Tablet coating:

• It is the application of a coating composition to a moving bed of

tablets with the concurrent use of heated air to facilitate evaporation
of the solvent.
Advantages of tablet coating:
1. mask unpleasant taste, odour and colour of the API.
2. Increase the stability. ( protection from environment)
3. Increase the mechanical integrity. ( strengthen)
4. Enhance the elegance.
5. Modify the drug release profile. ( sustaind release)
6. Avoid the side effects. ( enteric coating)
7 Reduces friction and increases packaging rate.
8 Enhance permeability due to target delivery and high
conc at site of absorption
9 To incorporate another drug or formula adjuvant in the
coating to avoid chemical incompatibilities or to provide
sequential drug release. ( just like layered tablet)
10 In a limited number of instances, tablets are coated to
prevent potentially harmful physical contact with the
drug substance and the effects of drug absorption.
For example, Proscar tablets (finasteride, Merck) are
coated for just this reason.
Disadvantages of tablet coating:
1. Relatively high cost.
2. Time consuming process.
3. Requires the expertise of highly skilled technician.
Types of tablet coating:
1. Sugar coating
2. Film coating
3. Enteric coating
4. Fluid bed coating/ air suspension coating
5. Compressed coating
1. SUGAR COATING:

It is a multistep process.
• In suitable sugar coating equipment, the tablet cores are successively
treated with aqueous sucrose solutions.
• Water evaporates from the syrup leaving thick film.
• Sugar coats are often shiny and highly coloured.
Advantages:
• Constituent raw materials are widely accepted.
• No complex equipment are required.
• For high humidity climates, it offers stability advantage over film
coated tablets.
Disadvantages:
• Time consuming process.
• Logo or break lines not possible.
• 30-50% weight increase due to coating material.
Sugar coating process involves following steps:
1. water proofing and Sealing
2. Subcoating
3. Smoothing
4. Colouring
5. Printing
6. Polishing
1 Waterproofing and Sealing Coats:
• For tablets containing components that may be adversely
affected by moisture, one or more coats of a waterproofing
substance, such as shellac, are applied to the compressed
tablets before the subcoating application.
• The waterproofing solution (usually alcoholic) is gently
poured or sprayed on the compressed tablets rotating in the
coating pans.
• Warm air is blown into the pan during the coating to fasten
the drying and to prevent tablets from sticking together.
2 Subcoating
• After the tablets are waterproofed , three to five subcoats of a sugar-
based syrup are applied.
• This bonds the sugar coating to the tablet and provides rounding. The
sucrose and water syrup also contains gelatin, acacia, or PVP to
enhance coating.
• When the tablets are partially dry, they are sprinkled with a dusting
powder, usually a mixture of powdered sugar and starch but
sometimes talc, acacia, or precipitated chalk as well.
• Warm air is applied to the rolling tablets, and when they are dry, the
process is repeated until the tablets are of the desired shape and size.
• The subcoated tablets are then scooped out of the coating pan, and
the excess powder is removed by gently shaking the tablets on a cloth
screen.
3 Smoothing:
• After the tablets are subcoated, 5 to 10 additional coatings of a thick
syrup are applied to complete the rounding and smooth the coatings.
• This syrup is sucrose based, with or without additional components
such as starch and calcium carbonate.
• As the syrup is applied, the operator moves his or her hand in
opposite direction of rotation through the rolling tablets to distribute
the syrup and to prevent the tablets from sticking to one another.
• A dusting powder is often used between syrup applications.
• Warm air is applied to hasten the drying time of each coat.
4 Colouring:
• It usually consists of thin sucrose syrup containing the required
coloring material (water soluble dyes or water insoluble pigments)
• Water insoluble pigments along with the opacifier such as titanium
dioxide develop desired colour more rapidly, thus resulting in thinner
color coat.
• This step is performed in a clean pan, free from previous coating
materials
5 Imprinting:
• Solid dosage forms may be passed through a special imprinting
machine to impart identification codes and other distinctive symbols.
• By FDA regulation, all solid dosage forms for human consumption,
including both prescription only and over-the-counter ( OTC) drug
