent is dependent, to a large extent, on the amount of
plasticizer added to the film coating formulation and the extent of polymer
plasticizer interaction.

Plasticizer Efficiency:

It can be seen that if lowering of the yield point is taken as the end-user property the rank
order of plasticizer is
Glycerol>polyethylene6000>propylene glycol

If lowering of the tensile strength is the end-use property glycerol and propylene is reversed.

If increased elongation is the end-use property the rank order is

Propylene glycol>glycerol>Polyethylene glycol 6000

Effect of plasticizer on properties of film coating:

Plasticizer permanence:
This is related to the retention of the plasticizer in the film under such
conditions as elevated temperature.

The effects of plasticizer on thermal properties of polymers:

The incorporation of polyols of the water-soluble cellulose ether can affect the
thermal gelation temperature of the solution, with propylene glycol and
polyethylene glycol and polyethylene glycol causing an increase but glycerol a
decrease.

Mechanical properties of Plasticizer films:

in free volume of a polymer matrix on the addition of plasticizer
results in a in the Young's modulus of elasticity.

Permeability of plasticized films:

The influence of a plasticizer on the film permeability vary much
depends on their chemical nature and polarity and the properties of
the polymer film former and the diffusing species.

A modern tablet coating system

combines several components:

a coating pan,
a spraying system,
an air handling unit,
a dust collector, and
the controls.

The coating pan is actually a

perforated drum that rotates within a
cabinet.
The spraying system consists of
several spray guns mounted on a
manifold, a solution pump, a supply
tank and mixer, and an air supply.
The pump delivers the coating
solution to the guns, where it
combines with atomizing air to create
a fine mist that is directed at the bed
of tablets in the coating pan.
The air handling unit heats and
filters the air used to dry the coating
on the tablets .it may include a
humidifier or dehumidifier.
The dust collector extracts air from
the coating pan and keeps a slightly
negative pressure within the cabinet.
The controls enable to orchestrate
the operation of all the components
to achieve the desired results.

There are three types of coating equipment used to apply polymeric

materials:
1.Standard coating pan
e.g., Pellegrin pan system
Immersion sword system
Immersion tube system

2.Perforated pan system

e.g.,Accela cota system
Hicoater system
Glattcoater system
Driacoated system
3.Fluidized bed coater

Standard Coating
pan:

1.

Circular metal pan

2.

Rotated on horizontal axis by motor

3.

Coating solutions applied by

Spraying or ladling

Fig :Standard coating Pan

system (Courtesy of Colorcon,
West Point, Pennsylvania.)

Perforated or partially
perforated drum

Exhaust duct

Spraying nozzles

Columnar chamber

Spray nozzle

Support screen

I. Coating solution preparation:

The polymer is solubilized into solvent. Other additives like
plasticizers and pigments are added. Resulting solution or
suspension is sprayed on to a rotating, mixed tablet bed or
fluid bed.

II. Coating procedure :

The film coating process as such is a combination of four processes
going on simultaneously :
1.Distribution of coating material on large number of tablets
2. Mixing of large batch for homogeneous result
3. Drying or evaporation of solvent
4.Solvent vapor removal
Loading and warming: Load a batch of tablets into the
coating pan,
preheat the tablets and allow time for dust and tablet flash to
exit
the pan.
Spraying :Once the temperature of the outlet air reaches 42
to 46C,
usually within 15 minutes, spraying can begin.

Drying :The spray guns create a fine mist of coating solution

that
dries just after it contacts the tablet. As the water evaporates, it
leaves the solids behind to form a thin film on the tablet. The key
to
tablet coating is to get the surface slightly wet and immediately
dry.

Cooling

Unloading

Materials used in film coating

Film formers, which may be enteric or
nonenteric
Solvents
Plasticizers
Colorants
Opaquant-Extenders
Miscellaneous coating solution components
like
Flavors and sweeteners
Surfactants
Antioxidants
Antimicrobials

Fig 1 :Coating
solution

Tablet coating

Sugar Tablet

C:\Documents and
Settings \murs hida\My Do

Fig 3 :Principles Film

Film-coating of tablets is a multivariate process, with many different factors,

such as coating equipment, coating liquid, and process parameters which
affect the pharmaceutical quality of the final product.
Coating equipment
In equipment spray nozzle,
number of spray nozzle, pan
size, etc may also affect the
quality of final product.
Nozzle-to-bed distance,
Coating liquid
Solid content of coating
solution
Droplet size
Viscosity

Process parameter
Inlet & outlet temperature
Bed temperature
Pan speed/ pressure,
Liquid spray rate,
Atomization air pressure.
Drying time.
Relative humidity

Basic process requirements for film coating

These fundamental requirements are more or less independent of the
actual type of equipment being used and include:

1. adequate means of atomizing the spray liquid for application to the tablet
cores;
2. adequate mixing and agitation of the tablet bed. Spray coating relies upon
each core passing through the area of spraying. This is distinct from sugar
coating, where each application is spread from tablet to tablet prior to
drying;
3. sufficient heat input in the form of drying air to provide the latent heat of
evaporation of the solvent. This is particularly important with aqueousbased spraying;
4. good exhaust facilities to remove dust- and solvent-laden air.

