Tablet Coating Process

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CONTENT
S
 DEFINITION
 OBJECTIVES

 PROPERTIES

 EQUIPMENTS

 PROCESS INVOLVED

 DEFECTS AND REMEDIES

 CONCLUSION
2
Tablet coating is the last critical step in
the tablet production cycle.

It is the phenomenon of application of


coating to the tablet.
OBJECTIVES OF TABLET
COATING

4
COMPONENTS CONSIDERED IN
TABLET COATING
 Tablet Properties- Shape, tolerance, Surface area

 Coating process -
A. Coating equipment
B. Coating parameters
C. Facility & ancillary equipment
D. Automation of coating process

Coatingcomposition which involves 5

polymers, color ,plasticizer ,solvent.


TABLET
PROPERTIES
 Tablet to be coated must posses the proper
physical characteristics like spherical shape and
uniform surface.


To tolerate attrition of tablets during
coating process they must be resistant to
abrasion and chipping.


As the tablet surfaces that are brittle and
soften in presence of heat or effected by
coating composition and tend to become rough
in the early stages of coating process are 6

unacceptable for film coating.


TABLET COATING PROCESS

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Wetting and Accumulation and Partial Spreadi Coalescence and
Adherence Drying ng Cohesion

8
COATING COMPOSITION

Tablet coating is
accomplished by the IS APPLIED TO
movement of tablets in
MOVING BED OF TABLETS
Perpendicular or vertical
direction to the
application of the coating HEATED AIR IS
INTRODUCED
composition
EVAPORATION OF THE SOLVENT

9
A.
EQUIPMENTS
 The equipments used for the tablet
coating are :-

I. Standard coating pan

I. Perforated coating pan

II. Fluidized bed coater 10


STANDARD COATING
PAN

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I. STANDARDCOATING
 It is also PAN
known as conventional pan system


Circular metal pan(mounted angularly
on a stand)
 8-60 inches in diameter

 Rotated on its horizontal axis by a motor

 Heated air is directed into the pan & on to the


tablet bed surface and is exhausted by means of
ducts through the front of the pan 12
 Coating solution are applied to the tablets by
ladling or spraying the material on to the rotating
tablet bed.

 Use of spraying systems-


Produces a faster, more even
distribution of the solution or suspension.

 Reduces drying time between solution application


in sugar coating .
13
 coating.
Allows continuous application of the solution in film
In standard coating pan ,the
drying efficiency is improved
by:-

 Pellegrini pan

 The immersion sword

 Immersion tube systems

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15
 Pellegrini pan-
 Baffled pan
 Diffuser(distributes the drying air uniformly over the tablet
bed surface).

 IMMERSION- SWORD SYSTEM-


 Perforated metal sword device immersed in the tablet bed.
 Drying air is introduced through this device and
flows upward from the sword through the tablet bed.

 IMMERSION-TUBE SYSTEM-
 Tube immersed in the tablet bed.
 Tube delivers the heated air.
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 In immersion tube system the coating solution is applied with
the
PERFORATED PAN
II .
SYSTEMS-

17
II. PERFORATED PAN SYSTEMS-
 Perforated or partially perforated drum.

 Rotated on its horizontal axis in an enclosed housing.

 Thecoting solution is applied to the surface of the


rotating bed of tablets through spraying nozzles,
which are present inside the drum.

 Perforatedpan coaters are efficient drying systems


with high coating capacity. 18
 PERFORATED PAN SYSTEM HAS-

$-
Accela-cota system

$- Hi
coater system

$- Dria
coater pan
19

$- Glatt
ACCELA
-COTA

20
 ACCELA COTA & HI COATER SYSTEM-

 Drying air is directed in to the drum,


 Passed through tablet bed,

 Exhausted through perforations in drum.

 DRIACOATER PAN-

 Drying air enters through hollow perforated ribs ,located


on inside periphery of the drum.
 As the coating pan rotates, the ribs dip into the tablet
and drying air passes up through
bed 21

 Exhaust is from the back of pan.