products, must be imprinted with product-specific identification
codes. Except those used in clinical investigations or
extemporaneously compounded in pharmacy, radiopharmaceutical
drug products (Iodine-131), and products that, because of their size,
shape, texture, or other physical characteristics, make imprinting
technologically not feasible.
• Technically, the imprint may be debossed, embossed, engraved, or
printed on the surface with ink. Debossed means imprinted with a
mark below the surface, embossed means imprinted with a mark
raised above the surface, and engraved means imprinted with a code
that is cut into the surface during production.
6 Polishing
• Coated tablets may be polished in several ways.
1. Special drum-shaped pans or ordinary coating pans lined with
canvas or other cloth impregnated with carnauba wax and/or
beeswax may be used to polish tablets as they tumble in the pan.
2. pieces of wax may be placed in a polishing pan, and the tablets
allowed to tumble over the wax until the desired sheen is attained.
3. A third method is light spraying of the tablets with wax dissolved in
a nonaqueous solvent. Two or three coats of wax may be applied,
depending upon the desired gloss. After each coat has been
applied, the addition of a small amount of talc to the tumbling
tablets contributes to their high luster.
2. FILM COATING:
• The film-coating process forms a thin, skin-tight coating of a plastic-
like material over the compressed tablet, having essentially the same
weight, shape, and size as the originally compressed tablet.
• Also, the coating is thin enough to reveal any identifying monograms
embossed in the tablet during compression by the tablet punches.
• Film-coated tablets also are far more resistant to destruction by
abrasion than are sugarcoated tablets. However, like sugarcoated
tablets, the coating may be colored to make the tablets attractive and
distinctive.
Advantages
• The film coating process of today was introduced in the early 1950s as
an improvement on the traditional sugar-coating process. The process
has proved successful as a result of the many advantages offered,
including but not limited to:
• Substantial reduction in the quantity of coating applied.
• Minimal weight increase.
• Increased process efficiency and output.
• Significant reduction in processing times
• Increased flexibility in formulations as a result of the availability of
suitable film forming polymers.
Disadvantages:
• These concerns arise from the fact that most solvents used in film
coating formulation can cause health and environmental hazards.
Fortunately, significant advancement in process technology and
equipment design, have facilitated the introduction of aqueous-based
coating formulations. The result is that less volatile, and safer,
solvents such as water can be easily accommodated by the process.
Mechanism of film formation:
• In the wet state, the polymer is present as a no. of discrete particles,
and these have to come together in close contact, deform, coalesce
and ultimately fuse together to form a discrete film.
Coating solutions:
• Tablets are film coated by application or spraying of the coating
solution on the tablets in ordinary coating pans.
Coating using organic solvents:
The volatility of organic solvent enables the film to adhere quickly to
the surface of the tablets but they are expensive and are not
environmental friendly .
Coating using aqueous solvents:
• Pharmaceutical manufacturers generally favor the use of aqueous
solutions. however, this process is time taking due to slow
evaporation of the water based solutions as compared to the volatile
organic solvent–based solutions.
The nonaqueous coating solutions
The nonaqueous solutions contain the following types of materials to
provide the desired coating to the tablets:
1. A film forming polymers capable of producing smooth, thin films
which are reproducible under conventional coating conditions and
applicable to a variety of tablet shapes.
Example: cellulose acetate phthalate
2. An alloying substance providing water solubility or permeability
to the film to ensure penetration by body fluids and therapeutic
availability of the drug.
Example: polyethylene glycol
3 A plasticizer to produce flexibility and elasticity of the coating and thus
provide durability.
Example: castor oil
4. A surfactant is added
• to enhance spreadability of the film during application.
• to Emulsify water-insoluble plasticizers
• To Improve substrate wettability
• To Stabilize suspensions
• Example: polyoxyethylene sorbitan derivatives

