Coated Pharmaceutical Dosage Forms

1
Coated Pharmaceutical Dosage Forms
Sontaya Limmatvapirat
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Scope of the study
Introduction 15 min Core and core
properties 20 min Coating apparatus 45
min Sugar coating 100 min Film
coating 100 min Evaluation 20 min
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Introduction
4
Introduction
History
9 BC. Coating of pill with psyllium Coating by
dipping 1800 Invention of tableting
machine Sugar coated tablet 1950 Semi-,
automatic coating machine 1953 Film
coating 1956 Microencapsulation
5
Introduction
Purpose of coating
- To mask unpleasant taste, odor or color
- To protect products from environment, e.g.
light, moisture, oxygen
- To reduce incompatibility
- To control drug release - enteric coating -
sustained release coating
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Introduction
Purpose of coating
- To promote aesthetic property
- To increase manufacturing effeciency
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Introduction
Type of coating
- Sugar coating
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Introduction
Type of coating
- Film coating
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Introduction
Type of coating
- Specialized coating e.g. compression coating,
hot melt coating, microencapsulation
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Core
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Core
- powders, granules, pellets, tablets, capsules,
liquid
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Core
Properties
Hardness
- sufficient hardness ( gt 6kg) and less
friability ( lt 0.5 )
- Less hardness is require for sugar coating
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Core
Properties
Shape
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Core
incomplete cover edge
twinning
agglomerate
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Core
Properties
Surface properties
- Wettability
- Surface roughness
- Logo
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Core
Properties
Other properties
- Stability of drug or excipients
- Melting point
- etc.
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Core
Calculation of surface area
Examples
r
T
h
d
CR
Surface area 2?(rhr2d2) ? 2?(r?T r2)
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Coating apparatus
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Coating apparatus
- Coating machine
- Polishing machine
- Coating parts and accessories
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Coating machine
- Conventional coating pan
- Modified conventional coating pan
- Perforated or side vented coating pan
- Air suspension or fluid bed coater
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Coating machine
Conventional coating pan
- Modified from pan used for confectionery
- mainly used for sugar coating
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Coating machine
Conventional coating pan
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Coating machine
Conventional coating pan
Drawbacks
- Insufficient mixing, dead spot
- Low drying efficiency
- Inadequate exhaust system
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Coating machine
Baffle
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Coating machine
Baffle
Advantages
- Increase mixing efficiency
- Ensure distribution of coating solution
Disadvantages
- Tablet erosion, break
- Difficult to clean
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Coating machine
Modified conventional coating pan
Pellegrini coating pan

• angular rotation
• (to increase mixing efficiency)

- baffle

• increase air flow efficiency

• increase drying efficiency

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Coating machine
Modified conventional coating pan
Pellegrini coating pan
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Coating machine
Modified conventional coating pan
Improved drying efficiency

• immersion tube
• immersion sword
• deep bed air extraction

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Coating machine
Modified conventional coating pan
Improved drying efficiency
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immersion tube
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Coating machine
Modified conventional coating pan
Drawbacks
- inadequate drying efficiency, especially for
film coating (aqueous formular)
- inadequate exhaust system
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Coating machine
Perforated coating pan
- improved drying efficiency - improved exhaust
system - suitable for film coating (both aqueous
and non-aqueous formula)
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Coating machine
Perforated coating pan
Accela Coata Hi Coater Driacoater Glatt
Perforated coating pan Dumoulin pan Huettlin
butterfly pan
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Coating machine
Perforated coating pan
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Accela Cota
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Coating machine
Perforated coating pan
Accela Cota model 75
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Coating machine
Fluidized bed coating pan
Principle
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Coating machine
Fluidized bed coating pan
Classification

• - Top spray coater
• Wurster bottom spray coater
• Rotor tangential spray coater
• Kugel coater

