DDT Issue10 NOVEMBER05 11/28/05 4:27 PM Page 1
NOVEMBER/DECEMBER 2005 Vol 5 No 10 IN THIS ISSUE
Corporate Profiles 12
Drug Delivery Technologies 76
Excipients, Polymers, Liposomes & Lipids 92
Contract Pharmaceutical & Biological Development Services 98
Laboratory Testing & Analytical Equipment & Sotware 109
Technology Spotlight 113
The science & business of specialty pharma, biotechnology, and drug delivery
www.drugdeliverytech.com DDT Issue10 NOVEMBER05 11/7/05 3:41 PM Page 2
NO BARRIERS.
NEW FRONTIERS.
COMPLEX CHALLENGES, INNOVATIVE SOLUTIONS. For 35 years, ALZA has led the drug delivery industry in developing extraordinary products based on our transdermal, oral, implantable, and liposomal delivery platforms. More than 30 products in 80 countries are based on ALZA’s novel drug delivery and targeting technologies. Today, ALZA’s dedicated researchers and scientists are addressing the complex challenges of delivering small molecules and biopharmaceuticals, with the commitment to create better medicines that improve healthcare for patients worldwide. Visit www.alza.com to learn more.
© 2003 ALZA Corporation LEADING THE NEXT GENERATION OF DRUG DELIVERY DDT Issue10 NOVEMBER05 11/5/05 8:12 AM Page 3
Inhalation and transdermal technology from 3M w Novel Dry Powder Inhaler Ne Gives you the edge in a from MicroDose Technologiescompetitive environment
The MicroDose dry powder inhaler, CFC-free metered dose inhaler and transdermal drug delivery systems customized to your specifications
៑ A wide variety of components to meet your needs ៑ Nearly 50 years’ experience in inhalation drug delivery technology and skin adhesion products ៑ Fully integrated development and manufacturing processes ៑ Global regulatory expertise ៑ Project management support available from concept through commercialization
Developing proven solutions that enable your success.
Phone U.S. : 1-800-643-8086 U.K.: 44 (1509) 613070 Japan: (81) 3-3709-9671 Visit: www.3M.com/DDS
© 3M 2004 DDT Issue10 NOVEMBER05 11/8/05 2:47 PM Page 4
November/December 2005 Vol 5 No 10 PUBLISHER/PRESIDENT Ralph Vitaro EXECUTIVE EDITORIAL DIRECTOR Dan Marino, MSc [email protected] CREATIVE DIRECTOR Karen Watts CONTROLLER Debbie Carrillo CONTRIBUTING EDITORS Cindy H. Dubin Guy Furness 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 Tel: (973) 299-1200 Fax: (973) 299-7937 E-mail: [email protected] Mailing List Rental Candy Brecht Tel: (703) 706-0383 Fax: (703) 549-6057 E-mail: [email protected]
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 responsibility for the accuracy of information supplied herein or for any opinion expressed. Drug Delivery Technology (ISSN 1537-2898) is published nine times in 2004, January/February, March, April, May, June, July/August, September, October, November/December by Drug Delivery Technology LLC, 350 Main Road, Montville NJ 07045. Subscription rates: $99.00 for 1 year in the United States, Canada, and Mexico. $153.00 for 1 year outside the United States, Canada, and Mexico. All subscriptions are payable in US funds, drawn on US banks. Send payment to: Drug Delivery Technology LLC subscription Department, 350 Main Rd., Montville NJ 07045. Single copies (prepaid) $15.00, US, Canada, and Mexico; $24.00 in all other countries. Add $5.00 per order for shipping and handling. Periodicals Postage Paid at Montville, NJ 07045-9998 and additional mailing offices. Postmaster: please send address changes to Drug Delivery Technology 350 Main Road, Montville NJ 07045. All rights reserved under the U.S., International and Pan-American Copyright Conventions. 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 photocopy, recording, 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 01923; phone: (978) 750-8400, fax: (978) 750-4470. DDT Issue10 NOVEMBER05 11/5/05 8:12 AM Page 5 DDT Issue10NOVEMBER0511/5/058:12AMPage6 6 Drug Delivery Technology November/December 2005 Vol 5 No 10 rdg o onn Medpharm Innercap Hovione DowCorning Coating Place Health Cardinal B Aradigm 12 ALZA 3M companies include: services aswellvisuals and completecontact information. Featured 2-page spread featuring core technologies, capabilities, products, and For eachparticipating company, thissection presents aspecial Company Profiles mlnsPlmr Lipids Vaginal Rectal Tr Polymers T N 76 Implants Gene Therapy Mucosal Pa Tr Inhalation Oral Remmele include: applications and stage of development, and partnerships. Technologies Shire Labs applications, pipeline/investigational technologies and their a checklist of currently marketed technologies orservices and their Remmele Contract Service, and Laboratory Testing &Analysis companies, provides NOF This Report,divided into four sections for DrugDelivery, Excipient, MedPharm Report NuSil Huber Facet Technologies &Pipeline Partnerships, SCOLR Kurve Technology We GlattPharmaceuticals Eurand DPTLabs Safety Syringes CRS Dowpharma InnerCap Filtertek Cirrus BD Baxter pclPoen etdsOcular Proteins & Peptides opical S eus Emerson Degussa ASF slBoaeil Devices Biomaterials asal nmcslCnrle ees Excipients Colon Controlled Release ansmucosal Capsules ansdermal re lrEgneigDrugDeliveryPartnerships iler Engineering n ea nrnslLiposomes Intranasal teral DDT Issue10 NOVEMBER05 11/5/05 8:12 AM Page 7
Unique
Unparalleledtaste Flexible dose Versatile release Robust tablet
The next generation ODT Eurand’s AdvaTab is an orally disintegrating tablet (ODT) technology that combines superior taste and mouth feel properties in a robust tablet. AdvaTab is unique, offering both high dose capacity and modified drug release making it www.eurand.com the most broadly applicable ODT available. Utilization of standard tabletting processes allows for cost-efficient manufacturing and conventional packaging. USA +01-937-898-9669 The next generation ODT is here! EU +39-02-95428-309
ODT CUSTOMIZED RELEASE TASTE MASKING ENHANCED BIOAVAILABILITY DDT Issue10NOVEMBER0511/5/058:15AMPage8
8 Drug Delivery Technology November/December 2005 Vol 5 No 10
D
T
I
s
s
u
e
1 J
ANUARY Vol 5 No 2005 1
J
A
N
U
A
R
Y
2
0
0 The science & business of specialty pharma, biotechnology, and drug delivery
5
1
/
7
/
0
5
Dragan Cicic, MD, MBA V 1 T Legal Considerations
echnologies: aluing Drugs & 1
:
3
6
A
M
P The science & business of specialty pharma, biotechnology, and drug delivery drug and biotechnology, pharma, specialty of business & science The a
g The science & business of specialty pharm specialty of business & science The
e MAY 2005 Vol 5 No 5 No 5 Vol 2005 MAY
1
FEBRUARY 2005 Vol 5 No 2 No 5 Vol 2005 FEBRUARY A
Companies are Companies
Delivery
Dysfunction (FSD) Dysfunction Industry: How Industry:
Macro Trends in Trends Macro
Guy Furness Guy Fe
Tr
T
Tr
dapting Stover
Jack E. Jack
estosterone for estosterone
eatment of eatment
male Sexual male ansdermal
Keyer R. Shah, MS An Evaluation of Nasal Spray Deposition & Clearance in Healthy Human Volunteers U Scintigraphy
sing Gamma
Delivery
Mediated Drug Mediated
With Enzyme- With
Interstitial Matrix Interstitial
Escaping the Escaping
alr PhD Haller,
Michael F. Michael
P
Hydrophobic
Hydrophilic & Hydrophilic
Process Combining Process
A Recently Patented Recently A
PhD olymers James Roszell, James
Ed L. Hamilton, PharmD Ad Disintegrating T Significant Benefits to Patients & Product Life Cycles ablets Bring
v
anced Orally
a, biotechnology, and drug delivery drug and biotechnology, a, g1
Extraction IN THIS Anesthesia for Tooth for Anesthesia
Infiltration
Hydrochloride for Hydrochloride
of
Mucoadhesive Patches Mucoadhesive
MPharm Jayvadan Patel, Jayvadan
www.drugdeliverytech.com
Lignocaine ISSUE
Interview with BASF’s Patient-
Independent
P Devices
on Drug-Release on Laurence Peyronnet, MS Matrices & Effect & Matrices
P
Study of Softening of Study Dissolution
PhD
attern Profiles A.V. Gothoskar, A.V. SIMON MEDLEY
Rakesh P. etPatel, al oint of Swellable of oint T Coupled Vice President, Liposomes Fine Chemicals S ransferrin- Comparative Promotional Claims .K. PhD Jain, Natasha V.Leskovsek
T Drug Products Joseph PhD Mo,
Intrathecal ransdermal Delivery Balaji Ramamurti
Manufacturing Execution Systems Joseph Vinhais
66
38
56
24 www.drugdeliverytech.com
77 www.drugdeliverytech.com
26
62
bii .Gtokr PhD V. Gothoskar, Abhijit
Matrices
Swellable
.Gpa PhD Gupta, M.
Designs
Experimental
G.P.Ag
Scintigraphy
Gamma
John A. Bermingham A. John
Failures
Successful
Salim Haffar Salim
T
Dose-Counting
W
Strategies
Development
John A. Bermingham A. John
The Close! The
echnology
Dhiraj Amani Dhiraj
Injectables
Needle-Free oyByn PhD Bryan, oody
RALF AUERBACH RALF
IN THIS THIS IN lfodM aisn Esq. Davidson, M. Clifford
Status
Small-Entity
GENERAL DIRECTOR GENERAL
oe osr,PhD Bossart, Josef
V
FERTIN PHARMA’S FERTIN
Defining Product Defining
INTERVIEW WITH INTERVIEW
T
raw Propellants
ISSUE Medical
alue
mNae,PhD Noakes, im ae .Bno,PhD Benson, R. James
Release
Zero-Order
Cindy H. Dubin H. Cindy
Overview
Outsourcing
l PhD al,
MATHIAS ROMACKER MATHIAS
DIRECTOR, BUSINESS DIRECTOR,
IN THIS THIS IN
INTERVIEW WITH INTERVIEW
BUENDER GLAS’ BUENDER DEVELOPMEMT
ISSUE
46
53
72
82
20
34
82
26
30
22
75
48
32
Th
MARCH 2005 Vol 5 No 3 No Vol5 2005 MARCH
e scien e
Flexibility
A
Drug Delivery: Drug
Simulation for Simulation
Modeling & Modeling
Pauli
Ms. Emily K. Emily Ms.
ce
ccuracy, Speed & ccuracy,Speed
&
bu
color visuals and contact information. technologies, services, and devices, featuring dynamic 4- this section examines innovative and emerging To Spotlight113 Delivery Drug
sin
e ss of sp of ss
complement the Company Profiles and Special Report,
ecia
lty p lty
Deposition
Nasal Drug Nasal
Flow to Optimize to Flow
Applying Vortical Applying
Dispersion™:
Controlled Particle Controlled
Mr. Marc Giroux Mr.Marc
h
arm a, b a,
D
D
T
iote
I
s
s
u ch e
July/August Vol 5 No 2005 7 7
n
J olo U
L
Y
/ gy,a
A
U
G
Gates
Eight Assessment Eight
A
T
Drug Delivery Drug
uk,PhD Burke, Matthew D. Matthew
echnology ssessment: The ssessment:
2 The science & business of specialty pharma, biotechnology, and drug delivery n
0
0 d
5 d
ru
7
/ g 5
/
0 de
5
Jason McKinnie Nanobiotechnology Offers a Promising
Solution to Overcoming Common live Drug Delivery F ailures
1
0
: ry
4 www.drugdeliverytech.com 0
A
M
P
a
g
e
lfodM aisn Esq. Davidson, M. Clifford
Management
Life-Cycle
oe osr,PhD Bossart, Josef
P
erjKmr PhD Kumar, Neeraj
Conjugates Polymer Drug Polymer
akArr,PhD Aurora, Jack
ODDFs
..Ptl MPharm R.P.Patel,
Profiles
Dissolution
Guy Furness Guy
T
Cancer
..Eee MPharm Emeje, M.O.
Polymers
1 DD Hydrophilic
argeting
MR. GUY VILLAX GUY MR.
IN THIS THIS IN
INTERVIEW WITH INTERVIEW
= (E =
HOVIONE’S CEO HOVIONE’S
ISSUE
3
T) e
Cindy H. Dubin R T L P S h e u ro t e fo
ra c 26 22
M 67
te ra 50
62 r 34
t 56
m e tive c o
g tio u s
y t la
?
n t Pa
io
t n e
: n
t
Sunil K. Jain, MPharm Gastroretentive Floating Drug Delivery: An Overview
IN THIS
ISSUE www.drugdeliverytech.com FA
T Adhesives BILL TAYLOR Paul Foreman, PhD INTERVIEW WITH Polymeric Gel ransdermal CET TECHNOLOGIES’ V Mandip Sachdeva, PhD
Merck v. Integra Clifford M. Davidson, Esq. ehicles
Osmotic Delivery PRESIDENT Vishal Gupta
Alliance Governance Roger G. Harrison, PhD
Niosomes S
.K. MPharmShah,
46
62
24
68
20
38 DDT Issue10 NOVEMBER05 11/5/05 8:15 AM Page 9 Proof No.: 1 04/12/05 jl Page No. 1
Now open for business.
The power of pulmonary delivery with Add powerful new potential to your drug PROMAXX microsphere technology. pipeline with PROMAXX. To learn more, visit www.baxterbiopharmasolutions.com. For specific By giving you precise control over microsphere size requests, send an e-mail to [email protected], and uniformity, PROMAXX facilitates development of or call 1-800-422-9837. pulmonary formulations. This versatile platform works with a wide range of compounds, from proteins and PROMAXX microsphere peptides to small molecules. technology delivers unique particle size control ideal for Plus, you can trust the experienced Baxter team to work 1 µm inhalation therapies. with you to solve your unique formulation challenge.
BioPharma Solutions Connect to the resources you need.
Baxter Healthcare Corporation, Route 120 and Wilson Road, Round Lake, IL 60073 920302 4/05 Baxter and PROMAXX are trademarks of Baxter International Inc., its subsidiaries or affiliates. DDT Issue10 NOVEMBER05 11/7/05 2:22 PM Page 10
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, Exploratory Pharmaceutics Research & Development Ampad, LLC GlaxoSmithKline Pharmascience, Inc
Sarath Chandar, MBA Mahesh Chaubal, Gary W. Cleary, PhD, Vice President, Global PhD, MS PharmD, MBA Marketing & Commercial Associate Director Development President & CTO SPI Pharma Baxter Healthcare Corium International
Sonya Summerour James N. Czaban, JD John Fraher Clemmons, PhD, MBA, MS Attorney at Law President, North Director, Business Heller Ehrman White & America Development McAuliff, LLPP Eurand MediVas, LLC
Philip Green, PhD Keith Horspool, PhD Ravi Kiron, PhD, MBA Director of Business Director, Research Executive Director, New Development Formulations Technology Assessment & Advanced Drug Delivery Pfizer Global Research & Planning BD Development ALZA Corporation
David C. Klonoff, MD, FACP Uday B. Kompella, PhD James W. McGinity, PhD Clinical Professor of Medicine Associate Professor of Professor of Pharmaceutics - UC San Francisco Pharmaceutics University of Texas Medical Director at Austin Mills-Peninsula Diabetes University of Nebraska Research Institute Medical Center
Ketan A. Mehta, PhD Kinam Park, PhD Philip L. Smith, PhD US Regional Business President Investment Manager
ol 5 No 10 ol 5 No Manager
V Akina, Inc S.R. One, Limited, Röhm America GlaxoSmithKline
Ronald L. Smith, PhD Cornell Stamoran Tom Tice, PhD Director of Exploratory VP, Strategy & Business Executive Vice President Biopharmaceutics & Process and Chief Scientific Officer Drug Delivery November/December 2005 November/December Cardinal Health, PTS Brookwood Bristol-Myers Squibb Pharmaceuticals Research Institute
James Vaughan Howard S. Wachtler Henry Y. Wu, PhD, MS General Manager President & CEO Associate Director
Drug Delivery Technology Drug Delivery Technology 3M Drug Delivery Systems Actinium Pharmaceuticals Merck Research 10 Laboratories DDT Issue10 NOVEMBER05 11/5/05 8:15 AM Page 11 DDT Issue10NOVEMBER0511/5/058:15AMPage12 12 Drug Delivery Technology November/December 2005 Vol 5 No 10 development, regulatory, and manufacturing expertise. andmanufacturing regulatory, development, you willbenefitfrom ourglobal inhalation componentsfor your own development program, andmarketed product support. operations, qualityassurance, affairs, regulatory analytical, toxicology, clinical affairs, metabolism, drug In-houseresources include pharmacokinetics, divisions producing component materials. Corporate resources and include technology centers early stages through post-approval. on6continents. 60 countries Systemsare currently soldinmore Products Delivery manufactured than 3MDrug by system. 7-day anddevelopment transdermal ofthefirst CFC-Free development ofthefirst MDI, (MDI), 3M’s proven track record includes metered-dose development inhaler ofthefirst delivery. hashelpedmakeusaworld drug leaderininhalationandtransdermal firms pharmaceutical Whether accessing our systems development capabilities or using our transdermal or Whether accessingoursystems development orusingourtransdermal capabilities 3M in-houseresources are each available tosupport step ofthedevelopment process from technology withmoleculesfromSuccessfully many teamingourdelivery major 3M Drug Delivery Systems T: (651) 733-7853 St. Paul,Minnesota55144-1000 E: W 3M Center, Bldg.275-3E-10 3M DrugDeliverySystems ebsite: [email protected] www.3M.com/DDS of more than$1billion. 3M’s by corporation supported annualR&Dbudget multinational with theresources ofa major, market sooner. commercialization &expertise tohelpyou get to arrangements from development through inworking flexibility provides partners 3M conventional ornovel technology. transdermal r solutions companies withinnovative delivery drug andbiotechnologyleader providing pharmaceutical 3M DrugDeliverySystems anging from MDIstoDPIsfor inhalation& • F: We combine the agility ofaleadingcompanycombine theagility (651) 737-5265 is aglobal DDT Issue10 NOVEMBER05 11/5/05 8:15 AM Page 13
Inhalation and transdermal technology from 3M w Novel Dry Powder Inhaler Ne Gives you the edge in a from MicroDose Technologiescompetitive environment
The MicroDose dry powder inhaler, CFC-free metered dose inhaler and transdermal drug delivery systems customized to your specifications
៑ A wide variety of components to meet your needs ៑ Nearly 50 years’ experience in inhalation drug delivery technology and skin adhesion products ៑ Fully integrated development and manufacturing processes ៑ Global regulatory expertise ៑ Project management support available from concept through commercialization
Developing proven solutions that enable your success.
Phone U.S. : 1-800-643-8086 U.K.: 44 (1509) 613070 Japan: (81) 3-3709-9671 Visit: www.3M.com/DDS
© 3M 2004 DDT Issue10NOVEMBER0511/5/058:15AMPage14 14 Drug Delivery Technology November/December 2005 Vol 5 No 10 LEADING THE NEXTGENER INNOVATIVE SCIENCE MEDICINES SUPERIOR P ASSIONATE PEOPLE DDT Issue10 NOVEMBER05 11/5/05 8:15 AM Page 15
ATION OF DRUG DELIVERY
ALZA was founded on a vision of improving medicines to enhance patient care worldwide. Today, employees share in this vision and are exploring new ways to advance therapies. Through problem- solving strategies that address unmet patient and technology needs, ALZA is focused on drug delivery and drug targeting as a way to optimize the therapeutic utility of small molecules and biopharmaceuticals.
ALZA’s commitment to develop solutions that address unmet patient needs has resulted in the industry’s most extensive portfolio of drug delivery- based pharmaceuticals. Through substantial research and development, collaborative partnerships and a dedication to the highest scientific and ethical ideals, ALZA will continue to be at the forefront of novel drug delivery solutions.
AN EXPANDING BREADTH OF TECHNOLOGIES
MACROFLUX® OROS® D-TRANS® DUROS® D-TRANS® STEALTH® ALZAMER®
FOR MORE INFORMATION about ALZA’s technologies, contact Dr. Ravi Kiron, Executive Director, New Technology Assessment & Planning Tel: (650) 564-2113 Fax: (650) 564-7118
© 2003 ALZA Corporation DDT Issue10NOVEMBER0511/5/058:15AMPage16
16 Drug Delivery Technology November/December 2005 Vol 5 No 10 Needle-Free Delivery–Intraject Needle-Free inthespecifiedarea ofthelung. ofdrug delivery rate inorder tooptimize aerosol are particles flow produced andinhaledatthecorrect technology toensure thatsmall andproprietary systemutilizesliquiddrugs device.The The AERx systemiscomposedofasingle-usedosage form andasimplepatient-controlled broad range ofareas including: preference for Intraject over needleand syringe. thealternative Significantamountsofdatademonstrate highpatient the subcutaneousregion oftheskin. canberapidly drug andcomfortably delivered to Inthree easysteps, late-stage development. systemin disposable needle-free delivery single-use, pre-filled, Intraject istheonly pen-sized, Pulmonary Delivery-AERx differentiated products. andhighly patient-preferred, including value derivedfrom patentprotected, Intraject, Aradigm’s alsobenefitfrom thefeatures andbenefitsof partners AERx and system. delivery ofthetherapeutic agent delivery viaaneasy-to-useandcomfortableaccurate andefficient including deliverefficiently significant patientbenefits, liquidformulations whileoffering • • • • • • rdg’ w rpitr ehooypafrs AERx Aradigm’s technology platforms, two proprietary Aradigm is a fully integrated drug delivery company, and our staff isexperienced ina andourstaff Aradigm company, isafully integrated delivery drug Chemical &Mechanical Engineering Aerosol TechnologyAerosol Drug Formulation T: (510) 265-9000 W ebsite: ® Aradigm Corporation 3929 PointEdenWay Hayward, CA94545 Hayward, ® eliminate theneedfor needles! www.aradigm.com efamnse hi hrp ntm nwee we anytimeself-administer theirtherapy anywhere, and safely easily, enable patientstoconveniently, e Leveraging and novel systems. needle-free delivery v dedicated tocommercializing differentiated and Aradigm xpertise in innovative drug delivery systemsthat ininnovative delivery xpertise drug alue-added products through two advanced-stage • F: • • • • (510) 265-0277 Implementation Clinical &RegulatoryStrategy Project & Process Management &Process Project is an integrated drug delivery company is anintegrated delivery drug ® and Intraject ® ,a re designed to DDT Issue10NOVEMBER0511/5/058:15AMPage17
3929 POINTEDENWAY, HAYWARD, CA94545|T: 510.265.9000 |F:510.265.0277 |WWW.ARADIGM.COM ©2005 Aradigm Corporation. All rights reserved. Intraject system, call Aradigm today. And bringthewowfactortoyourbrand. Intraject system,callAradigmtoday.And your productintothemarketplacequicklyandefficiently. To learnmoreabouttheproven,proprietary integrated drugdeliverycompany,ourhighlyexperienced, specializeddevelopmentteamswillmove too.Asafully subcutaneous injections—butwithoutaneedle.You’llbedelighted withAradigm, to autoinjectorsandconventionalneedlessyringes.Allwhiledemonstratingbioequivalence and small-moleculedrugs.Plus,Intrajectispen-sized simple steps.It’s idealforabroadrangeofproteins,peptides,monoclonalantibodies,viscousliquids physicians alike.TheIntrajectsystemis The uniquedesignofthe Intraject WOW. OW. ® Needle-FreeDrugDeliverySystem prefilled and disposable, overwhelmingly preferred offeringrapiddeliveryinthree willdelightpatientsand bypatients DDT Issue10 NOVEMBER05 11/5/05 8:15 AM Page 18
BASF BASF Pharma Solutions 100 Campus Drive Florham Park, New Jersey 07932 T: (800) 443-0627 • F: (973) 245-6763 E: [email protected] Website: www.pharma-solutions.basf.com
Key contacts for BASF Pharma Solutions in North America: Folker Ruchatz, Director • Manuel Solbach, Marketing Manager • Kelley DaVanon, Sales Manager • Anisul Quadir, Technical Services Manager
Company Description BASF helps pharmaceutical companies to be successful with: • a broad portfolio of excipients and active ingredients; • contract manufacturing services including pharmaceutical finishing and exclusive custom synthesis; • the services of an experienced technical staff with industry-specific formulation expertise. BASF offers excipients and active ingredients with proven quality and reliability, and expertise in chemistry that dates back to 1865. Products and Services BASF offers excipients such as Kollidon® binders and disintegrants, Ludipress® direct tableting aids, Lutrol® and Cremophor® solubilizers and emulsifiers, and Kollicoat® coatings. Actives include ibuprofen, pseudoephedrine, ephedrine, caffeine, theophylline, and retinols. BASF’s Shreveport, La., pharmaceutical finishing plant is a flexible, high capacity site for the manufacture of solid and semi-solid tablets, capsules, liquids and creams. What’s New
Kollicoat® IR polyvinyl alcohol-polyethylene glycol graft copolymer, which offers low viscosity, high flexibility and high solubility to help pharmaceutical companies reduce costs and coating time and improve quality.
Kollicoat IR White,aready-to-use coating system based on Kollicoat IR.
®
ol 5 No 10 ol 5 No Kollidon VA 64 Fine copovidone, a dry binding agent that improves tablet hardness and friability. V
Lutrol® micro 68 and Lutrol micro 127, micronized poloxamers that provide content uniformity and compatibility for poorly soluble actives. Services BASF’s Shreveport, La., pharmaceutical finishing plant is a flexible, high capacity site able to handle the manufacturing of solid and semi-solid dosage forms of tablets, capsules, liquids and creams.The site has been producing quality pharmaceuticals for nearly two decades and is among the leading U.S. manufacturers of
November/December 2005 November/December prescription-strength ibuprofen tablets.The facility meets cGMP and is able to handle up to Schedule II compounds, from raw materials through packaging of finished product. Our capabilities include: manufacturing of solid dosage forms: aqueous and solvent granulations, compression, coating, printing, manufacturing of creams and liquids and packaging. On the exclusive custom synthesis side, BASF is building a new, multi-product plant for pharmaceutical active ingredients – an expansion of our current production site in Minden, Germany. BASF’s Technical Service Center in Ledgewood, N.J. houses laboratory equipment used for dosage-form formulations and physical/chemical analysis. Our pharmacists and chemists provide specialized expertise to assist Drug Delivery Technology Drug Delivery Technology customers with their product and process developments. One of the main advantages of this facility is its New Jersey location – which is close to many pharmaceutical companies and their research and development 18 laboratories. DDT Issue10 NOVEMBER05 11/5/05 8:15 AM Page 19
Kollicoat® IR Reduces Coating Time and Cut Improves Quality BASF helps you reduce time and costs for the coating process – and improve quality – with Kollicoat IR polyvinyl alcohol-polyethylene glycol graft copolymer. With its low viscosity, Coating high flexibility and rapid rate of disso- lution, Kollicoat IR can be applied in spraying solutions at a high-solids content. Kollicoat IR is one example of BASF’s comprehensive portfolio of coatings, which includes: Costs. Kollicoat EMM 30 D Poly(ethylacry- late, methyl methacrylate) Kollicoat MAE Enteric Coatings Methacrylic Acid/Ethyl Acrylate Copolymers Kollicoat SR 30 D Polyvinyl Acetate
BASF offers a full range of binders, disintegrants, solubilizers and high quality active ingredients, plus phar- maceutical finishing and exclusive custom synthesis – all supported by an experienced and expert technical services staff that can provide solu- tions to your formulations challenges.
I Excipients
I Actives
I Value Added
I Contract Manufacturing
Helping Make Pharmaceuticals Better™ To find out how BASF Kollicoat IR can help you improve quality and reduce costs:
In US call: 1-800-443-0627 or fax: 1-973-245-6763 For Technical Support call: 1-800-469-7541
www.pharma-solutions.basf.com DDT Issue10 NOVEMBER05 11/5/05 8:16 AM Page 20
Baxter Healthcare Corporation US: 1 (800) 422-9837 Direct: 1 (847) 948-4770 F: 1(847) 948-3642 E: [email protected] Website: www.baxterdrugdelivery.com
Baxter Healthcare Corporation’s BioPharma Solutions business offers proprietary technologies and best-in-class contract services, addressing outsourcing needs throughout development and commercialization of parenteral (injectable and pulmonary) drugs.The company has partnered with more than 150 clients, working with the top 15 bio/pharmaceutical companies.
Contract Services also eliminates the need for undesirable co- solvents and can offer higher drug loading and Baxter is a parenteral market leader providing a subsequent lower dose volume. range of proven contract services from process The PROMAXX microsphere technology is a development of biopharmaceutical active unique, elegant, and cost-effective formulation ingredients to form/fill/finish of drug product into platform, tailored to fit your specific syringes, vials, and cartridges. Baxter offers the requirements. It is applicable to a broad range of advantage of providing cytotoxic contract molecules - from small molecules and nucleic services from chemical synthesis (API) to scale-up acids to peptides and proteins. PROMAXX for commercial production.With over 15 years of technology can offer high-drug loading and experience, we provide contract development precise particle size control and enable dosing and manufacturing services for antibodies and flexibility across various administration routes, protein therapeutics. Our licensed facilities in such as injectable, and pulmonary with various Hayward and Thousand Oaks,California, have drug-release profiles, such as immediate and capacity for pre-clinical to commercial scale sustained release. production. Baxter’s Bloomington facility has expanded
ol 5 No 10 ol 5 No Enhanced Packaging V capacities for syringe and vial filling/finishing; it has added new capability in cartridge Baxter also offers an extensive portfolio of Ready- filling/finishing, as well as a fully automated To-Use and Ready-To-Mix systems that can help kitting line. Lyophilization capacity has increased differentiate your molecule and simplify end- along with the establishment of the Lyophilization users’ drug preparation and administration.An Center of Excellence. Baxter can also provide established franchise into critical care clinicians analytical and microbiological services as well as globally supports end-user acceptance and market presence. November/December 2005 November/December validation and regulatory assistance.
Proprietary Formulation Technologies Corporate Relationships Sought NANOEDGE dispersion technology offers Baxter is actively pursuing and strengthening innovative formulations for your solubility partnerships including co-development challenges and is applicable for multiple routes of opportunities, out-licensing of internally
Drug Delivery Technology Drug Delivery Technology administration. It reduces the particle size of most developed products, strategic and/or full drugs to nanometer size, which can enhance a development programs. 20 drug’s saturation solubility and dissolution rate. It DDT Issue10 NOVEMBER05 11/5/05 8:34 AM Page 21
A shot of innovation saves you time and money
Although our name has changed, the Baxter Bloomington, IN, facility’s commitment remains focused on your parenteral contract services needs.
axter BioPharma Solutions is the improve and expand our facilities, we ensure B innovative parenteral contract service that we will have the equipment and processes leader of prefilled syringes in North America. you need to get your products to the market. We have streamlined the process needed for validation of sWFI, bWFI, and customized Built-in flexibility prefilled diluent syringes. This innovation Flexibility is a key component in parenteral gives you significant savings in costs and manufacturing, and our facilities are resources to help accelerate your prefilled continually expanding to ensure we can diluents to the marketplace. meet your demands, including lyophilized vial and diluent syringe kitting as well as Syringe Filling A history of innovation customized labeling and packaging. But this innovation comes as no surprise. Our history of innovation in parenteral contract Our commitment to excellence ensures Vial Filling services began in the mid 1990s. Since then, we will remain the industry leader and we have become the parenteral contract continue to be your partner for success. Cartridge Filling services leader for prefilled syringes with the To learn more about our capabilities, capacity to fill vaccines, biologics, biotech, call 1-800-353-0887, e-mail specialty diluents, and other injectables. [email protected] Lyophilization , or visit Today, our capabilities include syringe www.baxterbiopharmasolutions.com filling to meet your clinical and commercial R&D/Clinical Supply needs. We fill syringes in sizes from 0.5 to 20 mL. In sizes 1 to 3 mL, our state-of- the-art equipment can fill up to 300 million Labeling/Packaging BD HYPAK® syringes a year. The Bloomington, IN, facility is designed to meet regulatory Additional Services requirements, including aseptic formulation in a Class 100 environment. By continuing to
Connect to the resources you need.
Baxter Pharmaceutical Solutions LLC, 927 S. Curry Pike, Bloomington, IN 47403 Baxter is a trademark of Baxter International Inc., registered in the U.S. Patent and Trademark Office BD HYPAK is a trademark of Becton, Dickinson and Company 11/04 920151
BPS052147_DrugDeliv_SyrIng.indd 1 10/7/05 7:10:51 PM DDT Issue10NOVEMBER0511/5/058:34AMPage22
22 Drug Delivery Technology November/December 2005 Vol 5 No 10 parenteral drug delivery products to keep up with the advances of modern healthcare. products tokeepupwiththeadvances ofmodern parenteral delivery drug systems–constantly rethinkingconcept behindourparenteral delivery andreforming drug T can beaddedaseasily toproducts thatare indevelopment asthosealready onthemarket. prefills or syringes toanasalspray, Whether you want togo from vialstoprefilled syringes, BDdelivers. in self-injectiontechnology, of each product, and provide the support andresources andprovide thesupport to helpyou achieve your goals. of each product, partner.We delivery in your drug systemstotheunique requirements customizeourdelivery W systemsthatsetthestandard. delivery BD isdedicatedtodeveloping drug healthcare needs. andpatient-friendly products tofulfillhome demands, that meethealthcare professionals’ oday’s systemsmustevolve delivery isthe andadapttomeettomorrow’s drug demands.That t oeta 0 er feprec,BDprovides theexpertise andexperience you need ith more ofexperience, than100years We Prefills canbeaddedatany aproduct’s pointduring life cycle tomakeitmore desirable. rvd otefcieatraie ocnetoa rgdlvr,innovative designs provide cost-effective delivery, toconventional alternatives drug T: Franklin Lakes,NewJersey07417 (800) 225-3310 W ebsite: 1 BectonDrive www.bdpharma.com r drug dry diluentsyringe, system, IVinfusion system, delivery nasaldrug syringe, itisaprefilled industry.Whether pharmaceutical systemsforparenteral delivery the drug prefillable leaderinproviding quality, is theindustry BD Medical- cnttto ytm aeynel,orthelatest asafety needle, econstitution system, BD • F: (201) 847-4847 Pharmaceutical Systems DDT Issue10 NOVEMBER05 11/5/05 8:35 AM Page 23
"$© 3ELF )NJECTION 3OLUTIONS "RINGING YOU SOLUTIONS FOR THE HOME CARE MARKET
"$ ,IQUID $RY 0EN
7HILE MOST PATIENTS CAN USE THE TRADITIONAL VIAL AND SYRINGE EFFECTIVELY IT CAN ALSO PROVE TO BE COMPLICATED AND INACCURATE FOR THOSE WHO ARE YOUNG ELDERLY ANDOR PHYSICALLYVISUALLY IMPAIREDI 0ATIENTS MUST GAUGE THE DOSE VISUALLY AND TYPICALLY INJECT AIR INTO THE VIAL BEFORE WITHDRAWING THE PRODUCT 4HE "$ ,IQUID $RY 0EN IS EASIER MORE CONVENIENT AND PORTABLE THAN SYRINGES AND VIALS 4HIS PEN ALLOWS THE PATIENT TO RECONSTITUTE AND INJECT WITH A SINGLE DEVICE )N ONLY SECONDS THE PATIENT CAN HAVE YOUR DRUG RECONSTITUTED PRIMED AND READY FOR INJECTION WITHOUT THE USE OF ADDITIONAL NEEDLES OR COMPLICATED RECONSTITUTION DEVICES
s !UTOMATIC RECONSTITUTION s !UTOMATIC PRIMING s #USTOMIZABLE BODY DESIGNS AND COLORS s &OR USE WITH LYOPHILIZED DRUGS
&OR MORE INFORMATION PLEASE CALL OR VISIT WWWBDPHARMACOM
"$ -EDICAL 0HARMACEUTICAL 3YSTEMS I 7IESS 0- HTTPWWWFEMALEPATIENTCOMHTMLARCSIGPHARMAARTICLES??ASP "ECTON $RIVE 4HE DUAL CHAMBER CARTRIDGE SHOWN IS A 6ETTER ,YO #ARTRIDGE 6 ,+ &RANKLIN ,AKES .* 6ETTER ,YO #ARTRIDGE IS A TRADEMARK OF 6ETTER 0HARMA "$ AND "$ ,OGO ARE TRADEMARKS OF "ECTON $ICKINSON AND #OMPANY ¥ "$ "$03?MARKETING BDCOM
"$03 0%.*2.,!D 2EV INDD !- DDT Issue10 NOVEMBER05 11/5/05 8:35 AM Page 24
Cardinal Health 14 School House Road Somerset, New Jersey 08873 T: (732) 537-6200 • F: (732) 537-5949 E: [email protected] Website: www.cardinal.com/pts
Cardinal Health provides its pharmaceutical and biotechnology customers integrated, enabling technologies, and services that help bring quality products to market faster and deliver greater value. From laboratory to launch and beyond, Cardinal Health offers an unmatched range of world-class technologies and services to help our customers accelerate drug development, streamline the supply chain, and grow market share. Serving the pharmaceutical and biotechnology industry, Cardinal Health is a global leader in development, drug delivery technologies, contract manufacturing, packaging, and product launch services. With several decades of experience and more than 1,500 patents and patent applications, Cardinal Health brings its customers innovative expertise throughout a drug’s development, launch, and entire life cycle. Cardinal Health also offers the broadest range of dose form manufacturing options in the industry - from traditional and proprietary oral forms to sterile parenterals, inhaled forms, and topicals - in 40 facilities on 5 continents.
