Coating

Coating Technology
Definition: Coating is an art and science. It is mainly defined as the formation of thin layer on the
preformed core tablets.
Or
Coating is the process by which we can apply one or more layer of polymer on the core tablet or
granules.
Reasons for coating:
a.
To identify the product during manufacture, dispensing & in use by the

patient e.g.
Color
Carb- 500 mg Tablet Mastercote white-FA-0961G
Levox -500 mg Tablet Mastercote Orange-FA-4212
b.
To mask the bitter test, bed smell & color of the drug. e.g.
Bitter test Ciprox -500 mg, Ciprox -250 mg etc.
Bed smell Opsonil -100 mg, Moxin -250 mg etc.
Bed Color Bec .
c.
To improve product stability by providing a barrier to light & moisture

Moisture Ranitid -150 mg, Clontas -75 mg etc.
Light Metherspan -0.125 mg.
d.
e.
f.
g.
h.
i.
j.
k.
To protect the drug from the gastric environment of the stomach or to reduce the stomach
irritation with an acid resistant enteric coating e.g. Diclofen -50, Duralax 5, Crezyme 325,
Pantid -20, Pantid 40 mg.
An enteric coated tablet remain intact in the stomach but to disintegrate rapidly in
the intestinal tract.
To improve appearance or elegancy offer where the core tablet is of poor color e.g. Permival,
Opsovit pot, Opsovit MM.
To improve patient compliance by masking active ingredients which have an
unpleasant test and color e.g. Opsonil 100, Moxin 250 mg.
To improve opportunities for brand imaging & trade marking. e.g. Ranitid 150 mg (white color),
Diclofen 50 mg (pink color)
To control the release of the drug from the tablet.
To provide physical and chemical protection for the drug.
To improve esthetic qualities of the product.
To facilate handling, particularly in high packaging lines.
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cGMP Requirement :
1. Product Name & Strength.
2. Date of manufacture.
3. Batch identification.
4. Complete formulation.
5. Labeling, Cleanliness, Man, Machine & Materials safety ensuring.
6. Analytical control no. of each component used in the formulation .
7. Actual yield obtained at different stages of manufacture of the batch as compared
with the theoretical yield.
8. A duly signed record of each steps followed, precautions taken and special
observations made through out the manufacturing of the batch.
9. A record of all in process controls followed and of the results obtained.
10. A specimen of the actual coated label used.
11. Signature of the expert responsible for the manufacturing operations and the date of
his signature.
12. An analytical report showing whether the batch complies with the prescribed
specifications for drying date and duly signed by the responsible.
13. A record of decision regarding the release or rejection of the batch by the QA
Department
Type of coating:
Coating are mainly two types :
1. Sugar coating
2. Film coating
Film coating is classified into two categories:
a. Normal film coating
b. Enteric film coating
Specialized coating is several categories:
a.
b.
c.
d.
e.
Compression coating
Electrostatic coating
Dip coating
Vacuum coating.
Micro encapsulation
Sugar coating: It is one of the oldest technology of coating the tablets, sugar coating is
still considered to be more of an art rather a science.
Film coating: A more recent method of coating tablets is film coating. Film coated
tablets are compressed tablets coated with thin layer of a water soluble
or insoluble polymer capable of forming a film over the tablet.
The film is generally colored.
Enteric coating: Enteric coating is applied to the tablets which are required to pass the stomach as
such but readily disintegrate in the intestine. It is one of the parts of film coating pH dependant
coating.
Purpose: a) The product which are decomposed in the acidic media of the
Stomach eg. Enzymes or certain antibiotics
b) To prevent gastric distress or nausea due to irritation from drug eg.
Sodium Salicylate
c) To deliver drugs intended for local action in the intestine. eg
Intestinal antiseptics
d) To deliver drugs those are optimally absorbed in the small intestine
e) To provide delayed release components for repeat action tablets.
Specialized coating:
Compression coating: This method also known as process coating or dry coating as no water or
solvent in the coating. Only dry granules are compressed around the pre compressed tablets.
This type of coating requires a specialized tablet m/c. The finished product is a
tablet within a tablet. This type of tablet may be either two components or three
component system. Two or three layer tablet within a tablet or a tablet within a
tablet. This tablet usually undergo a light compression as such component is laid
down, with main compression being the final one. The outer layer of the
compression coated tablet provides the initial dose, rapidly disintegrate in the
stomach. The outer layer or inner tablet is formulated with components that are
insoluble in gastric media but are released in the small intestine.
Compression coating is not widely used. But it has advantages some causes in which the tablet
core cannot tolerate organic solvent or water and yet needs to be coated for taste making or to
provide delayed or enteric properties to the products.
Electrostatic coating : Electrostatic coating is an efficient method of applying coating to
conductive substrates. A strong electrostatic charge is applied to the substrate. The coating
materials containing conductive ionic species of opposite charge is sprayed on to the charged
substrate.
Dip coating : Coating is applied to the tablet cores by dipping them into the coating liquid. The
wet tablet are dried in a conventional manner in coating pans. Alternate dipping and drying
steps may be repeated several times to obtain the desired coating. This process lacks the speed ,
versatility, and reliability of spray coating techniques. Specialized equipment has been
developed to dip coat tablets. But no commercial pharmaceuticals application has been obtained..
Vacuum film coating : Vacuum film coating is a new coating procedure that employs a
specially designed baffled pan. The pan is hot water jacketed and it can be sealed to achieve a
vacuum system. The tablets are placed in the sealed pan and the air in the pan is displaced by
nitrogen before the desired vacuum level is obtained. The coating solution is then applied with a
airless (Hydraulic) spray system. The evaporation is caused by the
heated pan and the vacuum
are removed by the vacuum system. Because there is no high velocity heated air, the energy
requirement are low and coating efficiency is high. Organic solvent can be effectively used with
the coating system with minimal requirement or safety concerns.
Micro encapsulation: Micro encapsulation is placed in the section of capsules only because of
the relationship in terminology to that of encapsulation. Micro encapsulation is a process or
technique by which solids, liquids, or dispersion are given thin coating of microscopic size
ranging from several tenths of the micron to 5000 micron in size.
A number of methods are available for micro encapsulations which are:
a)
b)
c)
d)
e)
Purpose:
a)
b)
c)
d)
e)
Air suspension
Conservation phase separation
Electrostatic deposition
Spry drying
Congealing
To make the taste of bitter drugs.

