Tablet Coating

Outline
 INTRODUCTION

 WHY COATING IS REQUIRED?

 COATING TECHNIQUES

 COATING EQUIPMENTS

 COATING DEFECTS

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 Learning objectives
After completing this course, you will be able to:
Know the importance of coating

Describe the different types of coating : sugar, film and

compression coating
Know polymers used for coating purpose

Describe defferent types of coating equpiments

Discuss various defects during tablet coating

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 Introduction

Tablet coating

A process by which a coating material is applied

to the surface of a dosage form in order to confer

specific benefits

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Why Tablet coating is required?

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 Why tablet coating...
 Mask the odor and taste of the drug
 If the drug has bitter taste or unpleasant odor
By coating the core: mask the taste and odor. Example
Aspirin and Quinine

 Film coating eases swallow-ability

 Reduces risk of the tablet sticking in the throat and causing
localised mucosal irritation
 Speeds up oesophageal transit times
 A tablet that is easy to take improves patient
compliance
 Improve attractiveness of the product

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 Why tablet coating...
 Improve physical and chemical stability of the drug
 The core may contain a substance which is unstable in the
presence:
Light
Moisture
Oxygen CO2
2

O2 LIGHT

H20

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 Why tablet coating...
 It helps to modify the drug release profile, e.g. enteric coating,
sustained release coating, etc.

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 Non-functional coat Immediate release

 Provide release of drug at time

various GI sites depending on pH %

Delayed release
(enteric protection)

 Change rate of release of active Time

e.g. control rate of active release %
over 24 hours Extended release

time
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 Why tablet coating...
 Coating help to improve processing

 Increase packaging speed

 Reduces damage during the packaging process

 Printing efficiency and clarity

 Product identification

 Reduces operator exposure to active substances

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 Tablet coating processes

The most common process are:

Film coating

Sugar coating

Compression coating

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 FILM COATING
Modern approach to coat 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, whereby a

polymer based coating is applied to the substrate

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 FILM COATING...

Classification of film coating based on the

function it renders:

 Protective coating

 Functional coating

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 Protective coating
Thin films of water soluble polymers are often applied
use:
 Taste or odor masking
 Improve the stability of moisture sensitive products
 Better mechanical resistance of the product during handling
 Such protective coatings assure immediate drug release
without retardation
 Cellulose ethers (e.g. hydroxypropyl methylcellulose
(HPMC)),
 Polyvinyl acetate (PVA)
 Polyvinyl pyrrolidone (PVP)

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 Functional coating
Film coatings, which are applied to achieve a certain

desired release profile of the incorporated drug

Two types:

Enteric coatings

Extended release coating

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 Enteric coating
 Enteric coatings are prepared from gastric resistant polymers
 The coatings prepared from such polymers remain intact in acidic
environment, but dissolve readily at the elevated pH of the small
intestine.
 Reason: enteric polymers contain many carboxylic acid groups
STOMACH
Polymers: unionise at low pH► remain insoluble
LOW
pH Ionisation of acidic
pH functional groups of
the polymer

HIGH
Polymer: swells (becomes soluble) ►release
SMALL INTESTINE the drug for absorption
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 Enteric coating...
Aims of Enteric protection: The ideal properties of
enteric coated material :
 To mask taste or odour
• Permeable to intestinal fluid
 Protection of API, from the
acidic environment of the • Compatibility with coating
stomach solution and drug
• Formation of continuous film
 Protection from local irritation
of the stomach mucosa
• Nontoxic and cheap
 Release of API in specific target
area within GIT • Resistance to gastric fluids

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 Enteric coating...
Polymers used for enteric coating purpose

 Shellac, a natural polymer (secretion of the insect Laccifer

laccause) : not popular now a days

 Cellulose acetate phthalate (CAP)

 Polyvinyl acetate phthalate (PVAP)

 Hydroxypropyl methylcellulose phthalate (HPMCP)

 Methacrylate copolymers (e.g. Eudragit®L and S): the most widely

used polymers currently

 Methacrylic acid copolymers require a lower amount of polymer
compared to cellulose derivatives which usually require higher
amounts of polymer to achieve the same core protection as the
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former
 Extended release coatings
 Extended release coating are used to provide a sustained action by
a controlled release over time

 Polymers for extended release are in general insoluble in water

over the entire pH-range
 The drug release is thus controlled by diffusion through
 The hydrated polymer
 cracks or water-filled pores

 Polymers for extended release:

Cellulose acetate, Ethylcellulose
Combinations of ethylcellulose with water-soluble or enteric polymers

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 FORMULATION PARAMETERS

Film coating solution containing the following

components:

Polymer/film-former
Plasticizer
Colorant
Solvent

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 Polymer for film coating

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 Ideal characteristics of a film coating polymer

Solubility

For conventional film coating the polymer should have good

solubility in aqueous fluids to facilitate the dissolution of the API

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
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 Ideal characteristics…
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 vapor or other atmospheric gases. These
properties vary widely between the individual polymers
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 Ideal characteristics…
Mechanical properties
Polymer chosen for a film coat formulation must be:

One with adequate strength to withstand the impact and

abrasion encountered in normal handling.
 Insufficient coating strength will be demonstrated by the
development of cracks and other imperfections in the coating

It should be mentioned that the polymer chosen must also

comply with the relevant regulatory and pharmacopoeial
requirements current in the intended marketing area
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 Formulation parameters…
Plasticizers
Help to increase film flexibility

Plasticizers function by weakening the intermolecular

attractions between the polymer chains

Concentration (0.5-2.0 %)

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 Formulation parameters…
Colorants
 Colorants for film coating are having, in more or less amount,
property of opacifiers
 Give protection to active ingredients in presence of light
 Concentration (2.5-8%)