Drug Delivery Systems Streamlining the Supply Chain Sometimes the right dosage form makes all the In every technology that we offer, we have difference.A significant factor in the marketing experience in helping our customers resolve success of a new drug is how much it improves quality, formulation, and supply issues. By ol 5 No 10 ol 5 No
V results for patients. Even the most sophisticated integrating dose form development, manufacture, new compound can benefit from a formulation and packaging, Cardinal Health can reduce time - that will optimize bioavailability or enhance and often total cost - to shipment.And by patient compliance. Cardinal Health has a track integrating Cardinal Health’s launch acceleration record of improving the success of many products services, we can help you get to pharmacy shelves by developing dosage forms that offer reduced quicker, with greater visibility to prescribers, side effects or have broadened acceptance among pharmacists, and patients.We provide the right ®
November/December 2005 November/December different patient types. Zydis ,for example, makes capacity - when and where you need it.Through pill-taking easier for children or older patients our global network of facilities, Cardinal Health who may have difficulty swallowing a traditional provides our customers the manufacturing tablet.Trust the precision, speed, and ingenuity of capacity and support required to meet even the Cardinal Health to engineer a more efficient, most challenging launch planning requirements. patent-protected formulation or dose form for And through creative arrangements for back-up your product. manufacturing sites and dedicated capacity, Drug Delivery Technology Drug Delivery Technology Cardinal Health provides a range of creative 24 options. DDT Issue10 NOVEMBER05 11/5/05 8:35 AM Page 25 DDT Issue10 NOVEMBER05 11/5/05 8:35 AM Page 26
Cirrus Pharmaceuticals, Inc. P.O. Box 14748 Research Triangle Park, North Carolina 27709-4748 T: (919) 884-2064 • F: (919) 884-2075 E: [email protected] Website: www.cirruspharm.com
Cirrus Pharmaceuticals, Inc. is a contract product development company assisting biotechnology and pharmaceutical companies with dosage form development projects.With partnerships that span the globe, Cirrus works with start-up, mid-size, and multinational companies. Cirrus can assist or manage projects as needed by providing a broad array of R&D services, including physical and chemical characterization, formulation development, stability testing, container/closure selection, process development, scale-up and technical transfer to manufacturing for inhaled, oral, topical, and parenteral products. Services can include submission-ready regulatory documentation and assistance with regulatory submission questions. Cirrus was founded and incorporated in June 1997 by Anthony Hickey and Jean-Marc Bovet.The company is headquartered in Research Triangle Park, North Carolina. Since its creation, Cirrus has exponentially expanded its capabilities to include many aspects of drug development.The growth of the company is due largely to its focus on ol 5 No 10 ol 5 No V providing timely research and project development support to the pharmaceutical industry. One of the biggest assets of the company is the diverse professional and educational backgrounds of the staff.The experienced professionals at Cirrus work side by side with our sponsors to ensure that all their research goals are achieved.The commitment of Cirrus to exceptional service is reflected in our high rate of return business. It is the combination of scientific competency and the timely delivery of quality services that keeps our sponsors November/December 2005 November/December coming back time and time again. Drug Delivery Technology Drug Delivery Technology
26 DDT Issue10 NOVEMBER05 11/5/05 8:35 AM Page 27
Strategic Product Development
From drug characterization, to NDA submission, to Cirrus Product Development Services: market, our strategic product development teams help • Physical & Chemical Characterization bio-technology and pharmaceutical companies around • Fine Particle Generation & Particle Size Analysis the world characterize, formulate, and scale-up products • Formulation Development to meet critical business timelines. Moreover, our • Reformulation strategic approach helps maximize returns on investments • Peptide and Protein Formulation & Characterization by shortening development cycles to keep costs low. • Device Evaluation • Pharmaceutical Analysis Through close collaboration with our sponsors, our • Stability Testing highly experienced scientists work to combine state of • Process Development the art instrumentation in a cGMP regulatory compliant • Manufacturing for GLP Toxicology Studies facility with customized development strategies for each • Line Extension project. So, whether your company needs inhalation, • Product Maintenance parenteral, topical, oral, specialty dosage forms or a • Scale-Up and Technical Transfer to Manufacturing range of sample-based services, feasibility studies, or • Packaging Component Evaluation & Selection full-scale product development, we are here to assist • Manufacturing Oversight and Batch Release you. Contact us today! • Regulatory Submission
For inquires please call 1-919-884-2064 • email: [email protected] • www.cirruspharm.com DDT Issue10 NOVEMBER05 11/5/05 8:35 AM Page 28
The Coating Place, Inc. 200 Paoli Street Madison, WI 53593 T: (608) 854-9521 • F: (608) 845-9526 E: [email protected] Website: www.encap.com
Coating Place Inc. specializes in Wurster fluid bed microencapsulation of fine powders, granules, crystals, and beads.We provide contract formulation development, technology transfer, scale-up, and commercial manufacturing in a GMP environment with analytical support. Coating Place formulation chemists have been able to apply this process to particles ranging from less than 50 µm up to several centimeters in diameter. Our facility has organic solvent capabilities that allow formulations to be developed in either solvent or aqueous coating processes. Coating properties can be optimized with formulation, coat percent thickness, and other processing parameters. Our new ion resin drug-release system allows us to create 12-hour time-release liquid suspensions that can match the profiles of sustained-release solid dosage forms.These easy-to-swallow liquids make it simple to take your medicine wherever you go. The original management, with 34 years of Wurster coating experience, remains active in the development of formulations and new technology. Our production staff includes numerous employees with more than 20 years of coating experience. Our history and expertise in this coating technology is unmatched in the industry. Coating Place provides Wurster coating and other manufacturing services to the following markets:
• Rx, Branded, and Generic • OTC • Controlled Substance (Schedule II –V) ol 5 No 10 ol 5 No V Services offered include tablet compression, capsule filling, and pan coating for both R&D and commercial manufacturing. Coating capabilities include softgels, hard shell capsules, and tablets. Development applications include controlled oral delivery, such as enteric, delayed, or sustained release. Other coating applications include moisture or oxygen barrier and taste-masking. Our 110,000-sq-ft FDA-registered facility is located in Verona,Wisconsin. Production suites are equipped with a range of Wurster fluid bed coating units that will accommodate batch sizes ranging from 0.010 to over 600 kg. Coating Place Inc. continues to develop, manufacture, and operate proprietary cutting-edge November/December 2005 November/December Wurster coating equipment for our operations. Our chemists have successfully developed a wide range of formulations and applied them to an equally wide range of core materials. Our formulations are designed for a wide variety of desired outcomes, including improved stability, shelf life, taste, or odor masking, enteric delivery, controlled release, sustained release, delayed release, and surface property modification.The possibilities are almost limitless.The innovative, creative staff of the Coating Place is prepared to take on all your particle, bead, or tablet coating needs. Every project is handled in a confidential manner and scheduled Drug Delivery Technology Drug Delivery Technology to meet your needs. Honest and confidential research and manufacturing services have made us the leader 28 and most trusted in the industry. DDT Issue10 NOVEMBER05 11/5/05 8:36 AM Page 29
ÀÕ}Ê iÛiÀÞÊ-ÞÃÌið `ÊvÀÕ>ÌÊ`iÛi«iÌ]ÊVÌÀ>VÌÊ>Õv>VÌÕÀ}o
Ê ÀÊÛiÀÊÎäÊÞi>ÀÃÊ >Ì}Ê*>ViÊV°Ê >ÃÊ «ÀwÊiÃÊÕV ÊiÊÃ`Ê LÀÕ} ÌÊÛ>ÌÛiÊ`i>ÃÊÌÊÌ iÊ>ÀiÌ«>Vi°Ê `Ã>}iÊvÀðÊ/ iÃiÊ / ÃÊÌiÊÃÊÊ`vviÀiÌo°Ê }`ÊÌ>ÃÌ}ʵÕ`ÃÊ Ê *i«iÊÜÊÌiÊÞÕÊÌ >ÌÊÌÊÃÊ«ÃÃLiÊÌÊ >iÊi`ViÊi>ÃiÀ VÀi>ÌiÊ>Ê£ÓÊ ÕÀÊÌiÊÀii>Ãi`ÊÃÕëiÃoÊ ÌÊÃÜ>Ü°Ê ÌÊ>ÞÊÀi°ÊÌÀ`ÕV}Ê£ÓÊ ÕÀÊÌiÊÀi Ê7iÊ >ÛiÊiÝ«iÀiViÊÊ i>ÃiÊÃÕëiÃÃÊÌ >ÌÊ Ì iÀÊÌÞ«iÃÊvÊvÀÕ>ÌÊ`iÛi«iÌÊ>ÃÊÜiÆÊ >VÌÕ>ÞÊÌ>ÃÌiÊ}`°Ê Ì>ÃÌiÊ>Ã}]ÊiÌiÀV]Ê>`Ê`i>Þi`ÊÀÊÃÕÃÌ>i`Ê "ÕÀÊiÜÊÊÀiÃÊ Àii>ÃiÊV>Ì}ðÊ/ iÃiÊ>««V>ÌÃÊ>ÀiÊ>Û>>LiÊ `ÀÕ}Ê`iÛiÀÞÊÃÞÃÌiÊ ÊLÌ Ê>µÕiÕÃÊÀÊÀ}>VÊÃÛiÌÊÃÞÃÌið >ÜÃÊÕÃÊÌÊVÀi>ÌiÊ ÊÀÊ`iÛi«iÌÊÌ ÀÕ} ÊViÀV>Ê µÕ`ÊÃÕëiÃÃÊ >Õv>VÌÕÀ}ÊÊ>ÊV *ÊiÛÀiÌ] À°Ê >iÊ7ÕÀÃÌiÀÊÊÛiÌÀ ÜÌ ÊVÕÃÌÀii>ÃiÊ >Ì}Ê*>ViÊ >ÃÊÞÕÊVÛiÀi`°Ê
^ÊÓääxÊ >Ì}Ê*>Vi]ÊV°Ê ÊÊÊÊÊÊ >Ì}Ê*>Vi]ÊV°]Ê ÝÊÎäΣäÊÊUÊÊ6iÀ>]Ê7ÃVÃÊxÎxÎÊ1°-°°ÊÊUÊÊ£Èänn{xxÓ£ÊÊUÊÊÜÜÜ°iV>«°V DDT Issue10NOVEMBER0511/5/058:36AMPage30
30 Drug Delivery Technology November/December 2005 Vol 5 No 10 and animalhealthcare andotherapplications. r ofcontrolled ofthe understanding “added value” controlled-release technology.A clear social benefitsthatcanbederivedfrom r duetothe and broadened inscopeever since, r of thescienceandtechnology ofcontrolled devoted totheadvancement profit organization, y Five thatCRSwas conceived in1973. applications, andinotheragrochemical this latterfield, Itwas in antifoulants from rubber inthe1950s. development ofcontrolled release ofmarine andtothe late 1940sandearly 1950s, successful oral sustained-release products inthe commerciallythe development ofthefirst era ofcontrolled releasemodern canbetraced to applications are probably asoldmankind.The v temporal release ofsubstances for agricultural, toregulate thespatialand tousematerials Efforts Background promoting education by releasingpromoting educationby sciencetodeliver abetterfuture. and society dedicatedtothescienceandtechnology ofcontrolled release anddelivery elease is crucial for involvedelease iscrucial all parties inhuman and therapeutic, ealization oftheeconomic, Interest incontrolled release hasgrown elease. asltr CRSwas incorporated asanot-for- later, ears trnr,csei,mdcnl andhousehold medicinal, cosmetic, eterinary, T: 3650 AnnapolisLaneNorth,Suite107 W E: (763) 512-0909 ebsite: Minneapolis, Minnesota55447 [email protected] Controlled ReleaseSociety Controlled www.controlledrelease.org The Controlled ReleaseSocietyisamulti-disciplinary Mission r andone-third represents industry, membership more than50countries.Two-thirds oftheCRS from which 3,000members serves Minneapolis area, inthe organizationwithheadquarters an international The Controlled ReleaseSociety(CRS) epresents academiaandgovernment. • F: delivery ofactive substances. delivery to the biologicalorenvironmental barriers the interactions systemand between the delivery of future dependsonathorough understanding r science ofcontrolled controlled release.The are beingaddressed asotherforms of therapy, such asgene Newer approaches, etc. medicine, cellbiology, physiology, molecular biology, biophysics, biological sciences—biochemistry, andthe science, materials physics, pharmaceutics, chemical engineering, chemistry, many disciplines: Controlled release draws upontheexpertise of the fate oftheagent oncebeyondthesebarriers. ormanipulationof targeting, biological barriers, manipulationoftheappropriate materials, through theuseofrate-controllingparameters r objective may beachieved control ofdiffusion, by ortomaximizeefficacy.This reactions, adverse tominimize duration ofactionanactive agent, objective may betoprolong the applications.The ag andofotheractive human andanimalhealth, the biologicaleffects oftherapeutic agents in withthecontrol intimeandspaceof concerned Controlled release isthefieldofscientificactivity Science elease hasbecomearesearch disciplinewhose orotherphysicochemical eaction rates, nsi niomna,cnue,andindustrial consumer, ents inenvironmental, (763) 765-2329 is DDT Issue10 NOVEMBER05 11/5/05 8:36 AM Page 31
DGCWVKHWN8KGPPC#WUVTKC CVVJG#WUVTKC%GPVGT 0R]DUW 9HWHULQDU\ %LRDFWLYH 0DWHULDOV -XO\ 0DUN\RXUFDOHQGDU 6WUDXVV &RQVXPHU 7KH$UWRI/LYLQJ 'LYHUVLILHG3URGXFWV *RWRZZZFRQWUROOHGUHOHDVHRUJIRUIXUWKHU GHWDLOVDQGSURJUDPLQIRUPDWLRQ DDT Issue10 NOVEMBER05 11/5/05 8:36 AM Page 32 USA Germany Degussa Corporation - Rohm America LLC Degussa AG - Pharma Polymers 2 Turner Place Röhm GmbH & Co. KG Piscattaway, NJ 08855 Kirschenallee 45 T: (877) 764-6872 Option 4 • F: (732) 981-5371 64293 Darmstadt, Germany E: [email protected] T: +49-6151-18-4019 • F: +49-6151-18-3520 Website: www.pharma-polymers.com E: [email protected] Website: www.pharma-polymers.com Who we are The Pharma Polymers business line belongs to the Specialty Acrylics unit of the Röhm GmbH & Co. KG, a subsidiary of the Degussa AG, the global leader in specialty chemistry. Pharma Polymers is one of the world leaders in the manufacturing and supplying of functional coatings for the pharmaceutical industry. Based on more than 50 years of know how, Pharma Polymers is a strategic partner for the industry and supports the customer at all stages of formulation development. EUDRAGIT® Customer Benefits EUDRAGIT® is the trade name for copolymers derived Pharma Polymers is a strategic partner, providing global from esters of acrylic and methacrylic acid, whose support for local custom-tailored applications: from properties are determined by functional groups. formulation development via enhanced formulation EUDRAGIT® polymers are today’s products of choice for technologies to unique customer products with solid oral formulations.The following possibilities exist individually designed release profiles. for controlled drug release: Pharma Polymer helps you to: • Enteric Coatings (GI targeting,) • Sustained-release Formulations (delayed drug • increase your efficiency of R&D release). • reduce time to market • Protective Coatings (taste and odor masking, • make your production efficient ol 5 No 10 ol 5 No V protection against moisture) • mange the Life Cycle of your product Drug Delivery Technologies Our international network of technical service centers Based on more than 50 years of experience in gives you on-site support at every stage of EUDRAGIT® polymer design and formulation know-how pharmaceutical development, with the same high for pharmaceutical applications, Pharma Polymers has quality standard and flexible performance anywhere in developed advanced oral drug delivery technologies: the world. November/December 2005 November/December • EUDRACOL™ Capabilities Colon-targeted sustained-release oral drug delivery • Design: product development, formulation technology modifications, feasibility studies • EUDRAPULSE™ • Process: process optimization, scale-up/ Oral drug delivery technology providing variable technology transfer, GMP conditions lag times and pulsatile release profiles • EUDRAGIT®: portfolio with enteric, protective or Drug Delivery Technology Drug Delivery Technology sustained-release properties • EUDRAMODE™ • • Solutions to Customers: flexible drug delivery Oral drug delivery technology platform providing 32 design and life cycle management diffusion- and time controlled modulated release DDT Issue10 NOVEMBER05 11/5/05 8:36 AM Page 33 EUDRAGIT–P® ower Through Flexibility Add flexibility and power to your development process with EUDRAGIT®. Our wide range of polymers allows you to design any number of combinations to match your targeted release profile. Designing Drug Delivery Project Target Optimization Product For innovative product opportunities, contact us at Europe: +49-6151-18-4019 USA: (732) 981-5383 Pharma Polymers www.pharma-polymers.com DDT Issue10 NOVEMBER05 11/5/05 8:36 AM Page 34 Dow Corning Corporation PO Box 0994 Midland, MI 48686 T: (989) 496-6000 • F: (989) 496-6731 E: [email protected] Website: www.dowcorning.com/content/healthcare Dow Corning is the global leader for healthcare solutions using silicone technology. For more than five decades, Dow Corning has drawn upon the versatility and biocompatibility of silicones to help customers develop innovative solutions for drug delivery, pharmaceutical processing, wound care, and medical device fabrication. Our approach to provide solutions for delivery systems can help extend the life of key products, improve the clinical efficacy of drugs, and provide enhanced aesthetics for better patient compliance. Our continued experience in the healthcare industry as well as the quality, reliability, and innovation we bring to every project helps the materials engineer, formulator, or fabricator to develop new or improve existing products.We offer one of the most expansive lines of performance-enhancing materials for healthcare in the industry - materials that are safe and beneficial in numerous applications. For more information visit Dow Corning's website or sign up for our newsletter updates on emerging technologies in ol 5 No 10 ol 5 No healthcare! V November/December 2005 November/December Drug Delivery Technology Drug Delivery Technology 34 DDT Issue10 NOVEMBER05 11/5/05 8:36 AM Page 35 Delivering on what matters most to you. Dow Corning can help you create optimal delivery systems for Adhesives for transdermal the controlled release of active ingredients. Our silicone materials, drug delivery systems technologies and expertise deliver: Film-forming technologies • Improved bio-availability of actives to form in situ drug • Biocompatibility, nonirritating, and nonsensitizing delivery patches • Customization of existing technologies to meet your needs Excipients for topical drug delivery systems • Properties desirable for controlled release: conformability, barrier properties Elastomers for controlled • Improved comfort and aesthetics release devices-films, inserts and implants • Solutions Coatings Visit us on the web at www.dowcorning.com/healthcare. Fluids and emulsions Active Pharmaceutical Ingredients DDT Issue10 NOVEMBER05 11/5/05 8:37 AM Page 36 Dowpharma The Dow Chemical Company 5501 Oberlin Drive San Diego, California 92121 T: (800) 745-7475 • F: (858) 352-4560 E: [email protected] Website: www.dowpharma.com Dowpharma is a business unit of The Dow Chemical Company. DowpharmaSM contract manufacturing services delivers innovative technologies, products, and services in drug discovery, development, delivery, and manufacturing to pharmaceutical and biopharmaceutical companies. Dowpharma has one of the broadest capabilities in the global outsourcing industry with services that include process development, route selection, methods development, custom solubilization, chiral capabilities, and associated analytical services, as well as manufacturing and scale-up from feasibility, through clinical trials, to commercial manufacturing. Customers can leverage Dowpharma’s experience and track record to transport their biopharmaceuticals from discovery to commercialization. Dowpharma offers a broad spectrum of process development and manufacturing services for the production of recombinant proteins, peptides, and vaccines from microbial hosts. • Systems biology approach • Application of bioinformatics, genomics, functional genomics & genome scale metabolic modeling • Unmatched fermentation infrastructure enabling innovative experimental design & rapid execution • World-class analytical capability enables complete characterization of proteins • Structured & disciplined project execution teams Dowpharma’s Pfenex Expression Technology™, a Pseudomonas-based technology for the production of recombinant proteins is built around specially designed strains of Pseudomonas fluorescens. Pfenex Expression Technology: • Improves yields through very high cell density fermentation and higher specific protein expression per cell • Avoids the complexity and inefficiency of protein refolding through soluble expression • Enables expression of hard-to-express proteins, peptides, Fab’s, single-chain fragments, and antigens • Contains a full set of applicable host vectors & promoters • Does not require the use of antibiotics or animal-derived components at any point in the production process Pfenex Expression Technology is a cost-effective alternative to traditional synthetic methods and a more efficient long-term option for the production of peptides exceeding 25 amino acids.The improved yields translate into lower cost of goods, while strain optimization helps to eliminate production problems early and avoid costly delays on the back end.This technology can be combined with other Dowpharma technologies, such as PEGylation and the BioAqueousSM solubilization services, to positively impact a product’s bottom line. Dowpharma also develops high-quality activated PEGs with fully characterized functionality and lot-to-lot consistency. PEGs ol 5 No 10 ol 5 No are a proven drug delivery technology that can extend the half-life of a drug candidate and reduce dosing frequency. Customers V can take advantage of Dowpharma’s royalty-free pricing and complete PEGylation conjugation services and support to PEGylate a protein, peptide, antibody, or oligonucleotide fragment-based biopharmaceutical. Molecular weights can range from 5 to 40 kDa. Additionally, Dow offers BioAqueousSM solubilization services designed to help pharmaceutical and biopharmaceutical companies address complex challenges of dissolution-rate limited drug compounds. Based on a portfolio of solubilization technologies, Dow provides evaluation of customers’ drug compounds, development of tailored solutions for drug solubilization, provision of materials for clinical trials, and licensing of technology to help their clients successfully develop their drugs. With its biopharmaceutical enterprise headquartered in San Diego, Dowpharma is focused on becoming a process development partner with its customers, as well as providing control and flexibility in enhancing the expression and production of therapeutics. Dowpharma has the infrastructure to handle the rapid and linear scale-up of process development programs from November/December 2005 November/December analytical development through a technology transfer to a cGMP manufacturing facility, such as those in Dow’s external Contract Manufacturing Network. Customers can jump onto Dowpharma’s process development pathway at any phase. Dowpharma’s San Diego site consists of four facilities housing commercial, project management and operational staff, as well as researchers and scientists working and operating in microbiology laboratories and pilot plants. Capabilities at the site include: • Molecular biology • Bioprocessing, including process development & scale-up for fermentation (20 L- 1500 L), recovery & purification for microbial-based processes Drug Delivery Technology Drug Delivery Technology • Analytical method development • Pfenex Expression Technology for the production of therapeutic proteins, peptides, scFvs, and fAbs 36 • • Solvent Extraction Technology for the efficient recovery of protein from production media DDT Issue10 NOVEMBER05 11/5/05 8:37 AM Page 37 DDT Issue10 NOVEMBER05 11/5/05 8:37 AM Page 38 DPT 318 McCullough San Antonio, TX 78215 T: (866) CALL DPT • F: (210) 829-8733 E: [email protected] Website: www.dptlabs.com Founded: 1990 No. of Employees: 1500 Key Personnel Paul Dorman, CEO; John Feik, COO; Paul Johnson, President; Paul Josephs,Vice President Sales and Commercial Operations; Marc Iacobucci,Vice President Project Management and Marketing Company Description DPT,aDFB Pharmaceuticals, Inc. company, has a reputation for quality, expertise, leading-edge technologies, and an excellent regulatory compliance record - reasons why DPT is the market leader in semi-solid and liquid contract services. DPT provides customers confidence in full-service, turnkey, or stand-alone development, production, packaging, and worldwide distribution services for a variety of semi-solid and liquid, Rx, biopharmaceutical, and consumer products. DPT has turned the science of formulation into an art. Employing over 100 of the industry’s top scientists, DPT can find a solution for every formulation. DPT scientists have expertise in pre-formulation, formulation and analytical development, scale-up, validation, and stability. DPT provides distinctive platform technologies with proven performance benefits to optimize delivery and stability of active ingredients.And as one of the fastest growing R&D groups in the industry, DPT offers two of the newest drug delivery methods – aerosol foam and intranasal. ol 5 No 10 ol 5 No V Services Advanced Development Solutions DPT has expertise in pre-formulation, formulation and analytical development, validation, and stability. DPT can find a solution for every formulation and manage your product through to commercialization. Specialized Production Solutions DPT conducts scale-up, site transfers, and commercial manufacturing of complicated Rx, biotech, and consumer products – even hard-to-handle substances – in various batch sizes. November/December 2005 November/December Innovative Packaging Solutions Offering comprehensive packaging solutions from solid and semi-solid to liquid, DPT also specializes in unique delivery systems, such as aerosol foam and intranasal. Facilities Drug Delivery Technology Drug Delivery Technology Headquartered in San Antonio,Texas, DPT has four facilities there and two in Lakewood, New Jersey, with approximately 1 million square feet of state-of-the-art development, manufacturing, packaging, and 38 distribution space. DDT Issue10 NOVEMBER05 11/5/05 8:37 AM Page 39 C740AC>534E4;>?<4=C 5^a\d[PcX^] 8c·b P bRXT]RT 1dc PSS cWT X]VaTSXT]c ^U _PbbX^] P]S cWT _a^RTbb QTR^\Tb P] Pac >da _PbbX^] U^a RaTPcX]V d]X`dT U^a\d[PcX^]b Xb fWPc T]PQ[Tb db c^ P__a^PRW TeTah U^a\d[P Ua^\ P UaTbW P]S RaTPcXeT _Tab_TRcXeT 8c·b fWPc P[[^fb db c^ TgRTTS ^da Rdbc^\Tab· Tg_TRcPcX^]b 0]S Xc·b fWPc \PZTb db P [TPSTa X] _WPa\PRTdcXRP[ STeT[^_\T]cP]SUd[[bTaeXRTR^\\TaRXP[\P]dUPRcdaX]V EXbXcdb ^][X]TPcfff S_c[PQb R^\ ^aRP[[ '%% 20;; 3?Cc^SXbR^eTaW^ffTRP]PSS_PbbX^]c^h^da]TgcU^a\d[P B4<8 B>;83B ;8@D83B =0B0;B?A0H 04A>B>;5>0< 2>A >dcb^daRTfXcW2^]UXST]RT3- ''OL7K% $0 DDT Issue10 NOVEMBER05 11/7/05 4:12 PM Page 40 DDT Issue10 NOVEMBER05 11/5/05 8:37 AM Page 41 DDT Issue10 NOVEMBER05 11/5/05 8:37 AM Page 42 Emerson Resources, Inc. 600 Markley Street Norristown, Pennsylvania 19401 T: PA (610) 279-7450; NC (252) 292-2384 F: PA (610) 292-9722 E: [email protected] Website: www.emersonresources.com Contact: Walter Strathy, Business Development Date Founded: 1987 Corporate Description Emerson Resources, Inc. delivers industry-leading research, development, technical services, technical training, and value- added ingredients to the pharmaceutical industry. Emerson Resources, Inc., as it exists today, is the result of three technology companies joining forces.The principals of the current corporation have over 120 years of combined experience in the industries we serve.All our associates in Emerson Resources, Inc. are highly educated and seasoned professionals. Emerson Resources, Inc. was built on two core concepts: unmatched service quality and complete client satisfaction. Our mission is to deliver unparalleled, value-added service, ingredients, and expertise to our customers with a dedication to honesty, innovation, creativity, and hard work; and an unrelenting commitment to quality. Services Emerson Resources, Inc. has three areas of focus: Formulation development and technical support (Emerson Pharma Services, Inc.),Technical training (Emerson Science Center), and Value-added ingredient supply (Emerson Ingredient Technology). Emerson Pharma Services, Inc. provides delivery system development and technical services including: characterization, preformulation studies, excipient compatibility studies, analytical method development and validation, formulation development, stability studies, Phase I and II clinical supply batch preparation, process development and engineering, process capability studies, and process validation. Our lab has a schedule II–V control license. Delivery System Capability & Expertise • All Oral Solid Dosage Forms • Extrusion/Spheronization • Controlled Release Technology ol 5 No 10 ol 5 No V • Tablet & Particle Coating • Oral Liquids & Suspensions • Topical (Creams, Lotions, Gels, Ointments) Emerson Science Center provides technical and operations training. Some training offerings include: Hands-on Formulation Development,Training for Operators, Science-Based Tablet Development, Design of Experiments, and Solid Dosage Forms for Non-technical Professionals. Emerson Ingredient Technology provides value-added coating ingredients that solve unique coating challenges. November/December 2005 November/December Marcoat provides a oxygen and moisture barrier film that improves delivery system stability. Plasacryl is an additive for acrylic coating systems that improves processing. Emgloss is a coating that imparts a high shine to tablets. Facilities Emerson Resources, Inc. is located in its own well-equipped 46,000-sq-ft building in Norristown, PA. Norristown is strategically located in the heart of “Pharma Country” at the cross roads of all major transportation Drug Delivery Technology Drug Delivery Technology routes.The building houses our development laboratory, GMP pilot plant, ingredient manufacturing facility, and classroom.The pilot plant is certified class 10,000 for manufacturing Phase I and II clinical supplies.The facility has 42 a schedule II–V control license. DDT Issue10 NOVEMBER05 11/5/05 8:37 AM Page 43 RULES FOR FORMULATING FLAWLESS DOSAGE SOLUTIONS When you give us your product to develop, you’re delivering on every promise we make. And on putting your success in our hands. So naturally, people who inherently accept nothing less than your challenge becomes our challenge.Your success absolute success. To transfer ownership of your becomes our success. Our business is built on next challenge, call Emerson at 610-279-7450. www.thinkoutsidethebeaker.com DDT Issue10 NOVEMBER05 11/5/05 8:38 AM Page 44 Eurand Via M. Luther King, 13 845 Center Drive 20060 – Pessano con Bornago, Vandalia, Ohio 45377 (Milan) Italy T: (937) 898-9669 T: +39-02-95428-309 F: 937-898-9529 F: + 39-02-95745018/12 E: [email protected] Website: www.eurand.com Eurand is a specialty pharmaceutical company that develops enhanced pharmaceutical and biopharmaceutical products using our innovative drug delivery technologies. Eurand is dedicated to the continued development and commercialization of breakthrough technologies and products that better satisfy patients’ needs.To this end, the Company develops treatment options with superior safety, enhanced efficacy and convenient dosing. For more than 30 years, Eurand has been a world leader in drug delivery.We offer comprehensive technology platforms designed to optimize the delivery of drug substances. Using these technologies, Eurand turns difficult drug candidates into easy-to-administer, successful pharmaceutical products. Additionally, our technologies can be used to enable the creation of innovative and effective products for life-cycle management. Eurand has a well-established technology portfolio that is one of the broadest in the industry. The Company’s drug development efforts are based on four commercialized technology platforms: • Bioavailability enhancement of poorly soluble drugs; • Customized release; ol 5 No 10 ol 5 No • Taste masking V • • Fast-disintegrating formulations. Our commercialized technology platforms are made up of 13 novel drug delivery technologies that can be used alone or in tandem to provide unique drug delivery solutions. Eurand has a fifth technology platform, drug targeting, that, once commercialized, can be applied to small molecule and biotechnology derived products for improved drug delivery.The breadth of our technology platforms November/December 2005 November/December enables us to have more than one solution for any drug delivery problem. We are experts in using our technologies to solve the most difficult drug delivery challenges and to develop novel pharmaceutical products. To date, more than 50 products, marketed by Eurand customers in over 50 countries, have been developed using our technologies. Eurand is a global company with more than 500 employees. Its principal operating offices are in Milan, Italy.The Company has research, development, and manufacturing facilities throughout the Drug Delivery Technology Drug Delivery Technology world, including sites in Milan and Trieste, Italy; Dayton, Ohio (US) and Paris, France. For more 44 information, please call us or visit our website, where you will find detailed technical information on our drug delivery systems. DDT Issue10 NOVEMBER05 11/5/05 8:38 AM Page 45 Unique Unparalleledtaste Flexible dose Versatile release Robust tablet The next generation ODT Eurand’s AdvaTab is an orally disintegrating tablet (ODT) technology that combines superior taste and mouth feel properties in a robust tablet. AdvaTab is unique, offering both high dose capacity and modified drug release making it www.eurand.com the most broadly applicable ODT available. Utilization of standard tabletting processes allows for cost-efficient manufacturing and conventional packaging. USA +01-937-898-9669 The next generation ODT is here! EU +39-02-95428-309 ODT CUSTOMIZED RELEASE TASTE MASKING ENHANCED BIOAVAILABILITY DDT Issue10NOVEMBER0511/5/058:38AMPage46 46 Drug Delivery Technology November/December 2005 Vol 5 No 10 performance isoptimized inthehandsofend-user. performance delivery and availableresources necessarytoensurethatpharmaceutical design, developmentandmanufactureofhand-helddevices,hastheexperience confidently administerthecourseoftherapy.FacetTechnologies, aleaderinthe and relateddisposablesthatenablethepatient(orcaregiver)tosafely,easily drug deliverysystemsisthe Co.), tonameafew. Laboratories, Bayer, BD,RocheDiagnosticsandLifeScan,Inc.(aJohnson &Johnson Core Competencies Facilities &Clients Corporate Description Product Specialty • • • • end-user. Corecapabilitiesandcontractservicesinclude: efficacy ofyourdiagnostic,medicalordrugdelivery technologyinthehandsof are availabletocreateproprietarydesignsthat facilitatethesafety,comfort,and intuitive andpreciseinthehandsofend-user. leading developerandmanufacturerofcomplex,hand-helddevices,whichare in themedicalanddrugdeliveryindustries.Facethasestablisheditsexpertiseasa organization providingdesign,developmentandmanufacturingservicestoClients Facet isanISO-13485:2003certified,FDAregisteredengineeringandmanufacturing needs ofsuch generation) productinnovationstomarket quickly. Theycontinuetoservethe community. Facet’sProjectManagersarehighlyadeptatdrivingnew(ornext medical standards oftheFDAaswelltorequirementsinternational Northampton, UK,Facethasdemonstratedtheircommitmenttothestringent ehnclDsg Clinical Support/UserStudies Lowand HighVolume Manufacturing • • RegulatoryAffairs • DistributionLogistics& SupplyChain • Manufacturing Engineering Mgmt. Mechanical Design Mechanical Engineering Industrial Design Fortune 100 Website: A DivisionofMatriaHealthcare 1850 ParkwayPlace,Suite900 Located inAtlanta(MariettaandMcDonoughsites) A criticalcomponentofmanymedical,diagnosticand patient interfacedevice Facet Technologies,LLC Facet’s designers,engineersandsupportprofessionals OEM organizationsasALZACorporation,Abbott www.FacetTechnologies.com Marietta, GA30067 A divisionofMatriaHealthcare,Inc.