EUDRAGIT®

Acrylic Polymers for Solid

Oral Dosage Forms

EUDRAGIT® Technical Formulation Proof of GMP Advanced

1Products
2Support
3
Development
4 Concept
5 Services
6Drug Delivery

Evonik. Power to create.

When it comes to targeted drug release profiles, EUDRAGIT®
is the pharmaceutical industry’s preferred choice of product.
The range of EUDRAGIT® Poly(meth)acrylate-based products
provides full flexibility for your solid oral dosage forms.
EUDRAGIT® Polymers –
Pharmaceutical Properties
The basis of our offerings are masking to increase patient A distinction is made between 2. Poly(meth)acrylates; inso-
our Poly(meth)acrylates for compliance. The range of our 1. Poly(meth)acrylates; soluble luble but permeable in digestive
pharmaceutical applications, product portfolio provides full in digestive fluids by salt forma- fluids EUDRAGIT® RL and RS
which are known worldwide flexibility for your targeted tion EUDRAGIT® L, S, FS and E polymers with alkaline and
in the industry under the trade drug release profiles by offering polymers with acidic or alkaline EUDRAGIT® NE polymers with
name EUDRAGIT®. These po- best performance for enteric, groups enable pH-dependent neutral groups enable con-
lymers allow the active in your protective or sustained-release release of the active ingredient. trolled time release of the active
solid dosage form to perform properties. Applications: from simple taste ingredient by pH-independent
during the passage of the human masking through gastric resis- swelling.
body. The flexibility to combine EUDRAGIT® polymers are tance to controlled drug release Applications: delayed and
the different polymers enables copolymers derived from esters in all sections of the intestine sustained drug release
you to achieve the desired drug of acrylic and methacrylic acid,
release profile by releasing the whose physicochemical proper-
drug at the right place and at ties are determined by functio-
the right time and, if necessary, nal groups (R). EUDRAGIT®
over a desired period of time. polymers are available in a wide
Other important functions are range of different physical forms
protection from external influ- (aqueous dispersion, organic
ences (moisture) or taste/odor solution granules and powders).

Methacrylic copolymers
Functional group: carboxylic acid
R = COOH (anionic) Aminoalkyl
methacrylate copolymers
EUDRAGIT® L 100/S 100/L 100-55 (powders) Functional group: dimethyl aminoethyl
EUDRAGIT® L 30 D-55 / FS 30 D R = COOCH2 CH2 N(CH3)2 (cationic)
(aqueous dispersion 30%) EUDRAGIT® E 100 (granules)
EUDRAGIT® L 12,5 / S 12,5 EUDRAGIT® E 12,5 (organic solution 12.5%)
(organic solution 12.5%)
Gastroresistant and EUDRAGIT® E PO (powder)
enterosoluble
Gastrosoluble and
enteroresistent

CH3(H) CH3
I I
--- C – CH2 – C – CH2---
I I
COO-Alkyl R
Ammonioalkyl
Methacrylate copolymers methacrylate copolymers
Functional group: trimethylammonioethyl
Functional group: neutral esters
R = COOCH2 CH2N+(CH3)3CI- (neutral)
R = COOCH3 or COOC4H9 (neutral)
EUDRAGIT® RL 100 (granules)
EUDRAGIT® NE 30 D / 40 D / NM 30 D EUDRAGIT® RL PO / RS PO (powders)
(aqueous dispersion 30% / EUDRAGIT® RL 30 D / RS 30 D
40% polymer content) (aqueous dispersion 30%)
EUDRAGIT® RL 12,5 / RS 12,5
(organic solution 12.5%)
Insoluble, permeable; Insoluble, permeable or dispersable;
pH-independent pH-independent

