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DDT Cover/Back April 2006.Qx July/August 2006 Vol 6 No 7 IN THIS ISSUE INTERVIEW WITH PALATIN TECHNOLOGIES’ VP & CTO SHUBH SHARMA, PHD Market Evolution 2020 Howard S. Wachtler Particle- Mediated Epidermal Delivery 3030 John Beadle, MD, MBA 21st CenturCenturyy pMDIs & DPIs 3232 Georgina Fradley Long-ActingLong-Acting InjectionInjection FormulationsFormulations 3636 Roger G. Harrison, PhD Sweat Gland Delivery 4242 Wei Chen, PhD Buccal Adhesive The science & business of specialty pharma, biotechnology, and drug delivery Systems 5151 A.K. Bandyopadhyay, PhD Clifford M. Mr. Girish Miles Davidson, Patel Hutchings, Esq. Oral Colon-Specific PhD Drug Delivery: Accelerating Drug Are Inventions An Overview Based on Delivery Solutions www.drugdeliverytech.com Discoveries of With Polymer & Natural Phenomena Analytical Expertise Patentable? July/August 2006 Vol 6 No 7 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 7 Montville, NJ 07045 o N Tel: (973) 299-1200 6 Fax: (973) 299-7937 l o V E-mail: [email protected] 6 0 Mailing List Rental 0 2 Candy Brecht t s Tel: (703) 706-0383 u g Fax: (703) 549-6057 u A / E-mail: [email protected] y l u J 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 2006, 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. 32 Living in Harmony – pMDIs & DPIs in the 21st Century Ms. Georgina Fradley says that increases in DPI sales have strengthened their position and led to predictions they will increase in popularity across global markets. However, research has shown pMDIs offers many advantages to developers and prescribers and will remain the dominant device in the inhalation market. 36 Development & Applications of Long-Acting Injection Formulations Dr. Roger G. Harrison indicates that the injectable product market, which currently holds 15% of the drug delivery market, could grow thanks to long- acting formulations that offer improved safety/efficacy and patient compliance. 42 Transdermal Drug Delivery Through the Sweat Glands “Various pharmaceutical approaches that can be Wei Chen, PhD; Vardan Ter-Antonyan, MS; Heidi Kay, PhD; Michael Salewski (PhD student); and Feiran exploited for the development of colon-targeted Huang, PhD; conduct a study that introduces an alternative means of drug transportation through the drug delivery systems include the use of prodrugs, skin by means of sweat gland activation and pH-sensitive polymers, bacterial degradable reduction of an applied voltage to ensure that the iontophoresis is safe. polymers, hydrogel and matrices, and multicoating time-dependentdelivery systems.” 48 Accelerating Drug Delivery Solutions 7 With Polymer & Analytical Expertise o N Miles Hutchings, PhD; Michael Ruberto, PhD; and 6 l Dean Hamel explain that the real difference o V between “partnering” with a consultant 6 0 0 practitioner and hiring the standard consultant 2 t boils down to extensive, hands-on experience, an s u g u intimate knowledge of the materials involved in A / y l medical device applications, and an overall vision u J of and influence on the entire supply chain. y g o l o n h c e T y r e v i l e D g u r D p.62 6 51 Advances in Buccal Adhesive Drug Delivery Drs. A.K. Bandyopadhyay and Yajaman Sudhakar discuss how buccal adhesive systems are well suited for orally inefficient drugs as well as a feasible and attractive route for non-invasive delivery of potent peptide and protein drug molecules. 56 Palatin Technologies: A Leader in Melanocortin-Based Therapeutics Drug Delivery Executive: Shubh Sharma, PhD, Vice President and Chief Technical Officer of Palatin Technologies, discusses his company’s MIDAS technology and the melanocortin-based therapeutics in the works. “Recent increases in dry powder inhaler 62 Oral Colon-Specific Drug Delivery: An Overview (DPI) sales have strengthened the position Girish Patel, MPharm student; Gayatri Patel, MPharm student; Ritesh Patel, MPharm student; Sanjay Patel, of DPIs and led to predictions in some MPharm student; Jayavadan Patel, PhD; and Praful Bharadia, PhD; review the considerable amount of reports that DPIs will increase in research on the development of colon-specific drug popularity across global markets. However, delivery systems. research has shown the pMDI offers many advantages both to developers and prescribers and will remain the dominant Departments device in the inhalation market.” Market News & Trends . .12 7 Business Development . .20 o N Market Evolution & Sector Confusion 6 l o V Attorney Review . .24 6 0 Are Inventions Based on Discoveries of Natural 0 2 t Phenomena Patentable? s u g u A / Advanced Delivery Devices . .28 y l u J Particle-Mediated Epidermal Delivery of y DNA Vacciness g o l o n h Drug Delivery Showcase . .59 c e T y r e External Delivery . .74 v i l e D g u r D 8 p.32 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 Director, Pharmaceutical President & CEO Principal Scientist, Research & Development Ampad, LLC Exploratory Pharmaceutics Pharmascience, Inc 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 C. Klonoff, MD, FACP Uday B. Kompella, PhD James W. McGinity, PhD Clinical Professor of Associate Professor of Professor of Pharmaceutics Medicine - UC San Francisco Pharmaceutics University of Texas at Austin Medical Director University of Nebraska Mills-Peninsula Diabetes Medical Center Research Institute Nasser Nyamweya, PhD Kinam Park, PhD Philip L. Smith, PhD Technical Service Manager President Investment Manager 7 o Degussa Akina, Inc S.R. One, Limited, N 6 GlaxoSmithKline l o V 6 0 0 2 t s u Ronald L. Smith, PhD Cornell Stamoran Tom Tice, PhD g u Director of Exploratory VP, Strategy & Business Executive Vice President A / y Biopharmaceutics & Process and Chief Scientific Officer l u J Drug Delivery Cardinal Health, PTS Brookwood y Bristol-Myers Squibb Pharmaceuticals g o l Research Institute o n h c e T y r e v James Vaughan Howard S. Wachtler Henry Y. Wu, PhD, MS i l e General Manager President & CEO Associate Director D g 3M Drug Delivery u Actinium Merck Research r D Systems Pharmaceuticals Laboratories 10 Fertin Pharma & Generex Biotechnology
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