· Advantages
of continuous extrusion as compared to batch processes
· Staging of unit operations in an extruder
to continuously manufacture a drug delivery system
· Upstream considerations for feeding, material handling and containment
· Scale-up of the extrusion process from laboratory to production
· Downstream systems for pelletizing,
spheronization, films and transdermal
products
· Material considerations, applications and advances
· Cleaning and maintenance of extrusion equipment in a GMP environment
· Equipment and process validation
· Control issues pertaining to CFR 21 part 11 compliance
· New technologies, i.e. foaming, co-extrusion and continuous spheronization |
Classroom
sessions are held at the Holiday Inn Select in Clinton, NJ and equipment
demonstrations at the Leistritz facility in Somerville, NJ
Day 1 – June
3, 2009
8:45am
• Extrusion Theory and Developments for Pharmaceutical Applications – Charlie
Martin, Leistritz (USA)
• Twin Screw Extrusion Techniques and Practices: Screw Design,
Processing and Scale-up – Bill Thiele, Leistritz (USA)
• Gravimetric Continuous Feeding Technologies for Pharmaceuticals
Including Low Rate and Contained Powder Feeding - Sharon Nowak,
K-Tron
America
• Bioavailibility Enhancement of Poorly Soluble Drugs by Melt Extrusion
with Eudragit Polymers – Shawn Kucera, Evonik-Degussa
Lunch
• Development of Oral Dosage Forms via Hot Melt Extrusion– Feng
Zhang, PharmaForm
• Downstream Extrusion Equipment and Processing for Pharmaceutical
Applications – Bob Bessemer, Conair
• Twin Screw Extrusion Process Design - Josh Shockey, Green Ridge
Consulting
Bus to Leistritz facility for extrusion demonstrations (3:15pm)
Reception & dinner
for all participants (6:00pm)
Day 2 – June
4, 2009
8:30am
• Melt Extrusion: Process Case Studies – Tony
Listro, Foster Corp.
• Dispersive and Distributive Mixing - Principles and Extrusion
Practice – Costas G. Gogos, Polymer Processing Institute, NJIT
• Solid Dispersion Particle Design to Enable Oral Drug Delivery
- Craig McKelvey, Merck & Co.
• Screw Design in Wet Granulation Extrusion - Michael Thompson,
McMaster University
• Hot Melt Extrusion (HME) of Ethylcellulose, Hypromellose, and
Polyethylene Oxide – Mark Hall, Dow Chemical
Lunch
• Effect
of Twin Screw Extrusion Process Parameters on Product Characteristics
- Hibre Terefe, ExxPharma
• Fourier Transfer Near Infrared Analysis Techniques for Extruded
Materials - Joe Smith, ABB Inc.
• A European Update/Perspective on Pharma Extrusion – Richard
Steiner, Leistritz (Germany)
• Die and Downstream Extrusion Techniques for Pelletizing, Shapes
and Wet Granulation – Augie Machado, Leistritz (USA)
• Control Systems for Pharma Extrusion – Pete Palmer, Wolock & Lott
• Cleaning and Validation of Extrusion Equipment – Bert Elliott,
Leistritz (USA)
Interactive screw design and assembly session
Adjournment (5:00pm)
Extrusion system demonstrations in the new Leistritz pharmaceutical
extrusion laboratory will reinforce the classroom theory and will include:
• Nano-16
twin screw extrusion system processing 20 gram batch samples
• Film/lamination extrusion system for transdermal or dissolvable
film dosage applications
• Micro-pelletization extrusion system producing ½ mm pellets
for direct capsule filling
• Wet-granulation extrusion technology for high potency/strength
tablets
• Extrusion system for heat/shear sensitive API’s via hot
melt extrusion |
COST TO REGISTER
- Early
registration, if received by April 18, 2009 $820 ...
if received after this date $920
- Prices include handout
materials, the textbook Pharmaceutical Extrusion Technology, and meals/reception.
-
Registrations are
limited and available on a first come, first served basis.
 |
All attendees
will receive the textbook entitled Pharmaceutical
Extrusion Technology,
the only resource currently available to bring together the technical
information to develop pharmaceutical dosage forms that meet current
quality and regulatory requirements - this is a $200 value! |
HOTEL/TRAVEL INFORMATION
The Holiday Inn
Select
111 Route 173, Clinton, NJ 08809
Ph: 908/735-5111 or visit http://www.hisclinton.com/
When contacting the
hotel, state you are with the PHARMACEUTICAL EXTRUSION SEMINAR (Group
Code 'ACE')
to receive a $129 rate.
Rooms in the area
are at a premium, so we suggest that you make a reservation as soon as
possible.
The nearest airport
is Newark Int'l, approx. 30 miles away.
Directions and travel information
will follow with your confirmation package.
For
additional information e-mail sscovens@alec-usa.com |
