Evonik Corp, Agilent, Suven Life Sciences, Recro Gainesville
Date/Time: Sunday, July 22, 2018 - 11:15 AM to 12:15 PM
Open to all registered attendees on a complimentary basis, these forums offer in-depth coverage of technologies and services hosted by the presenting companies.
EUDRATEC® PEP - An Innovative Smart Oral Delivery Technology for Proteins and Peptides
Presented By: Firouz Asgarzadeh, Ph.D., Director Formulation and Application Services, Products and Formulations, Evonik Health Care
Most proteins and peptides are BCS class III. To overcome their often-poor bioavailability, Evonik recently introduced a new modular platform technology for improving the bioavailability of peptides. The EUDRATEC® PEP technology allows treatment with an oral solid form, replacing unpleasant injections and therefore tremendously enhancing patient compliance.
The concept of small volume dissolution arises from the need to analytically determine the rate of dissolution from low dose, generally high potency drugs. Novel drug delivery design has demanded more from typical official dissolution and drug release apparatus. To maintain quantitative levels of analyte during the dissolution test, a reduction in vessel volume accompanied by an alteration of compendial dissolution apparatus may be required. The need to develop small volume dissolution apparatus stems from the need to provide accurate, reliable data for decision making during drug development stages and assurance of quality when the formulation reached full-scale production and to maintain future assurance of product quality and stability. This forum will explore the use of USP apparatus and modifications to the standard USP apparatus designed to yield small volume dissolution methods with reliable results.
Strategies for the Formation and Coating of Multiparticulates for use in modified release products using the Conical Rotor Processor
Long processing times are common in the manufacture of high potency, modified release beads. Using the Granurex©, a conical rotary system, spherical beads can be manufactured and coated in a fraction of the time required when compared to traditional processes.
Richard Sidwell, PhD, Sr. Director Product Development - Recro Gainesville
Ryan Crawford, Process Development Scientist – Freund Vector.
In development of differentiated drug products, Pharmaceutical companies often outsource animal testing to preclinical CROs for establishing bioequivalence / superiority to the RLD. This presentation will address the strategies involving canine as a best animal model for development of differentiated drug product dosage forms.