To separate the in compatible ingredients
To prepare sustained action dosage from
To protect drugs from moisture and oxidation
To prevent volatilization of volatile substance.
Sugar coating: It is one of oldest technology of coating the tablets, sugar coating is
still considered to be more of an art rather a science.
The concept of building up a protective layer on a medicinal solid by
reposted application and drying of a coating liquid dates back more than
1000 years.
The process and materials that we recognize today has its origins in 19th censure.
At that time the tablet was becoming popular due to its convince and accuracy of
dosage and at that time cheap & plentiful supplies of sucrose become available.
Sucrose & water plus readily available, low cost, insoluble solids are the basic
materials used in common sugar coating system.
Application techniques : The basic application procedure in each case involves three
steps in sequence.
a)Application of an appropriate volume ( Sufficient to completely cover the surface
of every tablet in the batch) of coating liquid to a cascading bed of tablets.
b ) Distribution of the coating liquid uniformly across the surface of each tablet in the
batch.
c) Drying of the coating liquid are uniform distribution is achieved.
Process flow diagram of Sugar coating:
Materials Dispensing
Weight checking
Sugar coating
Process unit
Solution preparation
Tablet de dusting
Seal coating
Sub coating
Plain Syruping
Color coating
Rolling and Jogging
Polishing
Sorting
Ready for packing
Sugar coating process involves the following steps:

1.
2.
3.
4.
Sealing/ water proofing

Sub coating
Syrup ping/ plain syrup coating
Coloring/ color coating
5. Polishing.
1. Seal coating (2 6 applications) :Seal coating is applied to prevent moisture penetration into the
core tablets. Since water is used as vehicle for dissolving sugar required for coating. When it will
come to contact with drug they may be destroyed.
Coating materials :
a) Polyvinyl acetate
b) Shellac
c) Poly ethyl cellulose.
2. Sub coating : (40 80 application) : Sub coating is applied to minimize the amount of materials
which must be used to round the edges and build up the tablet size.
Coating materials :
Solution form
1. Gelatin
2. Acacia
Powder form
1.Kaolin
2.Dextrin
3. Sucrose syrup
3. Cocoa powder
4. Cane syrup
5. Corn syrup
6. Titanium dioxide
4. Sugar
5. Corn starch
6. Lactose
7. Cellulose derivatives
4. Syruping/ Smoothing : (up to 10 application) Syruping helps to get smooth surface

of tablets.
Coating materials: Sucrose, DM water
5. Color coating : (20 30 application): Color coating is applied to developed beautiful
color. Sucrose syrup plus color to establish the overall finished tablet
appearance.
Coating materials:
a)
b)
c)
d)
Iron oxide
Caramel
Indigo etc
Turmeric. etc
6. Polishing: (2 applications) : This is the final steps and usually performed in a clean pan to improved
the shining properties of the tablets.
a)
b)
c)
d)
Carnauba wax
Bees wax
White wax
Paraffin
Film coating : : To reduce process time & cost the first commercial systems were
developed in the 1960 with the development of the cellulose &
polymers and with the introduction of spray techniques.
A more recent method of coating tablets is film coating. Film coated
tablets are compressed tablets coated with thin layer of a water soluble
or insoluble polymer capable of forming a film over the tablet.
The film is generally colored.
Criteria of film coating : Ideally the film coating materials should have the
following criteria ;
a.
b.
c.
d.
e.
f.
g.
Should be soluble in gastrointestinal tract

Should be soluble in organic and aqueous solvents.
Should not interfere with tablet disintegration and drug availability.
Should be stable in presence of liquid , heat and oil.
Should be non toxic, inert
Should be free from odor, taste, and color.
Should be smooth and elegant.
Process flow diagram of film coating:

Materials Dispensing
Weight checking
Film coating
Process unit
Enteric coating
Non enteric coating
Seal coating if req
Polishing
Sorting
Ready for packing
Advantage of film coating over sugar coating;

1. In film coating various steps like sealing, sub coating, smoothing are not necessary, thereby
the coating time is reduced to a greater extent.
2. Reduction of raw materials costs.
3. Reduction of labor costs.
4. Durable coating which is resistant to cracking and chipping.
5. Correct formulation offers greater stability to light, air , heat and water
6. Permeable to gastrointestinal juices..
7. Odorless and taste less.
8. Simple procedure
9. No dusting powder is required.
10. No separate environment is required for polishing
11. Technician training is easier.
12. Less shinning compared to sugar coating.
Theory of film coating:

Film coating technology has been developed mainly of two factors :
1. Modernization of coating machines & subsequent automation of the total process.
2 . Development of coating formulation : These factors ultimately reduced the coating
time and improved batch to batch variation.
Film coating technique involves the deposition of polymeric materials as a continuos
non porous membrane over a solid pharmaceuticals dosage form. This polymeric
membrane are very thin. Usually 30 to 100 micron thickness. Tablet film coating is
based on two distinct phenomena. 1. Formation of film over the core tablet ( Cohesion force)
2. Bonding between the polymeric film and the core tablet surface. (Adhesion force)
Cohesion also known as auto adhesion or self adhesion. Refer to the ability of film
formation by the same materials at molecular levels. To obtain high level of cohesion,
two phenomena are necessary
a. The cohesion forces between polymeric molecules must be high.
b. Coalescence of polymer droplets at the point of contact.
The degree of cohesion in a film structure determine several polymer properties,
such as tensile strength, degree of elongation, flexibility, brittleness etc. which inter
related to coated tablet quality , both stability elegance.
The degree adhesion determine the strength of bonds between polymeric film and
substrate poor adhesion may result in several coating problems.
Formation of coating :
A: Droplet formation by a spay gun
B: Impingement of droplet over the tablet surface
C: Spreading of polymer on surface
D: Wetting of tablet by the polymer solution
E: Coalescence adhesion & auto adhesion of polymer film.
The application of coating solution has been changed to a spray method. This spray method
permits the delivery of finely atomized droplets of coating solution in the tablets mass, which is in
continuous motion. This ensure uniform coverage of tablet surface i,e the coating materials & also
prevent adjacent tablets from sticking together as the coating solution dries Although all the phases of
spray process occur continuously and concurrently.
Formulation of film coating :
Generally coating formulation considers the following materials.
1. Polymer or film former: Polymers are used for coating to form thin layer. A wide no. of polymers
are currently available. film coating polymer are
divided into three classes depending under their solubility.
a) Water soluble polymer: Which are soluble at all pH range, e.g. MC, HPMC, HEC, Na CMC,
povidone.
b) PH sensitive polymers : Which are soluble in intestinal pH, eg Shellac, CAP, PVAP.
c) Water insoluble & pH independent polymers.
The following factors considered during you chose the polymer :
i) Tensile strength
ii) Elastic Modulus E
iii) Adhesion to substrate
On the other hand polymers are classified into two categories :
a. Enteric polymer : Shellac, polyvinyl acetate phthalate, Hydroxy propyl methyl cellulose phthalate (
HPMCP), cellulose acetate phthalate (CAP).
b. Non enteric polymer :
Hydroxy propyl methyl cellulose (HPMC)
Methyl hydroxy ethyl cellulose ( MHEC)
Ethyl Cellulose (EC)
Hydroxy propyl Cellulose ( HPC)
Povidone
Na- carbxy methyl cellulose
Eudragit
2. Plasticizer: It is an important part of coating and integral part of coating process. These are used to
produce flexibility and elastically of the coating and thus provide durability. Normally 1-5% of
plasticizer is used.
The function of the plasticiser is to modify the basic mechanical properties of the polymer plasticizer
have the high affinity for polymer. The interactions reduce the beaching between polymer molecules,
causing a redaction in electric modulus.
The amount of plasticizer depend on
a) Type of polymer
b) Method of application
c) Type of solvent
d) Presence of other additive
Generally used plasticizers are as follows:
a) Water soluble plasticizer - Polyethylene glycol, glycerin, propylene glycol, Eudragit
E30D, L30D
b) Water in soluble plasticizer :Triacetin, acetylated, monoglyceride, castor oil, sorbiton
esters, phthalate etc.
C) Both water and organic soluble: Glycerol, propylen glycol.
The following factor considered when you chose the plasticizers :
a.Good interaction with the polymer
b.Miscible with the solvent
c.Type & concentration depends on mechanical properties of the film e.g.
Solution viscously
Tensile strength
Elastic modulo
Film adhesion
Moisture permeability
3. Solvent : It is an important part of coating process . ( Droplet formation depend on solvent, rate of
evaporation also depends on the type and nature of the solvent. The thickness also depends on the
type and nature of the solvent. Though it is the integral part of coating process.) The primarily
function of a solvent is to dissolve the polymer and other additive.
Two types of solvent are used :
a) Aqueous solvent : Distilled water
b) Organic solvent : Methanol, Methylene chloride , ethaxol, Isopropyl alcohol,
chloroform, acetone, methyle ethyl ketone
Solvent combination are :
Methylene chloride/ Ethanol

Methylene chloride/Methanol
Methylene chloride/Isopropanol
Methylene chloride/ Ethanol/Acetone
Acetone/ isopropanol
Ethanol/ Isoproponal/water
Ethanol/water
Methylene chloride/ water
The following factors are considered when you chose the solvent
a. Product nature
b. Polymer solubility
c. Environmental impact
d. Rapid drying rate
e. Colin less, don less, non toxic, inert & noninflammable
4. Opaquant Extenders: Occasionally there are solids contents as a color, pigment etc.
They should be used in micronised form on desirable size. Other than coloring agent as opaquant
extendant of solid is used. It is used to improve the color and shining property. It has whitish property
which are used to prevent the undesirable condition It should be used in optimum level in the range (
30-50) % of polymer and it is actually depends on the volume of pigment. e.g.
Silicates ( Aluminum silicates)

