issue 2017 harke pharma news agent stability improver (no peroxide) tablet size reduction multi-...
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ADVANCE NOTICE – Preview 2018 DDF SUMMIT March 12 - 14 Berlin/Germany For further information please contact Dr. Brunemann: drb@harke.com
MAKING PHARMACEUTICALS March 13 - 14 Brussels/Belgium For further information please contact Mrs. Rösner: akr@harke.com
PBP WORLD MEETING March 19 - 22 Granada/Spain For further information please contact Dr. Shmyrova: dry@harke.com
MAKING PHARMACEUTICALS April 24 - 25 COVENTRY/UKFor further information please contact Dr. Brunemann: drb@harke.com
CPHI WORLDWIDE October 09 - 11 Madrid/SpainFor further information please contact Mrs. Rehländer: mr@harke.com
PHARMA TECH EXPO October 09 - 11 Kiev/UkraineFor further information please contact Dr. Shmyrova: dry@harke.com
PHARMTECH & INGREDIENTS November 20 - 23 Moscow/RussiaFor further information please contact Dr. Shmyrova: dry@harke.com
Content – HARKE Pharma News Issue 2017
1
Dear customer,
We are glad to present you our newsletter 2017. The focus this time is on Shin-Etsu excipients:
Application Overview Shin-Etsu Portfolio read more >> page 2
New Technical Information read more >> page 3
Granulation Seminar June 2018 read more >> page 3
Scientific Article„Modifying Mini-Tablet Dissolution With Cellulose Ethers“ read more >> page 4
We hope to give you some valuable information and would be happy to get feedback from you.
Please, don’t hesitate to contact us, if you need further information. You can either contact your local HARKE contact or use pharma@harke.com.
Your HARKE Pharma team
HARKE Pharma News Issue 2017
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Since more than 50 years, Shin-Etsu offers a range of special phar-maceutical cellulose derivatives with secured availability and com-petitive prices.
Application Overview Shin-Etsu Portfolio
HPMC (Hypromellose)
Key points Technical information1
Low viscous: coating, granulation § Stability of cellulose products§ Color coating with Pharmacoat®
§ Effect of plasticizers and other additives on themechanical properties of cast hypromellose films§ An advanced coating formulation with PVA and HPMC§ QbD approach to the formulation of hydrophilic
matrix tablets using Metolose® SR
High viscous: thickening, suspending, sustained release § Special SR-types2: narrow specification of
particle size distribution and substitution levelfor optimal reproducability of extended release
L-HPC (low substituted HPC)
Key points Technical information1
Binder + disintegrant: § Wet granulation, pellet extrusion § Dry granulation (roller compaction) § Direct compression
§ Roller compaction using L-HPC§ Pellets extrusion-spheronization using L-HPC§ Twin screw granulation using L-HPC§ Bilayer tablets using L-HPC and Metolose® SR§ Mini-tablets using L-HPC§ Super-high speed direct compression using
L-HPC NBD
Anti-capping agent
Stability improver (no peroxide)
Tablet size reduction
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SHIN-ETSU AQOAT® (HPMC acetate succinate)
Key points Technical information1
Enteric coating (aqueous or organic) § Solid dispersion using Shin-Etsu AQOAT® (HPMC AS)by hot melt extrusion§ Aqueous based enteric formulation of Shin-Etsu
AQOAT® containing amino acid as a stabilizerSolubility enhancement § Solid dispersion
(HME3, spray drying, co-precipitation)
1 More technical information available on request2 Sustained release3 Hot melt extrusion
For further information please contact us: dry@harke.com or drb@harke.com.
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■ Glass transition temperature of Hypromellose ■ Nifedipine solid dispersion using Shin-Etsu AQOAT® – preparation by HME and downstream processing ■ Aqueous enteric coating using Shin-Etsu AQOAT® from mini-tablets ■ Influence of tablet shape on capping tendency ■ Stability of HPMCP under humid storage conditions ■ Metolose® SR in 500 mg Metformin HCl extended release tablets: simulation of high speed compaction
For further information please contact us: dry@harke.com or drb@harke.com.
■ Roller compaction ■ High shear granulation ■ Fluid bed granulation ■ Twin screw granulation ■ Compaction simulation
The lectures will be held at Courtyard by Marriott, Wiesbaden-Nordenstadt. The practical demonstrations will take place in the laboratory of Shin-Etsu Pharma & Food Materials Distribution GmbH, Wiesbaden.
Current invited speakers are:
Dr. Frank Oprach, Global Technical Steward Solids, Novartis, Switzerland:Process Optimization in Tabletting
Dr. Valérie Vanhoorne, University of Ghent, Belgium:Continuous twin screw granulation with HPMC for controlled release
Dr. Joao Henriques, Hovione, Portugal:Roller Compaction Process Development for Amorphous Solid Dispersions
For further information please contact us: dry@harke.com or drb@harke.com.
ImprintHARKE Pharma GmbH, Xantener Straße 1, 45479 Mülheim an der Ruhr, Germany n Phone: +49 (0)208 3069 2000, Fax: +49 (0)208 3069 2300, e-mail: pharma@harke.com, web: www.harke.comCommercial register: Local Court Duisburg HRB Nr. 14531, VAT ID: DE 120339841 n Managing Directors:Dipl.-Kfm. Thorsten Harke, Daniel BurchartPublisher: Daniel Burchart (db@harke.com) n Authors: Dr. Jörg Brunemann (drb@harke.com), Mandy Rehländer (mr@harke.com), Dr. Julia Shmyrova (dry@harke.com), Madeleine Weselek-Norris (mwn@harke.com) n Editor: Wojciech Brzeska (wb@harke.com) n Picture: HARKE Pharma GmbH, fotolia.com, istockphoto.comPlease note: In case you are unwilling to receive our newsletter, please click here and send an e-mail to our editorial office (rk@harke.com).
Shin-Etsu is continuously striving to deliver new technical data for your formulation development. This is an extract of the latest new technical information sheets available from Shin-Etsu:
Save the date: 27th – 28th of June 2018, Wiesbaden, GermanyShin-Etsu is preparing a granulation seminar. The demonstrations in this seminar will be:
New Technical Information
Granulation Seminar June 2018
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„Modifying Mini-Tablet Dissolution with Cellulose Ethers“Dr. Andreas Sauer, Shin-Etsu Pharma & Food Materials Distribution GmbHDr. Dirk Schmalz, HARKE Pharma GmbH
Scientific Article
During the last twenty years the development of mini-tablets (de-fined to as being tablets smaller than 3 mm) has gained more and more interest.
Mini-tablets offer a flexible, yet robust and easy-to-manufacture approach to the requirements of heterogeneous patient groups like children or senior citizens, as well as patients with swallowing difficulties. Mini-tablets are pro-duced on standard tablet presses equipped with multi-tip-tooling.
Mini-tablets may be further pro-cessed into larger tablets (MUPS1) or filled into capsules. On long term, blends of mini-tablets may open a realistic way towards per-sonalized medicine.
Standard analysis methods have to be modified however to ac-count for their small dimensions compared to standard size tab-lets.
Functional cellulose derivatives can be used to prepare a wide range of mini-tablets as orodis-persible mini tablets (SmartExTM), acid-resistant ones (Shin-Etsu AQOAT®) or sustained release mini-tablets using high viscous Metolose® SR (HPMC 2208).
Published in:Pharmind, Pharm. Ind. 79,Nr. 11, 1556–1559 (2017)For complete article click here(http://bit.ly/HARKE_Mini-Tablet).
41 Multiple Unit Pellet System
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