Abhijit Sonje et al. Int. Res. J. Pharm.

2013,
4 (5)

INTERNATIONAL RESEARCH JOURNAL OF PHARMACY

www.irjponline.com

ISSN 2230 8407

Review Article

COMPREHENSIVE REVIEW ON EUDRAGIT POLYMERS

Abhijit Sonje1*, Amrish Chandra2
1Research Scholar, Bhagwant University, Ajmer, Rajasthan, India
2Department of Pharmaceutics, Assistant Professor, Amity University, Noida,
UP, India
*Email: abhi.sonje4u@gmail.com
Article Received on: 10/03/13 Revised on: 01/04/13 Approved for publication:
11/05/13
DOI: 10.7897/2230-8407.04515
IRJP is an official publication of Moksha Publishing House. Website:
www.mokshaph.com
All rights reserved.
ABSTRACT
For ideal Pulsatile drug delivery system, dosage form should possess three main properties: (a) It will be a single dose for the whole duration of
treatment. (b)
It will deliver the active drug directly at the
site of action. (c) It will possess possible fewer side effects.
Above approaches are achieved
with the help of
suitable choice of polymer. Release rate of drug from the formulation and duration depend on selection of polymer. One would always like to have
an ideal
polymer for controlled release of drug from particular dosage form that must possess the following two properties. 1) Polymer stability in acidic
environment
with desired buoyancy. 2) It should dissolve slowly enough to serve predictable release rate. This review focuses on recent literature regarding
use of Eudragit
to
INTRODUCTION
Highly
coatings
polymer
in different drug delivery systems with special attention
used flexible
in its fabrication
along with their physiochemical properties.
1,2,3

If you data
needofto protect your active from the gastric fluid
Collected
Suitable
for
multiparticulate
tablet
and will provide a deep and current knowledge for further researchers to conduct study regarding Pulsatile
polymers
drug delivery system.
preparation.
Keywords:
Pulsatile
drug delivery
Polymers, Controlled
release,
Eudragit,
properties.
would like
to improve
drugsystem,
effectiveness
EUDRAGIT
Eudragit
RLPhysicochemical
1003

L
It is a copolymer of Ethyl acrylate, methyl methacrylate
and S Pharma
polymers
are your
preferred
intestine.
Polymers
offers
a broad choice
productofportfolio
low content of methacrylic acid ester with
and a
coating
quaternary
ofpolymers.
anionicIn
EUDRAGIT
They enable
grades
targeting
which
dissolve
specific
areas
pH andammonium
groups. The ammonium groups are
values.
addition,
the
different
grades
can at
berising
salts
make the polymers
present
of theas with
combined
permeable.
each
other,
making the
it possible
the forProduct
Form-Targeted
GranulesDrug Release Area- Time controlled
and
thus
to achieve
required toGIadjust
targeting
the drug.
dissolution
pH,
release,
pH
Targeted drug release in the colon is requiredindependent
for
local
Characteristicstreatment of intestinal disorders such as Crohns
Insoluble
disease,
High permeability
ulcerative colitis or intestinal cancer. It is also
pH independent swelling
required for
Customized release profile by combination of RL and
drugs that are poorly soluble in the upper
RS
gastrointestinal
grades in different ratios.
Moreover, the gastroresistance of the coating
tract.
Aqueous
Suitable for matrix structures
ensures
processing
that
the
oral
dosage
form
is
patient
compliant.
The
Structure
preferred
coating is EUDRAGIT FS 30 D, which combines release
in
the colon with the following technical advantages:

Nonproprietary
Names
Category
Description
Solubility
Film formation
Dry substance / Residue on
evaporation
Loss on drying
Storage
Stability
Incompatibilities