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Coating machine
Fluidized bed coating pan
Advantage
- maximize drying efficiency - suitable for
particle coating
Disadvantage
- not suitable for friable core
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Coating machine
Selection criterion
- core properties e.g. hardness, size.,etc.
- required coated product e.g. sugar, film coated
tablet
- specification of coating machine e.g. capacity,
GMP, accessories
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Polishing machine
- necessary for sugar coating
- polishing by wax
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Coating parts and accessories
Air system
Application system
Product charging
Product discharging
Other accessories
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Coating parts and accessories
Air system
- air inlet system, exhaust system - air inlet
system clean, dry, optimum temperature drying -
air exhaust system gt air inlet (30) dust,
moisture removal
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Coating parts and accessories
Application (feeding) system
- ladle application, spray application
ladle application suitable for sugar coating
spray application airless atomization, air
atomization, ultrasonic spray system
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Spray application
airless atomization

• - high pressure, small orifice
• - suitable for large scale production
• suitable for organic solvent based coating
  solutions
• suitable for sugar or film coating
• not suitable for small scale or lab scale
• easily clogged by coating solution

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Spray application
air atomization

• - lower pressure, larger orifice
• - suitable for lab scale production
• suitable for aqueous based coating solutions
• suitable for film coating
• less clogged by coating solution

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Sugar coating
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Sugar coating
Advantages and disadvantages
Coating materials
Steps of sugar coating
Problems of sugar coating
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Advantage and disadvantage
Advantage

• - cheap, safe coating materials
• - cheap coating machine
• good patient compliance
• can be reprocessed
• require less hardness core

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Advantage and disadvantage
Disdvantage

• - time consuming process
• - high weight gain
• required trained personnel
• fragile

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Coating materials
Sugar

• - main component of syrup
• - cold or hot syrup
• be avoided formation of invert sugar by
  excessive heat and low pH (lt6)
• be avoided crystallization of sugar from syrup
  before coating

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Coating materials
Sugar substitutes

• glucose, lactose, isomalt, sugar alcohols
• some sugar substitutes can not be single use due
  to low solubility e.g. lactose, mannitol

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Coating materials
Sugar substitutes
- sugar alcohols - non cariogenic material -
low calorie - no aldehyde group - cooling
effect - some produce laxative effect - e.g.
sorbitol, mannitol, xylitol, maltitol
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Coating materials
Sugar substitutes
- sugar alcohols - sorbitol ? hygroscopic
- mannitol ? less hygroscopic ? low
solubility can not be used alone ? can be
used by hot melting with sorbitol
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Coating materials
Sugar substitutes
- sugar alcohols - Xylitol ? hygroscopic
?can be used by hot melting with sorbitol -
maltitol ? less laxative effect ? same
syrup viscosity as sucrose
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Coating materials
Sugar substitutes
- sugar alcohols - xylitol ? hygroscopic ?
can be used by hot melting with sorbitol
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Coating materials
Binders or film formers
- promote binding effect of coating layer -
moisture protection - produce enteric property -
acacia, gelatin, cellulose derivatives, PVP
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Coating materials
Coloring agents
- aesthetic purpose - classification - water
soluble ? dyes - water insoluble ?
lakes, pigments
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Coating materials
Coloring agents
- properties - covering power ? depend on
properties of material, e.g. type, size,
refractive index ? white pigments ? e.g.
TiO2, CaCO3, CaSO4
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Coating materials
Coloring agents
- properties - brightness - gloss ? depend
on smoothness, moisture content of core, type and
amount of wax, amount of coloring agent, etc.
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Coating materials
Coloring agents
- properties - tinctorial strength ? depend on
mass of coloring agents (dyes, pigments or
lakes) ? depend on size of coloring agents
(pigments or lakes)
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Coating materials
Coloring agents
- properties - colorfastness ? heat, light,
pH, oxygen, interaction ? check stability of
each coloring agents
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Coating materials
Antiadherants
- prevent sticking - can be added in coating
solution or use in form of dusting powder -
talcum, colloidal silica
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Coating materials
Fillers

