Sie sind auf Seite 1von 12

RESOMER

Reaching the target


without leaving traces

Evonik offers bioresorbable


polymers and drug delivery systems
that not only set industry standards,
but also open new directions
for therapy development.

Proven high-tech products


Evonik offers a broad range of biodegradable polymers for medical device,
parenteral controlled drug release
and regenerative medicine applications.
The polymers we develop and manufacture expand the possibilities for
improved targeting combined with
precise delivery timing for one or
even several active pharmaceutical
ingredients.

Semi-crystalline polymers such as homoand copolymers of L-lactide, D,L-lactide,


glycolide, caprolactone, dioxanone
are typically used to produce medical
devices such as orthopedic and soft tissue
fixation devices.
Amorphous polymers such as homo- and
copolymers of D,L-lactide and glycolide are
the key excipients for many sustained release drug delivery systems.

Highest process standards


The polymers are produced by complex
processes which have been optimized
to assure consistent quality.
One key strength is Evoniks purification
process that yields material with very
low residual monomer, which is essential for thermal processing and the
controlled delivery of proteins and
peptides.

Evonik is your partner through your entire


product life cycle. You can determine the
scope of our involvement and always count
on us for reliable supply around the world
and around the corner.
We maintain safety inventory levels for all
standard products, and when it comes to
RESOMER Select, we deliver customized
solutions.

Quality that you can rely on


Evonik places particular emphasis on
the quality of its products. All materials
are carefully tested prior to further
processing.
All products are subjected to continuous
quality control measures during the
production process which complies with
GMP guidelines. A certificate of analysis
is issued for every batch produced.

All plant operations meet relevant


Environment, Health, and Safety (EHS)
requirements.
All our business activities are DIN ISO
9001 certified. Our products are covered
by a DMF or MAF, filed with the FDA and
are updated annually.
Technical documentation can be provided
for all non-US registrations on request.

Polymer properties that are outstanding


The main benefit of RESOMER is that
it is safely resorbed by the body after
implantation or injection.
By modification of molecular weight
and polymer composition, the degradation rate and mechanical stability can
be adopted to the individual requirements of the application.

Degradable polymers do not pose any


handling problems with regard to processing, storage or safety. They are available
in granular form mainly for medical
applications or as a powder for pharmaceutical formulations.
Stability studies are available, showing the
long-term shelf life of the polymers under
proper storage conditions.

Medical application
The RESOMER product portfolio contains polymers for the production of
bioresorbable implants, medical devices
and tissue engineering solutions for
either repairing bones, replacing body
functions or helping organs repair
themselves.
These medical devices can also be combined with drugs for controlled release
over time.

Bioresorbable plates and screws for trauma


and orthopedicapplications, bioabsorbable
stents and coatings for next generation
cardiovascular treatments are just a few
products made by our RESOMERfamily
of bioresorbable polymers.
The advantages are:
proven safety track record,
no adverse reactions,
complete metabolization,
easy processing.

Pharmaceutical application
RESOMER is synonymous with parenteral controlled release delivery systems
that keep pushing the therapeutic frontier, from nanoparticles to drug-eluting
films and particles.
This opens the possibility of more treatment options for APIs, reducing drug
loads and enhancing patient compliance
and comfort.

Our implant technology works with biodegradable as well as non-biodegradable


polymers, providing you with a drug
delivery platform that offers more possibilities for fine-tuning drug release and
degradation profiles. We can formulate
most drug classes into implants, such as
small molecules and peptides.
Evoniks proprietary FormEZEdelivery
technology, for instance, can deliver drug
solids via a 27-G needle for enhanced bioavailability and greater patient comfort,
including easier self-administration.

RESOMER Select Your vision realized


Depending on your requirements, we
can synthesize customized polymers
from lab to production scale.
Let us know your needs. Our polymer
development experts are up to any
challenge!

You can be sure that we leave no avenue


unexplored and take into account all the
relevant drivers, such as
monomer choice and ratios,
end group chemistry,
inherent viscosity or molecular weight,
PEG or mPEG chemistry,
solubility,
degradation.

RESOMER Select naming


Monomer ratio
Example
85 mole % DL-lactide
15 mole % glycolide
Momomer ratios vary
between 0:100 and 100:0
allowing for a broad range
of polymer properties

85

15

DLG

Polymer identifier
Example
DL-lactide-co-glycolide
DLG Poly(DL-lactide-co-glycolide)
DL Poly(DL-lactide)
LG Poly(L-lactide-co-glycolide)
CL Polycaprolactone
DLCL Poly(DL-lactide-co-caprolactone)
LCL Poly(L-lactide-co-caprolactone)
G Polyglycolide
L
Polylactide
PEG
Poly(ethylene glycol)
mPEG
Methoxy-poly(ethylene glycol)

Target IV designator
Example
IV Spec 0.350.45 dL/g
Target IV: 0.40 dL/g
IV Designator IV Range*
1 0.050.15
1.5 0.100.20
2 0.150.25
2.5 0.200.30
3 0.250.35
3.5 0.300.40
4 0.350.45
4.5 0.400.50
5 0.450.55
6 0.500.70
7 0.600.80
8 0.700.90
9 0.801.00
*0.1% w/v in CHCl3 at 25C

Custom polymers available


up to 8 dL/g

End group
Control various polymer
properties (degradation and water
uptake) by modifying end-groups:
Acid (A) or Ester (E)

RESOMER product range


Medical device applications

Controlled release applications

Product name

IV [dL/g]

Poly(L-lactide)

Product name

IV [dL/g]

Poly(D,L-lactide)

