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Troubleshooting

in Film Coating
MD. ESHRAK -E- ALAHI
TECHNICAL MANAGER
COLORCON BANGLADESH
EMAIL: EALAHI@COLORCON.COM
MOBILE: +880-171-3451832
DATE: SEPTEMBER 24,2011

Critical components of film coating

Troubleshooting

Coating Process and Equipment


Copyright 2006 Colorcon Inc.
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately .

Examples of tablet breakage

Copyright 2006 Colorcon Inc.


The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately .

Tablet breakage
Cause

Solution

Tablets are too soft

Change core formulation

Tablets are too brittle

Change core compression

Tablets cap/laminate

parameters

Poor tablet shape for coating

Change tablet shape

Excessive pan speed

Reduce pan speed

Poor baffle design

Change baffle design

Copyright 2006 Colorcon Inc.


The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately .

Example of tablet twinning

Copyright 2006 Colorcon Inc.


The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately .

Twinning
Cause
Inappropriate tablet shape

Pan speed too low


Spray droplet size too large

Solution
Chose tablet design that

eliminates flat areas

refer tablet core section

Increase pan speed


Increase atomising air pressure

Spray rate too high


Reduce spray rate
Insufficient drying

Increase drying

higher inlet air temperature

higher drying air flow rate

Copyright 2006 Colorcon Inc.


The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately .

Examples of tablet surface erosion

Copyright 2006 Colorcon Inc.


The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately .

Tablet surface erosion


Cause
Hygroscopic tablet core

Solution

Application rate too low/high

Reduce hygroscopic core materials


(e.g. superdisintegrant)

Pan speed too fast

Select appropriate spray rate

Friable tablet core

Decrease pan speed

Low coating film strength

Use tablet punches with deeper

Punch design

concave or double radius shape

Punch wear

Check punches for damage

Logo placement or design

Select Opadry formulation to solve

Low coating suspension solids

problem

Opadry is a trademark of Colorcon Inc.


Copyright 2006 Colorcon Inc.
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately .

Examples of edge erosion

Copyright 2006 Colorcon Inc.


The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately .

Edge erosion
Cause

Solution

Worn tablet tooling

Replace tablet tooling

Sharp edges on tablets

Change tablet shape/design

High core attrition

Change core formulation

Low spray application rates

Select correct application rate

Solids content of the coating


solution is too low

Raise suspension solids level

Excessive pan speed


Low film strength coating
Incorrect coating pan fill

Select correct pan speed


Select high film strength Opadry

Fill pan to correct volume

Copyright 2006 Colorcon Inc.


The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately .

Examples of splitting & peeling

Copyright 2006 Colorcon Inc.


The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately .

Splitting & peeling


Cause
Low film mechanical strength
Poor adhesion of coating to core

Solution
Select optimised coating:

film strength

adhesion

plasticisation

Poorly plasticised film

Core tablet erosion

Improve tablet core

Over heating of tablet cores

Avoid overheating tablet cores

Copyright 2006 Colorcon Inc.


The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately .

Examples of core expansion

Copyright 2006 Colorcon Inc.


The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately .

Cracking of the coating


Cause
Core and coating have different
thermal expansion properties
Inadequate coating formulation
Expansion of core due to
overheating
Lack of relaxation time following
tabletting

Solution
Avoid mineral-type fillers, calcium
carbonate, calcium sulfate,
magnesium carbonate,
Encompress etc
Extend time between tabletting &
coating
Select coating formula with correct
mechanical properties
Do not over heat tablet cores

Copyright 2006 Colorcon Inc.


The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately .

Examples of within-tablet colour


variation

Copyright 2006 Colorcon Inc.


The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately .

Examples of within-tablet colour


variation

Copyright 2006 Colorcon Inc.


The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately .

Within-tablet colour variation


Cause

Solution

Pigments are poorly dispersed

Use Opadry

Core ingredients (usually moisture


sensitive) bleed through the
coating

Use an isolating subcoat

Core ingredients interact with


coating to cause colour instability
Liquid plasticiser migration

Change coating formulation


Choose a solid plasticiser system
Choose high opacity coating

Low opacity coating system

Copyright 2006 Colorcon Inc.