Ammonio Methacrylate Copolymer

Ph.Eur.
Bio adhesive material; controlled-release agent; emulsifying agent; emulsion stabilizer; rheology
modifier;
stabilizing agent; suspending agent; tablet binder, film former.
Colorless,
clear to cloudy
granules
a faint amine-like
1 g of the substances
dissolves
in 7with
g aqueous
methanol, odour
ethanol and isopropyl alcohol (containing
approx. 3 %
water), as well as in acetone, ethyl acetate and methylene chloride to give clear to cloudy solutions.
The
substances are practically insoluble in petroleum ether, 1 N sodium hydroxide and water.
When the Test solution is poured onto a glass plate a clear film forms upon evaporation of the
solvents.
Protect from warm
Not lessfrom
thanmoisture.
97.0 %. 1Itgtends
of thetosubstances
is at
dried
in an
oven for 5 hrs
in has
vacuum
at 80 C.on the
temperatures.
Protect
form lumps
warm
temperatures.
This
no influence
Max. 3.0The
% according to "Dry substance / Residue on evaporation."
quality.
lumps are easily broken up again.
Stable
at roomshowed
temperature.
Some NSAIDS
incompatibilities with Eudragits specifically Eudragit RL100 and
RS100.

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Abhijit Sonje et al. Int. Res. J. Pharm. 2013,

4 (5)
Eudragit RS
Characteristics100
3
Insoluble
It is a copolymer of Ethyl acrylate, methyl methacrylate
and a
High permeability
low content of methacrylic acid ester with pH independent swelling
quaternary
Customized release profile by combination of RL
ammonium groups. The ammonium groups are
and RS
present as
grades in different ratios.
salts and make the polymers permeable.
Suitable for matrix structures.
Product Form- Granules
Targeted
Structure Drug Release Area- Time controlled
release, pH
independent

Nonproprietary
Names
Category
Description
Solubility

Film formation
Dry substance /
Residue on
evaporation
Loss on drying
Storage
Stability
Incompatibilities

Ethacrylic acid copolymer

USP
Bio adhesive material; controlled-release agent; emulsifying agent; emulsion stabilizer; rheology modifier;
stabilizing
agent;
suspending
agent;
binder, film
White powder
with tablet
characteristic
faintformer.
odour
1 g of EUDRAGIT L 100 or EUDRAGIT S 100 dissolves in 7 g methanol, ethanol, in aqueous isopropyl alcohol
and
acetone (containing approx. 3 % water), as
well as in 1 N sodium
hydroxide to give clear to slightly cloudy
solutions.in ethyl acetate, methylene chloride, petroleum ether and
insoluble
EUDRAGIT
L 100
and is
EUDRAGIT
S 100
are plate,
practically
water.
When the Test
solution
poured onto
a glass
a clear film forms upon evaporation of the
solvent.
At least 95.0 %. 1 g powder is dried in an oven for 6 hrs at 110 C, according to Ph. Eur. 2.2.32
method.
Max. 5.0 % according to "Dry substance / Residue on
evaporation."
Protect from warm temperatures.
Protect
against
moisture
Stable at
room temperature.
The use of acidic film former like Eudragit L100 in instability of the acid labile proton pumps
inhibitors.

Figure: Versatile Polymers for Oral Solid Dosage

Formulations

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Abhijit Sonje et al. Int. Res. J. Pharm. 2013,