RESOMER L 206 S

0.81.2

RESOMER R 202 S

0.160.24

RESOMER L 207 S

1.52.0

RESOMER R 202 H

0.160.24

RESOMER L 209 S

2.63.2

RESOMER R 203 S

0.250.35

RESOMER L 210 S

3.34.3

RESOMER R 203 H

0.250.35

RESOMER R 205 S

0.550.75

Poly(L-lactide-co-D,L-lactide) 70:30
RESOMER LR 704 S

2.02.8

Poly(D,L-lactide-co-glycolide) 50:50

RESOMER LR 706 S

3.34.2

RESOMER RG 502

0.160.24

RESOMER LR 708

5.76.5

RESOMER RG 502 H

0.160.24

RESOMER RG 503

0.320.44

RESOMER RG 503 H

0.320.44

RESOMER RG 504

0.450.60

Poly(L-lactide-co-glycolide) 82:18
RESOMER LG 824 S

1.72.6

Poly(L-lactide-co-glycolide) 85:15
RESOMER LG 855 S

2.53.5

RESOMER RG 504 H

0.450.60

RESOMER LG 857 S

5.07.0

RESOMER RG 505

0.610.74

Poly(L-lactide-co-e-caprolactone) 70:30

1.31.8

1.31.7

1.52.2*

RESOMER C 202

0.20.26

RESOMER C 203

RESOMER C 209

RESOMER LC 703 S
Poly(D,L-lactide)

Poly(D,L-lactide-co-glycolide) 65:35
RESOMER RG 653 H

0.320.44

Poly(D,L-lactide-co-glycolide) 75:25
RESOMER RG 752 H

0.140.22

RESOMER RG 752 S

0.160.24

RESOMER RG 753 H

0.320.44

RESOMER RG 753 S

0.320.44

RESOMER RG 755 S

0.500.70

0.350.43

RESOMER RG 756 S

0.71.0

0.81.2

RESOMER RG 750 S

0.81.2

RESOMER C 212

1.131.38

Poly(D,L-lactide-co-glycolide) 85:15

RESOMER C 217

1.531.87

RESOMER RG 858 S

RESOMER R 207 S
Poly(dioxanone)
RESOMER X 206 S
Poly(caprolactone)

Inherent viscosity is measured at 0.1 % w/v in CHCl3 at 25C with a Ubbelhode size 0c glass capillary viscometer
*Inherent viscosity is measured at 0.1 % w/v in HFIP at 30C with a Ubbelhode size 0b glass capillary viscometer

1.31.7

Europe, Middle East, Africa


Evonik Industries AG
Kirschenallee
64293 Darmstadt
Germany
PHONE +49 6151 18-4019
fax +49 6151 18-3520
resomer-germany@evonik.com
North America
Evonik Corporation
2 Turner Place, PO Box 365
Piscataway, NJ 08855
USA
PHONE +1 973 929 8163
fax +1 973 929 8160
resomer-usa@evonik.com
Latin America, Mexico
Evonik Degussa Brasil Ltda
Alameda Campinas 579 - 5 andar
CEP 01404-000 - So Paulo
Brazil
PHONE +55 11 3146 4138
fax +55 11 3146 4140
resomer-latinamerica@evonik.com
India, Bangladesh
Evonik India Pvt. Ltd.
Krislon House, Saki Vihar Road,
Sakinaka, Andheri (East)
Mumbai 400072
India
PHONE +91 22 6624 6908
fax +91 22 6624 6996
resomer-india@evonik.com

South East Asia, Australia &


New Zealand, Pakistan
Evonik (SEA) Pte. Ltd.
3 International Business Park
#0718 Nordic European Centre
Singapore 609927
Republic of Singapore
PHONE +65 6809 6666
fax +65 6809 6663
resomer-sea@evonik.com
China
Evonik Specialty Chemicals
(Shanghai) Co. Ltd.
55 Chundong Road
Xinzhuang Industry Park
Shanghai 201108
Peoples Republic of China
PHONE +86 21 6119 1032
fax +86 21 6119 1473
resomer-china@evonik.com
Japan, Taiwan
Evonik Japan Co. Ltd.
Shinjuku Monolith 12 F
2-3-1, Nishi-Shinjuku
Shinjuku-ku, Tokyo 163-0938
Japan

Disclaimer
This information and all further technical
advice is based on our present knowledge
and experience. However, it implies no
liability or other legal responsibility on
our part, including with regard to existing
third party intellectual property rights,
especially patent rights. In particular, no
warranty, whether expressed or implied,
or guarantee of product properties in the
legal sense is intended or implied. We
reserve the right to make any changes
according to technological progress or
further developments. The customer is not
released from the obligation to conduct
careful inspection and testing of incoming
goods. Performance of the product described herein should be verified by testing,
which should be carried out only by qualified experts in the sole responsibility of a
customer. Reference to trade names used
by other companies is neither a recommendation, nor does it imply that similar
products could not be used.

= registered trademark

RESOMER = reg. trademark of


Evonik Rhm GmbH, Darmstadt, Germany

PHONE +81 3 5323-7375


fax +81 3 5323-8789
resomer-japan@evonik.com
South Korea
Evonik Korea Ltd.
#601603 CCMM B/D,
101 Yeouigongwon-ro,
Yeongdeungpo-gu, Seoul 150869
Korea
PHONE +82 2 320 4792
fax +82 2 783 2530
resomer-korea@evonik.com

Evonik Industries AG

resomer@evonik.com
resomer-select@evonik.com
www.resomer.com
www.evonik.com

April 2015, V 2.5

Pharma Polymers & Services


Kirschenallee
64293 Darmstadt
Germany

Das könnte Ihnen auch gefallen