D RIA COATER
PAN

22
H I - COATER
SYSTEM

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GLATT COATER

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 GLATT COATER

 Itis the latest perforated pan coater to


be introduced in the industry.

 In this, drying air can be directed


from inside the drum through tablet
bed

 Exhausted out through an exhaust


duct. 25
III . FLUIDIZED BED
SYSTEM

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III. FLUIDIZED BED SYSTEM

In this system fluidization of the tablet mass
is achieved in a columnar chamber by the
upward flow of drying air.

 The air flow is controlled, so that more air enters


the center of the column, causing the tablets to
rise in the center.

 The movement of tablets is upward trough the


center of the chamber. 27
FLUID BED COATING MACHINE
MECHANISM

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FLUIDIZED BED SYSTEM
 They then fall towards the chamber wall,

 Move downwards to reenter the air


stream At the bottom of the chamber.

 Coating solutions are applied from a


spray nozzle which is located at the
bottom of the chamber.
{Or }

are sprayed onto the top of the Cascading


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tablet bed by nozzles located in the upper
region of
SPRAY APPLICATION SYSTEM

2 Basic systems used to apply a
finely divided (atomized) spray of
coating solutions or suspensions on to
tablet are-

* High pressure, airless

* Low pressure, air


atomized
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 AIR LESS SPRAY SYSTEM-

Liquid is pumped at high pressure{250-3000 pounds per


square inch gauge(psig) },
through a small orifice (.009 inch to .020
inch) in the fluid nozzle Which results in a finelydivided
spray.

In this ,the degree of atomization & the


spray rate are
controlled by
Fluid pressure,

orifice size and


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Viscosity of the liquid.


LOW PRESSURE AIR- ATOMIZED SYSTEM
 Liquidis pumped through a somewhat large orifice
(0.020 inch-0.060 inch in diameter ) at relatively low
pressure(5-50 psig)

 Low pressure air contacts with the liquid stream at


the tip of the atomizer,& a finely divided spray is
produced.
 The degree of atomization is controlled by the fluid

pressure , Fluid cap orifice


Viscosity of liquid
Air pressure 32

Air cap design.


T ABLET COATING
PROCESS
 The coating of tablets classified into three types

I. Sugar coating

II. Film coating

III. Enteric coating

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SUGAR
COATING
 It involves the application of sugar solution
with color for
several times to give -
UNIFORM AND ELEGANT FILM.

ADVANTAGES

 It prevents unpleasant odour ,

 Give sweet taste to tablet by masking bitter taste,


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 Highly elegant and glossed tablets are obtained.
DURATION  HOURS-FEW DAYS
 Sugar coating involves following steps -

 Sealing

 Sub-coating

 Syruping(smoothing)

 Finishing

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 Polishing
 Thetablet having deep convex surfaces
with thin rounded edges are suitable
for sugar coating.

 In
sugar coating, the tablet should
be resistant to breakage, chipping,
and abrasions.

Because sugar coating tends


to be long and vigorous.
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1.SEALING
 It prevents moisture penetration in to the tablet core.
 Seal coating agents -
shellac,zein,Oleicacid,PG,PEG4000,alcohol,methylen
e chloride.

 Zein is alcohol-soluble protein derivative.

 Shellac is more effective(because of polymerization


of shellac),
 But it lengthens tablet disintegration
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and dissolution times.
Over wetting of tablet

Moisture is absorbed
Leads to

Tablet softening or
disintegration
and effects

Physical and chemical stability

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(To over come this problem seal coating is
done)
2.SUB
 Sub coating is COATING
applied :

To form
uniform edges, To build
up the tablet size.

Sub coating increases the tablet weight from 50 to 100


percent.
Examples- Gelatin, sugarcane powder, corn syrup,
syrup , distilled water, Gum acacia. 39
 It involves
Application of binder solution
To the

Tablets
followed by

Dusting of sub coating with


powders

and drying until


the tablet edges have been covered
&
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The desired thickness is achieved.
3.SYRUPIN
G
 It is done to cover the imperfections in the Tablet
surface caused during sub coating step.
 It involves-

 Application of syrup coating with grossing syrups


followed by the addition of dilute colorants to provide
tinted base.

