* Tablet coating is the application of a coating material to

the exterior of a tablet with the intention of conferring

* 1
* Cover the unpleasant taste, odor and color.
* Physical and chemical protection in medicine from
environment (light, moisture, and air).
* Control of drug release as in enteric coating or sustained
release or more usually to coated multi particulates.
* To protect drug from the gastric environment of the
stomach with an acid-resistant enteric coating.
* Improve the appearance of tablets.
* Assist and facilitate the identification of drug.
* Easing the process of blistering.

* 2
* There are three primary components involved in tablet
coating:
* 1. Tablet properties.
* 2. Coating process. → Coating equipment. → Parameters of
coating process. → Facility and ancillary equipment. →
Automation in coating process.
* 3. Coating composition.
* Various kinds of tablet coating
* Sugar coating
* Film coating
* Enteric coating
* Press coating

* 3
* Various kinds of tablet coating
* Sugar coating
* Film coating
* Enteric coating
* Press coating

*
4
*These are compressed tablets that have been coated with
concentrated sugar solution to improve patient‟s compliance, increase
aesthetic appeal, mask objectionable tastes or odours, increase
stability and/or modify the release of therapeutic agent(s).
* Sugar coating was once quite common but lost commercial appeal
due to the time and expertise required in the coating process, the
increase in size and weight of coated tablets, high cost of process
validation and shipping.
*Also, they permit separation of incompatible ingredients between
coating and core, and this fact has been widely utilized in preparing
many multivitamin and multivitamin mineral combinations.
* Time consuming and requires skilled labour.
* Examples of sugar-coated tablets include Reasulf tablets – dried
ferrous sulphate BP 200mg (Reagan Remedies Ltd.), Advil – Ibuprofen
tablet BP 200mg (Pfizer Consumer Healthcare), Ebu-200 – Ibuprofen
tablet BP 200mg

* 5
* Sugar coating is a multistage process and can be divided into the
following steps:
* Sealing of the tablet cores
* Sub coating
* Smoothing
* Coloring
* Polishing
* Sealing/Water proofing: Provides a moisture
* barrier and harden the tablet surface.
* e.g. :Shellac, Zine, Cellulose acetate phthalate (CAP), Polyvinyl
acetate phthalate, Hyroxylpropylcellulose, Hyroxypropylmet
hylcellulose etc

6
*
* Subcoating: Causes a rapid build up to round off the tablet
edges.
* Generally two methods are used for subcoating:
* 1)The application of gum based solution followed by dusting
with powder and then drying. This routine is repeated until the
desired shape is achieved.
* 2)The application of a suspension of dry powder in gum/sucrose
solution followed by drying.
* III. Grossing/Smoothing: It is specifically for smoothing and filing
the irregularity on the surface generated during subcoating. It
also increases the tablet size to a predetermined dimension.
* IV. Colouring: Gives the tablet its colour and finished size.

7
*
* F/C tablets are conventional tablets coated with a thin layer of
polymer (e.g., hydroxypropyl methylcellulose, hydroxypropyl
cellulose) or a mixture of polymers (e.g., Eudragit E100) capable of
forming a skin-like film.
* The film is usually coloured and also impacts the same general
characteristics as sugar coating with the added advantage of being
more durable, less bulky, and less time-consuming to apply.
* By its composition, the coating is designed to break and expose the
core tablet at the desired location in the gastrointestinal tract.
* Coating compositions contains one or more polymers, which usually
includes a plasticizer for the polymer and possibly a surfactant to
facilitate spreading, in solution from in a organic solvent.
* After coating there is little increase in wt. of tablet compared to SC.
* CR tablets can be prepared by film coating. less aesthetic appeal as
compared to sugar coated tablet.(SC).
* Ex; Curefenac 100 – Diclofenac potassium USP , Valsartan 320mg, etc

*
8
* Involves spraying a solution of polymer + pigments
* plasticizers on to a rotated, mixed tablet bed forms a thin,
uniform film on tablet surface.
* Coating suspension formulation:
* Typically this comprises:
* Polymer
* Plasticizer
* Colourants
* Solvent.
*

