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DDT Cover/Back April 2006.Qx February 2007 Vol 7 No 2 IN THIS ISSUE INTERVIEW WITH 3M DDS’ GENERAL MANAGER MR. JAMES VAUGHAN Formulating Proteins & Peptides 18 Cindy H. Dubin Implant Technologies 44 Daniel Ruppar MDI Valve Technology 48 John Olley Ocular Delivery 52 Aniruddha C. Amrite Uday B. Kompella, PhD Lecithin Organogels 60 I.M. Shaikh, MPharm K.R. Jadhav, MPharm Underpaid CEOs 74 The science & business of specialty pharma, biotechnology, and drug delivery John A. Bermingham Mr. Derek Mr. John Stephen E. Hennecke Sullivan Zweig, PhD Xcelience: Excelling Growing Global Smart Self- & Accelerating its Market for Injection: Partners’ Science “Combination Incorporating Products” Presents Drug Stability www.drugdeliverytech.com Regulatory Monitors Into the Challenges for Injection Device American Firms February 2007 Vol 7 No 2 PUBLISHER/PRESIDENT Ralph Vitaro EXECUTIVE EDITORIAL DIRECTOR Dan Marino, MSc [email protected] CREATIVE DIRECTOR Shalamar Q. Eagel CONTROLLER Debbie Carrillo CONTRIBUTING EDITORS Cindy H. Dubin Debra Bingham Jason McKinnie TECHNICAL OPERATIONS Mark Newland EDITORIAL SUPPORT Nicholas D. Vitaro ADMINISTRATIVE SUPPORT Kathleen Kenny Corporate/Editorial Office 219 Changebridge Road, Montville, NJ 07045 Tel: (973)299-1200 Fax: (973) 299-7937 www.drugdeliverytech.com Advertising Sales Offices East & Midwest Victoria Geis - Account Executive Cheryl S. Stratos - Account Executive 103 Oronoco Street, Suite 200 Alexandria, VA 22314 Tel: (703) 212-7735 Fax: (703) 548-3733 E-mail: [email protected] E-mail: [email protected] West Coast Warren De Graff Western Regional Manager 818 5th Avenue, Suite 301 San Rafael, CA 94901 Tel: (415) 721-0644 Fax: (415) 721-0665 E-mail: [email protected] International Ralph Vitaro 219 Changebridge Road Montville, NJ 07045 2 Tel: (973) 299-1200 o N Fax: (973) 299-7937 7 E-mail: [email protected] l o V Mailing List Rental 7 Candy Brecht 0 0 Tel: (703) 706-0383 2 y Fax: (703) 549-6057 r a u E-mail: [email protected] r b e F All editorial submissions are handled with reasonable care, but the publishers assume no responsibility for the safety of artwork, photographs, or manuscripts. Every precaution is taken to ensure accuracy, but publishers cannot accept y responsibility for the accuracy of information supplied herein or for any opinion expressed. Drug Delivery Technology g o (ISSN 1537-2898) is published 10 times in 2007, January, February, March, April, May, June, July/August, September, l o October, and November/December by Drug Delivery Technology LLC, 219 Changebridge Road, Montville NJ 07045. n h Subscription rates: $99.00 for 1 year in the United States, Canada, and Mexico. $153.00 for 1 year outside the United c e States, Canada, and Mexico. All subscriptions are payable in US funds, drawn on US banks. Send payment to: Drug T Delivery Technology LLC subscription Department, 219 Changebridge Road, Montville NJ 07045. Single copies (prepaid) y r $15.00, US, Canada, and Mexico; $24.00 in all other countries. Add $5.00 per order for shipping and handling. e v i Periodicals Postage Paid at Montville, NJ 07045-9998 and additional mailing offices. Postmaster: please send l e address changes to Drug Delivery Technology, 219 Changebridge Road, Montville NJ 07045. All rights reserved under D the U.S., International and Pan-American Copyright Conventions. All rights reserved. No part of this publication may g u be reproduced or transmitted in any form or by any means, electronic or mechanical, including by photocopy, recording, r D or information storage and retrieval system, without written permission from the publisher. Authorization to photocopy items for internal or personal use, or the internal or personal use of specific clients, is granted by Drug Delivery Technology LLC for libraries and other users registered with the Copywrite Clearance, 222 Rosewood Drive, Danvers, MA 4 01923; phone: (978) 750-8400, fax: (978) 750-4470. 18 Overcoming Formulation Challenges of Proteins & Peptides Contributing Editor Cindy H. Dubin interviews several experts who believe interest in the delivery of proteins and peptides is increasing daily, and due to certain constraints, this area of research offers an interesting challenge to conduct further research and to achieve acceptable and cost-effective delivery of proteins and macromolecules for patients. 