2 3
Enteric Formulations

EUDRAGIT® offers valuable Gastroresistance and

advantages for your enteric GI Targeting
coatings:
If you need to protect your active product portfolio of anionic
▯ pH-dependent drug release from the gastric fluid and would EUDRAGIT® grades which
like to improve drug effective- dissolve at rising pH values. Targeted drug release in the gastrointestinal tract. Moreover, with the following technical
▯ Protection of actives sensitive ness – EUDRAGIT® L and S In addition, the different colon is required for local treat- the gastroresistance of the advantages:
to gastric fluid polymers are your preferred grades can be combined with ment of intestinal disorders such coating ensures that the oral ▯ aqueous processing
choice of coating polymers. each other, making it possible as Crohn’s disease, ulcerative dosage form is patient compliant. ▯ highly flexible coatings
▯ Protection of gastric mucosa They enable targeting specific to adjust the dissolution pH, colitis or intestinal cancer. It is The preferred coating is ▯ suitable for multiparticulate
from aggressive actives areas of the intestine. Pharma and thus to achieve the required also required for drugs that are EUDRAGIT® FS 30 D, which tablet preparation
Polymers offers a broad GI targeting for the drug. poorly soluble in the upper combines release in the colon
▯ Increase in drug effectiveness
▯ Good storage stability
▯ GI and colon targeting 350

300

250
EUDRAGIT® Polymer Availability Dissolution Properties

L 30 D-55 30 % Aqueous Dispersion 200

Dissolution rate [mg/min g]

Dissolution above pH 5.5
L 100-55 Powder 150

L 100 Powder
100
Dissolution above pH 6.0 EUDRAGIT® L 30 D-55
L 12,5 12.5 % Organic Solution
50 EUDRAGIT® L 12,5
S 100 Powder
EUDRAGIT® L/S 12,5 (1:1)
0
S 12,5 12.5 % Organic Solution Dissolution above pH 7.0 EUDRAGIT® FS 30 D
5 5.5 6 6.5 7 7.5 8
FS 30 D 30 % Aqueous Dispersion pH-value EUDRAGIT® S 12,5

Take your active to the right place. When it is a long

way to the target and still the target has to be hit exactly,
EUDRAGIT® offers the right solution.

4 5
Protective Formulations

Our protective polymers are melt extrusion process. During interacts with the anionic active
suitable for aqueous or organic the melt extrusion process the which provides excellent taste
coatings and can be applied in a cationic EUDRAGIT® E polymer masking properties.

Moisture Protection and

Odor/Taste Masking
Do you need to protect your EUDRAGIT® E polymers help making it an extremely eco- Take advantage of protective
active from moisture or light and
would like to increase patient
you to seal sensitive actives and
increase patient compliance by
nomical application. Pharma
Polymers offer various cationic
EUDRAGIT® coatings:
compliance? masking tastes and odors. EUDRAGIT® E grades for
Even thin layers of EUDRAGIT® protective coatings. ▯ pH-dependent drug release
provide the desired effect,
▯ Protection of sensitive actives
▯ Taste and odor masking
▯ Moisture protection
EUDRAGIT® Polymer Availability Dissolution Properties ▯ Economical application
E 100 Granules Soluble in gastric fluid
up to pH 5.0
▯ Improved passage of the dosage form
E 12,5 12.5 % Organic Solution
Swellable and permeable
above pH 5.0
▯ Smooth and glossy surfaces, good color coating
E PO Powder

EUDRAGIT® offers a strong protection

of sensitive contents and improved
patient compliance.

6 7
 Sustained-Release
Formulations

Time-Controlled Drug Release Matrix tablets Multiparticular tablets

Whether you need your drug profile. Drug delivery can be allow custom-tailored release There are two EUDRAGIT® serves as a matrix EUDRAGIT® is employed as a
to release over a specific period controlled throughout the entire profiles to achieve the desired formulation options: within which the active ingre- coating material, usually for the
of time or would like to benefit gastrointestinal tract to increase drug delivery performance. dient is embedded. The matrix coating of pellets or particles
from the advantages of multi- the therapeutic effect and EUDRAGIT® NE and NM grades structure is obtained by direct that are filled into capsules or
particulate or matrix formula- patient compliance. Different are neutral ester dispersions compression, granulation, or compressed into tablets. These
tions – EUDRAGIT® can help polymer combinations of which do not require addition melt extrusion. EUDRAGIT® pellets or particles act as diffusion
you achieve your desired release EUDRAGIT® RL and RS grades of plasticizer. NM 30 D is particularly suitable cells in the digestive tract and
for granulation processes in the release a constant drug quantity
manufacture of matrix tablets. per unit of time (multi-unit
dosage forms).