Carbonates ( Magnesium carbonate)
Sulphates ( Calcium sulphates)
Oxides
( Magnesium oxides)
Dioxides ( Pitanium dioxides)
Hydroxides (Aluminum hydroxide)
Tale.
5. Color Color is the most important stimulus for the conveyance of a visual message. Colorants for
film coating are normally restricted to pigments owing to the limited solubility of dyes in organic
solvents. The aluminum lakes and inorganic solvents like iron oxides and titanium dioxide are
commonly used.
The most common colorant in use are certified by food drug &cosmetic(FD&C) drug & cosmetic
(D&C). e.g. Iron oxide an thocyanins, caramel, carotenoids, chlorophyll, indigent turmeric, carminic
acid & etc.
Justification for the use of colorants:
1. From a purely commercial viewpoint color is an important tool in the marketing of product.
2. Tests have shown that certain colors are more acceptable than others for certain type of
product.
3. Color is an important part of gaining patient compliance, patients eventually stop taking
their medicine if it is unappealing.
4. The most important use of color is simply for identification. Thus it become an aid to GMP
by avoiding mix up of products in-house , especially in a packing department where
numerous Products are being packed.
5. There is less risk of confusion in dispensing.
6. There is less risk of confusion by the patient when more than one tablet has been prescribed.
7. It is an aid to recognition in emergency.
6. Preservative : Generally in coating formulation used preservatives are Sodium Benzoate,
Benzoic acid etc.
7.Miscellaneous additives : In coating formulation some time flavoring agent, sweetening agent,
anti oxidant and surfactant also used.
Flavoring agent Vanillin
Sweeten gents Sucrose
Preservative Bezoic acid
Surfactant Cellulose derivatives
Antioxidant Sodium bi sulfite
Factors effecting film coating: Film formation and the quality depends on following factors :
1. Core tablet properties: eg.
a)
b)
c)
d)
e)
Tablet size and shape ,

Tablet hardness
Tablet weight
Tablet surface property
Friability
2. Formulation factors: eg
a) Polymer
- water soluble polymer
- water in soluble polymer
- pH dependent polymer
- Non enteric polymer
- Enteric polymer
- Particle size of polymer
- Polymer concentration and viscosity
If polymeric compound is low
Polymeric concentration will be decreased

Viscosity will be decreased
Coating time will be more.
Productivity decreased
**
If polymeric compound is high
Polymeric concentration will be increased

Viscosity will be increased
Coating time will be less.
Productivity increased
b) Plasticizer: eg. Plasticizer depends on :

- Types of polymer
- Method of application
- Types of solvent
- Presence of other additives
- Water soluble plasticizer
- Water in soluble plasticizer
- Amount of plasticizer
If plasticizer amount higher
Soften the polymer

Sticking to the coating pan
**
If plasticizer amount lower
Hardening the polymer

Film becomes brittle
C) Solvent: eg.
-
Droplets formation and rate of droplets formation

Depends on types and nature of solvent
Rate of evaporation depends on types and nature of solvent
Thickness also depends on solvent
Drying rate depends on solvent
Speed of coating operations depends on solvent
Solvent selection depends on product active nature
If solvent is organic in nature the bonding mechanism
Is wonderful. So strong cohesive force achieve
D) Dispersed solid: e.g. Cellulose derivatives.

i) The particle size of the pigment is of Particularly importance not just because it has to pass through
fine nozzle during spraying but become large particle will spoil the appearance of the coated tablets.
The lake particle should be no greater in size than 5 micron. The large particle causing a rough
surface. The very large particle will appear individually as specks
ii) The addition of pigments to film actually reduced their strength. So an optimum level must be
determined. A high level of coloring matter will give good coverage but provide weak, rough film with
no gloss.
iii) Too low concentration of color will provide a more shiny film but poor coverage. Resulting in a
need to increase the amount of coating required to achieve an acceptable appearance. Thus the
processing time is increased
iv) If dry lake is used a high share mixture is required and can lead to excessive evaporation of volatile
solvents.
e) Coating thickness :
-
Do not required extra thickness

Require maximum bonded with surfactant
If coating thickness is more it tends to become
brittle,Cracking in appearance.
Generally the coating thickness is in case of film coating ranging from 2-6%
of the total weight.
f)Reconstitution level :
-
Reconstitution level is a vital factors in coating

formulation because of it is directly related to the viscosity
of the coating solution.
3) Processing and operational factors:
i)
Inlet temperature: Inlet temperature is vital factors during coating operations. A lot of
factors related to the inlet temperature which are directly affect on the tablets. They are
described as follows :
a)
Inlet temperature is high

Solvent evaporation rate is high
Drying rate is high
Coating process time is lower
Productivity increase
b)
Inlet temperature is low

Solvent evaporation rate is low
Drying rate is low
Coating process time is higher
Productivity decrease
c)
Inlet temperature high

Solvent evaporation rate is high
Coating surface tends to becomes shrinking or
cracking and colors also becomes fading
d)
Inlet temperature low

Solvent evaporation rate is low
Coating surface tends to becomes sticking
e)

Heat sensitive product degraded
f)
Incase of aqueous solvent
Inlet temperature comparatively higher than

organic solvent due to evaporation rate is lower
than organic solvent.
g)
Incase of organic solvent
Inlet temperature comparatively lower than

aqueous solvent due to evaporation rate is higher
than aqueous solvent because of their volatile
nature.
h)
Dispersion rate is high
i)
Dispersion rate is low
Inlet temperature lower
From the above discursion, we see that inlet temperature is vital factor in coating processing. So it
should be maintained carefully. Generally, inlet temperature should be setup in such a way :
Title
Aqueous solvent
Organic solvent
Seal coating
Sub coating
Plain syruping
Color coating
Heat sensitive product
Inlet temperature range in