(Nasdaq:MATR), F: (770)767-7320 T: (770)767-8344 – thehand-heldcomponent DDT Issue10 NOVEMBER05 11/5/05 8:38 AM Page 47 Delivery Devices Engineered for Precise Performance A critical component of many drug delivery systems is the hand-held user interface device...the device that enables the patient to safely and confidently self- dose. Facet Technologies®, a leader in the design and development of hand-held dosing devices, has the necessary experience to ensure that your drug delivery platform is optimized in the hands of the patient. If your delivery platform requires a hand- held dosing device, contact us today. Our designers, engineers and support specialists can create proprietary design concepts and mechanisms that ensure safety and comfort to your patients. Call 800-526-2387 (ext. 8344) Email [email protected] Visit www.FacetTechnologies.com DDT Issue10 NOVEMBER05 11/5/05 8:38 AM Page 48 FILTERTEK INC. 11411 Price Road Hebron, Illinois 60034 T: (800) 648-0791 (Main) Contact: Chris Maar, Marketing Specialist T: (815) 648-2416 E: [email protected] Website: www.filtertek.com Pinpoint precision and strict attention to details keep Filtertek medical filters, valves, and critical components in line with leading edge medical technology and the needs of our customers. Filtertek develops and manufactures a full range of products for use in the medical industry including products for drug delivery, respiratory therapies, surgical preparation, pharmaceutical processing, and equipment protection. Meeting the needs of large and small OEM suppliers, the company has developed and produced hundreds of product innovations designed to provide high-performance filtration and fluid control solutions. Filtertek has cost-effective, high-quality products for any medical application from simple, traditional components to highly sophisticated devices. If the right product is not yet available, we have the expertise to design custom parts from basic specifications, such as flow rate, pressure drop, and application to better serve the needs of the ever-evolving medical market. Drug delivery and bioprocessing science continue to advance, providing new product development programs for Filtertek in separations technology applications. For small-scale fermentation vessels and bioreactors used in pharmaceutical applications, Filtertek is introducing a new line of 50-mm vent filters.This new 50-mm product platform will also be widely used as a medical device for procedures including laproscopic surgery, laser smoke removal, and drug admixture. Filtertek is committed to proactive, solution-driven product development to help our customers ol 5 No 10 ol 5 No V achieve optimal results.A close collaboration with its suppliers and customers keeps Filtertek in pace with “tomorrow’s” medical technology.With its wide range of product applications expertise, medical clean rooms, and strategic manufacturing locations, Filtertek is uniquely positioned as a global partner in the development of advanced products for growing medical markets. Customers’ growing desire for “turn-key” projects affords Filtertek the opportunity to quickly and efficiently offer finished products tailored to the most widely used drug applications. With so much riding on product quality and performance, designing and developing components November/December 2005 November/December for critical medical applications takes design ingenuity, technical knowledge, and manufacturing precision. By choosing Filtertek to produce your medical filtration and drug delivery components, you’re assured of partnering with a source that puts as much into the development of your product as you do. Filtertek, a worldwide leader in the design and manufacture of filters for the automotive, commercial, and medical industries, has nearly 1000 employees located across three continents and Drug Delivery Technology Drug Delivery Technology annual revenues of over $90 million.The company, recognized for its innovation in the filtration industry, designs custom solutions that meet or exceed customer requirements for performance, 48 durability, delivery and cost.Visit www.filtertek.com or call 1-800-648-0791 for more information. DDT Issue10 NOVEMBER05 11/5/05 8:38 AM Page 49 TO STAY AHEAD OF YOUR COMPETITION, IT PAYS TO HAVE THE RIGHT CONNECTIONS. When the patent on your drug expires, so do many of your hopes for maintaining market share. But Filtertek gives you the edge you need. The fi rst of its kind, and the last word in needle-safe drug transfer, our breakthrough technology eliminates the potential for needlesticks, contamination and waste by combining venting and transfer into one safe, spill-proof action— providing unmatched protection for those administering and receiving your drug. And unmatched protection for your bottom line. Because when your customers know they won’t get stuck by a needle, they’ll be more likely to stick by your drug. For more information, call 1-800-648-0791 and connect with us today. DDT Issue10 NOVEMBER05 11/5/05 8:38 AM Page 50 Glatt Pharmaceutical Services 20 Spear Road Ramsey, New Jersey 07446 T: (201) 825-8700 F: (201) 825-0389 E: [email protected] Website: www.glattpharmaceuticals.com Year Founded: 1954 Number of Employees: Glatt Air Techniques, Inc., USA ~ 150 Glatt Group,Worldwide ~ 1500 VITAL STATISTICS Key Personnel: Glatt Pharmaceutical Services Division: Oliver W.Mueller, Executive Vice President; David Jones, Vice President Process Technology;Thomas Salus, Director Business Development; Christopher Sheehan, Manager, Manufacturing; Richard A. Collins, Manager, Product Development; Susan Saffar, Manager, Corporate Compliance; Mary Anne Dorman, Plant Engineer & Safety Manager. Who We Are: Glatt Pharmaceutical Services is the leading global provider of solid dosage form product development, drug delivery technology, and contract manufacturing to the pharmaceutical industry.With over 30 years of experience and innovation, this division of Glatt Air Techniques, Inc., in collaboration with its global Glatt Group affiliates, continues to successfully partner with pharmaceutical companies to bring their immediate-release and complex controlled-release products to market.All of our services are provided with the greatest attention to quality and customer service. SERVICES OFFERED Product Development We feature a highly experienced and accomplished group of scientists who participate in a teamwork-focused environment in the development of your products. Our R&D team has succeeded in developing products from a broad list of categories, including New Chemical Entities, Product Line Extensions, Over-the-Counter, and Generic Drug Products. Our R&D services are supported by a complete line of analytical capabilities in our newly expanded laboratory. Building on our expertise in fluid bed and solid dosage technology, we deliver a complete R&D program including: • Formulation Development • Process Development (Aqueous and Organic Solvent Processing) • cGMP Clinical Trial Material Production ol 5 No 10 ol 5 No V • Process Scale-Up • Technology Transfer for Manufacturing Drug Delivery Technologies Contract Manufacturing With a focus on controlled release, Glatt offers new and Our experienced staff provides first-class cGMP novel enabling proprietary technologies for both ANDA manufacturing of both bulk intermediates and final and NDA products including: solid dosage form products.We are committed to a schedule of up to 24 hours/7 days a week to meet the November/December 2005 November/December CPS Technology™ - Controlled Release market demands placed on the supply of your products. Pellet System Our pellet manufacturing capabilities are expanding to Direct Pelletization further focus on Wurster HS drug layering and High Drug Loading (up to ~ 90%) functional film coating and direct pelletization using Dense, Spherical, and Uniform Pellets our CPS Technology™. ZRx™ Technology – Zero-Order Release Tablet System Drug Delivery Technology Drug Delivery Technology Extended-Release Tablet Matrix System 50 Zero- or First-Order Release Characteristics Once-per-Day Dosing DDT Issue10 NOVEMBER05 11/5/05 9:39 AM Page 51 Glatt Pharmaceutical Serv i c e s P roduct Deve l o p m e n t Solid Dosage Forms Modified Release & Immediate Release Products Multi-particulate Systems D rug Delive ry Te ch n o l og i e s CPS Technology™ - Controlled Release Pellet System ZRx™ Technology - Zero Order Release Tablet System MicroPx™ Technology - Micro Pellet Delivery System C o n t ract Manu fa c t u r i n g Global cGMP Production Sites Commercial Scale Wurster HS Systems Pelletizing & Modified Release Coating G l at t Granulating/Drying & Blending P h a rmaceutical Serv i c e s offers premier solid dosage form product development, drug delivery technologies, and contract manufacturing to the pharmaceutical industry. With our facilities in Ramsey, NJ; Binzen and Dresden, Germany: and Reinach, Switzerland, we provide our clients services ranging from formulation development and process scale-up, to clinical supply manufacturing and full-scale cGMP production. For over 5 decades, we have helped to produce some of the world’s leading pharmaceutical products. Our global R&D and manufacturing team will treat your products with the same skill and care as we would our own. D e l ivering Solid Experience 20 Spear Road, Ramsey, NJ 07446 • 201.825.8700 Fax: 201.825.0389 w w w.glattpharmaceuticals.com • e-mail: glattpharmaceuticals@glattair. c o m DDT Issue10 NOVEMBER05 11/8/05 3:10 PM Page 52 Hovione SA Sete Casas 2674-506 Loures Portugal T: + 351 21 982 9000 F: + 351 21 982 9118 Website: www.hovione.com Contact: Isabel Pina, Corporate Communications Exclusively Focused on Pharmaceutical Fine Chemicals Hovione is a fine chemicals Company dedicated to the process development and manufacture of active pharmaceutical ingredients (APIs) and regulated intermediates for the Pharmaceutical Industry.With FDA-inspected plants in Europe and the Far East and a Technology Transfer Centre in New Jersey, Hovione is committed to the highest levels of service and quality. Our capabilities include process chemistry, analytical development, worldwide regulatory affairs, and kilo to multi-ton manufacture of APIs under FDA and ICH cGMP standards.With more than 45 years experience, our ability to provide customers with timely and reliable solutions that are dependable and economical has given us a worldwide reputation for quality products, superior customer service, and regulatory compliance. ol 5 No 10 ol 5 No V Particle Design Technologies & cGMP Spray Drying Hovione has recently developed new capabilities in the area of particle design, enabling the production of advanced APIs (aAPI™). Building on our accumulated expertise in micronization, freeze-drying, and jet milling, our new state-of-the-art cGMP spray drying facilities give us greater control in optimizing crystal characteristics.With operating units at November/December 2005 November/December every scale, our technology supports both API synthesis and product formulation development. From just a few grams for feasibility testing at lab scale to full commercial production, Hovione can carry out complete R&D and analytical studies on particle design as per your specific product requirements. No manufacturing partner is better equipped to meet the challenges of bringing new APIs to market quickly, while ensuring “right first-time” Drug Delivery Technology Drug Delivery Technology delivery. 52 DDT Issue10 NOVEMBER05 11/5/05 9:39 AM Page 53 rug delivery technology ad 4/10/05 12:47 pm Page 1 Your API is now available in multiple shapes and sizes. Announcing GMP spray drying at every scale. Building on our accumulated expertise in all major areas of API development and cGMP manufacture, Hovione has further expanded its specialist capabilities in the latest particle design technology. We have completed the installation of a state-of- 3µm 100µm the-art cGMP spray drying facility operating from just a few grams in a lab scale unit to full commercial scale, designed to support both API synthesis and drug product formulations. 100µm 100µm Hovione offers APIs for all drug delivery systems, Summary of the benefits provided by Hovione's from oral to injectable and from inhalation to spray drying equipment: topical applications. With FDA inspected plants Improved bioavailability in Europe and the Far East and a Technology Transfer • • Elimination of micronization issues associated with Center in New Jersey, no manufacturing partner is conventional grinding and jet milling processes better positioned to support your pharmaceutical • Reduction of OVIs and residual solvents development from gram scale to commercialization. • Variety of encapsulation options • Improved product stability To find out more, call us on +1 609 918 2600 • Suitable for thermally labile compounds in the USA and +351 21 982 9245 in Europe or • Optimal sizing and shaping of particles. visit us at www.hovione.com Exclusively focused on pharmaceutical fine chemicals DDT Issue10 NOVEMBER05 11/5/05 9:39 AM Page 54 Huber Engineered Materials USA Headquarters 1000 Parkwood Circle, Suite 1000 Atlanta, Georgia 30339 T: (678) 247-7300 F: (678) 247-2797 Website: www.hubermaterials.com Huber Engineered Materials – Your Expert Partner for Oral Dosage Huber’s expertise and innovation in oral dosage is embodied in the company’s recently announced excipients and granulation options for oral dosage formulations. From carriers and glidants, to custom granulation options and advanced fast-disintegration excipients, Huber’s broad portfolio of options can assist in any oral dosage challenge. RxCIPIENTS® Rapid-Disintegration Excipients (www.rxcipients.com) • Efficient, complete disintegration for smooth mouthfeel • Create robust tablets for bottles or push-through blister packs • Manufacture on your own equipment (no outsourcing) • Avoid paying royalty fees Hubercal® Granulation (www.hubermaterials.com) • Naturally mined and oyster shell calcium carbonate granulation • Customizable binder systems • Continuous, high-volume, high-shear granulation production • Trusted supplier to national brands RxCIPIENTS® Glidants (www.rxcipients.com) • Precipitated silica, not colloidal • Create smooth, consistent powder flow • Enables faster tablet production ol 5 No 10 ol 5 No • Significantly less dust V Huber Carriers (www.hubermaterials.com) • Convert liquid API’s into free-flowing powders • Create oral solid dosage forms of liquid formulations • Load up to 70% by weight • Active ingredients are effectively released into the body November/December 2005 November/December Huber technologists work diligently with their own tableting and excipient production equipment to simulate customer requirements. This focused approach to serving its customers has been a hallmark of the company’s values for decades. Huber Engineered Materials is part of the family-owned J.M. Huber Corporation. J.M. Huber Corporation, headquartered in Edison, NJ, is a diversified, multinational supplier of engineered materials, natural resources and technology-based services to customers spanning many industries from paper and energy to plastics and construction.With announced sales exceeding $2 billion, J.M. Huber Corporation is one of the largest family-owned Drug Delivery Technology Drug Delivery Technology companies in the United States. 54 DDT Issue10 NOVEMBER05 11/5/05 9:40 AM Page 55 Concept. Reality. Introducing RxCIPIENTS® FM1000 from Huber Engineered Materials, an excipient that enhances tablet disintegration. It’s fast, with tablet disintegration in 5-30 seconds. It’s strong – low tablet friability allows for standard packaging. It provides consistent tablet disintegration. It’s the excipient you can formulate in house without need for a drug delivery company. Request a sample or learn more at www.rxcipients.com or by calling Huber Engineered Materials at 866-881-6480. Collaborative GeniusTM RxCIPIENTS® is a registered trademark of J.M. Huber Corporation for pharmaceutical excipients. Collaborative GeniusTM is a trademark of J.M. Huber Corporation for consulting. RxCip_DDT_ad.indd 1 8/18/05 11:53:39 AM DDT Issue10 NOVEMBER05 11/8/05 3:13 PM Page 56 InnerCap Technologies, Inc. 5420 Bay Center Drive, Suite 100 Tampa, Florida 33609-3413 T: (813) 837-0796 • F: (813) 837-0207 E: [email protected] Website: www.innercap.com Contact: Fred H. Miller INNERCAP Technologies, Inc., introduces the new NOVACAPS™ multi-phase, multi-compartment single pill solution for difficult combination drugs.The proprietary NOVACAPS™ delivery system accommodates otherwise incompatible pharmaceutical agents, solid or liquid, in a single-dosage, combination product.The delivery system also provides the option of working with multiple release profiles for the actives administered in the delivery system. Surging worldwide interest in such combination formats is evidenced by the FDA’s recent initiative to advance the development of single-dosage forms for delivery of multiple HIV/AIDS drugs. With the INNERCAP delivery system, therapeutic entities that have never been combined before can be administered together, via an oral, implanted, or a suppository capsule, in the most advantageous pharmacokinetic profile, utilizing different physical phases.This approach maximizes bioavailability and, at the same time, addresses patient compliance issues that often plague multi-drug regimens.The NOVACAPS™ delivery system can be used for all therapeutic classes, such as immunologic, cardiovascular, neurologic, ol 5 No 10 ol 5 No V psychiatric, oncologic, and pain management. The INNERCAP delivery system also provides a solution to overcome the difficult development issues related to bilayer tablets.This will provide companies with a quicker and efficient solution to transition innovations smoothly from development, through the clinical phase, and into commercialization — ultimately reaping the financial fruits of their labor. November/December 2005 November/December NOVACAPS™ offers a significant first-to-market advantage by minimizing valuable time in R&D when the product could be in clinical trials determining the patient response to a new combination product. Companies interested in a novel solution for lifecycle management issues, patent protection, increased compliance, combination drugs, reduced counterfeiting, increased stability, multiple release profiles, increased bioavailability, barriers to entry, higher Drug Delivery Technology Drug Delivery Technology perceived value and branding opportunities with difficult formulation issues can contact 56 INNERCAP Technologies. DDT Issue10 NOVEMBER05 11/5/05 9:40 AM Page 57 advantagesthe of multi-phase, multi-compartment capsules are clear Higher Perceived Value Smaller Capsules Consumers view multi-phase, multi-compartment Hard-shell capsules have thinner wall construction, capsules as having a higher perceived value than allowing them to contain more ingredient in a smaller ordinary tablets, capsules and soft gels. capsule versus thicker-shelled soft gel capsules. Hard shells have faster and more complete dissolution Choice of HPMC or than soft gels. Gelatin Capsules With multi-phase, multi-compartment Less Odor and Less Irritation capsules you are not limited to just Reduces unpleasant ingredient taste and gelatin (animal-based product) but odor commonly found with tablets and have the option of natural HPMC traditional capsules. And, liquids (hydroxypropyl methyl- cellulose) provide less irritation than traditional and alternative capsule materials. delivery methods. Better Visual Appeal Tamper Proof Sealing Multi-phase, multi-compartment Band sealing reduces tampering and capsules have none of the dust and provides a non-permeable barrier to residue associated with powder retard oxidation and increase shelf-life. capsules. Better visual product appearance translates to higher Unique Appearance perceived value. This new delivery system stands apart from look-alike products that crowd Increased Absorption retail shelves. and Bioavailability Liquids naturally offer faster and Faster Development increased absorption and Multi-phase, multi-compartment availability of active ingredients. capsules reduce the development time compared to bi-layer tablets to get a Increased Profit Potential new product into clinical trials faster. Add up all the advantages. Expect higher sales…and high margins! Compounds Deliver Pharmaceutical, Deliver Incompatible bio-pharmaceutical and nutraceuticals Compounds Deliver incompatible in a single dosage form. compounds in a single dosage form with different release Multi-Phase System profiles. Compounds can be delivered with the most advantageous pharmacokinetic Multiple Release Profiles profile such as liquids and solids Incorporate one or more release profiles into a single dosage form such as immediate, enteric, targeted, chronotherapy and pulsatile. Patent Pending US-2005-0008690-A1 5420 Bay Center Drive • Suite 100 • Tampa, FL 33609-3425 • (813) 837-0796 • www.innercap.com • [email protected] DDT Issue10 NOVEMBER05 11/5/05 9:40 AM Page 58 Kurve Technology Inc. 19125 North Creek Parkway Bothell, WA 98011 T: (425) 640-9249 • F: (425) 483-1058 E: [email protected] Website: www.kurvetech.com Kurve Technology, Inc. offers pharmaceutical companies nasal delivery device systems for local, systemic, and nose-to-brain medical therapies. Controlled Particle Dispersion (CPD)™ Kurve Technology’s flexible CPD technology platform can deliver a wide range of formulations with greater efficacy and efficiency than traditional devices. Clinical results show that the average area of intranasal deposition was as much as 300% greater for CPD compared to spray pumps. Using the principal of vortical flow, CPD effectively disrupts inherent nasal cavity airflows to deliver formulations to the entire nasal cavity, the olfactory region and the paranasal sinuses. CPD optimizes droplet size and trajectory to saturate the nasal cavity, lengthen compound residence time, and minimize deposition to the lungs. ViaNase ID™ Electronic Atomizer The first nasal delivery device to incorporate CPD technology and electronic intelligent delivery,ViaNase ID™ offers superior efficacy, rapid onset of action, improved patient compliance, compliance monitoring, and abuse control. With built-in electronics and power,ViaNase ID includes the following features: • Drug Recognition recognizes specific drug information, such as product identification and expiration date, by reading a coding technology placed on the drug packaging or unit dose ampoule. ol 5 No 10 ol 5 No V • Lockout Control powers up device only if it reads the correct product code and the drug is not past its expiration date. • Operational Parameter Control sets droplet size, atomization rate, and vortex characteristics based on drug type. • Dosing/Abuse Controls: • Sets specific atomization time in min/day or number of doses/day November/December 2005 November/December • Sets the total number of doses per prescription • Sounds an alarm when a dose is required • Data Storage & Transmission. Information, such as drug ID, time/date of doses, total amount of drug delivered, and operating parameter records, can be saved to a data storage card or downloaded to a PC or PDA. Drug Delivery Technology Drug Delivery Technology Corporate Relationships Sought Kurve Technology is offering global, exclusive licenses in topical, systemic and nose-to-brain therapy areas to 58 pharmaceutical companies. DDT Issue10 NOVEMBER05 11/5/05 9:40 AM Page 59 DDT Issue10 NOVEMBER05 11/5/05 9:40 AM Page 60 MedPharm Ltd. Business Centre Sheep Street Charlbury OX7 3RR United Kingdom T: +44 (0) 16 0881 9267 • F: +44 (0) 16 0881 9268 E: [email protected] Website: www.medpharm.co.uk MedPharm is a drug delivery and formulation development company of international reputation, focusing in particular on topical (skin, nail, mucous membranes) and airway drug formulations. Established in 1999 to provide fee-for-service pharmaceutical development to the industry, the Company today boasts a hybrid business model comprising a first-class service offering together with a product development pipeline based on its innovative delivery systems. With over 50 customers worldwide, MedPharm’s contract service business spans the entire pharmaceutical development process, from simple feasibility studies, dosage design, and optimization through to the production of GMP supplies for Phase I/II clinical trials. It has GLP-accredited laboratories in central London and a GMP manufacturing facility in Scotland. MedPharm has its own portfolio of patents describing novel drug delivery systems, which it is exploiting in its internal drug development pipeline.The strategy is to reformulate existing and proven off-patent drugs where innovative drug delivery systems offer a significant competitive advantage. The Company is developing spray formulations for eczema and acne, a nail lacquer for onychomycosis and, in collaboration with OptiNose, a nasally delivered sedative for insomnia. The aim is to take each product to clinic before licensing out for further development and marketing, in return for a share of future success. MEDPHARM DEVELOPMENT SERVICES of the service offering or as stand-alone licences, for instance in non-competing indications. These Particular focus is on design and development of technologies include: topical (dermal, nasal, pulmonary, other mucous surfaces), injectable, and oral (capsules) dosage forms. • MedNail® – a novel ungual penetration system ol 5 No 10 ol 5 No V Services include: • MedSpray™ – a novel,“patch-in-a-can” topical spray • Mathematical modelling of drug absorption • Analytical development In addition, MedPharm is seeking to out-license that IP • Preformulation for which it has no further plans to develop internally. • Formulation development and optimization Such opportunities include several technologies that • In vitro performance and efficacy studies could enhance drug delivery via the airways, for • Small-scale GMP manufacture and stability studies instance: November/December 2005 November/December for all pharmaceuticals, except tablets • Scale-up to Phase III/IV supplies • MedAir®, MedAir® HP – for small molecules manufacturing sites • MedEole® – for biologicals • Preclinical support advices • MedCrys™ – to control recrystallization of • Clinical trials services - dermatology therapeutic agents LICENSING OPPORTUNITIES As well as via the skin: Drug Delivery Technology Drug Delivery Technology Technologies that MedPharm is exploiting in its drug • D3S™ – a device for dermal drug delivery, eg, of 60 development pipeline are also available, either as part large molecules like peptides DDT Issue10 NOVEMBER05 11/5/05 9:40 AM Page 61 ,EXINGTON +ENTUCKY +EYSTONE #OLORADO 7ILLIAMSBURG 6IRGINIA 2ICHMOND 6IRGINIA2ICHMOND 6IRGINIA 0HOENIX !RIZONA 0HOENIX !RIZONA (ILTON (EAD 3OUTH #AROLINA (ILTON (EAD 3OUTH #AROLINA 44ARPON 3PRINGS &LORIDA ARPON 3PRINGS &LORIDA 44UCSON !RIZONA UCSON !RIZONA 0ALM $ESERT #ALIFORNIA 0ALM $ESERT #ALIFORNIA 2$$ 82$$ 8 !PRIL !PRIL "OCA 2ATON &LORIDA"OCA 2ATON &LORIDA WWWRDDONLINECOMWWWRDDONLINECOM DDT Issue10 NOVEMBER05 11/5/05 9:41 AM Page 62 NOF Corporation 20-3, 4-chome NOF America Corporation Ebisu, Shibuya-ku, Tokyo 150-6019, US contact: JAPAN 11 Martin Avenue, Suite 1170 T: +81-3-5424-6741 • F: +81-3-5424-6769 White plains, NY 10606 E: [email protected] T: (914) 681-9790 • F: (914) 681-9791 Website: www.nof.co.jp/dds Promoting Innovative Drug Delivery System As an integrated chemical manufacturer featuring all kinds of human activity from Biosphere to Outer Space, NOF CORP.has now focused on the development on innovative drug modifier, carrier and solubilizer such as PEG, phospholipids, highly purified oleic acid nonionic surfactants, cholesterol pullulan, MPC polymers and chitosan. As a worldwide leader for DDS, NOF will provide excellent quality of these products in view of pharmaceutical field. 1. PEGYLATION TECHNOLOGY profile, provides the following great features of Polysorbate 80: We produce not only excellent purity of methoxypolyethylene glycols ranging from 200 to • Low Deguranulation (Low Allergic Reaction) 30,000 molecular weight, but also activated PEG • Low Cell Toxicity derivatives such as methoxy-PEG amines, maleimides • Low Hemolysis and carboxlic acid.With arranging terminal group of • Multi-Compendial-ND, EP,JP PEG, various kinds of customers’ drugs can be modified. In addition, half-life of drugs in the blood Ultrapurified PEGs and PEG 200, 300, and 400 stream can be lengthened when our PEG modified are only available at NOF CORPORATION, and phospholipids are injected as liposomal formulation. feature extremely low impurities (EG and DEG) and low POV.NOF’s PEG 200, 300, and 400 meet with 2. PHOSPHOLIPIDS and EMPTY LIPOSOME multi-compendial of NF,EP,and JP. We have successfully supplied our GMP grade of 4. Novel Solubilizing Kit for PUREBRIGHT SL ol 5 No 10 ol 5 No V phospholipids for worldwide drug products since Series 90’s with customer’s good reputation. Not only developing new types of phospholipids, but also PUREBRIGHT SL Series are Novel Solubilizing formulated lyophilized liposomes so called EMPTY Kit for any Hydrophobic Drugs (Protein, Peptide LIPOSOME (EL-series) have been developed, with and small which customers can easily encapsulate their drugs molecular etc.) by their hand. Special cationic type EL-01-D is 1. PUREBRIGHT SL-100 series recently commercialized for gene delivery in which MPC polymer base formulation November/December 2005 November/December better transfection efficiency can be obtained. 2. PUREBRIGHT SL-200 series 3. Ultra-Pure Polysorbate 80 and PEG 200, PEG Phospholipids base formulation 300, and 400 3. PUREBRIGHT SL-300 series NOFABLE ESO-9920 (Polysorbate 80) of NOF Cholesterol PEG base formulation CORPORATION, which consists of ultra-purified Drug Delivery Technology Drug Delivery Technology Oleic Acid (99% up) and an extremely low impurity 4. PUREBRIGHT SL-400 series 62 Phospholipids mixture base formulation DDT Issue10 NOVEMBER05 11/5/05 9:41 AM Page 63 DDT Issue10NOVEMBER0511/5/059:41AMPage64 64 Drug Delivery Technology November/December 2005 Vol 5 No 10 DDT Issue10 NOVEMBER05 11/5/05 9:41 AM Page 65 Twilight of his life. Forgets everything. But never his meds. NuSil Technology. Noncompliance. For many doctors, that’s what keeps their patients from getting the right medication at the right time. But thanks to advances in transmucosal technology, getting the right dose isn’t hit or miss. NuSil is there. While our silicones make the device that elutes the drug, your needs might be very different. From ingestible Simethicone materials to internal hormonal delivery devices, large batches or small, you can count on NuSil to deliver quality silicone materials based on your unique property requirements. Precise, custom formulations backed by more than 15 years of pharmaceutical materials expertise and first-hand regulatory knowledge. What? When? Where? If it’s NuSil, it’s no problem. What’s your challenge? www.nusil.com or 805/684-8780 ©2005 NuSil Corporation. All rights reserved. DDT0305-P DDT Issue10 NOVEMBER05 11/5/05 9:41 AM Page 66 Remmele Engineering - Automation Division 677 Transfer Road St. Paul, MN 55114 T: (651) 643-3700 • F: (651) 642-5665 E: [email protected] Website: www.remmeleautomation.com Since 1949, Remmele Engineering has designed and built custom manufacturing equipment for leading suppliers in the drug delivery industry worldwide. From implantable devices to transdermal patches to pulmonary dosage forms, Remmele is the ideal partner to help you bring your drug delivery system to market. Remmele operates under an ISO 9001:2000- certified quality system and provides manufacturing solutions from proof-of-concept through commercial production. Our core competencies include comprehensive Project Management, best-of-class engineering, and superior collaboration through our Client Relationship Process. Our expertise encompasses such critical issues as clean-room environments, lights-out manufacturing, curing, liquid-filling, and validation support. Our goal is to make our clients more profitable and competitive. Whether you’re beginning development of a new drug delivery system or ramping up production on a proven winner to meet market demand, our world-class facility is equipped to streamline critical manufacturing while reducing risk in even the most complex ol 5 No 10 ol 5 No V applications.We have experience throughout all phases of the product development process, including pilot lines, proofs-of-principle, clinical manufacturing, commercial manufacturing, and validation testing.We utilize leading edge applied technologies for web processing, discrete assembly, and packaging & filling. Our recent acquisition of May Coating Technologies adds continuous web handling capabilities to our existing arsenal of technology solutions. November/December 2005 November/December No one can rival our ability to identify your unique needs.We are experts in providing sophisticated custom equipment for products that require stringent process controls to maximize production yields. Our culture, systems, and processes make us an industry leader in on-time delivery and client satisfaction. Drug Delivery Technology Drug Delivery Technology Remmele Engineering — your custom equipment partner for drug delivery solutions. 66 DDT Issue10 NOVEMBER05 11/5/05 9:41 AM Page 67 DDT Issue10 NOVEMBER05 11/5/05 9:41 AM Page 68 COMPANY Profile leaderYou can’t be a without thinking ahead. 2000 2001 2002 2003 2004 2005 A commitment to safety Industry-leading solutions Albert Einstein observed: “The significant Safety Syringes, Inc. is actively developing COMPANY: problems we face cannot be solved at the same and marketing its delivery systems for level of thinking we were at when we created prefilled glass syringes used for vaccines, them.” We wholeheartedly agree. And since low molecular weight heparins, and other CORPORATE HEADQUARTERS: Carlsbad, CA 1991, Safety Syringes has led the way in the medicines—including many of the newer development of anti-needlestick devices for biotechnology drugs. As the first and only PHONE: 760.918.9908 the healthcare industry. Our commitment to provider of an overt deterrent—the Tamper FAX: innovative safety technology has consistently Evident UltraSafe Passive® Delivery System— ol 5 No 10 ol 5 No V 760.918.0565 helped us bring new products to market. Our we are also actively attacking the threat of WEB: core competency is drug delivery systems for drug counterfeiting. This industry-leading www.safetysyringes.com prefilled pharmaceutical glass syringes. delivery system effectively helps prevent That commitment has become indispensable or make evident attempts to adulterate— to our customers which include companies or counterfeit—unit-dosed, prefilled Christer Andreasson, Chairman such as Amgen, AstraZeneca, Bayer, Johnson pharmaceutical presentations. and CEO of Safety Syringes, Inc., presented at the PDA Conference, & Johnson, and Pfizer. They have found Safety Keep in mind that the Tamper Evident ® November/December 2005 November/December “The Universe of Prefilled Syringes” Syringes to be an intuitive and dependable part- UltraSafe Passive Delivery System is available October 2005. ner with patented technology that allows them now. And, it’s because we have stayed focused to gain a competitive advantage. What’s more, on our partners’ problems and industry trends our UltraSafe® product platform has delivered while maintaining a steadfast desire to make over 100 million devices worldwide while our a real difference. In other words, we put our partner count has increased steadily. Within money where our future is, and the resulting the next 6 to 12 months we will have a total investment has become a clear asset for our Drug Delivery Technology Drug Delivery Technology of 12 partners with over 20 drug products on partners. That’s the way we think. And that’s 68 the market. why business leaders think of us. SSI Advertorial indd 1 10/27/05 4:17:04 PM DDT Issue10 NOVEMBER05 11/5/05 9:41 AM Page 69 At last. A drug delivery system that helps stop counterfeiting. With the number of counterfeit drug cases almost tripling between 2000 and 2004, we knew something had to be done. Drug counterfeiting costs billions of dollars and undermines your brand name. The result is our Tamper Evident UltraSafe Passive® Delivery System. It’s the industry’s first—and only—overt deterrent designed to help ensure the integrity of unit-dose, prefilled pharmaceutical presentations. Tamper evident, safe and available today, it 2000 2001 2002 2003 2004 Counterfeit drug cases combines the ultimate in user preference, compliance, and passive needle protection. opened by the FDA each year continue to climb.* For more information, call 760.918.9908 or go to www.safetysyringes.com. We live up to our name everyday *Combating Counterfeit Drugs: A Report of the Food and Drug Administration Annual Update, May 18, 2005 ©2005 Safety Syringes, Inc. All rights reserved. UltraSafe and UltraSafe Passive are trademark of Safety Syringes, Inc. 54:17:04 PM DDT Issue10 NOVEMBER05 11/8/05 3:17 PM Page 70 SCOLR Pharma, Inc. 3625 132nd Avenue SE, Suite 300 Bellevue, Washington 98006 T: (425) 373-0171 • F: (425) 373-0181 E: [email protected] Website: www.scolr.com Background Based in Bellevue,Washington, SCOLR Pharma is a specialty pharmaceutical company that leverages its formulation expertise, and its proprietary and patented drug delivery technologies to introduce distinctive and novel pharmaceutical, Over-the-Counter, and nutritional products. The Company enjoys a significant differentiated intellectual property position in drug delivery consisting of four (4) young and broadly applicable patents. Its first unique robust technology was licensed from Temple University in 1998. Since then, SCOLR has expanded its intellectual property to include a full platform of related delivery technologies capable of handling challenging classes of drugs and nutritional ingredients. The Company believes its lead OTC pharmaceutical product candidate to be the only 12-hour extended-release ibuprofen formulation currently in clinical evaluation for the US OTC market. It also believes that its lead prescription drug candidate also in clinical evaluation, an immediate-release CDT- Raloxifene formulation for osteoporosis, will potentially be easier to manufacture and use less drug than currently approved formulations. In the area of dietary supplements, the Company’s efforts are concentrated on meaningful improvements and value-added formulations for human nutritional product applications.The Company has successfully created multiple private label products for large retailers that generate a source of royalty revenues. For further information, visit us at Drug Delivery Partnerships 2006 booth No. 215. ol 5 No 10 ol 5 No V Technology Summary • Electrolyte Platform (US Patent No. 6,090,411-Issued July 18, 2001) “Salt Patent” allows for simple two step processing and uses ionic interactions to correct for limitations in other first generation matrix-based systems. • Dual Polymer Platform (US Patent No. 6,337,091-Issued January 8, 2002) November/December 2005 November/December “Dual-Polymer Patent” allows for simple production of tablets and capsules and uses ionic and anionic polymers to correct for limitations in other biphasic/triphasic systems. • Amino Acid Platform (US Patent No. 6,517,868 – Issued February 11, 2003, US Patent No. 6,936,275 – Issued August 30, 2005) “Amino Acids Patents” allows for simple production of tablets and uses hydrophobic/polar interactions to facilitate solubility and potentially permeability. Drug Delivery Technology Drug Delivery Technology 70 DDT Issue10 NOVEMBER05 11/5/05 9:42 AM Page 71 DDT Issue10 NOVEMBER05 11/5/05 9:42 AM Page 72 Shire Laboratories 1550 East Gude Drive Rockville, Maryland 20850 T: (301) 838-2681 • F: (301) 424-1364 E: [email protected] Website: www.shirelabs.com Contact: Jones W. (Woody) Bryan, PhD Shire Laboratories dedicates multidisciplinary teams of highly experienced scientists to solve its partner’s drug delivery challenges. Shire has a multi-faceted portfolio of technologies containing powerful in silico (ProPhileSM), in vitro (ProScreen®) and in vivo (RADARSM) models to identify barriers and mechanisms to oral delivery. These models create a focused path to bioavailability enhancement and establish critical baseline information that can be used to assess viability of controlled release for selected compounds. Once these rate-limiting factors and mechanisms have been identified, Shire uses its OptiScreen® platform to select appropriate enhancers to overcome the specific barriers, Emutrol™ to enhance oral bioavailability or to apply the appropriate controlled-release platform for efficient oral delivery. ProPhileSM, ProScreen®, RADARSM and OptiScreen® have been applied in concert to: • Identify the best preclinical candidates for oral delivery; • Assess critical region of absorption characteristics; • Enhance bioavailability of clinical stage compounds; and • Optimize delivery of marketed products as a line extension or brand management initiative. Shire has parlayed its oral candidate profiling (ProPhileSM), selection expertise (ProScreen®), and in vivo screening (RADARSM) into an enabling feature for its broad based portfolio of patented controlled-release technology platforms. Shire’s innovative controlled-release platforms include: Microtrol® — a multiparticulate platform that has been successfully applied to deliver an array of soluble and insoluble compounds ranging from low to high dose. Customization of the multiparticulate populations can yield first-order, pulsatile, delayed- and extended-release profiles. ol 5 No 10 ol 5 No V Solutrol® — is an innovative platform capable of delivering soluble compounds or combining solubility enhancement expertise with matrix release to enable delivery of compounds that are poorly soluble or have pH dependent solubility profiles. Solutrol® can be customized to yield first order, zero order and pulsed release profiles of single and combination presentations. EnSoTrol® — is an enabling osmotic platform that is driven by Shire’s expertise in solubility enhancement and is capable of accommodating soluble and poorly soluble compounds while generating zero-order and non-zero-order release profiles. November/December 2005 November/December All three of Shire’s controlled-release platforms are proven with human clinical data and protected by multiple patents. AvertSM — is a platform to reduce abuse potential of formulations designed to deliver scheduled substances. Its mini-tablet or multiparticulate construct makes the abuse-resistant formulation an incremental application to existing products or can be designed into a new formulation.AvertSM uses a combination of malodorous agents, SM Drug Delivery Technology Drug Delivery Technology coloring agents, and precipitants. Multiple patent applications have been filed for Avert . 72 DDT Issue10 NOVEMBER05 11/5/05 9:42 AM Page 73 DDT Issue10 NOVEMBER05 11/5/05 9:42 AM Page 74 Weiler Engineering, Inc. Global Sales & Service Department 1395 Gateway Drive Elgin, Illinois 60123 T: (847) 697-4900 E: [email protected] Website: www.weilerengineering.com The corporate focus of Weiler Engineering, Inc. is to provide the most advanced aseptic liquid processing technology available through the application of customized ASEP-TECH® Blow/Fill/Seal machinery and integrated services.Weiler’s unique combination of world- class engineering and cutting-edge technical expertise helps ensure its continuing world-wide leadership position, serving the marketplace with the latest in advanced, sterile, aseptic liquid packaging technology. Weiler’s manufacturing facilities and corporate offices are conveniently located near Chicago’s O’Hare International Airport.ASEP-TECH® Blow/Fill/Seal machines are designed and built in a 120,000-sq-ft, state-of- the-art manufacturing plant. All equipment is designed and manufactured in the USA.Approximately 100 people are involved in the design and construction of these machines, providing 21st Century Solutions® for parenterals, ophthalmics, respiratory drugs, biologicals, nutraceuticals, and other complex solutions. Weiler began manufacturing BFS machines more than 30 years ago under the Bottlepack® brand, continued with the ALP® trademark and is now building the latest generation of ASEP-TECH® Blow/Fill/Seal Systems.The Weiler design incorporates the three-step process of blow molding, aseptic filling, and hermetic sealing of liquid products in one sequential operation on a compact machine frame.The ASEP-TECH® brand identity provides increased focus for future development and advancement of Blow/Fill/Seal technology as a core competency. Weiler’s patented electronically controlled fill system, automatic sterilization system with integral data collection, and filter integrity test system are provided as standard equipment for each machine configuration. Each machine is also equipped with a HEPA air shower to ensure a Class 100 environment under dynamic conditions in the nozzle shroud area. Optional parison shrouding is available to ensure a ol 5 No 10 ol 5 No V Class 10,000 environment under dynamic conditions in the extrusion zone and the critical transport area. Weiler Engineering continues to place a strong emphasis on the science of Blow/Fill/Seal technology as it relates to the optimization of machine design to enhance process capabilities relating to sterility assurance. These efforts are recognized by the worldwide regulatory community and will change the future of aseptic manufacturing. Weiler’s proactive stance has positioned it prominently at the forefront of these developments.We are continually applying the results of our scientific research to the design of our next- generation Blow/Fill/Seal machines, firmly setting the standards to the highest level of sterility assurance for November/December 2005 November/December aseptic technology. Our customer commitment extends beyond that of typical machine builders, providing expertise and support derived from years of design and manufacture of high quality, automated equipment.Weiler has the ability to integrate complete finishing lines with its Blow/Fill/Seal systems for deflashing, leak detection, labeling, and final packaging. Our Technical Services staff is available to assist with container design and development, and technical support. Our R&D department can assist with prototyping, product trials, and outsourcing of key support Drug Delivery Technology Drug Delivery Technology functions, such as process validation to help complete your project package. 