Releasing Technology Workshops

Sunday, July 13

This series of complimentary 1- and 2-hour workshops are scheduled throughout the day and open to all registered attendees. These informative sessions focus on in-depth facets of controlled release technology.

RTW A

10:00-11:00 – Sutton South
Dynamic Hyperspectral Imaging Solutions for Controlled-Release Systems

Hosted by: ChemImage Corporation
Presented by: David Tuschel, Director of Product and Applications Development and Oksana Olkhovyk, Senior Scientist

Wide-field Hyperspectral Imaging Platform (W.H.I.P.) technology will be introduced and multiplex advantage of real time spectral imaging will be discussed. W.H.I.P. will be compared to conventional spectroscopic methods suitable for research, development and troubleshooting in controlled-release systems. ChemImage’s full field-of-view spectroscopic imaging solutions will be described for systems possessing moving objects or time-dependent chemical or physical structure changes. High light flux phenomena (e.g. reflection absorption, luminescence), as well as Raman scattering, will be evaluated with respect to those applications, for which high quality, high-resolution fast chemical imaging are adequate and uniquely suited. Assessment of dissolution/crystallization rate, mass transport, fluorescence/colorimetry-based pharmacokinetics will be discussed using W.H.I.P. technology. Advantages of dynamic hyperspectral imaging will be communicated with respect to monitoring in-situ drug-excipient interaction under different stress conditions.

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RTW B

10:30-12:30 – Sutton North
Controlled Release Technologies for the Delivery of Protein Therapeutics

Hosted by: OctoPlus NV
Presented by: Michiel Lodder, Director Business Development

The workshop will start with an overview of the opportunities and challenges of controlled release drug delivery technologies for protein delivery. Then the formulation aspects and analytics of encapsulated proteins will be discussed, followed by an overview of some of our controlled release technologies. Finally the application of biodegradable polymers for the development of single-shot vaccine delivery will be discussed.

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RTW C

11:00-12:00 – Sutton Center
Spray Drying in Laboratory Scale

Hosted by: Büchi Labortechnik AG
Presented by: Cordin Arpagaus, Product Manager Spray Drying

The workshop will focus on the current state of the laboratory scale spray drying in pharmaceutical research and development. Buchi, the world leader of laboratory scale spray dryers, presents complete lab-scale solutions to build up a system tailored to your requirements. You will learn about how to make feasibility studies, parameter optimization and production of small powder batches, as well as how to proceed with a scale-up from laboratory to industrial scale. Working closely with our customers enables us to provide excellent solutions to applicative questions, like microspheres preparation for controlled drug delivery systems. Whether the requirement is the gentle drying of natural products, the isolation of highly effective pharmaceutical agents or the micro-encapsulation of flavours - the outstanding features of the Buchi Mini Spray Dryer greatly extends the number of applications. Learn how to find optimal process parameters for spray drying of biodegradable polymers for drug delivery systems!

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RTW D

12:30-13:30 – Sutton Center
Oral Extended Release Dosage Forms with Carbopol® Polymers

Hosted by: Lubrizol Advanced Materials,Inc.
Presented by: Elena Draganoiu, Senior R&D Pharmacist

This workshop will present key concepts and benefits of using Carbopol® polymers for extended release solid dosage forms. These crosslinked polyacrylic acids are widely known as rheology modifiers for topical applications. However, they have also proven to be efficient hydrophilic matrix forming excipients for tablets. The following information will be reviewed to assist pharmaceutical scientists in formulating extended release tablets with Carbopol® polymers:
1) Available product grades and characteristics
2) Mechanism of drug release compared to linear water soluble polymers
3) Effect of formulation and processing variables on the drug release profile
4) Mathematical model to demonstrate how Carbopol® polymers affect drug release in a specific formulation
5) Comparison/synergies of various Carbopol® polymer grades and other extended release excipients

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RTW E

13:00-14:00 – Sutton North
Lecithins and Phospholipids for Advanced Drug Delivery

Hosted by: Lipoid GmbH
Presented by: Bruce Baretz, Director of Business Development

Lecithins and Phospholipids are widely used raw materials for different advanced drug delivery systems. They are body-own substances, biodegradable, non-toxic and ecologically sound. The first part of the workshop will give an introduction into the different lecithins and phospholipids for pharmaceutical application. It will explain the purification of raw lecithin and characterize different pharmaceutical lecithins and phospholipids, like natural products from egg and soybean, as well as synthetic and functionalized phospholipids. The second part will cover different phospholipid-based formulations, like lipid emulsions, mixed micelles and liposomes and give an overview about approved drug products.

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RTW F

13:00-15:00 – Sutton South
Drug Tampering and Abuse Deterrence: What You Need to Know and What Drug Abuser's Don't Want You To Know

Hosted by: DecisionLine Clinical Research Corporation and SOLIQS
Presented by: Beatrice Setnik, Director of Scientific Business Development

The abuse of prescription drugs has received increasing media and regulatory attention in recent years. In response to this growing problem, novel abuse deterrent formulations are being developed which are designed to withstand certain forms of intentional tampering (e.g. crushing, dissolving etc.). This workshop will explore the various in vitro and clinical methodologies that assess the tamperability, effectiveness and robustness of such formulations; and therefore, their potential utility in the real world. Attendees will gain an in-depth view of the techniques used by drug abusers to defeat controlled release compounds, and how that information may be used to design more robust abuse deterrent formulations. Experimental and clinical trial methodology will be presented from both a regulatory and marketing perspective.

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RTW G

14:00-15:00 – Sutton Center
Cerense....Like Counting Cars on the Brooklyn Bridge: The Delivery to, and Assesment of, Potential Therapeutics into the CNS

Hosted by: Genzyme Pharmaceuticals
Presented by: Peter Hoffmann, Vice President-Technology

Due to a natural defense of the Blood Brain Barrier (BBB), sufficient quantities of potentially effective therapeutic agents for the treatment of central nervous system (CNS) based pathologies such as Alzheimer's, Multiple Sclerosis, Stroke and Brain cancer have been unsuccessfully delivered to the site of their required action. Working closely with academic collaborators, Genzyme Pharmaceuticals and Pharmidex have designed CerenseSM to deliver and assess the transfer of a variety of molecules across the BBB.