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Solid Dosage and Excipients 2014 - Pharmaceutical Technology Magazine

Solid Dosage and Excipients 2014 - Pharmaceutical Technology Magazine

Ratings: (0)|Views: 85 |Likes:
Published by Kirbyx
Pharmaceutical Technology ebook series
Pharmaceutical Solid Dosage and Excipient 2014

EDITORIAL

Editorial Director Rita Peters rpeters@advanstar.com
Managing Editor Susan Haigney shaigney@advanstar.com
Scientific Editor Adeline Siew, PhD asiew@advanstar.com
Manufacturing Editor Jennifer Markarian jmarkarian@advanstar.com
Community Editor Melanie Sena msena@advanstar.com
Art Director Dan Ward
Contributing Editors Jill Wechsler jwechsler@advanstar.com; Jim Miller info@
pharmsource.com; Hallie Forcinio editorhal@cs.com; Susan J. Schniepp sue.schniepp@mac.com;
Eric Langer info@bioplanassociates.com; and Cynthia A. Challener, PhD challener@vtlink.net
Correspondents Hellen Berger (Latin/South America, hellen.berger@terra.com.br),
Sean Milmo (Europe, smilmo@btconnect.com), and Jane Wan (Asia, wanjane@live.com.sg)
485 Route One South, Building F, Second Floor, Iselin, NJ 08830, USA
Tel. 732.596.0276, Fax 732.647.1235, PharmTech.com


4 Controlled-Release Technologies
Create Opportunities for
Solid-Dosage Drug Formulators
by Cynthia A. Challener

16 Selection of Excipients
in Generic Formulations
by Aloka Srinivasan

24 A Practical Guide to Hot-Melt Extrusion
Scale-Up for Pharmaceutical Applications
by Justin R. Hughey

30 Safety by Design—Mitigating the Risk
of Medication Errors Through Product Design
An Interview with Kamlesh Oza and Perry Cozzone of Colorcon

36 Using Modular Systems
in Solid-Dosage Manufacturing
by Pär Almhem, Reiner Lemperle, and Camilla Sivertsson

44 Obtaining User-Defined Particle
Size Distribution Using Dry Granulation
by Dejan Djuric

48 A Quality-by-Design Approach to Optimize
In-Process Curing of EUDRAGIT NM 30 D
by Thomas Dassinger, Jessica Müller-Albers, and Sascha Jautze
Pharmaceutical Technology ebook series
Pharmaceutical Solid Dosage and Excipient 2014

EDITORIAL

Editorial Director Rita Peters rpeters@advanstar.com
Managing Editor Susan Haigney shaigney@advanstar.com
Scientific Editor Adeline Siew, PhD asiew@advanstar.com
Manufacturing Editor Jennifer Markarian jmarkarian@advanstar.com
Community Editor Melanie Sena msena@advanstar.com
Art Director Dan Ward
Contributing Editors Jill Wechsler jwechsler@advanstar.com; Jim Miller info@
pharmsource.com; Hallie Forcinio editorhal@cs.com; Susan J. Schniepp sue.schniepp@mac.com;
Eric Langer info@bioplanassociates.com; and Cynthia A. Challener, PhD challener@vtlink.net
Correspondents Hellen Berger (Latin/South America, hellen.berger@terra.com.br),
Sean Milmo (Europe, smilmo@btconnect.com), and Jane Wan (Asia, wanjane@live.com.sg)
485 Route One South, Building F, Second Floor, Iselin, NJ 08830, USA
Tel. 732.596.0276, Fax 732.647.1235, PharmTech.com


4 Controlled-Release Technologies
Create Opportunities for
Solid-Dosage Drug Formulators
by Cynthia A. Challener

16 Selection of Excipients
in Generic Formulations
by Aloka Srinivasan

24 A Practical Guide to Hot-Melt Extrusion
Scale-Up for Pharmaceutical Applications
by Justin R. Hughey

30 Safety by Design—Mitigating the Risk
of Medication Errors Through Product Design
An Interview with Kamlesh Oza and Perry Cozzone of Colorcon

36 Using Modular Systems
in Solid-Dosage Manufacturing
by Pär Almhem, Reiner Lemperle, and Camilla Sivertsson

44 Obtaining User-Defined Particle
Size Distribution Using Dry Granulation
by Dejan Djuric

48 A Quality-by-Design Approach to Optimize
In-Process Curing of EUDRAGIT NM 30 D
by Thomas Dassinger, Jessica Müller-Albers, and Sascha Jautze

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Published by: Kirbyx on May 23, 2014
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USA
1515 South Federal Highway, Suite 204Boca Raton - Florida
Tel: (561) 416-5513Fax: (561) 416-5663
www.blanver.com
A global leader, with 30 years of experience and customers in over 100 countries, Blanver provides fundamental performance ingredients for the pharmaceutical, food and cosmetic industries. Our consistent investment in R&D has ensured that our products are recognized worldwide for their quality and efficiency.
Microcel
(Microcrystalline Cellulose)
Tabulose SC
(Microcrystalline Cellulose +Carboxymethylcellulose Sodium)
Solutab
 (Croscarmellose Sodium)
Explosol
(Sodium Starch Glycolate)
Sorb-Cel
(Effervescent Base)
Excipients
Excipients for Nutritional &
Pharmaceutical Industries
 
Advancing Development & Manufacturing
PharmTech.com
2014
SOLID DOSAGEAND EXCIPIENTS
eBOOK SERIES
 
