PRESENTED BY

B.MAHALAKSHMI
M.PHARMACY,
IstSEMISTER
PHARMACEUTICS

ST.PETERS INSTITUTE OF PHARMACEUTICAL SCIENCES

VIDHYANAGAR ,HANMAKONDA
WARANGAL.
 CONTENTS

HISTORICAL PERSPECTIVE
INTRODUCTION
KEY FACTORS
TYPES OF TABLET COATING
- FILMCOATING
- SUGAR COATING
TABLET DEFECTS
ADVANCES IN TABLET COATING
CONCLUSION
REFERENCES
 HISTORICAL PERSPECTIVE

 Based on Islamic literature (850-923) “Rhazes”

 Sugar coating (1800, 1837-1840) for Cubeb and Copaiba

 Dr. “Dale wurster”(1950)-Air suspension coater

 Abbott laboratories (1953)

 Accela cota, Hi-coater, Dria coater

 INTRODUCTION

6.Protection from DEFINITION

GI fluids Of coating

1.Identification
WHAT IS TABLET
5.Control the release
COATING?

WHY COAT TABLETS?

2.Improve
4.To Mask Color,
Odour, Taste elegance
of the drug

3.Stability
 KEY FACTORS
 TABLET PROPERTIES
- Shape
- Tolerance
- Surface area

 COATING PROCESS
- Equipments
- Parameters
- Facility and ancillary equipment
- Automation

 COATING COMPOSITION
- Polymers
- Solvents
- Plasticizers
- Colorants
 COATING PROCESS

Equipments Parameters

 Conventional Pan Systems  Air Capacity

 Perforated Pans Systems  Coating Composition

 Tablet Surface Area
 Fluid Bed Systems
 Equipment efficiency

Spray application systems

 High-pressure air automated systems
 Low pressure air automated systems
 CONVENTIONAL PANS

Immersion-
tube system
Standard Coating Pan

Glatt
Immersion
sword
system

Pellegrini
pan system
PERFORATED PANS

Accela cota
system

Hi-coater
system
PERFORATED PANS (continue…)

Dria coater pan

Glatt coater
FLUID BED COATING SYSTEMS
 SPRAY APPLICATION SYSTEMS

 High-pressure airless automated

systems

 Low-pressure air automated systems

• High pressure airless system
• Low pressure air atomized system
Difference in the system is atomization of liquid.
• Airless system - Liquid pumped at high pressure (250-3000 psig) through
small orifice, fine spray.
Degree of atomization depends on
- Fluid pressure
- Orifice size
- Viscosity of liquid
• Air atomized - Liquid pumped through large orifice at low pressure (5-50
psig).
Air contacts liquid stream at tip of atomizer and fine spray is produced.
Controlling variables
- Fluid pressure
- Fluid cap orifice
- Viscosity of liquid
- Air pressure
- Air cap design
Choice depends on coating solution composition for a particular product.
 TYPES OF COATING PROCESSES

• Three main types are used in the pharmaceutical industry

today;
• - Film coating
• - Sugar coating
• - Compression coating
• 1- FILM COATING (the most popular today)
• It involves the deposition, usually by spraying method, of a
thin uniform film of a polymer formulation surrounding a
tablet.
 TYPES OF FILM COATING

FILM COATING

Types of film coating

• Immediate release

• Modified release
Film coating formulation (Composition of the coating liquid)
1- Polymer
2- Plasticizer
3- Colorants
4- Solvent (vehicle): Examples: water, ethanol, methanol,
isopropranol, chloroform, acetone, methylethyl ketone, and
methylene chloride
Ideal characters of coating material
Solubility in the coating solution
Solubility required for intended use- Free water solubility, Slow water
solubility, pH- dependent solubility
Capacity to produce elegant looking product
Stability in presence of water, heat, moisture, air, and substrate
being coated and no change in properties with aging.
Essentially no color, odor, or taste
Compatibility with common coating solution additives
Nontoxic and ease of application
Resistance to cracking and should act as barrier
No bridging or filling of the debossed tablet surfaces by the film
former
Ease of printing procedure on high-speed equipment
Low cost & Ease of application without specialized equipment
PLASTICIZERS
• Internal plasticizers: Chemical modification of the polymer
that alters the physical properties.
– Degree of substitution
– Type of substitution
– Chain length.