4 (5)
Applications
the
nano and ofmicrospheres/Tat
Eudragit RL andformulations
Eudragit RSare safe and
immunization
resistant to gastric
using novel
fluid. bilayer
Eudragit
films
L and
(109S
are 6-microm
+/soluble
induce
robustinand long-lasting cellular and humoral responses
thickness) containing plasmid DNA led to
Ophthalmic Drug Delivery
intestinal fluid at pH 6 and 7 respectively.
comparable
Eudragit
in
mice after
L issystemic
and/or concentration
mucosal immunization.
Weight
antigen-specific
IgG
to that
attainment
of an optimal
at the siteaqueous
of
dispersion.
Eudragit
S istiter
available
onlyofas an
A on
subcutaneous
major
problem
protein
being
faced
in ocular
therapeutics
is the
available
as the
ansolid.
organic
solution
action.
organic
adhesion
time
of bilayer
films.
Postloaded
plasmid
solution
buccal
route
(Isopropanol)
but none by
and
subcutaneous
Sodium
route
para with
(Isopropanol),
ratio
Poor
of bioavailability
Noveon solid
and Eudragit
or
of drugs
S-100
from
hadocular
a significant
dosageeffect
injection.
Allwere
rabbits
immunized
with plasmid
DNA
protein
aminosalicylate
Pellets
coated
with Eudragit
L 30 DNA
and
remained
stable
being releasedoffrom
antigen
splenocyte
proliferative
via
forms
thebeta-gal
is residence
D-55
transient
time,
andafter
impermeability
corneal demonstrated
using fluidized
bed processor
and evaluated
mainly
due to the tear production, non-productive immune
forbilayer
in vitro
absorption,
films
(release
-60-80%
in
2 behavior,
h for
both).
epithelium.
Eudragit
exhibits
favorable
suchresponses.
as no was changed
dissolution
behavior in
0.1 pH
N 6.8.
HCl Afor
two
Eudragit
Tests of
with
their
toxicity, positive
charge
and
controlled
release
media
to phosphate
buffer
60%
limits
3,10
Buccal
hours
and
then
profile
this
w/w
make them
suitable for opthalic application. 2,4,5,6,7,8,9
coating Limit
level of Eudragit L30 D 55 has produced
Test
theto most
cloudy crystals with faint amine like odour.
Buccal Description
and Sublingual Drug Delivery Colorless, clear
1 gm substance + 7 gm aq. Methanol
+ Ethanol + IPA + Acetone + Dichloromethane to give clear cloudy
acceptable
The oralSolubility
mucosae in general
are somewhat leaky
Colon Drugresults against the gastric attack.
solution.
Residue On
NLT 97% (1 gm of substance is dried in an oven for 5hrs at
epithelia
intermediate
between that of the epidermis
intestinal
Evaporation
80c. and Delivery
NMT 3%Colonic drug delivery is a relatively recent
approachLoss
forOn
the
Drying
Eudragit RL 100-8.85%-11.96% (on DS); Eudragit RS 100-4.48%-6.77% (on
mucosa.Refractive
It Assay
is estimated
that the permeability
of the buccal treatment of diseases like ulcerative colitis,
DS)
Index
1.380-1.385
Crohn's disease,
Relative Density
Sulphated
Ash
NMT
mucosa
is of
4-4000
timesgreater
greater
than
thatand
of buccal
theTegaserod
skin.0.816-0.836
In 0.1%
and irritable
bowel
the order
sublingual
than
buccal,
maleate
was used
assyndrome.
a drug forpH-sensitive
irritable
Maximum 20 ppm
polymers
that Metals
greaterHeavy
bowel
Arsenic
Maximum 2 ppm
than palatal.
At physiological
mucus
network
syndrome,
L 100
and
S100
general,
the
permeabilities
of pH
thethe
oral
mucosae
decrease
in whereas
dissolve,Eudragit
or above
pH 7
used
for colonic
Contains small amount of
Residual Solvent
drug
delivery.
carries a
mixture
(1:1,Eudragit RS-NMT 1%
Eudragit
Methanol
RL-NMT 1.5%;
3
negative
charge
(due to the sialic acid and sulfate 1:2,
and 1:3)
were used.
Microbial
Count
Transdermal
NMT 10 CFU Drug
/g
residues)
Delivery
the epithelial
cell surface as a gelatinous layer. Major
The mechanical properties of casted Eudragit
By IR Spectroscopy
Identification
whichfilms
may
a role route
in mucoadhesion.
At this
pH In between 8 to 25C
E-100
Storage
limitation
of play
the buccal
of administration
is the
mucus
were tested for the combined effect of two cohesion
lack
of
can
dosage
form
form
apolymers
strongly
retentionhave
cohesive
at theextensively
site
gel
of structure
absorption.