C
55 to 75
40 to 55
55 to 60
60 to 80
50 to 60
55 to 75
35 to 45
During conventional coating pan processing inlet temperature setup comparatively higher than auto
coating processing.
Title
Seal coating
Sub coating
Color coating
Polishing
Inlet temperature range in

C
60 to 100
100 to 150
70 to 90
60 to 80
ii) Tablet bed temperature: Actually tablet bed temperature is directly related to
the inlet temperature and vis-versa.
Bed temperature high
Inlet temperature low
Bed temperature low
Generally, The relationship between inlet temperature and bed temperature are as follows :
Inlet temperature range in C
Bed temperature range in
C
30-35
35-45
45-55
55-65
40-50
50-60
60-70
70-80
iii) Exhaust temperature : Exhaust temperature should be measured as close to the tablet
bed as possible. Once determined by experiment it is a useful guide to the progress of film
coating process. If temperature should increase it is an indication that either
a) Insufficient coating materials is being applied. or
b) The temperature of the drying air is too high
This will result in spray drying of the coating materials producing a non integral, rough
film.
If temperature should fall it is an indication that either
a) Too much coating materials is being applied. or
b) The temperature of the drying air is too low. Or
c) The volume of drying air is too low.
iv)
Removal of solvent / Exhaust capacity :

In order to film coating successfully balance must be obtained between the input of heat
in the form of hot air and removal of solvent. A steady state must be achieved. Sufficient
exhaust capacity is important from the safety view point. Poor exhaust lead danger of
explosion and toxicity hazard for the process workers. It is only possible to film coat as
fast as the solvent can be removed. Thus poor exhaust will cause an extension of the
coating time with lower productivity. In case of conventional coating pans or those
cylindrical pans having their exhaust at the rear the exhaust volume should be double
that of the coming air. It need only be a little greater in volume for the cylindrical pans
having perforated drums.
v)
Pan RPM : Pan RPM is a vital factor for coating processing. Pan RPM is directly
related to the following factors :
a)
In case of dispersion rate :

Dispersion rate high
Pan RPM high
Dispersion rate low
Pan RPM low
b)
Pan RPM high
Tablets becomes erosion and surface

roughness
c)
Pan RPM low
Tablets becomes sticking and twinning
d)
In case of evaporation rate :

Evaporation rate/ drying rate high
Pan RPM low
Evaporation rate/ drying rate low
Pan RPM high
e) In case of hardness :
Tablet hardness lower
Pan RPM low
Tablet hardness higher
Pan RPM high
From the above discussion , we see that pan RPM is directly related to dispersion
rate, evaporation rate and tablet hardness.
vi)
Pan size : Actually pan size should be adjusted to existing standard batch size.
Standard batch size low

Pan size big
Solution sprayed on the surface of pans
Higher coating solution loss
Desired coating is not found

And also color variation
vii)
Pan shape : To ensure the proper movement of the tablet on to the pan proper designed
pan must be selected. Selection of pan depends on :
a)
b)
c)
d)
Quantity of the tablets

Nature of the tablets
Coating formulation
Method of application of coating solution
Different pan shapes like angle of pan, rotation of pan speed , no of spray gun must be
considered to ensure proper movement of the tablet bed on the pan during coating
operations. Standard pan size is generally 42 contains 75 kg .
viii)
Baffle : It should be design in proper way. It changes the movement of direction of

tablets to eliminate any type of destruction.
The DRIA COATER made by driam in Germany is interesting development in this
machine the hot air passes from an outer chamber into the coating pan through the baffle
which are themselves perforated. The mixing properties of this pan are found very good.
ix)
Perforated coating pan : Actually in perforated pan dry air can pass through the
tablet bed. For this reason tablets are dried quickly. So processing time is lower and
productivity improved.
Perforated coating pan
Air can pass through the tablet bed.
Drying rate is high
Processing time is shorter
Productivity improved
In perforated coating pan there is vital problem i,e cleaning operations. So

cleaning is a vital factor in case perforated coating pan.
x)
Perforated paddle: Perforated paddle system is a latest technology to increase the drying
rate.
Perforated paddle
Immersed in the tablet bed
Inlet dry air pass through the tablet bed
Finally exhausted through perforated paddle
Drying rate higher
Processing time shorter
xi)
Compressed air quality: Compressed air quality should be maintained due to it is