EUDRAGIT® Polymer Availability Dissolution Properties

RL 100 Granules

RL PO Powder Insoluble
High permeability
RL 30 D 30 % Aqueous Dispersion pH-independent swelling Benefit from EUDRAGIT® coatings
RL 12,5 12.5 % Organic Solution
with sustained release:
RS 100 Granules

RS PO Powder Insoluble ▯ Time-controlled release of active ingredients

RS 30 D 30 % Aqueous Dispersion
Low permeability
pH-independent swelling ▯ Therapeutically customized release profiles
RS 12,5 12.5 % Organic Solution ▯H igher patient compliance due to reduced number
NE 30 D 30 % Aqueous Dispersion Insoluble, low permeability
pH-independent swelling
of doses to be taken
NE 40 D 40 % Aqueous Dispersion No plasticizer required
Highly flexible
▯ Cost-effective processing
NM 30 D 30 % Aqueous Dispersion

Controlled release:
EUDRAGIT® enables formulations which
allow customer-tailored release profiles and
releases over a specific period of time.

8 9
 Value Chain

Market Strength by means of

Strategic Partnership
Pharma Polymers, a business line ▯ advanced technical support ▯ increased efficiency in their
of Evonik Industries, offers the ▯ formulation development R&D and manufacturing
complete line of EUDRAGIT® ▯ proof of concept processes
products and related services ▯ GMP services. ▯ new drug delivery
along the value chain of our technologies
customers. For over 50 years Our customers see us as a ▯ reduction of the time to
we have proven our reliability strategic partner for their market for their developments
as a quality partner to the developments of solid oral ▯ professional management of
pharmaceutical industry. Our dosage forms with a targeted their product’s life cycle
state of the art services cover drug release profile. By using
various stages of the develop- our value adding business
ment processes, including model our customers get:

Our contribution
Advanced
to your value chain
6 Drug Delivery

GMP ▯Highly sophisticated

5 Services drug release profiles

▯Transfer of enabling
concepts
Proof of ▯Clinical batch

4
▯IP protection &
Concept manufacturing exclusivity
▯EUDRAGIT®
Value added by Pharma Polymers

expertise for various

Formulation ▯E
 fficient develop-

3
process technologies
Development ment to reduce time
to market
▯C
 ustomer tailored
Technical ▯ Matching desired

2
formulation concept
Support release profiles by
various process
technologies
EUDRAGIT ®
▯ Technical training

1
▯ One source from
Products ▯ On site scale-up & feasibility to clinical
production support sample
▯ Feasibility testing
▯U
 nique drug release
functionality
▯F
 lexible toolbox
(enteric, protective
& time control)

Intensity of partnership
10
 Further information is available This information and all further technical
from the following addresses: advice is based on our present knowledge and
experience. However, it implies no liability or

EUDRAGIT®
www.eudragit.com other legal responsibility on our part, including
with regard to existing third party intellectual
Germany China property rights, especially patent rights. In parti-
Evonik Röhm GmbH Evonik Degussa (China) Co., Ltd. cular, no warranty, whether express or implied,
Pharma Polymers Pharma Polymers or guarantee of product properties in the legal
Kirschenallee 55 Chungdong Road sense is intended or implied. We reserve the
64293 Darmstadt Xinzhuang Industry Park right to make any changes according to techno-

Versatile Polymers for Oral

PHONE +49 6151 18-4019 Shanghai 201 108 logical progress or further developments. The
FAX +49 6151 18-3520 PHONE +86 21 6119 1032 customer is not released from the obligation
[email protected] FAX +86 21 6119 1116 to conduct careful inspection and testing of
[email protected] incoming goods. Performance of the product

Solid Dosage Formulations

described herein should be verified by testing,
USA Japan which should be carried out only by qualified
Evonik Degussa Corporation Evonik Degussa Japan Co. Ltd. experts in the sole responsibility of a customer.
Pharma Polymers Pharma Polymers Reference to trade names used by other com-
2 Turner Place, PO Box 365 Shinjuku Monolith 12F panies is neither a recommendation, nor does it