promoters
will Manipulation
or The
citric
acid) and
triacetin
as a
of drug release
usingprepared
Eudragit
L100-55
and elastic,
CONCLUSION
bioadhesive
beenthat
employed
in (succinic
plasticizer.
films
were
Eudragit
bind tothe above review process it can be
Consequently,
self-adhesive,
From
transparent
and
pale
yellow
in
colour.
Eudragit
E100
S100 combinations. J. Control. Rel.58, 215-222.
concluded
that
buccal
drug delivery
systems. Polymers which can adhere
to
polymer
7. http://dx.doi.org/
Eudragit
polymers
have
vast
role
in
the
either
hard
or
soft
tissue
have
been
used
for
many
years
in
was found to result in wrinkle-free
10.1016/S0168-3659(98)00151-5
surgery and dentistry. Diverse classes of polymers have
Madgulkar A., Kadam S and Pokharkar V., Development of
Formulation
and with
transparent
films
been
8. trilayered
Development
of suitable
dosage
formmonomeric
in treatment
of
adhesion
to
skin.E100
Release
kinetics
transdermal
include synthetic
polymers
such as
a good
hydrophilic
Eudragit
polymer,
and from
100%
mucoadhesive
tablet of itraconazole
with zero-order
release, Asian
various
investigated
for
their
potential
use
as
mucoadhesives.
These
therapeutic
system
was
observed
due to
release
was
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1
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K., Zeljko M. I. P., Nevenka K., 1999. A pH-dependentAbhijit
Various
vaginal
reversed
by
Eudragit
colon
mucoadhesive
including
tablets, acid
films,polymers.
infections.
gene
delivery.
addition,
many acquired diseases
Int. Res. J.In
Pharm.
2013; 4(4):71-74
targeted oral drugdevices,
delivery
using methacrylic
Gastrointestinal
Drug system
patches,
Delivery
copolymers.
The
need forI. gastroretentive dosage forms hassuch
led asto
genes could be treated by genetic therapy.
disks, strips, ointments, and gels, have recently
multigenetic disorders and those diseases caused
Nanoparticles
been
extensive
efforts
in
both
academia
and
industry
towards
by
the
viral
prepared
blending
PLGA
with
methacrylate
development of such drug delivery systems. These
(Eudragit(R)
E100) canby
efficiently
and
safely
deliver
developed. Eudragit providing good drug release barier
copolymer
efforts
plasmid
Source of support: Nil, Conflict of interest: None
with
resulted
in gastroretentive dosage
forms that were DNA encoding mouse interleukin-10 leading to
Declared
good adhesive strength.
designed,
prevention of
in large part, based on the following approaches, Low
autoimmune diabetes. New Anionic nanoparticles
density
were
form
of
the
dosage
form
that
causes
buoyancy
in
prepared
Eudragit
L100/55 provide
a versatile
the gastrointestinal tract by concomitant administration
of byactive
conformation
is required
for
gastric emptying
fluid,
platform oligodeoxynucleotides were successfully
vaccine
efficacy. of the dosage form through the
drugs
Antisense
Highdensity
dosage form that is retained in the bottom
for
protein surface adsorption and a promising
pyloric
delivered
of the
delivery
sphincter.
All these techniques we can achieved
by
nanoparticles prepared by Eudragit RL100, RS100.
stomach, Bioadhesion to stomach mucosa, Slowed system
with
Vaccineparticularly
Delivery when the maintenance of the
motility of
biologically
different
grades
of eudragit.
Anionic
surfactant-free polymeric core-shell
Intestinal
Drug Delivery
Sustained intestine delivery of drugs was developed
nanospheres
that
microspheres
and
were prepared by Eudragit
L100/55.
Vaccines
could bypass
the stomach and release the loaded
were administeredby different routes, including
drug for
intramuscular, subcutaneous or intranasal and the
long periods
the intestine
coating
eudragit
results
Eudragit
L andinto
Eudragit
S areby
two
formsofof
commercially
were compared to immunization with Tat alone
orpolymer.
with Tat
available enteric acrylic resins. Both of them produce films
delivered with the alum adjuvant. The data
demonstrate that
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