directly related to tablet quality. International standard for compressed air quality a
simple system of classification for three main contaminants present in all compressed air
system: Dirt, water, oil.
Quality
class
1
2
3
4
5
6
Dirt ( Micron)
Water (PDP)
Oil (PPM)
0.1
1
5
15
40
-
-70 0 c
- 40
-20
3
7
10
0.01
0.1
1
5
25
-
For pharmaceuticals industry air quality should be 1:2:1 in accordance to ISO 8573.1.
xii)
Compressed air pressure : Compressed air pressure is vital factor during coating
processing due to the following cases :
a) T o create atomization
b) To operate the peristaltic pump
c) To clean
Generally compressed air should be ranging from 6-7 bar.
xiii)
Atomizing air pressure : The atomizing pressure required for a given system is
depended on the viscosity of that system in that it must be sufficient to produce a fine
spray which when deposited on the tablets will provide an elegant film. The so called
(orange peel) effect will be obtained if the viscosity is too high. or the atomizing
pressure is too low.
Generally, the atomizing pressure should be 40-60 psi or 2.8-3.4 bar.
For both type of aqueous solvent system and organic solvent
xiv)
Spray guns : There are two types of spray gun.a) Air spray gun : Air spray guns in which the atomizing air is mixed with
coating fluid. The main advantage of such gun is that both the gun and the feed
systems are easily controlled providing a fine spray pattern. Though pressure
vessels may be used to feed the gun, the use of peristaltic pump is preferred as it
provides infinite fingertip control. Another big advantage of air spray guns is
their low cost. They are suitable for all types of equipment with multiple guns
being used where necessary depending on the capacity of the machine.
Continuous spraying is usually possible.
The advantages of these cheaper guns far outweigh the negative
factors.
The fact that compressed air is mixed with the spray causes some spray to bounce back and
thereby interfere with the spray pattern. This problem can be overcome by careful choice of
atomization pressure and gun positioning.
Air mixed with the coating fluid can cause spray drying. This potential difficulty is overcome by
choosing the correct feed rate and gun position.
The air spray guns are only capable of handling systems of a lower viscosity compared with
those sprayed in airless systems.
b) Airless guns: Air less gun in which the coating fluid is pumped to the gun by
compressed air though no air actually mixes with the fluid. Atomization is a very high
pressure area (the gun ) to a low pressure area (the coating pan). Pressures of 8001200 psi. (56-84 bar) or even higher are commonly used thus making the spraying of
higher viscosities possible.
c)Ultrasonic spray techniques still considered to be experimental technique .Weighing
to certain to limitation imposed by the rheology of the coating liquid.
Application tends to be more efficient with very little scattering of the spray though at the highest of
pressures the sheer force of the spray can cause bounce- back.
A great variety of spray tips provides various delivery rates and spray patterns. The rate of delivery
is determined by viscosity pump pressure and size of the spray tip. Therefore controlled variation of
the delivery rate is difficult to achieve due to those three variables being inter- related.
Airless spray systems are very expensive compared with air spray equipment.
xv)
No of the spray gun:Actually it depends on M/C capacity, drying capacity and tablet bed
surface area
No of spray gun higher
Dispersion rate higher
Processing time lower
xvi)
Pore size of spray gun:-
It should be optimum in size. It also depends on droplet particle size ,dispersion

flow rate & also drying capacity. Generally the pore size of spray gun should
be ranging from 1-1.5mm.
xvi)
Distance between spray gun :

It depends on pan size and design of pan.
xvii)
Distance between spray gun & tablet bed:Generally it should be 6-12.
xviii) Delivery RPM of peristaltic pump:- Delivery RPM should be in optimum level.
Mainly it depends on dispersion rate.
xix)
Dispersion rate: It depends on drying rate.
xx)
Inlet air Humidity: Inlet air humidity should be controlled for the
following two factors.
a) Those product which are hygroscopic or moisture sensitive in nature in
that humidity directly effect on the tablet because air directly come in
contact to the tablet bed.
b) Another is drying rate :
Relative Humidity less
Drying rate more
Processing
time low
Productivity improve
xxi) Air inlet filtration system: Inlet air must be filtered due to air directly come in contact
with the tablet bed. Filter pore size should be EU3 as per European standard.
xxii)
Inlet air volume: Sufficient air volume and flow rate should be
required for proper drying.
xxiii) Room tem & Humidity:- It should be maintained.

Generally Room tem ( 252) 0 C
Relative humidity : (605)%
xxiv) Some factors influencing the blocking of the spray gun (spray nozzle) and
suggestions for resolving (check list).
1. In sufficient wetting of the talc in the pigment Suspension
Solution: a) Stir thoroughly the pigment Suspension (1-2 hours) if possible over
Night.
b)Keep stirring (gently) the lacquer/pigment Suspension during spray
process.
2.
The concentration of the lacquer/ pigment Suspension (total solid content) is too high.
Solution : Reduce the total concentration by adding more solvent
The diameter of the spray nozzle is too small ( smaller than 1mm)
Solution: Increase the diameter of the nozzle to 1- 1.5mm.
4. The inlet air temperature is too high, so that the film starts forming in the spray gun
Solution: Reduce the inlet air temperature The core temperature should be 30-35degree C.
To obtain proper drying,. The amount of air can be increased instead of the temperature.
5. The grain size of the pigment Suspension (Talc, colors, Titanium Dioxide etc.) is
too big (more than 15um).
Solution: The pigment Suspension has to be milled and homogenized by
means of a suitable dispersion system such as toothed colloid
mills, corundum disc mills or ball mills.
Note: The pigment suspension has to be milled alone without the EUDRAGI dispersion. After
that the pigment Suspension can be poured into the EUDRAGIT dispersion and mixed together .
During the spray process a gentle stirring of the lacquer/pigment Suspension is sufficient .EUDRAGIT
dispersion is sensitive to high shearing force such as high- speed stirrers and mills.
6. The container of the lacquer/ pigment Suspension is placed too far from the spray
or the tube is dejected.
equipment
Solution: Bring the container near the equipment and pay attention to the tube.
7. The pressure in the spray gun is not correct.
Solution: Please check this point in accordance with the instruction given by the manufacture of the
equipment; as a suggestion the atomization pressure should be 1-2 bar and the operation pressure should
be 3.5- 4.5 bar.
8. The spray rate per minute is too low, so that some talc particles precipitate in the tube.
Solution: increase the spray rate.
9.The lacquer/ pigment Suspension contains some coagulation particles.
Solution: The suspension should be filtered through a fine sieve with openings of
before use in order to remove any coagulum or film particles.
some 0.1 mm
10. The diameter of the tube is to large (that means lower flow rate per square cm).
Solution: Try to use a tube of smaller diameter.
xxv) Factors influencing the dosing :
-
Solution density
Spray time
Spray pressure
Solution temperature
Nozzle wear
xxvi) Mixing of tablet :