• - increase mass
• some fillers are antiadherants, colorants
• - e.g. CaCO3, CaSO4, starch, talcum, TiO2, ferric
  oxide

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Coating materials
Polishing agents
- improve gross, palatability - prevent
moisture - beeswax, carnauba wax, paraffin
Other agents
- flavoring agents, surfactants
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Step of sugar coating
1. Sealing 2. Subcoating 3. Smoothing 4.
Coloring 5. Finishing 6. Polishing
Purpose
Materials
Methodology
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Sealing
Purpose
- to prevent water from coating solution - to
prevent migration from core - to produce enteric
coating (some cases) - to reduce core abrasion
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Sealing
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Sealing
Materials
- shellac, CAP, HPMCP, PVAP, zein
- Examples
F1 () F2 () F3 ()
Shellac PVAP Zein Alcohol Water 40 60 30 70 20 64 16
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Sealing
Methodology
core
dedusting
warming
coating solution
anti-adherent
hot air
1-2 cycles
moisture proof core
(5 or less weight gain)
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Subcoating
Purpose

• to round off sharp edge of core
• (smooth surface is not required)

• to provide a good substrate for subsequent
  smoothing step

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Subcoating
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Subcoating
Materials

• lamination or suspension process
• lamination process
• solution
• dusting powder

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lamination process
F1 () F2 () F3 () F4 ()
Solutions sucrose gelatin acacia water 61.8 5 33.2 50 8 42 50 4 4 42 45 6 8 41
Powders Calcium sulfate Calcium carbonate Talcum Titanium dioxide Sucrose Acacia 100 47.6 47.6 4.8 95 5 61 1 30
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Suspension process
F1 () F2 () F3 ()
Suspensions Calcium sulfate Calcium carbonate Talc Titanium dioxide Acacia, powdered Sugar Water 15 2 63 20 32 3 45 20 20 12 1 2 40 25
-can be used for smoothing
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Subcoating
Methodology (lamination)
core
dedusting
2 - 5 mins/cycle (lamination)
warming
coating solution
tumbling
dusting powder
hot air
2-10 cycles (lamination)
no edge core
cleaning
(20-50 or more weight gain)
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Subcoating
Methodology (suspension process)
core
dedusting
warming
2 - 5 mins/cycle (suspension)
suspensions
tumbling
hot air
15-45 cycles (suspension)
no edge core
cleaning
(20-60 or more weight gain)
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Subcoating
Methodology

• wet tumbling time
• ratio of solution to dusting powder
• pan need to be clean after subcoating

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Smoothing
Purpose

• to smooth the rough core surface

• to provide a smooth base for color coat

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Smoothing
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Smoothing
Materials

• suspensions or solutions (depend on surface
  roughness)

• suspensions
• same formula as suspension process

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Smoothing
Materials

• solutions (syrups)

F1 () F2 ()
solutions Sugar Water 60 40 70 30
larger pits need higher percent of syrup
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Smoothing
Methodology
core
suspensions or syrup
tumble wet longer
hot air
smooth surface core
(5-10 or more weight gain)
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Smoothing
Methodology

• - need longer wet tumbling time (as compared to
  subcoating)
• decreasing amount of coating solution are
  applied as surface become smoother
• color may be added after smooth surface is
  achieved