* 9
* Solubility: For conventional film coating the polymer should
have good solubility in aqueous fluids to facilitate the dissolution
of the active ingredient from the finished dosage form. However,
where a modified-release action is required then a polymer
system of low water solubility or permeability will be chosen.
* Viscosity: Polymers should have a low viscosity for a given
concentration. This will permit the easy, trouble- free spraying
of their solutions in industrial film coating equipment.
* Permeability: Film coating can be used to optimize the shelf-
life of a tablet preparation, as some polymers are efficient
barriers against the permeability of water vapour or other
atmospheric gases. These properties vary widely between the
individual polymers.

* 10
* Plasticizers are generally added to film coating formulations to
modify the physical properties of the polymer to make it more
usable. One important property is their ability to decrease film
brittleness.
* Examples of plasticizers are:
* Polyols, such as polyethylene glycol 400
* Organic esters, such as diethyl phthalate
* Oils/glycerides, such as fractionated coconut oil. In general,
only water-miscible plasticizers can be used for aqueous-based
spray systems.

11
*
* Any permitted colourants in a film coat formula are invariably
water-insoluble colours (pigments). Pigments have certain
advantages over water-soluble colours: they tend to be more
chemically stable towards light, provide better opacity and
covering power, and optimize the impermeability of a given film
to water vapour.
* Examples of colourants are:
* Iron oxide pigments
* Titanium dioxide
* Aluminium Lakes.

12
*
* Modern techniques now rely on water as a polymer solvent because
of the significant drawbacks that readily became apparent with the
use of organic solvents.
* The disadvantages of organic solvents for the process:
* 1. Environmental: the venting of untreated organic solvent vapor
into the atmosphere is
* ecologically unacceptable, and efficient solvent vapor removal
from gaseous effluent is expensive.
* Safety: organic solvents provide explosion, fire and toxic hazards
to plant operators.
* Financial: the use of organic solvents necessitates the building of
flame- and explosion-proof facilities. Ingredient cost is also
comparatively high, and the associated costs of storage and quality
control must also be taken in to consideration.

*
13
* Enteric-coated tablets are compressed tablets that have delayed-
release properties.
* They are coated with polymeric substances (such as cellulose
acetate phthalate/cellulose acetate butyrate;
hydroxypropylmethylcellulose succinate; and methacrylic acid
copolymers)
* They resist solution in gastric fluid but disintegrate and allow drug
dissolution and absorption in the intestine.
* Primarily employed when the drug substance is inactivated or
destroyed by gastric acid or is particularly irritating to the gastric
mucosa or when bypass of the stomach substantially enhances drug
absorption.
* All enteric coated tablets which remain intact in the stomach but
release drug in the upper intestine. Not all delayed-action tablets
are enteric or are intended to produce the enteric effect.
* Ex. Diclofenac sodium delayed-release tablet, Ecotrin tablets
&caplets
* 14
* This technique is used to protect the tablet core from
disintegration in the acid environment of the stomach for one
or more of the following reasons:
* Prevention of acid attack on active constituents unstable at
low pH.
* To protect the stomach from the irritant effect of certain
drugs.
* To facilitate absorption of a drug that is preferentially
absorbed distal to the stomach.
* Polymer are insoluble in aqueous media at low pH, but as the
pH rises they experience a sharp, well defined increase in
solubility at a specific pH.

* 15
* Use of compression to form coat around a pre-formed core.

* Fig: Press coated tablet

* 16
 FEATURES FILM COATING SUGAR COATING
Appearance Retain contour of original Rounded with high degree
core. Usually not as shiny as of polish
sugar coat type

Weight increase 2-3% 30-50%

Logo or „break lines‟ Possible Not Possible

Process stages Usually single stage Multistage process

Typical batch coating 1.5 to 2.0 Hours Eight hours but easily
time longer

Functional coatings Easily adaptable for Not usually possible apart

* 17
Fig : Coating Machine
COATING MACHINE
Fig: Typical Spry Gun

18
* Check that coating Suite are properly cleaned & dry.
* All correct documents are available
* Check for QC approved (Green) status label and the re-testing
date on the container.
* Check that all balance are calibrated.
* Check that correct dispensed RM is available
* Check the gross weight of the container to be dispensed and the
quantity matches with the labeled quantity.
* Monitor that during material handling the operator should wear
mask and gloves.
* Monitor every step of coating.
* Any deviation during coating process should be immediately take
initiative to resolve.