22 Smart Self-Injection: Incorporating Drug Stability Monitors Into the Injection Device Stephen E. Zweig, PhD, says that because self-injection devices are frequently used outside of a normal clinical setting, there is an increased risk that the drugs may accidentally deteriorate due to inadvertent exposure to improper thermal conditions. The safety and effectiveness “As American companies develop new of drug injection devices can be improved by incorporating drug stability monitors into the injection medical devices and combination products, device. they will need to continue to be aware of 28 Growing Global Market for “Combination Products” Presents Regulatory Challenges recent and upcoming changes in the for American Firms regulatory environment of each European John Sullivan and Henrik Elbaek, MSc, MBA, believe as American companies develop new medical devices and and Asian country that presents a potential combination products, they will need to continue to be aware of recent and upcoming changes in the regulatory marketing opportunity. As these products environment of each European and Asian country that presents a potential marketing opportunity. grow more sophisticated, so does the regulatory process that is set in place to 44 Implant Technologies Expected to Remain a Niche but Effective Method of Drug 2 o N protect the consumers who will be Delivery 7 l o Frost & Sullivan Industry Manager Daniel Ruppar says that V 7 benefiting from them.” implant technologies, with the ability to reduce the 0 0 2 frequency of patient-driven dosing and deliver y r a u compounds in a targeted manner, have the capacity to r b e F provide a differentiated way to meet the unique y g therapeutic needs of patients. o l o n h c e T y r e v i l e D g u r D p.28 6 48 Developments in MDI Valve Technology Ensure Better Patient Compliance John Olley describes the development of a unique MDI valve (BK361 Easifill) designed to have fast fill/fast drain characteristics that allow the metering chamber to fully refill after actuation or storage, eliminating LOP, reducing dosing variability, and helping to improve patient compliance. 52 Nanoparticles & Microparticles: Particle Engineering, Cell Uptake, In Vivo Disposition & Efficacy Aniruddha C. Amrite and Uday B. Kompella, PhD, summarize their investigations in particle engineering, biopharmaceutics, and pharmacokinetics of particulate systems, and safety and efficacy of particulate systems, primarily as they relate to ophthalmic applications. “To overcome the aforementioned 57 3M Drug Delivery Systems: Providing Customer-Focused Solutions limitations of conventional topical and oral Drug Delivery Executive: Mr. James Vaughan, 3M Drug Delivery Systems’ General Manager, details his organization’s modes of administration for retinal delivery, new strategic direction now that it has sold one of its branded pharmaceuticals business segment. local delivery approaches are currently being investigated. The intravitreal and 60 Lecithin Organogels as a Drug Delivery System: A Review periocular routes are alternatives that can I.M. Shaikh, MPharm; K.R. Jadhav, MPharm; V.J. Kadam, PhD; and S.S. Pisal, PhD; review salient features, formation, and various deliver greater dose fraction to the retina, applications of lecithin organogels as drug delivery systems. resulting in dose reduction and reduced 67 Xcelience: Excelling & Accelerating its systemic toxicity.” Partners’ Science Drug Delivery Executive: Derek Hennecke, Chief Executive Officer of Xcelience, talks about his company as well as its 2 o drug development and manufacturing solutions. N 7 l o V 7 0 DEPARTMENTS 0 2 y r a u Market News & Trends . .. 11 r b e F Advanced Delivery Devices . 40 y g o l o Needle-Free Injections Using a Spring-Powered Device for n h c e Subcutaneous, Intramuscular & Intradermal Injections T y r e v i l Drug Delivery Showcase . .. 70 e D g p.52 u r External Delivery . .. 74 D Why CEOs are Underpaid! 8 9 Drug Delivery Technology April 2006 Vol 6 No 4 Dan Marino, MSc Executive Editorial Director Drug Delivery Technology Jack Aurora, PhD John A. Bermingham Matthew D. Burke, PhD Senior Director, R&D President & CEO Investigator, Perrigo Company Ampad, LLC Pharmaceutical Development GlaxoSmithKline Sarath Chandar, MBA Mahesh Chaubal, Gary W. Cleary, PhD, Vice President, Global PhD, MS PharmD, MBA Marketing & Commercial Associate Director President & CTO Development Baxter Healthcare Corium International SPI Pharma Sonya Summerour James N. Czaban, JD John Fraher Clemmons, PhD, MBA, MS Attorney at Law President, North America Director, Business Heller Ehrman White & Eurand Development McAuliff, LLPP MediVas, LLC Philip Green, PhD Keith Horspool, PhD Ravi Kiron, PhD, MBA Executive Director, New Director of Business Director, Research Technology Assessment & Development Formulations Planning Advanced Drug Delivery Pfizer Global Research & ALZA Corporation BD Development David Monteith, PhD, MBA Uday B. Kompella, PhD James W. McGinity, PhD Senior Director, Drug Associate Professor of Professor of Pharmaceutics Delivery & Life Cycle Pharmaceutics University of Texas at Austin Development University of Nebraska Schering-Plough Medical
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