Metolose SR QbD sample kits ®

Newsletter September-October 2013
Dear Readers,
We hope that you enjoyed reading our first newsletter last month.
As we move into the last quarter of this year we approach the busiest period with major trade shows.
Please take a look at this issue’s newsletter as we have new product technical information and details on our technical seminar in Europe.
Metolose SR® QbD sample kits
HME Cleaner
Quality by Design (QbD) principles have been used to advance
product and process quality, and most recently have been adopted
by the U.S. Food and Drug Administration (FDA) as a tool to
discover new drugs, developed, and commercially manufactured.
The focus of this concept is that quality should be built into a
product with a thorough understanding of the product and process
by which it is developed, and manufactured along with a
knowledge of the risks involved in manufacturing the product and
how best to mitigate those risks.
For the ICH Q8 guidelines on Pharmaceutical Development, many
customers are requesting samples of excipients which are having
an impact on the batch to batch quality of the final product.
Metolose SR is the simplest sustained release technology for oral
dosage forms. The ICH Q8 guidelines may require our customers
to evaluate samples that are on the edge of our specifications.
Due to our strict control in quality it is difficult to provide samples
within the outer limits of the specification, therefore Shin-Etsu this
year has produced Metolose SR QbD sample kits. Each kit contains
our regular specification, high and low viscosity and Hydroxypropoxy
(HPO) content and also large and small particle sizes. We have internally evaluated the sample kits and you can find this data in our
new technical information sheet SR-009.
Please ask one of your local Shin-Etsu representatives for further
information on our technical data and sample kits.
The Hot Melt Extrusion (HME) is an upcoming technology in the
pharmaceutical industry, especially for solubility enhancement for
poorly soluble drugs. One of the major advantages of this
technology is that it can be used in a continuous process.
With new technologies come new challenges within the industry,
and therefore Shin-Etsu has newly introduced the HME cleaner.
This cleaner makes the cleaning process easier after the
processing of solid dispersion by HME with enteric polymers such
as Shin-Etsu AQOAT® (HPMCAS) and HPMCP®. It consists of
hypromellose and other materials which have been widely accepted
as pharmaceutical excipients. HME cleaner is highly safe for the
operation and contributes effective cleaning due to its high
detergency and low residual property.
For further technical information on using our polymers in HME
application and cleaning agent, please contact your local
Shin-Etsu representative.
Trade shows
Please come and visit us at the following trade shows. We will have technical teams available
who will be happy to answer any questions and we can also book private or confidential meetings.
Shin-Etsu, Germany will exhibit at CPhI 2013. The biggest and most
important trade show in the pharmaceutical market is taking place
from 22nd - 24th October 2013 in Frankfurt, Germany.
This year is a very exciting year for us as we have new products and
technologies that we will be exhibiting with our sales and technical
team. If you are visiting CPhI then please come and visit our booth
which is at Hall no. 6.2, Stall no. 62E51. It will provide us opportunity
to make valuable contact with our customers and show the
strength of Shin-Etsu. We look forward to meeting you!
CPhI Worldwide
22nd-24th October 2013
Frankfurt, Germany
Hall no. 6.2 , Stall no. 62E51
The AAPS (American Association of Pharmaceutical Scientists)
will be held in San Antonio, USA from the 10th-14th November 2013.
We will be at the exhibition hall and would like to invite you to come
visit us at our booth 4123. Our technical team will be available and
very happy to discuss new and existing projects. With the launch
of our new application lab in New Jersey, USA we can also discuss
with you any technical support requirements for your projects.
We will also be presenting technical posters at the following sessions:
Preparation of ODTs with taste masked coated pellets –
M.Fukasawa AM-13-0707
Effect of polymer properties on improvement of drug dissolution
from solid dispersions: Solubility parameters and surface
tension-F.Tanno, S.Obara AM-13-3401
Shin-Etsu, India will exhibit at CPhI India 2013, which will be taking
place from 03rd to 05th December 2013 in Mumbai, India. As the
pharma industry is increasingly looking towards India for high
quality, low cost pharma solutions, this event is the perfect place
for companies to pick up on the latest trends and innovations the
market has to offer. Please visit us at Hall no. 1, Stall no. G2 and,
at Hall no. 1 Stall no E8 to discuss about new products and
technologies with Shin-Etsu sales and technical team.
CPhI India
03rd-05th December 2013
Mumbai, India
Hall no. 1, Stall no. G2 & Hall no. 1, Stall no .E8
A Robustness Study of an Extended-Release Tablet Formulation
Using a Sample Kit of Hypromellose for Quality-by-Design
Concept-S.Obara AM-13-2676
10th-14th November 2013
San Antonio, USA
Booth no. 4123
Technical Seminar
Novel Applications using cellulose derivatives in Solid dosage
We are pleased to announce that we have organised a two-day
technical seminar. The programme is a mixture of lectures and
demonstrations and this will be held at our Wiesbaden, Germany
site from the 10th-11th December 2013.
Shin-Etsu have advanced technologies to ensure that the products
that we deliver you are of the highest quality, and for the first time
we have organised a seminar at one of our plants. There will be a
tour of our HPMC plant and demonstrations on hot melt extrusion,
injection moulding, core coating and our new aqueous coating
The seminar is free of charge for our customers, however due to
small groups for our demonstration we highly recommend that you
register as soon as possible.
For further information please visit our website or e-mail: | [email protected]
Technical Information
Shin-Etsu are continuously striving to deliver new technical data
for your formulation development. Please take a look at this month’s
new technical information sheets that are available from your local
Shin-Etsu representative.
(Quality by Design) approach to the formulation of hydrophilic
matrix tablets using METOLOSE® SR
Examples of QbD study using METOLOSE QbD sample kits
(100, 4000, 15000, 100000, 28 samples in total) and Dipyridamole as
a model drug.
Aqueous Dispersion Coating Using Shin-Etsu AQOAT® Granule
Coating (Batch Size 10 kg) by bottom spray method
Introduction of coating trials with bottom spray and 10 kg batch
size from Nitin Bhusane (Shin-Etsu, India)
Orally disintegrating tablets using NBD grades
Preparation of ODT with NBD by spray granulation and direct
Partly neutralized coating technique using Shin-Etsu AQOAT®
New coating technique which the solution is partly (approx. 30%)
neutralized. With this technique, the chiller is not required and acid
resistance can be obtained with shorter processing time.
We have also updated our technical brochures: Pharmacoat®,
HPMCP®, Metolose®, Metolose SR® & Shin-Etsu Aqoat®.
Japan / Asia
SE Pharma & Food Materials Distribution GmbH
Rheingaustr. 190-196, 65203 Wiesbaden
Shin-Etsu Chemical Co., Ltd.
Cellulose Technical Support Center, YBP Technical center, 134,
Godo-cho, Hodogaya-ku, Yokohama, 240-0005, Japan
Phone +49 611 962-6199
Phone +81 45 459-5415
Fax +49 611 962-9777
[email protected]
SE Tylose USA, Inc.
Pharmaceutical Application Laboratory
140 Commerce Way, Suite H, Totowa, NJ 07512-1158
Shin-Etsu Singapore Pte. Ltd.
India Branch Office
Ashoka Estate, Barakhamba Road, New Delhi 110001
Phone: +1 973-837-8001
Phone +91 11 43623081
Fax: +1 973-339-9094
Fax +91 1143623084