74 DDT Issue10 NOVEMBER05 11/5/05 9:42 AM Page 75 DDT Issue10 NOVEMBER05 11/5/05 9:42 AM Page 76 DDT Issue10 NOVEMBER05 11/5/05 9:43 AM Page 77 DRUG DELIVERY TECHNOLOGIES DRUG DELIVERY TECHNOLOGIES See Company ALZA Corporation Profile 1900 Charleston Road 3M Center, Bldg. 275-3E-10 Mountain View, CA 94043 See Company Profile St. Paul, MN 55144-1000 Phone: (650) 564-5000 Phone: (800) 643-8086 Fax: (651) 737-5265 www.alza.com www.3m.com/dds Current Technologies/Platforms: Application(s): Current Partner(s): Current Technologies/Platforms: Application(s): Current Partner(s): OROS® Oral Pharmacia Corporation (Covera- HS®), Novartis (DynaCirc CR®), Inhalation Drug Delivery Systems Systemic/Pulmonary/Nasal Schering-Plough Corporation, Pfizer (Cardura® XL Glucotrol® (MDI & DPI) Forest Pharmaceuticals, Inc., XL, Procardia XL®, Sudafed® 24 Boehringer Ingelheim Hour), Muro Pharmaceutical, Pharmaceuticals, Inc., Novartis Inc. (Volmax®), Ortho-McNeil Pharmaceuticals Corporation, Pharmaceutical (Ditropan) XL®), GlaxoSmithKline, Sepracor, IVAX McNeil Consumer & Speciality Pharmaceuticals (Concerta®) Transdermal Drug Delivery Systems Transdermal Schering AG, Berlex Laboratories, Inc. D-TRANS® Transdermal GSK (Nicoderm® CQ® and Clear Pipeline Technologies/Platforms: Application(s): Development stage: Nicoderm® CQ®), Boehringer Ingelheim Pharmaceuticals Novel Excipients Pulmonary/Nasal (Catapres-TTS), Janssen Pharmaceuticals Inc. Microstructured Transdermal Systems Proteins & Peptides, Vaccines (Duragesic®), Novartis (Transderm-Nitro®,Transderm Contact: Business Development - Carl Dabruzzi, email: [email protected] Scop®, Estraderm®) Ortho-McNeil Pharmaceutical DRUG DELIVERY TECHNOLOGIES (Testoderm®) AKINA, Inc. DUROS® Implant Bayer (Viadur®) Business & Technology Center 1291 Cumberland Avenue Pipeline Technologies/Platforms: Application(s): Development stage: West Lafayette, IN 47906-1385 Macroflux® Transdermal/Theratechnologies Collaboration Pre-clinical Phone: (765) 464-0390 DUROS® Omega BMI Collaboration for hepatitis Pre-clinical www.akinainc.com STEALTH® her2 Liposomal targeted oncology Pre-clinical STEALTH® CKD 602 Liposomal oncology Pre-clinical Current Technologies/Platforms: Application(s): Current Partner(s): E-TRANS® fentanyl Transdermal, Acute pain in post operative Phase II Frosta® Oral fast melting tablets Samyang Corp. setting L-OROS™ Liquid formulation OROS, oral delivery Actively Seeking Partner HytroCelle™ Delivery of poorly soluble drugs (oral and ALZAMER® Depot Actively Seeking Partner parenteral) - ALZA is actively seeking partners for all of its technology platforms - PolyShell™ Delivery of protein drugs (parenteral) Aquagel™ Gastric retention devices and diet control Kos Pharmaceuticals Contact: [email protected] (for business development/partnership inquiries) (650) 564-5555 (for business development/partnership inquiries) Sentrix™ Drug delivery from stents Contact: Kinam Park, (765) 464-0390, email: [email protected] DRUG DELIVERY TECHNOLOGIES American Peptide Company, Inc. 777 East Evelyn Avenue Sunnyvale, CA 94086 Phone: (408) 733-7604, x204 www.americanpeptide.com Current Technologies/Platforms: Application(s): Current Partner(s): Catalog Peptide, Custom Peptides, Research in Cell Biology, Microbiology, Immunology, Biotechnology and CGMP Peptides, Oligo-Nucleotides, and Drug Discovery. Clinical trial and new drug Pharmaceutical Dye Ptoducts, Process Development applications companies; as well as Diagnostic and Antibody companies Contact: Gary Hu, (800) 926-8272, x204 DRUG DELIVERY TECHNOLOGIES Antares Pharma, Inc. 707 Eagleview Boulevard, Suite 414 Exton, PA 19341 Phone: (610) 458-6200 Fax: (610) 458-0756 www.antarespharma.com Current Technologies/Platforms: Application(s): Current Partner(s): Medi-Jector VISION® needle-free Insulin, growth hormone Ferring, JCR, SciGen injectors Pipeline Technologies/Platforms: Application(s): Development stage: Antares Pharma Vibex™ mini-needle Large and small molecule delivery Clinical trials injectors - single-dose, disposable Needle-free injection technology Diabetes, obesity Lilly ATD™ Advanced Transdermal Gel Transdermal delivery Clinical trials Easy Tec™ Oral Dissolving Tablet Oral delivery Pre-clinical Contact: Mike Kasprick: [email protected], Jim Hattersley: [email protected] Drug Delivery Technology November/December 2005 Vol 5 No 10 77 DDT Issue10 NOVEMBER05 11/5/05 9:43 AM Page 78 DRUG DELIVERY TECHNOLOGIES DRUG DELIVERY TECHNOLOGIES Aradigm Corporation BioDelivery Sciences International, Inc. 3929 Point Eden Way 2501 Aerial Center Parkway, Suite 205 Hayward, CA 94545 Morrisville, NC 27560 Phone: (510) 265-9000 Fax: (510) 265-0277 Phone: (919) 653-5160 Fax: (919) 653-5161 www.aradigm.com email: [email protected] Current Technologies/Platforms: Application(s): Current Partner(s): www.bdsinternational.com AERxPulmonary Delivery System Insulin Novo Nordisk Current Technologies/Platforms: Application(s): Current Partner(s): Asthma APT Pharmaceuticals Respiratory Undisclosed Bioral® cochleate technology for Oral delivery Sigma-Tau Anthrax Treatment Canadian Gov’t. oral delivery of products not normally Accentia Cystic Fibrosis Self-initiated available orally (hydrophobic drugs, Biopharmaceuticals Smoking Cessation Undisclosed nucleotides, vaccines, etc.) Pulmonary Hypertension United Therapeutics ompany BEMA™ technology for transmucosal Transmucosal delivery See C membrane administration of drugs Intraject Needle-Free Delivery Sumatriptan/MigraineProfile To be Partnered System Pipeline Technologies/Platforms: Application(s): Development Stage: Contact: Jonathan Rigby, (510) 265-9355, email: [email protected] Emezine® Nausea and vomiting NDA under review DRUG DELIVERY TECHNOLOGIES BEMA™ Fentanyl Breakthrough Cancer Pain Phase III Baxter Healthcare Corporation Route 120 & Wilson Road BEMA Long Acting Analgesic Pain Preclinical Round Lake, IL 60073 Bioral® Amphotericin B Oral Antifungal Preclinical Phone: (800) 422-9837 Fax: (847) 948-3642 BEMA™ Zolpidem Insomnia Preclinical email: [email protected] www.baxterbiopharmasolutions.com Bioral® siRNAs Oral delivery Preclinical Contact: Evan Gothard, [email protected] Current Technologies/Platforms: Application(s): Current Partner(s): DRUG DELIVERY TECHNOLOGIES Enhanced Packaging Premixed, Parenteral, Formulations BioJect Medical Technologies, Inc. - Ready-to-use Systems - Ready-to-mix Systems 211 Somerville Road, Route 202N See Company Bedminster, NJ 07921 Contact:David McDonough, (847) 270-3715 Profile Phone: (908) 470-2800 Fax: (908) 470-1728 email: [email protected] DRUG DELIVERY TECHNOLOGIES www.bioject.com BD (Becton, Dickinson & Company) Current Technologies/Platforms: Application(s): Current Partner(s): 1 Becton Drive BioJector® 2000 Needle-free injections - CO2 Power Serono Franklin Lakes, NJ 07417 UltraJet® Needle-free injections Spring Power Alkermes Phone: (800) 225-3310 Fax: (201) 847-4847 www.bdpharma.com Drug Reconstitution Systems Mixing of lyophilied Medication w/o needles Merial Current Technologies/Platforms: Application(s): Current Partner(s): Pipeline Technologies/Platforms: Application(s): Development stage: BD Hypak™ Parenteral (prefillable glass syringes) Aventis, Amgen, Teva IJECT™ Disposable needle-free injection Clinical trials BD™ Pens Parenteral (self-injection devices) Organon, Schering-Plough IJECT-R™ Prefilled Disposable Syringes Pre-clinical VETJET™ Needle-free injections for food production Pre-clinical BD Monovial™ Reconstitution of dry drugs/transfer of liquid drugs GSK, Merck See Company animals BD Accuspray™ Profile Nasal drug delivery Medimmune BD Sterifill™ Plastic prefillable syringe GE Amersham DRUG DELIVERY TECHNOLOGIES Contact: (800) 225-3310 BioValve Technologies, Inc. 155 Flanders Road DRUG DELIVERY TECHNOLOGIES Westborough, MA 01581 Bespak, Inc. Phone: (508) 366-2300 Fax: (508) 366-9852 2450 Laura Duncan Road email: [email protected] Apex, North Carolina 27523 www.biovalve.com Phone: (919) 387-0112 Fax: (919) 387-1241 Current Technologies/Platforms: Application(s): Current Partner(s): email: [email protected] Mini-Ject™ Pre-filled, Disposable Needle-free Delivery Johnson & Johnson (2), Schering www.Bespak.com Plough, NIH, Undisclosed (2) Current Technologies/Platforms: Application(s): Current Partner(s): e-Patch™ Controlled Release Disposable Micro Pump BioValve (Diabetes, Analgesia, System CDI, Nocturia, Testosterone, Metered Dose Inhaler Valves Pulmonary, Nasal, Buccal, & General Aerosolisation Aldo Union, Armstrong, Parkinson’s) Atlanta, Andrx, Aventis, Boehringer Ingelheim, Pipeline Technologies/Platforms: Application(s): Development Stage: Chiesi, Cipla, Generex, GlaxoSmithKline, IVAX, Micro-Trans™ Microneedle Transdermal Delivery Pre-Clinical, Phase II Novartis, Sepracor, Contact:Peter Larsen, (508) 366-2300, ext 275, email: [email protected] Schering-Plough, Viatris Metered Dose Inhaler Actuators Pulmonary, Nasal, Buccal, & General Aerosolisation Aldo Union, Armstrong, Forest, Aventis, Chiesi, Cipla, Generex, IVAX, Sepracor, Schering-Plough Medical Check Valves Catheters Hudson, Mallinkrodt, Tyco Pipeline Technologies/Platforms: Application(s): Development stage: Single Dose Nasal Dry Powder Device Systemic & Local Nasal Delivery Test Data Package Available Single Dose Nasal Liquid Devices Systemic & Local Nasal Delivery Concept Development Breath Coordination/Actuation Devices Respiratory Metered Dose Inhaler Concept Mechanical & Electronic Dose Respiratory / Nasal Metered Dose Inhaler Prototype for mechanical Counting Concept for electronic Contact Person: Robert Swann 78 Drug Delivery Technology November/December 2005 Vol 5 No 10 DDT Issue10 NOVEMBER05 11/5/05 9:43 AM Page 79 DRUG DELIVERY TECHNOLOGIES DRUG DELIVERY TECHNOLOGIES Brookwood Pharmaceuticals, Inc. Cardinal Health 756 Tom Martin Drive 14 Schoolhouse Road Birmingham, AL 35211 Somerset, New Jersey 08873 Phone: (205) 917-2200 Phone: (866) 720-3148 Fax: (732) 537-5949 www.brookwoodpharma.com email: [email protected] www.cardinal.com/pts Current Technologies/Platforms: Application(s): Current Partner(s): Current Technologies/Platforms: Application(s): Current Partner(s): Microparticles Biodegradable microparticle formulations for the Undisclosed Zydis® Oral (fast-dissolve tablets) delivery of small molecules, peptides, and proteins for weeks or months using various routes of Capsules Soft gelatin & hardshell gelatin systemic or local administration. Microsponge® Topical (Cross-linked polymethacrylate copolymer Injectable solid implants Biodegradable polymeric rods loaded with drug Undisclosed particles) ® (small molecules, peptides, and proteins) for EnSolv Oral Modified Release See Company systemic or local delivery for weeks or months. Profile EnCirc® Oral Modified Release VAXCAP™ vaccine delivery Microparticle-based, targeted delivery to antigen Undisclosed EnVel® Oral Modified Release presenting cells to elicit systemic and mucosal immune responses, antibody and cell-mediated Contact: (866) 720-3148 responses, and auto boosting by all routes of administration DRUG DELIVERY TECHNOLOGIES Injectable hydrophobic drug Clinical trial and commercial manufacturing of Undisclosed Celsion Corporation particles hydrophobic drug particles to produce long-acting 10220-L Old Columbia Road injectable formulations. Columbia, MD 21046 Phone: (410) 290-5390 Fax: (410) 290-5394 Biodegradable polymers cGMP lactide/glycolide biodegradable polymers Undisclosed for drug-delivery formulations and medical email: [email protected] devices. www.celsion.com Current Technologies/Platforms: Application(s): Current Partner(s): Contact:Tom Tice, PhD, (205) 917-2220 Adaptive Phased Array Treatment Focused microwave heating (Breast Cancer) MIT DRUG DELIVERY TECHNOLOGIES Camurus Thermodynamic Therapy Drug Focused delivery of encapsulated drugs using Duke University (in Phase I Ideon Science Park, Solvegatan 41 Delivery System thermosensitive liposomes (Prostate, Liver, for Prostate Cancer and Lund, NA SE-22370 entering Phase I for Liver Sweden Cancer) Phone: +46 46 2865730 Fax: +46 46 2865739 email: [email protected] Pipeline Technologies/Platforms: Application(s): Development stage: www.camurus.se Targeted Gene Therapy Technology Heat-activated Gene Expression Preclinical (Memorial Sloan Current Technologies/Platforms: Application(s): Current Partner(s): Kettering) Liquid Crystals (LC) Oral, Parenteral (s.c. depot), Topical Non-disclosed US, Eur. and Contact: Anthony Deasey, EVP & COO, (410) 290-5390 x4899 Japanese companies Liquid Crystal Nanoparticles (LCNP) Oral, Parenteral (i.v.), Topical Non-disclosed US, Eur. and DRUG DELIVERY TECHNOLOGIES companies Chr. Hansen Applicable to peptides, proteins and sparingly 9015 W. Maple Street soluble small molecules Milwaukee, WI 53214 Available as capsules, solutions, sprays, gels, etc. Phone: (800) 558-0802 Fax: (414) 607-5959 Pipeline Technologies/Platforms: Application(s): Development stage: email: [email protected] www.chr-hansen.com Low density powder for inhalation Pulmonary (systemic or local) Pre-clinical/Exploratory Current Technologies/Platforms: Application(s): Current Partner(s): Contact: Bengt Westrin, VP Bus Dev, +46 46 2865730 Chr. Hansen Sugar Spheres NF Timed release Contact: Margot Connor, VP of Sales, Human Health & Nutrition DRUG DELIVERY TECHNOLOGIES Capsugel 535 North Emerald Road Greenwood, SC 29646 Phone: (888) 783-6361 Fax: (888) 783-6360 email: [email protected] www.capsugel.com Current Technologies/Platforms: Application(s): Current Partner(s): Capsules Hard gelatin, HPMC and pullulan Licaps® Liquid-filled gelatin & HPMC capsules Contact: Glenda Oliver-Smith Drug Delivery Technology November/December 2005 Vol 5 No 10 79 DDT Issue10 NOVEMBER05 11/5/05 9:43 AM Page 80 DRUG DELIVERY TECHNOLOGIES DRUG DELIVERY TECHNOLOGIES CIMA LABS INC. CP Kelco 10000 Valley View Road 8355 Aero Drive Eden Prairie, MN 55344 San Diego, CA 92123 Phone: (952) 947-8700 Phone: (858) 292-4900 Fax: (858) 292-4901 www.cimalabs.com email: [email protected] www.cpkelco.com Current Technologies/Platforms: Application(s): Current Partner(s): Current Technologies/Platforms: Application(s): Current Partner(s): KELTROL® xanthan gum Oral drug delivery systems OraSolv® An orally disentegrating tablet that combines taste Bristol-Meyers Squibb XANTURAL® xanthan gum Mucosal drug delivery masked active drug ingredients with a low (Tempra FirsTabs), Novartis KELCOGEL® gellan gum Transdermal drug delivery effervescence system; blistered (Triaminic Softchews), GELRITE® gellan gum Controlled & sustained drug release Organon (Remeron SolTab) GENU® pectin Colonic drug delivery Alamo (FazaClo), Schering- GENU® carrageenan Edible film delivery systems Plough (CLARINEX Reditabs) Contact: Anne Sinha, (858) 467-6615 DuraSolv® An orally disentegrating tablet that combines taste AstraZeneca (Zomig-ZMT), masked active drug ingredients with or without a Schwarz-Pharma (NuLev), low effervescence system; blistered or bottled Wyeth (Alavert & Dimetapp DRUG DELIVERY TECHNOLOGIES ND), Schwarz-Pharma (NuLev, Parcopa, Niravam) CyDex, Inc. 10513 West 84th Terrace PakSolv® Light and moisture proof proprietary packaging All partners utilize PakSolv Lenexa, KS 66214 system; also physically protects ODTs as either product or trade sample packaging Phone: (913) 685-8850 Fax: (913) 685-8856 email: [email protected] OraVescent® Enhanced-absorption drug delivery system Cephalon (fentanyl) www.cydexinc.com intended to improve the transport of active drug ingredients across mucosal membranes; may improve biovailability and accelerate the onset of Current Technologies/Platforms: Application(s): Current Partner(s): action of some active drug ingredients CAPTISOL® (sulfobutylether beta- Parenteral, Oral Allergan, Inc.; Bristol-Myers Contact: Business Development, (952) 947-8700 cyclodextrin) drug Pulmonary, Squibb; Daiichi Suntory Pharma delivery technology Ophthalmic, Other Co., Ltd.; Merck & Co., Inc.; OSI DRUG DELIVERY TECHNOLOGIES Pharmaceuticals, Inc.; Pfizer Inc.; OncoPept AG; Taisho Cirrus Pharmaceuticals, Inc. Pharmaceutical Co., Ltd.; P.O. Box 14748 TargeGen, Inc.; Teva Research Triangle Park, NC 27709-4748 Pharmaceutical Industries Ltd. Phone: (919) 884-2064 Fax: (919) 884-2075 CAPTISOL® - gamma (sulfobutylether Parenteral, Oral, Pulmonary, Ophthalmic, Other email: [email protected] gamma-cyclodextrin) drug delivery www.cirruspharm.com technology Current Technologies/Platforms: Application(s): Current Partner(s): Pipeline Technologies/Platforms: Application(s): Development stage: Captisol-Enabled® Formulations: Dry Powder Inhaler Formulation & • Amiodarone IV antiarrhythmic Preclinical - Clinical; Seeking Development • Budesonide Inhaled steroid development/marketing partners • Fexofenadine Oral antihistamine Meter Dose Inhaler Formulation & • Fosphenytoin IV anti-epilepsy Development See Company • Melphalan IV Oncology Profile • Propofol IV anesthetic Nasal Spray Formulation & • Sertraline Oral antidepressant Development Nebulizer Solution Formulation & Contact: John M. Siebert, PhD Development DRUG DELIVERY TECHNOLOGIES Parenteral Formulation & DelSite Biotechnologies, Inc. Development 1505 Walnut Hill Lane Oral Drug Formulation & Development Irving, TX 75038 Phone: (972) 717-5009 Fax: (972) 831-1132 Topical Formulation & Development email: [email protected] Peptide & Protein Formulation & www.delsite.com Development Pipeline Technologies/Platforms: Application(s): Development stage: Contact: Michael Branciforti & Kathy Meserve GelVac™ Nasal Powder System Vaccine delivery Phase I completed GelSite® Polymer Injectable System Injectable delivery of protein & peptide drugs Pre-clinical DRUG DELIVERY TECHNOLOGIES Contact: Jean Anne Mire, Director, Business Development, (972) 650-7320, email: [email protected] Corium International 2686 Middlefield Road, Suite G Redwood City, CA 94063 Phone: (650) 298-8255 www.coriumgroup.com Current Technologies/Platforms: Application(s): Current Partner(s): Corplex™ Hydrogel Rx Transdermal and Mucosal Products Pharmaceutical Co., Wound Care Co, Generic and Specialty Advanced Microneedle Delivery Co, Oral Care Co, Device Co System Delivery Modifiers/Permeation Enhancers Contact: Deborah Fox PhD, V.P. of Business Development, (203) 775-7124, email: [email protected] 80 Drug Delivery Technology November/December 2005 Vol 5 No 10 DDT Issue10 NOVEMBER05 11/5/05 10:26 AM Page 81 DRUG DELIVERY TECHNOLOGIES DRUG DELIVERY TECHNOLOGIES Dendritic Nanotechnologies, Inc. Dow Corning Corporation 2625 Denison Drive PO Box 0994 Mount Pleasant, MI 48858 Midland, MI 48686 Phone: (989) 774-6565 Fax: (989) 774-2322 Phone: (989) 496-6000 Fax: (989) 496-6731 email: [email protected] email: [email protected] www.dnanotech.com www.dowcorning.com/content/healthcare Current Technologies/Platforms: Application(s): Current Partner(s): Current Technologies/Platforms: Application(s): Current Partner(s): STARBURST™ Dendrimer Platform Drug Delivery, Imaging Large Pharma Companies Enhanced Drug Solubility Actively Seeking Partner Adhesives Adhesives, pressure sensitive adhesives (silicone, acrylic and rubber based) and soft skin adhesives Priostar™ Dendrimer Platform Drug Delivery, Imaging Actively Seeking Partner for transdermal drug delivery applications Enhanced Drug Solubility Actively Seeking Partner Tubing Tubing for use in devices that deliver life-saving Pipeline Technologies/Platforms: Application(s): Development stage: drugs or nutritional therapy MRI Agent undisclosed Blood pool, targeted organs Pre-clinical Wound care Silicone, acrylic and synthetic rubber adhesives for Cisplatin-Dendrimer formulation Ovarian cancer Pre-clinical skin protection or delivery of actives Drug Formulation undisclosed Oncology Late Development See Company siRNA Formulation Transfection Pre-clinical Topical excipients Volatile excipients, fluids, blends, waxes and Profile Contact: Ryan Hayes, PhD, Director of Business Development, (989) 774-6565 emulsifiers to aid the delivery of topical forms and actives DRUG DELIVERY TECHNOLOGIES Contact: Stacey Chapin, (989) 496-7759, [email protected] Depomed, Inc. 1360 O’Brien Drive DRUG DELIVERY TECHNOLOGIES Menlo Park, CA 94025 Phone: (650) 462-5900 DPT www.depomed.com 318 McCullough San Antonio, TX 78215 Current Technologies/Platforms: Application(s): Current Partner(s): Phone: (210) 476-8159 Fax: (210) 829-8733 Gastric Retention (GR) System Proprietary, oral, controlled-release drug delivery Biovail, Inc., ActivBiotics and email: [email protected] system AVI BioPharma www.dptlabs.com Pipeline Technologies/Platforms: Application(s): Development stage: Current Technologies/Platforms: Application(s): Current Partner(s): Metformin GR Type II diabetes (oral) Conducting second phase III Topical, Oral, Nasal creams, lotions, ointments, gels, solutions, Ciprofloxacin GR Urinary Tract Infection (oral) Phase III suspensions, aerosol foams Gabapentin GR Seizures/Pain (oral) Phase I completed See Company Profile Furosemide GR Diuretic (oral) Phase I completed Contact:Paul Josephs Metformin/Sulfonylurea GR combo Type II diabetes (oral) Preclinical NEUGENE product Undisclosed Preclinical Rifalazil GR GI Infection (oral) Preclinical DRUG DELIVERY TECHNOLOGIES Contact: Thadd Vargas, (650) 462-5900 DURECT Corporation 10240 Bubb Road DRUG DELIVERY TECHNOLOGIES Cupertino, CA 95014 Phone: (408) 777-1417 Fax: (408) 777-3577 The Dow Chemical Company email: [email protected] Midland, MI 48674 www.durect.com Phone: (800) 436-9876 Fax: (989) 636-6964 International: (989) 638-1565 Current Technologies/Platforms: Application(s): Current Partner(s): email: [email protected] ® www.bioaqueous.com DUROS systemic and site-directed implantable Endo Pharmaceuticals ® Current Technologies/Platforms: Application(s): Current Partner(s): SABER parenteral, oral, dermal and others Cardinal Health, BioPartners, Pain Therapeutics BioAqueousSM solubilization services Oral, Parenteral, Pulmonary Currently partnering with big from Dowpharma. and emerging pharma DURIN™ biodegradable implant Voyager Pharmaceuticals A portfolio of advanced particle companies to enable them engineering technologies to improve to overcome peformance MICRODUR™ microsphere injectables bioavailability of poorly soluble drug challenges with poorly compounds. soluble drug compounds LACTEL® biodegradable polymers Various See Company and support their advance- Profile Contact: Schond Greenway, (408) 777-1417 ment through development and into commercialization. Contact: Rob Connors, (989) 636-2616 Dowpharma 574 Building Midland, MI 48667 Phone: NA (866) 332-5805; EU 44-1223-728048 Fax: (989) 636-0986 email: [email protected] www.dowpharm.com Current Technologies/Platforms: Application(s): Current Partner(s): PEGs Drug Delivery, Drug Formulation Pƒenex Expression Systems, Drug R&D, Custom Strain Engineering, Manufacturing Scale-Up Contact: [email protected] Drug Delivery Technology November/December 2005 Vol 5 No 10 81 DDT Issue10 NOVEMBER05 11/5/05 10:26 AM Page 82 DRUG DELIVERY TECHNOLOGIES DRUG DELIVERY TECHNOLOGIES Eastman Chemical Company Emisphere Technologies, Inc. 200 S Wilcox Drive, Box 431 765 Old Saw Mill River Road Kingsport, TN 37662 Tarrytown, NY 10591 Phone: (800) 327-8626 Fax: (423) 229-2707 Phone: (914) 347-2220 www.eastman.com www.emisphere.com Current Technologies/Platforms: Application(s): Current Partner(s): Current Technologies/Platforms: Application(s): Current Partner(s): C-A-P NF Enteric coating eligen™ Oral Drug Delivery Oral delivery of macromolecules and other non- Proprietary Technology Technology orally available therapeutics Eastacryl™ 30D NF acrylic coating Enteric coating material Pipeline Technologies/Platforms: Application(s): Development stage: Heparin Solid Dose Cardiovascular (oral) Phase I Eastman CA-398-10 NF Sustained/Controlled Release; Taste Masking; Semi-Permeable Films LMWH Solid Dose Cardiovascular (oral) Phase I Eastman CAB-171-15-PG Sustained/Controlled Release; Taste Masking; Salmon Calcitonin Osteoporosis (oral) Phase II Semi-Permeable Films Recombinant Parathyroid Osteoporosis (oral) Phase I Eastman Vitamin E TPGS NF Absorption Enhancer, Solubilizer, Bioavailability Hormone1-34 (Terapeptide) Enhancer Insulin Diabetes (oral) Phase II Contact: Carolyn Baker, (423) 229-2987 Cromolyn Sodium Asthma/allergies (oral) Phase II DRUG DELIVERY TECHNOLOGIES Recombinant Human Growth Growth disorders (oral) Phase I E.I. DuPont de Nemours Company Hormone (Somatropin) DuPont Fluorochemicals, Chestnut Run Plaza Wilmington, DE 19880-0711 Ciliary Neurotrophic Growth Obesity (oral) Pre-clinical Phone: (302) 224-0426 Fax: (302) 224-0427 Factor (CNGF) www.dupont.com/dymel Daptomycin Anti-infectives (oral) Pre-clinical Current Technologies/Platforms: Application(s): Current Partner(s): Contact: Dory Lombardo - Valiquette, (914) 593-8240 Technical Service Assistance (i.e. Metered Dose Inhalers, Dry Powder Inhalers and Confidential Basic Propellant Properties and other medical aerosols Characteristics, Formulation DRUG DELIVERY TECHNOLOGIES Properties Data, Formulation Testing, Analytical Services, Toxicity Ethypharm Information, Regulatory Assistance, 194 Bureaux de la Colline Safe Storage and Handling 92213 Saint-Cloud Cedex - France Phone: +33 1 41 12 17 20 Particle Science Technology, Metered Dose Inhalers, Dry Powder Inhalers and Confidential Engineering Evaluations for Heat, other medical aerosols www.ethypharm.com Mass & Momentum Transfer, Quality Management and Technology, Chemical & Reaction Engineering, Current Technologies/Platforms: Application(s): Current Partner(s): Electrical & Energy Engineering, Oral Modified Release Oral, site-specific, sustained, delayed Biovail, Astra Environmental and Process Safety Taste-Masking, Orodispersible Oral, rapid dispersion Jansen, BMS Oral Enhanced Absorption Oral, pulmonary (macromolecules) Novartis, Sanofi Contact: Mr. Joe Creazzo, email: [email protected] Injectable Modified Release Parenteral / implantation parenteral DRUG DELIVERY TECHNOLOGIES Vaccine Delivery/Cancer & Adjuvants Parenteral Elan Drug Technologies Contact: Bruno Delie, Senior VP, Business Development, +33 1 41 12 17 20 Monksland Athlone, Co Westmeath, Ireland DRUG DELIVERY TECHNOLOGIES Phone: +353 90 64 95000 Fax: +353 90 64 95807 Eurand, Inc. www.elan.com/EDT 845 Center Drive Current Technologies/Platforms: Application(s): Current Partner(s): Vandalia, OH 45377 NanoCrystal® Technology Oral: enhanced bioavailability, rapid absorption, Number of clients including Phone: (937) 898-9669 Fax: (937) 898-1093 decreased fed/fasted variability. Solid oral dosage commercialized products email: [email protected] forms, waterless tablets, oral liquids with Merck, Wyeth, www.eurand.com Fournier/Abbott and Par. Parenteral: low volume, high dose aqueous formula- Current Technologies/Platforms: Application(s): Current Partner(s): tions for IV, IM and Sub-Q administration AdvaTab™ Taste Masking/Fast Dissolve Respiratory: liquid and dry powder formulations for upper respiratory or deep lung delivery; sterile, Biorise® Bioavailability Enhancement Multiple International Partners preservative-free aqueous nasal spray suspensions Diffucaps® Customized Release Oral Controlled Release Platform Solid oral — tablets and capsules Number of clients including which includes: commercialized products Diffutabs® Customized Release with Ligand, Mitsubishi, SODAS® Technology Multiparticulate delivery system Novartis, Schwarz Pharma Liquitard Taste Masking/Suspension Tanabe, Watson CODAS™ Technology Delayed Release technology Microcaps® Taste Masking/Fast Dissolve ® ® See Company IPDAS Technology Controlled Release technology Minitabs Customized Release Profile PRODAS® Technology Multiparticulate minitab technology system Orbexa™ Customized Release Contact: Sarah Carty, PhD, +353 1 7094046 Pipeline Technologies/Platforms: Application(s): Development stage: Drug Targeting/Drug Conjugation Parenteral Pre-Clinical 82 Drug Delivery Technology November/December 2005 Vol 5 No 10 DDT Issue10 NOVEMBER05 11/5/05 10:26 AM Page 83 DRUG DELIVERY TECHNOLOGIES DRUG DELIVERY TECHNOLOGIES Ferris Pharmaceuticals Inc. Generex Biotechnology Corporation 16W300 83rd Street 33 Harbour Square, Suite 202 Burr Ridge, IL 60527-5848 Toronto, ON, Canada M5J 2G2 Phone: (630) 734-7810 Fax: (630) 887-1008 Phone: (416) 364-2251 Fax: (416) 364-9363 email: [email protected] email: [email protected] www.FerrisCares.com www.generex.com Current Technologies/Platforms: Application(s): Current Partner(s): Current Technologies/Platforms: Application(s): Current Partner(s): RapidMist™ pMDI to the Buccal Mucosa Polyurethane matrix (contains Wound dressings Marketed by Ferris Mfg. absorbent starch, glycerol, surfactant) Corp. Pipeline Technologies/Platforms: Application(s): Development stage: drug free Oral-lyn™ - Oral insulin spray for the Insulin spray absorbed in the Buccal Mucosa treatment of diabetes Polyurethane matrix containing Antimicrobial dressings Marketed by Ferris Mfg. Fentanyl antimicrobial (nanocrystalline silver) Corp. Morphine Pipeline Technologies/Platforms: Application(s): Development stage: Low Molecular Weight Heparin Loaded foam and gel formulations to Transdermal - healthy or injured skin/tissue Contact:Fabio Chianelli, Business Development, email: [email protected], (416) 364-2551, x 240 which drugs, carriers, biologicals, or Mucosal - (mouth, nose, rectum) healthy/injured cosmetics (dry or liquid form) can be DRUG DELIVERY TECHNOLOGIES added without heat/shear Glatt Pharmaceutical Services degradation, sterile/non-sterile 20 Spear Road Contact:Paul Kay Ramsey, NJ 07446 Phone: (201) 825-8700 DRUG DELIVERY TECHNOLOGIES www.glattpharmaceuticals.com Fertin Pharma A/S Current Technologies/Platforms: Application(s): Current Partner(s): Industrivej 8 CPS™ Proprietary Drug Delivery Technology, High Potency Pellets, Uniformly Distributed Low DK-7120 Vejle Doses, Advantages over Extrusion/ Denmark Spheronization, Dense, Spherical,Uniform Phone: (+45) 72 15 13 00 Fax: (+45) 72 15 13 01 Pellets email: [email protected] MicroPx™ Proprietary Drug Delivery Technology, High See Company www.fertin.com Potency Pellets, Pellets sizes of 50 micro and Profile larger, Continuous Process, Dense, Spherical, Current Technologies/Platforms: Application(s): Current Partner(s): Uniform ZRx™ Zero-Order Release Tablet System, Extended ® MediChew Oral, Buccal Novartis, GlaxoSmithKline Release Tablet Matrix System, Zero or First- Order Release Characteristics DRUG DELIVERY TECHNOLOGIES Contact: Thomas M. Salus, (201) 818-3778 Filtertek Inc. DRUG DELIVERY TECHNOLOGIES See Company 11411 Price Road Profile Honeywell Speciality Films Hebron, IL 60034 101 Columbia Road Phone: (800) 648-0791 Fax: (800) 648-2929 Morristown, NJ 07962 www.filtertek.com Phone: (973) 455-2491 Fax: (973) 455-2487 www.aclar.com Current Technologies/Platforms: Application(s): Current Partner(s): Current Technologies/Platforms: Application(s): Current Partner(s): Needles Access Products Drug Delivery/Transfer Various Aclar® Film Blister packaging for oral solid dosage forms, Aclar® Cx Coextrusions including fast-dissolve systems, Secondary blister Various Filters and Fluid Control Intravenous Drug Delivery Various Aclam® Coated Films or flexible packaging for solid and liquid dosage Components Capran® Emblem® Biaxially Oriented forms for oral and parenteral applications, Primary Nylon blister or flexible packaging for solid or liquid Air and Liquid Filters Pharmaceutical/Laboratory Processing Various Capran Medallion® Biaxially Oriented dosage forms for oral or pulmonary systems Nylon Contact: Bruce Daniels, VP Medical Marketing DRUG DELIVERY TECHNOLOGIES Flamel Technologies S.A. DRUG DELIVERY TECHNOLOGIES Parc Club Du Moulin á Vent Hospira, Inc. 33, Avenue du Docteur Georges Lévy One 2 One 69693 Vénissieux Cedex - France D988, H1 275 North Field Drive Phone: (+33) 4-72-78-34-34 Lake Forest, IL 60045 www.flamel.com Phone: (224) 212-2267 Fax: (224) 212-3210 email: [email protected] Current Technologies/Platforms: Application(s): Current Partner(s): www.hospira.com MicroPump Oral (MicroPump) GSK, Servier Monde, Current Technologies/Platforms: Application(s): Current Partner(s): MEDUSA Parenteral Merck & Co. (all with Ansyr Syringe® Pre-filled plastic syringe compatible with IV Multiple MicroPump) systems Pipeline Technologies/Platforms: Application(s): Development stage: ADD-Vantage System® IV admixture system used when medication is Multiple Genvir (MicroPump) Oral Phase III not stable in a premix format Metformin XL (MicroPump) Oral Phase I Ace Inhibitor (MicroPump) Oral Confidential Carpuject Syringe System® Pre-filled unit-dose injection system designed for Multiple Augmentin SR (MicroPump) Oral Confidential compatibility with IV sets Basulin (MEDUSA) Parenteral Phase I (completed) Various Drugs Various Preclinical Premix IV medication containers Ready-to-use IV medication delivery Multiple Contact:Frederick Simonin, (+33) 4-72-78-34-34 Drug Delivery Technology November/December 2005 Vol 5 No 10 83 DDT Issue10 NOVEMBER05 11/5/05 10:26 AM Page 84 DRUG DELIVERY TECHNOLOGIES DRUG DELIVERY TECHNOLOGIES Hovione Laureate Pharma, Inc. Sete Casas 201 College Road East 2674-506 Loures Princeton, NJ 08540 Portugal Phone: (609) 919-3400 Fax: (609) 452-7211 Phone: + 351 219 829 000 Fax: + 351 219 829 388 See Company email: [email protected] Profile email: [email protected] www.laureatepharma.com www.hovione.com Current Technologies/Platforms: Application(s): Current Partner(s): Current Technologies/Platforms: Application(s): Current Partner(s): Microspheres & Microparticle Parenteral, Extended/Sustained Release Southern Researh Institute Spray Drying Encapsulation, agglomeration, reduction residual Formulations solvents, particle sizing and shaping Contact: Stan Zeichner, (609) 919-3325 Micronization Particle size control Freeze Drying Processing thermally labile APIs DRUG DELIVERY TECHNOLOGIES Pipeline Technologies/Platforms: Application(s): Development Stage: Lipocine Inc. Sonocrystallization 675 Arapeen Drive, Suite 202 Super critical crystallization Manipulate degree of crystallinity Salt Lake City, UT 84103 Contact: Mrs. Carla Vozone Phone: (801) 994-7383 Fax: (801) 994-7388 email: [email protected] DRUG DELIVERY TECHNOLOGIES www.lipocine.com INNERCAP Technologies, Inc. Current Technologies/Platforms: Application(s): Current Partner(s): 5420 Bay Center Drive, Suite 100 Lip’ral® Oral poorly water soluble compounds Schwarz Pharma Tampa, FL 33609 Phone: (813) 837-0796 Fax: (813) 837-0207 Lip’ral® SSR Oral extended release for poorly water soluble Schwarz Pharma email: [email protected] compounds www.innercap.com Hydroance® Oral poorly permeable compounds N/A Pipeline Technologies/Platforms: Application(s): Development stage: LilV™ Parenteral delivery N/A Contact: Jerry Simmons, Corporate Business Development Officer NOVACAPS™ Multi-Phase, Multi-Compartment Capsules Actively seeking Licensees Multiple Dual Drug Delivery and partners See Company Controlled and Site Specific Drug Delivery DRUG DELIVERY TECHNOLOGIES Profile Incompatible combination drugs Pulsatile Drug Delivery Lipoxen Technologies Ltd. Contact: Fred H. Miller, (813) 837-0796 Suite 303, Hamilton House, Mabledon Place London, England WC1H 9BB DRUG DELIVERY TECHNOLOGIES Phone: ++44(0)20 7753 5822 Fax: +44(0)20 7753 5820 International Specialty Products (ISP) www.lipoxen.com 1361 Alps Road Wayne, NJ 07470 Current Technologies/Platforms: Application(s): Current Partner(s): Phone: (973) 628-4000 Fax: (973) 628-4117 email: [email protected] PolyXen™ (employs polysialic acids; Peptide and Protein therapeutics Please see website www.ispcorp.com see below) Current Technologies/Platforms: Application(s): Current Partner(s): ImuXen™ (employs liposomes; see Genetic, Protein and Polysaccharide vaccines Please see website below) Solid Dispersions Bioavailability Enhancement Contact: Dr.Tim Bee VesicAll™ (employs liposomes; see Oncology therapeutics Please see website below) DRUG DELIVERY TECHNOLOGIES Pipeline Technologies/Platforms: Application(s): Development stage: Intranasal Therapeutics, Inc. (formerly Intranasal Technology, Inc.) 1513 Bull Lea Boulevard A variety of peptide and protein Haematology, cancer, infectious diseases Various stages of development Lexington, KY 40511-1200 therapeutics, small oncology drugs, Phone: (859) 252-5080 Fax: (859) 252-7280 and an array of prophylactic/thera- email: [email protected] peutic vaccines www.intranasal.com Contact: Dr. Peter Laing Current Technologies/Platforms: Application(s): Current Partner(s): Aseptic filling Sterile nasal spray drug products DRUG DELIVERY TECHNOLOGIES Pipeline Technologies/Platforms: Application(s): Development stage: MacroMed, Inc. Nasally delivered butorphanol Migrane pain Phase 3 9520 South State Street Nasally delivered hydromorphone Acute/breakthrough pain Phase 1/2 Sandy, UT 84070 Nasally delivered lorazepam Sedation; anxiety; seizures Phase 1 Phone: (801) 565-8561 Fax: (801) 565-8562 Nasally delivered midazolam Procedural sedation; anxiety; amnesia Phase 1 email: [email protected] Nasally delivered THC Anorexia; antiemetic Preclinical Nasally delivered calcitonin Osteoporosis Preclinical www.macromed.com Contact: Ralph Johnston, Vice President Business Development Current Technologies/Platforms: Application(s): Current Partner(s): DRUG DELIVERY TECHNOLOGIES ReGel Parenteral Depot HySolv Parenteral/Oral Solubilizer Kurve Technology, Inc. SQZgel Oral Sustained Release 19125 North Creek Parkway, Suite 120 Bothell, WA 98011 Contact: Alex S. Kim, Executive Vice President, (801) 565-8561 Phone: (425) 640-9249 Fax: (425) 483-1058 email: [email protected] www.kurvetech.com Pipeline Technologies/Platforms: Application(s): Development stage: Controlled Particle Dispersion™ Nasal drug delivery of topical and systemic Medel, S.p.A therapies ny ompa See C Profile Contact: Robert Kamp, VP Corporate Development 84 Drug Delivery Technology November/December 2005 Vol 5 No 10 DDT Issue10 NOVEMBER05 11/5/05 10:26 AM Page 85 DRUG DELIVERY TECHNOLOGIES DRUG DELIVERY TECHNOLOGIES MedPharm Ltd NanoSystems Business Centre - Sheep Street 3000 Horizon Drive, 3500 Horizon Drive Charlbury 0X7 3RR King of Prussia, PA 19406 Oxfordshire, United Kingdom Phone: (610) 313-5100 Fax: (610) 313-5170 Phone: +44 (0) 16 0881 9267 Fax: +44 (0) 16 0881 9268 www.nanocrystal.com email: [email protected] www.medpharm.co.uk Current Technologies/Platforms: Application(s): Current Partner(s): Pipeline Technologies/Platforms: Application(s): Development Stage: NanoCrystal® Technology Oral: enhanced bioavailability, rapid Merck & Co. (Emend®), Wyeth absorption, decreased fed/fasted variability. (Rapamune®), Various undisclosed MedSpray™ a novel topical/transdermal spray Pre-clinical Solid oral dosage forms, waterless tablets, MedNail® a novel ungual penetration system Pre-clinical oral liquids. D3S™ A device for dermal drug delivery Seeking out-licensing partner Parenteral: low volume, high dose aqueous formulations for IV, IM or Sub-Q administration. MedAir®, MedAir® HP Pulmonary drug delivery technology (DDT) for Seeking out-licensing small molecules partner Respiratory: liquid and dry powder MedEole® Pulmonary DDT for biologicals Seeking out-licensing formulations for upper respiratory or deep lung See Company partner delivery; sterile, preservative-free aqueous Profile nasal spray suspensions. MedCrys™ Pulmonary DDT to control re-crystallization of Seeking out-licensing therapeutic agents partner Pipeline Technologies/Platforms: Application(s): Development stage: Contact:Dr. Simon Bennett, Director of Business Development Bioadhesive NanoCrystal® Topical: increased particle residence time on Preclinical DRUG DELIVERY TECHNOLOGIES Formulations mucosa, skin, and hair. Merrion Pharmaceuticals, Inc. Contact: Elaine Liversidge, PhD, (610) 313-5130 219 Racine Drive, Suite D Wilmington, NC 28403-8702 DRUG DELIVERY TECHNOLOGIES Phone: (910) 799-1847 Fax: (910) 395-1843 Nastech Pharmaceutical Company, Inc. email: [email protected] 3450 Monte Ville Parkway 45 Adams Avenue www.merrionpharma.com Bothell, WA 98021 Haupauge, NY 11788 Current Technologies/Platforms: Application(s): Current Partner(s): Phone: (212) 845-4268 Gastrointestinal Permeation Applicable to solid and liquid-filled dosage www.nastech.com Enhancement Technology (GIPET) forms. GIPET is an enhancer-based technology for poorly permeable compounds for oral administration of small molecules, Current Technologies/Platforms: Application(s): Current Partner(s): macro-molecules, peptides, biologics, and polysaccharides STAT-T™ - Systemic Transnasal Intranasal Pharmacia, Phol-Boskamp Absorption Technology Gastrointestinal Retention System Applicable to a wide range of drugs; there is (GIRES) - capsule containing a no change in the chemical composition of API. PTS™ - Paracellular Transport Intranasal Seeking additional controlled-release tablet inside an Targeted at once-a-day dosing for compounds System partnerships for these inflatable pouch with short biological half-lives, narrow technologies absorption windows, narrow therapeutic JAT™ - Junction Activator Intranasal indices, or which require local delivery to GIT. Technology Pipeline Technologies/Platforms: Application(s): Development stage: Contact: Robert Stanislaro, (212) 845-4268 Blood Brain Barrier (BBB) Delivery Preclinical DRUG DELIVERY TECHNOLOGIES Systems Nektar Therapeutics Oral Vaccine Delivery Systems Preclinical 150 Industrial Road Contact: Michael J. McKenna, PhD San Carlos, CA 94070 Phone: (650) 631-3100 DRUG DELIVERY TECHNOLOGIES www.nektar.com MGlas AG Otto-Liebmann-Strasse 2 Münnerstadt, Germany 97702 Current Technologies/Platforms: Application(s): Current Partner(s): Phone: +49(0)9733 808-0 Fax: +49(0)9733 808-160 PEG-INTRON® Parenteral Schering-Plough email: [email protected] www.mglas.de Neulasta™ (PEG-filgrastim) Parenteral Amgen Current Technologies/Platforms: Application(s): Current Partner(s): Pipeline Technologies/Platforms: Application(s): Development stage: Containers made of tubular glass: Parenteral Pharmcos, among others: PEGASYS® (PEG-a-interferon) Parenteral Roche Syringes, cartridges (one- and two- Nasal Apotex, Aradigm, AstraZeneca, Somavert® (PEG-hGHra) Parenteral Pharmacia chamber), vials, ampoules, Oral Biotage, Chiron, Sanofi Aventis, Exubera® (inhaled insulin) Inhalation Pfizer specialities on customer request Diagnostic Sanofi Pasteur, Baxter, Glaxo- EYE001 (PEGylated aptumer) Parenteral Eyetech SmithKline, Roche Diagnostics, SprayGel™ adhesion barrier Gel Confluent Schering-Plough, Vetter system (PEG) Pipeline Technologies/Platforms: Application(s): Development stage: CDP870 (PEGylated antibody Parenteral Pharmacia fragment) Needle-free devices Transdermal Clinical Phase II Inhaled alpha I Inhalation Phase I Innovative needles (V Bevel®/Spoon Parenteral Market Inhaled Forté (PTH) Inhalation Phase I Point®/Spoon Point Plus®) Inhaled tobramycin Inhalation Phase I Inhaled leuprolide Phase I Pre-washed/pre-sterilized Parenteral Development PEGylated interferon beta Parenteral Phase I cartridges for aseptic filling PEG-AXOKINE Parenteral Phase I Laser technology Manufacture of containers for Market & Developmet PEG-TPO Parenteral Pre-clinical parenterals PEG-prostacyclin Parenteral Pre-clinical Contact: Mr. Wolfgang Heidl, +49(0)9733 808-125 PEG proteins Parenteral Pre-clinical Inhaled dronabinol (MDI) Inhalation Pre-clinical Inhaled small molecules Inhalation Pre-clinical Single chain antibodies Inhalation Pre-clinical PA2794 Inhalation Pre-clinical Contact:Joyce Strand, (650) 631-3138 Drug Delivery Technology November/December 2005 Vol 5 No 10 85 DDT Issue10 NOVEMBER05 11/5/05 10:26 AM Page 86 DRUG DELIVERY TECHNOLOGIES DRUG DELIVERY TECHNOLOGIES NeoPharm Inc. NOVAGALI PHARMA 1850 Lakeside Drive 1 rue Pierre Fontaine / Genavenir IV Waukegan, IL 60085 Evry, France 91058 Phone: (847) 887-0800 Fax: (847) 887-9281 Phone: 00 33 1 69 87 40 20 Fax: 00 33 1 69 87 40 20 email: [email protected] email: [email protected] www.neophrnm.com www.novagali.com Current Technologies/Platforms: Application(s): Current Partner(s): Current Technologies/Platforms: Application(s): Current Partner(s): NeoLipid® Technology Delivery of broad range of difficult to formulate Submicron Cationic Emulsions Topical, Oral, Injectable, Ophthalmic drugs NeoPhectin (In Vitro) Delivery of Nucleic acids (plasmid, antisense, Cationic Self-Emulsifying Systems Oral, Subcutaneous, Intramuscular siRNA) NeoPhectin-AT (In Vivo) Delivery of Nucleic acids (plasmid, antisense, Self-Nano-Emulsifying Oily Oral siRNA) Formulations Pipeline Technologies/Platforms: Application(s): Development Stage: Immuno-Emulsions Injectable NeoLipid® Technology Easy to use Liposome based drugs for treatment Liposome based SN-38 Pipeline Technologies/Platforms: Application(s): Development Stage: of cancer (LE-SN38), SN-38 is an active metabolite of Active-free cationic emulsion for Treatment of dry eye syndrome Phase II Campostar® - Phase II ophthalmic use (Cationorm™) Liposome based Paclitaxel Cyclosporine A cationic emulsion Treatment of severe dry eye syndrome Phase I (LEP-ETU) - Phase I/II for ophthalmic use Liposome based raf Oral Paclitaxel Self-Nano- Oral oncology Phase I antisense (LErafAONETU) - Emulsifying Oily Formulation Phase I Contact: Jean-Sebastien Garrigue, 00 33 1 69 87 40 28 Contact: Saif Sheikh DRUG DELIVERY TECHNOLOGIES DRUG DELIVERY TECHNOLOGIES NOF Corporation NuSil Technology 11 Martin Avenue, Suite 1170 1050 Cindy Lane White Plains, NY 10606 Carpinteria, CA 93013 pany Phone: (914) 681-9790 Fax: (914) 681-9791 Phone: (805) 684-8780 Fax: (805) 566-9905 See Com Profile International: + 81-3-5424-6741 email: [email protected] email: [email protected] www.nusil.com www.nof.co.jp/dds Current Technologies/Platforms: Application(s): Current Partner(s): Current Technologies/Platforms: Application(s): Current Partner(s): silicone elastomers transdermal, mucosal, in-vitro PEG Derivitives Suitable & ideal for producing PEGylated drugs N/A pressure sensitive adhesives silicone gels pany Phospholipids & Liposomes Ideal for screening tests and liposomal formulations N/A See Com silicone fluids Profile custom development HIghly Purified Oleic Acid Formulation development N/A Contact: Mark Paulsen, (805) 684-8780 Cholesterol Pullulan Encapsulated antigen or protein can be delivered to N/A dendritic cells, so these nanoparticles can be suitable for stimulating immune system DRUG DELIVERY TECHNOLOGIES Oakwood Laboratories, L.L.C. Contact: [email protected] 7670 First Place, Suite A DRUG DELIVERY TECHNOLOGIES Oakwood Village, OH 44146 NovaDel Pharma, Inc. Phone: (440) 359-0000 Fax: (440) 359-0001 25 Minneakoning Road, Suite 101 email: [email protected] Flemington, New Jersey 08822 www.Oakwoodlabs.com Phone: (908) 782-3431 Fax: (908) 782-2445 Current Technologies/Platforms: Application(s): Current Partner(s): email: [email protected] CHRONIJECT™ Injectables Sustained Release of Parenteral Injectables Domestic & International www.novadel.com Microsphere Technology NMEs, Peptides, Approved APIs Current Technologies/Platforms: Application(s): Current Partner(s): Sterile Lyophilized Dosage Forms Oral spray technology platform • Oral spray technology potentially achieves: Par Pharmaceuticals - Pipeline Technologies/Platforms: Application(s): Development stage: applicable to a broad range of - rapid delivery of drugs directly to bloodstream NitroMist™ (nitroglycerin therapeutic areas & product - quick onset of action lingual aerosol) Novel Advanced Drug Delivery categories: - Lower doses Hanna Biosciences - Technologies • Currently marketed Rx and OTC - Avoids the GI tract and first pass liver metabolism Zensane™ (ondansetron Contact: Michael G. Lanzilotti, EVP & COO drugs • Strong patent position oral spray) • New molecular entities in Manhattan Pharmaceuticals development for Diprivan (Propofol) Contact: Barry Cohen 86 Drug Delivery Technology November/December 2005 Vol 5 No 10 DDT Issue10 NOVEMBER05 11/5/05 10:26 AM Page 87 DRUG DELIVERY TECHNOLOGIES DRUG DELIVERY TECHNOLOGIES Development Octoplus Particle and Coating Technologies, Inc. Zernikedreef 12 5445 Highland Park Drive 2333 CL Leiden Netherlands St. Louis, MO 63110 Phone: +31 71 5244044 Fax: +31 71 5244043 Phone: (314) 535-1516 Fax: (314) 535-1514 email: [email protected] email: [email protected] www.octoplus.nl www.pctincusa.com Current Technologies/Platforms: Application(s): Current Partner(s): Current Technologies/Platforms: Application(s): Current Partner(s): Spinning-disk coating Many (confidential) OctoDEX™ A biodegradable dextran-based drug delivery Undisclosed system for the controlled release of proteins and Micro-capacity spray dryer (marketed Preformulation Biotechnology Samples Several particulate systems early 2006 PolyActive™ A biodegradable polymeric drug delivery system Undisclosed Mini-Fluid-Bed (marketed early 2006) Expensive Materials Several for the controlled release of proteins and lipophilic Forming narrow-size distributions Many small molecules Fluid-bed coating, spray-drying, Many SynBiosys™ A biodegradable polymeric drug delivery system InnoCore spray-chilling for peptides and small molecules Bioavailability enhancement Hydrophobic drugs Pipeline Technologies/Platforms: Application(s): Development stage: Fast-melt tablets Pharmaceuticals OctoDEX™-hGH Metabolic diseases Phase I completed Pipeline Partners: Application(s): Development stage: succesfully Coating liquid droplets Widely applicable Successful initial applications Very fast coater, high capacity Feed, seed, fertilizer Successful initial applications Locteron™, a controlled-release Hepatitis, cancer Pre-clinical Coating particles down to 1 micron Widely applicable Successful initial applications formulation of alfa interferon Extended release technology Fragrance, flavor, biocides, etc. Successful initial applications Japanese encephalitis vaccine Japanese encephalitis Pre-clinical Contact: Robert Sparks (single-shot delivery) DRUG DELIVERY TECHNOLOGIES Contact Person: Dr. Henrik Luessen, Director Business Development Pfeiffer of America DRUG DELIVERY TECHNOLOGIES 12 Roszel Road, Suite C-104 OSG Norwich Pharmaceuticals, Inc. Princeton, NJ 08540 6826 State Highway 12 Phone: (609) 987-0223 Fax: (609) 987-1511 Norwich, NY 13815 email: [email protected] Phone: (607) 335-3000 Fax: (607) 335-3100 www.Pfeiffer.de email: [email protected] Current Technologies/Platforms: Application(s): Current Partner(s): www.norwichpharma.com Metered dose dispensing systems Nasal, Bucal, Topical & Dermal N/A Current Technologies/Platforms: Application(s): Current Partner(s): for Aqueous solutions & suspensions Tablets Numerous Capsules Numerous Pipeline Technologies/Platforms: Application(s): Development Stage: Non-sterile liquids Numerous Microhaler Pulmonary Contact Person: Bob Calabro Contact: Richard Sica DRUG DELIVERY TECHNOLOGIES DRUG DELIVERY TECHNOLOGIES Oxford Lasers Inc. 29 King Street Pharmaceutical Profiles Littleton, MA 01460-1528 Mere Way, Ruddington Fields, Ruddington Phone: (978) 742-9000 Fax: (978) 742-9100 Nottingham, NG11 6JS, United Kingdom email: [email protected] Phone: +44 115 974 9000 www.oxfordlasers.com www.pharmprofiles.com Current Technologies/Platforms: Application(s): Current Partner(s): Current Technologies/Platforms: Application(s): Current Partner(s): EnVision System range (high quality Automatic measurements systems: One system Chiesi, Vectura, Bespak, ENTERION™ CAPSULE Oral drug development Pharma & Biotech companies high speed imaging system) for Nasal, MDI, DPI and softmist devices. GlaxoSmithKline TECHNECOAT™ Pulmonary drug development EnVision QC system (information for Information obtained: Spray Pattern, Plume Gamma Scintigraphy Nasal, drug development, rectal drug FDA submissions) geometry, Event duration and high speed imaging. development, vaginal drug development EnVision R&D (Full suite of R&D application: additional information on flow capability to provide detailed field velocity through the actuation of the device information on the device) Pipeline Technologies/Platforms: Application(s): Development stage: Confidential at present. Confidential Confidential Micro-Machining Systems For machining of small hole and feature in a wide Micro-Machining Application Labs range of material Contact:Dr. Paul J. Clewlow, Business Development Director, +44(0) 115 974 9000 Contact Person: Dr. Seamus D. Murphy, (978) 742-9000, email: [email protected] Drug Delivery Technology November/December 2005 Vol 5 No 10 87 DDT Issue10 NOVEMBER05 11/5/05 10:26 AM Page 88 DRUG DELIVERY TECHNOLOGIES DRUG DELIVERY TECHNOLOGIES Polygenetics, Inc. RxKinetix, Inc. PO Box 33115 1172 Century Drive, Suite 260 Los Gatos, CA 95031 Louisville, CO 80027 Phone: (408) 356-1815 Fax: (408) 356-7094 Phone: (303) 926-1900 Fax: (303) 926-1906 email: [email protected] email: [email protected] www.rxkinetix.com www.polygenetics.com Current Technologies/Platforms: Application(s): Current Partner(s): Current Technologies/Platforms: Application(s): Current Partner(s): ® Cavilink™ Porous Polymers Drug delivery, embolotherapy Boston Scientific Corp. ProGelz Parenteral, topical, mucosal n/a Micronix® Parenteral, pulmonary, oral n/a Cavilink™ Polymers Zero-order release Boston Scientific Contact: Christopher Bonny, (303) 926-1900 Pipeline Technologies/Platforms: Application(s): Development stage: Cavilink™ Gene therapy Intermediate DRUG DELIVERY TECHNOLOGIES Cavilink™ Artificial organs Preliminary SafetySyringes, Inc. 1939 Palomar Oaks Way (Suite A) Contact:Dr. James Benson, (408) 356-1815 Carlsbad, CA 92011 Phone: (760) 918-9908 Fax: (760) 918-2216 DRUG DELIVERY TECHNOLOGIES email: [email protected] Respirics, Inc. www.safetysyringes.com 6008 Triangle Drive, Suite 101 Raleigh, NC 27617 Current Technologies/Platforms: Application(s): Current Partner(s): Phone: (919) 789-4220 Fax: (919) 789-4254 www.respirics.com Configurations available for staked, SafetySyringes specializes in the development AMGEN, AstraZeneca, Ortho- luer and luer-lock applications w/ of anti-needle stick devices for prefilled Clinical Diagnostics, Pfizer, syringe sizes from 0.5mL to 2.25mL pharmaceutical glass syringes Talecris Biotherapeutics, YPSOMED Current Technologies/Platforms: Application(s): Current Partner(s): Auto-Injector compatible MD Turbo™ Breath-triggered device with electronic dose TEAMM Pharmaceuticals (U.S. Tamper Evident configuration counter for use with pMDIs Market Only) available pany See Com Profile Pipeline Technologies/Platforms: Application(s): Development Stage: UltraSafe Passive® Delivery System Acu-Breathe™ Single Dose Pulmonary DPI; for infrequent dosing; single Pre-Clinical available since 2002 blister Contact: Mark Hassett, VP - Marketing/Business Development Acu-Breathe™ 15-Dose Pulmonary DPI; for chronic dosing; replaceable Pre-Clinical cartridge DRUG DELIVERY TECHNOLOGIES Sciarra Laboratories, Inc. Acu-Breathe™ 30-Dose Pulmonary DPI; for chronic dosing; disposable Pre-Clinical 485-09 S. Broadway Acu-Breathe™ Twin Pulmonary DPI; for two or more drugs Design Development Hicksville, NY 11801 Phone: (516) 933-7853 Fax: (516) 933-7807 Contact: Gilbert S. Mott,Jr., President & CEO email: [email protected] www.sciarralabs.com DRUG DELIVERY TECHNOLOGIES REXAM PHARMA Current Technologies/Platforms: Application(s): Current Partner(s): 287 Bowman Avenue, Suite 302 Purchase, NY 10577 Metered Dose Inhalers Asthma Medication Phone: (914) 251-8420 Fax: (914) 251-1450 Pharmaceutical Aerosols Foams, Solutions email: [email protected] Contact: John J. Sciarra www.rexam.com/pharma DRUG DELIVERY TECHNOLOGIES Current Technologies/Platforms: Application(s): Current Partner(s): SCOLR Pharma, Inc. The Sof’ Bag: 2 components delivered Dermal N/A 3625 132nd Avenue SE, Suite 300 by Rexam: a multilayer bag in a Bellevue, WA 98006 plastic bottle combined a metering pump to guarantee a maximum Phone: (425) 373-0171 Fax: (424) 373-0181 protection against contamination email: [email protected] and oxidation www.scolr.com Pill jars & value added closures with Oral N/A Current Technologies/Platforms: Application(s): Current Partner(s): or without tamper evidence, child resistance or dessicant CDT® Controlled Delivery Technologies Solid Oral Delivery, Small Molecule Platform consists of Three Issued Patents: pany Our patented Safe’n Sound safety Parenteral N/A See Com system for prefilled syringes Transfer Profile sets, veterinary syringes, auto- “Dual Polymer” technology BCS class 1 & 2 injectors, implanters, injectable vials “Salt” technology BCS class 1 & 2 ADM, Sinphar Pharmaceuticals Diabolo: COC vials closed with a Parenteral Aseptic Technologies TPE cap in a class 100A room and “Amino Acid” technology BCS class 2, 3 & potentially 4 sterilized to avoid any additional step before filling Pipeline Technologies/Platforms: Application(s): Development stage: CDT® “Asymmetrical” technology #4 Combinatition, cocktail therapies, Gastric Pre-Clinical, Patent pending Dry Powder Inhalers and pressurized Pulmonary N/A retention and site specific Metered Dose Inhalers Contact: Stephen Turner, ext. 1004 Pumps, valves and applicators Nasal, Buccal & Auricular N/A Pipeline Technologies/Platforms: Application(s): Development Stage: Preservative Free solutions, Ophthalmics ophthalmic pumps and devices Contact: Philippe DEPOIS 88 Drug Delivery Technology November/December 2005 Vol 5 No 10 DDT Issue10 NOVEMBER05 11/5/05 10:27 AM Page 89 DRUG DELIVERY TECHNOLOGIES DRUG DELIVERY TECHNOLOGIES Sensirion - the sensor company Shire Laboratories, Inc. Laubisruetistr. 50 1550 East Gude Drive Staefa, Zurich CH-8712, Switzerland Rockville, MD 20850 Phone: +41 44 306 4000 Fax: +41 44 306 4030 Phone: (301) 838-2681 Fax: (301) 424-1364 email: [email protected] email: [email protected] www.sensirion.com www.shirelabs.com Current Technologies/Platforms: Application(s): Current Partner(s): Current Technologies/Platforms: Application(s): Current Partner(s): Micro fluidic flow sensors and Dosing and metering of liquid drugs in the Medical device manufacturers EnSoTrol® Osmotic systems based on digital CMOS chips micro liter and nano liter range and bio-tech companies Solutrol® Matrix CMOSens Technology - The combina- Calibrated, digital, ready to use sensor solutions tion of sensor elements and digital Microtrol® Multiparticulate pany See Com signal processing on one single micro Profile chip OptiScreen® Predictive, Bioavailability Enhancement Pipeline Technologies/Platforms: Application(s): Development stage: ProScreen™ Oral candidate selection Disposable Flow Sensors Dosing and metering of liquid drugs in the Functional samples available AvertSM Reduce abuse potential micro liter and nano liter range RADARSM/PROPHILESM In silico modeling/In vivo evaluation Contact: Ulf Kanne +41 44 306 4000 Emutrol™ Enhanced Oral Bioavailability DRUG DELIVERY TECHNOLOGIES CollaGenex Pharmaceuticals Indevus Pharmaceuticals SHARMATEK, Inc. QRx Pharmaceuticals 12 Walnut Drive Contact: Woody Bryan, PhD Long Valley, NJ 07853 Phone: (908) 852-5087 DRUG DELIVERY TECHNOLOGIES email: [email protected] www.stk-inc.net SAFC 3050 Spruce Street St. Louis, MO 63103 Current Technologies/Platforms: Application(s): Current Partner(s): Phone: (800) 336-9719 Pulsatile Macroparticulate Drug Oral, pulsatile, site-specific, diltiazem hydrochloride, Wockhardt Limited www.sigmaaldrich.com Delivery System (PMDDS™) capsules, qd Current Technologies/Platforms: Application(s): Current Partner(s): Hydrophilic Matrix Drug Delivery Oral, Swelling/Erosion Controlled Super Case II Wockhardt Limited Polyamineo Acids Carrier/excipient System (HMDDS™) release mechanism, felodipine, extended release Lipids Liposomes tablets, qd Lipisomes Carrier/excipient Tween 20/80 GMP,Low Peroxide Detergent/surfactant Delayed Release Drug Delivery Oral, enteric delayed release, omeprazole, Wockhardt Limited System (DRDDS™) capsules, qd Pipeline Technologies/Platforms: Application(s): Development stage: Pipeline Technologies/Platforms: Application(s): Development stage: Biphasic HMDDS™ Oral, biphasic release, hydrophilic matrices, qd, as Seeking partners PEGylation Stability, solubility Prototype applied to ciprofloxacin, clarithromycin, or metoprolol succinate Contact: Tom Gelineau, (314) 301-2077, email: [email protected] Convolution-Based Predictive Applied to the design of modified release products Seeking partners DRUG DELIVERY TECHNOLOGIES Modeling Using Fractional Release for cost-effective and timely clinical optimization SOLIQS Times/In-Vitro In-Vivo Correlation SOLIQS Business Unit (FRT/IVIVC™) ABBOTT GmbH & Co. KG Stochastic Design and Convolution- Development of non-commodotized, new products Phase I (Modeling) PO Box 21 08 05 Based Predictive Modeling of such as Methylphenidate PMDDS™, and completed, seeking partners 67008 Ludwigshafen, Germany Pelletized Drug Delivery Systems Carvedilol PMDDS™ Phone: +49-621 589 2427 Fax: +49-621 589 3092 email: [email protected] Programmable Tabsule Drug Delivery Oral, multi-phasic release, site-specific, minitablets Currently in progress in www.soliqs.com System- (PTDDS™) named as Tabsules™, bid or qd conjunction with stochastic design and convolution- Pipeline Technologies/Platforms: Application(s): Development stage: based predictive modeling Meltrex™ Melt extrusion technology n/a Microfluidization Processing Low solubility, high permeability drug candidates Seeking partners Xellux™ Polymeric film technology n/a Technology (MPT™) NanoMorph™ Amorphous nanoparticle technology n/a SoliScreen™ Qualitative & quantitative screening systems n/a Contact: Vinay K. Sharma, PhD , Chairman, (908) 852-5087, Mobile: (908) 616-3319 Contact: [email protected] DRUG DELIVERY TECHNOLOGIES Shionogi Qualicaps 6505 Franz Warner Parkway Whitsett, NC 27377 Phone: (336) 449-3900 www.qualicaps.com Current Technologies/Platforms: Application(s): Current Partner(s): Quali-V® capsules Empty two-piece capsule of non-gelatin origin F/S Machine Combination filling and sealing encapsulation Contact:Tamara Smith, (336) 449-3953 Drug Delivery Technology November/December 2005 Vol 5 No 10 89 DDT Issue10 NOVEMBER05 11/5/05 10:27 AM Page 90 DRUG DELIVERY TECHNOLOGIES DRUG DELIVERY TECHNOLOGIES Sontra Medical Corporation Travanti Pharma Inc. (formerly Birch Point Medical Inc.) 10 Forge Parkway 473 Hayward Avenue North Franklin, MA 02038 Phone: (508) 553-8850 Fax: (508) 553-8760 St. Paul, MN 55128 email: [email protected] Phone: (651) 730-1008 Fax: (651) 730-1013 www.sontra.com www.travantipharma.com Pipeline Technologies/Platforms: Application(s): Development stage: Current Technologies/Platforms: Application(s): Current Partner(s): SonoPrep® Topical Anesthesia Transdermal delivery of skin anesthetic, Accelerates Final product development ® onset time 510k submission WEDD (Wearable Electronic Pain, Inflammation Undisclosed Disposable Drug Delivery) Technology Symphony™ Diabetes Management Continuous non-invasive glucose monitor Phase I clinicals R&D --Proprietary active transdermal System partnership with Bayer (iontophoretic) drug delivery system Diagnostics that is self-contained, portable & disposable SonoPrep® vaccine delivery Ultrasonic skin permeation for non-invasive Pre-clinical transdermal vaccinations Pipeline Technologies/Platforms: Application(s): Development Stage: SonoPrep® dermatology drug Ultrasonic skin permeation for non-invasive Pre-clinical WEDD® Active Transdermal Drug Pain, Inflammation, Nausea/Emesis, Thrombosis, Phase I Clinical delivery transdermal skin treatment Delivery System Osteoporosis, Cosmetic, among others Contact: Thomas W. Davison, PhD (508) 553-8850, ext. 229 Contact: Robert Arnold DRUG DELIVERY TECHNOLOGIES DRUG DELIVERY TECHNOLOGIES SPI Pharma UPM Pharmaceuticals, Inc. 321 Cherry Lane 6200 Seaforth Street New Castle, Delaware 19720 Baltimore, MD 21224 Phone: (302) 576-8500 x 8554 Phone: (410) 843-3738 Fax: (410) 633-4438 Fax: (302) 576-8567 [email protected] www.spipharma.com www.upm-inc.com Current Technologies/Platforms: Application(s): Current Partner(s): Current Technologies/Platforms: Application(s): Current Partner(s): Pharmaburst™ Fast Melt Excipient Oral Dispersible Tablet Generic & Brand Rx System Cushioning Beads™ Pediatric, geriatric, HIV patients undisclosed Pharmafreeze™ Fast Melt Lyophilized ODT, Sublingual Tablet Brand Rx Accomodates high and low dose drugs, quick System dissolve form Pharmasperse™ Dry Powder Reconstitutable Syrup Generic Rx, OTC Suspension Trap & Trigger™ Pediatric, geriatric, HIV, cancer patients undisclosed Pharmagum™ DC Chewing Gum Buccal Gum Tablet Rx, OTC, Nutraceutical Current Technologies/Platforms: Application(s): Current Partner(s): Powder Cushioning Beads™ Oral quick dissolve tab early Taste-masking/Controlled release Solid Oral Dose Rx, OTC Custom Processing Granulation, Chilsonation Micronizing, Extrusion Rx, OTC Trap & Trigger™ Oral SR suspension for electrolytic drugs early Pipeline Technologies/Platforms: Application(s): Development Stage: Contact: Rich Ryzenga Pharmachew™ Excipient System Chewable Tablet Platform OTC, Nutraceutical Pharmatab™ Excipient System Swallow Tablet Platform Rx, OTC DRUG DELIVERY TECHNOLOGIES Contact: Ellen London Valois DRUG DELIVERY TECHNOLOGIES 50 Avenue de l’Europe Marly-le-Roi, France 78164 Sympatec, Inc. Phone: +33 (0) 1 39 17 20 20 Fax: +33 (0) 1 39 58 12 98 9A Princess Road www.valoispharma.com Lawrenceville, NJ 08648 Current Technologies/Platforms: Application(s): Current Partner(s): Phone: (609) 844-1020 www.sympatec.com Metering Spray Pumps Nasal, Throat, Dermal/Transdermal, Ear Metering Valves for pMDIs Pulmonary (Asthma, COPD) Current Technologies/Platforms: Application(s): Current Partner(s): Unit-Dose Nasal Spray Devices Nasal Helos Laser Particle/Droplet Analyzer Inhaler module for DPI/MDI/Nebulizers, sprayer for All major pharma companies Pipeline Technologies/Platforms: Application(s): Development Stage: MDI/Nasal, dry powders Dose Indicator for pMDIs Contact: Joe Wolfgang, (609) 844-1020 Dry Powder Inhaler Electronic Devices New Pumps, Valves and Unit-Doses DRUG DELIVERY TECHNOLOGIES Contact: Pierre Carlotti - VP Marketing Texmac Inc. 3001 Stafford Drive Charlotte, NC 28208 Phone: (704) 393-6555 Fax: (704) 392-1621 email: [email protected] www.texmac.com Pipeline Technologies/Platforms: Application(s): Development Stage: Soluble Microneedle Technology Drug delivery Distribute sample micro- needles for customer’s evaluation Cosmeceutical Distribute sample micro- needles for customer’s evaluation Contact:Yashi Osaka 90 Drug Delivery Technology November/December 2005 Vol 5 No 10 DDT Issue10 NOVEMBER05 11/5/05 10:27 AM Page 91 DRUG DELIVERY TECHNOLOGIES DRUG DELIVERY TECHNOLOGIES Vectura Limited West Pharmaceutical Services, Inc. One Prospect West Drug Delivery Systems Chippenham 101 Gordon Drive Wiltshire, SN14 6FH Lionville, PA 19341 United Kingdom Phone: (610) 594-3157 Phone: (+44) 1249 66700 Fax: (+44) 1249 667701 www.westdrugdelivery.com [email protected] www.vectura.com Current Technologies/Platforms: Application(s): Current Partner(s): ChiSys® Pectin-based Nasal Drug Delivery Technologies Current Technologies/Platforms: Application(s): Current Partner(s): POWDERHALE Pulmonary (DPI formulation) Zambon, GSK TARGIT® Oral Colonic Targeting ASPIRAIR Pulmonary (DPI Device) Available Pipeline Technologies/Platforms: Application(s): Development stage: ACCUSTAR Oral (Device for powders) Available Gastrorentention Oral Proof of Principle MAXSOL Oral (Bioavailability enhancer) Available Contact: Vinod Vilivalam, (610) 594-3157 GENCONTAB Oral (Controlled release tablet) Ranbaxy DRUG DELIVERY TECHNOLOGIES PANDERMAL Dermal (Unit dose presentation) Available Ypsomed AG Brunnmattstrasse 6 Pipeline Technologies/Platforms: Application(s): Development Stage: CH-3400 Burgdorf Pipeline Product VR004 Inhaled apomorphine for MGD Phase II Switzerland Pipeline Product AD237 Inhaled bronchodilator for COPD Phase II (partner=Arakis) Phone: +41 34 424 41 11 Fax: +41 34 424 41 22 Pipeline Product VR478 Inhaled drug for epilepsy Pre-clinical email: [email protected] Pipeline Product VR496 Inhaled drug for COPD/CF Pre-clinical Pipeline Product VR694 Inhaled drug for asthma Pre-clinical www.ypsomed.com Current Technologies/Platforms: Application(s): Current Partner(s): DRUG DELIVERY TECHNOLOGIES Reusasble injection pens Regular subcutaneous self-injections Aventis (insulin), Dongbao (insulin), Pfizer (hGH), Eli Lilly Ventaira Pharmaceuticals, Inc. (hGH), Genentech (hGH) and 1801 Watermark Drive, Suite 100 Roche (EPO and alfa-interferon) Columbus, OH 43235 Phone: (614) 340-2325 Fax: (614) 340-2320 Disposable injection pens Regular subcutaneous self-injections Aventis (insulin) and Serono (FSH) email: [email protected] Pipeline Technologies/Platforms: Application(s): Development stage: www.ventaira.com Reusable and disposable auto- Subcutaneous and intramuscular self- Ongoing development Current Technologies/Platforms: Application(s): Current Partner(s): injector systems injection of bio-molecules programmes with a number of partners Mystic drug inhalation technology Pulmonary (uses electrostatic energy to form a Contact: Ian Thompson, Manager Business Development, [email protected] uniform fine particle spray) Drug formulation technology Pulmonary Seeking qualified strategic (allowing the company to optimize partners for co-develop the delivery of drugs - small opportunities molecules and are expanding to biomolecules) Internal Pipeline Technologies Partners: Application(s): Development stage: Fluticasone Propionate Asthma Completed Phase I clinical trial Undisclosed Asthma Formulation Undisclosed Pain Formulation Undisclosed Undisclosed Formulation Contact: Leslie Williams, (614) 340-2338 DRUG DELIVERY TECHNOLOGIES Vyteris, Inc. 13-01 Pollitt Drive Fair Lawn, NJ 07410 Phone: (201) 703-2299 www.vyteris.com Current Technologies/Platforms: Application(s): Current Partner(s): Active Transdermal Systems Transdermal B. Braun Pipeline Technologies/Platforms: Application(s): Development stage: Lidocaine System Transdermal NDA filed on Lidocaine System Drug Delivery Technology November/December 2005 Vol 5 No 10 91 DDT Issue10 NOVEMBER05 11/5/05 10:27 AM Page 92 EXCIPIENTS, POLYMERS, LIPSOMES, LIPIDS, COATINGS EXCIPIENTS, POLYMERS, LIPSOMES, LIPIDS, COATINGS AKINA, Inc. Baxter Healthcare Corporation Business & Technology Center Route 120 & Wilson Road 1291 Cumberland Avenue, #E130 Round Lake, Illinois 60073 Phone: (800) 422-9837 Fax: (847) 948-3642 West Lafayette, IN 47906-1385 email: [email protected] Phone: (765) 464-0390 www.baxterbiopharmasolutions.com www.akinainc.com Current Technologies/Platforms: Application(s): Current Partner(s): Current Technologies/Platforms: Application(s): Current Partner(s): PROMAXX Microsphere Technology - Protein/Peptides/Organic Drugs/DNA Highly Plastic granules Fast melting tablets Samyang Corp. - Injectable Drug Delivery - Inhalable Drug Delivery See Company Contact:Pedro Salcedo, (763) 464-0390 - Ophthalmic Profile - Nasal EXCIPIENTS, POLYMERS, LIPSOMES, LIPIDS, COATINGS NANOEDGEDispersion Technology -Lyophilized Not Disclosed A.P. Pharma -Aseptic & Terminally Sterilized Parenterals 123 Saginaw Drive -Direct Homogenization Redwood City, California 94063 -Microprecipitation with Homogenization Phone: (650) 366-2626 Fax: (650) 365-6490 Contact: Tom Westerkamp (847) 270-3472 E-mail: [email protected] www.appharma.com EXCIPIENTS, POLYMERS, LIPSOMES, LIPIDS, COATINGS Camurus Current Technologies/Platforms: Application(s): Current Partner(s): Ideon Science Park, Solvegatan 41 MICROSPONGE® Topical J&J (Retin-A-Micro®), Lund, NA SE-22370 Aventis (Carac™) Sweden BIOCHRONOMER™ Parenteral Actively seeking partners Phone: +46 46 2865730 Fax: +46 46 2865739 BIOERODIMER™ Parenteral Actively seeking partners email: [email protected] ALGINATES Oral Actively seeking partners www.camurus.se Pipeline Technologies/Platforms: Application(s): Development Stage Current Technologies/Platforms: Application(s): Current Partner(s): APF112 Parenteral, Post-operative Pain Relief Cubosome(R), Hexosome(R) and Oral, Parenteral (i.v.), Topical Non-disclosed US and Eur. OSTEOARTHRITIS Parenteral, Local Anti-inflammatory Flexosome(R) LCNP companies ANTI-NAUSEA/VOMITING Parenteral, Post-chemotherapy Relief ANTI-ADHESIONS Parenteral, Post-surgical Contact: Bengt Westrin, VP Bus Dev, +46 46 2865730 Contact: Mike O’Connell, (650) 366--2626 EXCIPIENTS, POLYMERS, LIPSOMES, LIPIDS, COATINGS EXCIPIENTS, POLYMERS, LIPSOMES, LIPIDS, COATINGS Cardinal Health 14 Schoolhouse Road Aqualon Division, Hercules Incorporated Somerset, New Jersey 08873 1313 North Market Street Phone: (732) 537-6200 Fax: (732) 537-5949 Wilmington, DE 19894 email: [email protected] Phone: (800) 345-0447 www.cardinal.com/pts www.aqualon.com Current Technologies/Platforms: Application(s): Current Partner(s): Current Technologies/Platforms: Application(s): Current Partner(s): Klucel® hydroxypropylcellulose (HPC) Applications for all 4 products/technologies: Matrix Tablets All are for oral applications for functional release N/A Natrosol® hydroxyethylcellulose (HEC) solid dosage (immediate and controlled Tablet Coating N/A Aqualon® ethylcellulose (EC) release), film coatings, liquid system thickeners Drug Layering N/A Aqualon® carboxymethylcellulose (oral, topical, nasal) Fine-Particle Coating N/A (CMC) Contact: (866) 720-3148, email: [email protected] See Company Profile Contact: Richard Salzstein, PhD, Pharmaceutical Sales Manager, (302) 995-3173 EXCIPIENTS, POLYMERS, LIPSOMES, LIPIDS, COATINGS EXCIPIENTS, POLYMERS, LIPSOMES, LIPIDS, COATINGS BASF Chr. Hansen 100 Campus Drive 9015 W. Maple Street Florham Park, NJ 07932 Milwaukee, WI 53214 Phone: (800) 443-0627, Fax: (973) 245-6763 Phone: (800) 558-0802 Fax: (414) 607-5959 email: [email protected] www.chr-hansen.com www.basf.com/pharma Current Technologies/Platforms: Application(s): Current Partner(s): Current Technologies/Platforms: Application(s): Current Partner(s): Kollicoat® Coatings & Coating Systems Pigmented and clear coating systems: solid dosage forms Chroma-Tone™, Dri-Klear™, Chroma- Kollidon® Binders & disintegrants Tone™, Chroma-Kote™, Chroma- Teric™, Chroma-SRF™, Chroma- Ludipress® Direct compression aids See Company GDF™, Chroma-Seal™, Gel-Klear™ Profile ® Lutrol® & Lutrol® Micro Solubilizers Compressible excipients: Foremost solid dosage forms Lactose, Nu-Tab®, Cal-Carb®, ® Solutol® Solubilizer Pharma-Carb Cremophor® Solubilizer & emulsifier Contact: Margot Connor, VP of Sales, Human Health & Nutrition Contact: BASF Pharma Solutions, (800) 443-0627 92 Drug Delivery Technology November/December 2005 Vol 5 No 10 DDT Issue10 NOVEMBER05 11/5/05 10:27 AM Page 93 EXCIPIENTS, POLYMERS, LIPSOMES, LIPIDS, COATINGS EXIPIENTS, POLYMERS, LIPOSOMES, LIPIDS, COATINGS Colorcon Croda Inc. 415 Mayer Boulevard 300-A Columbus Circle West Point, PA 19486-0024 Edison, NJ 08837 Phone: (215) 699-7733 Phone: (732) 417-0800 Fax: (732) 417-0804 www.colorcon.com email: [email protected] www.crodausa.com Current Technologies/Platforms: Application(s): Current Partner(s): Current Technologies/Platforms: Application(s): Current Partner(s): ® Acryl-EZE® Oral, Enteric, Modified Release, Film coating Super Refined (High-purity Topical, Oral, Parenteral triglycerides) Surelease® Oral, Modified Release, Film coating Super Refined® Oleic Acid NF Topical, Oral, Transdermal (TDD) Opaglos® 2 Oral, High Gloss, complete film coating system Super Refined® PEG 300 NF, Super Topical, Oral, Parenteral Refined® PEG 400 NF, Super Refined® Opadry® II Oral, High Performance, complete film coating PEG 600 NF system Crillet HP (High purity polysorbate) Topical, Oral, Parenteral Opadry® AMB Oral, Aqueous Moisture Barrier, complete film coating system Cholesterol HP (High purity Parenteral cholesterol) ® Starch 1500 Partially Pregelatinized Maize Starch, excipient Medilan™ (Medium Grade Lanolin) Topical Contact: Donna Marano, (215) 661-2630 Crodamols (Fatty Esters) Topical, Oral, Parenteral Contact: Nigel Langley, (732) 417-0800, ext. 4281 EXCIPIENTS, POLYMERS, LIPSOMES, LIPIDS, COATINGS Corium International, Inc. EXIPIENTS, POLYMERS, LIPOSOMES, LIPIDS, COATINGS Corium Technology Group Degussa Rohm America, LLC. 2686 Middlefield Road, Suite G 2 Turner Place Redwood City, CA 94063 Piscataway, NJ 08855-0365 Phone: (650) 298-8255 Phone: (732) 981-5383 www.coriumtech.com www.rohmamerica.com Current Technologies/Platforms: Application(s): Current Partner(s): Current Technologies/Platforms: Application(s): Current Partner(s): CORPLEX™ Hydrogel Wound care, device, diagnostic, mucosal, Pharmaceutical Co., Wound transmucosal, dermal, transdermal Care Co., Generic Rx Co., EUDRAGIT L30D-55 Oral (Enteric Drug Delivery) Cosmetic Co., Oral Care Co., Device Co. EUDRAGIT L100-55 Oral (Enteric Drug Delivery) Contact: Gary Cleary, PhD - President, CTO, (650) 298-8255, email: [email protected] EUDRAGIT L-100 Oral (Enteric Drug Delivery) EXCIPIENTS, POLYMERS, LIPSOMES, LIPIDS, COATINGS EUDRAGIT S-100 Oral (Colonic Drug Delivery) CP Kelco EUDRAGIT EPO Oral (Immediate Release Coatings) 8355 Aero Drive San Diego, CA 92123 EUDRAGIT E-100 Oral (Immediate Release Coatings) Phone: (858) 292-4900 Fax: (858) 292-4901 email: [email protected] EUDRAGIT RL30-D Oral (Sustained Release Coatings) See Company www.cpkelco.com EUDRAGIT RS30-D Oral (Sustained Release Coatings) Profile Current Technologies/Platforms: Application(s): Current Partner(s): EUDRAGIT RL-100 Oral (Sustained Release Coatings) KELTROL® Xanthan gum Encapsulation EUDRAGIT RS-100 Oral (Sustained Release Coatings) XANTURAL® Xanthan gum Tablet coatings EUDRAGIT NE30-D Oral (Sustained Release Coatings) GELRITE® Gellan gum Pharmaceutical Emulsions EUDRAGIT NE40-D Oral (Sustained Release Coatings) KELCOGEL® Gellan gum Ostomy & Wound Care Products GENU® Pectin Ointments, Creams & Lotions EUDRAGIT RL/PO Oral (Matrix Sustained Release Delivery) GENU® Carrageenan EUDRAGIT RS/PO Oral (Matrix Sustained Release Delivery) ® GENU Gum Refined LBG Pipeline Technologies/Platforms: Application(s): Development Stage: NYMCEL® Carmellose Sodium Tablet Coating EUPERGIT Enzyme Immobilization Technology Pipeline Technologies/Platforms: Application(s): Development Stage: ® KELCOGEL® Gellan Gum Ophthalmic Compositions EUDRAGIT GENU® Pectin Edible Film Delivery Systems Contact: Andrew S. Honeycheck, (732) 981-5383 Pharma Polymers Contact: Anne Sinha, (858) 467-6615 EXCIPIENTS, POLYMERS, LIPSOMES, LIPIDS, COATINGS DelSite Biotechnologies, Inc. 1505 Walnut Hill Lane Irving, TX 75038 Phone: (972) 717-5009 Fax: (972) 831-1132 email: info@delsite www.delsite.com Pipeline Technologies/Platforms: Application(s): Development Stage: GelSite® Polymer Mucosal DMF GelSite® Polymer Injectable Preclinical Contact: Jean Anne Mire - Director, Business Development, (972) 650-7320, email: [email protected] Drug Delivery Technology November/December 2005 Vol 5 No 10 93 DDT Issue10 NOVEMBER05 11/5/05 10:27 AM Page 94 EXCIPIENTS, POLYMERS, LIPSOMES, LIPIDS, COATINGS EXCIPIENTS, POLYMERS, LIPSOMES, LIPIDS, COATINGS Depomed, Inc. Eastman Chemical Company 1360 O’Brien Drive 200 S. Wilcox Drive Menlo Park, CA 94025 Kingsport, TN 37662 Phone: (650) 462-5900 Phone: (800) 327-8621 www.depomedinc.com www.eastman.com Current Technologies/Platforms: Application(s): Current Partner(s): Current Technologies/Platforms: Application(s): Current Partner(s): Eastman CAP Enteric Coating Gastric Retention Diffusional Oral, Liquid, Controlled release of soluble drugs Biovail, Inc. Technology Eastman Eastacryl® 30D Acrylic Enteric Coating Coating Material Gastric Retention Erosional Oral, Constant delivery rate of insoluble drugs Technology Eastman CA-398-10 NF Sustained/Controlled Release; Taste Masking Gastric Retention Bi-Layer Oral, Controlled release of 2 drugs with different Eastman CAB-171-15-PG Sustained/Controlled Release Technology characteristics Eastman Vitamin E TPGS Absorption Enhancer, Solubilizer, Bioavailability Gastric Retention Combination Oral, Controlled release of 2 drugs Biovail, Inc. Enhancer Technology simultaneously or in sequence Contact: Carolyn Baker, (423) 229-2987 Contact: Thadd Vargas, (650) 462-5900 EXCIPIENTS, POLYMERS, LIPSOMES, LIPIDS, COATINGS EXCIPIENTS, POLYMERS, LIPSOMES, LIPIDS, COATINGS DMV International Ethypharm PO Box 13 194 Bureaux de la Colline Veghel, 5460 BA 92213 Saint-Cloud Cedex - France The Netherlands Phone: +33 1 41 12 17 20 Phone: +31 413372222 Fax: +31 413372930 www.ethypharm.com email: [email protected] www.dmv-international-pharma.com Current Technologies/Platforms: Application(s): Current Partner(s): Current Technologies/Platforms: Application(s): Current Partner(s): Spherulites® Vaccines Pharmatose® Direct compression lactose Multiparticles, Sustained Release Enhanced Absorption Forms Respitose® Inhalation lactose Contact: Bruno Delie, Senior VP - Business Development, +33 1 41 12 17 20 Primojel® Superdisintegrant Primellose® Superdisintegrant EXCIPIENTS, POLYMERS, LIPSOMES, LIPIDS, COATINGS Contact:Maaike Freriks Flamel Technologies 33 Avenue Du Drive Georges Levy EXCIPIENTS, POLYMERS, LIPSOMES, LIPIDS, COATINGS Venissieux, France 69693 Dow Chemical Company Phone: +33 472-783-434 Fax: +33 472-783-435 PO Box 1206 E-mail: [email protected] Midland, Michigan 48642 www.flamel.com Phone: (800) 447-4369 Fax: (989) 832-1465 Current