 Insubsequent steps, the syrup solution containing


dye are applied until
final size and Color are achieved.
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 The final step a clear syrup coat without dye are applied.
 No colour is added until the tablets are
quit smooth,

Premature application to the rough tablets


can produce a Mottled appearance in the
final coated tablets.

Syrup coating constituents- colorant , sub


coating powder , calcium carbonate ,cane
sugar powder, corn starch, syrup , distilled
water.
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4.POLISHIN
 The desired luster to theGtablet is obtained by polishing .

Tablets are polished


in a

Standard coating pans

by application of

carnauba wax(yellow), bees wax(white),paraffin wax


(Or) warm solutions of waxes innaphtha
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(or) suitable volatile solvent.
F ILM
 It is the process ofCOATING
polymeric solution to bring a
uniform film.
Advantages


Film coating gives a tablet with less Weight
and small size.

 The film formed is very thin.

 In film coating engravings are possible on tablet


surface which are not possible in sugar coating. 44
 Bettermechanical strength is
obtained.
 The cost of the film coated tablets is
less.

45
FILM FORMING
AGENTS
The film forming agents tablet coating
are classified into:

1.Non - enteric film

formers 2.Enteric film


46
NON-ENTERIC FILM
FORMERS
 They are incorporated to give uniform film with desired
mechanical strength which are as follows:
1. HPMC(Hydroxy propyl methyl cellulose)
2. MHEC(Methyl hydroxyl ethyl cellulose)
3. EC(Ethyl cellulose)
4. HPC(Hydroxy propyl cellulose)
5. POVIDONE
6. SCMC
7. PG
8. ACRYLATE POLYMERS 47
1.
HPMC
 It is prepared by reacting alkali treated
cellulose
with
methyl chloride with propylene oxide.

 Asit forms bridging & rough Tablet surface, it


has to
be mixed with other polymers or plasticizers.
48
2.MHE
C
 It is prepared by reacting alkali treated cellulose
with methyl chloride
& then with ethylene oxide.

 It has similar properties as that of HPMC,


But it is soluble in fewer organic solvents, it is
not used as frequently as HPMC .
49
 Thesepolymers used in combinations
with other
polymers to modify film Properties.

 FOR EXAMPLE-

Combinations of PG waxes with


Cellulose acetate phthalate
provide film that are soluble in
GI fluids. 50
3.E
C
 Itis manufactured by the reaction of ethyl
chloride with cellulose dissolved in
NaOH.

 It is available in different viscosity grades.

 Unplasticized EC forms brittle films &


requires film modifiers to obtain
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acceptable film.
 It is water insoluble & thus Cannot be
used alone for tablet coating.


It is usually combined with water
Soluble additives
E.G.- HPMC to prepare film
with reduced water soluble
Properties &This combinations are
widely Used
in sustained release coating. 52
4.HP
C
 It is manufactured by the treatment of

cellulose with NaOH


followed by the reaction with propylene
oxide
at
Elevated temperature and pressure.

 It forms tacky films.


53
 Usedin combinations with other polymers
to improve film characteristics.

It is soluble in water (below 40 cͦ &


insoluble above 45°�) ,
GI fluids

& in many
polar
Organic
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solvents.
5.POVIDONE
 Itis synthetic polymer consisting of linear
1-vinyl-2-pyrrolidinone groups.

 Itgives clear, glossy, hard films when


dry.

 It
give tacky films which can be overcome
by plasticizer or other polymer.
55
6.ACRYLATE
POLMERS
 These are marketed under the trade Name
of Eudragit.

 Eudragit RL & RS are copolymers of


Acrylic and

meth acrylic acid


est
ers
.