• External plasticizers : They are non-volatile or the other

polymer, which when include with primary polymeric film
former, changes the
– Flexibility
– Tensile strength, or
– Adhesion properties of the resulting film.
Concentration Of Plasticizer Expressed As

- The amount of polymer being plasticized.

• Recommended Level of Plasticizer : 1 to 50% by weight of the

film former.

EXAMPLES

• Castor oil; propylene glycol of 200 and 400 series; and

surfactants eg; Tweens; Spans; and organic acid esters.

• Water- soluble plasticizer : PEG, propylene glycol.

• Organic- soluble plasticizer : castor-oil and Spans.

COLORANTS

• Colorants may be soluble in the solvent system or suspended

as insoluble powders.

• Used to provide distinctive color and elegance to a dosage

form.

• To achieve proper distribution of suspended colorants in the

coating solutions requires the use of fine-powdered colorants
(< 10 microns ).

• Most of colorants are synthetic DYES or LAKES OF DYES

approved by the FD&C and D&C.
LAKES : derived from dyes by precipitating with carriers. Eg ; alumina or talc.

• Lakes contains 10 to 30 % of the pure dye content.

• For very light shade, concentration : less than 0.01 %.

• For dark shade, concentration : more than 2.0 %

• Examples
– Inorganic materials: iron oxides
– Natural coloring materials :Anthocyanins, caramel, carotenoids,
chlorophyll, indigo, flavones, turmeric, and carminic acid.

• Various concentrates promoted as achieving less lot-to-lot color variation

• Opalux – Opaquant color concentrate for sugar coating.

• Opaspray- Opaque color concentrate for film coating.
• Opadry – Complete film coating concentrate
OPAQUANT-EXTENDERS

• These are very fine inorganic powders used in the coating

solution formulation to provide more pastel colors and
increase film coverage.

• Opaquant provides a white coating or mask the color of the

tablet core, and thus the less amount of the colorants are
required.

• Examples: Silicates (talc, aluminium silicate); Carbonates

(magnesium carbonate); Sulfates (calcium sulfate); Oxides
(Mg oxides)
 ENTERIC COATING
The technique involved in enteric coating is protection of the tablet core from
disintegration in the acidic environment of the stomach by employing pH
sensitive polymer, which swell or solubilize in response to an increase in pH to
release the drug.

Aims of Enteric protection:

 To mask taste or odour
 Protection of active ingredients, from the acidic environment of the stomach.
 Protection from local irritation of the stomach mucosa.
 Release of active ingredient in specific target area within gastrointestinal tract.
Enteric Coating
 Examples of enteric coated OTC
products

• Enteric coated aspirin E.g. Micropirin®

75mg EC tablets

• Enteric coated peppermint oil E.g.

Colpermin®
- Typically, tablets are sugar coated by panning
technique, using traditional rotating sugar-coating
pan with a supply of drying air (thermostatically
controlled).

- The pan is automatically rotated, allowing tablets to

tumble over each other while making contact with the
coating solutions which are gently poured or sprayed,
portion wise onto the tablets with warm air blown to hasten
drying. Each coat is applied only after the previous coat is
dried.
Simplified representation of sugar coating
process
 SUGAR COATING
• Seal coating
• Sub coating
• Syrup coating
• Color coating
• Polishing
• printing
1- Sealing (Waterproofing)
This involved the application of one or more coats of a
waterproofing substance in the form of alcoholic spray, such as
pharmaceutical Shellac (traditionally) or synthetic
polymers, such as CAP.
( Unless a modified-release feature needs to be introduced, the amount of
the sealing coat applied should be carefully calculated so that there is no
negative effect on the drug release characteristics in case of immediate
release product.)
(WHY Sealing?)
a- Sugar-coatings are aqueous formulations which allow
water to penetrate directly into the tablet core and thus
potentially affecting product stability and possibly causing
premature tablet disintegration.
b- Application of many coats of partially or completely
water-insoluble polymers in this step, enables sugar-coated
product to exhibit modified-release pattern (extendedrelease
or delayed "enteric"- release characteristics).
• 2. Subcoating
• - Large quantities of sugar-coatings are usually applied to the
tablet core (typically increasing the tablet weight by( 50-
100%)
• WHY?
• In order to round off the tablet edge. Much of this material
build-up occurs during this stage and is achieved by adding a
bulking agent such as Calcium carbonate, to the sucrose
solution.