Technologies/Platforms: Application(s): Current Partner(s): www.dow.com MEDUSA Parenteral Bristol-Myers Squibb & other Current Technologies/Platforms: Application(s): Current Partner(s): undisclosed partners METHOCEL® Cellulose Ethers Controlled Release Matrix Tablets, Controlled Release Coatings, Conventional Tablet Coating, MICROPUMP Oral Biovail, Merck, Servier Conventional Wet Granulation, Bulk Laxatives, GlaxoSmithKline & others Creams, Gels, and Ointments, Ophthalmic undisclosed See Company Preparations, Suspensions, Antacids Profile Pipeline Technologies/Platforms: Application(s): Development Stage ETHOCEL® Ethyl cellulose Controlled Release Coatings, Microencapsulation, Solvent-Based Coating for Barrier or Taste Masking Genvir (MICROPUMP) Oral Phase III Properties, Direct Compression Granulation, Solvent- Based Granulation Basulin (MEDUSA) Parenteral Phase I POLYOX™ Poly (Ethylene Oxide) Controlled Release Matrix Tablets, Melt Extrusion, Metformin XL (MICROPUMP) Oral Phase I Resins Creams, Gels, and Ointments, Mucosal Bioadhesives Augmentin SR (MICROPUMP) Oral Confidential Dow Polyglycols Suppositories Ace Inhibitor (MICROPUMP) Oral Confidential EXCIPIENTS, POLYMERS, LIPSOMES, LIPIDS, COATINGS Various MEDUSA & MICROPUMP Oral & Parenteral Preclinical Dow Corning Corporation Projects PO Box 0994 Midland, MI 48686 Phone: (989) 496-6000 Fax: (989) 496-6731 Contact: Federick Simonin, +33 472-783-434 email: [email protected] www.dowcorning.com Current Technologies/Platforms: Application(s): Current Partner(s): Topical Excipients Volatile excipients, fluids, blends, waxes and emulsifiers to aid the delivery of topical forms and actives See Company Profile Contact: Stacey Chapin, (989) 496-7759, email: [email protected] 94 Drug Delivery Technology November/December 2005 Vol 5 No 10 DDT Issue10 NOVEMBER05 11/5/05 10:28 AM Page 95 EXCIPIENTS, POLYMERS, LIPSOMES, LIPIDS, COATINGS EXCIPIENTS, POLYMERS, LIPSOMES, LIPIDS, COATINGS Grain Processing Corporation JRS Pharma LP 1600 Oregon Street 2981 Route 22, Suite 1 Muscatine, IA 52761 Patterson, NY 12563 Phone: (563) 264-4265 Phone: (800) 431-2457 Fax: (845) 878-3484 www.grainprocessing.com email: [email protected] Current Technologies/Platforms: Application(s): Current Partner(s): www.jrspharma.com Current Technologies/Platforms: Application(s): Current Partner(s): MALTRIN® Maltodextrins NF Aqueous Film Coating, Bulking, Carrying, Blending, Capsules, Creams & Lotions, Dry PROSOLV® SMCC Silicified Micro- High Functionality Excipients PURE-DENT® Corn Starches USP/NF Granulation, Film Forming, Liquid crystalline cellulose Pharmaceuticals, Medical Nutritionals, Soaps & PURE-COTE®, INSTANT PURE-COTE® Cleansers, Spray Drying, Tableting, Throat PRUV® Sodium Stearyl Fumarate Lubricant Modified Starches Lozenges, Wet Granulation EXPLOTAB® Sodium Starch Glycolate Superdisintegrant Spress® Pregelatinized Starches NF VIVASTAR® Sodium Starch Glycolate Superdisintegrant WATER LOCK® Superabsorbent Polymers EMCOCEL® Microcrystalline Cellulose Tablet Binder VIVAPUR® Microcrystalline Cellulose Tablet Binder Contact: Bob Bahn, (563) 264-4281 LUBRITAB® Hydrogenated Vegetable Tablet Lubricant EXCIPIENTS, POLYMERS, LIPSOMES, LIPIDS, COATINGS Oil Huber Engineered Materials, part of J.M. Huber Corporation Contact: Renee Mill, (845) 878-8390 907 Revolution Street Havre de Grace, Maryland 21078 EXCIPIENTS, POLYMERS, LIPSOMES, LIPIDS, COATINGS Phone: (866) 881-6480 Fax: (410) 939-7313 Lipoxen Technologies Ltd. email: [email protected] Suite 303, Hamilton House, Mabledon Place www.rxcipients.com London, England WC1H 9BB Phone: ++44(0)20 7753 5822 Fax: +44(0)20 7753 5820 Current Technologies/Platforms: Application(s): Current Partner(s): www.lipoxen.com RxCIPIENTS™ FM1000 Fast dissolve oral dosage tablets Current Technologies/Platforms: Application(s): Current Partner(s): ® Hubersorb calcium silicate Carrier Lipoxen’s proprietary drug delivery Please see website Please see website technologies employ POLYSIALIC ® Zeopharm silica Glidant ACIDS (a natural biodegradable Contact: Mike Carpenter polymer found in the body and considered a next generation to PEGylation) for peptide and protein EXCIPIENTS, POLYMERS, LIPSOMES, LIPIDS, COATINGS delivery, and LIPOSOMES tailored for INEOS Fluor the delivery of vaccines and oncology The Heath, Runcorn drugs Cheshire, UK WA7 4QX Contact: Dr. Peter Laing Phone: +44 (0) 1928 51 5525 Fax: +44 (0) 1928 51 1418 email: [email protected] EXCIPIENTS, POLYMERS, LIPSOMES, LIPIDS, COATINGS www.ineosfluor.com • www.zephex.com MacroMed, Inc. Current Technologies/Platforms: Application(s): Current Partner(s): 9520 South State Street ZEPHEX 134a and ZEPHEX 227ea HFA Metered Dose Inhalers, other medical aerosols and Supply many of the World’s Sandy, Utah 84070 medical propellants devices leading MDI companies Phone: (801) 565-8561 Fax: (801) 565-8562 E-mail: [email protected] CFC11 and CFC12 medical propellants Made available to support the smooth transition www.macromed.com from CFC propelled MDIs to HFA propelled ones Current Technologies/Platforms: Application(s): Current Partner(s): Pipeline Technologies/Platforms: Application(s): Development Stage HySolv™ Oral, Parenteral Solubilizer Electrostatic effects from propellant Enhancing reproducibility and delivery of pulmonary Early research Contact: Kirk Fowers interactions with can and drug medications Contact: Tim Noakes EXCIPIENTS, POLYMERS, LIPSOMES, LIPIDS, COATINGS International Specialty Products (ISP) 1361 Alps Road Wayne, NJ 07470 Phone: (973) 628-4000 Fax: (973) 628-4117 email: [email protected] www.ispcorp.com Current Technologies/Platforms: Application(s): Current Partner(s): Advantia™ Coating Systems Oral Solids Contact: Ann Druffner Drug Delivery Technology November/December 2005 Vol 5 No 10 95 DDT Issue10 NOVEMBER05 11/5/05 10:28 AM Page 96 EXCIPIENTS, POLYMERS, LIPSOMES, LIPIDS, COATINGS EXCIPIENTS, POLYMERS, LIPSOMES, LIPIDS, COATINGS NeoPharm Inc. Particle and Coating Technologies, Inc. 150 Field Drive, Suite 195 5445 Highland Park Drive Lake Forest, IL 60045 St. Louis, MO 63110 Phone: (847) 295-8678 Fax: (847) 295-8854 Phone: (314) 535-1516 Fax: (314) 535-1514 www.neophrm.com email: [email protected] www.pctincusa.com Current Technologies/Platforms: Application(s): Current Partner(s): NeoLipid™ Technology Delivery of broad range of difficult to formulate Current Technologies/Platforms: Application(s): Current Partner(s): drugs Very viscous coatings Better barriers Burst-release coatings Delayed release NeoPhectin™ (In Vitro) Delivery of Nucleic acids (siRNA, plasmids, antisense) Pipeline Technologies/Platforms: Application(s): Development Stage: NeoPhectin-AT™ (In Vivo) Delivery of Nucleic acids (siRNA, plasmids, New barrier coatings antisense) Contact: Robert Sparks Pipeline Technologies/Platforms: Application(s): Development Stage: EXCIPIENTS, POLYMERS, LIPSOMES, LIPIDS, COATINGS NeoLipid™ Technology Easy to use Liposome-based drugs for treatment Liposome-based SN38 of Cancer (LE-SN38), SN-38 is an Paulaur Corporation active metabolite of 105 Melrich road ® Camptosar - Phase I/II Cranbury, NJ 08512 Liposome-based Paclitaxel Phone: (609) 395-8844 Fax: (609) 395-8850 (LEP-ETU) - Phase I/II email: [email protected] www.paulaur.com Liposome-based raf anti- sense (LE-rafAON) - Phase I Current Technologies/Platforms: Application(s): Current Partner(s): Sugar Spheres USP/NF Oral, Solid Dosage, Sustained, Controlled & Contact: Saif Sheikh, PhD, MBA, (847) 295-8678, x363, email: [email protected] Extended Release EXCIPIENTS, POLYMERS, LIPSOMES, LIPIDS, COATINGS DURO-TAB® Direct Compacting & Tableting Sugar Noveon, Inc. 9911 Brecksville Road MEGATAB® Direct Compacting & Tableting Sucrose Cleveland, OH 44141 MEGADEX® Direct Compacting & Tableting Dextrose Phone: (216) 447-5000 www.pharma.noveon.com Contact: Alex Martello Current Technologies/Platforms: Application(s): Current Partner(s): EXCIPIENTS, POLYMERS, LIPSOMES, LIPIDS, COATINGS Carbobol® Polymers Controlled release solid dosage forms (tabs, caps); topical lotions, creams and gels PIL 117-B Docks Corner Road Pemulen® Polymeric Emulsifiers Topical lotions, creams and gels Dayton, New Jersey 08810 Noveon® Polycarbophils Bioadhesion in vaginal, buccal and ophthalmic Phone: (732) 438-1111 Fax: (732) 438-1414 applications; taste masking E-mail: [email protected] Current Technologies/Platforms: Application(s): Current Partner(s): EXCIPIENTS, POLYMERS, LIPSOMES, LIPIDS, COATINGS EFFERVES Quick-Dissolve/Effervescent Tablets Development Octoplus DCP-GRAN Excipient, Oral Zernikedreef 12 PUREMAG (MAG Oxide USP) Oral, Tablets 2333 CL Leiden Netherlands Calcium Sulfate (TERALBA) Excipient, Oal Phone: +31 71 5244044 Fax: +31 71 5244043 Calcium Carbonate Excipient, Oral Calcium Citrate Excipient, Oral email: [email protected] www.octoplus.nl Contact: R. Parvez Pipeline Technologies/Platforms: Application(s): Developments: EXIPIENTS, POLYMERS, LIPOSOMES, LIPIDS, COATINGS Biodegradable polymer-based drug Microspheres and liposomes for controlled Pharmaceutical and biotech PURAC America, Inc delivery technologies parenteral release companies worldwide 111 Barclay Boulevard Lincolnshire, IL 60069 Advanced formulation technologies Pharmaceutical development of biopharmaceuticals Pharmaceutical and biotech and low soluble compounds companies worldwide Phone: (847) 634-6330 Fax: (847) 1992 email: [email protected] Contact:Dr. Henrik Luessen, Director Business Development www.purac.com EXCIPIENTS, POLYMERS, LIPSOMES, LIPIDS, COATINGS Current Technologies/Platforms: Application(s): Current Partner(s): OSG Norwich Pharmaceuticals, Inc. PURAC® Oral PURASAL® Parenteral 6826 State Highway 12 PURASORB® (Biodegradable Polymers) Parenteral, Implants, Microspheres Norwich, NY 13815 Phone: (607) 335-3000 Fax: (607) 335-3100 Contact:Claudia Bratrude email: [email protected] www.norwichpharma.com Current Technologies/Platforms: Application(s): Current Partner(s): Aqueous and solvent tablet coating Tablets Numerous Contact: Bob Calabro 96 Drug Delivery Technology November/December 2005 Vol 5 No 10 DDT Issue10 NOVEMBER05 11/5/05 10:28 AM Page 97 EXCIPIENTS, POLYMERS, LIPSOMES, LIPIDS, COATINGS EXCIPIENTS, POLYMERS, LIPSOMES, LIPIDS, COATINGS SAFC Stepan Company 3050 Spruce Street 100 West Hunter Avenue St. Louis, MO 63103 Maywood, NJ 07607 Phone: (800) 244-1173 (314-534-4900) Fax: (800) 368-4661 (314-652-0000) Phone: (201) 712-7642 Fax: (201) 712-7648 email: [email protected] email: [email protected] www.safcglobal.com www.stepan.com Current Technologies/Platforms: Application(s): Current Partner(s): Current Technologies/Platforms: Application(s): Current Partner(s): Polyamino Acids Carrier/excipient NEOBEE® Medium Chain Solvent, carrier Lipids Liposomes Triglycerides Liposomes Carrier/excipient Tween 20/80 GMP,Low Peroxide Detergent/surfactant WECOBEE® Triglycerides Suppository base Synthetic Cholesterol Emulsifier/liposomes Keyhole limpet hemocyanin (KLH) Carrier/adjuvant Contact: James M. Butterwick Pipeline Technologies/Platforms: Application(s): Development Stage: EXCIPIENTS, POLYMERS, LIPSOMES, LIPIDS, COATINGS PEGylation Stability, solubility Prototype Texmac Inc. Conjugation 3001 Stafford Drive Contact: Tom Gelineau, (314) 301-2077, email: [email protected] Charlotte, NC 28208 EXCIPIENTS, POLYMERS, LIPSOMES, LIPIDS, COATINGS Phone: (704) 393-6555 Fax: (704) 392-1621 email: [email protected] SPI Pharma www.texmac.com 321 Cherry Lane New Castle, Delaware 19720 Current Technologies/Platforms: Application(s): Current Partner(s): Phone: (302) 576-8500 x 8554 Micro-/Nan particle surface coating, Drug delivery, cosmetics Nara Machinery Fax: (302) 576-8567 modification www.spipharma.com Contact: James M. Butterwick Current Technologies/Platforms: Application(s): Current Partner(s): Mannogem™ EZ, 2080, Granular, Solid Oral Dose Rx, OTC Nutraceutical Powder Advantose™ 100 Spray-dried Solid Oral Dose Rx, OTC Maltose Sorbogem™ Sorbitol Special Soft Gelatin Capsules Rx, OTC Nutraceutical Barcroft™ CS-90 Spray-dried Solid Oral Dose Rx, OTC Nutraceutical Calcium Barcroft™ MS-90 Spray-dried Solid Oral Dose Rx, OTC Nutraceutical Magnesium Contact: Ellen London Drug Delivery Technology November/December 2005 Vol 5 No 10 97 DDT Issue10 NOVEMBER05 11/5/05 10:28 AM Page 98 CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES AKINA, Inc. Business & Technology Center 3M Drug Delivery Systems 1291 Cumberland Avenue, #E130 3M Center, Bldg. 275-3E-10 West Lafayette, IN 47906-1385 See Company St. Paul, Minnesota 55144-1000 Profile Phone: (765) 464-0390 Phone: (800) 643-8086 Fax: (651) 737-5265 www.akinainc.com www.3m.com/dds Please check the categories in which your company provides the service. Please check the categories in which your company provides the service. ❏ Drug Discovery ❏ Analytical Development ❏✔Formulation Development ❏ Stability Testing ❏ ❏✔✔❏ ❏ Drug Discovery Analytical Development Formulation Development Stability Testing ❏ Clinical Trial MFG/Scale-up ❏✔Technology/Transfer ❏ Manufacturing ❏ Packaging ❏✔ ❏✔ ❏✔✔❏ Clinical Trial MFG/Scale-up Technology/Transfer Manufacturing Packaging ❏ Other: ❏✔ Laboratory Testing ❏ Current Partnerships: Samyang Corporation, Immusol ❏ Other: Contact: Kinan Park, PhD, (765) 464-0390 Contact: www.3m.com/dds CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES AAI Development Services Alcoa Flexible Packaging 2320 Scientific Park Drive 6603 West Broad Street Wilmington, NC 28405 Richmond, VA 23230 Phone: (800) 575-4224 or (910) 254-7000 Phone: (804) 281-2603 Fax: (804) 281-2238 Fax: (910) 815-2300 www.alcoa.com www.aaidevelopment.com Please check the categories in which your company provides the service. Please check the categories in which your company provides the service. ❏ ❏ ❏ ❏ ❏ Drug Discovery ❏✔✔Analytical Development ❏ Formulation Development ❏ ✔Stability Testing Drug Discovery Analytical Development Formulation Development Stability Testing ❏ ❏ ❏ ❏✔ ❏✔ Clinical Trial MFG/Scale-up ❏✔✔Technology/Transfer ❏ Manufacturing ❏ ✔Packaging Clinical Trial MFG/Scale-up Technology/Transfer Manufacturing Packaging ❏✔ Other: Regulatory Affairs Services, Clinical Trials Services, Bioanalytical Services, Pharmaceutics Services Contact: Victoria C. Welch, (804) 281-2262 Contact: email: [email protected] CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES American Peptide Company, Inc. ABC Laboratories, Inc. 777 East Evelyn Avenue 7200 East ABC Lane Sunnyvale, CA 94086 Columbia, MO 65202 Phone: (408) 733-7604, x204 Phone: (573) 443-9000 Fax: (573) 443-9033 www.americanpeptide.com email: [email protected] www.abclabs.com Please check the categories in which your company provides the service. Please check the categories in which your company provides the service. ❏ Drug Discovery ❏ Analytical Development ❏ Formulation Development ❏ Stability Testing ❏ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏✔Manufacturing ❏ Packaging ❏✔Drug Discovery ❏✔✔Analytical Development ❏ Formulation Development ❏ Stability Testing ❏✔ Other: Peptides, cGMP, Process Development ❏ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏ Manufacturing ❏ Packaging Contact: Nancy Berrey Contact: Gary Hu, (800) 926-8272, ext. 204 CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Advion BioSciences 15 Catherwood Road assa international Inc Ithaca, New York 14850 3B East Lake Road Phone: (607) 266-0665 Fax: (607) 266-0749 Danbury, CT 06811 email: [email protected] Phone: (203) 312-0682 Fax: (203) 312-0722 www.advion.com email: [email protected] www.assainternational.com Please check the categories in which your company provides the service. Please check the categories in which your company provides the service. ❏ Drug Discovery ❏ Analytical Development ❏ Formulation Development ❏ Stability Testing ❏ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏ Manufacturing ❏ Packaging ❏ Drug Discovery ❏ Analytical Development ❏ Formulation Development ❏ Stability Testing ❏✔ Analytical Testing & Analysis ❏ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏ Manufacturing ❏ Packaging ❏✔ Other: LC/MS Bioanalytical Services; Sample Management Services ✔❏ Other: Education & Training: assainternational® is a training and consulting company specialized on pharmaceutical applications of solid- state analytical techniques. Specifically, assa: Contact: Gaye Martin • organizes in-depth International Workshops and Conferences on Solid State Characterization in the Pharmaceutical area. • offers specialized courses for pharmaceutical applications on Polymorph Screening, X-Ray Powder Diffraction, Near IR and Terahertz Spectroscopy, and Patent related issues. • Also offers a wide range of Analytical Services for Pharmaceutical Solid State problems, including four Polymorph Screening programs. We are available for Expert Witness services. Contact:Dr. Angeline Zakrzewski, email: [email protected] 203-312-0682 98 Drug Delivery Technology November/December 2005 Vol 5 No 10 DDT Issue10 NOVEMBER05 11/5/05 10:28 AM Page 99 CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Azopharma, Contract Pharmaceutical Services Bioserv Corporation 10320 USA Today Way 5340 Eastgate Mall Miramar, FL 33025 San Diego, California 92121 Phone: (954) 433-7480 Fax: (954) 432-9015 Phone: (858) 450-34123 Fax: (858) 450-0785 email: [email protected] email: [email protected] www.azopharma.com www.bioservcorp.com Please check the categories in which your company provides the service. Please check the categories in which your company provides the service. ❏ Drug Discovery ❏✔Analytical Development ❏✔ Formulation Development ❏✔ Stability Testing ❏ Drug Discovery ❏ Analytical Development ❏ Formulation Development ❏ Stability Testing ✔ ❏ Clinical Trial MFG/Scale-up ❏✔Technology/Transfer ❏ Manufacturing ❏ Packaging ❏✔ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏✔✔Manufacturing ❏ Packaging ❏✔ Laboratory Testing ❏ Analytical Testing & Analysis ❏ Process Development ❏✔ Other: Characterization Services, Synthesis, Preformulation ❏✔ Other: Lyphilization Contact:David Greeley, VP Sales and Marketing Contact: Lee Starr, (858) 450-4676 CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES BASF CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES 100 Campus Drive Biovail Contract Research Florham Park, NJ 07932 460 Comstock Road Toronto, Ontario, Canada MIL4S4 Phone: (800) 443-0627, Fax: (973) 245-6763 Phone: (416) 752-3636 Fax: (416) 752-7610 See Company email: [email protected] Profile email: [email protected] www.basf.com/pharma www.biovail-cro.com Please check the categories in which your company provides the service. Please check the categories in which your company provides the service. ❏ Drug Discovery ❏ Analytical Development ❏ Formulation Development ❏ Stability Testing ❏ Drug Discovery ❏ Analytical Development ❏ Formulation Development ❏✔ Stability Testing ❏ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏✔✔Manufacturing ❏ Packaging ❏ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏ Manufacturing ❏ Packaging ❏ ❏ Other: Solid and semi-solid dosage form contract manufacturing Laboratory Testing ❏✔ Contact: BASF Pharma, (800) 443-0627 Other: Clinical Trials & Bioanalysis, Analytical Testing & Analysis Contact:Tamar Aghamanoukian, Director, Marketing & Sales CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Baxter Pharmaceutical Solutions LLC CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES 927 South Curry Pike Calorimetry Sciences Corporation Bloomington, Indiana 47403 890 West 410 North, Suite A Phone: (800) 353-0887 Fax: (812) 332-3079 Lindon, UT 84042 email: [email protected] Phone: (801) 763-1500 Fax: (801) 763-1414 email: [email protected] www.baxterbiopharmasolutions.com www.calorimetrysciences.com Please check the categories in which your company provides the service. Please check the categories in which your company provides the service. ❏ Drug Discovery ❏✔Analytical Development ❏✔✔Formulation Development ❏ Stability Testing ❏ Drug Discovery ❏ Analytical Development ❏ Formulation Development ❏✔ Stability Testing ❏✔ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏✔✔Manufacturing ❏ Packaging ❏ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏ Manufacturing ❏ Packaging ❏✔ Other: Pre-filled syringes, vials, lyophilization & cartridges ❏ Laboratory Testing See Company Contact:Ryan Akers, (812) 355-7136 Profile Contact:Peter Zumbrennen CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Bespak, Inc. Cardinal Health 2450 Laura Duncan Road 14 Schoolhouse Road Apex, North Carolina 27523 Somerset, New Jersey 08873 Phone: (919) 387-0112 Fax: (919) 387-1241 Phone: (732) 537-6200 Fax: (732) 537-5949 email: [email protected] email: [email protected] www.bespak.com www.cardinal.com/pts Please check the categories in which your company provides the service. Please check the categories in which your company provides the service. ❏ Drug Discovery ❏✔✔Analytical Development ❏ Formulation Development ❏ ✔Stability Testing ❏ Drug Discovery ❏✔Analytical Development ❏✔ Formulation Development ❏ Stability Testing ✔❏ Clinical Trial MFG/Scale-up ❏✔✔Technology/Transfer ❏ Manufacturing ❏ ✔Packaging ❏✔ Clinical Trial MFG/Scale-up ❏✔ Technology/Transfer ❏✔✔Manufacturing ❏ Packaging ❏✔ Analytical Testing & Analysis ❏✔Process Development ❏✔ Other: Device and Manufacturing Service: Design, Development, Molding and Assembly of Drug Delivery Devices (eg ❏✔ Respiratory, Diagnostic disposables, Needle free injection, Safety needle) Other: Product Launch Services, Medical Education, Post-Launch Services See Company Profile Contact: Robert Swann Contact: (866) 720-3148 Drug Delivery Technology November/December 2005 Vol 5 No 10 99 DDT Issue10 NOVEMBER05 11/5/05 10:28 AM Page 100 CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Capsugel Chr. Hansen 535 North Emerald Road 9015 W. Maple Street Greenwood, SC 29646 Milwaukee, WI 53214 Phone: (888) 783-6361 Fax: (888) 783-6360 Phone: (800) 558-0802 Fax: (414) 607-5959 email: [email protected] email: [email protected] www.capsugel.com www.chr-hansen.com Please check the categories in which your company provides the service. Please check the categories in which your company provides the service. ❏ Drug Discovery ❏ Analytical Development ❏✔ Formulation Development ❏ Stability Testing ❏ Drug Discovery ❏ Analytical Development ❏✔ Formulation Development ❏ Stability Testing ❏✔ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏ Manufacturing ❏ Packaging ❏ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏ Manufacturing ❏ Packaging ❏ Analytical Testing & Analysis ❏ Laboratory Testing ❏✔ Other: Supplies probiotics (capsules, tablets and powders), phytonutrients, colors, flavors and maskants Contact: Glenda Oliver-Smith Contact: Margot Connor, VP of Sales, Human Health & Nutrition CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Celsion Corporation 10220-L Old Columbia Road Ciba® Expert Services Columbia, MD 21046 540 White Plains Road Phone: (410) 290-5390 Fax: (410) 290-5394 Tarrytown, NY 10591 email: [email protected] Phone: (914) 785-2533 Fax: (914) 785-4241 www.celsion.com email: [email protected] www.cibasc.com/cxs Please check the categories in which your company provides the service. Please check the categories in which your company provides the service. ❏ Drug Discovery ❏ Analytical Development ❏ Formulation Development ❏ Stability Testing ❏ Drug Discovery ❏✔Analytical Development ❏ Formulation Development ❏ Stability Testing ❏ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏ Manufacturing ❏ Packaging ❏ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏ Manufacturing ❏ Packaging ❏ Analytical Testing & Analysis ❏ Process Development ✔❏ Other: Leachables and Extractables Analysis, Quality Management, Life Cycle Consultation, EH&S testing and Consulting ❏✔ Other: Cancer Drug Development Contact: Miles Hutchings and Dean Hamel Contact: Anthony P. Deasey, EVP & COO, (410) 290-5390 x4899 CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Cirrus Pharmaceuticals, Inc. Center for Advanced Drug Development P.O. Box 14748 100 Oakdale Campus Room 1 PRL Research Triangle Park, NC 27709-4748 Iowa City, Iowa 52242-5000 Phone: (919) 884-2064 Fax: (919)884-2075 Phone: (319) 335-4096 Fax: (319) 335-4374 email: [email protected] email: [email protected] www.cirruspharm.com www.pharmacy.uiowa.edu/rxserve/index.htm Please check the categories in which your company provides the service. ❏ Drug Discovery ❏✔✔Analytical Development ❏ Formulation Development ❏✔ Stability Testing Please check the categories in which your company provides the service. ❏✔ Clinical Trial MFG/Scale-up ❏✔Technology/Transfer ❏ Manufacturing ❏ Packaging ❏✔ ❏ Drug Discovery ❏✔Analytical Development ❏✔Formulation Development ❏✔ Stability Testing Laboratory Testing ❏✔ Other: Physical & Chemical Characterization, Particle Size Analysis, Fine Particle Generation, Analytical Method ❏✔ Clinical Trial MFG/Scale-up ❏✔Technology/Transfer ❏✔ Manufacturing ❏ Packaging Development & Validation ❏✔ Other: Method development and validation according to ICH guidelines, development of dissolution procedures and Contact: Jean-Marc Bovet validation of the analytical method, pre-formulation, development of formulations, API, excipient and drug product testing according to official monographs. CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Contact: Dr. Alta Botha Coating Place, Inc. 200 Paoli Street, PO Box 930310 CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Verona, WI 53593 Cerilliant Corporation Phone: (608) 845-9521 811 Paloma Drive www.encap.com Round Rock, Texas 78664 Phone: (800) 848-7837 Fax: (800) 654-1458 Please check the categories in which your company provides the service. email: [email protected] ❏ ❏✔✔❏ ❏✔ www.cerilliant.com Drug Discovery Analytical Development Formulation Development Stability Testing ❏✔ Clinical Trial MFG/Scale-up ❏✔✔Technology/Transfer ❏ Manufacturing ❏ Packaging Please check the categories in which your company provides the service. ❏✔ Other: ❏ Drug Discovery ❏✔Analytical Development ❏ Formulation Development ❏✔ Stability Testing Contact:Fred Schulze, (817) 477-2766 ❏✔ Clinical Trial MFG/Scale-up ❏✔Technology/Transfer ❏✔ Manufacturing ❏✔ Packaging ❏✔ Analytical Testing & Analysis ❏✔Process Development CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Corium International, Inc. Contact: Debbie Palmon, Account Manager/Tradeshow Coordinator Corium Manufacturing Group 4558 50th Street Grand Rapids, MI 49512 Phone: (616) 656-4563 www.coriumgroup.com Please check the categories in which your company provides the service. ❏ Drug Discovery ❏✔✔Analytical Development ❏ Formulation Development ❏ ✔Stability Testing ❏ Clinical Trial MFG/Scale-up ❏✔Technology/Transfer ❏✔✔Manufacturing ❏ Packaging ❏✔ Other: (Co-Development, Contract Development, Prdt Dev Partnerships, Product Re-engineering) ❏✔ Current Partnerships: Pharmaceutical Co., Wound Care Co., Generic Rx Co., Cosmetic Co., Oral Care Co., Device Co. Contact: Deb Fox, VP Business Development, (616) 656-4563 100 Drug Delivery Technology November/December 2005 Vol 5 No 10 DDT Issue10 NOVEMBER05 11/5/05 10:29 AM Page 101 CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Covance Laboratories DelSite Biotechnologies, Inc. 3301 Kinsman Blvd. Otley Road 1505 Walnut Hill Lane Madison, WI 53704 Harrogate, North Yorkshire, UK Irving, TX 75038 HG3 1PY Phone: (972) 717-5009 Fax: (972) 831-1132 Phone: (888) COVANCE Fax: (608) 241-7227 email: info@delsite email: [email protected] www.delsite.com www.covance.com Please check the categories in which your company provides the service. Please check the categories in which your company provides the service. ❏✔ Drug Discovery ❏✔Analytical Development ❏ Formulation Development ❏✔ Stability Testing ❏ Drug Discovery ❏✔Analytical Development ❏✔✔Formulation Development ❏ Stability Testing ❏ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏ Manufacturing ❏ Packaging ❏ Clinical Trial MFG/Scale-up ❏✔Technology/Transfer ❏ Manufacturing ❏ Packaging ❏ Analytical Testing & Analysis ❏ Process Development ❏ Other: CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Contact: Jean Anne Mire, (972) 650-7320, email: [email protected] CP Kelco 8355 Aero Drive CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES San Diego, CA 92123 Depomed, Inc. Phone: (858) 292-4900 Fax: (858) 292-4901 1360 O’Brien Drive email: [email protected] Menlo Park, CA 94025 www.cpkelco.com Phone: (650) 462-5900 Please check the categories in which your company provides the service. www.depomedinc.com ❏ Drug Discovery ❏ Analytical Development ❏ Formulation Development ❏ Stability Testing Please check the categories in which your company provides the service. ❏ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏ Manufacturing ❏ Packaging ✔ ❏✔ Other: Fermentation Capability ❏ Drug Discovery ❏ Analytical Development ❏ Formulation Development ❏ Stability Testing ❏ Current Partnerships: ❏ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏ Manufacturing ❏ Packaging ❏ Other: Contact: Anne Sinha, (858) 467-6615 ❏✔ Current Partnerships: Biovail, Inc., ActivBiotics, AVI Biopharma CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Contact: Thadd Vargas, (650) 462-5900 CyDex, Inc. 10513 West 84th Terrace CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Lenexa, KS 66214 Dowpharma Phone: (913) 685-8850 Fax: (913) 685-8856 574 Building email: [email protected] Midland, MI 48667 www.cydexinc.com Phone: NA (866) 332-5805; EU 44-1223-728048 Fax: (989) 636-0986 email: [email protected] See Company Please check the categories in which your company provides the service. www.dowpharm.com Profile Please check the categories in which your company provides the service. ❏ Drug Discovery ❏ Analytical Development ❏✔ Formulation Development ❏ Stability Testing ❏ Drug Discovery ❏✔Analytical Development ❏✔✔Formulation Development ❏ Stability Testing ❏ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏ Manufacturing ❏ Packaging ❏✔ Clinical Trial MFG/Scale-up ❏✔Technology/Transfer ❏ Manufacturing ❏ Packaging ❏ Other: Contact: [email protected] CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES DeDietrich Process Systems, Inc. P.O. Box 345 / 2333 US Highway 22, W Dow Pharmaceutical Sciences Union, NJ 07083 1330 Redwood Way Phone: (908) 686-4900 Fax: (908) 686-8340 Petaluma, CA 94954 email: [email protected] Phone: (707) 793-2600 Fax: (707) 793-0145 www.ddpsinc.com www.dowpharmsci.com Please check the categories in which your company provides the service. Please check the categories in which your company provides the service. ❏ Drug Discovery ❏✔✔Analytical Development ❏ Formulation Development ❏ ✔Stability Testing ❏ Drug Discovery ❏ Analytical Development ❏ Formulation Development ❏ Stability Testing ❏✔ Clinical Trial MFG/Scale-up ❏✔Technology/Transfer ❏ Manufacturing ❏✔Packaging ❏ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏✔Manufacturing ❏ Packaging ❏✔ Other: Topical Product Development Dermatology for dermatologicals, ophthalmics, vaginals, otics, nasals, and orals; ❏ Other: Skin Permeation; and Dermatology Clinical Trial Sites Contact: Jennifer Kubiak Contact: Steve Smith, VP Marketing & Business Development (707) 793-2600 CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Degussa Rohm America, LLC. 2 Turner Place Piscataway, NJ 08855-0365 Phone: (732) 981-5383 www.rohmamerica.com Please check the categories in which your company provides the service. ❏ Drug Discovery ❏ Analytical Development ❏✔Formulation Development ❏ Stability Testing ❏ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏ Manufacturing ❏ Packaging ❏ Other: ® See Company EUDRAGIT Contact:Dr. Ketan Mehta, (732) 981-5366 Profile Pharma Polymers Drug Delivery Technology November/December 2005 Vol 5 No 10 101 DDT Issue10 NOVEMBER05 11/5/05 10:29 AM Page 102 CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES DPT Facet Technologies 318 McCullough 1850 Parkway Place, Suite 900 San Antonio, Texas 78215 Marietta, GA 30067 Phone: (210) 476-8159 Fax: (210) 829-8733 Phone: (770) 767-8344 Fax: (770) 767-7320 email: [email protected] email: [email protected] www.dptlabs.com www.facettechnologies.com Please check the categories in which your company provides the service. Please check the categories in which your company provides the service. ❏✔ Drug Discovery ❏✔Analytical Development ❏✔ Formulation Development ❏✔Stability Testing ❏ Drug Discovery ❏ Analytical Development ❏ Formulation Development ❏ Stability Testing ❏✔ Clinical Trial MFG/Scale-up ❏✔Technology/Transfer ✔❏ Manufacturing ❏✔ Packaging ❏ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏ Manufacturing ❏ Packaging ny ✔ ✔ ompa ❏ Analytical Testing & Analysis ❏ Process Development ❏ Analytical Testing & Analysis ❏ Process Development See C rofile See Company P ❏✔ Profile Contact:Paul Josephs Other: Dosage Device Development and Mfg. Contact: Michael Flater CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Elan Drug Technologies Ferris Pharmaceuticals Inc. Monksland 16W300 83rd Street Athlone, Co Westmeath, Ireland Burr Ridge, IL 60527-5848 Phone: +353 90 64 95000 Fax: +353 90 64 95807 Phone: (630) 734-7810 Fax: (630) 887-1008 www.elan.com/EDT email: [email protected] www.FerrisCares.com Please check the categories in which your company provides the service. Please check the categories in which your company provides the service. ❏ Drug Discovery ❏✔Analytical Development ❏✔ Formulation Development ❏✔ Stability Testing ❏ Drug Discovery ❏ Analytical Development ❏✔ Formulation Development ❏ Stability Testing ❏✔ Clinical Trial MFG/Scale-up ❏✔✔Technology/Transfer ❏ Manufacturing ❏ ✔Packaging ❏✔ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏✔✔Manufacturing ❏ Packaging ❏ Laboratory Testing ❏✔ Other: Transdermal and mucosal patches/pads/inserts, with/without adhesive. Materials added to foam or gel Contact: Sarah Carty, Associate Director, European Business Development, +353 1 7094046 formulas without heat/shear degradation. Quality system accredited to international requirements. CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Contact: Paul Kay E.I. DuPont de Nemours Company CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES DuPont Fluorochemicals, Chestnut Run Plaza Wilmington, DE 19880-0711 Filtertek Inc. Phone: +1-302-224-0426 Fax: +1-302-224-0427 11411 Price Road www.dupont.com/dymel Hebron, IL 60034 Phone: (800) 648-0791 Fax: (815) 648-2929 Please check the categories in which your company provides the service. www.filtertek.com ❏ Drug Discovery ❏ Analytical Development ❏ Formulation Development ❏ Stability Testing Please check the categories in which your company provides the service. ❏ Clinical Trial MFG/Scale-up ❏✔Technology/Transfer ❏✔✔Manufacturing ❏ Packaging ❏ ❏ ❏ ❏✔ ❏✔ Laboratory Testing Drug Discovery Analytical Development Formulation Development Stability Testing ❏ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏ Manufacturing ❏ Packaging Contact: Mr. Joseph Creazzo, Technical Service Manager, email: [email protected] ❏ Other: See Company Profile CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Contact: Bruce Daniels, VP Medical Marketing Emerson Resources, Inc. 600 Markley Street CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Norristown, PA 19401 Flamel Technologies S.A. Phone: (610) 279-7450 Fax: (610) 292-9722 Parc Club Du Moulin á Vent email: [email protected] 33, Avenue du Docteur Georges Lévy www.emersonresources.com 69693 Vénissieux Cedex - France Phone: (+33) 472-783-434 Fax: (+33) 472-783-435 Please check the categories in which your company provides the service. email: [email protected] / website: www.flamel.com ❏ Drug Discovery ❏✔✔Analytical Development ❏ Formulation Development ❏ ✔Stability Testing ✔ ✔ y ❏ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏ Manufacturing ompan ❏ Packaging Please check the categories in which your company provides the service. See C Profile Contact:Walter Strathy ❏ Drug Discovery ❏✔✔Analytical Development ❏ Formulation Development ❏ Stability Testing ❏ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏✔Manufacturing ❏ Packaging CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES ❏✔ Process Development Eurand, Inc. ❏✔ Other: Drug Delivery 845 Center Drive Current Partnerships: Biovail (Genvir), Bristol-Myers Squibb (Basulin), GlaxoSmithKline (2 Products), Vandalia, OH 45377 Merck & Co. (1 Product), Servier (Ace Inhibitor) Phone: (937) 898-9669 Fax: (937) 898-1093 Contact:Frederick Simonin, (+33) 472-783-434 email: [email protected] www.eurand.com CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES See Company Profile Fluid Air, Inc. Please check the categories in which your company provides the service. 