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Coloring
Purpose
- to achieve an evenly colored, smooth surface
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Coloring
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Coloring
Materials
- sugar - gelatin, acacia may be added
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Coloring
Materials
F1 () F2 ()
solutions Sugar Gelatin Acacia Color dispersion Water 66.6 0.5-2.0 10 21.4-22.9 66.6 0.5-2.0 10 21.4-22.9
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Coloring
Methodology
core
dyes or pigments syrup
tumble wet longer
hot air
evenly colored smooth surface core
(5-10 weight gain)
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Coloring
Methodology
dye coating process pigment coating process
more gloss and elegant need experienced personnel more time consuming migration of color difficult to change to automated process need color dilution less elegant require less experienced personnel less time consuming no migration automated process can be achieved use constant color shading
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Finishing
Purpose
- to provide an extremely smooth surface suitable
for polishing
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Finishing
Materials
- sugar (syrup)
F1 ()
Sugar Water 60 40
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Finishing
Methodology
core
syrup
jogging
hot air
1-2 cycles
very slow evaporation rate
extremely smooth surface core
(0.5-1 weight gain)
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Finishing
Methodology
- jogging
- slow evaporation
small crystals
smooth surface
- not too wet or too dry
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Polishing
Purpose
- to enhance gloss - to provide moisture
protection
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Polishing
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Polishing
Materials
- dry wax, wax solution, slurry or emulsion
F1 () F2 ()
Carnauba wax White wax Petroleum ether Alcohol 6.25 6.25 93.75 6.25 6.25 93.75
F2 contains finely ground wax dispersed in
alcohol (slurry)
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Polishing
Equipments
- canvas lined polishing pan - canvas lining
provides friction for polishing
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Polishing
Methodology
core
wax
polishing pan
- canvas lined - more rapid pan speed - room temp.
polishing
gloss core
(0.1-0.2 weight gain)
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Polishing
Factors affecting gloss
- surface smoothness - moisture content -
coloring process - type and amount of wax
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Problems of sugar coating
1. problems with tablet core robustness 2. surface
roughness 3. cracking 4. twinning 5.
chipping 6. uneven color 7. blooming or
sweating 8. non drying coating
core
coating material (formula)
process
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Problems of sugar coating
Problems with tablet core robustness
- friable, capping, laminating, chipping core
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Problems of sugar coating
Problems with tablet core robustness
- core ? hardness ? compressibility
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Problems of sugar coating
Surface roughness
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Problems of sugar coating
Surface roughness
- material ? dusting powder ? or ? coating
solution precipitation of sugar

• - process
• unevenly distribute of coating solutions
• incorrect powder adding interval
• ? wet tumble
• ? drying

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Problems of sugar coating
Cracking
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Problems of sugar coating
Cracking

• - core
• ? compressibility
• stress relaxation after tableting
• ? deep concave

- material ? binder (cracking of coating layer)
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Problems of sugar coating
Cracking
- process ? sealing ? moisture in coating
layer
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Problems of sugar coating
Twinning or building multiple
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Problems of sugar coating
Twinning or building multiple
- core ? concave
- material ? viscosity of coating solution ?
coating solution ? dusting powder
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Problems of sugar coating
Twinning or building multiple

• - process
• unevenly distribute of coating solution
• (localized of wetting bed)
• incorrect powder adding interval

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Problems of sugar coating
Chipping
- material ? polymer
- process ? impaction force e.g. pan speed
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Problems of sugar coating
Uneven color
soluble dye gt lake dark color gt light color
- core ? surface roughness
- material ? ? coating solution
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Problems of sugar coating
Uneven color

• - process
• migration of soluble dye
• washing back of lake
• ? drying

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Problems of sugar coating
Blooming or sweating
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Problems of sugar coating
Blooming or sweating
- core ? moisture content
- process ? drying
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Problems of sugar coating
Nondrying coating

• - material
• ? Invert sugar
• aluminum lake

• - process
• overheating of coating solution

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Problems of sugar coating
Marbling
- cause ? surface roughness
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Reprocess of sugar coated tablet
washing
- expensive drug
- process
Coated tablet
water
washing
stop
ethanol
drying
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Reprocess of sugar coated tablet
washing
- process
Coated tablet
Isopropanol
soaking
washing
add water
stop
Isopropanol
drying
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Production area
optimum temperature and humidity (25 Celsius
and 50 RH
adequate air supply and air exhaust system
no washing basin in coating area
clean and smooth wall, ceiling
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Film coating
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Film coating
Advantages and disadvantages
Types of film coating
Mechanism of film formation
Coating materials and formulas
Coating process
Factors affecting film coating
Problems of film coating
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Advantages and disadvantages
Advantages