4. Opaquants and colorants to make the appearance of the coated tablets

handsome and distinctive.
Examples: opaquant, titanium dioxide;
colorant, FD&C or D&C dyes
6 Sweeteners, flavors, and aromas to enhance the acceptability of
the tablet by the patient.
Examples: sweeteners, saccharin; flavors and aromas, vanillin
7 A glossant to provide luster to the tablets without a separate
polishing operation.
Example: beeswax
8 A volatile solvent to allow the spread of the other components
over the tablets while allowing rapid evaporation to permit an
effective yet speedy operation.
Example: alcohol mixed with acetone
Additionally, some film coatings may also contain
• preservative/ antimicrobials (e.g., carbamates, alkylisothiazloinone,
benzothiazoles etc.),
• adhesion enhancers (such as polydextrose, maltodextrin, and
lactose),
• antifoaming agents (e.g., caster oil, dimethylpolysiloxane),
• antioxidants (e.g., oximes, phenols etc.),
• In rare instances, the film coat itself may contain active drug
substance.
Water based coating solutions
One commercial water-based colloidal coating dispersion called
Aquacoat contains a 30% ethyl cellulose pseudolatex.
• Pseudolatex colloidal dispersions have a high solid content for greater
coating ability and a relatively low viscosity (due to particle size less
than 1 micron).
• The low viscosity allows less water to be used in the coating
dispersion, leads to
a) less evaporation time
b) reducing the chances of interference of water with tablet
formulation.
c) the low viscosity permits greater coat penetration into the
crevices ( cracks) of monogrammed or scored tablets.
Contents of aqueous film coating solutions:
• A typical aqueous film-coating formulation contains the following :
1. Film-forming polymer (7% to 18%).
A film former is capable of producing smooth thin films reproducible
under the prescribed coating conditions.
Examples: cellulose ether polymers such as hydroxypropyl
methylcellulose, hydroxypropylcellulose, and methylcellulose
2. Plasticizer (0.5% to 2.0%).
Plasticizers are relatively low molecular weight materials which are
added to film-coating formulations to modify the physical properties of
polymers. This reaction results in increased film flexibility.
Examples: glycerin, propylene glycol, polyethylene glycol, diethyl
phthalate, and dibutyl subacetate
3. Colorant and opacifier (2.5% to 8%).
Colorants provide an elegant appearance. They may be soluble in the
solvent systems or suspended as insoluble powders. Ex: Iron oxide
pigment,
Opaquant –extenders: These are fine inorganic powders used in coating
solution formulation to increase film coverage. e.g. Titanium dioxide.

4. Vehicle (water, to make 100%)

In aquous coating solutions vehicles is water.
Drawbacks of using aqueous coating solutions
• There are some problems of using aqueous film coating,
1. the appearance of small amounts (picking) or larger amounts (peeling) of
film fragments appearing on the tablet surface,
2. roughness of the tablet surface due to failure of spray droplets to
coalesce (orange peel effect),
3. an uneven distribution of color on the tablet surface (mottling),
4. filling-in of the score line or indented logo on the tablet by the film
(bridging),
5. disfiguration of the core tablet when subjected for too long to the
coating solution (tablet erosion).
The cause of each of these problems can be determined and the problem
rectified through appropriate changes in formulation, equipment, technique,
or process
Drawbacks of using aqueous coating solutions
1 PICKING :
Happens when part of film sticks to the pan resulting to some of the
tablet pieces being detached from the core.
Cause:
Over wetting and under drying of tablets by polymer solution causing
tablets to stick to each other and the pan.
2 PEELING:
• Appearance of larger amounts of film fragments appearing on the
tablet surface and coating peels off the tablet during and after coating
process.
• There is uneven , rough irregularities on the surface of a coating film.
3 CRACKING ( SPLITTING)
Tablet cracks in the crown area or splits around the edges ,on the top,
bottom surface of the tablet.
4 ORANGE PEEL EFFECTS (ROUGHNESS):
Roughness of tablet surface due to
I. Poor tablet composition causing it to become soft
II. Too high spray pressure combined with fast spray rate leading to
uneven coating.
III. Inadequate spreading of coating solution before drying causing a
bumpy surface of tablet.
5 MOTTLING:
Unequal distribution of color occurs on a tablet with light or dark spots
standing out in an otherwise uniform surface.
Reasons:
I. Coloured active ingredients used along with white excipients.
II. Dye migrate to the surface of granulation while drying.
III. Improper mixing of a dye specially during direct compression.
IV. Improper mixing of a coloured binding solution
V. Uneven spray pattern.
Remedy:
• Use of appropriate colourant
• Use smaller particle size of APIs and excipients.
• Proper mixing of reduced sized material to prevent segregation.
• Uniform spray.
6 BRIDGING:
Filling in score line or logos
Reason:
• Viscosity of coating solution is too high
• Spray rate is too high
• Plasticizer content is too low
• Spray pressure is not right.
• Remedy:
• Decrease viscosity of coating solution
• Increase plasticizer
• Decrease spray rate
• Adjust spray pressure.
7 TABLET EROSION:
• Tablet absorb too much water during coating application due to
prolong exposure of core to coating solution causing surface to
become softer.
 3. 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.
• Enteric-coated solid dosage forms are intended to pass through the
stomach intact to disintegrate and release their drug content for
absorption along the intestines.
• The design of an enteric coating may be based on the transit time required
for passage to the intestines and may be accomplished through coatings of
sufficient thickness.
• However, usually an enteric coating is based on factors of pH, resisting
dissolution in the highly acid environment of the stomach but yielding to
the less acid environment of the intestine. Some enteric coatings are
designed to dissolve at pH 4.8 and greater.
Aim:
• To mask taste or odour.
• Protection from local irritation of the stomach mucosa.
• Release of active ingredient in specific target site.
• Protection of active ingredients from acidic environment of the
stomach
• Enteric-coating materials may be applied either to whole compressed
tablets or to drug particles or granules used in the fabrication of
tablets or capsules. The coatings may be applied in multiple portions
to build a thick coating or as a thin film coat.
• The coating system may be aqueous or organic solvent based and
effective so long as the coating material resists breakdown in the
gastric fluid.
• Among the materials used in enteric coatings are pharmaceutical
shellac, hydroxypropyl methylcellulose phthalate, polyvinyl acetate
phthalate, diethyl phthalate, and cellulose acetate phthalate.
• Examples of Enteric coated products:

• Enteric Coated Aspirin. Eg. Micropirin 75mg EC tablets.

• Enteric Coated Peppermint oil. Eg. Colpermin.

Fluid Bed or Air Suspension Coating :
• These are high efficient drying systems.
• Fluidization of the tablet mass is achieved in a column shaped
chamber by the upward flow of drying air. The airflow 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 through the
center of the chamber. They then fall towards the chamber wall and
move downward to re-enter the air stream at the bottom of the
chamber.
• Fluid bed coating is spray coating of powders, granules, beads, pellets,
or tablets.
• Principle of operation: With fluid bed coating, particles are fluidized
and the coating fluid is sprayed on and dried. Small droplets and a low
viscosity of the spray medium ensure an even product coating.
Types of fluid bed coating:
1 Bottom spray method:
• In this process, the items to be coated are fed into a vertical cylinder
and are supported by a column of air that enters from the bottom of
the cylinder.
• Within the air stream, the solids rotate both vertically and
horizontally.
• As the coating solution enters the system from the bottom, it is
rapidly applied to the suspended, rotating solids, with rounding coats
being applied in less than an hour with the assistance of warm air
blasts released in the chamber.
• The bottom-spray method is recommended for sustained-release and
enteric-release products.
Bottom spray coating
Top spray method:
• In this type of fluid bed system, the coating solution is sprayed
downward onto the particles to be coated as they are suspended by
air from below.
• This method provides greater capacity, up to 1,500 kg, than the other
air suspension coating methods.
• The top-spray coating method is particularly recommended for taste
masking, enteric release, and barrier films on particles or tablets.
• It is most effective when coatings are applied from aqueous
solutions, latexes, or hot melts .
• Both the top-spray and bottom-spray methods may be employed
using a modified apparatus used for fluid bed granulation.
Top spray coating
Side /Tangential spray method
• A third method, the tangential spray technique, is used in rotary fluid
bed coaters.
• This process is slightly different from the other two fluid bed
processes in the sense that Nozzle is positioned on the side of
product container.
• The tangential method is used for layering coatings and for sustained-
release and enteric-coated products.
Factors affecting coating
Among the variables requiring control to produce the desired and consistent
quality are
1. equipment
2. the method of spraying (e.g., top, bottom, tangential),
3. spray nozzle distance from spraying bed,
4. droplet size,
5. spray rate,
6. spray pressure,
7. volume of the air column,
8. batch size,
9. method and time for drying,
10. air temperature
11. moisture content in the processing compartment.
Process advantages
• Uniform, continuous product coating.
• Aqueous or organic coatings can be applied. Coating and drying takes
place in one machine.
• In terms of Total Containment, the coating process and the filling and
emptying of the machine can be carried out in complete isolation and
without product spreading into the environment.
• When using organic solvents, the process machines can also be made
inert and used with a solvent recovery system.
Compression Coating
• In a manner similar to the preparation of multiple compressed tablets
having an inner core and an outer shell of drug material, core tablets
may be sugarcoated by compression.
• The coating material, in the form of a granulation or powder, is
compressed onto a tablet core of drug with a special tablet press.
• Compression coating is an anhydrous operation and thus may be
safely employed in the coating of tablets containing a drug that is
labile to moisture.
• Compared to sugarcoating using pans, compression coating is more
uniform and uses less coating material, resulting in tablets that are
lighter, smaller, and easier to swallow and less expensive to package
and ship.
• Irrespective of the method used in coating, all tablets are visually or
electronically inspected for physical imperfection.