2550 White Oak Circle SAurora, Illinois 60504 ❏ Drug Discovery ❏✔Analytical Development ❏✔ Formulation Development ❏✔Stability Testing Phone: (630) 851-1200 Fax: (630) 851-1244 ❏✔ Clinical Trial MFG/Scale-up ❏✔Technology/Transfer ❏✔ Manufacturing ❏ Packaging E-mail: [email protected] Website: pharmproservices.com Please check the categories in which your company provides the service. ❏ Drug Discovery ❏ Analytical Development ❏✔ Formulation Development ❏ Stability Testing ❏✔ Clinical Trial MFG/Scale-up ❏✔Technology/Transfer ❏✔ Manufacturing ❏ Packaging ❏ Analytical Testing & Analysis ❏✔Process Development 102 Drug Delivery Technology November/December 2005 Vol 5 No 10 DDT Issue10 NOVEMBER05 11/5/05 10:29 AM Page 103 CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Generex Biotechnology Corporation Hovione 33 Harbour Square, Suite 202 Sete Casas Toronto, ON, Canada M5J 2G2 2674-506 Loures Phone: (416) 364-2251 Fax: (416) 364-9363 Portugal email: [email protected] See Company Phone: + 351 219 829 000 Fax: + 351 219 829 388 Profile www.generex.com email: [email protected] Please check the categories in which your company provides the service. www.hovione.com ❏ Drug Discovery ❏ Analytical Development ❏✔Formulation Development ❏ Stability Testing Please check the categories in which your company provides the service. ❏ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏✔Manufacturing ❏ Packaging ❏ Drug Discovery ❏ Analytical Development ❏ Formulation Development ❏✔ Stability Testing ❏✔ Other: Drug delivery feasibility studies using RapidMist™ ❏✔ Clinical Trial MFG/Scale-up ❏✔Technology/Transfer ❏✔Manufacturing ❏ Packaging Contact:Fabio Chianelli, Business Development, (416) 364-2551 x 240, email: [email protected] CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Hospira, Inc. One 2 One Glatt Pharmaceutical Services D988, H1 275 North Field Drive 20 Spear Road Lake Forest, IL 60045 Ramsey, NJ 07446 Phone: (224) 212-2267 Fax: (224) 212-3210 Phone: (201) 825-8700 email: [email protected] www.glattpharmaceuticals.com www.hospira.com Please check the categories in which your company provides the service. Please check the categories in which your company provides the service. ❏ ❏ ❏ ❏ ❏ Drug Discovery ❏✔✔Analytical Development ❏ Formulation Development ❏ ✔Stability Testing Drug Discovery Analytical Development Formulation Development Stability Testing ❏ ❏ ❏✔ ❏✔ ❏✔ Clinical Trial MFG/Scale-up ❏✔✔Technology/Transfer ❏ Manufacturing ❏ Packaging Clinical Trial MFG/Scale-up Technology/Transfer Manufacturing Packaging ❏ ❏ ❏ Other: Analytical Testing & Analysis Process Development See Company Profile ❏✔ Other: Parenteral manufacturing: vials, cartridges, syringes, I.V. containers and ampoules Contact: Thomas M. Salus, (201) 818-3778 Contact: Mary Lou Glotzbach CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Hauser Contract Research Organization INEOS Fluor 6880 N. Broadway, Suite H The Heath, Runcorn Denver, CO 80221 Cheshire, UK WA7 4QX Phone: (720) 406-4700 Phone: +44 (0) 1928 51 5525 Fax: +44 (0) 1928 51 1418 email: [email protected] www.hausercro.com www.ineosfluor.com • www.zephex.com Please check the categories in which your company provides the service. ❏✔ Drug Discovery ❏✔Analytical Development ❏ Formulation Development ❏✔Stability Testing Please check the categories in which your company provides the service. ❏✔ Clinical Trial MFG/Scale-up ❏✔Technology/Transfer ❏✔✔Manufacturing ❏ Packaging ❏ Drug Discovery ❏ Analytical Development ❏ Formulation Development ❏ Stability Testing ❏✔ Other: Compliance Consulting ❏ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏ Manufacturing ❏ Packaging Contact: Rod McKeever, (720) 406-4700 ❏✔ Laboratory Testing ❏✔ Other: Specliazed medical propellant testing CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Contact:Tim Noakes Hill Top Research P.O. Box 429501 CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Cincinnati, OH 45242 International Specialty Products (ISP) Phone: (800) 785-2693 Fax: (513) 831-1217 1361 Alps Road email: [email protected] Wayne, NJ 07470 Phone: (973) 628-4000 Fax: (973) 628-4117 www.hill-top.com email: [email protected] Please check the categories in which your company provides the service. www.ispcorp.com Please check the categories in which your company provides the service. ❏ Drug Discovery ❏ Analytical Development ❏ Formulation Development ❏ Stability Testing ❏ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏ Manufacturing ❏ Packaging ❏ Drug Discovery ❏ Analytical Development ❏✔ Formulation Development ❏ Stability Testing ✔ ❏ Other: Clinical Research ❏✔ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏✔ Manufacturing ❏ Packaging ❏ Contact: Bryan Reynolds Laboratory Testing CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Contact: Ann Druffner CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Honeywell Speciality Films 101 Columbia Road Intranasal Therapeutics, Inc. (formerly Intranasal Technology, Inc.) Phone: (973) 455-3588 Fax: (973) 455-2487 1513 Bull Lea Boulevard www.honeywell.com Lexington, KY 40511-1200 Phone: (859) 252-5080 Fax: (859) 252-7280 email: [email protected] Please check the categories in which your company provides the service. www.intranasal.com ❏ Drug Discovery ❏✔✔Analytical Development ❏ Formulation Development ❏ Stability Testing Please check the categories in which your company provides the service. ❏✔ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏ Manufacturing ❏✔Packaging ❏ Drug Discovery ❏ Analytical Development ❏✔ Formulation Development ❏✔ Stability Testing ❏✔ Other: Technical Support, Package Design, Package Development, Material/Structure Development, Scale-up Support, ❏✔✔Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏✔ Manufacturing ❏✔Packaging ✔Probe Stability Trials,Chemical/Mechanical Testing, Packaging Proof-of-Concept Fabrication ❏ Analytical Testing & Analysis ❏ Process Development Contact:David J. Gibboni, [email protected], (610) 446-7468 Contact: Ralph Johnston, Vice President Business Development Drug Delivery Technology November/December 2005 Vol 5 No 10 103 DDT Issue10 NOVEMBER05 11/5/05 10:29 AM Page 104 CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES JRS Pharma LP Lyophilization Technology, Inc. 2981 Route 22, Suite 1 30 Indian Drive Patterson, NY 12563 Ivyland, PA 18974 Phone: (800) 431-2457 Fax: (845) 878-3484 Phone: (215) 396-8373 Fax: (215) 396-8375 email: [email protected] email: [email protected] www.jrspharma.com www.lyotechnology.com Please check the categories in which your company provides the service. Please check the categories in which your company provides the service. ❏ Drug Discovery ❏ Analytical Development ❏✔Formulation Development ❏ Stability Testing ❏ Drug Discovery ❏ Analytical Development ❏✔Formulation Development ❏✔Stability Testing ❏ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏ Manufacturing ❏ Packaging ❏✔ Clinical Trial MFG/Scale-up ❏✔Technology/Transfer ❏ Manufacturing ❏ Packaging ❏✔ Laboratory Testing ❏✔ Other: Lyophilization, Thermal Analysis Services, Validation-Manufacturing, Development Services, Process Engineering, ❏ Other: Excipients, Binders, Disintegrants, Lubricant, High Functionality Excipient Process Optimization, Clinical Material Preparation, Finished Product Testing, Consulting, Troubleshooting, Quality and Contact: Renee Mill Regulatory Services, On-site Training CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Contact: Christine Adams Lancaster Laboratories, Inc. CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES 2425 New Holland Pike Lancaster, PA 17601 MacroMed, Inc. Phone: (717) 656-2300 Fax: (717) 656-3772 9520 South State Street email: [email protected] Sandy, Utah 84070 Phone: (801) 565-8561 Fax: (801) 565-8562 www.lancasterlabs.com email: [email protected] Please check the categories in which your company provides the service. www.macromed.com Please check the categories in which your company provides the service. ❏ Drug Discovery ❏✔Analytical Development ❏ Formulation Development ❏✔Stability Testing ❏ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏ Manufacturing ❏ Packaging ❏ Drug Discovery ❏ Analytical Development ❏✔Formulation Development ❏ Stability Testing ❏✔ Laboratory Testing ❏ Clinical Trial MFG/Scale-up ❏✔Technology/Transfer ❏ Manufacturing ❏ Packaging ❏✔ Other: Drug Delivery Contact: Doug Hostetler Contact: Alex S. Kim, Executive Vice President, (801) 565-8561 CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Laureate Pharma, Inc. CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES 201 College Road East MedPharm Ltd Princeton, New Jersey 08540 Business Centre, Sheep Street Phone: (609) 919-3400 Fax: (609) 452-7211 Charlbury 0X7 3RR email: [email protected] Oxfordshire www.laureatepharma.com Phone: +44 (0) 16 0881 9267 Fax: +44 (0) 16 0881 9268 Please check the categories in which your company provides the service. email: [email protected] www.medpharm.co.uk See Company ❏ Drug Discovery ❏✔✔Analytical Development ❏ Formulation Development ❏✔ Stability Testing Profile Please check the categories in which your company provides the service. ❏✔ Clinical Trial MFG/Scale-up ❏✔Technology/Transfer ❏✔Manufacturing ❏ Packaging ❏✔ Analytical Testing & Analysis ❏✔Process Development ❏✔Other: Biopharmaceutical Manufacturing ❏ Drug Discovery ❏✔✔Analytical Development ❏ Formulation Development ❏ ✔Stability Testing ❏✔ Clinical Trial MFG/Scale-up ❏✔Technology/Transfer ❏ Manufacturing ❏ Packaging Current Partnerships: Southern Research Institute ❏ Other: Mathematical modeling of drug absorption, predictive models for formulation optimization and screening, in vitro efficacy and performance Contact: Stan Zeichner, (609) 919-3325 Contact:Carole Delauney, Business Development Manager CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Lipocine Inc. Merrion Pharmaceuticals, Inc. 675 Arapeen Drive, Suite 202 219 Racine Drive, Suite D Salt Lake City, UT 84103 Wilmington, NC 28403-8702 Phone: (801) 994-87383 Fax: (801) 994-7388 Phone: (910) 799-1847 Fax: (910) 395-1843 email: [email protected] email: [email protected] www.lipocine.com www.merrionpharma.com Please check the categories in which your company provides the service. ✔ ✔ ❏ Drug Discovery ❏ Analytical Development ❏ Formulation Development ❏ Stability Testing Please check the categories in which your company provides the service. ❏✔ Clinical Trial MFG/Scale-up ❏✔Technology/Transfer ❏ Manufacturing ❏ Packaging ❏✔ Drug Discovery ❏✔✔Analytical Development ❏ Formulation Development ❏ Stability Testing Contact: Jerry Simmons ❏✔ Clinical Trial MFG/Scale-up ❏✔Technology/Transfer ❏ Manufacturing ❏ Packaging CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Contact: Michael J. McKenna, PhD Lipoxen Technologies Ltd. Suite 303, Hamilton House, Mabledon Place CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES London, England WC1H 9BB Metrics, Inc. Phone: ++44(0)20 7753 5822 Fax: +44(0)20 7753 5820 1240 Sugg Parkway www.lipoxen.com Greenville, North Carolina Phone: (252) 752-3800 Fax: (252) 758-8522 Please check the categories in which your company provides the service. email: [email protected] ❏ Drug Discovery ❏ Analytical Development ❏✔Formulation Development ❏ Stability Testing www.metricsinc.com ❏ ❏✔ ❏ ❏ Clinical Trial MFG/Scale-up Technology/Transfer Manufacturing Packaging Please check the categories in which your company provides the service. ❏✔ Other: Drug Delivery Systems (polymers, liposomes) ❏ Drug Discovery ❏✔ Analytical Development ❏✔ Formulation Development ✔❏ Stability Testing Contact:Dr. Peter Laing ❏✔ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏ Manufacturing ❏ Packaging ❏✔ Analytical Testing & Analysis ❏ Process Development Contact: Jeffrey Basham, [email protected] 104 Drug Delivery Technology November/December 2005 Vol 5 No 10 DDT Issue10 NOVEMBER05 11/5/05 10:29 AM Page 105 CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES MGlas AG NOVAGALI PHARMA Otto-Liebmann-Strasse 2 1 rue Pierre Fontaine / Genavenir IV Münnerstadt, Germany 97702 Evry, France 91058 Phone: +49(0)9733 808-0 Fax: +49(0)9733 808-160 Phone: 00 33 1 69 87 40 20 Fax: 00 33 1 69 87 40 20 email: [email protected] email: [email protected] www.mglas.de www.novagali.com Please check the categories in which your company provides the service. Please check the categories in which your company provides the service. ❏ Drug Discovery ❏ Analytical Development ❏✔ Formulation Development ❏ Stability Testing ❏ ❏ ❏ ❏ Drug Discovery Analytical Development Formulation Development Stability Testing ❏ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏ Manufacturing ❏ Packaging ❏ ❏ ❏✔ ❏✔ Clinical Trial MFG/Scale-up Technology/Transfer Manufacturing Packaging ❏ Analytical Testing & Analysis ❏ Process Development ❏✔ Contact:Mr. Wolfgang Heidl, +49(0)9733 808-125 Other: Pharmaceutical development in ophthalmology CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Noveon, Inc. Micron Technologies Inc. 9911 Brecksville Road 435 Creamery Way Cleveland, OH 44141 Exton, PA 19341 Phone: (216) 447-5000 Phone: (610) 425-5100 Fax: (610) 425-5104 www.pharma.noveon.com www.microntech.com Please check the categories in which your company provides the service. Please check the categories in which your company provides the service. ❏ Drug Discovery ❏ Analytical Development ❏✔Formulation Development ❏ Stability Testing ❏ Drug Discovery ❏✔ Analytical Development ❏ Formulation Development ❏✔ Stability Testing ❏ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏ Manufacturing ❏ Packaging ❏ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏✔ Manufacturing ❏ Packaging ❏✔ Other: Excipients ❏✔Other: Analytical Testing & Analysis Contact: website: www.pharma.noveon.com CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Mylan Technologies, Inc. Oakwood Laboratories, L.L.C. 110 Lake Street 7670 First Place, Suite A St. Albans, Vermont 05478 Oakwood Village, OH 44146 Phone: (800) 532-5226 (U.S.) International: 1-802-527-7792 Phone: (440) 359-0000 Fax: (440) 359-0001 Fax: (802) 527-8151 email: [email protected] email: [email protected] www.Oakwoodlabs.com www.mylantech.com Please check the categories in which your company provides the service. Please check the categories in which your company provides the service. ❏ Drug Discovery ❏✔Analytical Development ❏✔Formulation Development ❏ Stability Testing ✔ ✔ ❏ Drug Discovery ❏ Analytical Development ❏ Formulation Development ❏ Stability Testing ❏ Clinical Trial MFG/Scale-up ❏✔Technology/Transfer ❏ Manufacturing ❏ Packaging ✔ ❏ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏✔ Manufacturing ❏ Packaging ❏ Laboratory Testing ❏ Analytical Testing & Analysis ❏ Process Development Contact: Michael G. Lanzilotti, EVP & COO Contact:Tom Campbell CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Development Octoplus Next Breath LLC Zernikedreef 12 1450 South Rolling Road 2333 CL Leiden Netherlands Baltimore, MD 21227 Phone: +31 71 5244044 Fax: +31 71 5244043 Phone: (410) 455-5904 email: [email protected] www.nextbreath.net www.octoplus.nl Please check the categories in which your company provides the service. Please check the categories in which your company provides the service. ❏ Drug Discovery ❏ Analytical Development ❏✔✔Formulation Development ❏ Stability Testing ❏ Drug Discovery ❏✔Analytical Development ❏✔Formulation Development ❏✔Stability Testing ❏ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏ Manufacturing ❏ Packaging ❏✔ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏✔Manufacturing ❏ Packaging ❏✔ Other: Nasal, Pulmonary Development, & Analytical Testing ❏✔ Other: Special expertise in pharmaceutical development and cGMP clinical trial manufacturing of biopharmaceuticals and low-soluble compounds Contact: Julie Suman, PhD, (410) 455-5904 Contact: Dr. Henrik Luessen, Director Business Development, +31 71 5244044 CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Northwest Kinetics 1401 North 5th Street OSG Norwich Pharmaceuticals, Inc. Tacoma, WA 98403 6826 State Highway 12 Phone: (253) 593-5304 Fax: (253) 682-4351 Norwich, NY 13815 email: [email protected] Phone: (607) 335-3000 Fax: (607) 335-3100 www.nwkinetics.com email: [email protected] www.norwichpharma.com Please check the categories in which your company provides the service. Please check the categories in which your company provides the service. ❏ Drug Discovery ❏ Analytical Development ❏ Formulation Development ❏ Stability Testing ❏ Drug Discovery ❏✔Analytical Development ❏✔Formulation Development ❏✔Stability Testing ❏ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏✔ Manufacturing ❏ Packaging ❏✔ Clinical Trial MFG/Scale-up ❏✔Technology/Transfer ❏✔Manufacturing ❏✔Packaging ❏ Analytical Testing & Analysis ❏ Process Development ❏✔ Laboratory Testing ❏✔ Other: Phase I & II Clinical Trials Contact: Bob Calabro Contact:Colleen Hoke Drug Delivery Technology November/December 2005 Vol 5 No 10 105 DDT Issue10 NOVEMBER05 11/5/05 10:29 AM Page 106 CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Oxford Lasers Inc. Pfeiffer of America 29 King Street 12 Roszel Road, Suite C-104 Littleton, MA 01460-1528 Princeton, NJ 08540 Phone: (978) 742-9000 Fax: (978) 742-9100 Phone: (609) 987-0223 Fax: (609) 987-1511 email: [email protected] email: [email protected] www.oxfordlasers.com www.Pfeiffer.de Please check the categories in which your company provides the service. Please check the categories in which your company provides the service. ❏ Drug Discovery ❏ Analytical Development ❏ Formulation Development ❏ Stability Testing ❏ Drug Discovery ❏ Analytical Development ❏ Formulation Development ❏ Stability Testing ❏ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏ Manufacturing ❏ Packaging ❏ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏ Manufacturing ❏ Packaging ❏✔Other: Imaging, Micromachining, Photonics ❏✔ Other: Metered dose dispensing systems for Aqueous solutions & suspensions (Nasal, Bucal, Topical & Dermal), Microhaler (Pulmonary Contact:Dr. Seamus D. Murphy, (978) 742-9000, email: [email protected] Contact: Richard Sica CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Particle and Coating Technologies, Inc. CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES 5445 Highland Park Drive Pharmaceutical Profiles St. Louis, MO 63110 Mere Way, Ruddington Fields, Ruddington Phone: (314) 535-1516 Fax: (314) 535-1514 Nottingham, NG11 6JS, United Kingdom email: [email protected] Phone: +44 115 974 9000 www.pctincusa.com www.pharmprofiles.com Please check the categories in which your company provides the service. Please check the categories in which your company provides the service. ❏ Drug Discovery ❏ Analytical Development ❏✔Formulation Development ❏ Stability Testing ❏ Drug Discovery ❏ Analytical Development ❏✔Formulation Development ❏ Stability Testing ❏✔ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏✔Manufacturing ❏ Packaging ❏ Clinical Trial MFG/Scale-up ❏✔Technology/Transfer ❏✔ Manufacturing ❏ Packaging ❏ Other: ❏✔ Laboratory Testing ❏✔ Current Partnerships: Phaeton Research, Biovu Limited Contact: Robert Sparks Contact:Dr. Paul J. Clewlow, Business Development Director, +44 (0) 115 974 9000 CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Patheon Inc. Pharmatek Laboratories Inc. 7070 Mississauga Road, Suite 350 5626 Oberlin Drive, Suite 100 Mississauga, ON, Canada L5N 7J8 San Diego, CA 92116 Phone: (905) 821-4001 Fax: (905) 812-6709 Phone: (858) 587-8783 Fax: (858) 587-8771 email: [email protected] email: [email protected] www.pharmatek.com www.patheon.com Please check the categories in which your company provides the service. Please check the categories in which your company provides the service. ❏ Drug Discovery ❏✔Analytical Development ❏✔Formulation Development ❏✔ Stability Testing ❏✔ ❏✔✔❏ ❏✔ Drug Discovery Analytical Development Formulation Development Stability Testing ❏ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏✔Manufacturing ❏ Packaging ❏✔✔✔❏ ❏ ❏✔ Clinical Trial MFG/Scale-up Technology/Transfer Manufacturing Packaging ❏ Laboratory Testing ❏✔ Other: High-potency manufacturing, Controlled Release products, Controlled substances, Over-encapsulation, ❏ Other: Lyophilization, Sterile injectables, Nasal Spray delivery Contact: Elizabeth Hickman, [email protected], (858) 587-8783 Contact:Pam Shirto CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES PharmPro® (Division of Fluid air) Paulaur Corporation 2550 White Oak Circle 105 Melrich road Aurora, IL 60504 Cranbury, NJ 08512 Phone: (630) 851-1200 Phone: (609) 395-8844 Fax: (609) 395-8850 www.pharmpro.com email: [email protected] Please check the categories in which your company provides the service. www.paulaur.com Please check the categories in which your company provides the service. ❏ Drug Discovery ❏ Analytical Development ❏✔Formulation Development ❏ Stability Testing ❏ Clinical Trial MFG/Scale-up ❏✔✔Technology/Transfer ❏ Manufacturing ❏ Packaging ❏ Drug Discovery ❏ Analytical Development ❏✔Formulation Development ❏ Stability Testing ❏ Other: ❏ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏ Manufacturing ❏ Packaging ❏ Laboratory Testing Contact:Tom Tappen, (630) 851-1200 Contact: Larry Toscano CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES PolyPeptide Laboratories 365 Maple Avenue Torrance, California 90503 Phone: (800) 770-0557 or (310) 782-3569 Fax: (310) 782-3645 www.polypeptide.com Please check the categories in which your company provides the service. ❏ Drug Discovery ❏ Analytical Development ❏ Formulation Development ❏ Stability Testing ❏ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏✔Manufacturing ❏ Packaging ❏ Analytical Testing & Analysis ❏✔Process Development ❏✔ Other: Peptide API Manufacturing Contact: Jane Salik, (310) 782-3569 106 Drug Delivery Technology November/December 2005 Vol 5 No 10 DDT Issue10 NOVEMBER05 11/5/05 10:30 AM Page 107 CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES PRACS Institute, Ltd. SCOLR Pharma, Inc. 4801 Amber Valley Parkway 3625 132nd Avenue SE, Suite 300 Fargo, North Dakota 58104 Bellevue, WA 98006 Phone: (701) 239-4750 Fax: (701) 239-4955 Email: [email protected] Phone: (425) 373-0171 Fax: (424-373-0181 Website: www.pracs.com email: [email protected] www.scolr.com Please check the categories in which your company provides the service. See Company Profile ❏ Drug Discovery ❏ Analytical Development ❏✔ Formulation Development ❏ Stability Testing Please check the categories in which your company provides the service. ❏ ❏ ❏ ❏ Clinical Trial MFG/Scale-up Technology/Transfer Manufacturing Packaging ❏ Drug Discovery ❏ Analytical Development ❏✔Formulation Development ❏ Stability Testing ❏✔ ❏ Analytical Testing & Analysis Process Development ❏ Clinical Trial MFG/Scale-up ❏✔Technology/Transfer ❏ Manufacturing ❏ Packaging ❏✔Other: Clinical Research Services Contact: John Pottier, Director, Business Development CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Shire Laboratories, Inc. Remmele Engineering, Inc. - Automation Division 1550 East Gude Drive 677 Transfer Road Rockville, MD 20850 St. Paul, MN 55114 Phone: (301) 838-2681 Fax: (301) 424-1364 Phone: (651) 643-3700 Fax: (651) 642-5665 email: [email protected] email: [email protected] www.shirelabs.com www.remmeleautomation.com See Company Please check the categories in which your company provides the service. Profile Please check the categories in which your company provides the service. ❏ Drug Discovery ❏✔Analytical Development ❏✔Formulation Development ❏ Stability Testing ❏ Drug Discovery ❏ Analytical Development ❏ Formulation Development ❏ Stability Testing ❏✔ Clinical Trial MFG/Scale-up ❏✔Technology/Transfer ❏ Manufacturing ❏ Packaging ❏ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏✔ Manufacturing ❏✔Packaging ❏ Laboratory Testing Contact:Woody Bryan, PhD See Company Profile Contact: Brian Raehsler CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES SPI Pharma REXAM PHARMA 321 Cherry Lane 287 Bowman Avenue, Suite 302 New Castle, Delaware 19720 Purchase, NY 10577 Phone: (302) 576-8500 x 8554 Phone: (914) 251-8420 Fax: (914) 251-1450 Fax: (302) 576-8567 email: [email protected] www.spipharma.com www.rexam.com/pharma Please check the categories in which your company provides the service. Please check the categories in which your company provides the service. ❏ Drug Discovery ❏✔✔Analytical Development ❏✔Formulation Development ❏ Stability Testing ❏ Drug Discovery ❏ Analytical Development ❏ Formulation Development ❏ Stability Testing ❏ Clinical Trial MFG/Scale-up ❏✔Technology/Transfer ❏ Manufacturing ❏ Packaging ❏ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏ Manufacturing ❏✔Packaging ❏ Laboratory Testing Contact: Sarath Chandar Contact: Philippe DEPOIS CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES SAFC SRI International 3050 Spruce Street 333 Ravenswood Avenue St. Louis, MO 63103 Menlo Park, CA 94025 Phone: (800) 244-1173 (314-534-4900) Fax: (800) 368-4661 (314-652-0000) Phone: (866-451-5998) Fax: (650) 859-3041 email: [email protected] email: [email protected] www.safcglobal.com www.sri.com/biosciences Please check the categories in which your company provides the service. Please check the categories in which your company provides the service. ❏ Drug Discovery ❏✔Analytical Development ❏ Formulation Development ❏✔Stability Testing ✔ ✔ ✔ ✔ ❏ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏ Manufacturing ❏ Packaging ❏✔ Drug Discovery ❏✔✔Analytical Development ❏ Formulation Development ❏ ✔Stability Testing ❏ Laboratory Testing ❏✔ Clinical Trial MFG/Scale-up ❏✔✔Technology/Transfer ❏ Manufacturing ❏ Packaging Contact:Tom Gelineau, (314) 301-2077, email: [email protected] Contact: Client Services CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Stepan Company Sciarra Laboratories, Inc. 100 West Hunter Avenue 485-09 S. Broadway Maywood, NJ 07607 Hicksville, NY 11801 Phone: (201) 712-7642 Fax: (201) 712-7648 Phone: (516) 933-7853 Fax: (516) 933-7807 email: [email protected] email: [email protected] www.stepan.com www.sciarralabs.com Please check the categories in which your company provides the service. ❏ Drug Discovery ❏ Analytical Development ❏ Formulation Development ❏ Stability Testing Please check the categories in which your company provides the service. ❏ Clinical Trial MFG/Scale-up ❏ Technology/Transfer ❏✔ Manufacturing ❏ Packaging ❏ Drug Discovery ❏ Analytical Development ❏✔Formulation Development ❏✔ Stability Testing ❏ Analytical Testing & Analysis ❏ Process Development ❏✔ Clinical Trial MFG/Scale-up ❏✔Technology/Transfer ❏✔Manufacturing ❏ Packaging Contact: James M. Butterwick Contact: John J. Sciarra Drug Delivery Technology November/December 2005 Vol 5 No 10 107 DDT Issue10 NOVEMBER05 11/5/05 10:30 AM Page 108 CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES SYMPATEC INC Vectura Limited 9 Princess Rd # A One Prospect West Lawrenceville, NJ Chippenham Phone: (609)844-1020 Wiltshire, SN14 6FH email: [email protected] United Kingdom www.sympatec.com Phone: (+)44 (0)1249 667667 Please check the categories in which your company provides the service. www.vectura.co.uk ❏ Drug Discovery ❏✔Analytical Development ❏ Formulation Development ❏ Stability Testing Please check the categories in which your company provides the service. ❏ ❏ ❏ ❏ Clinical Trial MFG/Scale-up Technology/Transfer Manufacturing Packaging ❏ Drug Discovery ❏✔✔Analytical Development ❏ Formulation Development ❏ ✔Stability Testing ❏✔ Other: Particle Size Analysis ❏✔ Clinical Trial MFG/Scale-up ❏✔Technology/Transfer ❏ Manufacturing ❏ Packaging ❏✔ Contact:Peter Faraday Other: Inhalers ❏✔ Current Partnerships: Various CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Texmac Inc. Contact: Doug Smalley, Director of Business Development, (+) 44 (0) 1249 667667 3001 Stafford Drive Charlotte, NC 28208 CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Phone: (704) 393-6555 Fax: (704) 392-1621 Xemplar Pharmaceuticals, LLC email: [email protected] 200 Riggenbach Road www.texmac.com Fall River, MA 02720 Please check the categories in which your company provides the service. Phone: (508) 676-6726 Fax: (508) 676-6546 ❏ Drug Discovery ❏ Analytical Development ❏ Formulation Development ❏ Stability Testing email: [email protected] www.xemplarpharm.com ❏ Clinical Trial MFG/Scale-up ❏✔Technology/Transfer ❏ Manufacturing ❏ Packaging ❏ Other: Machinery distribution - Transdermal patch film coating - Hirano Coating machine distribtion Please check the categories in which your company provides the service. ❏ Drug Discovery ✔❏ Analytical Development ❏✔ Formulation Development ❏✔ Stability Testing Contact:Yashi Osaka ❏✔ Clinical Trial MFG/Scale-up ✔❏ Technology/Transfer ❏ Manufacturing ❏ Packaging ✔❏ Analytical Testing & Analysis ❏✔ Process Development CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES ✔❏ Other: Aerosol Delivery Systems, Double Blind Masking Devices University of Iowa/College of Pharmacy/ Center for Advanced Drug Development Contact: Charles R. Eck 100 Oakdale Campus, Room 1 PRL Iowa City, IA 52242-5000 Phone: (319) 335-4096 Fax: (319) 335-4374 email: [email protected] www.pharmacy.uiowa.edu/service/index.htm Please check the categories in which your company provides the service. ❏ Drug Discovery ❏✔Analytical Development ❏✔ Formulation Development ❏✔ Stability Testing ❏✔ Clinical Trial MFG/Scale-up ❏✔Technology/Transfer ❏✔ Manufacturing ✔❏ Packaging ❏✔ Other: Method development and validation according to ICH guidelines, development of dissolution procedures and validation of the analytical method, pre-formulation, development of formulations, API, excipient and drug product testing according to official monographs. Contact: Alta Botha, D.Sc. CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES UPM Pharmaceuticals, Inc. 6200 Seaforth Street Baltimore, Maryland 21224 Phone: (410) 843-3738 Fax: (410) 633-4438 email: [email protected] www.upm-inc.com Please check the categories in which your company provides the service. ❏ Drug Discovery ❏✔Analytical Development ❏✔ Formulation Development ❏✔ Stability Testing ❏✔ Clinical Trial MFG/Scale-up ❏✔Technology/Transfer ❏✔ Manufacturing ✔❏ Packaging Contact: Rich Ryzenga CONTRACT PHARMACEUTICAL & BIOLOGICAL DEVELOPMENT SERVICES Valois 50 Avenue de l’Europe Marly-le-Roi, France 78164 Phone: +33 (0) 1 39 17 20 20 Fax: +33 (0) 1 39 58 12 98 www.valoispharma.com Please check the categories in which your company provides the service. ❏ Drug Discovery ❏✔Analytical Development ❏✔Formulation Development ❏✔ Stability Testing ❏✔ Clinical Trial MFG/Scale-up ❏✔Technology/Transfer ❏ Manufacturing ❏✔ Packaging ❏✔ Laboratory Testing Contact: Guillaume Brouet - Lab Manager 108 Drug Delivery Technology November/December 2005 Vol 5 No 10 DDT Issue10 NOVEMBER05 11/5/05 10:30 AM Page 109 LABORATORY TESTING & ANALYSIS INSTRUMENTS & SOFTWARE SYSTEMS LABORATORY TESTING & ANALYSIS INSTRUMENTS & SOFTWARE SYSTEMS The AEgis Technologies Group Emerson Resources, Inc. 13062 Highway 290 West 600 Markley Street Austin, TX 78737 Norristown, PA 19401 Phone: (800) 647-2275 Fax: (512) 615-3574 Phone: (610) 279-7450 Fax: (610) 292-9722 email: [email protected] email: [email protected] www.aegisxcellon.com www.emersonresources.com Type of Software & Brand Name: Application(s): Type & Brand Name of Instrument/System: Application: acsIXtreme acsIXtreme is a modeling, execution and analysis HPLC Formulation Development environment for continuous dynamic systems and TOC Analytical Methods Development & Testing processes. Versatile and powerful enough to address the GC most challenging simulation problems. IR UV ascIXtreme acsIXtreme is a powerful application for fast, efficient Dissolution simulation execution and analysis. It allows users to Texture analyzer See Company conduct sophisticated model analysis without having to be DSC Profile a model developer. Contact:Walter Strathy Contact: Mark Green LABORATORY TESTING & ANALYSIS INSTRUMENTS & SOFTWARE SYSTEMS LABORATORY TESTING & ANALYSIS INSTRUMENTS & SOFTWARE SYSTEMS Erweka America Corp. Arizona Instrument 70 Church Street, Suite 102 1912 West 4th Street Flemington, NJ 08822 Tempe, AZ 85281 Phone: (908) 788-4666 Fax: (908) 788-4667 Phone: (602) 470-1414 Fax: (480) 804-0656 email: [email protected] email: [email protected] www.erweka.com www.azic.com Type & Brand Name of Instrument/System: Application: Type & Brand Name of Instrument/System: Application: Inhaler Testers MDI and DPI models consisting of Anderson Type Moisture/Solids/Ash Analyzer - Computrac MAX, Computrac Used in R&D, quality control, and industrial process control. Cascade, Astra Draco Multi-Stage Liquid Impinger, as Vappor Pro Durable and easy to use, these anlayzers aer equally well as Single Stage Impinger’s are available, in suitable for production floor or laboratory environments. accordance with all testing procedures within the USP. Contact: Julie Driver or Terri Thomas DT Series Dissolution Testers Complete range of apparatus in two versions, standard High Head and Low Head model designed to reduce LABORATORY TESTING & ANALYSIS INSTRUMENTS & SOFTWARE SYSTEMS evaporation loss. Complete on-line & or off-line systems, in addition to integration with external AssurX Inc. HPLC units. 305 Vineyard Town Center, Suite 374 Morgan Hill, CA 95037 ZT Series Disintegration Testers From manually controlled units to fully automated systems, available with either single or multiple test Phone: (408) 778-1376 Fax: (408) 776-1267 baskets, either 6 cell and 3 cell test basket email: [email protected] configurations. www.assurx.com TBH Series & MC Series Tablet Tester Commencing with a hand-held unit designed for Type of Software & Brand Name: Application(s): hardness measurement; up to fully automated units which can be integrated with an external computer, for Enterprise Quality Tracking-CATSWeb AssurX offers CATSWeb, a browser-based corrective-action compliance with CFR 21 Part 11. tracking system that complies to FDA 21 CFR Part 11 regulations. The software helps manufacturers track and Friability Testers Three different models, available with either a single or manage issues, customer complaints, supplier returns, and dual drum configuration. The TA operates with a fixed other corrective actions. Customization and extensibility speed of 25 RPM, whereas the TAR and TDR is variable features have been designed into the core of the program, from 20-100 RPM. which is accessible from remote systems running a variety of operating systems. CWS Check Weigher Modular check weighing system permits up to 50 different test samples. Unit automatically individualizes Contact:Tamar June the samples and transports them to a balance, then displays & transports samples to a container. LABORATORY TESTING & ANALYSIS INSTRUMENTS & SOFTWARE SYSTEMS Powder and Granulate Tester Three different models designed to offer measurement Capsugel of flow time according to specified amount (weight or 535 North Emerald Road volume) or amount (weight). Greenwood, SC 29646 Suppository Testers Four different units designed to measure sample Phone: (888) 783-6361 Fax: (888) 783-6360 hardness and disintegration. Single and multiple test email: [email protected] cells are available. www.capsugel.com All Purpose Drive The AR402 is the drive system which permits the use of Type & Brand Name of Instrument/System: Application: twenty-one different attachments. Some modules Xcelodose Precision micro-filling system eliminates the need for include wet or dry granulator; planetary stirrer; sieve formulation or excipients for first in man trials. Precise from analysis; pelletizer; homogenizer & tablet press. 100 micrograms to 100 milligrams with an RSD of less than 2% Fluid Bed Tester Lab unit designed to accommodate all aspects of fluidizing (i.e. powder, crystals, granules, extrudates, CFS 1000 Liquid filling and sealing system for capsules for R&D pellets, etc.). Two sizes are 50 - 300 grams; as well as 250 – 1000 grams. Contact: Glenda Oliver-Smith VDT Blister Tester Vacuum blister density checker permitting samples in an external pressurized container (-200 to -800 mbar) which is then filled with liquid; then tested within a range of up to 99 minutes and 50 seconds. Contact: Leonard Minervini Drug Delivery Technology November/December 2005 Vol 5 No 10 109 DDT Issue10 NOVEMBER05 11/5/05 10:30 AM Page 110 LABORATORY TESTING & ANALYSIS INSTRUMENTS & SOFTWARE SYSTEMS LABORATORY TESTING & ANALYSIS INSTRUMENTS & SOFTWARE SYSTEMS Flexicon America Inc. LCI Corporation 156 College Street PO Box 16348 Burlington, VT 05401 Charlotte, NC 28297-8804 Phone: (802) 657-3232 Fax: (802) 657-3202 Phone: (704) 394-8341 Fax: (704) 392-8507 www.flexiconamerica.com email: [email protected] Type & Brand Name of Instrument/System: Application: www.lcicorp.com Peristaltic Liquid Filling Dispenser BioPharma small to medium scale liquid fillings Type & Brand Name of Instrument/System: Application: Liquid filling machinery: semi-automatic to fully automatic Liquid filling for labs, R&D pilot and production manufacturing. Multi Granulator MG-55 Allows formulation/product developers to evaluate three low pressure granulation techniques—dome, radial, and axial extrusion—and determine which LABORATORY TESTING & ANALYSIS INSTRUMENTS & SOFTWARE SYSTEMS one best suits their product. Horiba Instruments, Inc. 17671 Armstrong Avenue Laboratory Marumerizer QJ-230T Easily evaluates of the effectiveness of spheronization on extruded products; converts moist Irvine, CA 92614 cylindrical extruded granules into smooth, uniform Phone: (949) 250-4811 Fax: (949) 250-0924 spheres in a variety of applications. email: [email protected] www.horiba.com Contact: Sam Habash Type & Brand Name of Instrument/System: Application: LABORATORY TESTING & ANALYSIS INSTRUMENTS & SOFTWARE SYSTEMS Particle Size Analyzer - LA 930 Full range particle size analyzer, measuring dispersions or dry powders from 0.02-2000 microns, with complete Malvern Instruments accuracy and resolution, with a full range of accessories. 10 Southville Road Southborough, MA 01772 Particle Size Analyzer - LB 550 DLS particle size analyzer measuring 1nm - 6 microns over a wide range of concentrations. Accurate measurement of Phone: (508) 480-0200 Fax: (508) 460-9692 distribution shape and modes without operator input. email: [email protected] www.malverninstruments.com Contact: Duncan Griffiths LABORATORY TESTING & ANALYSIS INSTRUMENTS & SOFTWARE SYSTEMS Type & Brand Name of Instrument/System: Application: ImageTherm Laser Diffraction Systems, Mastersizer 2000, Spraytec, For particle size in solids, liquids, slurries and aerosols 142 North Road Also on-line particle sizing with Insitec Sudbury, MA 01776 Pipeline Technologies/Platforms Application(s): Phone: (978) 443-1989 Fax: (978) 443-8942 email: [email protected] Zeta Potential and sub-micron particle size, Zetasizer Nano For comprehensive analysis of suspensions and www.imagetherm.com emulsions Type & Brand Name of Instrument/System: Application: Contact: Mansa Fraser, (508) 480-0200 SprayVIEW® Measurement System Automated measurement system for pharmaceutical drug nasal sprays, metered dose inhalers and oral spray for the testing of spray pattern and plume geometry. LABORATORY TESTING & ANALYSIS INSTRUMENTS & SOFTWARE SYSTEMS Natoli Engineering SprayVIEW® Actuation System Automated actuation system for pharmaceutical drug nasal sprays, metered dose inhalers and oral spray for 28 Research Park Circle automated device actuation. St. Charles, Missouri 63304 Phone: (636) 926-8900 Fax: (636) 926-8910 Contact: Dino Farina email: [email protected] www.natoli.com LABORATORY TESTING & ANALYSIS INSTRUMENTS & SOFTWARE SYSTEMS Type & Brand Name of Instrument/System: Application: InnovaSystems, Inc. Manufacturing and Tablet Compression, Tablet Presses, and Production & Quality Control Replacement Parts 840 Lenola Road, Unit 8 Moorestown, NJ 08057 Type of Software & Brand Name: Application(s): Phone: (856) 722-0410 Fax: (856) 722-0042 Tablet CAD Tablet design email: [email protected] www.innovasystems.com Tool Management II (TMII) New Version 4.1 Inspections & tool record keeping Contact: Dale Natoli Type & Brand Name of Instrument/System: Application: Automated Testing for: Optical Spray Analysis Station - OSA Spray Pattern and Plume Geometry Pump Actuation and Weigh Station - PAW Priming and Repriming Nasal Product Dose Weight and Sample Preparation Station Dose Content through container life Metered Dose Inhaler Actuator Metered Dose Inhaler Wasting Station Metered Dose Inhaler Dose Weight Station Type of Software & Brand Name: Application(s): EZ Spray ™ Low-cost alternative to optical spray pattern analysis via easy-to-use, desktop scanner based technology. EZ Spray™ scans patterns on TLC plates and computes FDA-recommended Spray Pattern Test parameters. Contact: John Fracassi, (856) 722-0410 110 Drug Delivery Technology November/December 2005 Vol 5 No 10 DDT Issue10 NOVEMBER05 11/5/05 11:13 AM Page 111 LABORATORY TESTING & ANALYSIS INSTRUMENTS & SOFTWARE SYSTEMS LABORATORY TESTING & ANALYSIS INSTRUMENTS & SOFTWARE SYSTEMS OSG Norwich Pharmaceuticals, Inc. Pharmatek Laboratories Inc. 6826 State Highway 12 5626 Oberlin Drive, Suite 100 Norwich, NY 13815 San Diego, CA 92116 Phone: (607) 335-3000 Fax: (607) 335-3100 Phone: (858) 587-8783 Fax: (858) 587-8771 email: [email protected] email: [email protected] www.norwichpharma.com www.pharmatek.com Type of Software & Brand Name: Application: Type & Brand Name of Instrument/System: Application: SAP Full version of SAP to run the business Hot Road Chemistry® (HRC) Formulation Screening Kit Designed to solublize even the most difficult drug compounds for in vivo animal testing. The kit contains Type & Brand Name of Instrument/System: Application(s): eight non-toxic, FDA-approved, orally available Complete analytical, micro, and stability labs including but not Provide outsourcing services to our clients to support formulations. limited to HPLC, GC, UV/Vis Spec, FTIR Spec, Dissolution (manual the manufacturer and packaging of products for them and automated), Auto-titration, Complete wet chemistry, Bacteria/ Contact: Elizabeth Hickman, [email protected], (858) 587-8783 Yeast/Fungal ID, Method development and transfer, Product screening using Steri-Screen, Sterile products testing, Autoturb, LABORATORY TESTING & ANALYSIS INSTRUMENTS & SOFTWARE SYSTEMS Biolog, Bioluminescence. Full ICH Chambers available: 30˚C/65%RH, 25˚C/60%RH, SOTAX 30˚C/60%RH, 40˚C/75%RH 411 Caredean Drive, Suite A 30˚C/70%RH, (Zone IV), 30˚C/ambient Horsham, PA 19044 Contact:Bob Calabro Phone: (215) 442-1500 Fax: (215) 442-1514 email: [email protected] LABORATORY TESTING & ANALYSIS INSTRUMENTS & SOFTWARE SYSTEMS www.sotax.com Oxford Lasers Inc. Type & Brand Name of Instrument/System: Application: 29 King Street Dissolution Tester: SOTAX AT 7 smart Ideal for USP 1/2/5/6 Methods and every dissolution Littleton, MA 01460-1528 laboratory. Designed with the Autocompliance concept, eliminating daily routine validation. Stand- Phone: (978) 742-9000 Fax: (978) 742-9100 alone unit or upgraded to automatic system. email: [email protected] www.oxfordlasers.com Dissolution Tester: SOTAX AT 70 smart Fully automated serial release testing for up to 15 USP 2 tests. High sample throughput combined with efficient cleaning system. Easy to validate. Type & Brand Name of Instrument/System: Application: Dissolution Tester: SOTAX AT 70 BS 60 Fully automated serial release testing for USP 1/2 EnVision tests with basket station. Maximum flexibility and Type of Software & Brand Name: Application(s): sample throughput combined with efficient cleaning system. Easy to validate. EnVision Software (Plume and pattern) Software used to determine, event duration, spray pattern data (shape, size and orientation of pattern), Dissolution Tester: SOTAX CE 7smart Automated system for flow-through method tests Plume geometry (Angle, width, orientation and length) (USP 4). Suitable for all dosage forms with easy media/pH changes for simple in-vivo simulation. VidPIV software (velocity analysis software) Used to determine velocity vectors over defined Available online, offline, on-/offline. region. When used in combination with EnVision system, will report velocity changes over event Disintegration Tester: SOTAX DT 2 Detection of disintegration end point – the most duration. efficient way of testing the disintegration time, either manually or automated. VisiSizer Software Particle size analysis software Hardness Tester: SOTAX HT 1 Testing of four essential physical parameters: Contact:Dr. Seamus D. Murphy, (978) 742-9000, email: [email protected] hardness/thickness/diameter/weight of a tablet. Revolutionary Auto Alignment device rapidly aligns all common tablet forms for testing. LABORATORY TESTING & ANALYSIS INSTRUMENTS & SOFTWARE SYSTEMS Hardness Tester: SOTAX HT 10 Semi-automated testing of four essential physical Particle and Coating Technologies, Inc. parameters: hardness/thickness/diameter/weight of 5445 Highland Park Drive a batch (up to 20 tablets). With the revolutionary St. Louis, MO 63110 Auto Alignment device. Phone: (314) 535-1516 Fax: (314) 535-1514 Hardness Tester: SOTAX: HT 100 Fasted Automated tablet testing system with email: [email protected] revolutionary Auto Alignment/Auto Separator devices www.pctincusa.com ensures, consistent, trouble-free results for all shapes and sizes of tablets batch after batch. Type & Brand Name of Instrument/System: Application: Flowability Tester: SOTAX FT 300 Performs a variety of test conditions including mixing and vibration settings. Produces precise and Micro-Capacity Spray Dryer Can dry samples from 25 mg. to grams. Special reproducible results on the flowability handling for highly unstable molecules (peptides, characteristics of powders and granulates. hormones, etc.) On market early 2006. Friability Tester: SOTAX F 1 / F 2 The friability testers built with unique front loading Mini-Fluid-Bed Successful in coating samples down to 5 grams. On and automatic discharge system. market early 2006. Tap Density Tester: SOTAX TD 2 Compact microcontroller-based tap density tester for Contact: Robert Sparks, email: [email protected] simple measuring of the tapped density. Testing of powders, granulates, peelets, flakes and other bulk substances. Type of Software & Brand Name: Application(s) Dissolution software: WinSOTAX This advanced, menu-driven dissolution software was developed under the latest regulations (GAMP, GALP, ISO 9001) and completely complies with 21 CFR Part 11. Physical testing software: Q-Doc Q-Doc physical testing software is a validated Windows (98/NT/2000/XP) software which fully complies with 21 CFR Part 11. Q-Doc is also available with LIMS capabilities. Contact:Bates Stuart, Finn Marc, Majeski Ray Drug Delivery Technology November/December 2005 Vol 5 No 10 111 DDT Issue10 NOVEMBER05 11/5/05 11:13 AM Page 112 LABORATORY TESTING & ANALYSIS INSTRUMENTS & SOFTWARE SYSTEMS LABORATORY TESTING & ANALYSIS INSTRUMENTS & SOFTWARE SYSTEMS Waters Corporation Wyatt Technology 34 Maple Street 6300 Hollister Avenue Milford, MA 01757 Santa Barbara, CA 93117 Phone: (508) 478-2000 Fax: (508) 872-1990 Phone: (805) 681-9009 Fax: (805) 681-0123 email: [email protected] email: [email protected] www.waters.com www.wyatt.com Type & Brand Name of Instrument/System: Application: Type & Brand Name of Instrument/System: Application: ACQUITY Ultra Performance Liquid Chromatography™ First-of-its-kind LC system designed to take full DAWN light scattering detectors Multi-angle light scattering instruments for advantage of the potential of proprietary, sub two- determining absolute molar masses and sizes of micron particles. Provides chromatographic run polymers and biopolymers in solution times up to 9X shorter than today’s fastest HPLC systems, up to 2X better peak capacity or resolution, DynaPro Titan Light Scattering instrument Dynamic light scattering instruments for and 3X better routine sensitivity. determining solution properties of proteins and nanoparticles in solution The Waters® Protein Expression System Industry’s first multiplexed system to quantitatively assess changes in protein expression while DynaPro Titan Plate Reader Automates the dynamic light scattering to use performing enhanced qualitative protein standard 96 and 384-well plates. Reduces sample identification - all within the same LC/MS run. preparation and aanalysis time by a factor of 10. SunFire™ columns State-of-the-art reversed-phase C18 bonded silica, Contact: Geofrey Wyatt which provides the best peak shape, low-pH stability and efficiency. LABORATORY TESTING & ANALYSIS INSTRUMENTS & SOFTWARE SYSTEMS The Waters Micromass® Q-Tof Premier Mass Spectrometer Hybrid quadrupole, orthogonal acceleration time-of- flight mass spectrometer that enables automated Flexicon America Inc exact mass measurement of precursor and 156 College Street fragment ions to yield the highest confidence for metabolism studies, proteomics and structural Burlington, VT 05401 analyses. Phone: (802) 657-3232 Fax: (802) 657-3202 email: [email protected] Type of Software & Brand Name: Application(s): www.flexiconamerica.com MetaboLynx™ software Features advanced tools for mining complex LC/MS data sets and accelerating the process of identifying drug metabolites. Type & Brand Name of Instrument/System: Application: PF6 Peristaltic Dispenser eLab Notebook™ Software Allows companies to digitally capture and store FP50 Tabletop Filling & Plugging Machine Liquid filling of small to medium batch sizes scientific information — graphical, mathematical, FF20 Tabletop Filler of biopharma products. Unique peristaltic and textual information of all types — that, today, FF30 Tabletop Filler & Screw Capping dispenser provides fast start-up consistently researchers enter manually into paper laboratory FMB210 Fully Automatic Capper accurate fills with no risk of contamination. notebooks. DF32 Cream Dispenser Equipment designed for fast changeover. TL210 Double Tray Loader Contact: Brian J. Murphy, (508) 482-2614 W500 Vial Washer BU12 Bottle Unscrambler LABORATORY TESTING & ANALYSIS INSTRUMENTS & SOFTWARE SYSTEMS Contact: Peter Lambert Weiler Engineering, Inc. 1395 Gateway Drive Elgin, IL 60123 Phone: (847) 697-4900 Fax: (847) 697-4915 email: [email protected] www.weilerengineering.com Type & Brand Name of Instrument/System: Application: ASEP-TECH® Blow/Fill/Seal Systems Oral, parenteral (injectable), respiratory therapy, opthalmic, nutraceutical Model 640 Model 624 See Company Model 628 Profile Model 603 112 Drug Delivery Technology November/December 2005 Vol 5 No 10 DDT Issue10 NOVEMBER05 11/5/05 11:13 AM Page 113 TRANSDERMAL DEVELOPMENT TRANSDERMAL DELIVERY The MDTS® is a small and easy-to-use drug delivery system 3M adhesives are known for world-class performance across many containing an existing therapeutic drug and ACROSS® penetration applications. The synergy achieved through combination with other enhancers, which are small, lipid-like compounds that allow drugs to 3M core technologies will be put to work for it customers in pass through the skin. ACROSS penetration enhancers are GRAS due designing transdermal solutions. 