* 19
 IMPORTANT PROCESSING PARAMETERS
* Inlet & Outlet of bed temperatures.
* Relative humidity.
* Atomization air pressure.
* Pan speed.
* Liquid spray rate.
* Gun nozzles check.
* Spray gun calibration.
* Solid content of coating solution.
* Nozzle-to-bed distance.
* Droplet size.
* Drying time

* 20
* Check the appearance of coated tablets paying attention to the
* Color variation
* Sticking
* Twinning
* Cracking
* Capping
* Lamination
* Broken tablet
* Orange peel
* Fibers
* Black spot
* Oil spot, etc.

21 *
* Sticking and picking
* Roughness
* Orange peel
* Color variation
* Cracking
* Twinning
* Capping
* Lamination
* Blistering
* Catering

* 22
* Sticking and picking: Over wetting or excessive film thickness
causes tablets to stick each other or to the coating pan. - On
drying at the point of contact, a piece of film may remain adhere
to pan or tablet. -
* Giving “picked” appearances to the tablet surface. -
* Resulting in a small exposed area of the core.

23
* Roughness: A rough or gritty surface observed when the coating is
applied by spray.
* Causes : Some of the droplets may dry too rapidly before reaching
the tablet bed and deposits on tablet surface. On tablet surface
spray- dried particles of finely divided droplets of coating solution.
Surface roughness also increases with pigment concentration and
polymer concentration in the coating solution.
*

24
* Orange Peel: Inadequate spreading of coating solution before
drying causes a bumpy or Orange –peel effects on the coating.
* Causes :Indicates that spresding is impaired by rapid rate of
drying or by high solution viscosity.
*

*
25
* Colour variation: Colour variation Problem caused by process
conditions or the formulation Improper mixing, uneven spray
pattern and insufficient coating may results in colour variation. The
migration of soluble dyes, plasticizer and other additives give the
coating a mottled or spotted appearance.
*

26
* Cracking : Cracking occurs if internal stresses in the film exceed
the tensile strength of the film. The tensile strength of the film can
be increased by using higher molecular –weight polymers or polymer
blends.
* Remedies: Adjusting the plasticizer types and concentration can
minimize internal stresses Also adjusting the pigment types and
concentration can minimize internal stresses
* Blistering : Evaporation of solvents from the core in the
* oven. And effect of high temperature on the
* strength, elasticity and adhesion of the film may results
* in blistering.
* Remedies :Controlled drying conditions.

27
 * Twinning: Two or more tablets are stick together.
* Unbalancing the pan speed.
* Hi spray rate.
*

28
* Film-coated tablets must comply with the uniformity of mass test
unless otherwise justified and authorized
* Film-coated tablets comply with the disintegration test.
* Film-coated tablets should display
* An even coverage of film and colour.
* No abiasion of tablet edges or crowns.
* Logos and break lines should be distinct and not filled in.
* The tablet must also be within specifications and any relevant
compendial requirements.
* Tablets must comply with finished product specifications and any
appropriate compendial requirements.
* Sugar-coated tablets should ideally be of a perfectly smooth
rounded contour with even colour coverage. Most manufacturers
take advantage of the aethetic appeal of a sugar-coated tablet
and polish to a high gloss.
* Any printing should be distinct, with
29
no smudging or broken
print.
* Store the coated tablets in plastic drum with double
polythene bags with silica gel between the bags & close
the poly bags and fix-up lids of the plastic drum properly.
Label the plastic drum with Product name, Batch No,
Gross tare & Net weight ,Drum number & signature of the
authorized person.
*

30