The basic source of various defects in the final products may be arise due
to any three listed below :
1. Defects arising due to defective core formulation or the tablet shape (like
high friability, capping, logo or embossing, cratering, high contact surface
area causing twinning.
2. Non-optimised coating formulation (problems like logo bridging, poor
colour dispersion, film cracking and peeling)
3. Non-optimised coating conditions (like pricking & sticking, surface
roughness, color variation, spray drying, orange peel, poor coating
efficiency)

1.
2.
3.

4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.

Blistering
Blushing
Bridging (of the
intagliations)
Hipping
Cracking
Cratering
Flaking
Infilling
Orange peel
Peeling
Picking
Pimpling
Pitting
Pulling out( of a intagliation)
Splitting
Wrinkling

Blistering:
Film becomes detached from substrate forming a blister
Cause: Over heating during spraying of at end of coating run
Remedy: Milder drying condition.

Blushing:
Whitish specks or haziness in film(Best seen in non pigmented
film)
Cause: precipitation of polymer due to high temperature or poor
solvent.
Remedy: Decrease the drying air temperature

Bridging:
Films pulls out of intagliation forming bridge across the edges of
the mark
Cause: High internal stresses in film.
Remedy: the plasticizer content or changing plasticizer

Chipping:
Film becomes chipped and dented
Cause: Excessive attrition during coating process.
Remedy: hardness of the film by increasing the molecular weight grade
of
polymer.

Cracking:
Films cracks or splits
Cause: high internal stresses in film
Remedy: Adjusting the plasticizer type and concentration; Pigment type and
concentration.

Cratering:
Volcanic-like craters in film exposing tablet surface.
Cause: over-wetting and localized disintegration of tablet core.
Remedy: Use efficient and optimum drying conditions, viscosity of
coating solution to decrease spray application rate.

Flaking:
Film flakes off exposing the tablet surface.
Cause: Associated with cracking and splitting

Infilling:
Intagliation filled with either particles of dries polymer or solidified
foam.
Cause: over drying of spray or excessive foaming of coating
solution.
Remedy: Add alcohol or use spray nozzle capable of finer
atomization.

Orange peel:
Surface appearance similar to that of an orange or lemon
Cause: poor spreading or spreading of spray droplets associated
with non-optimum spray atomization.
Remedy: Thinning the solution with additional solvent

Peeling:
Film peels off exposing the best tablet surface
Cause: Associated with cracking and splitting.

Picking:
Isolated areas of film pulled off the surface.
Cause: Over-wetting. Tablets stick together then part.
Remedy: in the liquid application rate or in drying air temperature.

Pimpling: As Orange Peel

Pitting:
Pits occur in tablet surface, but film surface not disrupted.
Cause: Melting or dissolution of lubricants on tablet surface .
Remedy: Dispensing with preheating procedures at the initiation of coating and
modifying the drying (inlet air) temperature such that the temperature of the tablet
core is not greater than the melting point of the batch of additives used.

Pulling out (of the intagliation):

As Bridging(of the intagliations)

Splitting:
Film splits usually around the edges of the tablet
Cause: High internal stress in film.
Remedy: Use lower molecular weight polymers or polymeric
blends. Also adjust plasticizer type and concentration.

Wrinkling:
Film has a wrinkled appearance
Cause: Associated with Blistering

1.

Coating Technology Handbook by Arthur A. Tracton, Third Edition.

2.

The Theory and Practice of Industrial Pharmacy by Leo

Lachman, Herbert A.Liberman and Joseph L.Kanig, Third Edition.

3.

Encyclopedia of Pharmaceutical Technology, Third edition.

4.

Pharmaceutical Dosage Forms: Tablet, Volume-3 ,by Herberrt A.

Lieberman, Leo Lachman, Joseph L. Kanig, Second Edition.

5.

Pharmaceutics , Science of Dosage Form Design by M.E Aulton,

Second Edition.

6.

Remington: The Science and Practice of Pharmacy by Alfonso

R Gennaro, 20th edition