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 Formulation parameters…
Solvents
Film coating is classified into two based on the
type of solvent used during the process:

Organic (non-aqueous) coating

Aqueous coating

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 Organic (non-aqueous) coating
Film coating in the early 1950s was performed by applying
the polymers dissolved in organic solvents

The use of such polymer solutions has several advantages:

Highly reduced processing time, due to the rapid evaporation of

the solvent

Possibility to prepare thin, smooth continuous coatings

Water-free process

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 Organic coating…

Coating with organic polymer solutions however

decreased in popularity due to

Toxic

Explosive

Fire hazard
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 Aqueous coating
a. Solutions
Pre-requirement: water soluble polymers
Major application: For protective coatings

b. Dispersions
Pre-requirement: water-insoluble polymers
Size of the polymer particles is in the colloidal range(<1μm) ►assure
stability on storage without sedimentation

► low viscosity film

Application: For functional coating

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 Coating process

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 Coating process parameters

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 Coating process parameters
There are numerous coating parameters
that need to be optimized and controlled
for successful coating process:

Spray rate (coating solution flow rate]

Atomizing air pressure
Inlet air temperature
Rotating pan speed

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 Coating equipments

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 Coating equipments…

Most commonly used equipments

are:

The standard coating pan

Perforated coating pan
Air suspension coaters
 The Fluidized bed coater

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 The standard coating pan

 The pan coating system is generically composed of a metal pan

(drum) into which the tablets are placed and that may be rotated
at a range of speeds.

 The coating solution is sprayed on to the surface of the tablets

within the pan whilst the drum is rotated.

 Simultaneously warm air is passed over the surface of the tablets

to facilitate the evaporation of the solvent in which the coating
material has been dissolved.

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 The standard coating…

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 The standard coating…
Advantage:
The systems consumed little air and energy
The smooth pan surface is easy to clean
Application
neither systems
Sugar coatings
require high
volumes of air
Organic solvent-based coatings

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 The standard coating…
Disadvantage
 Not suitable for applying aqueous coatings which require high
drying efficiency

Limitations in both A dramatic

drying and mixing increase in
capabilities processing times

Substantially compromising product

quality and long-term stability

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 The perforated coating pan
 Hence, FOCUS is on the IMPLEMENTATION OF PERFORATED PANS
to improve the air transport in the core bed and consequently to
increase the mixing and drying efficiency

 In a typical film coating operation with a perforated pan, spray

guns apply the coating to the product while the pan rotates,
exposing each side of the product to promote coating uniformity

 At the same time, air enters the pan enclosure, typically from the
45-degree position (upper right) and flows diagonally, passing
through the product bed and thus drying the coating.

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 The perforated coating…
 The humid air that results then exits the pan through the
perforations in the pan’s circumference, often at the 225-degree
position (lower left)

 Tablet coating systems with perforated pans use large volumes of

air for high-efficiency drying and provide repeatable results
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 The perforated coating…

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 The Fluidized bed coater
 Principle: if a gas is allowed to flow through a bed of particulate
solids at velocity greater than the settling velocity of the
particles, the solids get partially suspended in the stream of
upward moving gas

 The resultant mixture of solids and gas behave like a liquid and
thus rightly solids are called Fluidized.

 The solid particles are continually in a random boiling motion so

that each fluidized particle is surrounded by the gas stream for
efficient drying or coating purpose

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 Types of Fluidized bed coater

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 Sugar coating
 It involves the application of sugar solution with color for several
times to give - UNIFORM AND ELEGANT FILM.
 Description of tablets: Smooth, rounded and polished to a high
gloss
 Process: Multistage Process involving 6 separate operations

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 Sugar coating...
Multistage process
1. Sealing tablet core
• Application of a water impermeable polymer such as
Shellac, cellulose acetate phthalate and polyvinyl acetate
phthalate
• The seal coat provides a moisture barrier which protects
the core from moisture, increasing its shelf life
2. Sub coating
• Subcoating is the actual start of the sugar coating process
and provides the rapid buildup necessary to round up the
tablet edge
• 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 thick sucrose syrup
• Pre-requsite for colour coating
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 Sugar coating...
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

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 Major difference between sugar and film coating
Features Sugar coating Film coating
Tablet
Apperance Rounded with high degree of Retain contour of original core.
polish Not as shine as sugar coat

Weight increase due 30 -50% 2-3%

to coating materials
Logo or break lines Not possible Possible
Other solid dosage Coating possible but little Coating of multiparticulates
forms industrial importance very important in modified
realease form

Process
Stages Multistage process Usually single stage
Coating time Eight hours 1.5 – 2 hrs
Functional coating Not usually possible appart from Easily adaptable for controlled
protective coating release
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 Sugar coating...
ADVANTAGES
• It prevents unpleasant odour
• Give sweet taste to tablet by masking bitter taste
• Highly elegant and glossed tablets are obtained

DISADVANTAGES
Skilled manipulative process
Long and vigorous
Operator must be highly skilled for such coating

Expensive
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 Compression coating- Reading assignment

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 COATING DEFECT

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 Summary of coating defects

Cause- over-wet tablets stick together and pull film off surface
as they move apart

Remedy- decreasing spraying rate

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 Summary of coating defects...

Remedy- alter suspension preparation to ensure pigment

aggregates are dispersed.
-Replace dyes with pigments
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 Summary of coating defects..

Remedy- Increase plasticizer concentration.

- Use stronger polymer
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 Summary of coating defects..

Remedy- Reduce solid content of coating suspension.

- Reduce drying temperature
- Reduce viscosity of polymer

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 Thank you!

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