EUDRAGIT®
Piscataway, NJ 08855 2-3-1, Nishi-Shinjuku imply that similar products could not be used.
PHONE +1 732 981-5383 Shinjuku-ku
FAX +1 732 981-5484 Tokyo 163-0938 Evonik Röhm GmbH is the owner of patent
Duodenum pH > 5.5 [email protected] PHONE +81 3 5323-8794 rights covering the use of EUDRAGIT® polymers
FAX +81 3 5323-8789 in compositions, procedures and/or applications
EUDRAGIT ® L 30 D-55
EUDRAGIT ® L 100-55 India
[email protected] which may be subject to license agreements.
Compositions, procedures and/or applications
falling within the claims of patents related
at a glance
Evonik Degussa India Pvt. Ltd. to EUDRACOL® and EUDRAPULSE® and
Pharma Polymers EUDRAMODE® will always require separate
Research Centre license agreements.
Ileum, Colon delivery pH > 7.0
Jejunum pH 6-7 Saki Vihar Road, Saki Naka
Mumbai 400 072
EUDRAGIT ® S 100
EUDRAGIT ® L 100 PHONE +91 22 6723-8800 ® = registered trademark
EUDRAGIT ® S 12,5 FAX +91 22 6723-8811
EUDRAGIT ® FS 30 D EUDRAGIT ® L 12,5 [email protected] EUDRAGIT = reg. Trademark of Evonik Röhm
GmbH, Darmstadt, Germany

Enteric Formulations
Stomach pH 1 - 5

EUDRAGIT ® E 100
EUDRAGIT ® E 12,5
EUDRAGIT ® E PO

P rote c tive Fo rm u l a ti o n s

EUDRAGIT®
1 2 3 4 5 6
Technical Formulation Proof of GMP Advanced
Time controlled release Products Support Development Concept Services Drug Delivery
pH independent Evonik Röhm GmbH
Pharma Polymers
EUDRAGIT ® RL 30 D Kirschenallee
EUDRAGIT ® RL PO
64293 Darmstadt
EUDRAGIT ® RL 100
Germany
EUDRAGIT ® RL 12,5
EUDRAGIT ® RS 30 D PHONE +49 6151 18-4019
EUDRAGIT ® RS PO FAX +49 6151 18-3520
EUDRAGIT ® RS 100 www.evonik.com
EUDRAGIT ® RS 12,5
EUDRAGIT ® NE 30 D
EUDRAGIT ® NE 40 D
EUDRAGIT ® NM 30 D

Evonik. Power to create. Evonik. Power to create.

S us t a i n e d - Re l ea s e Fo r m u l a ti o n s
Einhefter_EUDRAGIT_190x260 09 RZ.indd 4-6 18.08.2009 9:37:44 Uhr
 Further information is available This information and all further technical
from the following addresses: advice is based on our present knowledge and
experience. However, it implies no liability or

EUDRAGIT®
www.eudragit.com other legal responsibility on our part, including
with regard to existing third party intellectual
Germany China property rights, especially patent rights. In parti-
Evonik Röhm GmbH Evonik Degussa (China) Co., Ltd. cular, no warranty, whether express or implied,
Pharma Polymers Pharma Polymers or guarantee of product properties in the legal
Kirschenallee 55 Chungdong Road sense is intended or implied. We reserve the
64293 Darmstadt Xinzhuang Industry Park right to make any changes according to techno-

Versatile Polymers for Oral

PHONE +49 6151 18-4019 Shanghai 201 108 logical progress or further developments. The
FAX +49 6151 18-3520 PHONE +86 21 6119 1032 customer is not released from the obligation
[email protected] FAX +86 21 6119 1116 to conduct careful inspection and testing of
[email protected] incoming goods. Performance of the product

Solid Dosage Formulations

described herein should be verified by testing,
USA Japan which should be carried out only by qualified
Evonik Degussa Corporation Evonik Degussa Japan Co. Ltd. experts in the sole responsibility of a customer.
Pharma Polymers Pharma Polymers Reference to trade names used by other com-
2 Turner Place, PO Box 365 Shinjuku Monolith 12F panies is neither a recommendation, nor does it