©2014 Advanstar Communications Inc. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical including by photoco py, recording, or information storage and retrieval without permission in writing from the publisher. Authorization to photocopy items for internal/educational or personal use, or the internal/educational or personal use of specific clients is granted by Advanstar Communications Inc. for libraries and other users registered with the Copyright Clearance Center, 222 Rosewood Dr. Danvers, MA 01923, 978.750.8400 fax 978.646.8700 or visit http://www.copyright.com online. For uses beyond those listed above, please direct your written request to Permission Dept. fax 440.756.5255 or email: mcannon@advanstar.com.
PharmTech.com
 CONTROLLED RELEASE
4
 Controlled-Release Technologies Create Opportunities for Solid-Dosage Drug Formulators
Cynthia A. Challener
 GENERIC󰀭DRUG FORMULATIONS
16
 Selection of Excipients in Generic Formulations
 Aloka Srinivasan
 HOT󰀭MELT EXTRUSION
24
 A Practical Guide to Hot-Melt Extrusion Scale-Up for Pharmaceutical Applications
 Justin R. Hughey
 PRODUCT DESIGN
30
 Safety by Design—Mitigating the Risk of Medication Errors Through Product Design
An Interview with Kamlesh Oza and Perry Cozzone of Colorcon
 MODULAR SYSTEMS
36
 Using Modular Systems in Solid-Dosage Manufacturing
Pär Almhem, Reiner Lemperle, and Camilla Sivertsson
 GRANULATION
44
 Obtaining User-Defined Particle Size Distribution Using Dry Granulation
Dejan Djuric
 QUALITY BY DESIGN
48
 A Quality-by-Design Approach to Optimize In-Process Curing of EUDRAGIT NM 30 D
Thomas Dassinger, Jessica Müller-Albers, and Sascha Jautze
52
 Ad Index
Solid Dosage and Excipients 2014
Issue Editor: Rita Peters. On the Cover: Robert George Young/Photographer’s Choice RF/Getty Images; Dan Ward
EDITORIAL
Editorial Director
Rita Peters
 rpeters@advanstar.comManaging Editor
Susan Haigney
 shaigney@advanstar.comScientific Editor
Adeline Siew, PhD
 asiew@advanstar.comManufacturing Editor
 Jennifer Markarian
 jmarkarian@advanstar.comCommunity Editor
Melanie Sena
 msena@advanstar.comArt Director
Dan Ward
 Contributing Editors
 Jill Wechsler
 jwechsler@advanstar.com;
 Jim Miller
 info@pharmsource.com;
Hallie Forcinio
 editorhal@cs.com;
Susan J. Schniepp
 sue.schniepp@mac.com;
Eric Langer
 info@bioplanassociates.com; and
Cynthia A. Challener, PhD
 challener@vtlink.net Correspondents
Hellen Berger
 (Latin/South America, hellen.berger@terra.com.br),
Sean Milmo
 (Europe, smilmo@btconnect.com), and
 Jane Wan
 (Asia, wanjane@live.com.sg) 
485 Route One South, Building F, Second Floor, Iselin, NJ 08830, USATel. 732.596.0276, Fax 732.647.1235,
PharmTech.com
SALES
Publisher
Mike Tracey
 mtracey@advanstar.com Director of Sales
Paul Milazzo
 pmilazzo@advanstar.comMid-West Sales Manager
Irene Onesto
 ionesto@advanstar.comEastern Sales Manager
Cheryl L. Wall
 cheryl.wall@advanstar.comEuropean Sales Manager
 Chris Lawson
 clawson@advanstar.comEuropean Senior Sales Executive
Christine Joinson
 cjoinson@advanstar.comDisplay, Web, Classified, and Recruitment Representative
Tod McCloskey
 tmccloskey@advanstar.com,Executive Assistant
Barbara Sefchick
 bsefchick@advanstar.comSr. Production Manager
Karen Lenzen
International Licensing
Maureen Cannon
 mcannon@advanstar.com, tel. 440.891.2742 or toll-free 800.225.4569 ext 2742,
 
fax. 440.756.5255Audience Development Manager
Kristina Bildeaux
 kbildeaux@advanstar.com 
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Chief Executive Officer
Tom Florio,
Chief Executive Officer Fashion Group, Executive Vice-President
Tom Ehardt,
Executive Vice-President, Chief Administrative Officer & Chief Financial Officer
Georgiann DeCenzo,
Executive Vice-President
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Executive Vice-President
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Executive Vice-President
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Executive Vice-President, Business Systems
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Executive Vice-President, Human Resources
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Sr Vice-President
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Vice-President, Legal
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Vice-President, Media Operations
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Vice-President, Treasurer & Controller
Pharmaceutical Technology
does not verify any claims or other information appearing in any of the advertisements contained in the publication and cannot take any responsibility for any losses or other damages incurred by readers in reliance on such content.
Pharmaceutical Technology
welcomes unsolicited articles, manuscripts, photographs, illustrations, and other materials but cannot be held responsible for their safekeeping or return. Advanstar Communications provides certain customer contact data (such as customers’ names, addresses, phone numbers and e-mail addresses) to third parties who wish to promote relevant products, services, and other opportunities which may be of interest to you. If you do not want Advanstar Communications to make your contact information available to third parties for marketing purposes, simply call toll-free 866.529.2922 between the hours of 7:30 am and 5 pm CT and a customer service representative will assist you in removing your name from Advanstar’s lists. Outside the United States, please phone 218.740.6477.
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 Contact Tamara Phillips, Marketing Services, tel. 440.891.2773, tphillips@advanstar.com.
Display, Web,
Classified, and Recruitment Advertising: Contact Tod McCloskey, tel. 440.891.2739, tmccloskey@advanstar.com.
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