 Preparation
These is similar topHthat
films produce of EC formulations.
independent,
56

delayed actions.
ENTERIC FILM
FORMERS
 REASONS FOR ENTERIC FILM
FORMERS-

 To protect acid-labile drugs from


gastric fluid e.g. Enzymes & certain
Antibiotics.

 To prevent gastric distress or


due to irritation from the drug .
nausea
57
e.g., Sodium salicylate.
 To deliver drugs intended for local Action
in the intestines, e.g. Intestinal antiseptics.

 To deliver drugs that are optimally


Absorbed in the small intestine to their
primary
absorption site.

 To provide a delayed-release component


for repeat-action tablets. 58
PROPERTIES OF AN IDEAL ENTERIC
COATING MATERIAL
 Resistance to gastric fluids.

 Susceptibility or permeability to intestinal fluids.

 Compatibility with most coating


solution components & the drug
substrates.
 Stability alone and in coating solution.

The film should not change on 59

aging.
 Formation of a continuous film, nontoxicity,
with low cost.

 Easeof application without


Specialized equipment.

 Abilityto be readily printed and allow


film to be applied to debussed tablets.

60
ENTERIC FILM
FORMERS
 CAP(Cellulose acetate phthalate)

 ACRYLATE POLYMERS

 HPMCP( Hydroxypropyl methyl cellulose


phthalate)

 PVAP(Polyvinyl acetate phthalate)


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1.CA
 It is widely used. P
 As it is hygroscopic and relatively permeable to
moisture and gastric Fluids, film formed are brittle and
hence formulated with hydrophobic- Film forming
materials
to achieve better enteric films.

 Aquateric coating is a reconstituted colloidal dispersion


of latex particles. It is Composed of solid or semisolid
polymer spheressize
average particle of cap ranging in size from 0.05-3 Microns 62
of 0.2
microns.
with an a
2.ACRYLATE POLMERS
 2 forms of commercially available Enteric acrylic
resins are

Eudragit L and Eudragit S.

Eudragit l is available as an organic


Solution, solid or aqueous dispersion.

Eudragit s is available only as an organic solution and


solid.

Eudragit l & s are soluble in intestinal Fluid at pH


63
6&7.
3.HPMC
P by
 It is derived from HPMC

esterification with phthallic anhydride.

 Theseare stable than cap and dissolve At lower


pH compared to cap and acrylate polymers.

 The solubility characteristic may result in Higher


bioavailability of some specific drugs.

 It is available in various grades- 64

HP55,HP50 etc.
4
PVAP
 It
is manufactured by the esterification of partially
hydrolyzed Polyvinyl alcohol with phthallic
Anhydride.

 It is similar to HPMCP(HP55) in

stability and
pH dependent solubility.
65
COATING COMPOSITION
It involves 
1. Solvent

2. Plasticizers

3.Colorants

4.Opaquant-extenders
66
1.SOLVENT

It is to dissolve or disperse the polymers and
other additives and convey them to the substrate
surface.

 The ideal requirements of the solvent are



It should either dissolve or disperse the
polymer system.
 It should have no environmental impact.

It should easily disperse other coating
solution components in to the solvent system.

It should have rapid drying rate(ability to 67
coat 300kg load in 3-5 hours)
 It should be
Colorless, tasteless, odorless, Inexpensive,
nontoxic, inert and Noninflammable
and rapid drying Rate.

 Examples-

Water, Ethanol, Methanol, Isopropanol,


Chloroform, Acetone, Methylene chloride ,
Methylene ethyl ketone.
68
2.PLASTICIZE
RS
 It is used to modify the quality of the film .

 Plasticizing techniques involve internal


plasticizers and external plasticizers.

 Internal plasticizers involves Chemical modification of


the
basic polymer that alters
the physical properties of
the polymers.
 Chemical plasticizers Additives of the Coating
69
solution to
achieve the desire effect of the film
 Level of plasticizers ranges from 1-50% by weight of
film former.

