Coating introduction

and
Quality Control

What is the rationale for coating a

solid dosage form?
Coating of a solid dosage form is often designed to perform a specific function. For
example; protection against moisture, taste masking pH or time controlled release.
Tablets can be easily coated and a variety of products are available on the market.
The rationale for coating pharmaceutical dosage form such as a tablet can be
categorised into three main headings:

Therapy
Technology
Marketing

What is the rationale for coating a

solid dosage form?
Therapy

To minimise irritation of the oesophagus and stomach.

Minimise inactivation in the stomach.

Improve drug effectiveness.

Improve patient compliance e.g. easier to swallow, masks unpleasant taste.

What is the rationale for coating a

solid dosage form?
Technology

Minimise dust formation and contamination with respect to tablets.

Masks batch differences in the appearance of raw materials.

Facilitates their handling on high speed automated filling and packaging

equipment.

Improves drug stability e.g. Protection of active ingredient from

environment such as sunlight, moisture.

What is the rationale for coating a

solid dosage form?
Marketing

Aid sales appeal as improved appearance and

acceptability with respect to gloss and colouration.

Mask unpleasant taste.

Improve product identity.

Main coating processes

1.Film coating

2. Sugar coating

3. Press coating

Sugar coating

Traditionally sugar coatings formed the bulk of coated tablets but today film coatings
are the more modern technology in tablet coating.
Description of tablets: Smooth, rounded and polished to a high gloss.
Process: Multistage process involving 6 separate operations.
1.
2.
3.
4.
5.
6.

Seal tablet core

Sub coating
Smoothing
Colouring
Polishing
Printing

Multistage process
1.

Sealing tablet core- application of a water impermeable polymer such as

Shellac, cellulose acetate phthalate and polyvinyl acetate phthalate, which
protects the core from moisture, increasing its shelf life.

2.

Sub coating -by adding bulking agents such as calcium carbonate or talc in
combination with sucrose solution.

3.

Smoothing process

-remove rough layers formed in step 2 with the

application of sucrose syrup.

4.

Colouring

- for aesthetic purposes often titanium based pigments are

included.

5.

Polishing - effectively polished to give characteristic shine, commonly using

beeswax, carnauba wax.

6.

Printing -indelible ink for characterisation.

COATING PANS

COATING PROCESS

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

Film coating

1.
2.
3.
4.

Modern approach to coating tablets, capsules, or pellets by surrounding them with

a thin layer of polymeric material.
Description of tablets: Shape dictated by contour of original core.
Process: Single stage process, which involves spraying a coating solution
containing the following;
Polymer
Solvent
Plasticizer
Colourant
The solution is sprayed onto a rotating tablet bed followed by drying, which
facilitates the removal of the solvent leaving behind the deposition of thin film of
coating materials around each tablet.

Film coating
Advantages
Produce tablets in a single step process in relatively short
period of time. Process enables functional coatings to be
incorporated into the dosage form.
Disadvantages
There are environmental and safety implications of using
organic solvents as well as their financial expense.

Press coating
Press coating process involves compaction of coating material around a
preformed core. The technique differs from sugar and film coating process.

Advantages
This coating process enables incompatible materials to be formulated
together, such that one chemical or more is placed in the core and the other
(s) in the coating material.

Disadvantages
Formulation and processing of the coating layer requires some care and
relative complexities of the mechanism used in the compressing equipment.

Functional coatings
Functional coatings are coatings, which perform a
pharmaceutical function.
These include;

Enteric coating
Controlled release coating

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.

Examples of enteric coated OTC

products

Enteric coated aspirin E.g. Micropirin

75mg EC tablets

Enteric coated peppermint oil E.g.

Colpermin

Summary of Polymers used in pharmaceutical

formulations as coating materials.
Polymer

Trade name

Application

Shellac

EmCoat 120 N
Marcoat 125

Enteric Coatings
Taste/Odor Masking

Cellulose acetate

Aquacoat CPD
Sepifilm LP
Klucel
Aquacoat ECD
Metolose

Polyvinylacetate phthalate

Sureteric

Methacrylate

Eudragit

Enteric Coatings
Taste masking
Sustained release coating
Sub coat moisture and barrier
sealant pellet coating
Enteric Coatings

Enteric Coatings
Sustained Release Coatings
Taste Masking
Moisture protection
Rapidly disintegrating Films

Tests for coated tablets

General Appearance
Size, shape, and thickness
Organoleptic properties
Film tensile strength
Official and unofficial tests.
Official Tests: Weight variation, disintegration,
drug content.
Non-Official Tests: hardness, friability.

Disintegration specifications for

enteric coated tablets
According to the U.S.P:
1. Put 6 tablets in distilled water for five
minutes to dissolve the coat.
2. Then put in simulated gastric fluid (0.1M
HCL) for one hour.
3. Then put in simulated intestinal fluid for
two hours.

Disintegration specifications for

enteric-coated tablets

According to B.P.
Put 6 tablets in distilled water for five minutes to
dissolve the coat.
Put in simulated gastric fluid for two hours
(emptying time).
Put in phosphate buffer (PH 6.8) for one hour.
If one or two tablets fail to disintegrate repeat on
12 tablets. So 16 tablets should disintegrate. If
more than two tables fail to disintegrate reject
the patch.

Tablet Coating
Adhesion Fixture

This test provides a

quantitative
measure of the adhesion
strength
of the coating to the tablet
surface.
Such a test is useful for
studying
the consequences of
changes in
tablet coating formulation
variables.

Diametral crushing strength of

coated tablet

Tablet hardness testers are used.

This test gives information on the relative
increase in crushing strength provided by
the film and the contribution made by
changes in the film composition.

Temperature and humidity may cause film

defects.

Quantification of film surface roughness,

hardness, & colour uniformity.

Visual inspection is used.

Visual inspection

Blistering: It is local
detachment of film from
the substrate forming
blister.

Chipping: It is defect
where the film becomes
chipped and dented,
usually at the edges of
the tablet.

Visual inspection (continue)

Splitting/Cracking :
It is defect in which the film
either cracks across the crown
of the tablet (cracking) or splits
around the edges of the tablet
(Splitting)

Colour variation:
A defect which involves
variation in colour of the film.

Visual inspection (continue)

Roughness: It is surface
defect resulting in the film
being rough and non
glossy. Appearance is
similar to that of an
orange.

Picking: It is defect
where isolated areas of
film are pulled away from
the surface when the
tablet sticks together and
then part.

Thank You