Dosage Form Design

Tablet Coating

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Introduction
Additives Used in Sugar Coating & Film
Coating

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Need for coating

Mask taste, odor and color of drug
Provide physical and chemical protection
for the drug
Control release of drug
Protect drug from gastric environment
Avoid chemical incompatibilities or provide
sequential release
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Sugar Coating: Basic Steps

Seal Coating- to prevent moisture
penetration into tablet core especially in
pan-ladling method
Seal coating solution consists of:
Zein
Oleic acid
Polyethylene glycol 4000
Methylene Chloride
Alcohol
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SUBCOATING- applied to round the

edges and build up tablet size.
Consists of alternately applying a sticky
binder solution to the tablets followed by
dusting of subcoating powders and drying.
Subcoating Soln.
Subcoating Powder
Gelatin
Acacia
Sugar
Water
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Sugar
Acacia
Corn starch
Talc
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SYRUP COATING (SMOOTHING

COLOR)- Cover and fill imperfections in
the tablet surface caused by subcoating
step and impart desired color
Syrup Solns. Grossing
Colorant

q.s.

Heavy

Regular

q.s.

q.s.

2.73 kg

85 g

Subcoating Powder 22.7kg

Sugar
Water
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136 kg
76 kg

q.s.100ml
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POLISHING
Final step to impart lustre
Powdered wax or warm solution solution
waxes in naptha
Polishing soln.
Carnauba Wax
White Beeswax
Paraffin Wax
Naptha

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Film Coating
Developed to overcome disadvantages of
sugar coating
Advantages of film coating over sugar
coating:
Simpler and less time consuming
No increase in tablet weight
Allows monogramming or embossing of
tablets
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Film coating additives

Film coating solution consists of:
Film Formers
Solvents
Plasticizers
Colorants
Opacifying agents

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1. Film former: for producing smooth, thin

film.
Classified into:
Nonenteric
Enteric Materials

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Nonenteric Materials
Hydroxypropyl Methyl Cellulose (HPMC)
Excellent solubility characteristics
Noninterference with tablet disintegration
Flexibility, chip resistance and absence of
taste and odor
Stability
Ability to incorporate color
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Other nonenteric polymers

Povidone
Available in 4 grades
Used as binder and in coating
Solubility
Helps in incorporation of colorants
Tacky

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Sodium Carboxymethylcellulose
Easily dispersible
Insoluble in organic solutions
Films are brittle
Scope for aqueous-based film coating

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Polyethylene Glycols
Used in combination with other polymers
High MW PEGs are hard, smooth,
tasteless and nontoxic
Low MW PEG used as plasticizer

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Acrylate Polymers
Marketed as Eudragit
Eudragit E is cationic polymer based on
dimethylaminoethyl methacrylate and
other neutral methacrylic acid esters-is the
only Eudragit material freely soluble in
gastric fluid up to pH 5 and expandable
and permeable above pH 5
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Enteric Polymers
Cellulose acetate phthalate (CAP)
Aquateric a patented aq. colloidal
particles ( 0.05 to 3 microns) by FMC
Corporation
Solubility at pH 6

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Acrylate Polymers, enteric acrylic resin

Eudragit L soluble at pH 6, org sol., solid
or aq. dispersion
Eudragit S soluble at pH 7 organic solution
in IPA

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Hydroxy methyl cellulose phthalate

Esterification with phthalic anhydride of

HPMC
HPMCP 50, 55 and 55S
Solubility at pH 5 to 5.5

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Plasticizer
for flexibility and elasticity of coating and
thus produce durability.
Aqueous system: Low MW Polyethylene
glycol, Tweens, Propylene glycol
Nonaqueous system: Spans, Castor oil

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Solvents
Vehicle for film former and other additives.
Nonaqueous solvents include ethanol,
isopropanol methyl ethyl ketone,
chloroform and methylene chloride

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Colorants: To provide distinctive color and

elegance to dosage form. Dyes, lakes and
natural colorants

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Aqueous systems include:

AQUACOAT-30% Ethyl cellulose
pseudolatex.
Pseudolatex systems have a high solid
content for greater coating ability and
relatively low viscosity.
Methyl cellulose
HPMC
HPC
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More examples
HPMC Nonaqueous formula
HPMC 15 cps ---- 4 %
Propylene glycol--- 1.2%
Ethyl alcohol ------ 45%
Methylene chloride q.s. to make 100%

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 CAP/ Carbowax Nonaqueous Formula

CAP -------- 5 %
PEG 8000---15 %
Span 80------ 0.3%
Dye Yellow 0.05%
Titanium dioxide0.5 %
Vanillin ---------0.1%
Castor oil --------0.25 %
Ethanol ---------12 %
Acetone -------- q.s.to 100 %
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CAP Enteric Solution

CAP ------ 12 %
Propylene glycol---- 3 %
Span 80--- 1 %
Ethanol --- 45 %
Acetone q.s. to 100 %

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Summary
Sugar Coating- Time consuming
Film coating- simpler, feasibility of enteric
and nonenteric coating, aqueous coating
systems developed

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