EUDRAGIT®
Piscataway, NJ 08855 2-3-1, Nishi-Shinjuku imply that similar products could not be used.
PHONE +1 732 981-5383 Shinjuku-ku
FAX +1 732 981-5484 Tokyo 163-0938 Evonik Röhm GmbH is the owner of patent
Duodenum pH > 5.5 [email protected] PHONE +81 3 5323-8794 rights covering the use of EUDRAGIT® polymers
FAX +81 3 5323-8789 in compositions, procedures and/or applications
EUDRAGIT ® L 30 D-55
EUDRAGIT ® L 100-55 India
[email protected] which may be subject to license agreements.
Compositions, procedures and/or applications
falling within the claims of patents related
at a glance
Evonik Degussa India Pvt. Ltd. to EUDRACOL® and EUDRAPULSE® and
Pharma Polymers EUDRAMODE® will always require separate
Research Centre license agreements.
Ileum, Colon delivery pH > 7.0
Jejunum pH 6-7 Saki Vihar Road, Saki Naka
Mumbai 400 072
EUDRAGIT ® S 100
EUDRAGIT ® L 100 PHONE +91 22 6723-8800 ® = registered trademark
EUDRAGIT ® S 12,5 FAX +91 22 6723-8811
EUDRAGIT ® FS 30 D EUDRAGIT ® L 12,5 [email protected] EUDRAGIT = reg. Trademark of Evonik Röhm
GmbH, Darmstadt, Germany

Enteric Formulations
Stomach pH 1 - 5

EUDRAGIT ® E 100
EUDRAGIT ® E 12,5
EUDRAGIT ® E PO

P rote c tive Fo rm u l a ti o n s

EUDRAGIT®
1 2 3 4 5 6
Technical Formulation Proof of GMP Advanced
Time controlled release Products Support Development Concept Services Drug Delivery
pH independent Evonik Röhm GmbH
Pharma Polymers
EUDRAGIT ® RL 30 D Kirschenallee
EUDRAGIT ® RL PO
64293 Darmstadt
EUDRAGIT ® RL 100
Germany
EUDRAGIT ® RL 12,5
EUDRAGIT ® RS 30 D PHONE +49 6151 18-4019
EUDRAGIT ® RS PO FAX +49 6151 18-3520
EUDRAGIT ® RS 100 www.evonik.com
EUDRAGIT ® RS 12,5
EUDRAGIT ® NE 30 D
EUDRAGIT ® NE 40 D
EUDRAGIT ® NM 30 D

Evonik. Power to create. Evonik. Power to create.

S us t a i n e d - Re l ea s e Fo r m u l a ti o n s
Einhefter_EUDRAGIT_190x260 09 RZ.indd 4-6 18.08.2009 9:37:44 Uhr
 EUDRAGIT®
Versatile Polymers for Oral Solid Dosage Formulations Delivery and Packaging
Applications EUDRAGIT® Grades Product Form Functionality Dissolution Advantages Monographs + DMFs Grade Unit (kg, net) Packaging Storage Flash Point
Properties
Enteric Formulations EUDRAGIT® L 30 D-55 5, 30, 200*, 1000**

Aqueous Dispersions
EUDRAGIT® L 100-55 Powder Effective and stable enteric
Drug delivery in duodenum Dissolution above pH 5.5 coatings with a fast dissolution Ph. Eur., USP/NF, JPE, DMF 2584 EUDRAGIT® NE 30 D 5, 30, 600**

EUDRAGIT® L 30 D-55 Aqueous Dispersion 30 % in the upper bowel

Polyethylene Protect from freezing.
EUDRAGIT® NE 40 D canister Store at controlled room temperature.
EUDRAGIT® L 100 Powder Ph. Eur., USP/NF, JPE, DMF 1242
Granulation of drug substances EUDRAGIT® NM 30 D Polyethylene Not
Drug delivery in jejunum Dissolution above pH 6.0 drum* flammable
Anionic polymers with methacrylic in powder form for controlled release
EUDRAGIT® L 12,5 Organic Solution 12.5 % DMF 1242
acid as a functional group EUDRAGIT® RS 30 D 5, 30 Polyethylene
pH-dependent

container**
EUDRAGIT® S 100 Powder Site specific drug delivery in Ph. Eur., USP/NF, JPE, DMF 1242
EUDRAGIT® RL 30 D Protect from freezing and do
intestine by combinations of not store above 25 °C (77 °F).
Colon delivery EUDRAGIT® S 12,5 Organic Solution 12.5 % Dissolution above pH 7.0 EUDRAGIT® L/S grades DMF 1242
EUDRAGIT® FS 30 D Protect from freezing. Store between
+5 °C and +10 °C (41 °F and 50 °F).
EUDRAGIT® FS 30 D Aqueous Dispersion 30 % Variable release profiles DMF 13941