 Examples

Castor oil,
Propylene glycol,
Glycerin,
Surfactants

e.g., Polysorbate(tweens),sorbitan
esters(spans), organicacid esters. 70
3.COLORANTS
 It
is to provide the distinct color and
Elegance to the dosage form.

 Toachieve the proper distribution of suspended


colorants in the coating solutions requires
Use of fine powdered colorants
(<10 microns)

 The concentration of colorants in the coating solution


depends on the color shade, desired the type of dye
and the concentration of the opaquqnt extenders 71
 For very light shade conc. Lt 0.01%

 For dark shade Conc. Mt 2.0% is required.

 The most common colorants in use are certified


by FOOD DRUG AND COSMETICS (FD&C)
or DRUG AND COSMETIC (D&C) Colorants.

 These are lakes and dyes.

 Lakes are derived from dyes by precipitating


with carriers e.g., Alumina or talc.
72
 The inorganic materials and the natural colorants are-

 Iron oxides,
Caramel,
Carotenoid,
Chlorophyll, indigo,
Flavones,
Turmeric and carminic acid.
A variety of products that are
Commercially available are-

 Opalux- Opaquant color concentrate for sugar coating.

73
 Opaspray -for film coating.
 Opadry- complete film coating
OPAQUANT-
EXTENDERS
 These are very fine inorganic powders used In the

coating solution formulation to provide more


pastel colors and increase film
coverage.

 Provide white coating or mask the color of


the tablet core.
Examples Titaniundioxide
Silicates like (Talc, Aluminiumsilicate)
Carbonates like-magnesium
carbonate, Sulphates like calcium 74

sulphate.
FILM
DEFECTS
STICKING AND PICKING- Attaching of tablet to another.
REASONS REMEDY
OVER WETTING REDUCE LIQUID APPLICATION

CONTROL RATE OF DRYING


RAPID DRYING
CHANGE FORMULATIONS
TACKINESS OF TABLETS

ROUGHNESS- Formation of rough or gritty surface .

REASONS REMEDY
INCREASE IN PATH LENGTH OF DECREASE IN PATH LENGTH.
SPRAY NOZZLE TO TABLET BED.
75

RAPID DRYING CONTROL THE DRYING RATE.


FILM
Picking and sticking DEFECTS

Orange
Peel

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Capping and
Lamination

Roughness

B r id g i n g

77
Twinnin
g

Erosio
n

78
ORANGE PEEL EFFECT- Inadequate of spreading
coating solution.
REASONS REMEDY
RAPID DRYING. DECREASE IN DRYING RATE.

DECREASE THE VISCOSITY BY


HIGH VISCOSITY OF ADDING SOLVENT.
COATING SOLUTION.

BRIDGING – Shrinking or pulling away of film from


corners.
REASONS REMEDY

OVER WETTING. DECREASE THE APPLICATION


RATE.

LESS VISCOUS LIQUIDS. INCREASE VISCOSITY.


79
SPREADABILITY
PROBLEMS. CHANGE THE FORMULATION.
BLISTERING-Removal of film due to rapid evaporation of
solvent from tablet core.

REASONS REMEDY
RAPID EVAPORATION OF DECREASE THE
SOLVENT DUE TO INCREASE TEMPERATURE OF DRYING.
IN TEMPERATURE.
DILUTE THE COATING
HIGH VISCOSITY OF COATING SOLUTION.
SOLUTION.

80
Apart from the all mentioned film coating techniques
special techniques are used like

 COMPRESSION COATING,

 ELECTROSTATIC COATING,

 DIP COATING,

 VACUUM FILM COATING ,

 DRY COATING ,

 LAMINATED COATING are used. 81


CONCLUSI
ON
 Coating is one of the important technique in
manufacturing of dosage forms, improve
the stability, shelf life and release pattern .
 Coating of dosage forms helps in improving

patient compliance.
 Now-a-days, advanced techniques are preferred

over the conventional types, because of effective


coating, taking less time, and also improve the
stability of the product (chances of
degradation in coating time). 82

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