Mixing of an efficient nature is achieved in every case (except fluid bed) by the insertion of baffles.
Good mixing is of particular importance as the film coating process requires every tablet to pass through
the spray.
xxvii) Mixing of solution : To get homogenous mixing of solution optimum and continuous stirring
condition is required.
xxviii ) Inlet air volume : Sufficient air volume and flow rate should be required for proper drying.
Some others factors which are also important during coating operation are as follows
a)
b)
c)
d)
e)
f)
g)
Negative pressure
Air recycle
Cleaning
Surface contact time
Tablet flow rate
Air entrapment
Air flow rate.
Coating- Problems And solutions

1.Roughness :Rough tablets with poor definition of the engraving were produced when sprayed rapidly with a
coating suspension that was 15% solids
Solution :
Spraying under the same conditions with 12% solids. Typically, the higher the solids content, the
rougher the coating produced.
2. Picking:The tablets were over wetted or excessive film thickness causes tablet to stick to each other or
to the coating pan. On drying at the point of contact a piece of film may remain adhere to the
pan or to another tablet, giving a picked appearance to the tablet surface and resulting small
exposed area of the core.
Solution:
Reduce the dispersion and increased the drying rate.
3. Uniformity:A lack of uniformity in coating, more noticeable in the early stages of the process. However, the
problem remains present throughout the process, with variation obscured by color development.
Solution:
The variation is a function of the mixing and frequency of presentation in the spray zone . By
enlarging the spray zone and spraying more tablets at each pass, all tablets will receive more
applications and variation should be reduced.
4. Bridging:The logo on these tablets has been lost by bridging. It may look like the logo was filled in but
cleaving the tablet across the logo shows a void indicating the film did not adhere to the
engraving.
Solution:
Increasing plasticizer to give better flexibility or modifying the resin system. HPC and PVP both
improve the adhesion when replacing at least 20% of the HMPC.
5. Mottling:Mottling can be caused by poor dispersion of pigments or poor atomization of coating
suspension and is often found in dye coating. Dyes from a solution and can be sprayed very
uniformly. Mottling is caused by a dynamic process of moisture transport in the film. Dyes
migrate with the water and collect at evaporation sites causing mottling. This is an established
problem in dye sugar coating.
Mottling results from uneven distribution of color in the coating
Mottling can be caused by using water soluble dyes or by poor dispersion of the pigments.
Solution: Water insoluble color lakes should be used.
Homogenise the pigment Suspension properly.
6. Splitting:
Splitting was caused by a film that was weak and brittle due to excessive loading of pigment.
The system was 2parts resin. 1 part pigment and 0.4 parts plasticiser.. This pigment load would
be acceptable if the color was a pastel having mostly titanium dioxide- but this deep yellow
coating contained a lot of lake.
Solution:
Changing the coating suspension to 2.5 parts resin. 1 part pigment and 0.5 parts plasticiser.
7. Fading:
Light grey tablets had faded due to the small quantity of color. When lake concentration is very
low, there is a tendency to fade, especially in the presence of PEG.
Solution :
The more stable tablets were coated in a film without PEG. PEG has a deleterious effect on light
stability of all lakes.
8. Twinning :
The caplets twinned when they were over-wetted.

Solution :
Twinning can be prevented by keeping the spray rate within the limits of the drying capacity of
the equipment and by increasing the speed of the pan. Capsule shaped tablets should be
designed without straight edges. Any tablet with a flat surface will tend to twin .
9.Chipping :
The edge of the tablets was raised ( flashing due to worn punches ) and the film coating was
weak.
Solution :
Replacing 20% of 5cP with 15cP HPMC. This increased the tensile strength and toughened the
film enough to hold the weak edges. Reducing pigment may achieve the same result but
replacing worn punches and eliminating the flashing is the best solution.
10. Blistering :
In the most common problem associated with aqueous film coating , the tablets have become
over-wet (not to over wet ) activating a moisture-sensitive spot in the core. Swelling has taken
place, raising the point and causing excessive wear that breaks down the film. Some times the
film does not break but the tablets is disfigured, producing a scab on the tablet.
Solution :
Usually raising the bed temperature or process air volume or reducing the spray rate will prevent
this problem.
11. Erosion :
The tablets were friable though they had an adequate hardness. The surface was eroded during
the warm- up period in the pan. The coating process developed properly but the tablets were
ruined by crosiol. Edge erosion is similar to chipping. Usually it indicates excessive ware on the
edges due to the characteristics of the rolling action.
Solution :
Reducing pan speed or increasing strength of the film deposited. Generally , once a film covers
the coating. This is desirable to reduce
variation.
12.Edgewear :
The shape of these tablets has caused them to slide in the pan. This sliding has created an
abrasion on the leading edge.
Solution :
Extra slide bars and baffles
provided a uniform coating.
were necessary
to ensure that the tablets rolled in a way that