Protective Formulations
EUDRAGIT® L 100

EUDRAGIT® E 100 Granules Ph. Eur., USP/NF, JPE, DMF 1242

Insulating coatings: EUDRAGIT® L 100-55
• Taste masking Cationic polymer with dimethyl- Low viscosity, high pigment binding
• Odor masking EUDRAGIT® E 12,5 Organic Solution 12.5 % aminoethyl methacrylate as a Soluble in gastric fluid up to pH 5.0 capacity, good adhesion, low polymer DMF 1242

Solid Substances
• Moisture protection functional group Swellable and permeable above pH 5.0 weight gain EUDRAGIT® S 100
• Light protection
EUDRAGIT® E PO Powder Ph. Eur., JPE, DMF 1242 5, 20 PP box with Store at controlled room temperature.
EUDRAGIT® RS 100 polyethylene Protect against moisture.
inner bag
Sustained-Release Formulations Not
EUDRAGIT® RL 100 flammable
EUDRAGIT® RL 30 D Aqueous Dispersion 30 % USP/NF, DMF 1242
EUDRAGIT® RS PO
EUDRAGIT® RL PO Powder Insoluble
High permeability Ph. Eur., USP/NF, JPE, DMF 1242 EUDRAGIT® RL PO
EUDRAGIT® RL 100 Granules pH independent swelling

EUDRAGIT® E 100 Protect from warm temperatures.

Protect against moisture.
pH-independent

Customized release profiles by

EUDRAGIT® RL 12,5 Organic Solution 12.5 % Meth-/acrylate copolymers with combination of RL and RS grades in DMF 1242
Sustained release formulations trimethyl-ammonioethyl- different ratios EUDRAGIT® E PO 10 Store at temperatures up to 25 °C
methacrylate as a functional group (77 °F). Protect against moisture.
EUDRAGIT® RS 30 D Aqueous Dispersion 30 % USP/NF, DMF 1242
Suitable for matrix structures

EUDRAGIT® RS PO Powder
EUDRAGIT® E 12,5 -15 °C (5 °F)

Organic Solutions
Ph. Eur., USP/NF, JPE, DMF 1242 Protect from warm temperatures.
EUDRAGIT® RS 100 Granules Store in tightly closed containers.
EUDRAGIT® L 12,5
Insoluble 4, 20, 150
EUDRAGIT® RS 12,5 Organic Solution 12.5 % Low permeability DMF 1242 Steel drum with Protect from warm temperatures. -13.5 °C
pH independent swelling exterior lacquer coat Store in tightly closed containers. (56.3 °F)
EUDRAGIT® S 12,5
EUDRAGIT® NE 30 D Aqueous Dispersion 30 % Ph. Eur., USP/NF, JPE, DMF 2822 and poly- Do not store at temperatures below
ethylene lining 10 °C (50 °F).
Sustained release formulations, No plasticizer required,
suitable for matrix structures EUDRAGIT® NE 40 D Aqueous Dispersion 40 % Neutral polymer of meth-/acrylates highly flexible DMF 2822 EUDRAGIT® RS 12,5
and miscible with other Protect from warm temperatures.
EUDRAGIT® grades Suitable for matrix structures 4, 20 -15 °C (5 °F)
Store in tightly closed containers.
EUDRAGIT® NM 30 D Aqueous Dispersion 30 % Ph. Eur., DMF 2822 EUDRAGIT® RL 12,5

Stability: Minimum stability dates are stated on the product labels and batch related certificates of analysis. Storage stability data is available upon request.

