1.

Historical perspectives of film coating technology

2. Types of film coating and modern trends
3. Theories in film coating: Adhesive and cohesive strength
4. Polymers used film coating
5. Physico-mechanical properties of film coating
6. Thermal properties of film coating
7. Diffusion properties of polymer films
8. Effect of solvent on film properties
9. Effects of plasticizer on film coating
10. Coating machine and accessories
11. Processing conditions for both organic and aqueous system
12. 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 mid-

Fifties.

✓ 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 aqueous-
based 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(Eudragit®E).
 According to the United States Pharmacopeia/National Formulary
(USP/NF) a modified-release dosage form is one in which the drug-
release 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:
➢ This technique is used to protect the tablet core from disintegration
in the acid environment of the stomach for the following reasons:
1. To maintain the activity of drugs that are unstable when exposed
to the gastric milieu (e. g., erythromycin and pancreatin)
2. 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 20°C 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 the
polymer molecules at the
"solidification point“

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 factor in the typical
pharmaceutical film coating application.

✓ 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
 Good adhesion between a polymer and the surface of a solid is a major
prerequisite for the film coating of pharmaceutical dosage forms. Poor adhesion
may result in flaking or peeling of the coating from the solid substrate during
storage, which could significantly
jeopardize film functionality. Loss of adhesion may lead to an accumulation of
moisture at the film–tablet interface, affecting the stability of drugs susceptible to
hydrolytic degradation.
 Force involved in adhesion
The two major forces that have been found to affect polymer–tablet adhesion
include the strength of the interfacial bond and the internal stresses within the
coating.
 Theoretical considerations:
In 1967 Gardon proposed an equation for calculating the ideal tensile (butt) adhesive
strength(σmax)between two slabs of material (A and B) assumed to be separated by a plane of a
thickness (λAB ) corresponding to the equilibrium distance at

Where λAB is the work of adhesion

✓ ↑ 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 μm 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 system
B. Acrylic systems
C. The 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 used for cellulosic coating systems based
on organic solvents.
 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 and is between
10 to 1000nm.
✓ e.g.-
❖ Methacrylic acid copolymers,
❖ Methacrylic ester copolymers,
❖ Dimethyl aminoethyl methacrylate copolymer.
 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.
 Water soluble polymers pH dependent soluble polymers
used in film coating used in film coating

1. Methylcellulose 1. Cellulose acetate phthalate

2. Hydroxypropyl methyl (CAP)

cellulose 2. Hydroxypropyl methyl

cellulose phathalate (HP50)
3. Hydroxypropyl methyl
cellulose 3. Hydroxypropyl methyl

4. Hydroxypropyl-cellulose cellulose phathalate (HP55)

❑ Types of different mechanical From the stress –strain curve ( fig
properties of polymer film 1) Physical characteristic of the
film samples may be determined
 Impact strength  Tensile strength
 Flexural strength  Yield point
 Coat stability to temperature  Breaking strength
change  Modulus of elasticity

 Peel strength  Plastic deformation

 Other Properties
 Flexibility

 Coat resistance to physical stress The Modulus of elasticity , also

known as Young’s 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 Hooke’s law is then with

 σx = 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
• ηapp is apparent viscosity.
• K and n are constant for each polymer determined by
regression analysis.
• [η] 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
glass-transition 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 m2 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
◦Vegetable oils and glycerides
◦ Thermally stable

◦ Water-resistant

◦ Chemically stable

◦ Non-migrating in films

◦ Non-toxic
 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  The coating pan is actually a
perforated drum that rotates within a
combines several components: cabinet.
❑ a coating pan, ➢ The spraying system consists of
several spray guns mounted on a
❑ a spraying system, manifold, a solution pump, a supply
❑ an air handling unit, tank and mixer, and an air supply. The
pump delivers the coating solution to
❑ a dust collector, and the guns, where it combines with
atomizing air to create a fine mist that
❑ the controls. 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
 Materials used in film coating
I. Coating solution preparation: ✓Film formers, which may be enteric or
The polymer is solubilized into solvent. Other additives like ✓nonenteric
plasticizers and pigments are added. Resulting solution or
✓Solvents
suspension is sprayed on to a rotating, mixed tablet bed or fluid
✓Plasticizers
bed. ✓Colorants
II. Coating procedure : ✓Opaquant-Extenders
The film coating process as such is a combination of four processes ✓Miscellaneous coating solution components
going on simultaneously : like
1.Distribution of coating material on large number of tablets Flavors and sweeteners
2. Mixing of large batch for homogeneous result Surfactants
3. Drying or evaporation of solvent Antioxidants
4.Solvent vapor removal Antimicrobials
✓ 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 46°C,
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
Fig 1 :Coating solution

Tablet coating

Sugar Tablet

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
Process parameter
❑ In equipment spray nozzle,
❑ Inlet & outlet temperature
number of spray nozzle, pan
size, etc may also affect the ❑ Bed temperature

quality of final product. ❑ Pan speed/ pressure,

❑ Nozzle-to-bed distance, ❑ Liquid spray rate,

❑ Atomization air pressure.

Coating liquid ❑ Drying time.

❑ Solid content of coating ❑ Relative humidity

solution
❑ Droplet size

❑ Viscosity
 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 aqueous-based
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. Blistering
2. Blushing
3. Bridging (of the intagliations)
4. Hipping
5. Cracking
6. Cratering
7. Flaking
8. Infilling
9. Orange peel
10. Peeling
11. Picking
12. Pimpling
13. Pitting
14. Pulling out( of a intagliation)
15. Splitting
16. 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