• fast
• require less experienced personnel
• reduced weight gain
• flexibility of formulation
• identification
• possibly of automation

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Advantages and disadvantages
Disadvantages

• less elegance
• require more expensive machine

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Types of coating
Conventional film coatings (non-functional film
coatings)

• aesthetic
• masking
• identification
• protective coating

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Types of coating
Modified film coatings (functional film coatings)

• controlled release e.g. enteric or sustained
  release

126
Film formation
Film formation from polymeric solution
127
Film formation
Film formation from aqueous dispersion
128
Coating material and formula
polymers or film formers plasticizers solvents col
oring agents other materials
129
Coating material and formula
Film formers

• polymers for conventional coating
• polymers for controlled release coating

130
Coating material and formula
Polymers for conventional coating

• cellulose ethers

HPMC R H, CH3 , CH3CH(OH)CH2 HPC R H,
CH3CH CH3 OmH) EC R CH2CH3 NaCMC R CH2COONa
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Coating material and formula
Polymers for conventional coating

• cellulose ethers
• - soluble in water except ethyl cellulose (EC)
• - hydroxy propyl methyl cellulose (HPMC) is
  the most commonly used

132
Coating material and formula
Polymers for conventional coating

• Povidone (PVP)
• Polyethylene glycol (PEG)
• Acrylate polymers

133
Coating material and formula
Polymers for conventional coating

• Acrylate polymers
• (1) aminoalkyl methacrylate copolymers
• soluble in acid
• protective coating
• Eudragit E

134
Coating material and formula
Polymers for conventional coating

• Acrylate polymers
• (2) methacrylic acid copolymer

• (2.1) methacrylic acid methylmethacrylate 11
  copolymer
• soluble at pH gt 6.0
• enteric coating
• protective coating (lower level of coating)
• Eudragit L

135
Coating material and formula
Polymers for conventional coating

• Acrylate polymers
• (2) methacrylic acid copolymer

• (2.2) methacrylic acid methylmethacrylate 12
  copolymer
• soluble at pH gt 7.0
• enteric coating
• Eudragit S

136
Coating material and formula
Polymers for conventional coating

• Acrylate polymers
• (2) methacrylic acid copolymer

• (2.3) methacrylic acid ethyl acrylate 11
  copolymer
• soluble at pH gt 5.5
• enteric coating
• Eudragit L100

137
Coating material and formula
Polymers for conventional coating

• Acrylate polymers

(3) ammoniomethacrylate copolymers

• (3.1) type A
• insoluble in water but swellable
• protective coating
• sustained release coating
• Eudragit RL

138
Coating material and formula
Polymers for conventional coating

• Acrylate polymers

(3) ammoniomethacrylate copolymers

• (3.2) type B
• insoluble in water but swellable
• lower permeability (as compared to type A)
• sustained release coating
• Eudragit RS

139
Coating material and formula
Polymers for conventional coating

• Acrylate polymers

(4) ethylacrylate/methylmethacrylate 21
copolymer

• protective coating
• binder for sustained release
• Eudragit NE 30 D

140
Coating material and formula
Polymers for enteric coating

• insoluble at gastric pH but soluble at
  intestinal pH
• pH, stability, mechanical properties are
  depended on type, grade of polymers