Einhefter_EUDRAGIT_190x260 09 RZ.indd 1-3 18.08.2009 9:37:43 Uhr

 EUDRAGIT®
Versatile Polymers for Oral Solid Dosage Formulations Delivery and Packaging
Applications EUDRAGIT® Grades Product Form Functionality Dissolution Advantages Monographs + DMFs Grade Unit (kg, net) Packaging Storage Flash Point
Properties
Enteric Formulations EUDRAGIT® L 30 D-55 5, 30, 200*, 1000**

Aqueous Dispersions
EUDRAGIT® L 100-55 Powder Effective and stable enteric
Drug delivery in duodenum Dissolution above pH 5.5 coatings with a fast dissolution Ph. Eur., USP/NF, JPE, DMF 2584 EUDRAGIT® NE 30 D 5, 30, 600**

EUDRAGIT® L 30 D-55 Aqueous Dispersion 30 % in the upper bowel

Polyethylene Protect from freezing.
EUDRAGIT® NE 40 D canister Store at controlled room temperature.
EUDRAGIT® L 100 Powder Ph. Eur., USP/NF, JPE, DMF 1242
Granulation of drug substances EUDRAGIT® NM 30 D Polyethylene Not
Drug delivery in jejunum Dissolution above pH 6.0 drum* flammable
Anionic polymers with methacrylic in powder form for controlled release
EUDRAGIT® L 12,5 Organic Solution 12.5 % DMF 1242
acid as a functional group EUDRAGIT® RS 30 D 5, 30 Polyethylene
pH-dependent

container**
EUDRAGIT® S 100 Powder Site specific drug delivery in Ph. Eur., USP/NF, JPE, DMF 1242
EUDRAGIT® RL 30 D Protect from freezing and do
intestine by combinations of not store above 25 °C (77 °F).
Colon delivery EUDRAGIT® S 12,5 Organic Solution 12.5 % Dissolution above pH 7.0 EUDRAGIT® L/S grades DMF 1242
EUDRAGIT® FS 30 D Protect from freezing. Store between
+5 °C and +10 °C (41 °F and 50 °F).
EUDRAGIT® FS 30 D Aqueous Dispersion 30 % Variable release profiles DMF 13941

Protective Formulations
EUDRAGIT® L 100

EUDRAGIT® E 100 Granules Ph. Eur., USP/NF, JPE, DMF 1242

Insulating coatings: EUDRAGIT® L 100-55
• Taste masking Cationic polymer with dimethyl- Low viscosity, high pigment binding
• Odor masking EUDRAGIT® E 12,5 Organic Solution 12.5 % aminoethyl methacrylate as a Soluble in gastric fluid up to pH 5.0 capacity, good adhesion, low polymer DMF 1242

Solid Substances
• Moisture protection functional group Swellable and permeable above pH 5.0 weight gain EUDRAGIT® S 100
• Light protection
EUDRAGIT® E PO Powder Ph. Eur., JPE, DMF 1242 5, 20 PP box with Store at controlled room temperature.
EUDRAGIT® RS 100 polyethylene Protect against moisture.
inner bag
Sustained-Release Formulations Not
EUDRAGIT® RL 100 flammable
EUDRAGIT® RL 30 D Aqueous Dispersion 30 % USP/NF, DMF 1242
EUDRAGIT® RS PO
EUDRAGIT® RL PO Powder Insoluble
High permeability Ph. Eur., USP/NF, JPE, DMF 1242 EUDRAGIT® RL PO
EUDRAGIT® RL 100 Granules pH independent swelling

EUDRAGIT® E 100 Protect from warm temperatures.