The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately .

Example of logo bridging

Copyright 2006 Colorcon Inc.


The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately .

Logo bridging - mechanism


Uncoated tablet with break-line

Initial stage thin coating

Later stage - thick


coating traps residual
solvent

Stress relieved by film


bridging over break line

Stress develops due to


eventual evaporation
of residual solvent

Copyright 2006 Colorcon Inc.


The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately .

Logo bridging
Cause

Solution

Poorly plasticised coating system

Use optimally plasticised coating

Low adhesion coating system

Use high adhesion coating

Low adhesion core ingredients

Use high adhesion core materials

Spray rate too high

Reduce spray rate

Product temperature too low

Increase product (bed) temperature

Organic to aqueous conversion

Improve logo design

Poor logo design

Copyright 2006 Colorcon Inc.


The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately .

Example of spray drying/logo filling

Copyright 2006 Colorcon Inc.


The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately .

Spray drying/logo filling


Cause
High atomising air pressure

High drying air temperature

Solution
Use lower atomisation pressure
Reduce drying air temperature
Use low viscosity coating system

High solids coating suspension


Optimise gun-to-bed distance
Gun-to bed distance too high
Poor spray gun design (air cap)
Turbulent air-flow
Aeration of coating suspension

Reduce solids level

if longer coating time acceptable

Minimise pan depression


Optimise suspension preparation
to avoid aeration

Copyright 2006 Colorcon Inc.


The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately .

Examples of picking

Copyright 2006 Colorcon Inc.


The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately .

Picking and sticking


Cause

Solution

Application rate too high

Reduce spray rate

Drying air volume too low

Increase airflow

Drying air temperature too low


Pan speed too low

Increase the drying temperature


Increase pan speed
Increase atomising air pressure

Low atomisation pressure

Increase number of spray guns

Poor spray gun set-up

or fan width

Surface solubility

Increase gun to bed distance

Surface porosity high

Improve core characteristics

Low pan load

Optimise pan loading

Copyright 2006 Colorcon Inc.


The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately .

Example of Orange Peel


- Surface roughness

Copyright 2006 Colorcon Inc.


The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately .

Orange Peel roughness


Solution

Cause
Atomising air pressure too low

Increase the atomising / fan air

pressure
Coating suspension viscosity too
high

High spray rate

Poor spray gun performance

Reduce coating suspension solids


Choose a low viscosity coating
system
Decrease the spray rate
Use a better spray gun

Copyright 2006 Colorcon Inc.


The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately .

Example of poor tablet-to-tablet


colour uniformity

Copyright 2006 Colorcon Inc.


The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately .

Tablet-to-tablet colour variation


Solution

Cause
Insufficient number of spray guns

Increase number of spray guns

Poor spray gun set-up

Correct gun set-up

High coating suspension solids


Poor opacity of suspension
Inadequate mixing of tablets

Low pan speed

High core friability (needing low pan


speed)

Poor baffle design

Poor tablet shape

Low film coat weight gain


Low/high pan load

Spacing

Gun-to-bed distance

Fan width

Reduce suspension solids level


Increase opacity of suspension
Increase pan speed
Improve baffle design
Improve core friability/shape
Increase quantity of film coat
Load the correct quantity of tablets

Copyright 2006 Colorcon Inc.


The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately .

Release or disintegration issues

Copyright 2006 Colorcon Inc.


The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately .

Release or disintegration issues


Cause
Interaction between the core and
the coating ingredients

Solution
Select alternative core and/or coat
ingredients

Coating adheres to test


equipment
Coating formulation contains

Use a subcoat

ingredients that hinder the


solubility of the coating

Core ingredients are sensitive to

Select parameters to minimise

effect on core

heat or moisture in the coating


process
Copyright 2006 Colorcon Inc.
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately .

THANKS!

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