141
Coating material and formula
Polymers for enteric coating

• most polymers are phthalate ester

142
Coating material and formula
Polymers for enteric coating
- cellulose esters
cellulose acetate phthalate (CAP)
hydroxypropyl methyl cellulose phthalate (HPMCP)
hydroxylpropyl methylcellulose acetate
succinate HPMCAS
143
Coating material and formula
Polymers for enteric coating
- acrylate polymers methacrylic acid copolymers
- polyvinyl acetate phthalate (PVAP)
- shellac, etc.
144
Coating material and formula
Polymers for sustained release coating
- water insoluble (some may swell)
- acrylate polymers ammoniomethacrylate
copolymers ethylacrylate/methyl methacrylate
copolymer
145
Coating material and formula
Polymers for sustained release coating
- wax bee wax, carnauba wax, steary alcohol,
cetyl stearyl alcohol
- ethyl cellulose, cellulose acetate, etc.
146
Coating material and formula
Plasticizers
- ? glass transition point (Tg)
Tg
glass
rubber
- ? tensile strength, ? elongation
- ? ? permeability
147
Coating material and formula
Plasticizers
- permanence and compatibility

• - classification
• water soluble plasticizers
• PEG, PG, glycerin, triethyl citrate,
  triacetin, etc
• water insoluble plasticizers
• tributyl citrate, diethyl phthalate, dibutyl
  phthalate, castor oil, etc.

148
Coating material and formula
Solvents
- water or organic solvents

• selection of solvents
• solubility
• cohesion, mechanical properties, etc
• thermodynamic (solubility parameter)
• kinetic
• volatility

149
Coating material and formula
coloring agents
- see sugar coatings

• lakes gt dyes

? lakes

• tensile strength ? modulus of elasticity
• permeability
• ? hiding power

150
Coating material and formula
other materials
- anti-adherents e.g. talcum

• surfactant

• antifoaming e.g. silicone emulsion

151
Coating process
- less complicate than sugar coating
- depend on coating apparatus
- coating steps

152
Coating process
- coating steps

• calculation of core surface area
• - formulation step
• 2. determination of batch size
• - 70-75 maximum batch size
• 3. preparation of coating solution
• set up of coating machine
• - pan speed
• - feed rate
• - atomization press
• - inlet air temperature, etc.

153
Coating process
- coating steps

• 5. loading of core
• 6. dedusting and warming
• - reduced pan speed or jogging
• coating
• - pan speed
• - feed rate
• - atomization press
• - inlet air temperature, etc.
• 8. polishing
• 9. product discharge