Protect against moisture.
pH-independent

Customized release profiles by

EUDRAGIT® RL 12,5 Organic Solution 12.5 % Meth-/acrylate copolymers with combination of RL and RS grades in DMF 1242
Sustained release formulations trimethyl-ammonioethyl- different ratios EUDRAGIT® E PO 10 Store at temperatures up to 25 °C
methacrylate as a functional group (77 °F). Protect against moisture.
EUDRAGIT® RS 30 D Aqueous Dispersion 30 % USP/NF, DMF 1242
Suitable for matrix structures

EUDRAGIT® RS PO Powder
EUDRAGIT® E 12,5 -15 °C (5 °F)

Organic Solutions
Ph. Eur., USP/NF, JPE, DMF 1242 Protect from warm temperatures.
EUDRAGIT® RS 100 Granules Store in tightly closed containers.
EUDRAGIT® L 12,5
Insoluble 4, 20, 150
EUDRAGIT® RS 12,5 Organic Solution 12.5 % Low permeability DMF 1242 Steel drum with Protect from warm temperatures. -13.5 °C
pH independent swelling exterior lacquer coat Store in tightly closed containers. (56.3 °F)
EUDRAGIT® S 12,5
EUDRAGIT® NE 30 D Aqueous Dispersion 30 % Ph. Eur., USP/NF, JPE, DMF 2822 and poly- Do not store at temperatures below
ethylene lining 10 °C (50 °F).
Sustained release formulations, No plasticizer required,
suitable for matrix structures EUDRAGIT® NE 40 D Aqueous Dispersion 40 % Neutral polymer of meth-/acrylates highly flexible DMF 2822 EUDRAGIT® RS 12,5
and miscible with other Protect from warm temperatures.
EUDRAGIT® grades Suitable for matrix structures 4, 20 -15 °C (5 °F)
Store in tightly closed containers.
EUDRAGIT® NM 30 D Aqueous Dispersion 30 % Ph. Eur., DMF 2822 EUDRAGIT® RL 12,5

Stability: Minimum stability dates are stated on the product labels and batch related certificates of analysis. Storage stability data is available upon request.

Einhefter_EUDRAGIT_190x260 09 RZ.indd 1-3 18.08.2009 9:37:43 Uhr

Further information is available This information and all further technical
advice is based on our present knowledge
from the following addresses: and experience. However, it implies no
liability or other legal responsibility on
www.eudragit.com our part, including with regard to existing
third party intellectual property rights,
especially patent rights. In particular,
Germany China no warranty,whether express or implied,
Evonik Röhm GmbH Evonik Degussa (China) Co., Ltd. or guarantee of pro-duct properties in
the legal sense is intended or implied.
Pharma Polymers Pharma Polymers We reserve the right to make any changes
Kirschenallee 55 Chungdong Road according to technological progress or
Xinzhuang Industry Park further developments. The customer
64293 Darmstadt
is not released from the obligation to
phone +49 6151 18-4019 Shanghai 201 108 conduct careful inspection and testing
fax +49 6151 18-3520 phone +86 21 6119 1032 of incoming goods. Performance of
fax +86 21 6119 1116 the product described herein should be
[email protected]
verified by testing, which should be
[email protected] carried out only by qualified experts in
the sole responsibility of a customer.
Reference to trade names used by other
USA Japan companies is neither a recommendation,
Evonik Degussa Corporation Evonik Degussa Japan Co. Ltd. nor does it imply that similar products
Pharma Polymers Pharma Polymers could not be used.

2 Turner Place, PO Box 365 Shinjuku Monolith 12F Evonik Röhm GmbH is the owner of
Piscataway, NJ 08855 2-3-1, Nishi-Shinjuku patent rights covering the use of
phone +1 732 981-5383 Shinjuku-ku EUDRAGIT® polymers in compositions,
procedures and/or applications which
fax +1 732 981-5484 Tokyo 163-0938 may be subject to license agreements.
[email protected] phone +81 3 5323-8794 Compositions, procedures and/or
fax +81 3 5323-8789 applications falling within the claims of
patents related to EUDRACOL® and
[email protected] EUDRAPULSE® and EUDRAMODE®
will always require separate license
India agreements.

Evonik Degussa India Pvt. Ltd.

Pharma Polymers ® = registered trademark
Research Centre
EUDRAGIT = reg. Trademark of Evonik
Saki Vihar Road, Saki Naka Röhm GmbH, Darmstadt, Germany
Mumbai 400 072
phone +91 22 6723-8800
fax +91 22 6723-8811
[email protected]

Evonik Röhm GmbH

Pharma Polymers
Kirschenallee
64293 Darmstadt
Germany
phone +49 6151 18-4019
fax +49 6151 18-3520
www.evonik.com

Evonik. Power to create.