troubleshooting in film coating
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Troubleshootingin Film Coating
MD. ESHRAK -E- ALAHI
TECHNICAL MANAGER
COLORCON BANGLADESHEMAIL: EALAHI@COLORCON.COM
MOBILE: +880-171-3451832
DATE: SEPTEMBER 24,2011
mailto:EALAHI@COLORCON.COMmailto:EALAHI@COLORCON.COM -
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Copyright 2006 Colorcon Inc.
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
Troubleshooting
Coating Process and Equipment
Critical components of film coating
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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
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Copyright 2006 Colorcon Inc.
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
Cause
Tablets are too soft
Tablets are too brittle
Tablets cap/laminate
Poor tablet shape for coating
Excessive pan speed
Poor baffle design
Solution
Change core formulation
Change core compression
parameters
Change tablet shape
Reduce pan speed
Change baffle design
Tablet breakage
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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
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Copyright 2006 Colorcon Inc.
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
Cause
Inappropriate tablet shape
Pan speed too low
Spray droplet size too large
Spray rate too high
Insufficient drying
Solution
Chose tablet design that
eliminates flat areas
refer tablet core section
Increase pan speed
Increase atomising air pressure
Reduce spray rate
Increase drying higher inlet air temperature
higher drying air flow rate
Twinning
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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
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Copyright 2006 Colorcon Inc.
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
Cause
Hygroscopic tablet core
Application rate too low/high
Pan speed too fast
Friable tablet core
Low coating film strength
Punch design
Punch wearLogo placement or design
Low coating suspension solids
Solution
Reduce hygroscopic core materials
(e.g. superdisintegrant)
Select appropriate spray rate
Decrease pan speed
Use tablet punches with deeper
concave or double radius shape
Check punches for damage
Select Opadry formulation to solve
problem
Tablet surface erosion
Opadry is a trademark of Colorcon Inc.
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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
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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
Worn tablet tooling
Sharp edges on tablets
High core attrition
Low spray application rates
Solids content of the coating
solution is too low
Excessive pan speed
Low film strength coating
Incorrect coating pan fill
Solution
Replace tablet tooling
Change tablet shape/design
Change core formulationSelect correct application rate
Raise suspension solids level
Select correct pan speed
Select high film strength Opadry
Fill pan to correct volume
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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
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Copyright 2006 Colorcon Inc.
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
Cause
Low film mechanical strength
Poor adhesion of coating to core
Poorly plasticised film
Core tablet erosion
Over heating of tablet cores
Solution
Select optimised coating:
film strength
adhesion
plasticisation
Improve tablet core
Avoid overheating tablet cores
Splitting & peeling
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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
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Copyright 2006 Colorcon Inc.
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
CauseCore and coating have different
thermal expansion properties
Inadequate coating formulation
Expansion of core due to
overheating
Lack of relaxation time followingtabletting
SolutionAvoid mineral-type fillers, calciumcarbonate, calcium sulfate,magnesium carbonate,Encompress etc
Extend time between tabletting &coating
Select coating formula with correctmechanical properties
Do not over heat tablet cores
Cracking of the coating
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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 colourvariation
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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 colourvariation
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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
Pigments are poorly dispersed
Core ingredients (usually moisture
sensitive) bleed through thecoating
Core ingredients interact with
coating to cause colour instability
Liquid plasticiser migration
Low opacity coating system
Solution
Use Opadry
Use an isolating subcoat
Change coating formulation
Choose a solid plasticiser system
Choose high opacity coating
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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
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Copyright 2006 Colorcon Inc.
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
Uncoated tablet with break-line
Initial stage -
thin coating
Later stage - thickcoating traps residual
solvent
Stress develops due to
eventual evaporationof residual solvent
Stress relieved by film
bridging over break line
Logo bridging - mechanism
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Copyright 2006 Colorcon Inc.
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
CausePoorly plasticised coating system
Low adhesion coating system
Low adhesion core ingredients
Spray rate too high
Product temperature too low
Organic to aqueous conversion
Poor logo design
SolutionUse optimally plasticised coating
Use high adhesion coating
Use high adhesion core materials
Reduce spray rate
Increase product (bed) temperature
Improve logo design
Logo bridging
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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
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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 fillingCause
High atomising air pressure
High drying air temperature
High solids coating suspension
Gun-to bed distance too high
Poor spray gun design (air cap)
Turbulent air-flow
Aeration of coating suspension
Solution
Use lower atomisation pressure
Reduce drying air temperature
Use low viscosity coating system
Optimise gun-to-bed distance
Reduce solids level
if longer coating time acceptable
Minimise pan depression
Optimise suspension preparation
to avoid aeration
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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
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Copyright 2006 Colorcon Inc.
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
Cause
Application rate too high
Drying air volume too low
Drying air temperature too low
Pan speed too low
Low atomisation pressure
Poor spray gun set-up
Surface solubility
Surface porosity high
Low pan load
Solution
Reduce spray rate
Increase airflow
Increase the drying temperature
Increase pan speed
Increase atomising air pressure
Increase number of spray guns
or fan width
Increase gun to bed distanceImprove core characteristics
Optimise pan loading
Picking and sticking
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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
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Copyright 2006 Colorcon Inc.
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
CauseAtomising air pressure too low
Coating suspension viscosity too
high
High spray rate
Poor spray gun performance
SolutionIncrease the atomising / fan air
pressure
Reduce coating suspension solids
Choose a low viscosity coatingsystem
Decrease the spray rate
Use a better spray gun
Orange Peel roughness
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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-tabletcolour uniformity
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Copyright 2006 Colorcon Inc.
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
Cause
Insufficient number of spray guns
Poor spray 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
Solution
Increase number of spray guns
Correct gun set-up
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
Tablet-to-tablet colour variation
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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
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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
Coating adheres to testequipment
Coating formulation contains
ingredients that hinder the
solubility of the coating
Core ingredients are sensitive to
heat or moisture in the coating
process
Solution
Select alternative core and/or coat
ingredients
Use a subcoat
Select parameters to minimise
effect on core
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THANKS!
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