• - Antiadherents e.g. Talc may be added after partial drying to

prevent sticking of the tablets together.
• 3- Smoothing
• The subcoating stage results in tablets with rough surfaces. To
facilitate the color application (which requires smooth
surface), subcoated tablets are smoothed out by a thick sucrose
syrup coating.
• 4- Coloring
• Color coatings usually consist of thin sucrose syrup containing
the requisite coloring materials. (water-soluble dyes or water-
insoluble pigments may be used) This step must be done into a
clean pan deprived of any residues from the previous
operations.
• 5- Polishing
• After the coloring step, the tablet surfaces tend to be smooth
but somewhat dull in appearance. To achieve glossy finish,
final stage involving application of waxes (beeswax carnuba
wax) is employed.
• 6- Printing
• Different tablets could be identified by manufacturer'
logo,product name, dosage strength or other appropriate
code.For sugar-coated tablets, such identification could be
only achieved by printing process using special edible inks.
 Example of sugar coated tablets
Brufen® POM
• Available in 200mg and 400mg
strength

Premarin® POM
• Conjugated oestrogens 625mcg
(maroon) and 1.25mcg (yellow)

Colofac ® P
• Mebeverine hydrochloride
100mg Round, white, sugar
coated

Kalms ® GSL
• 45mg Hops powder,90mg
Gentian powdered extract, and
135mg Valerian powdered
extract
 Summary of Polymers used in pharmaceutical
formulations as coating materials.
Polymer Trade name Application
Shellac EmCoat 120 N  Enteric Coatings
Marcoat 125  Taste/Odor Masking

Cellulose acetate Aquacoat CPD®  Enteric Coatings

Sepifilm™ LP  Taste masking
Klucel®  Sustained release coating
Aquacoat® ECD  Sub coat moisture and barrier
Metolose® sealant pellet coating
Polyvinylacetate phthalate Sureteric®  Enteric Coatings

Methacrylate Eudragit®  Enteric Coatings

 Sustained Release Coatings
 Taste Masking
 Moisture protection
 Rapidly disintegrating Films
3- Compression Compression-coating of tablets
Although less popular, it gained increased interest in recent years
for creating modified-released products involves the compaction of
granular materials around preformed tablet core using specially
designed tableting equipment. Compression coating is a dry
process.
 TABLET DEFECTS

 STICKING AND PICKING

 ROUGHNESS
 ORANGE PEEL EFFECTS
 BRIDGING AND FILLING
 BLISTERING
 HAZING/DULL FILM
 COLOR VARIATION
 CRACKING
Coating Problems
• picking/chipping

• roughness

• sticking

• film cracking/peeling
• BRIDGING & FILLING

• ORANGE PEEL EFFECT

Advances in tablet coating
 SPECIALIZED COATING TECHNIQUICS

 DIP-COATING
• In this, cores to be coated are a held in a suitable device eg: baskets
• Dipped into coating solution and then dried taking care to prevent
adherence to one another.
• For obtaining more perfect or heavier coats the dipping and drying
steps may be repeated several times one after another.
• Several dipping arrangements are obtainable, amongst them the
sophisticated devices comprise tiny suction tubes, which hold the
individual tablets apart until drying is accomplished.
• Before proceeding to coat additional tablets or begin recoating cycles.
 SPECIALIZED TECHNIQUICS (continue…)
 ELECTROSTATIC-COATING
• Electrostatic coating is employed for applying films of electro-
conductive materials.
• In this, an ionic charge is imparted to the core and an opposite charge
to the coating material. This technology ensures thin, continuous and
electronically perfected film to the surface.
 SPECIALIZED TECHNIQUICS (continue…)

 LAMINATED-COATING

Laminated coating provides multiple layers for incorporation of

medicament; for example
• Repeat-action tablet, here a portion of the drug is kept in outer lamella
or coating
• Enteric tablet, here one drug could be made available for gastric
absorption while another for release in intestine
• Buccal-swallow tablet, this could first be administered sublingually,
and upon a signal, such as release of flavour from the inner core, the
same may be swallowed as a normal peroral tablet.
 SPECIALIZED TECHNIQUICS (continue…)

 VACCUM FILM-COATING

 This employs a specially designed baffled pan, which is water-jacketed

and could be sealed to achieve vacuum.
 Tablets are placed in the sealed pan, the vacuum is applied and the
coating material is introduced through airless hydraulic spray system.
Since the pan is completely sealed.
 Organic solvents could be effectively used with minimal environmental
or safety concern.
 ADVANCED TECHNIQUICS

 SUPERCELL-COATING

 Supercell coating technology is an invention of Niro Pharma,

which uses a small modular design where tablets are coated in
batches ranging from 30 to 40 grams, and which is amenable to
linearly scale up to the production capacities.