154
Factors affecting coating process
- see table 5.13 -5.15

155
Problems of Film Coating
1. sticking, picking 2. orange peel, roughness 3.
bridging of logos 4. cracking 5.
peeling 6. tablet attrition or erosion 7. loss
of logo definition
core
coating material (formula)
process
156
Problems of Film Coating
sticking or picking
twinning
157
Problems of Film Coating
sticking or picking
- process (overwetting) ? feed rate ? atomization
pressure ? drying rate (temperature, air inlet) ?
pan speed
- material contain low melting point material
- core ? concave
158
Problems of Film Coating
orange peel, surface roughness
159
Problems of Film Coating
orange peel, surface roughness
- process (spray drying effect) ? feed rate ?
atomization pressure ? drying rate (temperature,
air inlet) ? core-spray gun distance
160
Problems of Film Coating
bridging of logos
161
Problems of Film Coating
bridging of logos
- material ? adhesion change polymer ? talcum,
pigments ? cohesion ? plasticizer change polymer
162
Problems of Film Coating
bridging of logos
- core ? hydrophobic, gloss ? surfactant ?
lubricant ? deep logo
163
Problems of Film Coating
cracking
164
Problems of Film Coating
cracking
- materials ? film stress ? plasticizer ?
lubricant ? adhesion
- process ? overwetting ? spray rate
165
Problems of Film Coating
cracking
- core ? stress relaxation - ? storage time -
reformulation
166
Problems of Film Coating
peeling
167
Problems of Film Coating
peeling
- material ? adhesion change polymer (HPC gt
HPMC) ? talcum, pigments ? fragile film ?
plasticizer change polymer
168
Problems of Film Coating
peeling
- process ? fragile film ? drying temperature
169
Problems of Film Coating
tablet attrition and erosion
170
Problems of Film Coating
tablet attrition and erosion
- core ? friable core reformulation (increase
compressibility)
- process ? pan speed ?? feed rate reformulation
(increase compressibility)
171
Problems of Film Coating
tablet attrition and erosion
- materials fragile film adjust amount and type
of plasticizer
172
Problems of Film Coating
loss of logo definition
173
Problems of Film Coating
loss of logo definition
- core or film defect (bridging of logos)
- core ? friable core reformulation (increase
compressibility) ? hydrophobic, gloss ?
surfactant ? lubricant ? deep logo
174
Problems of Film Coating
loss of logo definition
- process ? feed rate (overwetting)
- material ? adhesion change polymer ? talcum,
pigments ? cohesion ? plasticizer change polymer
175
Problems of Film Coating
uneven distribution
- process ? pan speed ? feed rate, ? spray gun
- material ? coating solution
176
Evaluation
177
Evaluation
Film Evaluation
Coated Tablet Evaluation
178
Film Evaluation
mechanical properties
solubility
water and gas permeability
wetting
etc.
179
Film Evaluation
mechanical properties
solubility
water and gas permeability
wetting
etc.
180
Coated tablet evaluation
general consideration
uniformity of dosage unit
disintegration
dissolution and drug release
etc.
181
Coated tablet evaluation
general consideration
shape, color, thickness, hardness, etc.
182
Coated tablet evaluation
Uniformity of Dosage Units (USP, BP, Ph. Eur.) -
Weight (mass) variation - Content
uniformity Uniformity of Weight (Mass) (BP, Ph.
Eur.) Uniformity of Content (BP, Ph. Eur.)
183
Coated tablet evaluation
uniformity of dosage unit (USP 32, BP 2009)
content uniformity - for all coated tablet
except....
weight variation - film coated tablet drug gt
50 mg or weight of drug/total tablet weight gt 50

184
Coated tablet evaluation
Table 1. Application of Content Uniformity (CU)
and Weight Variation (WV) Tests for Dosage Forms
Dosage Form Type Subtype Dose Ratio of DrugSubstance Dose Ratio of DrugSubstance
Dosage Form Type Subtype gt25 mg and gt25 lt25 mg orlt25
Tablets Uncoated WV CU
Tablets Coated Film WV CU
Tablets Coated Others CU CU
Capsules Hard WV CU
Capsules Soft Suspension, emulsion, or gel CU CU
Capsules Soft Solutions WV WV
185
Coated tablet evaluation
BP 2009
uniformity of content - for all coated tablet
that less than 2 mg of drug or weight of
drug/total tablet weight lt 2 - specified in
monographs
uniformity of mass - for all film coated
tablets (except those have pass uniformity of
content
186
Coated tablet evaluation
Disintegration
USP 32 - plain coated tablet - same as
uncoated tablet - water, 37 ? 2 C , specified
time - delayed release (enteric coated)
tablet simulated gastric fluid 1 h and
simulated intestinal fluid, specified time
187
Coated tablet evaluation
Disintegration
BP 2009 - plain coated tablet - water (or 0.1
M HCl) - 30 min for film coated tablet - 60 min
for sugar coated tablet - gastro resistant
(delayed release) tablet - 0.1 M HCl for 2 h
and - phosphate buffer pH 6.8 for 60 min
188
Coated tablet evaluation
Dissolution
USP 32 - plain coated tablet (immediate release
dosage form) - same as uncoated tablet -
enteric coated tablet - 0.1 N HCl for 2 h and -
phosphate buffer pH 6.8 for specified time -
extended release tablet - depended on drug
189
Coated tablet evaluation
Dissolution
BP 2009 - same as USP
190
Coated tablet evaluation
other tests