2016 Technology Forums

These forums are open to all registered attendees on a complimentary basis, offering in-depth coverage of controlled release technologies and services, hosted by the following companies.

Interested in hosting a Technology Forum? Learn more here.

Sunday, July 17, 2016

Click on the title of the session to learn more.

Agilent Technologies, Inc.

9:00 – 10:00 a.m.  |  Room 610

Tools of the Trade: Agilent 280-DS and Enhanced Mechanical
Qualification of the Dissolution Apparatus

Presenter: Bryan Crist
Presentation Area: Quality & Analytical

Since 2010, enhanced mechanical qualification of the dissolution apparatus has been established as an allowable alternative to the longstanding USP Performance Verification Test. In either case, accurately measuring and documenting the physical parameters is difficult with traditional measuring tools. The 280-DS was designed for this purpose and will be presented.
Company website: www.agilent.com


Evonik Corporation

9:00 – 10:00 a.m.  |  Room 613

Debunking the Myths of Complex PLG Formulations

Presenter: Dr. Thomas R. Tice
Presentation Area: Formulation

Scientists for 40 years plus have used poly(lactide-co-glycolide) in parenteral formulations, resulting in countless publications and many commercial complex PLG-based parenteral products. With this vast activity, myths about PLG formulation have emerged, e.g., drug burst and low pH microenvironments. This presentation will address these myths and demystify their deductions.
Company website: www.evonik.com/pharma


Fuji Chemical Industries Co., Ltd.

9:00 – 10:00 a.m.  |  Room 605

The Use of Inorganic Excipients for the Development of Oral
Solid Dosage Forms by Means of Extrusion Processes

Presenter: Prof. Dennis Douroumis
Presentation Areas: Formulation, Processing

Inorganic excipients have attracted increased interest for the development of oral solid dosage forms. Prof. Douroumis will discuss formulation strategies of inorganic excipients for increased dissolution rates of water-insoluble drugs processed either by extrusion granulation or hot melt extrusion. Fujicalin® and Neusilin® offer great formulation advantages.
Company website: www.fujichemical.co.jp/english


Wyatt Technology Corporation

9:00 – 10:00 a.m.  |  Room 614

The Light Scattering Toolkit for Characterization and
Formulation of Drug Delivery Nanoparticles

Presenter: Daniel Some
Presentation Area: Formulation

Light scattering addresses many key analytical challenges in drug nanoparticle R&D, including accurate size distributions, conformation, payload, and formulation. We review light scattering fundamentals, then present examples illustrating how Wyatt’s unique light scattering instrumentation facilitates rapid and effective development of controlled release vehicles including liposomes, VLPs, polymer-encapsulated nanoparticles, and nanogels.
Company website: www.wyatt.com



10:30 – 11:30 a.m.  |  Room 614

Approaches to Taste Masking of Particles for Oral
Application and Examination of a Novel Biorelevant
Dissolution Testing Methodology

Presenter: Gus LaBella
Presentation Area: Formulation

Numerous pharmaceutical products contain actives that are bitter in taste. Patient acceptability of these products depends on development of formulations with palatable taste and mouthfeel profiles. This presentation covers technologies for taste-masking of particles for chewable, ODT, and other oral applications, as well as a novel biorelevant testing methodology.
Company website: www.colorcon.com


Evonik Corporation

10:30 – 11:30 a.m.  |  Room 613

EUDRATEC® – Innovative Formulation Technologies
for Advanced Drug Delivery

Presenter: Dr. Firouz Asgarzadeh
Presentation Area: Formulation

Modified release (MR) systems have revolutionized the delivery of APIs. EUDRATEC® technologies provide robust modified release coatings platforms for oral delivery of APIs in a myriad of applications including resistance to alcohol-induced dose dumping, precise time release, zero order release, pulse release, BCS III/IV bioavailability enhancement, and oral peptide delivery.
Company website: www.evonik.com/pharma



10:30 – 11:30 a.m.  |  Room 605

A Novel Method for the Elution of Sirolimus (Rapamycin)
in a Drug-Eluting Device

Presenter: Mel Merciadez
Presentation Area: Quality & Analytical

A sensitive and robust method for the determination of the elution of an active drug substance, sirolimus, from drug-eluting coronary stents was developed using a USP Apparatus 4 elution system. The in vitro elution profile obtained from USP Apparatus 4 over 24 h mirrors the 30 day in vivo porcine profile, providing in vitro–in vivo correlation.
Company website: www.sotax.com


Suven Life Sciences Limited

10:30 – 11:30 a.m.  |  Room 610

Preclinical Pharmacokinetic Services for Formulation Development of 505(b)(2) and ANDA Products

Presenter: Dr. Gopinadh Bhyrapuneni
Presentation Area: Quality & Analytical

In formulation development of 505(b)(2) and ANDA products, pharma companies often outsource animal testing to a preclinical contract research organization (CRO) for establishing bioequivalence or superiority to the reference listed drug (RLD). This presentation will address strategies for preclinical pharmacokinetic studies (mice to monkey) for the development of oral solid, injectable, dermatological, transdermal, nasal, and ophthalmic dosage forms.
Company website: www.suven.com


Cambridge Design Partnership

12:00 – 1:00 p.m.  |  Room 605

Smarter Combination Products: Development Strategies to Reduce Risk and Shorten Time to Launch

Presenter: Uri Baruch
Presentation Area: Formulation

In response to late-phase trial failures, pharma companies are compressing drug delivery device development timelines, manifesting in the market as suboptimal patient engagement, adherence, adverse events, and even recalls. Our discussion will cover strategies to reduce cost and risk when developing drug pipelines involving delivery devices with minimal early-phase investment.
Company website: www.cambridge-design.co.uk


EmulTech b.v.

12:00 – 1:00 p.m.  |  Room 613

Development and Manufacturing of Sustained Release
Microspheres Using Microfluidic Encapsulation

Presenter: Robin de Bruijn
Presentation Area: Formulation, Processing

Development and manufacturing of sustained release microspheres using conventional techniques is very costly and time consuming. EmulTech will present how thoroughly new microspheres are researched at academic partners, how fast development is done with the INFINITY Lab, and how scalable and flexible the GMP manufacturing pilot has been designed.
Company website: www.emultech.nl


Grünenthal GmbH

12:00 – 1:00 p.m.  |  Room 614

INTAC – A Versatile Hot-Melt Extrusion Platform to Create Outstanding Product Performance

Presenter: Dr. Eric Galia
Presentation Area: Formulation

The presentation will provide insight into the topic of prescription medication abuse and a technology that offers a state of the art formulation option to raise the hurdle against this abuse. Formulation, up-scaling, manufacturing, and abuse deterrence testing concepts will be addressed.
Company website: www.grunenthal.com


Nanotechnology Characterization Laboratory

12:00 – 1:00 p.m.  |  Room 610

Nanoparticle Characterization and Reformulation Opportunities

Presenter: Rachael Crist
Presentation Area: Formulation, Quality & Analytical

The NCL was established in 2004 to provide preclinical characterization services for nanomedicines, in an effort to bridge the gap to FDA approval to begin clinical trials. The Technology Forum will highlight expertise in nanoparticle characterization, novel methods developed, and nanotech reformulation capabilities and will discuss collaborative opportunities for nanotech developers.
Company website: http://ncl.cancer.gov


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