13. Orange peel : Roughness of the film. : Orange peel is occurred due to rapid
drying and improper distribution of coating solution on the surface of the tablet.
1. Spray rate is too high.
Solution: Reduce the spray velocity (about 2-4g/min/kg tablets.)
2. Inlet air volume is too low.
Solution: Increase the amount of drying air (about 0,3-0,5 m3/min/kg core)
3. Friability of the tablets is too high.
Solution: The friability should be less than 1% improve the physical
of the core (erosion, abrasion, edge breaking).
properties
4. The particle size of the pigment Suspension (Talc, colours, Titanium Dioxide) is too big.
Solution: The pigment Suspension has to be milled (recommended particle size about15um).
5. Atomizing air of the spray gun is not correct.
Solution: Adjust the atomizing pressure to 1-1,5bar. Both high and low atomizing pressures can
cause rough and uneven films.
6. Distance between spray nozzle and tablet bed is not correct.
Solution: Adjust the distance between spray nozzle and tablet (14-17cm).
14. Black spots on the film
Black spots can be caused by the friction between the Titanium dioxide in the formulation and the
coating pan.
Solution: The coating pan has to be isolated prior to loading the tablet cores. A
thin layer of EUDRAGIT will be sufficient. For isolation use the same type of
EUDRAGIT witch will be used in the specific coating formulate.
15. Cracking of the film
Low amount of plasicizer Swelling of the tablets Spray-drying-effect during the coating so that droplets
do not coflow
16. Sticking of the tablets to each other and to the sides of the coating pan :
Several factors may be responsible for the above.
a) The quantity of the plasticizer in the formulation is too high.
Solution :
i) The amount of plasticizer should be between 10 15% for EUDRAGIT L and S and should
be 20% for EUDRAGIT RL and RS (related to the amount of polymer).
b) The amount of glidant in the formulation is too low.
Solution : Increase the amount of glidant (e.g. talc).
c) The spray rate is too high.
Solution : Keep the spray rate within the limits of the drying capacity of the equipment.
d) Insufficient drying air and low product temperature
Solution : Adjust the product temperature to the applied film.Increase the amount of drying air (0.3
0.5 m3/kg/min)
e) Product temperature is too high

Solution : the product temperature must be reduced, since high product temperature
will lead to soft and sticky films.
17. Wrinkling: Development of wrinkling due to improper curing or improper drying oven the
tablet surface and also for coating thickness is very high. It is magnified when the film is too thick.
Solution:
a) By reducing the temp
b) By ting the drying time
c) By maintaining the thickness on the tablet.
18. Sweating: Because of any reason the presence of oily film or droplet of liquid over the
surface causes sweating.
If plasticizer is present in original formulation. It may exuded from the original
formulation. It may exuded from the original formulation and adhere on the surface of tablet.
Solution:
a) By maintaining proper drying condition.
19. Flaking: Flaking is occur when the coating material is remove from the surface as line as
sheet due to lack of colesiveness between the tablet surface and film.
Solution:
a .By controlling the temp.
b .By changing the formulation.
20. Bloom / dull film : Dull film is called bloom .When the process are proceeds under
uncontrolled humid condition , because of migration of solvent from the interior area to the external
surface , result in imbalance distribution (Not homogenous distribution). This is called bloom.
Solution:
a .By controlling the humid condition.
21. Spotting: It is also occurred by the migration of plasticizer or dies on some of the
chemicals from formulation to the tablet surface .
Solution:
a. By controlling the humid condition.
b. By proper selection of materials in the coating solution.

Coating

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Coating

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Coating Technology

To identify the product during manufacture, dispensing & in use by the

To improve product stability by providing a barrier to light & moisture

To make the taste of bitter drugs.

Process flow diagram of Sugar coating:

Ready for packing

Sugar coating process involves the following steps:

Sealing/ water proofing

4. Syruping/ Smoothing : (up to 10 application) Syruping helps to get smooth surface

Should be soluble in gastrointestinal tract

Process flow diagram of film coating:

Non enteric coating

Seal coating if req

Ready for packing

Advantage of film coating over sugar coating;

Theory of film coating:

substrate poor adhesion may result in several coating problems.

Solvent combination are :

Methylene chloride/ Ethanol

Silicates ( Aluminum silicates)

Tablet size and shape ,

If polymeric compound is low

Polymeric concentration will be decreased

Coating time will be more.

If polymeric compound is high

Polymeric concentration will be increased

Coating time will be less.

b) Plasticizer: eg. Plasticizer depends on :

If plasticizer amount higher

Soften the polymer

If plasticizer amount lower

Hardening the polymer

Droplets formation and rate of droplets formation

D) Dispersed solid: e.g. Cellulose derivatives.

Do not required extra thickness

Reconstitution level is a vital factors in coating

Inlet temperature is high

Inlet temperature is low

Inlet temperature high

Inlet temperature low

Inlet temperature high

Incase of aqueous solvent

Inlet temperature comparatively higher than

Incase of organic solvent

Inlet temperature comparatively lower than

Dispersion rate is high

Inlet temperature high

Dispersion rate is low

Inlet temperature lower

Inlet temperature range in

Inlet temperature range in

Inlet temperature high

Bed temperature high

Inlet temperature low

Bed temperature low

Bed temperature range in

Removal of solvent / Exhaust capacity :

In case of dispersion rate :

Pan RPM high

Dispersion rate low

Pan RPM low

Pan RPM high

Tablets becomes erosion and surface

Pan RPM low