3M leverages more than 30 to their long-term and extensive use on humans. MDTS provides a technology platforms to meet customer needs, and has a proven simple way of applying a preset dose of a drug to the skin. It is track record of success and global presence in transdermal delivery placed gently against the skin and depressed releasing a light spray, systems, including a 15-year history of development and which quickly dries on the skin. The ACROSS enhancers then allow manufacturing of Minitran™ (nitroglycerin) and Climara® (estradiol drugs to pass through the top layers of the skin. A once-a-day transdermal system), development of an estradiol/levonorgestrel application typically delivers consistent amounts through the skin to combination patch, and numerous partner programs. 3M has the blood stream. For more information visit Acrux at transdermal products registered in more than 60 countries. For more www.acrux.com. information, contact 3M Drug Delivery Systems at (800) 643-8086 or visit www.3M.com/DDS. OSMOTIC TECHNOLOGY NEEDLE-FREE INJECTION ol 5 No 10 ol 5 No V Aradigm’s Intraject technology is a prefilled disposable needle-free OROS® technology employs osmosis to provide precise, controlled delivery system. This pen-sized system enables patients to comfortably drug delivery for up to 24 hours and can be used with a range of self-administer drugs to the subcutaneous region of the skin. Targeting compounds, including poorly soluble or highly soluble drugs. OROS this area allows the drug to enter the systemic circulation with an identical can be used to deliver high drug doses meeting high-drug loading pharmacokinetic profile as seen with conventional needle-based requirements. L-OROS™ technology, adapted for liquid subcutaneous injection. The liquid formulations delivered via Intraject are 2005 November/December formulations, can enhance the bioavailability of drugs with low usually identical to those delivered via conventional subcutaneous solubility. Targeting specific areas of the GI tract, OROS technology injection, allowing for an abbreviated bioequivalence-based clinical and may provide more efficient drug absorption and enhanced regulatory pathway. Since the drug-containing capsule is made of glass, bioavailability. L-OROS can also enhance the bioavailability of drugs existing stability in glass ampules can also be used to support Intraject with low solubility. For many drugs, zero-order is not the optimal filings. Intraject has been evaluated in clinical trials involving more than delivery profile. OROS can be tailored to meet patterned delivery 700 subjects given more than 8000 injections and is currently being profiles to optimize a drug’s therapeutic efficacy. For more manufactured for registration lot testing. The most advanced program is Drug Delivery Technology Intraject Sumatriptan for the treatment of migraines which is in Phase 3 information, contact ALZA Corp. at (650) 564-5000 or v isit 113 www.alza.com. clinical testing. For more information, contact Aradigm at (510) 265-9000 or visit www.aradigm.com. DDT Issue10NOVEMBER0511/5/0511:14AMPage114 114 Drug Delivery Technology November/December 2005 Vol 5 No 10 Healthcare Corporation contact For moreinformation, products. competitive therapeutic and efficacious, problems andpotentiallydevelopingsafe, delivery providesmultipleoptionsforsolving drug routes, andadministration profiles, drugrelease intermsofaddressabledrugclasses, technology, platform ofthePROMAXX Theversatility arealsobeingexplored. administration Otherroutesof routes. administered viainjectableandpulmonary a Themicrospheresare application. tailored forthedesiredtherapeutic drugs andbothmicrospheresizedrug-releasecharacteristicscanbe ofbothsmallandmacromolecular These microspheresareidealfordelivery inatotallywater-based process. produces bioerodibleproteinmicrospheres, that technology drugdelivery protein-matrix PROMAXX isaproprietary, www.baxterdrugdelivery.com assainternational To transfer, knowledge encourage of-the artanalyticalservices. alsosupportsitscustomerswithstate- Thecompany pharmaceutical solids. of tothecharacterization and customizedanalyticaltrainingrelated dacdSldSaeAayi,Ic (assainternational Inc. Advanced SolidState Analysis, assainternational visit For moreinformation, cases. litigation orpatent preparation a NMRandinfraredRamanspectroscopyforpharmaceutical state pharmaceuticalsolid diffraction, courses inpharmaceuticalX-raypowder shorttraining equipmentforyourpharmaceuticallaboratory; laboratory including polymorphscreening;assistanceinchoosingtherightanalytical forpharmaceuticalapplications, offersanalyticalservices company The tothepharmaceuticalcommunity. modern physicalcharacterization pplicable to immediate- and sustained-release delivery andcanbe andsustained-releasedelivery pplicable toimmediate- piain,andpolymorphscreening;supportforitsclients inpatent pplications, P ROTEIN S ® OLID organizes international workshopsandconferenceson organizes international ® at www.assainternational.com at -M (800) 422-9837orvisit S TATE . A TRIX A NALYSIS D ELIVERY ® ) providesconsulting . Baxter or visit BASF PharmaSolutions’ contact For moreinformation, andexclusive customsynthesis. finishing, pharmaceutical alsooffershigh-quality activeingredients, The company Solutions visit For moreinformation, Excellence. along withtheestablishmentof Lyophilization Center of Lyophilization hasincreased capacity kittingline. fully automated aswella incartridgefilling/finishing, has addednewcapability forsyringeandvialfilling/finishing;it facility hasexpandedcapacities Baxter’s Bloomington for preclinical tocommercial-scaleproduction. capacity have CA, licensed facilitiesinHaywardand Thousand Oaks, Its forantibodies and proteintherapeutics. manufacturing services Baxterprovidescontractdevelopmentand for commercialproduction. c ofproviding Baxterofferstheadvantage andcartridges. vials, active ingredientstoform/fill/finishofdrugproductintosyringes, fromprocessdevelopmentofbiopharmaceutical contract services Baxter isaparenteralmarketleaderprovidingrangeofproven ytotoxic contract services fromchemical synthesis(API)toscale-up ytotoxic contractservices www.basf.com/pharma at E C www.baxterbiopharmasolutions.com X CIPIENT ONTRACT T echnical Services Line at (800)469-7541 Lineat echnical Services is Kollidon company’s excipientsportfolio powerful Oneexampleofthe its customers. toworkfor largest chemicalcompany BASF putstheresourcesofworld’s eieysses andmanufacturing. systems, delivery solidorliquiddosage, formulations, questionsabout day toanswer respond tocallswithinonebusiness experienced chemistsandpharmacists BASF’s skilledand technical service. and expertise, up byitsexperience, backed andsolubilizers, disintegrants, binders, range ofcoatings, portfolio ofexcipientsincludes afull BASF’s comprehensive dissolution. . P S ORTFOLIO ERVICES Baxter BioPharma ® L whichaccelerates CL, . DDT Issue10 NOVEMBER05 11/5/05 11:14 AM Page 115 NEDDLELESS SYSTEM LABORATORY TESTING SERVICES The BD Monovial™ Luer AXs is a needleless system designed for simpler, safer, and faster dry drug reconstitution. Featuring an innovative design, it is composed of a standard vial (13 or 20 mm), standard stopper (powder/liquid or lyo), and a transfer set supplied by BD. Transfer sets are delivered assembled, sterile, and ready to be crimped onto the vial. The system BioScreen is a full-service laboratory in industrial microbiology and offers a simple quick-flow analytical chemistry. The company is US FDA registered, ISO 9001:2000 reconstitution process; a reduction Certified, DEA registered, and California State Certified to test drinking in time, waste, and supplies for water. It now offers analytical reports direct from the Internet with reconstitution; a reduced risk of electronic signature, and a blend of science and business with a service- medication errors; and automatic oriented approach. BioScreen is capable of executing USP methods when activation for more simplicity and guarantee intuitiveness of use. The required as well as designing or researching specialized methods for a Monovial™ Luer AXs is compatible with all Luer and BD Luer- unique product or process. The company has also participated in numerous Lock™ syringes and works perfectly with diluents prefilled in BD projects for IND, NDA, and ANDA submissions to the FDA. There are four Hypak™. For more information, contact BD Pharmaceutical corporate divisions: Pharmaceutical & Biotechnology Services; Medical Systems at (201) 847-4017 or visit www.bdpharma.com. Device; Cosmetic, Household & Industrial Products; and Midwest Clinical Trials (Human Clinical & Claim Substantiations). For more information, contact BioScreen Testing Services, Inc., at (800) 229-9057 or visit www.bioscreen.com. FAST-DISSOLVE TECHNOLOGY STRATEGIC PRODUCT DEVELOPMENT ol 5 No 10 ol 5 No V ® Cirrus Pharmaceuticals is a contract product development company Cardinal Health’s Zydis fast-dissolve technology can help enhance a assisting biotechnology and pharmaceutical companies with dosage product's performance in several ways. The rapid dispersion and form development projects. Cirrus can assist or manage projects as coating with the Zydis technology in the buccal cavity creates needed by providing a broad array of R&D services, including physical products that can decrease onset time, modify absorption, increase and chemical characterization, formulation development, stability 2005 November/December bioavailability, and augment therapeutic efficacy. Because the Zydis testing, container/closure selection, process development, scale-up, and technology dissolves instantly on the tongue in less than 3 seconds, it technical transfer to manufacturing for inhaled, oral, topical, protein & can be swallowed without water. For more information, contact peptide, and parenteral products. Services can include submission- Cardinal Health at (866) 720-3148; [email protected]; or visit ready regulatory documentation and assistance with regulatory www.cardinal.com/zydis. submission questions. The company’s mission is to provide excellent service and scientific expertise to progress your pharmaceutical development projects. Cirrus’ combination of scientific competence, Drug Delivery Technology Drug Delivery Technology timely delivery of services, and attention to customer needs have generated strong customer loyalty. For more information, contact Cirrus 115 Pharmaceuticals at (919) 884-2064 or visit www.cirruspharm.com. DDT Issue10NOVEMBER0511/5/0511:14AMPage116 116 Drug Delivery Technology November/December 2005 Vol 5 No 10 Dow Corning For visit moreinformation anddispersions. emulsions, and fluids, adhesives; medicalgradetubing; polyurethanepottingcompounds; andsoftskin pressuresensitive, bonding, peroxide-cure materials; a andsupportedextrusion casting, transfer andcompressionmolding, rubbers andliquidsiliconesuitableforinjectionmolding, high-consistency including softfillingelastomers, based materials, a andpersonalcare woundcare, systemsforpharmaceuticals, delivery ofsiliconestohelpcustomersdevelopinnovative biocompatibility and upontheversatility Corningdraws Dow more than5decades, for A globalleaderforhealthcaresolutionsusingsiliconetechnology rjcs o oeifrain contact For moreinformation, projects. totakeonyourtoughest staffisready andinnovative creative Our and hot meltformulations. aqueous, facilities processsolvent, a moistureoroxygenbarrier and taste-masking or sustainedrelease, A manufacturing inaGMPenvironmentwithanalyticalsupport. andcommercial scale-up, transfer, technology development, include Ourservices contractformulation andtablets. capsules, hardshell include capabilities Othercoating softgels, beads. and crystals, granules, ofpowders, fluid bedmicroencapsulation specializingin development andmanufacturingcompany Wurster systems drugdelivery owned isaprivately Inc. Place, Coating 845 9521orvisit vailable in biomedical and Class VI grade, platinum-cure or platinum-cure vailable inbiomedicalandClass VI grade, Corningprovides arangeofbeneficialsilicon- Dow pplications. piain o x T,adcnrle usac rdcs Our and controlledsubstanceproducts. OTC, forRx, pplications piain nld otoldoa eiey uha nei,delayed, suchasenteric, includepplications controlledoraldelivery, D EVELOPMENT S at ILICONE www.dowcorning.com/content/healthcare/ www.encap.com & M T ECHNOLOGY . ANUFACTURING otn lc,Inc. Coating Place, at (608) . Dowpharma contact For moreinformation, market fastandcost-effectively. helpsyoumovethroughclinic Dowpharma to manufacturing options, andofferingcustomersmultiplecGMP using advancedtechnology By possiblecost. the lowest at process isdevelopedthefirsttime, anoptimized ensuresthat purification expression throughdownstream fromprotein Processintegration of targetproteinsorpeptides. problemsanddesignrobustsolutionsfortheexpression can diagnose Dowpharma andfunctionalgenomicscapabilities, and bioinformatics Usingcutting-edgeexpressiontechnologies programs forwardfaster. toanalyticaldevelopment)advancescustomers’drug purification to toprocessdevelopment(fromfermentation approach and integrated combinedwithitsdisciplined Dowpharma’s andservices, capabilities P at GerhardRenner pleasecontactDr. For moreinformation, processes. andwithstandard manufacturing based EUDRAGIT®polymers, including aqueous- manufactured usingconventionalexcipients, Thesystemcanbe form. asthefinaldosage be filledintocapsules ortheycan tablets, can thenbecompressedtoobtaindisintegrating Thesemultilayeredpellets ionicpolymerlayer. controlled release, EPTIDE +49 (0)6151184810orvisit M ODULATED at (866) 332-5805orvisit & PEG YLATION www.pharma-polymers.com D of drug and finally coated witha of drugandfinallycoated byalayer followed polymer layer, neutral withamodulating, coated whichare strong acidasthecore, ofasaltfromweakor crystals The pelletdesignstartswith embedded inpolymercoatings. salts withionicstructures interaction ofionsfromdissolved ofdrugreleaseviathe modulation systemenables multiparticulate This physiological needs. drug releasetomeetspecific ofcontrolling capable platform technology oral drugdelivery EUDRAMODE™ isamodulated RUG www.dowpharma.com R E ELEASE XPRESSION . . DDT Issue10NOVEMBER0511/5/0511:14AMPage117 AdvaTab combined withEurand’s leadingMicrocaps AdvaTab canbe andarobusttablet. modifiedrelease, flexible dosing, –unparalleledtaste, anduniqueapplications offers distinctadvantages lses o oeifrain contact For moreinformation, blisters. AdvaTab ineitherbottles orpush-through tablets canbepackaged provide afast-dissolvetabletwith sustained-releaseproperties. intothe drug granulescanbeincorporated AdvaTab formto dosage Modified-release granules issuitablefordelivering highdrugdoses. and thesmoothmixtureofcarrierexcipientstaste-maskeddrug AdvaTab inthemouthwithin15to30seconds, tabletsdissolverapidly to provideafast-dissolvetabletwithsuperiortasteandmouth-feel. [email protected] pcat oaedlvr om.Frmr nomto,visit For moreinformation, forms. delivery specialty dosage and andjarfilling;pouchpackaging; bottle, cup, tube, packaging; P Innovative the-art compartmentalizedmanufacturingservices. andstate-of- explosion-resistantmanufacturing, handle ingredients, hard-to- abilitytomanage manufacturing ofsemi-solidsandliquids, a technologies anddistinctiveplatform expertise, analytical chemistry www.dptlabs.com albefrlcnig SpecializedProductionSolutions include vailable forlicensing. 0654063$&8*5)$0/'*%&/$& ackaging Solutionsincludeackaging thermo-formandcold-formblister 4. F 3OLUTIONS 0VS1FPQMF±5IF4PMVUJPOTGPS0VUTPVSDJOHXJUI$POGJEFODF ® AST is a new generation of fast-dissolve tablet technology that offast-dissolvetablettechnology is anewgeneration -D C ONTRACT . ISSOLVE . liquids, formulation developmentand formulation liquids, expertise insemi-solidsandoral leveloftechnical unmatched Development Solutionsinclude Advanced time. product every get youtomarketwithaquality they compliancehistory, regulatory Combined withDPT’s excellent todetail. andattention excellence, commitment todeadlines, professionals shareyour Experienced outsourcing solutions. DPTprovidesconfidencein products, andbiotech OTC, solid andliquidRx, anddistributionofsemi- packaging, F rom developmenttomanufacturing, S T Eurand ECHNOLOGY ERVICES ® taste-masking technology at (937) 898-9669orat DPT at at contact For moreinformation, commercialization. tohigh-volume manufactureand fromconceptgeneration innovations device drivingnew(ornext-generation) arehighlyadeptat Managers Facet’s Project Additionally, reliable inthehandsofend-user. whichareintuitiveand designing anddevelopingcomplex devices, hasextensiveexperience Thecompany worldwide. utilized bypatients expertise asaleadingdesignerandmanufacturerofhand-helddevices Facet Technologies hasestablishedits medical deviceindustries. and toitscustomersinthedrugdelivery services commercialization and development, providingdesign, manufacturing organization engineeringand FDA-registered, 13485/EN-46001- certified, F www.thinkoutsidethebeaker.com contact For moreinformation, andanunrelentingcommitmenttoquality. work, hard creativity, innovation, tohonesty, customers withadedication andexpertisetoits ingredients, value-addedservice, unparalleled, T Technical SystemDevelopmentand Delivery Technical Services, including inourthreemainareasoffocus, and customerservice Ourcompaniesworktogethertooffercutting-edge expertise service. and NutritionalSupplementindustrieswithincomparablecustomer thePharmaceutical committedtoservicing expertise andknow-how, of builtonastrongfoundation Emerson Resourcesisanorganization ctTcnlge,advso fMti elhae n. isanISO- Inc., Healthcare, adivisionofMatria acet Technologies, ann,VleAddIgein upy Emersondelivers Value-Added IngredientSupply. raining, F (800) 526-2387orvisit ORMULATION mro eore,Inc. Emerson Resources, S PECIALTY www.facettechnologies.com & T ECHNICAL ,a S . t (610)279-7450orvisit ERVICES Facet Technologies S OLUTIONS . 117 Drug Delivery Technology November/December 2005 Vol 5 No 10 DDT Issue10NOVEMBER0511/5/0511:14AMPage118 118 Drug Delivery Technology November/December 2005 Vol 5 No 10 ste o o oeifrain contact For moreinformation, as theydo. putsasmuchinto the developmentoftheirproducts with asourcethat customersareassuredofpartnering andfluidcontroldevices, filtration BychoosingFiltertek toproducemedical manufacturing precision. or visit M nomto,visit information, For more sales consistsofproductslaunched lessthan5yearsago. Morethanhalfoftoday’s companies and50%genericproducts. business is50%customsynthesis forlargepharmaandbiotech Hovione’s forsuperiorcustomerservice. a worldwidereputation aredependableandeconomicalhasgiventhem timely solutionsthat itsabilitytoprovidecustomerswith time, Overthat experience. compliance tocGMPstandardsisbasedonmorethan40yearsof thecompany’s andregulatory expertiseinprocesschemistry entities, withtheindustrialproductionofcomplexchemical associated tosolving theproblems Dedicated intermediates. and regulated development andmanufactureofactivepharmaceuticalingredients specializesintheprocess that Hovione isafinechemicalscompany ANUFACTURER F www.filtertek.com ILTRATION Hovione . at & F www.hovione.com & APIS F neut,tcnclkolde and technicalknowledge, ingenuity, takesdesign medical applications developing componentsforcritical designingand performance, Withsomuchridingon discoveries. a keep pacewithnewmedical manufacture ofthesedeviceshasto behindthe realizes theknowledge Filtertek evolving, rapidly technology Withmedical the enduser. thesedevicesaffectsafetyfor how knows thecompany importantly, More medical product’s success. affecta and fluidcontrolultimately iltertek understands how filtration iltertek understandshow pplications andscientific pplications LUID Filtertek C ONTROL PECIALIST at . (800) 648-0791 Pharmaceuticals contact For moreinformation, unmetabolized. thecarrieritselfisexcreted that has beendemonstrated tobereversibleand Thispermeabilityhasbeenshown hemisphere. inaselected forincreasedconcentration of thebrainallowing pharmaceutical activescanbedeliveredintooneorbothhemispheres injections ofasimplemixtureLipobridgeandmodelcompoundsor intracarotic inseveral laboratories, Demonstrated side effects. reachingtheCNSbya factor upto100withouttoxic concentration someofthesemoleculescanincreasedrug that shows Data theBBB. pharmaceutical activesintotheCNSandtherebypermeate anduptakeof distribution, thedelivery, tofacilitate beenshown have Shortchainoligoglycerolipids brain-barrier (BBB)andintotheCNS. transportofdrugsacrosstheblood- Lipobridge™ compoundsfacilitate nomto,visit information, For more pharmaceutical andnutraceutical tabletingoperations. aproductwidelyusedas offers specialtycalciumcarbonate, that company HuberalsomaintainsacGMPgranulation taking medication. tabletsandmayboostcompliancein difficultyinswallowing who have forpeople RxCIPIENTS FM1000willprovideafast-dissolvealternative tabletswith oral dosage Itishopedthat consumer applications. the ofHuber’sVP andGeneralManager specialty ingredientsfor whois PhD, saidBob Wedinger, theway,” ispaving calcium carbonate and silicates, “Ourpedigreeinthesurfacescienceofsilica, action. tabletswillexperiencefastertherapeutic difficultyswallowing have particles who ofprimary sopatients speedthebreakdown silicate RxCIPIENTSFM1000calcium tablets, When usedinoraldosage www.rxcipients.com S PECIALITY BBB T Huber EngineeredMaterials at (800) 868-8208orvisit . RANSPORTER I NGREDIENTS Genzyme at DDT Issue10NOVEMBER0511/5/0511:14AMPage119 www.medpharm.co.uk MedPharm Ltd contact For moreinformation, prolonged periodscanalsobeachieved. over Modifiedand/orsustaineddelivery form. acceptable dosage ofacosmetically the surfaceofskinduring formation itonlyproducesapolymer/drugfilmon MedSpray™ isuniqueinthat non-combustiblesolvents. environmentallyfriendly, volatile, anditispropelledontotheskinusingablendofhighly polymers, biocompatible ismadefromamixtureofdrug-impregnated “patch” The itassemblesintoamicrofineocclusive film. during doseactuation, ismanufacturedasasolutionbut, technology drugdelivery patented this Unlikecurrentmarketedpatches, compounds. therapeutic of whichimprovesthelocalandtransdermaldelivery (MedSpray™), MedPharm hasdevelopedanovelself-assembling patch” “patchless C neCpTcnlge,Inc. InnerCap Technologies, contact For moreinformation, overthenext5years. patents blockbusterdrugswithexpiring existingpatented reformulate solutions totheindustry’s and highlypublicizedneedtorepackage pharmaceutical andbiopharmaceuticalindustrieswithbeneficial systemprovidesthe Thedelivery controlled-release profiles. active chemicalcompoundsindifferentphysicalphaseswith www.innercap.com M OMBINATION ICROFILM by e-mail at [email protected] by e-mailat . . (T C OPICAL APSULE ,a very effectivewaytodelivermultiple very Itisa biopharmaceutical products. enhance pharmaceuticaland systemwillbelicensedto delivery The and healthcareproviders. patients, pharmaceutical companies, solutions toproblemsaffecting offerstheindustry technology the two-piece hardshellcapsules, Utilizing biopharmaceutical products. benefits ofpharmaceuticaland used toenhancethevalueand Thesystemcanbe system. delivery compartmentalized capsular-based multi- pending multi-phased, offersanadvancedpatent- InnerCap t (813)837-0796orvisit D T ELIVERY ECHNOLOGY ) Neurotech atwww.neurotech.fr visit For moreinformation, areas. pipeline inmultipletherapeutic abroadproduct withthepotentialofgenerating and broadlypatented, strongly platform, technology ECTisanextremelypowerful protein, Becausecellscanbemodified geneticallytosecretealmostany eye. inthe being applied andisnow sclerosis, pain andamylotropiclateral inhumanclinical beendemonstrated chronic already trialstotreat Thefeasibility ofECTimplantabledeviceshas ifrequired. withdrawn theproductcanbe that devicewiththeaddedadvantage ready-to-use suppliedasa ECTisalsoaproduct-basedconcept, the membrane. producedbythecells todiffusethrough agents therapeutic allowing but from thelocalenvironmentandminimizingimmunerejection, them isolating withinasemi-permeablemembrane, encapsulated ECT Technology consistsofimplantabledevicescontainingcells www.kurvetech.com orvisit (425) 640-9249;[email protected] contact For moreinformation, devices. efficacygreater andefficiency thantraditionalnasaldelivery with andnose-to-brainmedicaltherapies systemic, delivers topical, ViaNaseIDintranasally technologies, intelligent nasaldrugdelivery BycombiningControlledParticle Dispersion™and compliance. counterfeit druguseandabusewhileimprovingpatient curb that andanelectronicdisplay–features technology, lock-out drugpedigreeconfirmation, incorporates device that The isthefirstnasaldrugdelivery ViaNase ID™electronicatomizer N I ASAL NTRAOCULAR . D ELIVERY . Kurve TechnologyKurve I MPLANT D EVICE at 119 Drug Delivery Technology November/December 2005 Vol 5 No 10 DDT Issue10NOVEMBER0511/8/0510:54AMPage120 120 Drug Delivery Technology November/December 2005 Vol 5 No 10 (512) 834-0449or visit aktapiain o oeifrain contact For moreinformation, market application. systemforyour todevelopahigh-quality transdermaldrugdelivery how ofknow- andlonghistory chemistry, formulation its pharmaceuticalexpertise, PharmaForm willcombine scale-up yourproductforcommercial manufacture. PharmaForm can selectioniscomplete, andfinalformulation assessment, clinical development, Afterformulation system developmentactivities. Analytical groupsworkclosely toplanandexecutethenumerousfacetsof TheFormulation andProductDevelopment transdermal systems. andmanufacturinggroupstodevelopoptimize materials, analytical, Delivery Technology development, withformulation teamisintegrated Thecompany’s Drug andproductapplications. drugcandidates to many canbeapplied systemthat polymericdelivery isaversatile platform delivery PharmaForm’s proprietary systemsareavailable. transmucosal delivery Licensing opportunitiesforPharmaForm’s transdermaland patented www.nof.co.jp/dds contact For moreinformation, andpolymer micelles. PEGylated-Liposomes, drugs, toproducePEGylated material the mostappropriate whichmakethem glycolswithvariousfunctional groups, polyalkylene TheSUNBRIGHTSeriesincludes other supplier’s PEGsintheworld. in whichdiolcontentsasimpuritiesareclaimed thanany tobelower butalsoproduceshigh-purity Methoxy-PEG-OH polymer distribution, manufactures variousmolecularweightsofMethoxy-PEGwithlow NOFnotonly pharmaceuticals andbiomedicalproducts. whichareidealforpreparing (SUNBRIGHTSeries), derivatives PEG hasdevelopedexcellent qualityactivated NOF Corporation P HARMACEUTICAL NOF Corporation PEG D www.pharmaform.com . at (914) 681-9790orvisit P ERIVATIVES RODUCT . PharmaForm D EVELOPMENT at euaoybde.Frmr nomto,contact For moreinformation, bodies. regulatory ISO 10993andUSPClass by VI standardstoexpediteproductapproval allsupportedbyFDAMaster Access Files andtestedto healthcare silicones, NuSiloffers200+ uniquearrayofpropertiestheyprovide. on thevast, ofchoicebased engineering professionalsperfectingsiliconesasmaterials and manufacturing, Nusil Technology compriseshundredsofresearch, Today, exclusively processdevelopment. andrelated onsiliconetechnology in1992tofocus ownership NuSilreturnedtoemployee support worldwide. engineering in-personapplication America andEuropeprovideson-site, andprocessingfacilitiesinNorth laboratories state-of-the-art operates NuSil ISO-9001certifiedsince1994, performance. cost-effective materials predictable, requiringprecise, and otherapplications electronics, healthcare, NuSil istheworld’s ofsiliconecompoundsforaerospace, leadingformulator visit Engineering visit For moreinformation, timeisunrivaled. every providecustom solutionsontimeandsuperiorresults customer needs, Itsabilitytoidentifyunique singular taskofmeetingcustomer needs. andexperienceonthe focusesallofitsenergy thecompany filling, & andpackaging discreteassembly, technologies forwebprocessing, www.nusil.com/dds M ANUFACTURING S at ILICONE www.remmeleautomation.com . T Utilizing leading-edgeapplied even themostcomplexapplications. manufacturing whilereducingriskin is equippedtostreamlinecritical Itsworld-class facility manufacturing. of-concept throughcommercial manufacturing solutionsfromproof- certified qualitysystemandprovides underanISO9001:2000- operates Remmele industry. drug delivery partner forleadingsuppliersinthe thought strategic is aninnovative, Thecompany worldwide. installation manufacturing equipmentfor has designedandbuiltcustom RemmeleEngineering Since 1949, ECHNOLOGY S NuSil OLUTIONS at Remmele . (805) 684-8780or DDT Issue10NOVEMBER0511/5/0511:15AMPage121 EnSoTrol Laboratories contact For moreinformation, variability. intra-patient andlessinter- and enhanced solubility, providing sustaineddelivery, challenges, excipients usedcombinetosolve severaldelivery Thesystem’s designandthe beenfiled. having other applications beenissued forthesystemwithnumerous have Sixpatents osmosis. by throughalaser-drilled hole(s), incoming fluidsandisdelivered, Thedrugissolubilizedby the fluidfoundingastrointestinaltract. enhancesthesurfaceareacontactofdrugwith wicking agent s anon- solubilizing agent, anon-swelling containsthedrug, core that consists ofasemipermeablemembranesurroundinghomogeneous It solubilize drugsandprovideextendeddrug-releaseproperties. time tomakeUltraSafePassive istheright Now including drugs. ofthenewerbiotechnology many andothermedicines, molecularweightheparins, low vaccines, arecommonlyusedfor prefilled pharmaceuticalglasssyringesthat olwd,theUltraSafe worldwide, Proven safeandeffectivewithmorethan100millionused www.safetysyringes.co contact information, company isactivelymarketingitsUltraSafe company The canmakeadifferenceonyourbottomline. that advantage itwillcontinuetoprovideacompellingcompetitive evolves, Andasourproductline enabling thefastestpossibletimetomarket. intoproductionlines, Plustheyareeasilyintegrated protection. incomplianceand andGERESwhileofferingtheultimate NIOSH, FDA, eln soi gn,adannseln ikn gn.The wickingagent. andanon-swelling welling osmoticagent, A ® is a patented osmotic drug delivery systemdesignedto osmoticdrugdelivery is apatented NTI Coating Flui GI at ds (301) 838-2681 or visit -N O O aeySrne,Inc. Safety Syringes, smotic Tablet System: EnSoTrol SMOTIC EEDLESTICK ® family of products combines the features of family ofproductscombinesthefeatures m. ® orpeerdcoc.For more your preferredchoice. Dr Sol C ORE ug in ution D ELIVERY www.shirelabs.com ® at Delivery Systemsfor Delivery D (760) 918-9908orvisit EVICES R E So Shire nhancers lubility . uulyare pnfnnilarneet.SCOLRPharma’s CDT uponfinancialarrangements. mutually agreed orother manufacturingcontracts, royalties, includethat licensingfees, SCOLR Pharmapartnerswithcompaniesundercontractualarrangements andconventionalproductionequipment. standardmaterials readily available controlled-release periodsforupto24hoursandcanbemanufacturedusing Theseelegantlysimpletechnologiescanbeused for nutraceutical products. and OTC, forcompanieswithpharmaceutical, develop formulations nomto,visit information, For more lifeandeasyenforcement). protection(fullpatent strong patent and higherpayload(whencomparedtoothertechnologies), excipients), costeffective(utilizesstandardtableting manufacturing equipment), conventional easytomanufacture(employs wide rangeofreleaseprofiles), including ofa highlyprogrammable(capable distinctadvantages, the many SCOLR Pharma applies its patented CDT itspatented SCOLR Pharmaapplies TECH W euniloeaino opc ahn rm.The ASEP-TECH onacompactmachineframe. sequential operation andhermeticsealingofliquidproductsinone asepticfilling, molding, l o oeifrain contact For moreinformation, Ml. systemsareofferedinsizesranging from3mLto1000 Isolation-insertion intheprocess. theneedforhuman interventions andeliminates integrity, ensuresproduct methods, flexibility incontainerdesignanddrug delivery offersadded package insertintotheblow/fill/seal other multi-entry or arubberstopper, ofasteriletipandcap, Theincorporation package. special trackmechanismforproductionofasterileBFScombination chamberand anisolation systemfeatures 624 BFSIsolation-Insertion www.weilerengineering.com [email protected]; orvisit 4900 ore-mailat eiler Engineering, Inc. is currently building the latest generation of generation iscurrentlybuildingthelatest ASEP- Inc. eiler Engineering, C ONTROLLED ® Blow/Fill/Seal Systems, incorporating thethree-stepprocessofblow incorporating Blow/Fill/Seal Systems, I SOLATION SCOLR Pharma -I D . NSERTION ELIVERY at W www.scolr.com ie niern,Inc. eiler Engineering, ® Controlled Delivery Controlled Delivery Technologies to P . LATFORM S YSTEM ,a t (847)697- ® ® has Model 121 Drug Delivery Technology November/December 2005 Vol 5 No 10 DDT Issue10 NOVEMBER05 11/8/05 4:05 PM Page 122 CCOMPANYOMPANY PPAGEAGE PHONEPHONE FAXFAX WEBWEB SITESITE 3M Drug Delivery Systems 3, 13 800-643-8086 www.3m.com/dds ALZA Corporation 2, 15 www.alza.com Aradigm 17 510-265-9000 510-265-0277 www.aradigm.com assa International 4 203-312-0682 201-312-0722 www.assainternational.com BASF Corp. 19 800-469-7541 www.pharma-solutions.basf.com Baxter Healthcare Corporation 9 800-422-9837 www.baxterbiopharmasolutions.com Baxter Pharmaceutical Solutions 21 800-353-0887 www.baxterbiopharmasolutions.com BD 23 800-225-3310 www.bdpharma.com BioScreen Testing Services 6 800-229-9057 www.bioscreen.com Cardinal Health 25, 124 866-720-3148 www.cardinal.com/pts Cirrus Pharmaceuticals 27 919-884-2064 www.cirruspharm.com Coating Place 29 608-854-9521 www.encap.com Controlled Release Society (CRS) 31 763-512-0909 www.controlledrelease.org Degussa 33 732-981-5383 www.pharma-polymers.com Dow Corning Healthcare Solutions 35 www.dowcorning.com/healthcare Dowpharma 37 866-332-5805 www.dowpharma.com DPT Labs 39 866-CALL-DPT www.dptlabs.com Drug Delivery Partnerships 41 888-670-8200 www.drugdeliverypartnerships.com Emerson Resources, Inc. 43 610-279-7450 www.thinkoutsidethebeaker.com Eurand 7, 45 937-898-9669 www.eurand.com ExcipientFest 123 787-746-5080 www.excipientfest.com Facet Technologies 47 800-526-2837 www.facettechnologies.com Filtertek 49 800-648-0791 www.filtertek.com Frost & Sullivan 11 www.frost.com Genzyme Pharmaceuticals 5 800-868-8208 www.genzymepharmaceuticals.com Glatt Pharmaceuticals 51 201-825-8700 www.glattpharmaceuticals.com Hovione 53 609-918-2600 www.hovione.com ol 5 No 10 ol 5 No V Huber Engineered Materials 55 678-247-7300 www.hubermaterials.com InnerCap Technologies 57 813-837-0796 www.innercap.com Kurve Technology 59 425-640-9249 www.kurvetech.com MedPharm 60 +44 16 0881 9267 www.medpharm.co.uk NOF Corporation 63 914-681-9790 www.nof.co.jp/dds NuSil Technology 65 805-684-8780 www.nusil.com November/December 2005 November/December PharmaForm 4 512-834-0449 www.pharmaform.com RDD 2006 61 www.rddonline.com Remmele Engineering 67 800-854-7742 www.remmeleautomation.com Safety Syringes, Inc. 69 760-918-9908 www.safetysyringes.com SCOLR Pharma, Inc. 71 425-373-0171 www.scolr.com Drug Delivery Technology Drug Delivery Technology Shire Labs 73 301-838-2681 www.shirelabs.com 122 Weiler Engineering 75 847-697-4900 www.weilerengineering.com DDT Issue10 NOVEMBER05 11/5/05 11:15 AM Page 123 DDT Issue10 NOVEMBER05 11/5/05 11:15 AM Page 124