Eudragit Enteric Film Coating Systems
Formula and Process Examples       Zhion@zhion.com
Enteric Film Coatings with Polymethacrylates

Many pharmaceutical dosage forms irritate the stomach due to their
chemical properties. Others undergo chemical changes in gastric acid
and through the action of enzymes, thus becoming less effective. One of
the widely used enteric film coating system is Eudragit.

For the processing of EUDRAGIT usually some additional excipients are
required. Plasticizers reduce the minimum film forming temperatures as
well as the glass transition temperatures. The addition of a plasticizer like
triethyl citrate increases the flexibility of the film coatings. To prevent the
film coatings from getting sticky some glidants such as talc or glycerol
monostearate are also necessary. EUDRAGIT polymers show very high
pigment binding capacity. Pigments as much as three times the amount of
EUDRAGIT can be incorporated or bound into the film coating. Various
Eudragit Enteric Coating Products are summarized as follows:


EUDRAGIT L 30 D-55 is pH dependent anionic aqueous polymer
dispersion solubilizing above pH 5.5 for targeted drug delivery in the
duodenum.

EUDRAGIT L 100-55 prepared by spray-drying, can be reconstituted for
aqueous formulations for targeted drug delivery in the duodenum.

EUDRAGIT L 100 is pH dependent anionic polymer powder solubilizing
above pH 6.0 for targeted drug delivery in the jejunum.

EUDRAGIT L S 100 is pH dependent anionic polymer powder solubilizing
above pH 7.0 for targeted drug delivery in the jejunum.

EXAMPLES

OPERATION PROCESS

Pre-warm to about 30 °C, by means of an air spray gun.
Adjust the spray rate, inlet air quantity and inlet air temperature such a
way that spraying can be performed continuously.
Maintain tablet-bed temperature of approx. 25 to 35 °C during the
process.
Spray at low rates initially for moisture-sensitive tablets (seal-coating).
Spray at faster rates after the 30 minute-sealing coating.
If twinning occurs, stop the spray and increase the pan speed.
After coating is done, dry the tablets by slow down the coating pan speed.

FORMULATIONS

A. EUDRAGIT  S 100 COATING SYSTEM
EUDRAGIT® S 100  1,000 g
Talc                            330 g
Triethyl citrate              500 g
1N NH3 (1.7% NH3)    508 g
Water                       6,662 g

B . EUDRAGIT  L 100 COATING SYSTEM
EUDRAGIT® L 100   1,000 g
Talc                             330 g
Triethyl citrate               500 g
1N NH3 (1.7% NH3)      339 g
Water                         6,661 g

OTHER COATING SYSTEMS
Ethylcellulose Disperision-Aquacoat
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