 In this, typically tablets are coated with coating spray in the

same direction as the drying gas, hence, resulting in a more
efficient process.
ADVANCED TECHNIQUICS

 SUPERCELL-COATING (continue…)
 DRYCOATING
• Dry coating avoids the use of water or, at least, allows it to be
reduced to very small amounts with respect to the coating
material, thus overcoming the need for time- and energy-
consuming drying phases, as well as possible drug stability
issues.

• In this technology, powdered coating materials are directly

coated onto solid dosage forms without using any solvent, and
then heated and cured to form a coat.
CURRENT DRY COATING TECHNOLOGIES

• Plasticizer-dry-coating
• Electrostatic-dry-coating
• Heat-dry-coating
• Plasticizer-electrostatic-heat-dry-coating
 PLASTICIZER DRY COATING

Film formation in the plasticizer-dry-coating

The film formation is the combined response of improved viscous flow

and particle deformation resulted from plasticizer and heat.

Applications - Both tablets and pellets can be coated.

Limitations

- Coat thickness increases with increasing plasticizer concentration.

- However,surplus plasticizer leads to very soft or sticky films.
 ELECTROSTATIC-DRY-COATING

Schematic diagram of: (a) an electrostatic coating apparatus for solid dosage
forms. (10) tablet feeding chute; (12, 12) rotary drum; (16, 16) electrostatic
spraying gun; (18, 18) tray to hold particles; (20, 20) infrared ray heater; (22)
tablet collection chute; (A) preconditioning station; (B) coating station; (C)
Applications

• This special design aims at making every tablet effectively

grounded, and directing and restricting the charged particles
onto the tablet surface without spraying onto the surrounding,
by which the coating efficiency is greatly improved.

• Moreover, the two sides of a tablet may be coated with

different color or different formulation.

Drawbacks

• This apparatus was found unable to focus all charged powder

to the tablets but the drum also received some powder. This is
wasteful of powder and also makes cleaning of the apparatus
time consuming.
 Heat-Dry-Coating

(1) rotating disk; (2) infrared lamp; (3) powder feeder; (4)
temperature probe; (5) coating tablets; (6) glass cover
• The advantages of heat-dry-coating include abandoning
plasticizer for lower Tg film-forming polymers or avoiding
high concentrations of plasticizer because of pre-plasticization.

• However, it is still a challenge for heat-dry-coating technology

to get a smooth, uniform and thick coating only by the help of
heat-based adhesion.
 PLASTICIZER-ELECTROSTATIC-HEAT-DRY-COATING

Coating process comprises the steps

• Positioning pre-heated solid dosage forms in a chamber of a rotatable,
electrically grounded pan coater
• Spraying powdered coating materials and plasticizer on the solid dosage forms
in the pan coater during rotation there of for a pre-selected length of time using
an electrostatic spray gun
• Curing the coated solid dosage forms to form continuous, uniform and flexile
coats.
It is an integration of five kinds of “forces”:
- Softening or melting effects
- Wetting
- Electrostatic attraction forces
- Hydrodynamic force
- Mechanical force.
• These are combined to enhance the adhesion of powdered coating materials to
solid dosage surface.
Applications
• Conventional coating pharmaceutical polymers,such as
Eudragit RS, Eudragit RL, Eudragit L, Eudragit EPO in
combination with standard excipients were successfully coated
onto tablets and beads.

• Produce smooth and uniform coating surfaces with controlled

coating thickness on both larger dosage forms and smaller
ones.

Limitations

Particularly applicable for pharmaceutical coating only with

a single colour.
CONCLUSION
 ADVANTAGES OF TABLET COATING

Enhance palatability, mask unpleasant taste, odour and color of the

API
Increase the stability
Increase the mechanical integrity
Enhance the elegance
Protect the patient
Modify the drug release profile
Avoid the side effects
 REFERENCES

The science and The Theory and

Practice of Pharmacy, Practice of Industrial
Remington Volume 1 Pharmacy by
A. Lachman, 3rd Edition
Pharmaceutical
Dosage forms by
Liberman, Volume 3 websites
www.pubmed.com
www.wikipedia.com
www.google.co
m
 THANK YOU
FOR
YOUR ATTENTION